US20140018913A1 - Methods for controlling the internal circumference of an anatomic orifice or lumen - Google Patents

Abstract

A method for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural orifice or lumen which is either too large or too small. Implants are disclosed which employ various means 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 circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a Divisional of U.S. patent application Ser. No. 12/013,086, filed Jan. 11, 2008, which is a continuation of U.S. patent application Ser. No. 10/651,851 filed Aug. 29, 2003, which claims priority to U.S. Provisional Application Ser. No. 60/462,435, filed Apr. 12, 2003; 60/447,383, filed Feb. 14, 2003; 60/444,005, filed Jan. 31, 2003; and 60/406,841 filed Aug. 29, 2002.
BACKGROUND OF THE INVENTION
• The present invention relates generally to surgical procedures and relates more specifically to surgical procedures for controlling the internal circumference of an anatomic orifice or lumen.
• Many anatomic structures in the mammalian body are hollow passages in which walls of tissue define a central lumen, which serves as a conduit for blood, other physiologic fluids, nutrient matter, or waste matter passing within the structure. In many physiologic settings, dysfunction may result from a structural lumen which is either too large or too small. In most such cases, dysfunction can be relieved by interventional changes in the luminal size.
• Thus in surgery, there is often a need to reduce the internal circumference of an orifice or other open anatomic structure to narrow 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 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 this narrowing effect, such that the degree of narrowing could be changed after its implantation, but 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.
• The 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 pathophysiology 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
• In a first aspect, the present invention is directed to a novel prosthetic implant and method for use for adjusting the internal circumference of an anatomic passage that can be adjusted after implantation but after the resumption of normal flow of anatomic fluids in situ. In another aspect, the present invention is directed to a novel delivery system and methods for its use for the delivery and placement of a prosthetic implant within an anatomic site. Furthermore, the delivery system and methods according to the present invention are capable of in situ adjustment of such a prosthetic implant following its placement.
• An adjustable prosthetic implant according to a first aspect of the present invention could allow in situ adjustment after initial narrowing of the circumference of an internal anatomic passage under physiologic assessment after primary surgical closure. Such an adjustable prosthetic implant according to the present invention could be placed through an open surgical incision, or it could be placed endoscopically, either percutaneously or with an endoscope placed within a body cavity or organ. 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. 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 anal incontinence, urinary incontinence, anastomotic strictures, arterial stenosis, urinary incontinence, cervical incompetence, ductal strictures, morbid obesity, and for tricuspid valvular dysfunction. 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.
• In another exemplary application according to the present invention, a dysfunctional cardiac valve could be replaced or functionally supplemented to relieve disease without the need for open heart surgery by a delivery system and methods for use that would allow placement of a prosthetic heart valve by a similar percutaneous or other minimally invasive procedure.
• Objects, 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 THE DRAWINGS
• 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 ofFIG. 1.
• 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, where
• FIG. 17 shows the implant in the folded position, and
• FIG. 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.
DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENT
• 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 adjustablecorrugated sections20 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 axle220. 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 axle240 that is joined to asecond band245. As shown inFIG. 8, the first andsecond axles220,240 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 thearrows662. 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 geared connector725.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 geared connector725 and curving internally within theimplant body705 to form a closed, round structure.FIG. 23 shows details of an exemplary geared connector725, in which a housing730 is connected to theimplant body705. The housing730 contains and supports a mechanical worm740 with an attached first gearedhead750 which mates with a second geared head755. The second geared head755 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 geared head755 allows motion of the first gearedhead750 and worm740, 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 a terminal 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 themitral 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.
• 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 (20)

1. A method of implanting a foldable prosthetic annular ring to a patient's heart comprising:

providing a prosthetic annular ring folded inside a catheter for delivery to the patient's heart;

inserting the catheter through an anatomic passageway into a native recipient anatomic site of the patient's heart;

expelling the prosthetic annular ring from the catheter whereby the prosthetic annular ring has an unfolded configuration;

securing the prosthetic annular ring when in the unfolded configuration to adjacent tissue, said securing including application of external force to allow the prosthetic annular ring to attach to the adjacent tissue using a mechanical tissue interface system thereby holding the prosthetic annular ring in place; and removing the catheter from the anatomic passageway.

2. The method ofclaim 1, wherein the mechanical tissue interface system comprises a plurality of retention barbs, said application of external force engages the retention barbs into the adjacent tissue.

3. The method ofclaim 1, wherein said expelling comprises use of support arms attached to the prosthetic annular ring that expand to deploy said prosthetic annular ring from a folded configuration to an unfolded configuration having a radial dimension.

4. The method ofclaim 1, wherein said prosthetic annular ring is expandable radially to anchor the prosthetic annular ring at an implantation position.

5. The method ofclaim 1, wherein the prosthetic annular ring and the mechanical tissue interface system are integrated into a one-piece construction.

6. A method of implanting a prosthetic heart valve, comprising:

folding said prosthetic heart valve into a collapsed position;

inserting a catheter into a patient and guiding a distal end of said catheter to a position adjacent an implantation position in a patient's heart;

inserting said prosthetic heart valve when in the collapsed position into said catheter and steering said prosthetic heart valve to said distal end of said catheter using a guiding device;

guiding said prosthetic heart valve beyond said distal end of said catheter so as to cause said prosthetic heart valve to unfold to an unfolded position;

guiding the prosthetic heart valve to the implantation position;

securing the prosthetic heart valve to adjacent tissue, said securing including application of external force to allow the prosthetic heart valve to attach to the adjacent tissue using a mechanical tissue interface system.

7. The method ofclaim 6, wherein the mechanical tissue interface system comprises a plurality of retention barbs, said application of external force engages retention barbs into the adjacent tissue.

8. The method ofclaim 6, wherein the prosthetic heart valve is unfolded using support arms attached thereto that expand to deploy the prosthetic heart valve to the unfolded position having a radial dimension.

9. The method ofclaim 6, wherein said prosthetic heart valve is expandable radially to anchor the prosthetic heart valve at the implantation position.

10. The method ofclaim 6, wherein the prosthetic heart valve and the mechanical tissue interface system are integrated into a one-piece construction.

11. A method for delivery of a foldable prosthetic heart valve, comprising:

removably coupling a prosthetic heart valve to an expansion assembly, the prosthetic heart valve having a folded configuration and an unfolded configuration when coupled to the expansion assembly;

slideably mounting the expansion assembly coaxially within an interior of a catheter along with the prosthetic heart valve; and

moving the expansion assembly relative to the catheter from a first position, wherein the expansion assembly and the prosthetic heart valve in the fold configuration are arranged within the interior of the catheter, to a second position, wherein the expansion assembly and the prosthetic heart valve in the unfolded configuration are arranged outside the interior of the catheter.

12. The method ofclaim 11, further including releasably coupling an adjustment tool to the prosthetic heart valve for adjusting at least one of the size and shape of the prosthetic heart valve.

13. The method ofclaim 11, further including securing the prosthetic heart valve to tissue adjacent an anatomic orifice or lumen, said securing includes application of external force to allow the prosthetic heart valve to attach to the adjacent tissue using a mechanical tissue interface system thereby holding the prosthetic heart valve in place.

14. The method ofclaim 13, wherein the mechanical tissue interface system comprises a plurality of retention barbs engaging the adjacent tissue.

15. The method ofclaim 13, wherein the prosthetic heart valve and the mechanical tissue interface system are integrated into a one-piece construction.

16. The method ofclaim 11, wherein the expansion assembly comprises a plurality of support arms that expand to deploy the prosthetic heart valve from the folded configuration to the unfolded configuration having a radial dimension.

17. The method ofclaim 11, wherein said prosthetic heart valve is adapted to fit in a mitral valve opening of a heart.

18. The method ofclaim 11, wherein said prosthetic heart valve is adapted to fit in an aortic valve opening of a heart.

19. The method ofclaim 11, wherein said prosthetic heart valve is adapted to fit in a pulmonary valve opening of a heart.

20. The method ofclaim 11, wherein said prosthetic heart valve is adapted to fit in a tricuspid valve opening of a heart.

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