US20130325118A1 - Post-operative adjustment tool, minimally invasive attachment apparatus, and adjustable tricuspid ring - Google Patents

Abstract

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 12/875,464 filed Sep. 3, 2010, which is a continuation of U.S. patent application Ser. No. 12/692,415, filed Jan. 22, 2010, which claims priority to U.S. Provisional Patent Application No. 61/146,560, filed Jan. 22, 2009; and U.S. Provisional Patent Application No. 61/157,649, filed Mar. 5, 2009, all of which are hereby incorporated by reference.
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
• An object of the present invention is to provide an implantable device for controlling at least one of shape and size of an anatomical structure or lumen.
• These and other objects of the present invention are achieved in an implantable device for controlling at least on of shape and size of an anatomical structure or lumen. An implantable device is provided that has an adjustable member configured to adjust the dimensions of the implantable device. In certain embodiments, a torqueable adjustment tool is configured to provide adjustment of the dimensions of the implantable device for a preferred dimension. In other embodiments adjustments for a preferred dimension may be accomplished remotely through activation of internal adjustment mechanisms.
• In another embodiment of the present invention, an implantable device is provided for controlling at least one of shape and size of an anatomical structure or lumen that includes an implantable device has an adjustable member configured to adjust the dimensions of the implantable device, a particularly a preferred dimension. An adjustment tool is configured to provide adjustment of the dimensions of the implantable device, the adjustment tool providing translated motion through rotation.
• In another embodiment of the present invention, an implantable device is provided for controlling at least one of shape and size of an anatomical structure or lumen. An implantable device has an adjustable member configured to adjust the dimensions of the implantable device and includes first and second bands. An adjustment tool is configured to provide adjustment of the dimensions of the implantable device for a preferred dimension.
• In still another embodiment of the present invention, an implantable device is provided for controlling at least one of shape and size of an anatomical structure or lumen. An implantable device has an adjustable member configured to adjust the dimensions of the implantable device. The implantable device has an anterior portion, a posterior portion and dual threads that provide preferential adjustment of one side or the other of the implantable device. An adjustment tool is configured to provide adjustment of the dimensions of the implantable device.
• In yet another embodiment of the present invention, an implantable device controls at least one of shape and size 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 provides reciprocating action to provide for the adjustment.
• In another embodiment of the present invention, an implantable device controls at least one of shape and size 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 provides both course adjustment and fine adjustment.
• Other features and advantages of the present invention will become apparent upon reading the following specification, when taken in conjunction with the drawings and the appended claims.
BRIEF DESCRIPTION OF FIGURES
• FIG. 1 is a front view of a first embodiment of an implant for reducing the circumference of an anatomic orifice.
• FIG. 2 is a front view of the implant ofFIG. 1 secured to the annulus of a mitral valve, with the implant in an expanded position.
• FIG. 3 is a front view of the implant ofFIG. 1 secured to the annulus of a mitral valve, with the implant in a contracted position to reduce the size of the heart valve opening.
• FIG. 4 is a perspective view of a second embodiment of an implant for reducing the circumference of an anatomic orifice, inserted through an open operative cardiac incision and secured around the mitral valve.
• FIG. 5 is a perspective view of the implant ofFIG. 4, showing the cardiac incision closed, an adjustment tool extending through the closed incision, and adjustment of the implant possible after the patient has been taken “off pump.”
• FIG. 6 is a perspective view of a first embodiment of an adjustment means for adjusting the circumference of an implant for reducing the circumference of an anatomic orifice.
• FIG. 7 is a right side view of the adjustment means ofFIG. 6.
• FIG. 8 is a left side view of the adjustment means ofFIG. 6.
• FIG. 9 is a right side view of a second embodiment of an adjustment means for adjusting the circumference of an implant for reducing the circumference of an anatomic orifice.
• FIG. 10 is a perspective view of a first alternate embodiment of an attachment means for the implant ofFIG. 1.
• FIG. 11 is a perspective view of a second alternate embodiment of an attachment means for the implant of FIG.
• FIG. 12 is a perspective view of a third embodiment of an implant for reducing the circumference of an anatomic orifice.
• FIG. 13 is a perspective view of one end of the implant ofFIG. 12 showing an optional keyed relationship between three coaxial cannulae to prevent relative rotation between the three components.
• FIG. 14 is a perspective view of the implant ofFIG. 12 showing the outer cannula extended to cover the implant.
• FIG. 15 is a perspective view of the implant ofFIG. 12 showing the outer cannula retracted to expose the implant.
• FIG. 16 is a perspective view of the implant ofFIG. 12 showing the middle cannula extended to unfold the implant.
• FIGS. 17 and 18 are schematic views illustrating how extension of the middle cannula causes the implant to unfold, whereFIG. 17 shows the implant in the folded position, andFIG. 18 shows the implant in the unfolded position.
• FIG. 19 is a perspective view of the lower end of a touchdown sensor of the implant ofFIG. 12, showing the sensor in an uncompressed condition.
• FIG. 20 is a perspective view of the lower end of the touchdown sensor ofFIG. 19, showing the sensor in a compressed condition.
• FIG. 21 is a perspective end view of a fourth embodiment of an implant for reducing the circumference of an anatomic orifice.
• FIG. 22 is a side view of the implant ofFIG. 21 with the implant opened up to show its full length.
• FIG. 23 is a side view of the adjustment mechanism of the implant ofFIG. 21.
• FIG. 24 is a close-up view of two of the retention barbs of the implant ofFIG. 21.
• FIG. 25 is a front view of a fifth embodiment of an implant for reducing the circumference of an anatomic orifice, with the implant shown in its expanded configuration.
• FIG. 26 is a front view of the implant ofFIG. 25, with the implant shown in its contracted configuration.
• FIG. 27 is an enlarged view of the area indicated by thecircle27 inFIG. 25, with the outer body removed to show interior detail.
• FIG. 28 is a schematic view showing the implant ofFIG. 12 anatomically positioned at the mitral annulus in a heart with the implant in a fully expanded state.
• FIG. 29 is a schematic view showing the implant ofFIG. 12 anatomically positioned at the gastroesophageal opening with the implant in a fully expanded state.
• FIG. 30 is a schematic view showing the implant ofFIG. 29 implanted to reduce the circumference of the gastroesophageal opening.
• FIG. 31 is a schematic view of an embodiment of an implantable device of the present invention.
• FIG. 32A is a schematic view of another embodiment of an implantable device of the present invention.
• FIG. 32B is a schematic view of a threaded member in an embodiment of an implantable device of the present invention.
• FIG. 33 is a schematic view of an embodiment of an implantable device of the present invention with an outer tubing and an inner tubing in a relative first position.
• FIG. 34 is a schematic view of an embodiment of an implantable device of the present invention with an outer tubing and an inner tubing in a relative second position.
• FIG. 35 is a schematic view of an embodiment of an implantable device of the present invention with an outer tubing and an inner tubing in a relative third position.
• FIG. 36 is a schematic view of an embodiment of an adjustable member of the present invention, with the distal tip of the adjustment tool coupled to the adjustment member.
• FIG. 37 is a schematic view of an embodiment of an adjustment member of the present invention having an integrated pinion gear.
• FIG. 38 is a schematic view of an embodiment of a flexible tube cover for an implant device.
• FIG. 39 is a cross-section view of an assembled embodiment of an adjustable implant device.
• FIG. 40 is a schematic view of an embodiment of a seal jacket for an adjustable member.
• FIG. 41 is a schematic view of an embodiment of an adjustment band in the implantable member of the present invention.
• FIG. 42 is a disassembled schematic view of part of the adjustment band and adjustment member ofFIG. 41.
• FIG. 43 is an assembled view of the adjustment band and adjustment member ofFIG. 42.
• FIG. 44 is a schematic view of an embodiment of the gearbox for the adjustment band ofFIG. 41.
• FIG. 45 is a schematic view of an embodiment of the implantable device of the present invention with a sliding band that can be opened and closed to effect a preferential shape change.
• FIG. 46 is a schematic view of an embodiment of the implantable device of the present invention with two adjustable screws used to achieve different pulling rates.
• FIG. 47 is a schematic view of an embodiment of the implantable device of the present invention with reciprocating motion and a clover gear.
• FIG. 48 is a schematic view of an embodiment of the implantable device system of the present invention with an adjustment tool having high column strength and stiffness.
• FIG. 49 is a schematic view of an embodiment of the implantable device of the present invention shown in vivo with an adjustment tool having reduced column stiffness.
• FIG. 50 is a cut-away view of an embodiment of the proximal portion of an adjustment tool.
• FIG. 51 is a schematic view of an embodiment of the implantable device of the present invention with an articulated shape.
• FIGS. 52-59 show one embodiment of an adjustment tool that can be reinserted into the body and reconnected to the adjustable member, so that additional adjustments to the implantable device can be made post-operatively.
• FIGS. 60-62 show a second embodiment of an adjustment tool that can be reinserted into the body and reconnected to the adjustable member so that additional adjustments to the implantable device can be made post-operatively.
• FIGS. 63-72 show a reversible attachment apparatus that can be used to attach an adjustable implant to an anatomic orifice or lumen using a minimally invasive procedure.
• FIGS. 73-84 show embodiments of an implantable device that can be used to adjust the shape and/or size of a tricuspid valve.
DETAILED DESCRIPTION OF THE INVENTION
• Referring now to the drawings, in which like numerals indicate like elements throughout the several views, anexemplary implant10 comprising animplant body15 is 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.
• Theimplant10 ofFIG. 1 comprises acircular implant body15 which is provided with adjustable corrugated sections alternating with intervening grommet-like attachment means25 having narrowed intermediate neck portions. As can be seen inFIGS. 2 and 3, theimplant body15 may be secured to the annulus of aheart valve30 by a fixation means such as asuture35 secured over or through the attachment means25. Thecorrugated sections20 fold and unfold as the circumference of theimplant body15 shortens or lengthens. Adjustment of theimplant10 in situ may decrease the overall size of theheart valve30, increasing the coaptation of thevalve leaflets40, and changing the configuration from that shown inFIG. 2 to that shown inFIG. 3.
• An additionalexemplary embodiment100 of the present invention is shown inFIGS. 4 and 5, with an open operativecardiac incision105 in aheart110 shown inFIG. 4, and closure of thecardiac incision105 inFIG. 5. As shown inFIG. 4, the exemplaryadjustable implant100 according to the present invention comprises animplant body115 with attachment means120 that allows fixation to the annulus of amitral valve125. The exemplaryadjustable implant100 is further provided with an adjustment means130 that is controlled by an attached or coupledadjustment tool135. After closure of themyocardial incision105 inFIG. 5, theadjustment tool135 remains attached or coupled to the adjustment means130, so that the size and shape of theimplant100 may further be affected after physiologic flow through theheart110 is resumed, but with the chest incision still open. Once the desired shape and function are achieved, theadjustment tool135 may be disengaged from the adjustment means130 and withdrawn from themyocardial incision105. In various embodiments according to the present invention, the adjustment means130 may be configured and placed to allow retention by or re-introduction of theadjustment tool135 for adjustment following closure of the chest incision.
• To use theimplant100 ofFIGS. 4 and 5, the physician makes the openoperative incision105 in theheart110, as shown inFIG. 4, in the conventional manner. Theimplant100, mounted at the forward end ofadjustment tool135, is then advanced through theincision105 and sutured to the annulus of themitral valve125. Theadjustment tool135 is then manipulated, e.g., rotated, depending upon the design of the adjustment means130, to cause the adjustment means to reduce the size of theimplant body115, and hence the underlyingmitral valve125 to which it is sutured, to an approximate size. Themyocardial incision105 can 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 theheart110 has resumed, but before the chest incision has been closed, further adjustments to the size of themitral valve125 can be made by manipulating theadjustment tool135.
• FIGS. 6-8 show an exemplary adjustment means200 for adjusting the circumference of an annular implant such as theimplant100 previously described. The adjustment means200 comprises a rack and pinion system in which afirst cam205 with gearedteeth210 and anengagement coupler215 turns on afirst axel220. In this example, thefirst cam205 engages a gearedrack225 on one or more surfaces of afirst band230. Thefirst band230 passes between thefirst cam205 and asecond cam235 that turns on asecond axel240 that is joined to asecond band245. As shown inFIG. 8, the first andsecond axels220,240 are maintained in suitable spaced-apart relation by means of abracket250 formed at the end of thesecond band245.
• The adjustment means200 is preferably set within a hollowannular implant100 of the type previously described, though it is possible to use the adjustment means in a stand-alone configuration wherein the first andsecond bands230,245 are 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 theengagement coupler215 on thefirst cam205 and rotates the first cam in a counterclockwise direction as shown inFIG. 7, as indicated by thearrow255. Rotation of thefirst cam205 causes theteeth210 to drive therack225 to move thefirst band230 toward the right, as indicated by thearrow260 inFIG. 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 theengagement coupler215 will loosen the implant.
• In various embodiments according to the present invention, the first andsecond bands230,245 may be separate structures, or they may be opposing ends of the same continuous structure. In such an embodiment, when motion is imparted to theengagement coupler215, thefirst cam205 is rotated, causing the gearedteeth210 to engage the gearedrack225, and causing thefirst band230 to move with respect to thesecond band245 to adjust the circumference of an implant.
• FIG. 9 shows a somewhat different configuration of an exemplary engagement means300 according to the present invention, in which there is no engagement coupler, and abracket350 is provided on both sides of the cams to maintain thefirst cam315 and thesecond cam320 in close approximation. In one proposed embodiment, the bracket is designed with close tolerances so as to press thefirst band330 closely against thesecond band345, thereby to hold the bands in fixed relative position by friction. In another proposed embodiment, thebrackets350 are fabricated from an elastic material such that thecams315,320 can be spread apart to insert thefirst band330 between the cams, whereupon the cams are pulled back together with sufficient force to hold thebands330,345 in fixed relative position by friction. In still another proposed embodiment involving an elastic mounting arrangement between thecams315,320, the lower edge of thefirst band330 and the upper edge of thesecond band345 have mating frictional or mechanical surfaces, whereby thecams315,320 can be spread apart to permit relative movement between the bands or released to clamp the bands together in fixed relation.
• FIG. 10 shows an exemplary attachment means400 for an implant according to the present invention. The attachment means400 could be used, for example, in place of the attachment means25 of theimplant10. The attachment means400 takes the form of agrommet410 comprising awall415 defining alumen420 and anattachment surface425. Such an attachment means would be used with the implant body extending through thelumen420 and with fixation devices such as sutures or wires either tied over or affixed through theattachment surface425.
• FIG. 11 shows another alternate embodiment of an attachment means500 for an implant according to the present invention. The attachment means500 could also be used, for example, in place of the attachment means25 of theimplant10.FIG. 11 shows an attachment means500 in the form of a hollow tube ortube segment510 comprising awall515 defining alumen520, anouter surface525, and anattachment tab530. Such an attachment means would be used with the implant body extending through thelumen520 and with fixation devices such as sutures or wires either tied or otherwise affixed over or through theattachment tab530. Such fixation devices might be placed throughholes535 provided in theattachment tab530. Alternately asolid attachment tab530 might 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. 12-18 show another embodiment of a percutaneous annuloplasty device according to the present invention, in which an implant/delivery system array600 includes a housing sheath605 (not seen inFIG. 12), anactuating catheter610 coaxially slidably mounted within thehousing sheath605, and acore catheter615 coaxially slidably mounted within theactuating catheter610. The core catheter has a central lumen616 (FIG. 13). Theactuating catheter610 andcore catheter615 may be round tubular structures, or as shown inFIG. 13, either or both of the actuating and core catheters may be provided with one or morekeyed ridges618,620 respectively to be received by one or morereciprocal slots622,624 within the inner lumen of either thehousing sheath605 or theactuating catheter610, respectively. Such keyedridges618,620 would 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 undesired rotational motion during use.
• The implant/delivery system array600 includes adistal tip625 at the forward end of thecore catheter615. One or more radialimplant support arms630 have theirdistal ends632 pivotably or bendably mounted to thecore catheter615 adjacent itsdistal tip625. The proximal ends634 of the radialimplant support arms630 normally extend along thecore catheter615 but are capable of being displaced outward away from the core catheter.
• One or more radial support struts636 have theirproximal ends638 pivotably or bendably mounted to the distal end of theactuating catheter610. Thedistal end640 of each radial support strut is636 pivotably or bendably attached to a midpoint of a corresponding radialimplant support arm630. As theactuating catheter610 is advanced with respect to thecore catheter615, the radial support struts636 force the radialimplant support arms630 upward and outward in the fashion of an umbrella frame. Thus theactuating catheter610,core catheter615, radial support struts636, andradial support arms630 in combination form adeployment umbrella642.
• Aprosthetic implant645 is releasably attached to the proximal ends634 of the radialimplant support arms630. Around the periphery of theprosthetic implant645 and extending proximally therefrom are a plurality ofretention barbs646. In addition, one or more of the radialimplant support arms630 comprisetouchdown sensors648 whose proximal ends extend proximal to theimplant645. Extending through the central lumen616 (FIG. 13) of thecore catheter615 in theexemplary embodiment600 and out lateral ports650 (FIG. 12) spaced proximally from thedistal tip625 are one ormore release elements660, which serve to release theimplant645 from the delivery system, and one ormore adjustment elements665 which serve to adjust the implant's deployed size and effect. Because therelease elements660 andadjustment elements665 extend through the proximal end of thecore 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 thedeployment umbrella642, therelease elements660, and theimplant645. In the disclosed embodiment, therelease elements660 may be a suture, fiber, or wire in a continuous loop that passes through laser-drilled bores in theimplant645 and in the radialimplant support arms630, and then passes through the length of thecore catheter615. In such an embodiment, theimplant645 may be released from the delivery system at a desired time by severing therelease element660 at its proximal end, outside the patient, and then withdrawing the free end of therelease element660 through thecore catheter610.
• FIGS. 14-16 show the operation of the implant/delivery system array600, in which an umbrella-like expansion of theprosthetic implant645 is achieved by sliding movement of thehousing sheath605, theactuating catheter610, and thecore catheter615. Referring first toFIG. 14, thehousing sheath605 is extended to cover the forward ends of theactuating catheter610 andcore catheter615 for intravascular insertion of the implant/delivery system array600. From this starting position, thehousing sheath605 is retracted in the direction indicated by the arrows662. InFIG. 15 thehousing sheath605 has been retracted to expose the forward end of theactuating catheter610 and the collapseddeployment umbrella642. From this position theactuating catheter610 is advanced in the direction indicated by thearrows664. This will cause the deployment umbrellas to expand in the directions indicated by thearrows666.FIG. 16 shows the expansion of thedeployment umbrella642 produced by distal motion of theactuating catheter610 relative to thecore catheter615. After theimplant645 has been positioned and adjusted to the proper size, thehousing sheath605 is advanced in the direction indicated by thearrows668 to collapse and to cover thedeployment umbrella642 for withdrawal of the device from the patient.
• FIGS. 17 and 18 are schematic views illustrating the radialimplant support arms630 and the radial support struts636 of the implant/delivery system array600. InFIG. 17, aradial support strut636 is pivotably attached at itsproximal end638 at a first pivotable joint670 to theactuation catheter610. Theradial support strut636 is attached at itsdistal end640 to a second pivotable joint672 at an intermediate point of a corresponding radialimplant support arm630. The radialimplant support arm630 is attached at itsdistal end632 by a third pivotable joint674 to thecore catheter620.FIG. 17 shows the assembly in a closed state. When theactuation catheter610 is advanced distally over thecore catheter615, as shown by thearrows676, theradial support strut636 and the radialimplant support arm630 are extended by the motion at the first pivotable joint670, the second pivotable joint672, and the third pivotable joint674, as shown by thearrow678. 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 20 show further details of thetouchdown sensors648 shown previously inFIG. 12. Thetouchdown sensor648 ofFIGS. 19 and 20 includes adistal segment680, anintermediate segment682, and aproximal segment684. Thedistal segment680 is spring-mounted, so that it is capable of slidable, telescoping displacement over theintermediate segment682 to achieve a seamless junction with theproximal segment684 upon maximal displacement. When thetouchdown sensor648 is 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, theproximal segment684 of thesensor648 is compressed against thedistal segment680, as shown inFIG. 20. Thedistal segment680 and theproximal segment684 are both constructed of, are sheathed by, or otherwise covered with a radio-opaque material. However, theintermediate segment682 is not constructed or coated with such a radio-opaque material. Therefore, when thedistal segment680 is at rest, it is fully extended from theproximal segment684, and the gap represented by the exposedintermediate segment682 is visible on radiographic examination. However, when thedistal segment680 is brought to maximum closeness with theproximal 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 thetouchdown sensor648 with respect to the degree of extension of thedistal catheter segment680. In the embodiment according to the present invention as shown, one ormore touchdown detectors648 are 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. 21-24 show animplant700 according to one embodiment of the present invention. In this embodiment, theimplant body705 is bandlike and flexible. Through much of its length, theimplant body705 is provided with a series ofretention barbs710 which are oriented to facilitate placement, retention, and removal of the device. Theimplant body705 is also provided with anadjustable section715, which is provided in this example with a series of adjustment stops720. The adjustment stops720 may be slots, holes, detents, dimples, ridges, teeth, raised elements, or other mechanical features to allow measured adjustment of theimplant700 in use. In the embodiment shown inFIGS. 21-24, the adjustment stops720 are engaged by a gearedconnector725.FIG. 21 is an end view, showing theimplant body705 curved on itself, with theretention barbs710 to the exterior, and with theadjustable section715 passing through its engagement with the gearedconnector725 and curving internally within theimplant body705 to form a closed, round structure.FIG. 23 shows details of an exemplary gearedconnector725, in which ahousing730 is connected to theimplant body705. Thehousing730 contains and supports amechanical worm740 with an attached first gearedhead750 which mates with a second gearedhead755. The second gearedhead755 is attached to anadjustment stem760 which 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 theadjustment stem760 is 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 theadjustment stem760 and second gearedhead755 allows motion of the first gearedhead750 andworm740, which creates motion of theadjustable implant section715 as the worm engages with the series of adjustment tops725. Excess length of theadjustable section715 passes through a band slot735 (FIG. 23), thus allowing the band to move concentrically inside theclosed 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 theadjustment stem760 may 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 employsunidirectional retention barbs710 which are attached to the outer perimeter of theimplant body705. Theretention barbs710 are oriented in a consistent, tangential position with respect to theimplant body705 such that rotational motion of the implant body will either engage or release theretention barbs710 upon contact with the desired tissue at the time of deployment. This positioning of theretention barbs710 allows the operator to “screw in” theimplant700 by turning theimplant700 upon its axis, thus engaging theretention barbs710 into the adjacent tissue. As shown inFIG. 24, theretention barbs710 may each be further provided with aterminal hook775 at the end which would allow for smooth passage through tissue when engaging theretention barbs710 by rotating theimplant700, without permitting theimplant700 to rotate in the opposite direction, because of the action of the terminal hooks775 grasping the surrounding tissue (much like barbed fish hooks). The terminal hooks775 thus ensure the seating of theimplant700 into the surrounding tissue.
• FIGS. 25-27 illustrate another embodiment of animplant800 as contemplated according to the present invention. Theimplant800 includes a band805 (FIG. 27), but the retention barbs of the previous example have been eliminated in favor of an outerfabric implant sheath810. Thefabric sheath810 can be sutured or otherwise affixed to the anatomic tissue in a desired location. The circumference of theimplant body800 is adjusted through a geared connector825 similar to the geared connector of the bandlike implant array shown inFIG. 23. More specifically, adjustment stops820 on the band are engaged by amechanical worm840 with an attached first gearedhead850. The first gearedhead850 mates with a second gearedhead855. The second gearedhead855 is attached to anadjustment stem860 which is machined to receive a screwdriver-like adjustment element.
• FIG. 28 illustrates an example of the method of use of an implant/delivery system array600 for positioning animplant645 in 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 theheart900 is 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 theleft ventricle905 and then into theleft atrium910. At this point, the operator retracts thehousing sheath605, thus unsheathing the collapseddeployment umbrella642 andimplant645. Thedeployment umbrella642 is then distended by the distal motion of the actuation catheter, causing the radial support arms and struts to fully distend. At this point, thetouchdown detectors648 are 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 twotouchdown detectors648 are 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 through 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, anumbrella deployment device600 withimplant645 is passed under guidance of anendoscope1000, through the patient's mouth,esophagus1005, and into thestomach1010, where thedeployment device600 is opened with expansion of theimplant645 andtouchdown detectors648 with a color-coded or otherwise visible gap. The touchdown detectors are then engaged onto the stomach around thegastroesophageal junction1015 under direct endoscopic control until alltouchdown detectors648 are visually activated. The implant is then attached to the stomach wall,1020 theumbrella642 is released and withdrawn, leaving behind theimplant645 and 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, animplantable device system1000 for controlling at least the size or shape of an anatomical structure or lumen includes animplantable device1002 and anadjustment tool1006. The anatomical structure or lumen is an anatomic site with dysfunction that can be relieved by theimplantable device1002 to change a size or shape of the anatomic site.
• Theimplantable device1002, in one exemplary embodiment, has a diameter no larger than 3.5 mm. In another embodiment theimplantable device1002 is configured to have variable size relative to its placement at an annulus of a heart valve. Theimplantable device1002 has anadjustable member1004 configured to adjust the dimensions of theimplantable device1002. In one embodiment, thetorqueable adjustment tool1006 provides adjustment of the dimensions of theimplantable device1002. Theadjustable member1004, in some embodiments, may be oriented to receive the adjustment tool from a direction generally perpendicular to the primary plane defined by theimplant device1002. Such an orientation is advantageous for intravenous access of the tool and in situ adjustment of theimplant device1002. Theimplantable device1002 can have a configuration where there are different pulling rates at different sections of theimplantable device1002. Theimplantable device1002 may optionally include a flexible tube (1032,FIG. 38) and an outer fabric sheath (810,FIGS. 25 and 26), which are not shown in the subsequent figures for clarity. The outer fabric sheath can be sutured, stapled, clipped, coiled, or otherwise affixed to anatomic tissue in a desired location. Generally the desired location is considered to be the internal surface of the area to be controlled, such as (for example) an interior wall of an organ, artery, or other internal anatomic passage. Also, while theimplantable device1002 is generally shown in the subsequent figures to have a “D”-shaped configuration, it should be understood that other shapes can be used in accordance with embodiments of the present invention.
• Still referring toFIG. 31, in certain embodiments, theadjustment tool1006 is at least partially hollow, and in one specific embodiment at least 50% hollow. Theadjustment tool1006 may be an elongated tool, which has a proximal end and a distal end releasably attached to theadjustable member1004 ofimplantable device1002. Theadjustment tool1006 may extend from its distal end coupled to theadjustable member1004 to a control interface (e.g., handle) at the proximal end located preferably outside of the patient's body. Theadjustment tool1006, when coupled to theadjustable member1004 ofimplantable device1002, can provide a preferential shape change of theimplantable device1002 in planar and non-planar directions. Theadjustment tool1006 can adjust theimplantable device1002 in terms of narrowing or widening the dimensions of theimplantable device1002.
• FIG. 32A is a schematic of theimplant device1002 without showing an optional flexible outer tube and fabric sheath. The implantable device includes anadjustable member1004 andadjustable tube portions1013aand1013b, which slide withinhollow tube portions1014aand1014b, and retainingtube1015.FIG. 32B is a schematic of a disassembled portion ofimplantable device1002 with retainingtube1015 removed. As shown inFIG. 32B, in various embodiments, theimplantable device1002 includes a threadedrod1008 threaded with right-handhelical grooves1010 and left-handhelical grooves1012. Other embodiments may include a threadedrod1008 with helical grooves in a single direction (e.g., all right-hand grooves or all left-hand grooves). Threadedrod1008 may be a rigid material such as titanium, stainless steel, or a polymer.Adjustable tube portions1013aand1013benclose at least a portion ofgrooves1010 and1012 so thatpins1016a,1016bor protuberances on the inside diameter of theadjustable tube portions1013a,1013bare engaged by thegrooves1010 and1012, respectively. In other embodiments, pins1016a,1016bmay be replaced by threads along the inside diameter of theadjustable tube portions1013a,1013b.Helical grooves1010 and1012 may be single channels or multiple channels to engagesingle pins1016a,1016bor multiple pins.Hollow tube portions1014a,1014bare relatively rigid to maintain curvature of theadjustable tube portions1013a,1013bregardless of the adjustment position.
• Theimplantable device1002 can have a coating including, but not limited to, heparin, and antibiotic, collagen, and an agent that promotes tissue in growth, PGLA, a de-calcification agent and the like. Theimplantable device1002 can be made of a variety of materials including, but not limited to, a shape memory alloy (SMA), a shape memory polymer (SMP), titanium, stainless steel, polymer, a suture-based material, a biological material and the like.
• In another embodiment of the present invention, illustrated inFIGS. 33 through 37, theadjustable member1004 provides translated motion through rotation.FIGS. 33 through illustrate a theory of operation of an embodiment of the present invention, whileFIGS. 36 and 37 shown details of theadjustment member1004.
• Referring to nowFIG. 33,adjustable member1004 ofimplantable device1102 is shown including adocking port1021 to receive the distal tip of the adjustment tool1006 (FIG. 31). In this embodiment, implant device includes a set ofinner tubing1028a,1028band a set ofouter tubing1026a,1026bthat can move relative to each other. The ends of theinner tubing1028a,1028bthat do not engage theouter tubing1026a,1026bare secured to a set ofhollow tubing1014a,1014bso that theinner tubing1028a,1028bdoes not move relative to thehollow tubing1014a,1014b. Althoughhollow tube portions1014a,1014bmay be separate pieces that are permanently abutted when assembled, in some embodiments, thehollow tube portions1014a,1014bmay be formed from a single tubing piece. Aninner cable1030 passes through the various tubing. Thus, the rigidity of the hollow tubing can be used to maintain theadjustable implant1102 shape in certain dimensions so that adjustment of the device can be restricted to a preferred dimension, for example, an anterior-posterior dimension.
• As shown in more detail inFIGS. 36 and 37,adjustable member1004 may also include a pinion gear1022 (which may be integral to a docking port1021) and acrown gear1024.FIG. 36 provides an isometric view of theadjustable member1004, andFIG. 37 provides a cut-away view of theadjustable member1004. As can be seen in the figures, thepinion gear1022 engages thecrown gear1024. In some embodiments, thepinion gear1022 may be eliminated fromadjustable member1004, and the distal tip of theadjustment tool1006 may serve as the pinion gear when the tool is coupled to thedocking port1021. When coupled to thedocking port1021, theadjustment tool1006 can rotate thepinion gear1022.
• Referring back toFIG. 33, theimplantable device1102 is shown generally at the middle of its adjustment range.Outer tubing1026a,1026bis affixed to theadjustable member1004 and extends along a portion of the circumference ofimplantable device1102.Inner tubing1028a,1028bis affixed tohollow tubing1014a,1014b, respectively. Similar to the single threadedrod1008 ofFIG. 32B, threaded rods1018a,1018bsit inside thehollow tubing1014a,1014band are threadedly engaged therewith. Threaded rods1018a,1018bmay be a rigid material such as titanium, stainless steel, or a polymer.Hollow tube portions1014a,1014benclose the threaded rods1018a,1018bsuch that rotation of the threaded rods1018a,1018bcauses them to move axially within thehollow tube portions1014a,1014b. The threaded rod1018amay have right-handed threads, and the threaded rod1018bmay have left handed threads. Other embodiments may include threaded rods1018a,1018bwith threads in a single direction (e.g., all right-hand grooves or all left-hand threads).
• Thecrown gear1024, and one end of each threaded rod1018a,1018bare all attached to aninner cable1030.Inner cable1030 may be a cable or tube of any material with sufficient flexibility to conform to a shape of theimplantable device1102 while translating torque. For example, suitable material forinner cable1030 may include titanium or stainless steel. As shown more clearly inFIGS. 36 and 37, the rotation ofcrown gear1024 imparts rotation tocable1030 in the same direction.
• Referring toFIG. 34, when the handle of adjustment tool1006 (not shown in this figure) is rotated clockwise in dockingport1021, it causes clockwise rotation of the pinion gear1022 (inFIG. 36). Rotation of thepinion gear1022 in turn rotatescrown gear1024. The rotation ofcrown gear1024 causes rotation ofinner cable1030, which imparts rotational movement to each threaded rod1018a,1018b. The rotation applied to the threaded rods1018a,1018bcauses them to advance into their respectivehollow tubing1014a,1014bin the directions A1, A2 shown. As shown inFIG. 34, when threaded rods1018a,1018badvance toward the middle of thehollow tubing1014a,1014bthe overall circumference of theimplant device1002 is reduced. Advancing the threaded rods1018a,1018bdrives theinner cable1030 into thehollow tubing1014a,1014b. Translation ofinner cable1030 into thehollow tubing1014a,1014bcauses thehollow tubing1014a,1014bto move towardsadjustable member1004 in the direction B1 shown.Inner tubing1028a,1028bslides intoouter tubing1026a,1026bto accommodate movement of theinner cable1030.
• Referring toFIG. 35, the handle of adjustment tool1006 (not shown in this figure) is rotated counter-clockwise in dockingport1021 to cause counter-clockwise rotation of the pinion gear1022 (FIG. 36). Rotation of thepinion gear1022, in turn rotatescrown gear1024. The rotation ofcrown gear1024 causes rotation ofinner cable1030, which imparts rotational movement to each threaded rod1018a,1018b. The rotation applied to the threaded rods1018a,1018bcauses them to begin to withdraw from their respectivehollow tubing1014a,1014bin the directions A2, A1 shown. As shown inFIG. 35, as threaded rods1018a,1018bwithdraw from the middle of thehollow tubing1014a,1014bthe overall circumference of theimplant device1002 is increased. Withdrawal of the threaded rods1018a,1018bpushes theinner cable1030 out of thehollow tubing1014a,1014b. Translation ofinner cable1030 out of the hollow tubing
• 1014a,1014bcauses thehollow tubing1014a,1014bto move away fromadjustable member1004 in the direction B2 shown.Inner tubing1028a,1028btelescopes out ofouter tubing1026a,1026bto accommodate movement of theinner cable1030.
• Theinner tubing1028a,1028b, theouter tubing1026a,1026b, and thehollow tubing1014a,1014bmay be covered by aflexible tube1032, such as a silicone tube, shown inFIG. 38. In one embodiment, outerflexible tube1032 is provided with no seam in the axial direction of the tube to allow for better tissue ingrowth after the implant procedure. In other embodimentsinner tubing1028a,1028bmay be eliminated, as shown inFIG. 39.
• FIG. 39 provides an assembled cross-section view of animplantable device1202 according to an embodiment of the invention. The implant device includes theadjustable member1004, theouter tubing1026a,1026b, thehollow tubing1014a,1014b, theinner cable1030, and the threaded rods1018a,1018bas discussed in relation toFIGS. 33-35. As shown inFIG. 39,hollow tubing1014a,1014bmay extend further along the length ofinner cable1030 than shown in other embodiments ofFIGS. 33-35 to better maintain a preferred shape of the implant.Hollow tubing1014a,1014bmay be threaded to receive the threaded rods1018a,1018b; or hollow tubing may optionally include a threaded insert (spar1019a,1019b) affixed to the inner diameter ofhollow tubing1014a,1014b. In operation, as previously described, an adjustment tool may impart motion to theadjustable member1004. Gears in the adjustable member translate motion to theinner cable1030 that, in turn translate motion to the attached threaded rods1018a,1018b. Depending on the direction of rotation, rotation of threaded rods1018a,1018bcauses the threaded rods1018a,1018bto be drawn toward or away from the middle of thehollow tubing1014a,1014b, thus reducing or increasing the overall circumference of theimplant device1002. The flexibleouter tube1032 and a seal jacket1100 (also shown inFIG. 40) encapsulate the device so that no moving parts are exposed. The flexibleouter tube1032 provide sufficient rigidity to maintain a generally planar dimension, while allowing the device to adjust shape generally in a preferred dimension, such as the anterior-posterior dimension. As shown inFIG. 39, the flexibleouter tube1032 may be further covered by anouter fabric sheath1110 or thin sewing cuff. Elimination of the inner tubing (1028a,1028bofFIG. 35) eliminates the need for telescoping parts and prevents the possibility of telescoping tubes being sutured or clipped together during attachment of the implant.
• Referring toFIG. 40, theadjustable member1004 can include aseal jacket1100.FIG. 40 shows an embodiment of theseal jacket1100. Theseal jacket1100 may include acover1102 for the docking port1021 (FIG. 33) of theadjustable member1004. Thecover1102 may be in the form of a slit septum, flaps, elastic material or the like. Theseal jacket cover1102 may be included as part of aseal jacket1100 that covers the entire housing of theadjustable member1004 or a separate piece. In one embodiment, theseal jacket1100 may be secured to theflexible tube1032. Theseal jacket1100 andflexible tube1032 may be secured by an adhesive bond, a wrap, sutures, or the like. Thecover1102 provides access for an adjustment tool to couple to the docking port, while reducing the possibility of thrombus. In some embodiments, sealjacket cover1102 and/or theseal jacket1100 may be made of silicone, and covered by a polyester sewing layer or fabric sheath (e.g.,1110 ofFIG. 39). In various embodiments, the seal jacket fits over the housing of theadjustable member1004 that includes a crown gear coupled to a cable, can provide pinion access, and the like. In operation, the distal tip of an adjustment tool passes through thecover1102 to engage the rotatable gear ofadjustable member1004.
• FIG. 41 shows an embodiment ofimplantable device1302 including afirst adjustment band1042aand asecond adjustment band1042b. The first andsecond adjustment bands1042a,1042bcan be overlapped, and the amount of overlap is effected by how theimplantable device1302 is sized. The first andsecond bands1042a,1042bcan be slidable relative to each other. Anadjustable member1304 is coupled to thefirst band1042aand thesecond band1042b, and pulls or pushes them toward or away from each other. Thefirst band1042aand thesecond band1042bcan haveflexible portions1046a,1046bconfigured to create a flexible zone at theprimary bend regions1047a,1047b. Theflexible portions1046a,1046bcan have varying lengths and may also include one or morerigid portions1044. Theserigid portions1044 can include welded braids or bands, or have a higher durometer material than theflexible portions1046a,1046b. Theflexible portions1046a,1046bandrigid portions1044 may be part of the same material as the first andsecond bands1042a,1042b, or one or more portions may be separate material that is joined to form continuous piece.
• The first andsecond bands1042a,1042bcan have different sizes or the same sizes. In one specific embodiment, the first andsecond bands1042a,1042bare about 0.5 to 3 mm in thickness and about 5 to 10 mm in width. The first andsecond bands1042a,1042bcan be made of a variety of materials including, but not limited to, an SMA, an SMP, titanium, stainless steel, polymer, a suture-based material, a biological material and the like. In one embodiment, the first andsecond bands1042a,1042binclude a plurality of band layers. At least a portion of the first andsecond bands1042a,1042bmay have superelastic properties.Implant1302 may include a flexible, extruded outer layer (not shown) or hollow tube, such asflexible tube1032 ofFIG. 38, to encase the structure formed by the first andsecond bands1042a,1042bflexible portions1046a,1046b, andrigid portions1044. The parts of the first andsecond bands1042a,1042b, that extend pastadjustable member1304 can be contained within the hollow interior of the outer layer.
• FIG. 42 provides a more detailed schematic view of the unassembled adjustment bands and adjustment member ofFIG. 41. The first andsecond bands1042a,1042bmay include a series of adjustment stops1048. Adjustment stops may be in the form of holes, detents, dimples, ridges, teeth, raised elements, other mechanical features or the like. Theseholes1048 on each of thebands1042a,1042bare coupled to anadjustable member1304. Theadjustable member1304 may be generally cylindrical (such as a spool) with a series ofteeth1050 or protrusions radially positioned to engage the adjustment stops1048.Adjustable member1304 may also include adocking port1320 to receive an adjustment tool to trigger rotational movement of the adjustable member.
• FIG. 43 provides an assembled view of the adjustment band and adjustment member ofFIG. 42. When mounted in a housing (not shown inFIG. 43), theadjustable member1304 may be mounted on an axis to allow for rotational movement. The first andsecond bands1042a,1042bpass on either side ofadjustable member1304 so that theteeth1050 engage the adjustment stops1048 in each of thebands1042a,1042b. Rotating the adjustable member in turn tightens or loosens the bands.
• FIG. 44 is a cut-away view of an embodiment of the gearbox for the adjustment band ofFIG. 41. In this embodiment, theadjustable member1304 rests on aspring1052 inside ahousing1040 for the adjustable member. Thehousing1040 includes access and guidance for the first and second bands (1042a,1042bofFIG. 43) to couple with theteeth1050 of theadjustable member1304. Thespring1052 forces theadjustable member1304 upward so thatteeth1056 on the top of theadjustable member1304 engage withteeth1058 on the inside upper surface of thehousing1040. Engagement of theadjustable member teeth1056 with thehousing teeth1058 locks theadjustable member1304 in place to prevent rotational movement. Downward force, applied for example by an adjustment tool, against thespring1052 disengages theteeth1056 and1058 so that theadjustable member1304 can be rotated to adjust the size or shape ofimplantable device1302.
• In another embodiment,FIG. 45 provides a schematic view of animplantable device1402 of the present invention with a plurality of sliding bands that can be opened and closed to effect a shape change. As with the previous embodiments ofFIGS. 41-44, the first andsecond bands1042a,1042bpass on either side ofadjustable member1304 so that theteeth1050 engage the adjustment stops1048 in each of thebands1042a,1042b.Additional bands1042cmay be incorporated to increase stiffness at different areas of theimplant device1402 to provide preferential shape change. Theadditional bands1042cmay be secured to the first andsecond bands1042a,1042busing welds1043, adhesive or other mechanical techniques known in the art.
• As illustrated inFIG. 46, in one embodiment, animplantable device1502 has ananterior portion1060, aposterior portion1062 and dual threads that provide preferential adjustment of one side or the other ofimplantable device1002. Theimplantable device1502 has two independently adjustable threadedportions1064a,1064bused to achieve different pulling rates and/or lateral dimensions. The adjustable threadedportions1064a,1064bcan be connected to one or moreadjustable member1004 of theimplantable device1502 and positioned at either the posterior or anterior portions of theimplantable device1502. In one embodiment, theposterior portion1062 may be a rigid member which includes threadedhex screws1066a,1066b, internal threads or similar structures. In one embodiment, the hex screws1066a,1066bare attached in a manner that allows rotation of the hex screws so that the threads may engage adjustable threadedportions1064a,1064b.Rigid posterior portion1062 may include one or more ofadjustable members1004 that can receive a tool to impart rotational motion through an inner tube or cable to one or more ofhex screws1066a,1066b, as described above.Anterior portion1060 may be a flexible tube to accommodate shape change as the anterior andposterior portions1060,1062 move relative to each other.
• In another embodiment, differently pitched threads or other mechanisms may be used to provide non-symmetrical shape change of the implant device. For example, referring toFIG. 46, wider threads on threadedportion1064b, in relation to the threads of threadedportion1064a, would allow anadjustable member1004 to expand or contract theimplant1502 more rapidly on the side of threadedportion1064bto provide preferential shape change for a selected region while using a single adjustable member.
• FIG. 47 is a schematic view of an embodiment of anadjustable member1604 for an implantable device. An adjustment tool may impart reciprocating motion to theadjustable member1604 that includes aclover gear1070 mounted in ahousing1072. The inner cable1030 (FIG. 33) of the implantable device, for example, is affixed to theclover gear1070 such that rotation of the clover gear transmits torque through theinner cable1030 to a screw or other adjustable portion of the implantable device as previously disclosed. In this embodiment, the adjustment tool can provide reciprocating action to provide for adjustment. The adjustable member takes an axial force applied to the control portion at the proximal end of the adjustment tool and converts it to a rotational force applied to theinner cable1030 of the implantable device. Reciprocating axial force may be provided from an adjustment tool by using spring-mounted buttons pressed by the user. Pressing a first button may transmit a downward axial motion to afirst ribbon1074 which engages theclover gear1070 to cause clockwise rotation of theclover gear1070. A spring or other return force pushes the first ribbon back to its original position after each click or press of the button. Similarly, pressing a second button may transmit a downward axial motion to asecond ribbon1076 that engages theclover gear1070 to cause counter-clockwise rotation of theclover gear1070.
• In another embodiment, the adjustment tool provides coarse adjustment and fine adjustment. This varied adjustment can be achieved with the adjustment tool having screws with different threads.
• FIG. 48 provides a schematic view of an embodiment of theimplantable device system1000 including anadjustment tool1706 with high column strength and stiffness. Theadjustment tool1706 has ashaft1794 and ahandle1096 with sufficient column strength to ensure a downward axial force on thehandle1096 provides proper engagement with theadjustable member1004 of theimplantable device1002. Thehandle1096 may be a grip-like handle, as shown, or a smaller pen-type handle. Theadjustment tool1706 can include mechanical locking at thedistal region1782 to lock with theadjustable member1004. The mechanical locking is configured to provide engagement and disengagement tactile feel to the physician.
• FIG. 49 is a schematic view of another embodiment of theimplantable device system1000 including anadjustment tool1806 with reduced column stiffness. Theadjustment tool1806 has a handle1096 ashaft1080 with reduced column stiffness for greater flexibility and easier articulation of theadjustment tool1806. Thehandle1096 may be a grip-like handle, as shown, or a smaller pen-type handle. The easier articulation offered by the this embodiment may facilitate user positioning of the device in vivo and clearing adjacent biological structures, particularly when it is docketed to theadjustable member1004 of theimplant1002. Flexibility may be varied along the length of theadjustment tool shaft1080. Flexibility may be increased at thedistal region1082 of theadjustment tool shaft1006, particularly in the region immediately proximal to the gear/fitting at the distal tip of theadjustment tool1006. This gear/fitting is constrained orthogonally to theadjustable member1004, and it is important that theadjustment tool1006 be easy to insert/connect and remain clear of biological structures.
• FIG. 50 provides a view of an embodiment of the proximal end of theadjustment tool1006. Referring toFIG. 50,adjustment tool1006 includes aflexible cable1094 or similar structure that is affixed to and rotates with ahandle1996. In other embodiments, theadjustment tool1006 can have cables, a band, tubes, rods, and the like to impart rotational and/or axial motion from the proximal end to the distal tip of thetool1006. Theflexible cable1094 may be enclosed by a flexible, low-friction cable jacket1098 that allows thecable1094 to rotate freely within thejacket1098. In some embodiments,adjustment tool1006 may also include a spring release mechanism to allow disengagement of the distal tip of the tool from the docking port1021 (FIG. 33) with minimal force being applied to the sutures (or other mechanisms) securing the implant device to the tissue of an anatomic orifice or lumen. As shown inFIG. 50, in some embodiments, ane-clip1099 or similar device may be used near thehandle1996 of theadjustment tool1006 to secure the release mechanism in the docking station until adjustments are complete.
• In one embodiment illustrated inFIG. 51, theadjustment tool1006 may be inserted inside arigid sheath1092 that reaches theimplantable device1002. Thus,FIG. 51 is a schematic view of an embodiment of theimplantable device system1000 of the present invention with an articulated shape. The rigidness of thesheath1092 provides the necessary column strength to support theflexible adjustment tool1006. An added benefit to this embodiment is that the sheath may be left in place, docked to theimplantable device1002. Theflexible adjustment tool1006 may be removed and then reinserted at some future time to engage with theadjustable member1004 ofimplantable device1002.
• Theadjustment tool1006 can have ahandle1096 that can be adjustable. Thehandle1096 can have a length of at least 8 inches, and in one embodiment at least 10 inches. Other embodiments may have a shorter or longer handle length. Thehandle1096 may be thick to provide a hand-grip, or, in other embodiments, smaller to provide a pen-like grip. The handle can have a device to quantify a size change of theimplantable device1002. For example, a half-turn of the adjustment tool handle can be correlated to a distance of travel of the threaded rods1018a,1018b(FIG. 33) of animplant1002, thus allowing for measured adjustment of the implant. The handle may include a click-counter or other known device to measure rotational movement. In one embodiment, theadjustment tool1006 may be included in a percutaneous delivery catheter.
• A sensor, such as the touchdown sensor described in relation toFIGS. 12-18 above, can be coupled to theimplantable device1002. A variety of different sensors can be utilized, including but not limited to, sensors that measure pressure, temperature and flow across theimplantable device1002. Pacing leads are coupled to the sensor and theimplantable device1002, and in this embodiment, the sensor is responsive to flow through theimplantable device1002.
• In another embodiment the implantable device system may include a micro-electromechanical motor system in conjunction with or instead of a separate adjustment tool to commence rotational movement in an adjustable member. Power and control of the micro-electromechanical motor system can be provided by electromagnetic radiation or through a direct wire connection and previously described herein.
• Finally, it will be understood that the preferred embodiment has been disclosed by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended claims.
• As discussed above, it is contemplated that theflexible adjustment tool1006 may be removed and then reinserted at some future time to engage with theadjustable member1004 ofimplantable device1002.FIGS. 52-59 show one embodiment of anadjustment tool2006 that can be reinserted into the body and reconnected to theadjustable member2004, so that additional adjustments to the implantable device can be made post-operatively. More specifically,FIG. 52 shows theadjustment tool2006 after it has been re-inserted into the left atrium, but before it has been reconnected to theadjustable member2004. In this example, theadjustment tool2006 is re-inserted into the left atrium via apurse string suture2010. This procedure can be performed using a purse string suture tensioning device, such as the one described in International Patent Application No. PCTIUS2008/080522, which is hereby incorporated by reference.FIG. 53 shows theadjustment tool2006 after it has been reconnected to theadjustable member2004.
• FIGS. 54-59 show the procedure for reconnecting theadjustment tool2006 to theadjustable member2004 of the implantable device.FIG. 54 shows anadjustable member2004 with agear2020 that can be designed to control the size and/or shape of the implantable device, in accordance with any of the embodiments of the present invention previously described herein. Thegear2020 of theadjustable member2004 is functionally connected to agear hex fitting2022, which in turn is functionally connected to ashaft hex fitting2024. In a preferable embodiment, the shaft hex fitting2024 is made of a rigid material that will allow it to most effectively transmit torque to thegear2020. After the implantable device has been attached to an anatomic orifice or lumen, both thegear hex fitting2022 and the shaft hex fitting2024 remain connected to theadjustable member2004 so that theadjustment tool2006 can be reconnected to theadjustable member2004 at a later time. In order to post operatively reconnect theadjustment tool2006 to theadjustable member2004, first, aguidewire2026 is inserted into the body and connected to thegear2020 of theadjustable member2004 by rotating a threadedscrew2028 on the distal end of theguidewire2026 using aknob component2030 attached to the proximal end of theguidewire2026, as shown inFIG. 54. Theknob component2030 andscrew2028 are rotated until ashoulder portion2032 of theguidewire2026 contacts the shaft hex fitting2024, as shown inFIG. 55.
• FIG. 56 shows theadjustment tool2006 being reinserted along theguidewire2026. The distal end of theadjustment tool2006 includes ashaft hex tip2034 with an internal hex that mates with shaft hex fitting2024 connected to theadjustable member2004. Once theadjustment tool2006 has been mated with the shaft hex fitting2024, theshaft2036 of theadjustment tool2006 can be rotated in order to impart rotation on theshaft hex fitting2024. As shown inFIG. 57, this will cause thegear2020 to rotate, which will cause the implantable device to change shape and/or size, as was explained above with respect to embodiments of the implantable device. After the desired adjustment has been completed, theadjustment tool2006 can be detached from theadjustable member2004 by rotating theknob component2030 and unscrewing theguidewire2026 from thegear2020, as shown inFIG. 58. Finally,FIG. 59 shows that, after theguidewire2026 has been unscrewed, theadjustment tool2006, guidewire2026, and shaft hex fitting2024 can all be removed from the body.
• FIGS. 60-62 show a second embodiment of anadjustment tool2050 that can be reinserted into the body and reconnected to theadjustable member2052 so that additional adjustments to the implantable device can be made post-operatively. In this embodiment, the shaft hex fitting2054 is constructed so that it is long enough to extend through thepurse string suture2056. Similar to the previous embodiment, the shaft hex fitting2054 andgear hex fitting2058 are left in the body when theadjustable implant2060 is attached to the anatomic orifice or lumen. The advantage of this embodiment is that, as shown inFIG. 60, it allows theadjustment tool2050 to connect to the shaft hex fitting2054 without having to be re-inserted through thepurse string suture2056. This is beneficial because it reduces the stress placed on the purse string suture during reconnection of the adjustment tool. The process for re-inserting and reconnecting theadjustment tool2050 to theadjustable member2052 is similar to that discussed above with respect toFIGS. 54-59, with one difference being that the connection takes place outside thepurse string suture2056. Furthermore, because the shaft hex fitting2054 is longer in this embodiment, it will need to be flexible (rather than rigid) to accommodate the anatomy of the heart, as shown inFIGS. 61-62.
• As discussed above, in various embodiments contemplated by the present invention, an adjustable implant may be placed and affixed in position in a native recipient anatomic site by a percutaneous or other minimally invasive routes during beating or non-beating cardiac surgical procedures.FIGS. 63-72 show a reversible attachment apparatus that can be used to attach an adjustable implant to an anatomic orifice or lumen using a minimally invasive procedure. It will be understood that the preferred embodiments disclosed below are by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended claims.
• Another aspect of the present invention enables implantation and adjustment of an implantable device using minimally invasive techniques. A further aspect enables an implantable device to be repositioned numerous times without invasive procedures. By way of non-limiting example, one aspect of the current invention relates to a mitral ring that can be positioned and then removed numerous times in order to ensure that it is in the proper location.
• By way of non-limiting example, a surgeon could deliver an adjustable implantable device using a French catheter and approaching the annulus in at least two ways. One way of approaching would be through the jugular vein to the superior vena cava to the right atrium to the transsseptal and to the left atrium. Another way to approach would be through the femoral vein, to the inferior vena cava, to the right atrium, to the transseptal then to the left atrium. Other minimally invasive techniques would also function without departing from the invention.
• Once the implantable device is at the location where it is to be deployed, the present invention allows for positioning and repositioning of the device to ensure that it is in its proper location. For example, a surgeon could assess the positioning of the device remotely using transesophageal echocardiography (TEE) or other diagnostic device or tools such that the position of the device can be ascertained. If the device is not in the correct position, then it can be detached and repositioned. This process can be repeated until the device is in an acceptable location. Once the device is in an acceptable position, its dimensions can be adjusted remotely. These adjustments can be tracked by TEE or other diagnostic imaging device.
• By way of example,FIG. 63 shows a side view of a device that embodies the invention. The ring has at least an upper and a lower compartment. Theupper compartment2999 can contain mechanical components such as those described and illustrated inFIG. 76-86,6-11 or21-24. Similar components or no mechanical components can be in the upper compartment without departing from the present invention. Thelower compartment2998 can contain a reversible attachment apparatus that enables repeated repositioning of the ring.
• By way of further example,FIG. 64 shows an embodiment of the invention. A moveableretainer ring guide3001 that can be moved in either direction and forms the floor of the upper compartment. Afoam material3002 is included through which all retainers pass. This foam can be made of a biocompatible, compressible or resilient material. Thefloor3003 of the lower compartment2988 is made of Dacron, or similar material, and makes contact with anannulus2997. The retainers pass through the Dacron. The combination of the foam and the Dacron create a ring that can approximate the surface of theannulus2997. In one embodiment displayed inFIG. 64, the Dacron is woven to a housing with aguide3004 that is made of material such as titanium. Thisguide3004 serves to position thebarbed retainer3005 into theannulus2997 tissue that, in turn, does the same for thecommon retainers3006. Theguide3004 serves to act as a stop or distance limiter between the Dacron cover and themoveable retainer guide3001 or roof of the lower compartment. Thus, when the ring attachments need to be removed so that the ring can be repositioned, thelower compartment2998 returns to its original shape.
• Thebarbed retainer3005 can be made of titanium or similar material and is rigid where it enters theannulus2997 tissue but flexible where it attaches to themoveable retainer guide3001. InFIG. 65-66, another lateral view of an embodiment of the invention is shown. In this view, thelower compartment2998 of the implantable device is shown in contact with theannulus2997 surface in an inactivated mode and then with both the barbed and common retainers deployed.
• FIG. 66 shows both retainers being deployed in theannulus2997 tissue. When themoveable retainer guide3001 is moved to the right, in this example, thebarbed retainers3005 leave their housing and deploy into theannulus2997 in a circular direction in the manner of a fish hook. Thebarbed retainers3005 are guided by the guide portion of thehousing3004. Thecommon retainers3006 deploy through thefoam3002 covered with Dacron. Thefoam3002 is compressed resulting in an intimate contact with theannulus2997 that comports to the shape of theannulus2997.
• In another example of an embodiment of the invention,FIG. 67 shows an implantable device. In this Figure, thelower compartment2998 is compressed such that the device is ready to be inserted into a #20 French canula (not shown). Adrive mechanism3007 moves theguide3004 which, in turn, compresses thefoam3002 and flattens thebarbed retainers3005 andcommon retainers3006.FIG. 68 shows an implantable device deployed out of the canula and resting passively on theannulus2997. Thedrive mechanism3007 can be used to move themovable retainer guide3001 to enlargetoe foam3002 to its maximum size. Thedrive mechanism3007 may also be used to move theretainers3005,3006 to their upright position.
• In the activated mode, an example of which is shown inFIG. 69, thedrive mechanism3007 moves themoveable retainer guide3001 in order to compress thefoam3002 and drive the barbed3005 and common3006 retainers into theannuls2997 tissue.
• Another embodiment of the invention is displayed inFIG. 70-72. In this figure, thecommon retainers3008 are made of a nickel titanium alloy and are pre-stressed. When deployed thecommon retainers3008 will spiral in the tissue thereby increasing retention. Thecommon retainers3008 made of nickel titanium alloy can be retracted into thefoam3002 where they resume their original shape. The retention and common barbs of the invention, as illustrated above by the non-limiting examples discussed, allow for repeatable attachment and detachment of an implantable device while removing or minimizing tissue damage.
• As discussed above, it is contemplated that embodiments of the present invention can be used to adjust the shape and/or size of other heart valves, such as the tricuspid valve. The tricuspid valve has three leaflets: the anterior leaflet, the septal leaflet, and the posterior leaflet. Regurgitation in the tricuspid valve is often due to a loss of coaptation between the anterior and posterior leaflets. The atrioventricular node (AV node) is located near the septal leaflet of the tricuspid valve. This is significant because causing trauma near the AV node, such as by suturing, can result in heart block.FIGS. 73-78 show one embodiment of an implantable device that can be used to adjust the shape and/or size of the tricuspid valve. In this embodiment, theimplantable device4002 has an open ring design, and can be positioned so that no suturing is needed near the AV node.
• FIG. 73 shows animplantable device4002 with anadjustable member4004 that includes adocking port4021 to receive the distal end of an adjustment tool, such as the adjustment tool shown inFIG. 31 and described above. Theadjustable member4004 can have a pinion gear that engages with a crown gear, such as the adjustable member shown inFIGS. 36 and 37 and described above. Theimplantable device4002 includes a set ofinner tubing4028a,4028band a set ofouter tubing4026a,4026b, which can move relative to one another. The ends of theinner tubing4028a,4028bthat do not engage theouter tubing4026a,4026bare secured to theadjustable member4004 so that theinner tubing4028a,4028bdoes not move relative to theadjustable member4004. Theimplantable device4002 also includes a set ofhollow tube portions4014a,4014b. Thehollow tube portions4014a,4014bmay be separate pieces of tubing that are permanently attached to theouter tubing4026a,4026bwhen theimplantable device4002 is assembled, or thehollow tube portions4014a,4014bmay be formed from the same piece of tubing as theouter tubing4026a,4026b. Thehollow tube portions4014a,4014bmay be threaded on the inside to receive threadedrods4018a,4018b(shown inFIG. 77), or a threaded insert may be affixed to the inner diameter of thehollow tube portions4014a,4014b. Theimplantable device4002 also includes apassive tube portion4040, which is a portion of theimplantable device4002 that does not include any of the mechanisms used to adjust the size and/or shape of theimplantable device4002. This is shown in more detail inFIG. 77. It is contemplated that thepassive tube portion4040 can be either flexible or rigid.
• FIG. 74 shows a cross-sectional view of theimplantable device4002 ofFIG. 76. As discussed above, theinner tubing4028a,4028bis affixed to theadjustable member4004 and extends into theouter tubing4026a,4026b. Theouter tubing4026a,4026bis affixed to thehollow tube portions4014a,4014b. Aninner cable4030 is functionally connected to theadjustable member4004, as shown inFIGS. 36 and 37 above, and passes through theinner tubing4028a,4028band theouter tubing4026a,4026b. Theinner cable4030 is also connected to a set of threadedrods4018a,4018b, which are engaged with the threads on the inside of thehollow tube portions4014a,4014b. The threadedrods4018a,4018bmay be a rigid material such as titanium, stainless steel, or a polymer. Thehollow tube portions4014a,4014benclose the threadedrods4018a,4018b, such that rotation of the threadedrods4018a,4018bcauses them to move axially within thehollow tube portions4014a,4014b. In one embodiment, the threadedrod4018amay have right-handed threads, and the threadedrod4018bmay have left-handed threads. In other embodiments, the threadedrods4018a,4018bmay both have right-handed threads or left-handed threads. Theinner cable4030 may be a cable or tube of any material with sufficient flexibility to conform to the shape of theimplantable device4002 while translating torque. For example, suitable materials for theinner cable4030 may include titanium or stainless steel. As shown more clearly inFIGS. 36 and 37, rotating the crown gear of theadjustable member4004 imparts rotation to theinner cable4030 in the same direction.
• FIG. 75 shows an embodiment of the present invention where theimplantable device4002 is covered by an outer flexible tube4032 (such as a silicone tube) and aseal jacket4100, so that no moving parts are exposed. The flexibleouter tube4032 can provide sufficient rigidity so that theimplantable device4002 maintains a generally planar dimension, while allowing it to adjust shape in a preferred dimension, such as the anterior-posterior dimension. In one embodiment, the outerflexible tube4032 is provided without a seam in the axial direction in order to allow for better tissue in-growth after it has been implanted. The flexibleouter tube4032 may be further covered by an outer fabric sheath. Theseal jacket4100 may cover theadjustable member4004 and also include a cover for thedocking port4021 in the form of a slit septum, flaps, elastic material or the like. In one embodiment, theseal jacket4100 may be secured to the outerflexible tube4032. Theseal jacket4100 and the outerflexible tube4032 may be secured by an adhesive bond, a wrap, sutures, or the like. Theseal jacket4100 provides access for an adjustment tool to couple to thedocking port4021, while reducing the possibility of thrombus formation. In some embodiments, theseal jacket4100 may be made of silicone and covered by a polyester sewing layer or fabric sheath.
• FIGS. 73-75 show theimplantable device4002 in an open position where it has its largest circumference. In order to reduce the circumference of theimplantable device4002, the handle of the adjustment tool (not shown) is rotated in thedocking port4021, such that it causes rotation of the pinion gear (not shown) of theadjustable member4004. As described above, rotation of the pinion gear (not shown) in turn rotates the crown gear (not shown). The rotation of crown gear (not shown) then causes rotation of theinner cable4030, which imparts rotational movement to each of the threadedrods4018a,4018b. The rotation applied to the threadedrods4018a,4018bcauses them to advance into their respectivehollow tube portions4014a,4014bin the directions At, A₂shown inFIG. 77. As the threadedrods4018a,4018badvance into thehollow tube portions4014a,4014b, theinner cable4030 also advances into thehollow tube portions4014a,4014b. The advancement of theinner cable4030 into thehollow tube portions4014a,4014bcauses theinner tubing4028a,4028bto slide into theouter tubing4026a,4026b, which reduces the overall circumference of theimplantable device4002.
• FIGS. 76-78 show theimplantable device4002 in a closed position where it has its smallest circumference. More specifically, as shown inFIG. 77, the threadedrods4018a,4018bare advanced completely into thehollow tube portions4014a,4014b, and theinner tubing4028a,4028bis completely inside theouter tubing4026a,4026b. In order to enlarge the circumference of theimplantable device4002, the handle of the adjustment tool (not shown) is rotated in a direction opposite to the direction used to reduce the circumference, so that it causes an opposite rotation of the pinion gear (not shown) of theadjustable member4004. As described above, rotation of the pinion gear (not shown) in turn rotates the crown gear (not shown). The rotation of crown gear (not shown) then causes rotation of theinner cable4030, which imparts rotational movement to each of the threadedrods4018a,4018b. The rotation applied to the threadedrods4018a,4018bcauses them to withdraw from their respectivehollow tube portions4014a,4014bin the directions A1, A₂shown inFIG. 77. As the threadedrods4018a,4018bwithdraw from thehollow tube portions4014a,4014b, theinner cable4030 also withdraws from thehollow tube portions4014a,4014b. The withdrawal of theinner cable4030 from thehollow tube portions4014a,4014bcauses theinner tubing4028a,4028bto telescope out of theouter tubing4026a,4026b, which increases the overall circumference of theimplantable device4002.
• FIGS. 79-81 show another embodiment of animplantable device4002 for adjusting the shape and/or size of a tricuspid valve. In this embodiment, theimplantable device4002 has anadjustable member4004, apassive tube portion4040, and a single threadedrod4018 that is engaged with a singlehollow tube portion4014. One end of aninner cable4030 is connected to theadjustable member4004 and the other end is connected to the threadedrod4018. Theimplantable device4002 also includes aninner tube4028 that can move relative to anouter tube4026. Theimplantable device4002 shown inFIGS. 79-81 can be adjusted in a similar fashion to the device shown inFIGS. 73-78 above. More specifically, in order to reduce the circumference of theimplantable device4002, the handle of the adjustment tool (not shown) is rotated in the docking port (not shown), such that it causes rotation of the inner cable4030 (as described above), which imparts rotational movement to the threadedrod4018. The rotation applied to the threadedrod4018 causes it to advance into thehollow tube portion4014 in the direction A1 shown inFIG. 81. As the threadedrod4018 advances into thehollow tube portion4014, theinner cable4030 also advances into thehollow tube portion4014. The advancement of theinner cable4030 into thehollow tube portion4014 causes theinner tubing4028 to slide into theouter tubing4026, which reduces the overall circumference of theimplantable device4002. In order to enlarge the circumference of theimplantable device4002, the handle of the adjustment tool (not shown) is rotated in a direction opposite to the direction used to reduce the circumference, so that it causes an opposite rotation of theinner cable4030. One advantage of this design is that theadjustable member4004 can be made with smaller gears.
• FIG. 83 shows another embodiment of animplantable device4002 for adjusting the shape and/or size of a tricuspid valve. This embodiment is similar to that shown inFIGS. 79-81, because it has a single threadedrod4018 engaged with a singlehollow tube portion4014. One difference is that anadjustable member4004 is located at one end of theimplantable device4002, and ahollow tube portion4014 is located at the other end. As a result, theimplantable device4002 inFIG. 83 does not include a passive tube portion. To adjust the size of theimplantable device4002, an adjustment tool (not shown) is rotated which causes aninner cable4030 to rotate. The rotation of theinner cable4030 causes the threadedrod4018 to move in or out of thehollow tube portion4014, which in turn causes aninner tube4028 to move in or out of anouter tube4026, thus decreasing or increasing the circumference of theimplantable device4002. One advantage of this design is that the entire device can be made with a uniform flexibility or stiffness.
• FIGS. 84A and 848 show another embodiment of animplantable device4002 for adjusting the shape and/or size of a tricuspid valve. This embodiment is similar to that described above with respect toFIGS. 73-78, in that it has a set ofhollow tube portions4014a,4014b. Although not shown, theimplantable device4002 also includes a set of threaded rods that are engaged with thehollow tube portions4014a,4014b, and a set of inner tubing that can move relative to a set of outer tubing. In the embodiment shown inFIGS. 84A and 848, thehollow tube portion4014acan be curved, and the hollow tube portion4014bcan be straight. Thehollow tube portion4014ahas fewer threads on the inside for engaging with the threaded rod than the hollow tube portion4014b. This design enables theimplantable device4002 to have a more curved profile. By varying the thread pitch on thehollow tube portions4014a,4014band the threaded rods they are engaged with, it also allows theimplantable device4002 to make more fine adjustments on certain portions of the tricuspid valve and more coarse adjustments on other portions of the tricuspid valve.
• It is further contemplated that embodiments of theimplantable device4002 described above can have both planar and non-planar designs. For example, theimplantable device4002 can have a spiral shape. It is also contemplated that, in some embodiments, theimplantable device4002 is a full, complete ring.
• It is also contemplated that theadjustable member4004 can be positioned in varying locations on theimplantable device4002 described in the embodiments above.
• It is also contemplated that theimplantable device4002 can be used to make adjustments to the tricuspid valve after a patient has been taken “off pump” and normal flow of blood through the heart has resumed. It is also understood that the adjustment tool for making post-operative adjustments described above can be used to make post-operative adjustments to theimplantable device4002.
• Finally, it will be understood that the preferred embodiment has been disclosed by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended claims.

Claims (8)

1. A reversible annular implant device comprising:

an annular implant having an upper compartment housing a flexible ring core and a lower compartment containing a series of retention barbs either integrally formed with or fixedly attached to the annular implant, wherein selected retention barbs further include a terminal hook for anchoring of the annular implant into the annular tissue; and

a movable retainer guide in communication with the lower compartment of the annular implant for controlling extension of the series of retention barbs.

2. The reversible annular implant device ofclaim 1, wherein said lower compartment contains a retention barb housing which prevents the retention barb from engaging the annular tissue prior to deployment.

3. The reversible annular implant device ofclaim 1, wherein the lower compartment comprises foam or a foam-like material through which the retention barbs extend to contact the annular tissue when deployed by the retaining guide.

4. The reversible annular implant device ofclaim 1, wherein the exterior of the annular implant is fabricated of a biologically compatible material selected from the group consisting of Dacron, PTFE, malleable metals, other biologically compatible materials, and a combination of such biologically compatible materials in a molded, woven, and non-woven configuration.

5. The reversible annular implant device ofclaim 1, wherein the annular implant comprises an annuloplasty ring device.

6. A reversible annular implant device comprising:

an annular implant having an upper compartment housing a flexible ring core and a lower compartment containing a series of retention barbs either integrally formed with or fixedly attached to the annular implant, wherein selected retention barbs further include a terminal hook for anchoring of the annular implant into the annular tissue; and

a movable retainer guide in communication with the lower compartment of the annular implant for controlling extension of the series of retention barbs;

wherein said lower compartment contains a retention barb housing which prevents the retention barb from engaging the annular tissue prior to deployment, the lower compartment comprising foam or a foam-like material through which the retention barbs extend to contact the annular tissue when deployed by the retainer guide.

7. The reversible annular implant device ofclaim 6, wherein the exterior of the annular implant is fabricated of a biologically compatible material selected from the group consisting of Dacron, PTFE, malleable metals, other biologically compatible materials, and a combination of such biologically compatible materials in a molded, woven, and non-woven configuration.

8. The reversible annular implant device ofclaim 6, wherein the annular implant comprises an annuloplasty ring device.

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