Fixation band for affixing a prosthetic heart valve to tissue

Information

  • Patent Grant
  • 9539088
  • Patent Number
    9,539,088
  • Date Filed
    Thursday, October 1, 2009
    15 years ago
  • Date Issued
    Tuesday, January 10, 2017
    7 years ago
Abstract
A fixation band for affixing a prosthetic heart valve to tissue having proximal and distal annular portions positionable relative to one another, the proximal and distal annular portions each having a proximal and distal sides, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and a prosthetic heart valve being attachable to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device operative between the proximal and distal annular portions for selectively positioning the proximal and distal annular members toward one another for compressing the staples therebetween and deploying the staples into tissue so as to affix the prosthetic heart valve to tissue.
Description
FIELD OF THE INVENTION

This invention relates to surgical apparatus in general, and more particularly to prosthetic heart valves.


BACKGROUND OF THE INVENTION

The human heart consists of four chambers: the right atrium for receiving blood from systemic circulation; the right ventricle for receiving blood from the right atrium and pumping it to the lungs; the left atrium for receiving oxygenated blood from the lungs; and the left ventricle for receiving oxygenated blood from the left atrium and pumping it to systemic circulation.


The human heart also consists of four valves: the tricuspid valve located between the right atrium and the right ventricle; the pulmonary valve located at the output of the right ventricle; the mitral valve located between the left atrium and the left ventricle; and the aortic valve located at the output of the left ventricle.


In some circumstances (e.g., a birth defect, disease, etc.) a natural heart valve may need to be replaced by a prosthetic heart valve. In this situation, sometimes referred to as “on pump” surgery, the patient must be placed on a heart-lung machine and the heart stopped while the defective heart valve is removed and the prosthetic heart valve installed through a major incision made in the wall of the heart. The prosthetic heart valve is typically sutured in place at the annulus, or seat, of the natural heart valve using a sewing cuff disposed about the circular periphery of the prosthetic heart valve.


While such surgery is typically successful, it is also highly traumatic to the body and the use of the heart-lung machine may raise issues of subtle mental impairment in the near term following surgery.


In view of the trauma associated with a major heart wall incision and possible subtle mental impairment which may be associated with the use of a heart-lung machine, it has been proposed to effect valve replacement without placing the patient on a heart-lung machine and stopping the heart. See, for example, PCT Patent Application No. PCT/US00/02126, filed Jan. 27, 2000 by Gregory Lambrecht et al. for CARDIAC VALVE PROCEDURE METHODS AND DEVICES, published Aug. 3, 2000 as PCT Patent Publication No. WO 00/44313. This type of surgery is sometimes referred to as “off-pump”, or “beating heart”, surgery.


It has been recognized that if a heart valve is to be replaced with “off-pump”, “beating heart” surgery, the incisions made into the vascular system should be as small as possible. However, this can make it difficult to secure the prosthetic heart valve in place, since the prosthetic heart valve is typically sutured to the annulus, or seat, of the natural heart valve, and since suturing (including knot tying) can be difficult to effect through small incisions. This can be particularly true where the incisions may be made into the vascular system at a location remote from the valve seat, e.g., in the superior vena cava in the case of the tricuspid valve, or in the pulmonary artery in the case of the pulmonary valve, or the pulmonary veins in the case of the mitral valve, or the aorta in the case of the aortic valve.


SUMMARY OF THE INVENTION

As a result, one object of the present invention is to provide novel apparatus for quickly, easily and conveniently affixing a prosthetic heart valve in position within the heart.


Another object of the present invention is to provide a novel fixation band for affixing a prosthetic heart valve in position within the heart.


And another object of the present invention is to provide a novel method for affixing a prosthetic heart valve in position within the heart.


These and other objects of the present invention are addressed by the provision and use of a novel fixation band for affixing a prosthetic heart valve in position within the heart.


In one preferred form of the invention, the fixation band generally comprises a tubular frame having a distal end and a proximal end, and a tube having a distal end and a proximal end. The tubular frame comprises a plurality of longitudinally-extending members each having a hook on its distal end and fixation means on its proximal end. The tubular frame also comprises at least one laterally-extending member for stabilizing the longitudinally-extending members relative to one another so as to form the complete tubular frame. The tube is positioned inside the longitudinally-extending members, with the distal end of the tube being everted back over the aforementioned hooks. A sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members.


In use, a standard prosthetic valve is secured to the distal end of the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff. Next, the prosthetic valve, with fixation band attached, is advanced to the valve's seat. Then the fixation band's tubular frame is pulled proximally slightly. This action causes the ends of the hooks to pass through the side wall of the everted tube and into the surrounding tissue at the valve's seat, whereby the fixation band, and hence the prosthetic valve, will be fixed against further proximal movement. Next, the fixation band's fixation means are deployed so as to secure the proximal end of the fixation band to the surrounding tissue, whereby the fixation band, and hence the prosthetic valve, will be fixed against distal movement.


In one form of the invention, the fixation means may be deployed by bending them radially outwardly so that they engage the surrounding tissue.


In another form of the present invention, the fixation means may be deployed by removing a restraining device, whereby the fixation means will automatically deploy against the surrounding tissue.


In another form of the present invention, there is provided a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a structure having a proximal end and a distal end in opposition to one another, and a lateral region between the proximal end and the distal end, wherein the prosthetic heart valve is attached to one of the proximal end and the distal end of the structure; a plurality of barbs selectively configurable between a first position and a second position, the barbs being contained within a peripheral boundary of the lateral region of the structure in the first position, and the barbs being extended from the peripheral boundary of the lateral region of the structure in the second position; and an actuator for selectively moving the plurality of barbs between the first position and the second position.


In another form of the present invention, there is provided a prosthetic heart valve assembly comprising: a prosthetic heart valve comprising a frame, at least one leaflet adapted to open and close relative to the frame; and a fixation band for affixing the prosthetic heart valve to tissue, the fixation band comprising: a structure having a proximal end and a distal end in opposition to one another, and a lateral region between the proximal end and the distal end, wherein the prosthetic heart valve is attached to one of the proximal end and the distal end of the structure; a plurality of barbs selectively configurable between a first position and a second position, the barbs being contained within a peripheral boundary of the lateral region of the structure in the first position, and the barbs being extended from the peripheral boundary of the lateral region of the structure in the second position; and an actuator for selectively moving the plurality of barbs between the first position and the second position.


In another form of the present invention, there is provided a method for affixing a prosthetic heart valve to tissue, the method comprising: providing a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a structure having a proximal end and a distal end in opposition to one another, and a lateral region between the proximal end and the distal end, wherein the prosthetic heart valve is attached to one of the proximal end and the distal end of the structure; a plurality of barbs selectively configurable between a first position and a second position, the barbs being contained within a peripheral boundary of the lateral region of the structure in the first position, and the barbs being extended from the peripheral boundary of the lateral region of the structure in the second position; and an actuator for selectively moving the plurality of barbs between the first position and the second position; positioning the fixation band adjacent to the tissue; and actuating the fixation band so as to affix the prosthetic valve to tissue.


In another form of the present invention, there is provided a method for affixing a prosthetic heart valve to tissue, the method comprising: positioning a fixation band adjacent to the tissue; and removing a pin in engagement with a spring in a loaded configuration so as to release the spring, cause a cog to rotate, and deploy barbs through a lateral portion of the fixation band into the tissue surrounding the fixation band.


In another form of the present invention, there is provided a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a proximal annular portion and a distal annular portion selectively positioned relatively to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and the prosthetic heart valve being attached to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; a plurality of staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device in attachment to the proximal annular portion and the distal annular portion, the compression device being configured to selectively position the proximal annular member and the distal annular member toward one another so as to compress the plurality of staples therebetween and deploy the plurality of staples into tissue so as to affix the prosthetic heart valve to the tissue.


In another form of the present invention, there is provided a prosthetic heart valve assembly comprising: a prosthetic heart valve comprising a frame, and at least one leaflet adapted to open and close relative to the frame; and a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a proximal annular portion and a distal annular portion selectively positioned relatively to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and the prosthetic heart valve being attached to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; a plurality of staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device in attachment to the proximal annular portion and the distal annular portion, the compression device being configured to selectively position the proximal annular member and the distal annular member toward one another so as to compress the plurality of staples therebetween and deploy the plurality of staples into tissue so as to affix the prosthetic heart valve to the tissue.


In another form of the present invention, there is provided a method for affixing a prosthetic heart valve to tissue, the method comprising: providing a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a proximal annular portion and a distal annular portion selectively positioned relatively to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and the prosthetic heart valve being attached to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; a plurality of staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device in attachment to the proximal annular portion and the distal annular portion, the compression device being configured to selectively position the proximal annular member and the distal annular member toward one another so as to compress the plurality of staples therebetween and deploy the plurality of staples into tissue so as to affix the prosthetic heart valve to the tissue; positioning the fixation band adjacent to the tissue; and actuating the compression device so as to move the proximal annular portion and the distal annular portion toward one another so as to deploy the plurality of staples into the tissue.


In another form of the present invention, there is provided a method for affixing a prosthetic heart valve to tissue, the method comprising: positioning a fixation band having the prosthetic heart valve attached thereto adjacent to the tissue; and actuating a compression device attached to the fixation band so as to move a proximal annular portion and a distal annular portion of the fixation band toward one another so as to deploy a plurality of staples into the tissue.


In another form of the present invention, there is provided a method for affixing a prosthetic heart valve to tissue, the method comprising: positioning a fixation band adjacent to tissue; actuating a compression device attached to the fixation band to move a proximal annular portion and a distal annular portion of the fixation band toward one another so as to deploy a plurality of staples into the tissue; and attaching the prosthetic heart valve to the fixation band.





BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:



FIG. 1 is a schematic view of a fixation band formed in accordance with the present invention;



FIG. 2 is a schematic view of the fixation band's tubular frame;



FIG. 3 is a schematic view of the fixation band's tube prior to its assembly with the tubular frame;



FIG. 4 is a schematic view of the complete fixation band shown in FIG. 1;



FIG. 5 is a schematic view showing a prosthetic heart valve secured to the fixation band of FIG. 1;



FIG. 6 is a schematic view showing the assembly of FIG. 5 after deployment of the fixation band's distal hooks;



FIG. 7 is a schematic view showing the assembly of FIG. 6 after deployment of the fixation band's proximal fixation means;



FIG. 8 is a schematic view showing a restraining device for restraining the fixation band's proximal fixation mean;



FIGS. 9A-12B are schematic views showing a fixation apparatus having side deploying barbs;



FIGS. 13A-13D are schematic views showing a heart valve replacement using the side deploying fixation apparatus shown in FIGS. 9A-12B;



FIGS. 14-30 are schematic views showing fixation apparatus having compression deploying barbs; and



FIGS. 31 and 32 are schematic views showing a heart valve replacement using a left ventrical approach;



FIGS. 33-35 are schematic views showing fixation of an prosthetic aortic heart valve at an annulus of the native aortic valve;



FIGS. 36-39 are schematic views showing fixation of an prosthetic heart valve using snap fit means; and



FIG. 40 is a schematic view showing another embodiment of a prosthetic heart valve using snap fit means.





DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Looking first at FIG. 1, there is shown a fixation band 5 which comprises one preferred form of the invention. Fixation band 5 generally comprises a tubular frame 10 and a tube 15.


Tubular frame 10 is shown in greater detail in FIG. 2. Tubular frame 10 generally comprises a distal end 20 and a proximal end 25. Tubular frame 10 comprises a plurality of longitudinally-extending members 30 each having a hook 35 on its distal end, and fixation means 40 (discussed in further detail below) on its proximal end. Tubular frame 10 also comprises at least one laterally-extending member 45 for stabilizing the longitudinally-extending members 30 relative to one another so as to form the complete tubular frame. In one form of the invention, each laterally-extending member 45 extends completely around the circumference of the frame, in the manner shown in FIG. 2. Alternatively, a series of separate laterally-extending members 45 may be used to span the circumference of tubular frame 10. Furthermore, in one form of the invention, laterally-extending member 45 may be in the form of a circular hoop, like the hoop of a barrel, such as the laterally-extending member 47 shown in FIG. 2. Alternatively, and/or in addition, laterally-extending member 45 may have a serpentine configuration, such as the laterally-extending member 48 shown in FIG. 2.


Tube 15 is, initially, an ordinary straight tube such as is shown in FIG. 3, i.e., it is a hollow structure having a distal end 50, a proximal end 55 and a central lumen 60 extending therebetween. Tube 15 is preferably formed out of material which is easily incorporated in tissue, e.g., Dacron polyester or the like. Tube 15 may be vertically pleated or elastic, whereby to allow the material to stretch radially.


Tube 15 is preferably mounted to tubular frame 10 as follows. First, the distal end 50 of tube 15 is passed, distally, down the interior of tubular frame 10. Then the distal end 50 of tube 15 is everted (FIG. 4) so as to fold it back over, and cover, the hooks 35 of longitudinally-extending members 30.


As this is done, a sewing cuff 65 is formed in tube 15 distal to the distalmost end of longitudinally-extending members 30. Tube 15 may then be secured in this position, e.g., with sutures 70 maintaining sewing cuff 65 and with sutures 80 holding tube 15 to longitudinally-extending members 30.


In use, a standard prosthetic heart valve 85 (FIG. 5) is secured to the distal end of fixation band 5 by sewing the prosthetic heart valve's sewing cuff 90 to the fixation band's sewing cuff 65. Next, the prosthetic valve 85, with fixation band 5 attached, is advanced to the valve's seat. Then the fixation band's tubular frame 10 is pulled proximally slightly. This action causes the ends of the hooks 35 to pass through the side wall of the everted tube 15 (FIG. 6) and into the surrounding tissue T at the valve's seat, whereby fixation band 5, and hence prosthetic valve 85, will be fixed against further proximal movement. Next, the fixation band's fixation means 40 are deployed (FIG. 7) so as to secure the proximal end of the fixation band to surrounding tissue, whereby the fixation band, and hence the prosthetic valve, will be fixed against distal movement. Where the fixation means 40 are secured to the proximal end of tube 15, the proximal end of tube 15 will follow the curvature of the deploying fixation means 40, such as is shown in FIG. 7. Alternatively, if fixation means 40 are free to move independently outboard relative to the proximal end of tube 40, either because they are not secured to tube 15 or they extend past the proximal end of the tube, fixation means 40 are free to move separately into the surrounding tissue.


In one form of the invention, fixation means 40 may be deployed by bending the proximal ends of longitudinally-extending members 30 outwardly, e.g., with an annular forming tool or a forceps-type device.


In another form of the invention, fixation means 40 may be deployed by removing a restraining device, e.g., a collar 87 (FIG. 8), whereby fixation means 40 will automatically deploy against the surrounding tissue.


Fixation band 5 may be used to affix prosthetic heart valve 85 to tissue in a conventional on-pump surgical procedure. Alternatively, and more preferably, fixation band 5 may be used to affix prosthetic heart valve 85 to tissue in a beating heart, off-pump surgical procedure. In this case, the assembled heart valve 85 and fixation band 5 are advanced to the intended valve seat by passing the assembly through an appropriate vascular pathway, e.g., in the case of the aortic valve, by passing the assembly down the aorta.


It should be appreciated that various modifications may be made to the preferred embodiments described above without departing from the scope of the present invention. Thus, for example, in the foregoing description, tubular frame 10 is described as being fully assembled (i.e., laterally-extending member 45 is secured to longitudinally-extending member 30) prior to being joined with tube 15 so as to form the complete fixation band 5. However, it should also be appreciated that longitudinally-extending members 30 and/or the laterally-extending member 45 may be secured to tube 15 prior to being joined to one another.


Furthermore, in the foregoing description, tube 15 is described as being, prior to eversion, an ordinary straight tube. However, if desired, tube 15 could be flared outwardly toward its distal end 50 to facilitate eversion over hooks 35, and/or it could include a radially-extending flange at its distal end to facilitate eversion over hooks 35, where the flange may be formed separately from the main body of the tube.


Referring next to FIGS. 9A-13D, there is shown a side deploying apparatus 90 for affixing an prosthetic aortic heart valve 95 in position inside the aorta. Side deploying apparatus 90 is a multi-state device that can be safely guided into the aorta, properly positioned near the annulus of the native aortic valve, and then, by either automatic action or operator control, be deployed by means of introducing a number of barbs 100 into the aortic valve annulus. Side deploying apparatus 90 may also have the capability of its barbs 100 being retracted for either better positioning or removal.


Looking now at FIGS. 9A-9D, in a preferred embodiment of the present invention, apparatus 90 comprises two shell portions 105 and two cog portions 110. In FIG. 9A, apparatus 90 is shown assembled and its barbs 100 deployed. In FIG. 9B, apparatus 90 is shown assembled, attached to a prosthetic valve 95 and its barbs 100 deployed, which keeps prosthetic valve 95 stationary relative to the wall of the aorta. Three significant features of shell 105 are: studs 115, which act as anchors for cog 110; the exit tracts 120, which allow for barbs 100 of cog 110 to exit shells 105; and the pinholes 125 through which actuating pins 130 (FIG. 11B) are inserted.


Looking now at FIGS. 11A and 11B, cog 110 is shown in a “loaded” form inside shell 105. Two cogs 110 are the moving parts of apparatus 90 and reside sandwiched next to each other inside shells 105, but in opposing directions to one another. Referring again to FIGS. 11A and 11B, cog 110 has several significant features integral to its function: eyelets 135, springs 140, barbs 100, and pinholes 142. When in the loaded state, springs 140 of cog 110 are stretched and barbs 100 are folded down while studs 115 on shell 105 protrude through eyelets 135 and pins 130 are inserted through pinholes 142 so as to maintain the position of each cog 110 relative to shell 105.


Looking now at FIGS. 12A and 12B, cog 110 is shown in the “deployed” form relative to shell 105. Here, barbs 100 are extended through exit tracts 120 and springs 140 are no longer stretched. Apparatus 90 can be transformed into the deployed state by removing pins 130 from pinholes 142 of each cog 110. When this happens, springs 140 each contract so as to rotate cog 110 relative to studs 115 of shell 105 and force barbs 100 out of exit tracks 120. To retract apparatus 90, force on pinholes 142 must be re-applied and cog 110 rotated back to its loaded position (see FIGS. 11A and 11B).


Looking next at FIGS. 13A-13D, there is shown an example of a typical heart valve replacement. In FIG. 13A, there is shown an aorta 145 with a native aortic valve 150. In FIG. 13B, aorta 145 is shown after valve 150 has been removed. In FIG. 13C, side deploying apparatus 90 is shown in an undeployed state (see FIGS. 11A and 11B) inside aorta 145. In FIG. 13D, side deploying apparatus 90 is shown in a deployed state (see FIGS. 12A and 12B) inside aorta 145.


In the preceding description, side deploying apparatus 90 is described in the context of affixing an prosthetic heart valve 95 in position within the aortic valve annulus. In this respect it should also be appreciated, however, that side deploying apparatus 90 may be used to affix some other heart valve within another cardiovascular structure.


Referring now to FIGS. 14-40, there is shown an apparatus 155 (FIG. 14) for affixing an prosthetic aortic valve 160 (FIG. 17) in position inside the aortic valve annulus. Apparatus 155 is a compressive device that can be safely guided into the aorta, properly positioned near the annulus of the native aortic valve, and then, by either automatic action or operator control, deployed by means of advancing staples 165 (FIG. 17) into the aortic valve annulus. Compressive apparatus 155 may also have the capability of having its staples 165 retracted for either better positioning or removal of the apparatus. Compressive apparatus 155 may be positioned for fixation above, below, or at the annulus of the native aortic valve. Compressive apparatus 155 may also be positioned using an aortic approach or a left ventricular approach so as to advance it toward the annulus of the native aortic valve.


Looking now at FIGS. 14-22, in a preferred embodiment of the present invention, compressive apparatus 155 comprises a top ring 170 and a bottom ring 175 selectively positionable relative to one another by connector portions 180. Top ring 170 and bottom ring 175 each have a surface, forming an anvil 185, facing one another. In a preferred embodiment of the present invention, each anvil 185 (on top ring 170 and bottom ring 175) is shaped in an opening curve configuration so as to form a “C” shaped staple 165 (see FIG. 19) when deployed. In an alternative preferred embodiment of the present invention, each anvil 185 is shaped with a closing curve so as to form a “B” shaped staple (not shown) when deployed.


Looking next at FIGS. 17-22, in a preferred embodiment of the invention, apparatus 155 includes deployment means 190 for selectively actuating top ring 170 and bottom ring 175 relative to one another. Deployment means 190 generally comprise a handle 195, a plurality of cables 200 selectively connected to bottom ring 175 and extending to handle 195, and a support 205 selectively engaging top ring 170 and slidably connected to handle 200. In one preferred embodiment of the present invention, support 205 (see FIG. 16) comprises a solid component having passages 210 for blood flow formed therein. In another preferred embodiment of the invention, support 205 comprises three legs 215 (FIG. 17), which allow blood flow therebetween.


Now referring to FIGS. 17-22, in a preferred embodiment of the present invention, there is shown the compressive apparatus 155 and the prosthetic aortic heart valve 160 in connection to one another. Preferably, this connection is performed prior to implantation, either in an operating room by a physician or a manufacturing site by a manufacturer. In another preferred embodiment of the present invention, apparatus 155 and prosthetic aortic heart valve 160 are connected to one another in vivo, either prior to, or subsequent to, the fixation of apparatus 155 at or adjacent to an annulus of a native aortic heart valve (not shown).


Looking next at FIGS. 17 and 18, apparatus 155 is shown prior to actuation, with top ring 170 and bottom ring 175 spaced apart from one another. While in this configuration, apparatus 155 is positioned at a desired deployment site, at or adjacent to the annulus of the native aortic valve (not shown).


Looking next at FIGS. 19 and 20, apparatus 155 is shown subsequent to actuation, with top ring 170 and bottom ring 175 having been brought toward one another. In this configuration, staples 165 are deployed in a “C” configuration, extending away from each anvil 185, as top ring 170 and bottom ring 175 are drawn together. This deployment is effected by moving handle 195 away from support 205 (while applying a force on support 205 to prevent it from also moving with handle 195) so that cables 200 pull bottom ring 175 toward top ring 170, which is held stationary by legs 215.


Looking now at FIGS. 21 and 22, deployment means 190 are shown disconnected from apparatus 155 and prosthetic aortic valve 160, with apparatus 155 shown configured for attachment at or adjacent to the annulus of a native aortic heart valve (not shown). Deployment means 190 is configured to disengage from apparatus 155 when handle 195 is moved away from apparatus 155 without holding support 205 stationary; as this occurs, cables 200 withdraw from bottom ring 175 and legs 215, which are pivotally attached together, collapse so that they can be withdrawn through a narrow opening.


Looking next at FIGS. 23-25, apparatus 155 is shown being actuated by a tubular controller 220. Tubular controller 220 generally comprises a grasper 225 for selective attachment to handle 195, and a tube 230 surrounding grasper 225 for selectively engaging support 205. When compression apparatus 155 is to be deployed (i.e., when it is to have its rings 170 and 175 drawn together so as to deform the staples 165), tube 230 is held against support 205 while grasper 225 pulls handle 195 away from support 205. When deployment means 190 are to be withdrawn from compression apparatus 155, tubular controller is withdrawn from compression apparatus 155 by simultaneously withdrawing both grasper 225 and tube 230.


Referring now to FIGS. 26-29, there is shown apparatus 155 having a single-anvil 185 for forming staple 165 into a “half-c” configuration. In this embodiment, apparatus 155 may be configured with a height of about half that of an apparatus 155 that forms a “C” configuration.


Looking now at FIGS. 30-32, in a preferred embodiment of the present invention, there is shown apparatus being placed super-annular, i.e., on the aorta side of the aortic valve. This placement of apparatus 155 superior to the annulus is preferably performed using a left ventricle approach through the heart. For such a procedure, a collapsible support 205 may be used. Alternatively, a non-collapsible support (not shown) may be used. As shown in FIGS. 31 and 32, a punch 235 may be used to resect the native aortic valve, with the punch approaching from either a left ventricle approach (FIG. 31) or an aortic approach (FIG. 32).


Looking at FIGS. 33-35, in a preferred embodiment of the present invention, there is shown apparatus 155 being affixed to the annulus of the native heart valve. In this embodiment, staples 165 are placed at the annulus so as to hold apparatus 155 in place.


Looking next at FIG. 36, a fixation ring 237 is shown with snap fit means 238 for attachment of a prosthetic valve 239 to the fixation ring 237. Fixation ring 237 is deployed adjacent to the annulus of the native aortic valve and prosthesis 239 is snap fit to fixation ring 237 using snap fit means 238.


Looking next at FIGS. 37-40, in a preferred embodiment of the present invention, there is shown apparatus 155 configured with spring snaps 240 for attachment of a prosthesis 245 to apparatus 155. Prosthesis 245 may be secured to apparatus 155 after attachment of apparatus 155 to the annulus is completed.


In the preceding description, compressive apparatus 155 is described in the context of affixing a prosthetic heart valve in position within the aorta. In this respect it should be appreciated, however, that compressive apparatus 155 may be used to affix some other heart valve within another cardiovascular structure.


Still other modifications and variations will be apparent to those skilled in the art in view of the present disclosure, and are considered to be within the scope of the present invention.

Claims
  • 1. A method for affixing a prosthetic heart valve to tissue, the method comprising: positioning a fixation band having the prosthetic heart valve attached thereto adjacent to the tissue; andactuating a compression device that is operatively attached to the fixation band for moving a proximal annular portion and a distal annular portion of the fixation band toward one another, and thereby deforming and deploying at least one staple that is supported between the proximal and distal annular portions into the tissue; wherein the proximal annular portion and the distal annular portion each define an arcuate surface for deforming the at least one staple.
  • 2. The method according to claim 1 wherein each staple has first and second ends that are movable with respect to one another.
  • 3. The method according to claim 2 wherein after the step of actuating the compression device, both of the first and second ends of each staple engage the tissue.
  • 4. The method according to claim 2 wherein the step of deforming and deploying at least one staple includes compressing the first and second ends of each staple with the compression device.
  • 5. The method according to claim 1 wherein each staple is C-shaped after being deformed.
  • 6. A method for affixing a prosthetic heart valve to tissue, the method comprising: positioning a fixation band adjacent to tissue;after the step of positioning the fixation band, actuating a compression device that is operatively attached to the fixation band for moving a proximal annular portion and a distal annular portion of the fixation band toward one another, and thereby deforming and deploying at least one staple that is supported between the proximal and distal annular portions into the tissue; andafter the step of actuating the compression device, attaching the prosthetic heart valve to the fixation band.
  • 7. The method according to claim 6 wherein each staple has first and second ends that are movable with respect to one another.
  • 8. The method according to claim 7 wherein after the step of actuating the compression device, both of the first and second ends of each staple engage the tissue.
  • 9. The method according to claim 7 wherein the step of deforming the at least one staple includes compressing the first and second ends with the compression device.
  • 10. The method according to claim 6 wherein each staple is C-shaped after being deformed.
  • 11. A method for affixing a prosthetic heart valve to tissue, the method comprising: providing a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising:a proximal annular portion and a distal annular portion selectively positioned relatively to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and the prosthetic heart valve being attached to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion;a plurality of staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion, each of the plurality of staples having two ends; anda compression device in attachment to the proximal annular portion and the distal annular portion, the compression device being configured to selectively position the proximal annular portion and the distal annular portion toward one another so as to compress the two ends of each of the plurality of staples therebetween so as to deform and deploy the plurality of staples into tissue so as to affix the prosthetic heart valve to the tissue;positioning the fixation band adjacent to the tissue; andactuating the compression device so as to move the proximal annular portion and the distal annular portion toward one another so as to deform at least one of the plurality of staples and to deploy the deformed staple into the tissue.
  • 12. A method according to claim 11 further comprising the step of removing the compression device from the proximal annular portion and the distal annular portion.
  • 13. The method according to claim 11 wherein the proximal annular portion and the distal annular portion each define an arcuate surface for deforming the plurality of staples during the step of actuating the compression device.
  • 14. The method according to claim 11 wherein after the step of actuating the compression device, both of the first and second ends of each respective staple engage the tissue.
  • 15. The method according to claim 11 wherein each of the plurality of staples is C-shaped after being deformed.
  • 16. The method according to claim 11 wherein, during the step of actuating the compression device, the proximal annual portion and the distal annular portion each shape one respective first and second end of each of the plurality of staples.
REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This application is a divisional application of prior application Ser. No. 11/479,357, filed Jun. 29, 2006, now allowed, now U.S. Pat. No. 7,611,535, which is a divisional application of U.S. application Ser. No. 10/414,766 filed Apr. 16, 2003, issued as U.S. Pat. No. 7,097,659, which is a Continuation-In Part of U.S. application Ser. No. 09/949,061, filed Sep. 7, 2001, issued as U.S. Pat. No. 6,846,325, which claims the benefit of U.S. Provisional Application No. 60/373,059, filed Apr. 16, 2002, the entire disclosures of which are hereby incorporated by reference.

US Referenced Citations (621)
Number Name Date Kind
3143742 Cromie Aug 1964 A
3334629 Cohn Aug 1967 A
3409013 Berry Nov 1968 A
3540431 Mobin-Uddin Nov 1970 A
3587115 Shiley Jun 1971 A
3628535 Ostrowsky et al. Dec 1971 A
3642004 Osthagen et al. Feb 1972 A
3657744 Ersek Apr 1972 A
3671979 Moulopoulos Jun 1972 A
3714671 Edwards et al. Feb 1973 A
3755823 Hancock Sep 1973 A
3795246 Sturgeon Mar 1974 A
3839741 Haller Oct 1974 A
3868956 Alfidi et al. Mar 1975 A
3874388 King et al. Apr 1975 A
4035849 Angell et al. Jul 1977 A
4056854 Boretos et al. Nov 1977 A
4106129 Carpentier et al. Aug 1978 A
4222126 Boretos et al. Sep 1980 A
4233690 Akins Nov 1980 A
4265694 Boretos May 1981 A
4291420 Reul Sep 1981 A
4297749 Davis et al. Nov 1981 A
4339831 Johnson Jul 1982 A
4343048 Ross et al. Aug 1982 A
4345340 Rosen Aug 1982 A
4425908 Simon Jan 1984 A
4470157 Love Sep 1984 A
4501030 Lane Feb 1985 A
4574803 Storz Mar 1986 A
4580568 Gianturco Apr 1986 A
4592340 Boyles Jun 1986 A
4610688 Silvestrini et al. Sep 1986 A
4612011 Kautzky Sep 1986 A
4647283 Carpentier et al. Mar 1987 A
4648881 Carpentier et al. Mar 1987 A
4655771 Wallsten Apr 1987 A
4662885 DiPisa, Jr. May 1987 A
4665906 Jervis May 1987 A
4681908 Broderick et al. Jul 1987 A
4710192 Liotta et al. Dec 1987 A
4733665 Palmaz Mar 1988 A
4777951 Cribier et al. Oct 1988 A
4787899 Lazarus Nov 1988 A
4787901 Baykut Nov 1988 A
4796629 Grayzel Jan 1989 A
4819751 Shimada et al. Apr 1989 A
4834755 Silvestrini et al. May 1989 A
4856516 Hillstead Aug 1989 A
4872874 Taheri Oct 1989 A
4878495 Grayzel Nov 1989 A
4878906 Lindemann et al. Nov 1989 A
4883458 Shiber Nov 1989 A
4909252 Goldberger Mar 1990 A
4917102 Miller et al. Apr 1990 A
4922905 Strecker May 1990 A
4954126 Wallsten Sep 1990 A
4966604 Reiss Oct 1990 A
4979939 Shiber Dec 1990 A
4986830 Owens et al. Jan 1991 A
4994077 Dobben Feb 1991 A
5002559 Tower Mar 1991 A
5007896 Shiber Apr 1991 A
5026366 Leckrone Jun 1991 A
5032128 Alonso Jul 1991 A
5037434 Lane Aug 1991 A
5047041 Samuels Sep 1991 A
5059177 Towne et al. Oct 1991 A
5061273 Yock Oct 1991 A
5085635 Cragg Feb 1992 A
5089015 Ross Feb 1992 A
5152771 Sabbaghian et al. Oct 1992 A
5161547 Tower Nov 1992 A
5163953 Vince Nov 1992 A
5167628 Boyles Dec 1992 A
5217483 Tower Jun 1993 A
5232445 Bonzel Aug 1993 A
5272909 Nguyen et al. Dec 1993 A
5295958 Shturman Mar 1994 A
5327774 Nguyen et al. Jul 1994 A
5332402 Teitelbaum et al. Jul 1994 A
5350398 Pavcnik et al. Sep 1994 A
5370685 Stevens Dec 1994 A
5389106 Tower Feb 1995 A
5397351 Pavcnik et al. Mar 1995 A
5411552 Andersen et al. May 1995 A
5415633 Lazarus et al. May 1995 A
5431676 Dubrul et al. Jul 1995 A
5443446 Shturman Aug 1995 A
5449384 Johnson Sep 1995 A
5480424 Cox Jan 1996 A
5489294 McVenes et al. Feb 1996 A
5489297 Duran Feb 1996 A
5496346 Horzewski et al. Mar 1996 A
5500014 Quijano et al. Mar 1996 A
5507767 Maeda et al. Apr 1996 A
5545209 Roberts et al. Aug 1996 A
5545211 An et al. Aug 1996 A
5545214 Stevens Aug 1996 A
5554185 Block et al. Sep 1996 A
5575818 Pinchuk Nov 1996 A
5580922 Park et al. Dec 1996 A
5591195 Taheri et al. Jan 1997 A
5609626 Quijano et al. Mar 1997 A
5645559 Hachtman et al. Jul 1997 A
5665115 Cragg Sep 1997 A
5667523 Bynon et al. Sep 1997 A
5674277 Freitag Oct 1997 A
5695498 Tower Dec 1997 A
5702368 Stevens et al. Dec 1997 A
5713953 Vallana et al. Feb 1998 A
5716417 Girard et al. Feb 1998 A
5746709 Rom et al. May 1998 A
5749890 Shaknovich May 1998 A
5766151 Valley et al. Jun 1998 A
5782809 Umeno et al. Jul 1998 A
5800456 Maeda et al. Sep 1998 A
5800508 Goicoechea et al. Sep 1998 A
5817126 Imran Oct 1998 A
5824041 Lenker et al. Oct 1998 A
5824043 Cottone, Jr. Oct 1998 A
5824053 Khosravi et al. Oct 1998 A
5824056 Rosenberg Oct 1998 A
5824061 Quijano et al. Oct 1998 A
5824064 Taheri Oct 1998 A
5840081 Andersen et al. Nov 1998 A
5843158 Lenker et al. Dec 1998 A
5851232 Lois Dec 1998 A
5855597 Jayaraman Jan 1999 A
5855601 Bessler et al. Jan 1999 A
5860996 Tower Jan 1999 A
5861028 Angell Jan 1999 A
5868783 Tower Feb 1999 A
5876448 Thompson et al. Mar 1999 A
5888201 Stinson et al. Mar 1999 A
5891191 Stinson Apr 1999 A
5906619 Olson et al. May 1999 A
5907893 Zadno-Azizi et al. Jun 1999 A
5913842 Boyd et al. Jun 1999 A
5925063 Khosravi Jul 1999 A
5944738 Amplatz et al. Aug 1999 A
5957949 Leonhardt et al. Sep 1999 A
5968068 Dehdashtian et al. Oct 1999 A
5984957 Laptewicz, Jr. et al. Nov 1999 A
5997573 Quijano et al. Dec 1999 A
6022370 Tower Feb 2000 A
6027525 Suh et al. Feb 2000 A
6029671 Stevens et al. Feb 2000 A
6042589 Marianne Mar 2000 A
6042598 Tsugita et al. Mar 2000 A
6042607 Williamson, IV Mar 2000 A
6051104 Jang Apr 2000 A
6059809 Amor et al. May 2000 A
6110201 Quijano et al. Aug 2000 A
6146366 Schachar Nov 2000 A
6159239 Greenhalgh Dec 2000 A
6162208 Hipps Dec 2000 A
6162245 Jayaraman Dec 2000 A
6168614 Andersen et al. Jan 2001 B1
6171335 Wheatley et al. Jan 2001 B1
6200336 Pavcnik et al. Mar 2001 B1
6203550 Olson Mar 2001 B1
6210408 Chandrasekaran et al. Apr 2001 B1
6218662 Tchakarov et al. Apr 2001 B1
6221006 Dubrul et al. Apr 2001 B1
6221091 Khosravi Apr 2001 B1
6241757 An et al. Jun 2001 B1
6245102 Jayaraman Jun 2001 B1
6248116 Chevilon Jun 2001 B1
6258114 Konya et al. Jul 2001 B1
6258115 Dubrul Jul 2001 B1
6258120 McKenzie et al. Jul 2001 B1
6277555 Duran et al. Aug 2001 B1
6299637 Shaolia et al. Oct 2001 B1
6302906 Goicoechea et al. Oct 2001 B1
6309382 Garrison et al. Oct 2001 B1
6309417 Spence et al. Oct 2001 B1
6338735 Stevens Jan 2002 B1
6348063 Yassour et al. Feb 2002 B1
6350277 Kocur Feb 2002 B1
6352708 Duran et al. Mar 2002 B1
6371970 Khosravi et al. Apr 2002 B1
6371983 Lane Apr 2002 B1
6379383 Palmaz et al. Apr 2002 B1
6380457 Yurek et al. Apr 2002 B1
6398807 Chouinard et al. Jun 2002 B1
6409750 Hyodoh et al. Jun 2002 B1
6425916 Garrison et al. Jul 2002 B1
6440164 DiMatteo et al. Aug 2002 B1
6454799 Schreck Sep 2002 B1
6458153 Bailey et al. Oct 2002 B1
6461382 Cao Oct 2002 B1
6468303 Amplatz et al. Oct 2002 B1
6475239 Campbell et al. Nov 2002 B1
6482228 Norred Nov 2002 B1
6485496 Suyker et al. Nov 2002 B1
6488704 Connelly et al. Dec 2002 B1
6494909 Greenhalgh Dec 2002 B2
6503272 Duerig et al. Jan 2003 B2
6508833 Pavcnik et al. Jan 2003 B2
6527800 McGuckin, Jr. et al. Mar 2003 B1
6530949 Konya et al. Mar 2003 B2
6530952 Vesely Mar 2003 B2
6562031 Chandrasekaran et al. May 2003 B2
6562058 Seguin et al. May 2003 B2
6569196 Vesely May 2003 B1
6585758 Chouinard et al. Jul 2003 B1
6592546 Barbut et al. Jul 2003 B1
6605112 Moll et al. Aug 2003 B1
6613077 Gilligan et al. Sep 2003 B2
6622604 Chouinard et al. Sep 2003 B1
6635068 Dubrul et al. Oct 2003 B1
6652571 White et al. Nov 2003 B1
6652578 Bailey et al. Nov 2003 B2
6656213 Solem Dec 2003 B2
6663663 Kim et al. Dec 2003 B2
6669724 Park et al. Dec 2003 B2
6673089 Yassour et al. Jan 2004 B1
6673109 Cox Jan 2004 B2
6676698 McGuckin, Jr. et al. Jan 2004 B2
6682558 Tu et al. Jan 2004 B2
6682559 Myers et al. Jan 2004 B2
6685739 DiMatteo et al. Feb 2004 B2
6689144 Gerberding Feb 2004 B2
6689164 Seguin Feb 2004 B1
6692512 Jang Feb 2004 B2
6692513 Streeter et al. Feb 2004 B2
6695878 McGuckin, Jr. et al. Feb 2004 B2
6702851 Chinn et al. Mar 2004 B1
6719789 Cox Apr 2004 B2
6730118 Spenser et al. May 2004 B2
6730377 Wang May 2004 B2
6733525 Yang et al. May 2004 B2
6736846 Cox May 2004 B2
6752828 Thornton Jun 2004 B2
6758855 Fulton, III et al. Jul 2004 B2
6769434 Liddicoat et al. Aug 2004 B2
6786925 Schoon Sep 2004 B1
6790229 Berreklouw Sep 2004 B1
6790230 Beyersdorf et al. Sep 2004 B2
6792979 Konya et al. Sep 2004 B2
6797002 Spence Sep 2004 B2
6821297 Snyders Nov 2004 B2
6830575 Stenzel et al. Dec 2004 B2
6830584 Seguin Dec 2004 B1
6830585 Artof Dec 2004 B1
6846325 Liddicoat Jan 2005 B2
6866650 Stevens Mar 2005 B2
6872223 Roberts Mar 2005 B2
6875231 Anduiza et al. Apr 2005 B2
6883522 Spence et al. Apr 2005 B2
6887266 Williams et al. May 2005 B2
6890330 Streeter et al. May 2005 B2
6893460 Spenser et al. May 2005 B2
6896690 Lambrecht et al. May 2005 B1
6908481 Cribier Jun 2005 B2
6913600 Valley et al. Jul 2005 B2
6929653 Streeter Aug 2005 B2
6936066 Palmaz et al. Aug 2005 B2
6939365 Fogarty et al. Sep 2005 B1
6951571 Srivastava Oct 2005 B1
6974474 Pavcnik et al. Dec 2005 B2
6974476 McGuckin et al. Dec 2005 B2
6986742 Hart et al. Jan 2006 B2
6989027 Allen et al. Jan 2006 B2
6989028 Lashinski et al. Jan 2006 B2
6991649 Sievers Jan 2006 B2
7018401 Hyodoh et al. Mar 2006 B1
7041128 McGuckin, Jr. et al. May 2006 B2
7044966 Svanidze et al. May 2006 B2
7048014 Hyodoh et al. May 2006 B2
7097659 Woolfson et al. Aug 2006 B2
7101396 Artof et al. Sep 2006 B2
7105016 Shiu et al. Sep 2006 B2
7115141 Menz et al. Oct 2006 B2
7128759 Osborne et al. Oct 2006 B2
7147663 Berg et al. Dec 2006 B1
7153324 Case et al. Dec 2006 B2
7160319 Chouinard et al. Jan 2007 B2
7175656 Khairkhahan Feb 2007 B2
7186265 Sharkawy et al. Mar 2007 B2
7195641 Palmaz et al. Mar 2007 B2
7198646 Figulla et al. Apr 2007 B2
7201761 Woolfson et al. Apr 2007 B2
7201772 Schwammenthal et al. Apr 2007 B2
7252682 Seguin Aug 2007 B2
7300457 Palmaz Nov 2007 B2
7300463 Liddicoat Nov 2007 B2
7316706 Bloom et al. Jan 2008 B2
7329278 Seguin Feb 2008 B2
7335218 Wilson et al. Feb 2008 B2
7338520 Bailey et al. Mar 2008 B2
7374571 Pease et al. May 2008 B2
7377938 Sarac et al. May 2008 B2
7381218 Schreck Jun 2008 B2
7384411 Condado Jun 2008 B1
7429269 Schwammenthal et al. Sep 2008 B2
7442204 Schwammenthal et al. Oct 2008 B2
7462191 Spenser et al. Dec 2008 B2
7470284 Lambrecht et al. Dec 2008 B2
7481838 Carpentier et al. Jan 2009 B2
7544206 Cohn et al. Jun 2009 B2
7547322 Sarac et al. Jun 2009 B2
7556646 Yang et al. Jul 2009 B2
7682390 Seguin Mar 2010 B2
7780726 Seguin Aug 2010 B2
7806919 Bloom et al. Oct 2010 B2
20010001314 Davison et al. May 2001 A1
20010002445 Vesely May 2001 A1
20010007956 Letac et al. Jul 2001 A1
20010010017 Letac et al. Jul 2001 A1
20010011189 Drasler et al. Aug 2001 A1
20010021872 Bailey et al. Sep 2001 A1
20010025196 Chinn et al. Sep 2001 A1
20010032013 Marton Oct 2001 A1
20010039450 Pavcnik et al. Nov 2001 A1
20010041928 Pavcnik et al. Nov 2001 A1
20010044647 Pinchuk et al. Nov 2001 A1
20020010508 Chobotov Jan 2002 A1
20020029014 Jayaraman Mar 2002 A1
20020032480 Spence et al. Mar 2002 A1
20020032481 Gabbay Mar 2002 A1
20020035396 Heath Mar 2002 A1
20020042650 Vardi et al. Apr 2002 A1
20020052651 Myers et al. May 2002 A1
20020058995 Stevens May 2002 A1
20020072789 Hackett et al. Jun 2002 A1
20020095209 Zadno-Azizi et al. Jul 2002 A1
20020099439 Schwartz et al. Jul 2002 A1
20020103533 Langberg et al. Aug 2002 A1
20020107565 Greenhalgh Aug 2002 A1
20020111674 Chouinard et al. Aug 2002 A1
20020123802 Snyders Sep 2002 A1
20020133183 Lentz et al. Sep 2002 A1
20020138138 Yang Sep 2002 A1
20020151970 Garrison et al. Oct 2002 A1
20020161392 Dubrul Oct 2002 A1
20020161394 Macoviak et al. Oct 2002 A1
20020193871 Beyersdorf et al. Dec 2002 A1
20030014104 Cribier Jan 2003 A1
20030023300 Bailey et al. Jan 2003 A1
20030023303 Palmaz et al. Jan 2003 A1
20030028247 Cali Feb 2003 A1
20030036791 Philipp et al. Feb 2003 A1
20030040771 Hyodoh et al. Feb 2003 A1
20030040772 Hyodoh et al. Feb 2003 A1
20030040792 Gabbay Feb 2003 A1
20030050694 Yang et al. Mar 2003 A1
20030055495 Pease et al. Mar 2003 A1
20030065386 Weadock Apr 2003 A1
20030069492 Abrams et al. Apr 2003 A1
20030109924 Cribier Jun 2003 A1
20030125795 Pavcnik et al. Jul 2003 A1
20030130726 Thorpe et al. Jul 2003 A1
20030130729 Paniagua et al. Jul 2003 A1
20030139804 Hankh et al. Jul 2003 A1
20030149475 Hyodoh et al. Aug 2003 A1
20030149476 Damm et al. Aug 2003 A1
20030149478 Figulla et al. Aug 2003 A1
20030153974 Spenser et al. Aug 2003 A1
20030181850 Diamond et al. Sep 2003 A1
20030191519 Lombardi et al. Oct 2003 A1
20030199913 Dubrul et al. Oct 2003 A1
20030199963 Tower et al. Oct 2003 A1
20030199971 Tower et al. Oct 2003 A1
20030212410 Stenzel et al. Nov 2003 A1
20030212454 Scott et al. Nov 2003 A1
20030225445 Derus et al. Dec 2003 A1
20040019374 Hojeibane et al. Jan 2004 A1
20040034411 Quijano et al. Feb 2004 A1
20040039436 Spenser et al. Feb 2004 A1
20040049224 Buehlmann et al. Mar 2004 A1
20040049262 Obermiller et al. Mar 2004 A1
20040049266 Anduiza et al. Mar 2004 A1
20040082904 Houde et al. Apr 2004 A1
20040088045 Cox May 2004 A1
20040092858 Wilson et al. May 2004 A1
20040092989 Wilson et al. May 2004 A1
20040093005 Durcan May 2004 A1
20040093060 Seguin et al. May 2004 A1
20040093075 Kuehn May 2004 A1
20040097788 Mourles May 2004 A1
20040098112 DiMatteo et al. May 2004 A1
20040106976 Bailey et al. Jun 2004 A1
20040106990 Spence et al. Jun 2004 A1
20040111096 Tu et al. Jun 2004 A1
20040116951 Rosengart Jun 2004 A1
20040117004 Osborne et al. Jun 2004 A1
20040122468 Yodfat et al. Jun 2004 A1
20040122514 Fogarty et al. Jun 2004 A1
20040122516 Fogarty Jun 2004 A1
20040127979 Wilson Jul 2004 A1
20040138742 Myers et al. Jul 2004 A1
20040138743 Myers et al. Jul 2004 A1
20040153146 Lashinski et al. Aug 2004 A1
20040167573 Williamson Aug 2004 A1
20040167620 Ortiz Aug 2004 A1
20040186563 Iobbi Sep 2004 A1
20040193261 Berreklouw Sep 2004 A1
20040210240 Saint Oct 2004 A1
20040210304 Seguin et al. Oct 2004 A1
20040210307 Khairkhahan Oct 2004 A1
20040215333 Duran Oct 2004 A1
20040215339 Drasler et al. Oct 2004 A1
20040225353 McGuckin, Jr. Nov 2004 A1
20040225354 Allen Nov 2004 A1
20040254636 Flagle et al. Dec 2004 A1
20040260389 Case et al. Dec 2004 A1
20040260394 Douk et al. Dec 2004 A1
20040267357 Allen et al. Dec 2004 A1
20050010246 Streeter Jan 2005 A1
20050010285 Lambrecht et al. Jan 2005 A1
20050010287 Macoviak et al. Jan 2005 A1
20050015112 Cohn et al. Jan 2005 A1
20050027348 Case et al. Feb 2005 A1
20050033398 Seguin Feb 2005 A1
20050043790 Seguin Feb 2005 A1
20050049692 Numamoto Mar 2005 A1
20050049696 Siess Mar 2005 A1
20050055088 Liddicoat et al. Mar 2005 A1
20050060029 Le Mar 2005 A1
20050060030 Lashinski et al. Mar 2005 A1
20050075584 Cali Apr 2005 A1
20050075712 Biancucci Apr 2005 A1
20050075717 Nguyen Apr 2005 A1
20050075719 Bergheim Apr 2005 A1
20050075724 Svanidze Apr 2005 A1
20050075727 Wheatley Apr 2005 A1
20050075730 Myers Apr 2005 A1
20050075731 Artof Apr 2005 A1
20050085841 Eversull et al. Apr 2005 A1
20050085842 Eversull et al. Apr 2005 A1
20050085843 Opolski et al. Apr 2005 A1
20050085890 Rasmussen et al. Apr 2005 A1
20050085900 Case et al. Apr 2005 A1
20050096568 Kato May 2005 A1
20050096692 Linder et al. May 2005 A1
20050096724 Stenzel et al. May 2005 A1
20050096734 Majercak et al. May 2005 A1
20050096735 Hojeibane et al. May 2005 A1
20050096736 Osse et al. May 2005 A1
20050096738 Cali et al. May 2005 A1
20050107871 Realyvasquez et al. May 2005 A1
20050113910 Paniagua May 2005 A1
20050119688 Berheim Jun 2005 A1
20050131438 Cohn Jun 2005 A1
20050137686 Salahieh Jun 2005 A1
20050137688 Salahieh et al. Jun 2005 A1
20050137692 Haug Jun 2005 A1
20050137695 Salahieh Jun 2005 A1
20050137701 Salahieh Jun 2005 A1
20050143807 Pavcnik et al. Jun 2005 A1
20050143809 Salahieh Jun 2005 A1
20050148997 Valley et al. Jul 2005 A1
20050149181 Eberhardt Jul 2005 A1
20050165477 Anduiza et al. Jul 2005 A1
20050187616 Realyvasquez Aug 2005 A1
20050197695 Stacchino et al. Sep 2005 A1
20050203549 Realyvasquez Sep 2005 A1
20050203605 Dolan Sep 2005 A1
20050203618 Sharkawy Sep 2005 A1
20050222674 Paine Oct 2005 A1
20050228495 Macoviak Oct 2005 A1
20050234546 Nugent Oct 2005 A1
20050240200 Bergheim Oct 2005 A1
20050240263 Fogarty et al. Oct 2005 A1
20050261759 Lambrecht et al. Nov 2005 A1
20050283962 Boudjemline Dec 2005 A1
20060004439 Spenser et al. Jan 2006 A1
20060004469 Sokel Jan 2006 A1
20060009841 McGuckin et al. Jan 2006 A1
20060052867 Revuelta et al. Mar 2006 A1
20060058775 Stevens et al. Mar 2006 A1
20060089711 Dolan Apr 2006 A1
20060100685 Seguin et al. May 2006 A1
20060116757 Lashinski et al. Jun 2006 A1
20060135964 Vesely Jun 2006 A1
20060142848 Gabbay Jun 2006 A1
20060167474 Bloom et al. Jul 2006 A1
20060178740 Stacchino et al. Aug 2006 A1
20060195134 Crittenden Aug 2006 A1
20060206192 Tower et al. Sep 2006 A1
20060206202 Bonhoeffer et al. Sep 2006 A1
20060212111 Case et al. Sep 2006 A1
20060247763 Slater Nov 2006 A1
20060259134 Schwammenthal et al. Nov 2006 A1
20060259136 Nguyen et al. Nov 2006 A1
20060259137 Artof et al. Nov 2006 A1
20060265056 Nguyen et al. Nov 2006 A1
20060271166 Thill et al. Nov 2006 A1
20060271175 Woolfson et al. Nov 2006 A1
20060276874 Wilson et al. Dec 2006 A1
20060276882 Case et al. Dec 2006 A1
20060282161 Huynh et al. Dec 2006 A1
20070005129 Damm et al. Jan 2007 A1
20070005131 Taylor Jan 2007 A1
20070010878 Raffiee et al. Jan 2007 A1
20070016286 Herrmann et al. Jan 2007 A1
20070027518 Case et al. Feb 2007 A1
20070027533 Douk Feb 2007 A1
20070038295 Case et al. Feb 2007 A1
20070043431 Melsheimer Feb 2007 A1
20070043435 Seguin et al. Feb 2007 A1
20070051377 Douk et al. Mar 2007 A1
20070073392 Heyninck-Janitz Mar 2007 A1
20070078509 Lotfy Apr 2007 A1
20070078510 Ryan Apr 2007 A1
20070088431 Bourang et al. Apr 2007 A1
20070093869 Bloom et al. Apr 2007 A1
20070100439 Cangialosi May 2007 A1
20070100440 Figulla May 2007 A1
20070100449 O'Neil et al. May 2007 A1
20070112415 Bartlett May 2007 A1
20070112422 Dehdashtian May 2007 A1
20070162102 Ryan et al. Jul 2007 A1
20070162113 Sharkawy et al. Jul 2007 A1
20070185513 Woolfson et al. Aug 2007 A1
20070203391 Bloom et al. Aug 2007 A1
20070225681 House Sep 2007 A1
20070232898 Huynh et al. Oct 2007 A1
20070233228 Eberhardt et al. Oct 2007 A1
20070233237 Krivoruchko Oct 2007 A1
20070233238 Huynh et al. Oct 2007 A1
20070238979 Huynh et al. Oct 2007 A1
20070239254 Marchand et al. Oct 2007 A1
20070239265 Birdsall Oct 2007 A1
20070239266 Birdsall Oct 2007 A1
20070239269 Dolan et al. Oct 2007 A1
20070239271 Nguyen Oct 2007 A1
20070239273 Allen Oct 2007 A1
20070244544 Birdsall et al. Oct 2007 A1
20070244545 Birdsall et al. Oct 2007 A1
20070244546 Francis Oct 2007 A1
20070244553 Rafiee et al. Oct 2007 A1
20070244554 Rafiee et al. Oct 2007 A1
20070244555 Rafiee et al. Oct 2007 A1
20070244556 Rafiee et al. Oct 2007 A1
20070244557 Rafiee et al. Oct 2007 A1
20070250160 Rafiee Oct 2007 A1
20070255394 Ryan Nov 2007 A1
20070255396 Douk et al. Nov 2007 A1
20070288000 Bonan Dec 2007 A1
20080004696 Vesely Jan 2008 A1
20080009940 Cribier Jan 2008 A1
20080015671 Bonhoeffer Jan 2008 A1
20080021552 Gabbay Jan 2008 A1
20080048656 Tan Feb 2008 A1
20080065011 Marchand et al. Mar 2008 A1
20080065206 Liddicoat Mar 2008 A1
20080071361 Tuval et al. Mar 2008 A1
20080071362 Tuval et al. Mar 2008 A1
20080071363 Tuval et al. Mar 2008 A1
20080071366 Tuval et al. Mar 2008 A1
20080071368 Tuval et al. Mar 2008 A1
20080077234 Styrc Mar 2008 A1
20080082165 Wilson et al. Apr 2008 A1
20080082166 Styrc et al. Apr 2008 A1
20080133003 Seguin et al. Jun 2008 A1
20080140189 Nguyen et al. Jun 2008 A1
20080147105 Wilson et al. Jun 2008 A1
20080147180 Ghione et al. Jun 2008 A1
20080147181 Ghione et al. Jun 2008 A1
20080147182 Righini et al. Jun 2008 A1
20080154355 Benichow et al. Jun 2008 A1
20080154356 Obermiller et al. Jun 2008 A1
20080161910 Revuelta et al. Jul 2008 A1
20080161911 Revuelta et al. Jul 2008 A1
20080183273 Mesana et al. Jul 2008 A1
20080188928 Salahieh et al. Aug 2008 A1
20080215143 Seguin et al. Sep 2008 A1
20080215144 Ryan et al. Sep 2008 A1
20080228254 Ryan Sep 2008 A1
20080228263 Ryan Sep 2008 A1
20080234797 Styrc Sep 2008 A1
20080243246 Ryan et al. Oct 2008 A1
20080255651 Dwork Oct 2008 A1
20080255660 Guyenot et al. Oct 2008 A1
20080255661 Straubinger et al. Oct 2008 A1
20080262593 Ryan et al. Oct 2008 A1
20080269878 Iobbi Oct 2008 A1
20090005863 Goetz et al. Jan 2009 A1
20090012600 Styrc et al. Jan 2009 A1
20090048656 Wen Feb 2009 A1
20090054976 Tuval et al. Feb 2009 A1
20090069886 Suri et al. Mar 2009 A1
20090069887 Righini et al. Mar 2009 A1
20090069889 Suri et al. Mar 2009 A1
20090082858 Nugent et al. Mar 2009 A1
20090085900 Weiner Apr 2009 A1
20090099653 Suri et al. Apr 2009 A1
20090138079 Tuval et al. May 2009 A1
20090164004 Cohn Jun 2009 A1
20090164006 Seguin et al. Jun 2009 A1
20090171447 VonSegesser et al. Jul 2009 A1
20090192585 Bloom et al. Jul 2009 A1
20090192586 Tabor et al. Jul 2009 A1
20090192591 Ryan et al. Jul 2009 A1
20090198316 Laske et al. Aug 2009 A1
20090216310 Straubinger et al. Aug 2009 A1
20090216312 Straubinger et al. Aug 2009 A1
20090216313 Straubinger et al. Aug 2009 A1
20090222082 Lock et al. Sep 2009 A1
20090234443 Ottma et al. Sep 2009 A1
20090240264 Tuval et al. Sep 2009 A1
20090240320 Tuval Sep 2009 A1
20090287296 Manasse Nov 2009 A1
20100004740 Seguin et al. Jan 2010 A1
20100030328 Seguin et al. Feb 2010 A1
20100036479 Hill et al. Feb 2010 A1
20100036485 Seguin Feb 2010 A1
20100069852 Kelley Mar 2010 A1
20100094411 Tuval et al. Apr 2010 A1
20100100167 Bortlein et al. Apr 2010 A1
20100131054 Tuval et al. May 2010 A1
20100137979 Tuval et al. Jun 2010 A1
20100145439 Seguin et al. Jun 2010 A1
20100152840 Seguin et al. Jun 2010 A1
20100161045 Righini Jun 2010 A1
20100198346 Keogh et al. Aug 2010 A1
20100234940 Dolan Sep 2010 A1
20100256723 Murray Oct 2010 A1
Foreign Referenced Citations (48)
Number Date Country
2007-100074433 Aug 2007 CN
3640745 Jun 1987 DE
195 32 846 Mar 1997 DE
195 46 692 Jun 1997 DE
195 46 692 Jun 1997 DE
198 57 887 Jul 2000 DE
199 07 646 Aug 2000 DE
100 10 074 Oct 2001 DE
100 49 812 Apr 2002 DE
100 49 813 Apr 2002 DE
100 49 815 Apr 2002 DE
1057460 Jun 2000 EP
1255510 Nov 2002 EP
1469797 Nov 2005 EP
1504329 Dec 1967 FR
2788217 Dec 1999 FR
2815844 May 2000 FR
2056023 Mar 1981 GB
2433700 Dec 2007 GB
1271508 Nov 1986 SU
9529640 Nov 1995 WO
0044313 Aug 2000 WO
0047136 Aug 2000 WO
0135870 May 2001 WO
0149213 Jul 2001 WO
0154625 Aug 2001 WO
0162189 Aug 2001 WO
0164137 Sep 2001 WO
0222054 Mar 2002 WO
0236048 May 2002 WO
03003943 Jan 2003 WO
03003949 Jan 2003 WO
03011195 Feb 2003 WO
2004019825 Mar 2004 WO
2004089250 Oct 2004 WO
2005004753 Jan 2005 WO
2005046528 May 2005 WO
2006026371 Mar 2006 WO
2008047354 Apr 2008 WO
2008138584 Nov 2008 WO
2008150529 Dec 2008 WO
2009002548 Dec 2008 WO
2009029199 Mar 2009 WO
2009042196 Apr 2009 WO
2009045338 Apr 2009 WO
2009061389 May 2009 WO
2009091509 Jul 2009 WO
2009111241 Sep 2009 WO
Non-Patent Literature Citations (41)
Entry
Machine Translation of FR1504329A, 1-5 pages.
Andersen, H.R. et al, “Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.” Euro. Heart J. (1992) 13:704-708.
Babaliaros, et al., “State of the Art Percutaneous Intervention for the Treatment of Valvular Heart Disease: A Review of the Current Technologies and Ongoing Research in the Field of Percutaneous Heart Valve Replacement and Repair,” Cardiology 2007; 107:87-96.
Bailey, “Percutaneous Expandable Prosthetic Valves,” In: Topol EJ, ed. Textbook of Interventional Cardiology. Volume II. Second edition. WB Saunders, Philadelphia, 1994:1268-1276.
Block, et al., “Percutaneous Approaches to Valvular Heart Disease,” Current Cardiology Reports, vol. 7 (2005) pp. 108-113.
Bonhoeffer, et al, “Percutaneous Insertion of the Pulmonary Valve,” Journal of the American College of Cardiology (United States), May 15, 2002, pp. 1664-1669.
Bonhoeffer, et al, “Percutaneous Replacement of Pulmonary Valve in a Right-Ventricle to Pulmonary-Artery Prosthetic Conduit with Valve Dysfunction,” Lancet (England), Oct. 21, 2000, pp. 1403-1405.
Bonhoeffer, et al, “Transcatheter Implantation of a Bovine Valve in Pulmonary Position: A Lamb Study,” Circulation (United States), Aug. 15, 2000, pp. 813-816.
Boudjemline, et al, “Images in Cardiovascular Medicine. Percutaneous Aortic Valve Replacement in Animals,” Circulation (United States), Mar. 16, 2004, 109, p. e161.
Boudjemline, et al, “Is Percutaneous Implantation of a Bovine Venous Valve in the Inferior Vena Cava a Reliable Technique to Treat Chronic Venous Insufficiency Syndrome?” Medical Science Monitor—International Medical Journal of Experimental and Clinical Research (Poland), Mar. 2004, pp. BR61-BR66.
Boudjemline, et al, “Off-pump Replacement of the Pulmonary Valve in Large Right Ventricular Outflow Tracts: A Hybrid Approach,” Journal of Thoracic and Cardiovascular Surgery (United States), Apr. 2005, pp. 831-837.
Boudjemline, et al, “Percutaneous Aortic Valve Replacement: Will We Get There?” Heart (British Cardiac Society) (England), Dec. 2001, pp. 705-706.
Boudjemline, et al, “Percutaneous Implantation of a Biological Valve in the Aorta to Treat Aortic Valve Insufficiency—A Sheep Study,” Medical Science Monitor—International Medical Journal of Experimental and Clinical Research (Poland), Apr. 2002, pp. BR113-BR116.
Boudjemline, et al, “Percutaneous Implantation of a Biological Valve in Aortic Position: Preliminary Results in a Sheep Study,” European Heart Journal 22, Sep. 2001, p. 630.
Boudjemline, et al, “Percutaneous Implantation of a Valve in the Descending Aorta in Lambs,” European Heart Journal (England), Jul. 2002, pp. 1045-1049.
Boudjemline, et al, “Percutaneous Pulmonary Valve Replacement in a Large Right Ventricular Outflow Tract: An Experimental Study,” Journal of the American College of Cardiology (United States), Mar. 17, 2004, pp. 1082-1087.
Boudjemline, et al, “Percutaneous Valve Insertion: A New Approach,” Journal of Thoracic and Cardiovascular Surgery (United States), Mar. 2003, pp. 741-742.
Boudjemline, et al, “Stent Implantation Combined with a Valve Replacement to Treat Degenerated Right Ventricle to Pulmonary Artery Prosthetic Conduits,” European Heart Journal 22, Sep. 2001, p. 355.
Boudjemline, et al, “Steps Toward Percutaneous Aortic Valve Replacement,” Circulation (United States), Feb. 12, 2002, pp. 775-778.
Boudjemline, et al, “The Percutaneous Implantable Heart Valve,” Progress in Pediatric Cardiology (Ireland), 2001, pp. 89-93.
Boudjemline, et al, “Transcatheter Reconstruction of the Right Heart,” Cardiology in the Young (England), Jun. 2003, pp. 308-311.
Coats, et al, “The Potential Impact of Percutaneous Pulmonary Valve Stent Implantation on Right Ventricular Outflow Tract Re-Intervention,” European Journal of Cardio-Thoracic Surgery (England), Apr. 2005, pp. 536-343.
Cribier, A. et al, “Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis: First Human Case Description,” Circulation (2002) 3006-3008.
Davidson et al., “Percutaneous therapies for valvular heart disease,” Cardiovascular Pathology 15 (2006) 123-129.
Hanzel, et al., “Complications of percutaneous aortic valve replacement: experience with the Criber-Edwards™ percutaneous heart valve,” Eurolntervention Supplements (2006), I (Supplement A) A3-A8.
Huber, et al., “Do Valved Stents Compromise Coronary Flow?” Eur. J. Cardiothorac. Surg. 2004;25:754-759.
Khambadkone, “Nonsurgical Pulmonary Valve Replacement: Why, When, and How?” Catheterization and Cardiovascular Interventions—Official Journal of the Society for Cardiac Angiography & Interventions (United States), Jul. 2004, pp. 401-408.
Khambadkone, et al, “Percutaneous Implantation of Pulmonary Valves,” Expert Review of Cardiovascular Therapy (England), Nov. 2003, pp. 541-548.
Khambadkone, et al, “Percutaneous Pulmonary Valve Implantation: Early and Medium Term Results,” Circulation 108 (17 Supplement), Oct. 28, 2003, pp. IV-375.
Khambadkone, et al, “Percutaneous Pulmonary Valve Implantation: Impact of Morphology on Case Selection,” Circulation 108 (17 Supplement), Oct. 28, 2003, p. IV-642-IV-643.
Lutter, et al, “Percutaneous Aortic Valve Replacement: An Experimental Study. I. Studies on Implantation,” The Journal of Thoracic and Cardiovascular Surgery, Apr. 2002, pp. 768-776.
Lutter, et al, “Percutaneous Valve Replacement: Current State and Future Prospects,” Annals of Thoracic Surgery (Netherlands), Dec. 2004, pp. 2199-2206.
Ma, Ling, et al., “Double-crowned valved stents for off-pump mitral valve replacement,” European Journal of Cardio Thoracic Surgery, 28:194-198, 2005.
Medtech Insight, “New Frontiers in Heart Valve Disease,” vol. 7, No. 8 (2005).
Palacios, “Percutaneous Valve Replacement and Repair, Fiction or Reality?” Journal of American College of Cardiology, vol. 44, No. 8 (2004) pp. 1662-1663.
Pelton et al., “Medical Uses of Nitinol,” Materials Science Forum vols. 327-328, pp. 63-70 (2000).
Ruiz, “Transcathether Aortic Valve Implantation and Mitral Valve Repair: State of the Art,” Pediatric Cardiology, vol. 26, No. 3 (2005).
Saliba, et al, “Treatment of Obstructions of Prosthetic Conduits by Percutaneous Implantation of Stents,” Archives des Maldies du Coeur et des Vaisseaux (France), 1999, pp. 591-596.
Webb, et al., “Percutaneous Aortic Valve Implantation Retrograde from the Femoral Artery,” Circulation (2006), 113;842-850.
Stassano et al., “Mid-term results of the valve-on-valve technique for bioprosthetic failure,” Eur. J. Cardiothorac. Surg. 2000; 18:453-457.
Pavcnik et al., “Aortic and venous valve for percutaneous insertion,” Min. Invas. Ther. & Allied Techol. 2000, vol. 9, pp. 287-292.
Related Publications (1)
Number Date Country
20100030244 A1 Feb 2010 US
Provisional Applications (1)
Number Date Country
60373059 Apr 2002 US
Divisions (2)
Number Date Country
Parent 11479357 Jun 2006 US
Child 12587041 US
Parent 10414766 Apr 2003 US
Child 11479357 US
Continuation in Parts (1)
Number Date Country
Parent 09949061 Sep 2001 US
Child 10414766 US