US20190000558A1 - Devices and methods for image-guided percutaneous cardiac valve implantation and repair - Google Patents

Abstract

Devices and methods for ultrasound image-guided percutaneous cardiac valve implantation and repair comprise, in combination, a plurality of devices including but not limited to an ultrasound-image guided catheter, a pericardial sheath, a cardiac valve delivery system and an ascending aortic filter. An image-guided catheter is utilized to introduce via an introducer needle and a guide wire a pericardium portal for permitting entry from the chest wall to inside the pericardial space between the pericardial outer lining and inner lining. The pericardium portal permits the use of ultrasound vision to locate a site proximate the left ventricular apex for introduction of a sheath via a myocardium needle into the left ventricular space at an angle and avoiding any coronaries or vessels. A first delivery system permits placement of at least one aortic filter which collects any emboli, particulate matter, plaque and prevents such matter travelling via the ascending aorta to the brain, causing a stroke. A second delivery system permits placement of an aortic and/or mitral valve replacement or repair using several types of repair tools.

Description

• This application claims the right of priority to U.S. Provisional Patent Application Ser. No. 62/527,905 of the same title and by the same inventor filed Jun. 30, 2017 and is a continuation-in-part of U.S. patent application Ser. No. 15/845,756 filed Dec. 18, 2018, which is a continuation-in-part of U.S. patent application Ser. No. 14/865,151 filed Sep. 25, 2015 by the same inventor (now U.S. Pat. No. 9,855,021 issued Jan. 18, 2018) and U.S. patent application Ser. No. 15/845,756 claims the right of priority to U.S. Provisional Patent application Ser. No. 62/526,170 filed Jun. 28, 2017 and U.S. Provisional Patent Application Ser. No. 62/590,464 filed Nov. 24, 2017.
TECHNICAL FIELD
• The invention relates to the field of cardiac valve replacement and repair and, in particular, to a plurality of devices and a sequential method for implanting via ultrasound and other image guidance a percutaneous cardiac valve, for example, the aortic valve between the left ventricle outflow tract and the ascending aorta or the mitral valve.
BACKGROUND OF THE INVENTION
• There is an increasing focus on the percutaneous treatment of valve disease. Mitral valve disease is very common. Rheumatic mitral valve disease is estimated to affect close to 16 million individuals worldwide. [See WHO Tech Series #924, 2004] with about 300,000 new cases per year and surgery indicated in approximately one million patients per year. Mitral regurgitation is common, affecting more than approximately four million Americans—nearly one in ten people aged seventy-five and older. [See https://www.dicardiology.com]. Aortic valve disease is also common and its prevalence increases with age. For people over the age of seventy-five years, the prevalence of aortic stenosis is 3%. More than one in eight people over the age of seventy-five have moderate or severe valve disease. As the population ages, this condition becomes an important public health problem. [See Nkomo V T, Gardin J M, Skelton T N, et al. Burden of valvular heart disease: a population-based study, Lancet 2006; 358:1005-11.]
• There are no good medical therapies for valve disease hence in moderate to severe valve disease with symptoms, the definitive treatment is valve repair or replacement. There has been a paradigm shift in treatment of valve disease with the introduction of transcatheter valve repair and replacement (collectively referred to as structural heart devices). This field is growing exponentially and the global structural heart device market is expected to hit $9.7 billion by 2022 and predicted to grow at a CAGR of 14.3% between now and 2022. Of this, aortic valve replacement occupies the largest share and greatest growth potential with the transcatheter aortic valve replacement and implantation (TAVR and TAVI) market valued at $5.9 billion by 2022. Allied Market Research (AMR) expects the market to grow at a compound annual growth rate (CAGR) of 16.5 percent from 2016 to 2020. The key drivers for market growth are increasing demand for minimally invasive surgery, focus on reducing healthcare costs, and a burgeoning aging population with valve disease. Additionally, the burden of valve disease in the developing world remains high. [See http://www. cardiovascularbusiness.com].
• The transcatheter approach is almost exclusively performed via femoral arterial access. Apical approaches are also performed but are minimally invasive surgical procedures rather than purely catheter based. More recently, mitral valve replacement is being performed using a trans-atrial approach. Similar, transcatheter solutions are being explored for the pulmonic and tricuspid valves.
• Consequently, there is a great need in the art for a minimally invasive method and apparatus for, for example, image-guided percutaneous cardiac valve implantation and repair.
SUMMARY OF THE INVENTION
• A trans-femoral approach to cardiac valve replacement and repair has been very successful, but the primary concern has been a high incidence rate of stroke. Strokes are thought to occur due to scraping off arterial plaque while advancing, the catheter into the aorta from the femoral artery. In a recent publication, “Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement,”Journal of the American College of Cargiology, November, 2016, despite deploying stroke prevention filters, stroke rates did not decrease substantially. The femoral approach also makes mitral valve intervention challenging since the operator may perform a transeptal puncture and orient the catheter tip and device almost perpendicular to the location of the mitral valve. Given the sharp turn needed to access the vicinity of the mitral valve, this alignment is difficult and may need several attempts.
• A trans-apical approach according to the present invention will avoid these issues and those of prior art techniques and apparatus but may require mini-surgery that is minimally invasive, but on the other hand, requires considerable operating room time. Both femoral and apical or atrial approaches may use separate intra-procedure ultrasound (or other) imaging. A trans-apical system that does not need surgery, prevents strokes and provides built-in imaging, and intra-procedure monitoring will allow safe and reliable deployment of cardiac valves and significantly expand the use of these transcatheter valves.
• The proposed invention comprises a multi-component/multi-device platform that will provide a single, integrated platform for delivery of valves (of any known type, biologic or artificial) or other devices into the heart with real-time ultrasound and other image guidance via prosthesis delivery to the region of the defective valve. In an image-guided catheter such as represented by U.S. Pat. No. 9,149,257 entitled “Image Guided Catheters and Methods of Use” issued Oct. 6, 2015 (the '257 patent) by the same inventor, perFIG. 3A, an ultrasound beam generated by atransducer element210 of an ultrasound imaging channel214 provides a cone-shaped imaging zone301 which can display a needle208 or guide wire or sheath or other tool extending from the distal (patient) end or provide device delivery and be directed parallel to the ultrasound beam and may be located within a sheath or lumen or plurality of lumens. (The '257 patent should be deemed to be incorporated by reference as to its entire contents). On the other hand, the needle208, a guide wire, sheath, delivery system for a filter or a prosthesis or tool being deployed parallel to the cone-shaped ultrasonic beam imaging zone301, may be difficult to see in the imaging zone301 because the needle, guide wire, sheath or lumen is very thin in diameter, may comprise a smooth surface, and may extend in the same direction as the ultrasound beam is projected (parallel to the sonic beam) from the thin, minimally invasive image-guided catheter limiting the amount of desired ultrasound echo. This can be improved by providing echogenicity by sanding, engraving or otherwise causing ultrasound beams to be reflected back to the source so that the sonic beam will tend to follow the angles of impingement and reflection and are intended to project from the needle, sheath or tool in a direction deeper into, for example, a human body in which the image guided catheter ofFIG. 3A is inserted and so may be captured by surface-mounted or implanted ultrasound transducers. The image guided catheter may be inserted by directing an introducer needle through the skin surface and guides the image guided catheter under ultrasound vision to a site of interest. Ultrasound waves may be echoed or returned to the ultrasound transducer source or scattered toward the human body surface. Also, it is desirable to visualize the needle, sheath or tool itself (via echogenicity) to determine the direction of its movement within the human body from the point of entry of the human body to an area of interest such as the human heart. In one embodiment, the needle or sheath may be hollow (in another, solid) and may be removed or moved forward via a lumen extending the length of the catheter once the catheter is located at a site of interest and may be replaced in real time with a guide wire or tool such as a micromechanical motor system (MEMS). In another embodiment, the tool may be used simultaneously (in its own lumen) with the needle or sheath to bend or guide the needle, guide wire or sheath to the region of interest from a patient's skin surface.
• The following additional U.S. Patents and published applications of Dr. Theodore Abraham should be deemed to be incorporated by reference as to their entire subject matter and refer to similar image guided catheters, implanted ultrasound devices, wired or wireless ultrasound devices and the like which may receive signals from echogenic needles, sheaths or tools and surrounding human tissue or blood or other fluids of interest at a site of interest for a minimally invasive surgical procedure: U.S. Pat. No. 8,038,622 issued Oct. 18, 2011; U.S. Pat. No. 8,147,413 and U.S. Pat. No. 8,147,414, issued Apr. 13, 2012; U.S. Pat. No. 8,403,858 and U.S. Pat. No. 8,403,859 issued Mar. 26, 2013, and U.S. 2016/008,1658 published Mar. 24, 2016. Most recently, U.S. Ser. No. 15/636,328 entitled “Image Guided Catheters and Methods of Use” was filed by the present inventor on Jun. 28, 2017 and U.S. Provisional Patent Application Ser. No. 62/526,170 entitled “Echogenic Needle, Sheath or Tool” was filed by the present inventor also on Jun. 28, 2017.
• The components of an apparatus and method for cardiac valve replacement comprise: a Vu-Path ultrasound imaging catheter which is a similar device to that described in prior patents of the inventor. There is also a Vu Path stabilization system for stabilizing the imaging guided catheter and any other components requiring stabilization to be sutured or otherwise stabilized with respect to an entry point through skin surface tissue into a patient body, typically, through the human chest wall, for example, to the heart. A further component of the present invention is a myocardial entry system. The myocardial system is intended to enter the myocardium at an angle to facilitate closure of the heart at the ventricular apex under ultrasound vision. If not inserted at an angle, closure of the myocardium due to blood pressure will be difficult. So a closure device comprising a pair of umbrella-like devices are used to close the opening at the ventricular apex. An initial incision is made of less than a centimeter, on the order of five to seven millimeters, in the chest wall proximate the heart. The introducer needle points under ultrasound guidance and the surgeon chooses a point of entry at an angle through the pericardium into the pericardial space. From a distal tip of a PeriPath pericardial image guided catheter, as described herein, a guide wire is deployed into the pericardial space under vision. The PeriPath may then be removed and replaced with a sheath that may be advanced through the chest wall via the remaining guide wire and enter the pericardial space under ultrasound vision guidance.
• Once the pericardial space has been penetrated via the sheath, the guide wire may be removed leaving the sheath displaced at an angle (a sharp angle less than ninety degrees) and entering the pericardial space. The operating space between the outer and inner pericardial linings may be expanded by injecting saline or other solution to create an operating space volume using a hollow needle moved through the sheath. Through the sheath and with ultrasound guidance, a periport (periport (pericardial space portal) now comprising an assembly of a particulate aortic filter (undeployed) followed by a prosthesis comprising a replacement heart valve may be deployed via first and second tubular pushers surrounding a guide wire. To provide ultrasound guidance, an imaging transducer may be moved from a lengthwise position along the periport to a position that is angled, for example, at an angle less than orthogonal with the peri-port to place the ultrasound imager at a location with a directed imaging zone that captures the heart and subsequent use of the periport. The ultrasound imager should have sufficient depth to reach within the heart and have sufficient resolution to view heart parts especially the heart valve to be replaced and beyond the valve to where a filter such as an ascending aortic filter may be utilized to prevent stroke demonstrated as problematic in the prior art.
• To achieve the goals of depth of ultrasound vision, the ultrasound transducer may be calibrated within a range of twenty-five kHz to 100 MHz and, more particularly, operate in a range between one and ten MHz. As taught in prior patent applications of the inventor, the image guided catheter may comprise a plurality of imaging lumens in which transducers, sheaths, guide wires, delivery systems and tools may be replaced in real time within a particular lumen under vision. In addition, as discussed above, it is important to prevent leaks from the pressure zone of the heart ventricle by inserting the periport device at an angle once in the pericardial space (which may be opened with saline solution (as discussed above) and its tip bent to point to the ventricular space at an angle at its apex to prevent leakage. Through the bent periport located just outside the ventricular apex, a needle may be introduced so as to puncture the ventricular apex of the heart at a sharp angle to minimize flow of blood from the ventricle into the pericardial space and then the periport may be straightened for continuing the procedure. Then, the periport is advanced through the left ventricle apex using the needle as a guide wire and at an angle to prevent blood loss. The periport is deployed (moved) into the ventricular space. The needle may then, having served its purpose, be removed by retraction through the periport and out the chest wall.
• In place of the needle there is now inserted via the periport a telescoping, multi-channel pericath which in cross-wise view comprises at its center, a guide wire such as a J-tipped guide wire, an aortic filter delivery system including at least one aortic filter (for capturing particulate matter such as plaque), a prosthetic valve which will be contained within a pericath outer cylinder delivery system attached to another delivery system tube just outside the filter tube. First, the J-tipped guide wire (with the J straightened) is fed through the existing, for example, aortic valve to be replaced. The J tip is automatically bent to form a curve so as note to inadvertently damage the wall of the ascending aorta. Then, the aortic filter, in a collapsed, cylindrical form, is deployed over the guide wire by advancement by pushing with a coated, slideable, cylindrical solid pushing tube. The collapsed aortic filter (or filters) may be moved through the existing valve to a position toward the end of the guide wire under vision, and the soft J-tip deployed automatically as discussed above. Once the aortic filter is positioned, it is opened (like an umbrella) to block the aortic passage for filtering and collect any particulate matter such as plaque under image guidance of a peripoint device (with similar ultrasound frequency range and sufficient depth of vision and resolution).
• Now the prosthesis containing a new heart valve, an artificial valve or one from a mammal (such as a pig) may be deployed using a similar coated pushing tube surrounding the filter tube. Under ultrasound guidance, the prosthesis is positioned at the location of the defective valve. The defective valve is pushed aside by the prosthesis to form part of the heart wall and so replaced by the prosthesis heart valve as the prosthesis is deployed to fill the entire space taken by the defective valve (for example, using deformation or fluid to expand a balloon shape. The prosthesis may comprise a source of pressure (sure as a balloon) which may be opened to completely fill the space where the defective valve has now become part of the ventricular, aortic wall, or a MEMS may be used to change its shape to fit the aorta cavity and press the defective valve against the walls.
• Once the prosthesis and replacement valve are in place and positioned to fill the entire space taken by the defective valve, ultrasound may be used to look for leakage of blood around the prosthetic valve and the valve expanded in size, like a balloon, or change shape from an elongated cylinder to a fat, short cylinder to fill the space entirely that was left by the defective, pushed aside valve. Once the new valve is placed, the aortic filter is collapsed like an umbrella for removal capturing any particulate matter inside, and may be removed by the plastic tube or pusher that now becomes a puller. When pulling the collapsed filter out of the heart, the J tip collapses, is automatically straightened and so the collapsed filter (like a collapsed umbrella) is easily pulled out through the prosthetic valve along with the, for example, J-tipped guide wire.
• the heart valve prosthesis is now capable of functioning normally replacing the defective valve. Remaining still at the ventricular apex is the periport which is now used for delivery of a closure device comprising two umbrella-like pads, a distal pad and a proximal pad for closing the myocardium, for example, at the ventricular apex. The closure device then comprises a distal pad a proximal pad and wires used for installation, control of opening and closing and, in particular, closing the angled hole remaining at the ventricular apex of the myocardium. The distal pad is pushed through the myocardial opening, opened and then pulled to a position closing about the myocardial angled opening. Then, the proximal pad is opened and is pushed upward until it reaches the myocardium under ultrasound vision. The two reverse, open “umbrella” pads, the distal and proximate pads, effectively close the angled myocardium entry point so as to preclude any release of blood through the ventricular apex.
• When the insulation is pulled off the two installation wires for the distal and proximal umbrella pads, the wires automatically coil like pig-tails, and the pig-tails hold the proximal pad against the myocardium and the distal pad to form a permanent stopper for the leakage of blood. The coating of the wires is removed through the periport, which is the only component remaining in the vicinity of the ventricular apex. All that is left to do then is to deflate the pericardial lining by removal of excess fluid (for example, through use of a syringe of a lumen and remove the periport from the pericardial wall having been freed of any suturing for stabilization, and the small incision area of the chest wall may be closed.
• In further embodiments, a mitral valve may be repaired or replaced and mitral valve repair will be described to include simultaneous deployment of an aortic filter, but first aortic valve replacement apparatus will be discussed in accordance with the following brief description of the drawings and the detailed description of the invention and its components which follows.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 comprises a drawing in two dimensions of the heart and chest wall (CW) which is penetrated by an image guided catheter and periport and other components. What are shown are the myocardium muscle, the left ventricle (LV), the left atrium (LA), the right ventricle (RV), the ascending aorta (AO), the descending aorta (DAo), the left ventricular apex and the left ventricular outflow tract (LVOT) of the heart. What is shown of the present invention comprises a guide wire150 (without any surrounding tube structures for filter or prosthesis delivery), a deployed prosthesis and a deployed, opened umbrella-like aortic filter to prevent stroke. The prosthesis and filter are shown located between the LVOT and the ascending aorta.
• FIG. 2 shows an initial step of using an image guided catheter type referred to herein as a peripath penetrating the chest wall and under ultrasound vision guidance reaching the outer lining of the pericardium, but not yet penetrating the pericardial space.
• FIG. 3 shows a similar view of the peripath having approached the pericardium, puncturing the pericardium and inserting a guide wire into the pericardium space between the outer and inner pericardial linings. Fluid may be delivered by a hollow introducer needle (not shown) to expand the pericardial space at the opening location of the pericardium located proximate the left ventricular apex to provide a workspace.
• FIG. 4 shows removal of the peripath device leaving the guide wire behind within the pericardial space.
• FIG. 5 shows the introduction of a sheath having ultrasound vision and advanced over the guide wire to the opening of the pericardium and penetrating the outer pericardium lining.
• FIG. 6 shows the removal of the guide wire leaving the sheath equipped with ultrasound vision behind penetrating both the chest wall and the pericardium to reach the pericardium space.
• FIG. 7 shows thesheath500 being an elongate cylinder for receiving a periport that is pushed through the sheath into the pericardium space.
• FIG. 8A andFIG. 8B show details of a periport transducer and an exemplary shape of the periport.FIG. 8A comprises an en face view showing a deployable linear transducer array.FIG. 8B shows a side view where the deployable linear transducer array is depicted at one side of the periport having twisted by the surgeon and moved to desired viewing position.
• FIG. 9 shows deployment of the linear transducer array from the periport elongate body at an approximate orthogonal angle by use of a microelectromechanical motor system (MEMS) or a mechanical pulley system. It should be noted that an imaging zone which comprises a wide diameter cone space of ultrasound imaging is intended to capture a large vision of the heart and any tools or devices delivered from the distal (patient end) tip of the periport. The periport may be twisted as discussed above by the surgeon before deployment to achieve an optimal ultrasound vision imaging zone
• FIG. 10A shows details of an exemplary pulley system for raising and for later lowering the linear transducer array of FIG.'s8A,8B and9. The system may comprise first and second pulleys and flexible wires for raising (via the top wire) and lowering (via the bottom wire) the linear ultrasound transducer array at a desired vision location.
• FIG. 10B shows details of an exemplary microelectromechanical motor system (MEMS) having an electric wire lead through the periport to the skin surface for turning on/off the motor and reversing the direction of the MEMS so that the linear transducer array may be either raised for vision or lowered for removal.
• FIG. 11 shows the periport with the linear transducer array deployed between the chest wall and the pericardium and twisted into a position where it may provide vision of the pericardium space, left ventricular apex and the left ventricle (and beyond).
• FIG. 12 shows that the periport, now comprising a portion including a needle referred to as a myopoint needle advanced through the periport which may comprise a distal, bendable periport tip portion deformable by pulley or a MEMS motor and at a proximate position with the linear transducer array having an imaging zone including the myocardium and ventricular apex, the bent periport tip and myopoint needle where myopoint is a contraction of myocardium and point. The bendable portion is bent so as to permit a solid flexible myopoint needle to penetrate the myocardium at an angle so as to preclude blood flow through the angled hole formed by the myopoint needle pushed through the left ventricular apex at an angle.
• FIG. 13 shows that the periport/myopoint solid needle may be straightened by straightening the periport tip portion back to be proximate the left ventricular apex. The straightening occurs in myocardium muscle which is expected to flex and withstand any blood pressure to leak into the pericardial space.
• FIG. 14 shows the periport advancing through the hole made by the myopoint needle into the ventricular space via the needle acting as a guide wire entering the left ventricular apex at an angle and under vision (not shown). The large diameter of the perioport effectively plugs the angular hole at the left ventricular apex and prevents blood from entering the pericardial space.
• FIG. 15 shows the removal of the myopoint needle leaving the periport, under vision, penetrating the myocardium at the left ventricular apex at an angle and preventing blood to flow through the plugged myocardium hole.
• FIG. 16 shows the advancement of a telescoping/multi-channel pericath that is shown in greater detail inFIG. 17. Pericath is short for pericardium, image-guided catheter. The pericath is a series of concentric tubular portions comprising and inner guide wire, an aortic filter delivery catheter, next, a prosthetic valve delivery tube or catheter and surrounded by an outer pericath comprising forward-directed ultrasound vision.
• FIG. 17 is a perspective cross-sectional view of the pericath showing its inner diameter delivery systems comprising tubes or catheters and a central guide wire. The central guide wire is followed in diameter by, an aortic filter delivery catheter tube system; next, a prosthetic valve delivery tube system follows as diameter increases or catheter and the prosthetic valve delivery system is surrounded by the outer pericath catheter.
• FIG. 18 shows deployment of a J-tipped (by way of example) guide wire from the telescoping/multi-channel pericath through a defective heart valve and deployment of the J portion of the tip of the guide wire as it is advanced under ultrasound vision into the ascending aorta. The J tip may prevent any inadvertent damage to the aortic walls and deploys automatically.
• FIG. 19 shows a first delivery of the next layer of the pericath showing a tube or catheter for pushing an undeployed aortic filter advanced over the guide wire to a position in the ascending aorta to filter blood (when opened like an umbrella) and collect particulate material such as plaque.
• FIG. 20 shows positioning and deploying (opening) the aortic filter (or a series of filters in alternative embodiments) like an umbrella and so the aortic filter may extend the entire diameter of the ascending aorta above the defective heart valve and be deployed under ultrasound image guidance.
• FIG. 21 shows the second delivery of the next diameter catheter tube (as it slides forward with the delivery system) for positioning and replacing the defective valve which prosthesis and defective valve remain in position until deployed or expanded like a balloon. The defective valve may operate better even given the prosthesis delivery system because a problem may be that the defective valve does not close tightly so as to deliver blood to the body. The prosthesis delivery system may plug any gap left by operation of the defective aortic valve.
• FIG. 22 shows deployment of the transcatheter valve (by changing its shape from narrow cylindrical to wide, short cylindrical or by releasing liquid as to fill the cylinder “balloon” and, as it is deployed, the defective valve is pushed to an open position and becomes part of the aortic wall. Meanwhile, deployment of the new transcatheter valve (mammal or artificial) should fill the entire gap above the left ventricle outflow tract, for example, like a balloon or by changing shape (for example, using a MEMS) under ultrasound image guidance. No delivery system catheter tubes have been removed yet (for the aortic filter or the prosthesis).
• FIG. 23 shows 1) valve delivery catheter withdrawal, now that the new aortic valve is functioning and 2) aortic filter deflation (like collapse of an umbrella) and subsequent removal of delivery system (not shown). The deflation of the umbrella should capture any captured particulate matter inside its deflated interior and not permit any plaque to escape.FIG. 24A throughFIG. 24D provide details.
• FIG. 24A provides exemplary aortic filter structural detail—closed in dwelling position; architecture and mechanism similar to operation of an umbrella. The distal end comprises an umbrella filter followed by a screw mechanism and an external manipulator is used to open and close the umbrella. For example, clockwise rotation may open the umbrella filter into a deployed position in the ascending aorta (by moving umbrella-like spokes (not shown) and counter-clockwise rotation may close the umbrella filter capturing any particulate material for removal via the catheter delivery system.
• FIG. 24B provides a detailed side cut-away view of the umbrella aortic filter comprising support spokes like an umbrella for opening and deploying the aortic filter or collapsing the filter, the spokes being opened and closed by the twisting represented byFIG. 24A.
• FIG. 24C shows a typical umbrella filter retraction of the delivery system to open the aortic filter via the spokes ofFIG. 24B. The arrow points in the direction of the delivery tube in opening the aortic filter.
• FIG. 24D shows pushing back to fold the spokes and collapse the aortic filter, the arrow again showing the direction of the delivery tube to collapse the filter.
• FIG. 25A shows an alternative aortic filter mechanism comprising a front hood. The filter delivery catheter is this embodiment has a front hood where the collapsed filter resides during transfer to an optimal location in the ascending aorta. Once located there under ultrasound vision, a portion of the delivery catheter is retracted to open the filter. An advantage of this embodiment is that the front hood may prevent any unwanted leakage of captured particulate matter such as plaque.
• FIG. 25B shows 1) the aortic filter ofFIG. 25A pulled back out of the hood (in a direction toward the skin surface) to permit expansion into a filter that fits the entire diameter of the ascending aorta and 2) pushing the hood back collapses the filter into the hood that may capture any particulate matter by the aortic filter inside the filter and inside protective hood portions.
• FIG. 26 shows that the aortic filter may be withdrawn via delivery tube over the guide wire and leaves the J-tip un-straightened and the prosthesis replacement heart valve in operation. The delivery tube for the new heart valve may also be withdrawn at the same time.
• FIG. 27 shows the further removal or withdrawal of the guide wire (all delivery catheter tubes also having been removed) leaving the prosthesis new replacement heart valve in place and the periport still protruding into the left ventricular space at an angle at the ventricular apex.
• The following figures will demonstrate closure of the myocardial angular opening via a closure device introduced through the periport.
• FIG. 28 shows a similar figure toFIG. 27 with a closure device contained within the periport for delivery via the distal (patient) end under image guidance. The periport is now withdrawn to merely serve as a plug to prevent leakage of blood via the myocardium.
• FIG. 29A shows an exemplary closure device arrangement comprising a distal pad and a proximal pad that may be deployed via the periport ofFIG. 28. Two spokes or catheter tubes are used under vision to move the distal and proximal pads into place at the myocardium as will be described by the following figures.
• FIG. 29B shows use of the periport to deliver the closure device through the myocardial wall of the left ventricular apex (apical myocardium shown with the periport still puncturing the myocardium and plugging the hole at the left ventricular apex.
• FIG. 30 shows first the withdrawal of the periport into the pericardial space and simultaneous deployment of the distal pad and its deployment and being pulled to an open position plugging the hole. As of this time, the proximate pad has not yet been deployed. As with the aortic filter, the distal pad may be opened like an umbrella and will prevent any blood leakage into the pericardial space. The closure device distal pad is deployed by withdrawing the catheter (periport) and exposing the self-expanding distal pad to open automatically.
• FIG. 31 shows further movement of the periport with respect to the proximal pad and simultaneous opening of the proximate pad. The closure device proximal pad is deployed by the further withdrawal of the delivery catheter (periport) but is not yet positioned (pushed) toward the myocardium.
• FIG. 32 now shows use of the closure device within the periport to push the proximal device against the myocardium using the delivery catheter (periport) to provide the pushing. The leads still remain and can be used to help pull the distal pad against the pushed proximal pad via respective catheter tubes from the peripad.
• FIG. 33 shows removal of the distal pad and proximal pad retaining tubes (like insulation on a wire), the ends of the harness wires automatically coil as the tubes are removed like pig tails and serve to hold tight the distal pad to the proximal pad with the apical myocardium in between and close off any flow of blood due to blood pressure in the left ventricle. The tubes are shown removed from the wires which automatically pigtail.
• FIG. 34 shows the periport remaining in the pericardial space (cavity) which may be inflated by insertion of fluid andFIG. 34 is intended to show the removal or withdrawal of residual pericardial fluid via a syringe deployed through the periport so that the pericardial space returns to normal via the periport under image guidance.
• FIG. 35 shows the removal of the periport leaving the prosthesis replacement heart valve in place and the myocardium sealed by the closure device with pigtails (not shown).
• FIG. 36 shows an exemplary mitral valve repair mechanism consisting of an inner cylindrical strut inside an outer cylindrical strut, with an elastic band mounted on the inner strut for subsequent deployment.
• FIG. 37A,FIG. 37B, andFIG. 37C show examples of surgical tools which may be delivered to the mitral valve in the inner cylindrical strut.FIG. 37A shows a loop,FIG. 37B shows scissors, andFIG. 37C shows a scalpel. Other tools that may be delivered in the same manner include a suction device, electro-cautery device , a cryo-cautery device, a plunger, or other surgical tools (not shown).
• FIG. 38 shows the use of a bifurcated delivery catheter (periport) to insert a mitral valve prosthesis. Two lumen of a periport may carry two different guide wires (not shown) or a bifurcated lumen (pair of pants legs) may be used for deployment in two different directions. An atrial filter is delivered to and deployed in the ascending aorta through the first opening of the bifurcated periport (in a similar manner as discussed above for an aortic valve replacement and repair), and a prosthetic mitral valve delivery system may be delivered to and deployed to replace a defective mitral valve through the second opening of the bifurcated periport (the defective valve may be deployed and replaced in a similar manner to the aortic valve using the ventricular apex and closed in a similar manner).
• FIG. 39 further shows the use of a bifurcated periport to perform repairs on the mitral valve using the repair mechanism depicted inFIG. 36. An atrial filter is delivered to and deployed in the ascending aorta through the first opening of the bifurcated periport, and a repair mechanism is delivered to the mitral valve region through the second opening of the bifurcated periport.
• FIG. 40 shows the replacement of a commissural stitch to reduce the opening of a valve that cannot fully close because of dilation in its leaflets.FIG. 41A shows a delivery needle for delivering a commissural stitch across two leaflets of a mitral valve.
• FIG. 41B shows the delivery needle advanced through both leaflets of the mitral valve with the pigtail end of the suture protruding from the second leaflet.
• FIG. 41C shows the delivery needle being retracted out of the second leaflet, leaving the suture held in place by the pigtail end.
• FIG. 41D shows a partially delivered commissural stitch with the delivery needle mostly retracted and the leaflets still apart.
• FIG. 41 E shows a fully delivered commissural stitch with the delivery needle fully removed and the suture holding the leaflets together. So as the delivery needle is removed, the leaflets are pulled together reducing the size of the opening in a defective mitral valve.
• FIG. 42A shows the redundant portion of a leaflet being suctioned into the inner cylinder strut carrying an elastic band as perFIG. 36.
• FIG. 42B andFIG. 42C show the redundant portion of the leaflet being suctioned into the inner cylinder strut and an elastic band or loop pushed off the strut and applied to the redundant portion to tighten the leaflet.
• What follows is a detailed discussion of embodiments and methods of the present invention comprising both apparatus and methods for replacement or repair of cardiac valves.
DETAILED DISCUSSION
• The aspects summarized above can be embodied in various forms. The following description shows, by way of illustration, combinations and configurations in which the aspects can be practiced by the various image guided catheter-like devices discussed and utilized in sequence in a method for replacing or repairing a defective heart valve. It is understood that the described aspects and/or embodiments are merely examples. It is also understood that other aspects and/or embodiments can be utilized, and that structural and functional modifications can be made, without departing from the scope of the present disclosure. Furthermore, modifications to the method(s) of repair and replacement of cardiac valves should not be considered limited in scope to the disclosure but may involve known processes and devices and procedures to those of ordinary skill in the art.
• Referring toFIG. 1, there is shown a drawing in two dimensions of theheart100 and chest wall (CW)105 which may be penetrated by an image guided catheter (not shown) or periport (not shown) and other components of a sequence of devices used for cardiac valve replacement and repair. The first example that will be discussed is aortic valve repair. What are shown are themyocardium muscle110, the left ventricle115 (LV), the left atrium120 (LA), the right ventricle130 (RV), the ascending aorta180 (AO), the descending aorta190 (DAo), theleft ventricular apex140 and the left ventricular outflow tract185 (LVOT) of the heart. What is shown of the present invention comprises a guide wire150 (without any surrounding tube structures for filter or prosthesis delivery,aortic filter160 shown), a deployedprosthesis valve170 and a deployed, opened umbrella-likeaortic filter160 to prevent stroke. The prosthesis and filter are shown located between the LVOT and the ascending aorta.FIG. 1 thus provides in abbreviated from a method and apparatus for repairing a heart valve such as theaortic valve170 and preventing stroke via anaortic filter160. The method may utilize many of the patented and patent pending devices disclosed in his prior patents and applications described briefly in the background of the invention but modified to provide specific functionality to facilitate cardiac valve replacement or repair.
• A convention used in this patent application relates to the use of reference numerals such as105 standing for chest wall. Thefirst number1 in105 refers to the figure in which the element first appears and the next two digits05 represent the element identified, in this case, a chest wall (CW).
• Referring toFIG. 2, there is shown an initial step of using an image guided catheter type referred to herein as aperipath220 penetrating thechest wall105 and under ultrasound vision or other vision guidance such as optical coherence tomographic (OCT) vision or other real-time vision method known, theperipath220 reaching the outer lining of thepericardium205, but not yet penetrating thepericardial space210 between inner and outer pericardial linings. Under vision, a site proximate theleft ventricular apex140 is selected for entry (with or without contrast) with no coronaries or vessels in view of a volume of myocardium taken by the introduction of an introducer needle (or guide wire) at an angle through the myocardium. A forward-directed ultrasound transducer at the distal tip of theperipath220 should be high resolution and shallow depth and so comprise high frequency ultrasound on the order of 10 MHz to 1 Gz to select a point of entry at an angle (so as to prevent the loss of blood into thepericardial space210. Themyocardium110 and innerleft ventricular space115 are also shown.
• Preferably a small incision of about five to seven millimeters is all that is required in thechest wall105 to permit entry of theperipath220. The peripath comprises an ultrasound transducer lumen and at least one other lumen for any one of a needle, guide wire, sheath or tool and the same lumen may be used to replace, for example, one ultrasound transducer range with another range for proper vision of a site of interest. Also, the same lumen may be used to replace a solid introducer needle with a hollow needle portion of a syringe if needed. As will be discussed further herein, a syringe may be used to expand the vicinity of the ventricular apex space between the inner and outer pericardial linings to provide room for the surgeon to work.
• Referring now toFIG. 3, a site of entry having been selected as described above, there is shown a similar view of theperipath220 having approached the pericardiumouter lining205, puncturing thepericardium205 outer lining, for example, with a needle and inserting aguide wire150 into thepericardium space210 via a lumen between the outer and inner pericardial linings under vision (for example, ultrasound, with or without a contrast agent. Fluid (not shown yet) may be delivered by a hollow introducer needle (not shown) to expand the pericardial space at the opening location of the pericardium located proximate the left ventricular apex to provide a workspace. Further shown are themyocardium110 and theleft ventricle space115 fromFIG. 1.
• FIG. 4 shows removal of the peripath device leaving theguide wire150 behind within thepericardial space210 and exiting thechest wall105.
• Referring now toFIG. 5, there is shown the introduction of a sheath500 (known in the art) through thechest wall105 having ultrasound or other vision and advanced over theguide wire150 to the opening of the pericardiumouter lining205 and penetrating theouter pericardium lining205.
• Referring now toFIG. 6, there is shown the removal of theguide wire150 leaving thesheath500 equipped with ultrasound vision behind, penetrating both thechest wall105 and the pericardiumouter lining205 to reach thepericardium space210.
• FIG. 7 introduces aperiport700 and shows thesheath500 being an elongate cylinder for receiving a periport700 (pericardium gateway or portal) that is pushed through the sheath into thepericardium space210. Thesheath500 still plugs the hole in the pericardiumouter lining205 and remains stationary (stabilized) for example by suturing at the chest wall.
• FIG. 8A andFIG. 8B show details of a periport transducer and an exemplary shape of the periport.FIG. 8A comprises an enface view of a periport ultrasound transducerlinear array800 of aperiport700 showing a deployablelinear transducer array800.FIG. 8B shows a side view where the deployablelinear transducer array800 is depicted at one side of the periport having been twisted by the surgeon and moved to desired viewing position under vision (ultrasound transducer or other vision not shown).
• Referring toFIG. 9, there is shown deployment of thelinear transducer array800 from theperiport700 elongate body at an approximate orthogonal angle by use of a microelectromechanical motor system (MEMS) or a mechanical pulley system. It should be noted that animaging zone900 which comprises a wide diameter cone space of, for example, ultrasound imaging (with or without a contrast agent, not shown) is intended to capture a large vision of the heart and any tools or devices delivered from the distal (patient end) tip of theperiport700 and surrounding tissue. Theperiport700 may be twisted by the surgeon under vision, as discussed above before deployment to achieve an optimal ultrasound vision cone ofimaging zone900.
• FIG. 10A shows details of an exemplary pulley system for raising and for later lowering the linear transducer array of FIG.'s8A,8B and9. The system may comprise first andsecond pulleys1030,1040 andflexible wires1010,1020 for raising (via the top wire1010) and lowering (via the bottom wire1020) the linearultrasound transducer array800 at a desired vision location for viewing, for example, the heart.
• FIG. 10B shows details of an exemplary microelectromechanical motor system (MEMS) having anelectric wire lead1060 through theperiport700 to the skin surface for turning on/off the MEMS motor and reversing the direction of the MEMS so that thelinear transducer array800 may be either raised for vision or lowered for removal.
• FIG. 11 shows theperiport700 ofsheath500 with thelinear transducer array800 deployed between thechest wall105 and the pericardiumouter lining205 and twisted into a position where it may provide vision of thepericardium space210, left ventricular apex and the left ventricle115 (and beyond).
• FIG. 12 shows that theperiport700, now comprising aportion750 including a needle (unnumbered) referred to as a myopoint needle1200 (advanced by handle1200) advanced through theperiport700 under vision which may comprise a distal, bendableperiport tip portion750 deformable by pulley or a MEMS motor and at a proximate position with thelinear transducer array800 having an imaging zone including themyocardium110 and ventricular apex, thebent periport tip750 andmyopoint needle1200, where myopoint is a contraction of myocardium and point. Thebendable portion750 is bent so as to permit a solidflexible myopoint needle1200 to penetrate the myocardium at an angle so as to preclude blood flow through the angled hole formed by the myopoint needle pushed through the left ventricular apex at an angle. Themyopoint needle1200 may be hollow to permit injection of saline or other benign solution into the pericardial space to produce a work-space within thepericardial space210. Note that thehollow myopoint needle1200 penetrates themyocardium110 at an angle to preclude blood flow into thepericardial space210. Consequently, subsequent closure of the myocardium at the point of entry will comprise a flap and not a direct hole through the myocardium. Intraventricular pressure may close the wound to the ventricular apex.
• FIG. 13 shows that the periport/myopointsolid needle1200 may be straightened by straightening theperiport tip portion750 back toform periport700 again and to be proximate theleft ventricular apex140. The straightening occurs inmyocardium muscle110 which is expected to flex and withstand any blood pressure to leak into thepericardial space210.
• FIG. 14 shows theperiport700 advancing through the hole made by themyopoint needle1200 at theventricular apex140 into theventricular space115 via themyopoint needle1200 acting as a guide wire, theperioport700 entering theleft ventricular apex140 at an angle and under vision (not shown. The large diameter of theperioport700 effectively plugs the angular hole at theleft ventricular apex140 and prevents blood from entering thepericardial space210.
• FIG. 15 shows the removal of themyopoint needle1200 leaving theperiport700, under vision, penetrating themyocardium110 at theleft ventricular apex140 at an angle atperiport portion750 and preventing blood to flow through the plugged myocardium hole. Thepericardial space210 is still shown with added fluid to create a workspace for the surgeon.
• FIG. 16 shows the advancement of a telescoping/multi-channel pericath1600 that is shown in greater detail inFIG. 17. Pericath is short for pericardium, image-guided catheter. Thepericath1600 is a series of concentric tubular portions comprising aninner guide wire150, an aorticfilter delivery catheter1710, next, a prosthetic valve delivery tube orcatheter1720 and surrounded by anouter pericath1600 best seen inFIG. 17 and thepericath1600 comprising forward-directed ultrasound or other vision vision via an elongate lumen and ultrasound transducer(not shown).
• FIG. 17 is a perspective cross-sectional view of thepericath1600 showing its inner diameter delivery systems comprising tubes or catheters and acentral guide wire150. Thecentral guide wire150 is seen inFIG. 17 followed in diameter by, an aortic filter deliverycatheter tube system1710; next, a prosthetic valvedelivery tube system1720 follows as diameter increases or catheter and the prostheticvalve delivery system1720 is surrounded by theouter pericath catheter1600 providing vision.
• Referring now toFIG. 18, there is shown deployment of a J-tipped (by way of example) guide wire150 (central guide wire150 above) from the telescoping/multi-channel pericath1600 through a defectiveaortic heart valve165 and deployment of theJ portion155 of the tip of theguide wire150 as it is advanced under ultrasound vision into the ascendingaorta180. The J tip may prevent any inadventent damage to the aortic walls and deploys automatically. The left atrium chamber of theheart120 is also shown and well as the mitral valve195 (to be discussed later herein). Themyocardium110 surrounds theleft ventricle115 and theleft ventricular apex140 is also shown as the entry point of thepericath1600.
• FIG. 19 shows a first delivery of the next layer of thepericath1600 showing a tube ordelivery catheter1710 for pushing an undeployedaortic filter160 advanced over theguide wire150 withJ tip155 to a position in the ascendingaorta180 to filter blood (when opened like an umbrella) and collect particulate material such as plaque. The delivery catheter passes through defectiveaortic valve165 and does not impact its operation and, as suggested before, may improve its operation by helping when the valve closes off backflow of blood flow. As suggested, but not show, theaortic filter160 may be a series of filters,160-1 and160-2 (not shown) such as a tandem filter or two filters in series within the ascendingaorta180. (Whatever the first aortic filter does not capture in the form of stroke-causing material may be captured by the next filter in line.) The two filters may be delivered by the same delivery system. The aortic filter catheter or delivery system may have a circumferential ultrasound transducer for detection of particulate or emboli matter captured by the filter or which passes to the next filter in line and is captured there. A further feature is the concept of an aortic valve balloon. Such as aortic valve balloon may be positioned and have ultrasound and/or a pressure transducer to gauge the amount of pressure applied circumferentially to the walls of the aorta during balloon inflation and valve deployment.
• In a similar manner, the closure device discussed herein for closure of the myocardium comprising a distal and proximal pad may have monitoring devices including but not limited to ultrasound transducer or Raman spectroscopy devices or pressure transducers to monitor, for example, the amount of squeezing applied under vision of a proximal pad to a distal pad before the insulation is removed and the pigtails deployed. The instruments may be left permanently in the closure device or the aortic valve (singular or tandem) for long-term monitoring.
• Referring now toFIG. 20, there is shown the positioning and deploying (opening) of the aortic filter160 (or a series of plaque-catching filters in alternative embodiments) like an umbrella and so the aortic filter may extend the entire diameter of the ascending aorta above thedefective heart valve165 and be deployed under ultrasound image guidance. Moreover, thefilter160 may be viewed under ultrasound vision, with or without contrast agent as a matter of choice, for blood leakage outside the diameter of theumbrella filter160 and carry plaque to the brain causing a stroke.
• FIG. 21 shows the second delivery of the next diameter catheter tube1720 (as it slides forward with the delivery system) for positioning and replacing thedefective valve165 which prosthesis170 and defective valve remain in position until deployed or expanded like a balloon or reshaped with a MEMS from an elongated cyclinder to a short, fat cylinder, replacing thedefective valve165. Thedefective valve165 may operate better even given theprosthesis delivery system1720 andprosthesis170 because a problem may be that thedefective valve165 does not close tightly so as to deliver blood to the body. Theprosthesis delivery system170 may plug any gap left by operation of the defectiveaortic valve165 and the defective valve better prevent backflow of blood (and loss of blood pressure to the brain).Delivery system1720 is a tube that travels overdelivery system tube1710 which in turn travels over guide wire150 (represented by J tip155).
• FIG. 22 shows deployment of the transcatheter valve170 (by changing its shape from narrow cylindrical to wide, short cylindrical or by releasing liquid as to fill the cylinder “balloon” and, as it is deployed, the defective valve165 (not shown) is pushed to an open position and becomes part of the aortic wall. Meanwhile, deployment of the new transcatheter valve170 (mammal or artificial) should fill the entire gap above the left ventricle outflow tract185 (not shown), for example, like a balloon or by changing shape (for example, using a MEMS) under ultrasound image guidance. No delivery system catheter tubes have been removed yet (for theaortic filter160 or the cardiac valve prosthesis that has just been deployed170).
• FIG. 23 shows 1)valve delivery catheter170 withdrawal withinprosthesis delivery tube1720, now that the newaortic valve170 is functioning and 2)aortic filter160 deflation (like collapse of an umbrella) and concurrent removal of delivery system1710 (not shown). The deflation of theumbrella filter160 should capture any captured particulate matter inside its deflated interior and not permit any plaque to escape. FIG.'s24A throughFIG. 24D provide details.
• FIG. 24A provides exemplaryaortic filter2410,2420,2430 structural detail, thesystem2400 comprising—closed in dwelling position; architecture and mechanism similar to operation of an umbrella. Thedistal end2410 comprises an umbrella filter followed by ascrew mechanism2420 and anexternal manipulator2430 is used to open and close theumbrella2410. For example, clockwise rotation may open theumbrella filter2410 into a deployed position in the ascending aorta180 (by moving umbrella-like spokes (not shown) and counter-clockwise rotation may close theumbrella filter2410 capturing any particulate material for removal via the catheter delivery system.
• FIG. 24B provides a detailed side cut-away view of the umbrellaaortic filter2410 comprisingsupport spokes2440A,2440B,2440C,2440D,2440E and further support spokes as needed such as eight support spokes in total like an umbrella for opening and deploying theaortic filter2410 or collapsing thefilter2410, the, for example, eight spokes being opened and closed by the twisting represented byFIG. 24A in clockwise and counter-clockwise directions.
• FIG. 24C shows atypical umbrella filter2410 retraction of thedelivery system2450 to open theaortic filter2410 via the spokes ofFIG. 24B. The arrow points in the direction of thedelivery tube2450 in opening theaortic filter2410 to its widest diameter possible without damaging aortic walls but precluding leakage of blood from leaking around the open umbrella within the aorta.
• FIG. 24D shows pushing back to fold the spokes and collapse theaortic filter2410, the arrow again showing the exemplary direction of thedelivery tube2450 to collapse thefilter2410.
• Referring now to FIG.'s25A and25B, there is first shown inFIG. 25A an alternativeaortic filter mechanism2500 comprising afront hood2520. Thefilter delivery catheter2540 in this embodiment has afront hood2520 where thecollapsed filter2510 resides during transfer to an optimal location in the ascendingaorta180. Once located there under ultrasound vision, a portion of the delivery catheter is retracted to open thefilter2510. An advantage of this embodiment is that thefront hood2520 may prevent any unwanted leakage of captured particulate matter such as plaque.
• FIG. 25B shows 1) theaortic filter2510 ofFIG. 25A pulled back out of the hood2520 (in a direction toward the skin surface) to permit expansion into afilter2510 that fits the entire diameter of the ascendingaorta180 and 2) pushing the hood back2520 collapses the filter into thehood2520 broken away fromrear delivery portion2540. The combination ofclosing hood2520 back ontorear portion2530 may capture any particulate matter by theaortic filter2510 inside thefilter2510 and insideprotective hood portions2520 and2530. The arrows denote deployment of the filter2510 (gray arrow and gray rear portion) and collapse of the filter (black arrow and back front hood) by pulling on delivery tube/catheter2540.
• FIG. 26 shows that theaortic filter160 may be withdrawn via its delivery tube1710 (not shown) over theguide wire150 and leaves the J-tip155 un-straightened and the prosthesisreplacement heart valve170 in operation. The aortic filter (not shown), being collapsed will not impact the operation of thenew heart valve170. Thedelivery tube1720 for the new heart valve may also be withdrawn at the same time, leaving the J tippedguide wire150,155.
• FIG. 27 shows the further removal or withdrawal of theguide wire150,155 (all delivery catheter tubes also having been removed) leaving the prosthesis newreplacement heart valve170 in place and thepericath1600 still protruding into theleft ventricular space115 at an angle at theleft ventricular apex140.
• The following figures will demonstrate closure of the myocardial angular opening via a closure device introduced through thepericath1600.
• FIG. 28 shows a similar figure toFIG. 27 with a closure device contained within thepericath1600 for delivery via the distal (patient) end under image guidance. Thepericath1600 is now withdrawn to merely serve as a plug to prevent leakage of blood via themyocardium110.
• FIG's29A and29B relate to a closure device for closing the angular hole formed in themyocardium110.
• FIG. 29A shows an exemplary closure device arrangement comprising a distal pad and a proximal pad that may be deployed via thepericath1600 ofFIG. 28. Two spokes orcatheter tubes2930,2940 are used under vision to move thedistal pad2910 andproximal pad2920 into place at themyocardium110 as will be described by the following figures.
• FIG. 29B shows use of the partial view pericath2950 to deliver theclosure device2910,2920,2930,2940,2945 through the myocardial wall of the left ventricular apex140 (apical myocardium shown with the pericath still puncturing the myocardium and plugging the hole at theleft ventricular apex140.
• FIG. 30 shows first the withdrawal of thepericath tip2950 into thepericardial space210 and simultaneous deployment of thedistal pad2910 and its deployment and being pulled to an open position plugging the hole by wire leads2935,2945. As of this time, theproximate pad2920 has not yet been deployed. As with theaortic filter160, thedistal pad2920 may be opened like an umbrella and will prevent any blood leakage into thepericardial space210. The closure devicedistal pad2920 is deployed by withdrawing the catheter (pericath) and exposing the self-expandingdistal pad2920 to open automatically (perFIG. 31).
• Referring toFIG. 31, there is shown further movement of thepericath portion2950 with respect to theproximal pad2920 and simultaneous opening of theproximate pad2920. The closure deviceproximal pad2920 is deployed by the further withdrawal of the delivery catheter (pericath) but is not yet positioned (pushed) toward themyocardium110.
• FIG. 32 now shows use of the closure device within the pericath to push theproximal pad device2920 up against themyocardium110 using the delivery catheter (pericath)portion2950 to provide the pushing. The wire leads2935,2945 still remain within theirinsulation2935 and2945 and can be used to help pull thedistal pad2910 against the pushedproximal pad2920 via respective catheter tubes (insulation)2930,2940 from thepericath portion2950.
• FIG. 33 shows removal of the distal pad and proximal pad retaining tubes orinsulation2730 and2740 (like insulation on a wire, the ends of theharness wires2735,2745 automatically coil as thetubes2730,2740 are removed and leavepermanent pig tails2735,2745 serve to hold tight thedistal pad2710 to theproximal pad2720 with theapical myocardium110 in between and close off any flow of blood due to blood pressure in theleft ventricle115. Thetubes2730,2740 are shown removed from the wires which automatically pigtail.
• FIG. 34 shows theperiport700 remaining in the pericardial space (cavity)210 which may be inflated by insertion of fluid, andFIG. 34 is intended to show the removal or withdrawal of residual pericardial fluid via a syringe (not shown) deployed through theperiport700 so that thepericardial space210 returns to normal via theperiport700 under image guidance.
• FIG. 35 shows the removal of theperiport700 leaving the prosthesis replacement heart valve in place and themyocardium110 sealed by the closure device with pigtails (not shown).
• The following features of the above-described system and method may become apparent to one of skill in the art. Then entry system for delivery of a closure device for closure of themyocardium110 at theleft ventricular apex140 becomes a closure system. An umbrella closure device or an umbrella aortic valve may be provided in alternative embodiments. One embodiment which comes to mind is that a typical umbrella is long and thin when collapse and may require a greater distance of travel in the ascending aorta than if a filter or the left ventricular space than if a known collapsible umbrella with bendable spokes were used and deployed in the manner of a collapsible umbrella (embodiment not shown).
• A further embodiment of an aortic filter or a distal or proximate pad for closure may be referred to as a clam shell like embodiment having first and portions made by cutting a hollow sphere and folding them together like an unopened clam shell comprising two partial hemispheres. These two partial hemispheres could then be opened, for example, by a MEMS to form the aortic filter or the distal or proximal pad closure device.
• In a further closure embodiment, the central channel of a clam shell central channel may be held open by a guide sheath having a valve. Then, the guide sheath is withdrawn and the central channel may collapse and the clam shell be equipped with an occlusive one-way valve mechanism such that the valve may collapse to prevent any blood exit.
• A further alternative scenario to that just described comprises a guide sheath with a one-way valve that becomes the myocardial portal (entry at the left ventricular apex). When the closure procedure has been completed, a guide wire may be introduced through the guide sheath, the guide sheath removed via the guide wire and the clam shell closure device deployed under ultrasound vision.
• FIG. 36, FIG.'s37A through37C,FIG. 38,FIG. 39,FIG. 40, FIG. 's41A through41 E and FIG.'s42A through42C relate to mitral valve repair or replacement. It will be seen that similar principles, apparatus and processes are utilized for the mitral valve and, under certain circumstances and with the surgeon's discretion, these Figures show processes that may be used simultaneously with aortic valve repair or replacement as discussed above. Under vision, such as ultrasound vision, with or without use of contrast agents, varying degrees of mitral repair may be performed using the same periport devices. Potential sites of mitral intervention comprise but are not limited to comprise the annulus, the commissure (discussed in some detail), one or both leaflets and the chords among other mitral components.
• FIG. 36 shows an exemplary mitral valve repair mechanism consisting of an inner cylindrical strut inside an outercylindrical strut3620, with anelastic band3630 mounted on theinner strut3620 for subsequent deployment. The intention is to capture loose leaflets of the mitral valve with the elastic band to repair a defective mitral valve which may have excess leaflet material that may be captured and banded by the elastic band (which should comprise a non-allergic material).
• FIG. 37A,FIG. 37B, andFIG. 37C show examples of surgical tools which may be delivered to the mitral valve in the innercylindrical strut3620 of the mitral valve repair mechanism ofFIG. 37 which may be used in conjunction withelastic band3630 or to capture leaflet material or cut the material. For example,FIG. 37A shows aloop3720 delivered bystrut3620 which may be used to surround and capture mitral valve leaflet material (for example, for banding or cutting).FIG. 37B showsscissors3720 which may be used to cut off excess leaflet material and be deployed viastrut3620. A similar tool, not shown, is a clasper that may clasp the cut excess material for removal.FIG. 37C shows ascalpel3730 which also may be used for making an incision or cutting leaflet material of the mitral valve or for any other known purposes a mini-scalpel would be useful for in regard to repair of a cardiac valve such as the mitral valve. Other tools that may be delivered in the same manner via theinner strut3620 include a suction device, an electro-cautery device, a cryo-cautery device, a plunger, or other surgical tools (not shown).
• FIG. 38 shows the use of a bifurcated delivery catheter (periport)3810 to insert amitral valve prosthesis3833 to replace a defective mitral valve in a similar manner to the process described above for replacement of an aortic valve except that two different paths will be followed by guide wires and delivery system tubes and the like to replace the defective mitral valve. In one embodiment not shown, two lumens of a periport3810 (image guided catheter) may carry two different guide wires (not shown) through the ventricular apex of amyocardium110 as discussed above. Shown inFIG. 38 is a bifurcated lumen (pair of pants legs)3811 and3812 forming a bifurcated front end which may be used for deployment in two different directions from thebifurcated periport body3810 toward, for example, the ascendingaorta180 and the mitral valve4000 (introduced below). An atrial filter3823 (opened like an umbrella as already discussed above) is delivered to and deployed in the ascendingaorta180 via, for example, a J-tippedguide wire3820 and an automatically deploying J protector. The filter delivery system, only theguide wire3820 is shown deployed through thefirst opening3811 of the bifurcated periport3810 (in a similar manner as discussed above for an aortic valve replacement and repair). As above, the purpose of the aortic filter is to capture any particulate matter which may cause a stroke as un-filtered blood may deliver, for example, plaque material to the brain. A prosthetic mitral valve delivery system (not shown but described above for the aortic valve) may be delivered to and deployed over a second J-tippedguide wire3830,3831 with the J protector automatically deploying.Prosthesis3833 carries a mitral valve which is deployed by a slender cylinder to comprise a short fat cylinder carrying thevalve3833 to replace a defectivemitral valve3832,4000 through the second opening of thebifurcated periport3812. (Thedefective valve3832,4000 may be deployed and replaced in a similar manner to the aortic valve using theleft ventricular apex140 entered at an angle and themyocardium110 closed in a similar manner as discussed above).
• Referring toFIG. 39, this figure further shows the use of abifurcated periport3810pant legs3811,3812 (or two lumens) to perform repairs on themitral valve3832 using the repair mechanisms depicted inFIG. 36, using tools shown inFIG. 36 and FIG.'s37A through37C and other tools used under discretion of the surgeon via thesecond pants leg3812 showing first and second repairmechanism delivery systems3600. For example, one delivery system may carry scissors and another delivery system a grasper to grasp any cut leaflet material by the scissors or scalpel of the defectivemitral valve3832. Anatrial filter3823 is delivered to and deployed in the ascendingaorta180 through thefirst opening3811 of thebifurcated periport3810 using, for example, a J-tippedguide wire3820,3823. The repair mechanism or combination of repair systems is delivered to themitral valve region3832 through thesecond opening3812 of thebifurcated periport3810.
• FIG. 40 shows the placement of acommissural stitch4050 to reduce the opening of amitral valve4000 that cannot fully close comprising afirst commissure4010 and a second commissure which are open because of dilation in its leaflets whereleaflet4030 comprises a first leaflet of themitral valve4000 andleaflet4040 comprises a second leaflet of themitral valve4000.
• FIG.'s41A through41E show a process for affecting a commissural stitch—either a corkscrew or a single stitch—delivered across twoleaflets4030 and4040 to attempt to partially close the large opening of the mitral valve between the two leaflets.
• FIG. 41A shows adelivery needle assembly4100 with an internal, unlabeled needle inside a sheath for delivering a commissural stitch across two leaflets of a mitral valve (not shown) inFIG. 41A.
• Referring now toFIG. 41B, there is seen theneedle sheath4110 carrying a needle within, thefirst leaflet4030, thesecond leaflet4040 and thehollow delivery needle4115 deployed in a circular fashion to puncture bothleaflets4030 and4040. Moreover, thedelivery needle4115 is advanced through bothleaflets4030,4040 of the mitral valve carrying a wire with an automatically deployedpigtail end4230 of the suture protruding from thesecond leaflet4040.
• FIG. 41C shows thedelivery needle4115 being retracted out of thesecond leaflet4040, leaving thesuture4120 held in place by thepigtail end4130.
• FIG. 41D shows that a pulling has occurred of thedelivery needle4115. The deliveredcommissural stitch4120 with thepigtail end4130 has been deployed from thesecond leaflet4040 with thedelivery needle4115 mostly retracted and the twoleaflets4030 and4040 still apart leaving the same sized opening. Then, the delivery needle is pulled through thefirst leaflet4030 tightening the stitch.
• FIG. 41E shows a fully deliveredcommissural stitch4120,4140 pigtail end and4130 pigtail end of the stitch with thedelivery needle4115 fully removed and the suture holding the leaflets closer together. So as thedelivery needle4115 is removed, theleaflets4030,4040 are pulled together reducing the size of the opening in a defective mitral valve. Theneedle delivery assembly4100 is then removed via theguide wire3830 and the J-tip3831 straightened (not shown).
• FIG.'s42A through42C demonstrate the use of suction to suck a portion ofleaflet material4210 intostrut3620 and then deliverelastic band3630 to tighten the opening of the mitral valve.
• FIG. 42A shows a redundant portion of aleaflet4210 being suctioned into theinner cylinder strut3620 carrying anelastic band3630 viaoutside strut3610 as perFIG. 36.
• FIG. 42B andFIG. 42C show the redundant portion of theleaflet4210 being suctioned into theinner cylinder strut3620 by applyingsuction4220 to gather material4210 into theelastic band3620 and then inFIG. 42C, the surgeon releases the elastic band3640 to tighten aroundexcess leaflet material4230 taken from first orsecond leaflet4210. Anelastic band3630 may be pushed off thestrut3620 and applied to the redundant portion to tighten the leaflet. Theloop3710 ofFIG. 37A may be used to gatherexcess leaflet4210 material.
• Access to other organs, structures, and spaces can be performed in similar fashion with appropriate procedural modifications specific for the particular organs, structures or spaces.
• All documents mentioned herein are incorporated by reference herein as to any description which may be deemed essential to an understanding of illustrated and discussed aspects and embodiments of devices and methods herein.
• Although the devices and methods discussed above and primarily illustrated and described herein provide instruments that also can be adapted for performing minimally invasive diagnostic or therapeutic procedures on humans, it will be appreciated by those skilled in the art that such instruments and methods also are adaptable for use in other surgical procedures as well as in performing various veterinary surgeries. Further, while several preferred embodiments have been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims.

Claims (3)

What is claimed is:

1. Apparatus for ultrasound image guided percutaneous cardiac valve replacement or repair comprising in combination:

an image guided catheter for entry via an incision in the chest wall and by ultrasound vision guidance to a site proximate the left ventricular apex of a heart myocardium,

a guide wire for introduction via the image guided catheter into the pericardial space,

a sheath for entry via the guide wire through the chest wall to pass through and into the pericardial space,

a pericardium portal introduced through the sheath into the pericardial space replacing the guide wire.

a pericardium ultrasound transducer deployable from the pericardium portal having an imaging zone of the left ventricle and the ascending aorta,

a myocardial needle delivery system comprising a bendable portion of the pericardium portal and a myocardial needle for puncturing the myocardium at a site proximate the left ventricular apex, and

an aortic valve delivery system for delivery of an aortic valve prosthesis and a further delivery system for delivering at least one aortic filter.

2. The apparatus ofclaim 1 further comprising

a closure device for closing the punctured myocardium comprising a distal pad and a proximal pad.

3. The apparatus ofclaim 1 further comprising

an aortic filter delivery catheter circumferentially surrounding a guide wire,

a prosthetic valve delivery catheter circumferentially surrounding the aortic filter delivery catheter, and

a pericardium catheter circumferentially surrounding the prosthetic valve delivery catheter.

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