Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ
Devices, systems and methods support tissue in a body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques.
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This application is a continuation of co-pending U.S. patent application Ser. No. 10/808,216, filed Mar. 24, 2004, entitled “Devices, Systems, and Methods for Supporting Tissue and/or Structures Within a Hollow Body Organ,” which is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002. This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 10/271,334, filed Oct. 15, 2002, which claims the benefit of U.S. Provisional Application Ser. No. 60/333,937 filed 28 Nov. 2001.
FIELD OF THE INVENTIONThe features of the invention are generally applicable to devices, systems, and methods that support tissue and/or structures within a hollow body organ. In a more particular sense, the features of the invention are applicable to improving heart function by supporting tissue and related structures in the heart, e.g., for the treatment of conditions such as congestive heart failure and/or atrial fibrillation and/or septal defects.
BACKGROUND OF THE INVENTIONHollow body organs are shaped in particular native ways to perform specific native functions. When a body organ looses its native shape due to disease, injury, or simply the natural aging process, the native functions can be adversely affected. The heart serves as a good example of this marriage between native shape and native function, as well as the dysfunctions that can occur should the native shape change.
I. The Anatomy of a Healthy Heart
The heart (see
The heart has four chambers, two on each side—the right and left atria, and the right and left ventricles. The atria are the blood-receiving chambers, which pump blood into the ventricles. A wall composed of membranous and muscular parts, called the interatrial septum, separates the right and left atria. The ventricles are the blood-discharging chambers. A wall composed of membranous and muscular parts, called the interventricular septum, separates the right and left ventricles.
The synchronous pumping actions of the left and right sides of the heart constitute the cardiac cycle. The cycle begins with a period of ventricular relaxation, called ventricular diastole. The cycle ends with a period of ventricular contraction, called ventricular systole.
The heart has four valves (see
At the beginning of ventricular diastole (i.e., ventricular filling)(see
The heart valves are defined by fibrous rings of collagen, each called an annulus, which forms a part of the fibrous skeleton of the heart. The annulus provides attachments for the cusps or leaflets of the valves. In a healthy heart, muscles and their tendinous chords (chordae tendineae) support the valves, allowing the leaflets of the valves to open and close in accordance with their intended functions.
II. Heart Dysfunctions
Infection, myocardial infarction, atrial fibrillation, other diseases, or anatomic defects can adversely affect the normal synchronous pumping actions of the left and right sides of the heart and/or the operation of heart valves during the cardiac cycle.
For example, due to one or more of these causes, a heart chamber may become stretched and enlarged. This condition can lead to adverse consequences. For example, (1) due to its enlarged condition the heart must pump harder to move the blood, and/or too little blood may move from the heart to the rest of the body. Over time, other chambers of the heart may also become weaker. The stretching and enlargement of a heart chamber, e.g., in the left ventricle, can lead to a condition called congestive heart failure. If not treated, congestive heart failure can lead to pulmonary embolisms, circulatory shutdown, and death.
The enlargement of a heart chamber can also lead to the enlargement or stretching a heart valve annulus. Also, the stretching or tearing of the chords surrounding a heart valve, or other forms of muscle failure in this region, can also change the shape of a heart valve annulus, even when enlargement of a heart chamber is absent. When the heart valve annulus changes its shape, the valve leaflets can fail to coapt. An undesired back flow of blood can occur between an atrium and a ventricle (called regurgitation), or back flow between an artery and a ventricle can occur. Such dysfunctions can eventually also weaken the heart and can result in heart failure.
Anatomic defects, e.g., in the septum, can also lead to heart dysfunction. These defects can be congenital, or they can result from disease or injury.
III. Prior Treatment Modalities
Medications can be successful in treating heart dysfunctions. For chronic or acute dysfunction, however, surgery is often necessary. For congestive heart failure, a heart transplant may be required. Like invasive, open heart surgical approaches have been used to repair or replace a dysfunctional heart valves or to correct septal defects.
The need remains for simple, cost-effective, and less invasive devices, systems, and methods for treating heart conditions such as congestive heart failure and/or heart valve dysfunction and/or septal defects. A parallel need also remains for similarly treating other dysfunctions that arise from unintended shape changes in other body organs.
SUMMARY OF THE INVENTIONThe invention provides devices, systems and methods that support tissue in a hollow body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques.
One aspect of the invention provides systems and methods for supporting tissue within a hollow body organ. The systems and methods employ first and second implants that are coupled together. The first implant is sized and configured to penetrate a first region of tissue in the hollow body organ. The second implant is sized and configured to penetrate a second region of tissue in the hollow body organ spatially distinct from the first region. At least one tension element couples the first and second implants together, to apply tension to the first and second implants, and thereby draw tissue inward, supporting it. The supporting effect serves, e.g., to draw tissue surfaces together to reduce tissue volume within the hollow body organ, as well as resist subsequent enlargement of tissue volume. Desirably, the supporting effect does not interfere with contraction of the hollow body organ to a lesser tissue volume. However, if desired, this form of bracing can be achieved.
Another aspect of the invention provides systems and methods for forming a tissue fold within a hollow body organ. The systems and methods employ first and second implants. The implants are sized and configured to penetrate spatially distinct regions of tissue in the hollow body organ. At least one tension element couples the first and second implants together to apply tension on the first and second implants. The tension creates a tissue fold between the first and second implants. The tissue fold serves, e.g., to reduce internal tissue volume within the hollow body organ, as well as resist subsequent enlargement of tissue volume. Desirably, the tensioning does not interfere with contraction of the hollow body organ to a lesser tissue volume. However, if desired, this form of bracing can be achieved with tissue folding.
In one embodiment, the first and second implants are part of an array of implants that penetrates spatially distinct regions of tissue in the hollow body organ. In this embodiment, at least one tension element extends among the array of implants to apply tension between adjacent implants and thereby create a pattern of multiple tissue folds. The multiple tissue folds serve, e.g., to draw a circumferential region of tissue together, forming a closure or seal.
Another aspect of the invention provides systems and methods for supporting tissue in a hollow body organ. The systems and methods employ a prosthesis sized and configured for placement either within an interior of the hollow body organ or about an exterior of the hollow body organ to regulate a maximum size and/or shape of the hollow body organ. The systems and methods also employ at least one fastener to secure the prosthesis to tissue in the hollow body organ. In one embodiment, the fastener comprises a helical fastener.
Another aspect of the invention provides systems and methods for supporting tissue within a hollow body organ making use of an elongated implant. The elongated implant is sized and configured to penetrate tissue and extend along a curvilinear path within or partially within a tissue wall. The elongated implant regulates a maximum size and/or shape of the hollow body organ. In one embodiment, the elongated implant comprises a helical shape.
The systems and methods that embody all or some of the various aspects of the invention, as described, are well suited for use in, e.g., a heart. The systems and methods can be used to support tissue within a heart chamber, e.g., of congestive heart failure or other conditions in which the volume of the heart becomes enlarged. The systems and methods can be used to seal or close perforations, holes, or defects in tissue. The systems and methods can be used to close or seal atrial appendages or septal defects.
Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims.
DESCRIPTION OF THE DRAWINGS
Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention, which may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
The technology disclosed in this specification is divided for clarity of presentation into sections, as follows:
-
- I. Implants for Externally Supporting Tissue in a Hollow Body Organ
- A. Overview
- B. Systems and Methods for Supporting Tissue in a Heart Chamber
- C. Systems and Methods to Support Tissue In or Near a Heart Valve Annulus
- II. Implants for Creating Tissue Folds
- A. Overview
- B. Systems and Methods Defining Discrete Tissue Folds
- 1. Tissue Folding with Overlaying Patch Component
- C. Systems and Methods Defining Patterns of Tissue Folds
- 1. Overview
- 2. Appendage Isolation and Sealing
- 3. Closing Perforations, Holes, or Defects
- III. Prostheses for Externally Supporting Tissue in a Hollow Body Organ
- A. Overview
- B. Systems and Methods for Supporting Tissue in a Heart Chamber
- C. Systems and Methods for Supporting Tissue In or Near a Heart Valve Annulus
- IV. Implants for Internally Supporting Tissue in a Hollow Body Organ
- I. Implants for Externally Supporting Tissue in a Hollow Body Organ
It should be appreciated that the technology described in a given section can be combined with technology described in another section, and that there are features that are common to all technology described herein.
I. Implants for Externally Supporting Tissue in a Hollow Body Organ
A. Overview
The body 12 includes a distal region 14. The distal region 14 is sized and configured to penetrate tissue. The body 12 and its distal region 14 are sized and configured to take purchase in tissue (see
The body 12 also includes a proximal region 16. The proximal region 16 is sized and configured to engage an instrument or tool 20 (see
As shown in
The tether element 18 comprises a thread, braid, wire, or tube structure with a metallic or polymer material (e.g., polyester suture) having a break strength that is desirably at least equal to the resistance the distal region 14 of the body 12 has to release or migration from tissue. The tether element 18 is desirably flexible, to enable its deployment through an intra-vascular path. The tether element 18 is desirably not significantly elastic, but it can be, depending upon the tissue conditions encountered.
The tether element 18 is securely fastened to the proximal region 16, e.g., by soldering, gluing, riveting, or like attachment techniques. The junction between the tether element 18 and the body 12 desirably has a material strength that is greater than the material strength of the tether element 18 itself.
The body 12 of the implant 10 can take various forms. In the illustrated embodiment (as
Also, in the illustrated embodiment (as
The system 24 includes at least one clip element 26 joined to the tether elements 18 of the implants 10.
The length of each individual tether element 18 and the magnitude of the tension it applies to its respective implant 10 collectively dictate a maximum shape for the body organ. In this way, the system 24 supports and shapes tissue in a body organ.
The system 24 as just described can be established in various parts of the body and for various therapeutic purposes. Two embodiments will be described for the purpose of illustration. The first embodiment is directed to the treatment and/or repair of congestive heart failure. The second embodiment is directed to heart valve remodeling.
B. Systems and Methods for Supporting Tissue in a Heart Chamber
In the intra-vascular approach shown in
The guide component 28 can comprise, e.g., a guide sheath that desirably has a steerable or deflectable distal tip. The guide wire can be withdrawn after the guide component 28 is deployed and positioned, so that the applier instrument 20 can be introduced through the guide component 28, as
In this arrangement (see
The implantation force of the drive mechanism 22 is desirably resolved in some manner to provide positional stability and resist unintended movement of the drive mechanism 22 relative to the implantation site. A resolution force is desirably applied to counteract and/or oppose the implantation force of the drive mechanism 22. It is desirable to resolve some or all or a substantial portion of the implantation force within the vessel lumen (or other hollow body organ) itself, and preferably as close to the implantation site as possible.
The tubular body of the guide component 28 and/or the shaft of the applier instrument 20 can be sized and configured to possess sufficient column strength to resolve some or all or at least a portion of the implantation force within the vessel lumen or hollow body organ.
The guide component 28 is reposition in succession to other intended myocardial delivery sites. At each site, the applier instrument 20 is actuated to place an implant 10. In this way (see
Once the desired number of implants 10 are deployed inside the left ventricle, the applier instrument 20 is withdrawn from the guide component 28. The tether elements 18 of the implants 10 are left gathered and channeled through the guide component 28, as
As
Once in the left ventricle, the clip-applier instrument 36 is held stationary, while the tether elements are pulled taut through the clip-applier instrument 36 (shown by arrow T is
The system 24 has been established to support the left ventricle to treat, in this instance, congestive heart failure.
It should be appreciated that one or more implants 10 of the system 24 can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants 10 are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart.
C. Systems and Methods to Support Tissue at or Near a Heart Valve Annulus
The intra-vascular approach shown in
The guide component 28 is positioned in succession at intended implant delivery sites at or near the inferior region of the aortic valve annulus. At each site, the applier instrument 20 is actuated to place an implant 10.
Once the desired number of implants 10 are deployed at or near the aortic valve annulus, the applier instrument 20 is withdrawn, and the clip-applier instrument 36 is tracked through the guide component 28 and over the bundle of tether elements 18 into the left ventricle (see
Once the clip-applier instrument 36 is in place, the tether elements 18 are pulled taut. Growing taut, the tether elements 18 apply tension on the individual implants 10, as the arrows in
The system 24 has been established to reshape the aortic valve annulus to treat, in this instance, congestive heart failure and/or retrograde flow through the aortic valve. The system 24 can also be used to treat retrograde flow through any other heart valve, e.g., the mitral valve.
It should be appreciated that one or more implants 10 of the system 24 can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants 10 are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart.
II. Implants for Creating Tissue Folds
A. Overview
The tissue folding system 38 as just described can be established in various parts of the body and for various therapeutic purposes.
B. Systems and Methods Defining Discrete Tissue Folds
The embodiment shown in
In the intra-vascular approach into the left ventricle, as shown in
As
Alternatively, or in combination with the clip element 42, the implants 10 and 40 can include interlocking structural components 46 (see
As shown in
In the foregoing embodiments, a single tether element 18 has been used to apply tension between the implant 10 that carries the tether element 18 and another implant 40 that does not. Alternatively, as shown in
In any of the foregoing manners, the system 38 can be established to reduce the interior volume of a heart chamber to treat, in this instance, a left ventricle affected by congestive heart failure.
The tether element(s) 18 may be elastic and/or possess a spring constant and/or be shaped and/or be otherwise compliant in the region between the implants 10 and 40. This material characteristic can help minimize or dampen peak load conditions upon the system 38, particularly when the tissue region is dynamic, as is the case with cardiac tissue.
1. Tissue Folding With Overlaying Patch Component
As shown in
The patch component 50, when installed, comprises a relatively planar frame, or a sheet of prosthetic material, or combinations thereof. The patch material is selected on the basis of its biocompatibility, durability, and flexible mechanical properties. The patch material can comprise a polymeric or metallic material, e.g., polyester, or ePTFE, or a malleable plastic or metal material, or a self-expanding plastic or metal material like Nitinol® wire. The patch material desirably possesses some elasticity, e.g., by using stretchable materials and/or weaves/knits, like Spandex™ material or elastic waist bands. The patch material also desirably possesses a resistance to expansion. The material may be drug coated or embedded with drugs, such as with heparin.
The patch component 50 is desirable sized and configured to permit non-invasive deployment of the prosthesis by an intra-vascular catheter. In this respect, the patch component 50 is desirably sized and configured to assume a compressed or collapsed, low profile condition, to permit its intra-vascular introduction into the hollow body organ by a catheter. The patch component 50 is likewise desirably sized and configured for expansion in situ from a collapsed condition into an expanded condition for contact with tissue overlaying the fold 44.
The patch component 50 carry radiopaque markers to help fluoroscopically position it. The markers can take the form, e.g. of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, or gold.
The guide elements 60 comprise wires with eyes 62. In the illustrated embodiment, the eyes 62 are secured to the patch component 50 by releasable suture 64. The suture 64 can, e.g., comprise a loop that is threaded through each eye 62 and the patch component 50. The ends of the suture loop extend out the proximal end of the catheter 58. Pulling on one end of the suture loop will withdraw the suture 64 from the eyes 62, thereby releasing the patch component 50.
The guide elements 60 (and/or the patch component 50 itself) are desirably biased to hold the patch component 50, once released, in an open and taut fashion, as
It should be appreciated that one or more implants 10 and/or 40 of the system 38, or the implants 56 associated with the patch component 50, can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants 10 and/or 40, or the patch component 50 are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart.
C. Systems and Methods Defining Patterns of Tissue Folds
1. Overview
As
The system 52 as just described can be established in various parts of the body and for various therapeutic purposes. Two embodiments will be described for the purpose of illustration. The first embodiment is directed to isolation or sealing of an atrial appendage in the treatment of, e.g., atrial fibrillation. The second embodiment is directed to the repair of perforations, holes, or defects in tissue, e.g., atrial or ventricular septal defects.
2. Appendage Isolation/Sealing
As shown in
The tether element 18 of the implant 10 is cinched through an adjacent implant 40, which, in turn, is cinched through the next adjacent implant 40, and so on. The cinching between adjacent implants creates a fold 44. The cinching between a sequence of adjacent annular implants creates a pattern of adjacent, folds 44 about the native junction.
The tether element 18—cinched sequentially about the implants 10 and 40—is held in tension by a clip element 54. The system 52 draws the junction together, thereby essentially closing the atrial appendage from blood flow communication with the remainder of the atrium. The number and pattern of implants 10 and 40 in the system 52 can vary according to the size and geometry of the targeted junction sought to be isolated and sealed.
The system 52 can be deployed to seal or otherwise isolate an atrial appendage, either by open surgical techniques or intra-vascular access, using the instruments and methodologies that have been previously described.
It should be appreciated that a patch component 50 like that shown in
3. Closing Perforations, Holes, or Defects
The system 52 shown in
The number and pattern of implants 10 and 40 in the system 52 can vary according to the size and geometry of the targeted junction sought to be isolated and sealed. Furthermore, the system 52 can be deployed to seal a perforation, hole of defect in tissue either by open surgical techniques or intra-vascular access, using the instruments and methodologies previously described.
It should be appreciated that, given the dimensions of the perforation, hole, or defect, a discrete system 38 like that shown in
In one embodiment (see
In the foregoing indications in the heart, it is desired that the implants 10 and/or 40, and the patch component 50 and its associated fasteners 56, are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart.
III. Prostheses for Externally Supporting Tissue in A Hollow Body Organ
A Overview
The body 72 can comprise a fully formed, three dimensional structure, as
In the illustrated embodiments, the body 72 is shown to include a prosthetic material 74. The prosthetic material 14 is selected on the basis of its biocompatibility, durability, and flexible mechanical properties. The material 74 can comprise, e.g., woven polyester or ePTFE. The prosthetic material 74 desirably possesses some elasticity, e.g., by using stretchable materials and/or weaves/knits, like Spandex™ material or elastic waist bands. The prosthetic material 74 also desirably possesses limited expansion or a resistance to expansion that can increase rapidly. The prosthetic material 74 may be drug coated or embedded with drugs on the inside surface, such as with heparin. Alternatively, the prosthetic material 74 may be relatively non-compliant, but can be compressed along with the rest of the prosthesis by crumpling, folding, etc. The prosthetic material 74 could also comprise a polymeric or metallic grid structure.
In the illustrated embodiments, the prosthetic material 74 is shown to be supported by a scaffold-like structure 76. It should be appreciated, however, that the prosthetic material 74 could be free of a scaffold-like structure 76, or, conversely, the scaffold-like structure 76 could be free of a prosthetic material 74.
The prosthetic material 74 and/or scaffold-like structure 76 are desirable sized and configured to permit non-invasive deployment of the prosthesis by an intra-vascular catheter. With this criteria in mind, the prosthetic material 74 and/or scaffold-like structure 76 are sized and configured to assume a compressed or collapsed, low profile condition, to permit their intra-vascular introduction into the hollow body organ by a catheter. Also with this criteria in mind, the prosthetic material 74 and/or scaffold-like structure 76 are sized and configured for expansion in situ from a collapsed condition into an expanded condition in contact with tissue in the targeted region.
In this respect, the scaffold-like structure 76, if present, can comprise, e.g., a malleable plastic or metal material that expands in the presence of an applied force. In this arrangement, the deployment catheter can include, e.g., an expandable body, such as a balloon, to apply the expansion force to the scaffold-like structure 76 in situ. Alternatively, the scaffold-like structure 76, if present, can comprise a self-expanding plastic or metal material (e.g., from Nitinol® wire) that can be compressed in the presence of a force, but self-expands upon removal of the compressive force. In this arrangement, the deployment catheter can include, e.g., a sleeve that can be manipulated to enclosed the scaffold-like structure 76 in a collapsed condition, thereby applying the compressive force, and to release the scaffold-like structure 76 when desired to allow the scaffold-like structure 76 to self-expand in situ.
The scaffold-like structure 76 can take various alternative forms, some of which are shown for the purpose of illustration. The scaffold-like structure 76 can include longitudinally extending spines, which form an umbrella-like structure shown in
The prosthesis body 72 can carry radiopaque markers to help fluoroscopically position the prosthesis. The markers can take the form, e.g. of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, or gold.
The structural strength of the prosthesis 70 resists distension of the tissue wall en masse beyond the maximum size and shaped imposed by the prosthesis body 72. In this way, the prosthesis body 72 dictates a maximum size and shape for the body organ. However, the prosthesis body 72 does not interfere with the contraction of the hollow body organ to a lesser size and shape.
Desirably, as
The fasteners 56 can be variously constructed. They can, e.g., comprise staples or (as shown) helical fasteners, like that shown in
The prosthesis 70 as just described can be installed in various parts of the body and for various therapeutic purposes. Two embodiments will be described for the purpose of illustration. The first embodiment is directed to implantation within a heart chamber for treatment and/or repair of congestive heart failure. The second embodiment is directed to implantation in a heart valve annulus for heart valve remodeling.
B. Systems and Methods for Supporting Tissue in a Heart Chamber
The presence of the prosthesis 70 shapes the left ventricle in a desired fashion, pulling the chamber walls laterally closer together and thereby reducing the overall maximum internal volume. The presence of the prosthesis 70 resists further enlargement of the left ventricle during ventricular diastole and provides a shape is better suited to efficient ventricular pumping. However, the presence of the prosthesis 70 does not interfere with contraction of the left ventricle during ventricular systole.
In this embodiment, it is desired that the prosthesis 70 is not inherently electrically conductive, so as not to interfere with electrical conduction within the heart.
In the intra-vascular approach shown in
The first catheter 78 carries the prosthesis 70 in a radially reduced or collapsed configuration. Once inside the left ventricle (see
The guide component 28 (previously described) is delivered over the guide wire 80 (which is then withdrawn) (see
As
The prosthesis 70 has been installed to shape the left ventricle to treat, in this instance, congestive heart failure.
In an alternative embodiment, the prosthesis 70 could be sized and configured to contain a fluid, e.g., saline or blood. For example, the prosthesis 70 can carry fluid receiving tubes or pockets. The delivery of fluid causes the tubes or pockets to expand, thereby enlarging the occupying volume of the prosthesis 70. As a result, the usable internal volume of the heart chamber is reduced.
As shown in
The system 82 comprising an array of discrete patch components 50 can shape all or a portion of the ventricles, resisting further enlargement of the ventricles and provides a shape is better suited to efficient ventricular pumping. The presence of the patch components 50, however, desirably does not interfere with contraction of the ventricles to a lesser volume.
The prostheses 70 and prosthesis system 82 shown and described in foregoing FIGS. 19 to 24 can be used alone or in combination with the tissue folding systems shown and described in FIGS. 10 to 15, as well as in combination with the tissue support systems described and shown in FIGS. 5 to 10. Furthermore, an implant 10 and/or 40, previously described, can be implanted in association with an individual patch component 50, with the patch component 50 in this arrangement serving to protect underlying tissue from abrasion and providing compliance between the implant 10/40 and tissue. Also, fasteners 56 used to secure a given prosthesis to any tissue wall (e.g., as shown in
C. Systems and Methods for Support Tissue At or Near a Heart Valve Annulus
In this embodiment, the body 72 includes a prosthetic material 74 that promotes tissue ingrowth, to aid in fixing the prosthesis 70 to tissue in or near the annulus. In this embodiment, it is desired that the material of the prosthesis body 72 is not inherently electrically conductive, so as not to interfere with electrical conduction within the heart.
As before described, the prosthesis body 72 in this embodiment is also desirable sized and configured to permit its non-invasive deployment by an intra-vascular catheter. Alternatively, however, the prosthesis body 72 can be installed using conventional open heart surgical techniques or by thoracoscopic surgery techniques.
In this arrangement, the prosthesis body 72 desirably includes eyelet regions 84 to receive fasteners 56, so that the prosthesis 70 can be secured to tissue in or near the targeted heart valve annulus.
As
The prosthesis 70 shown and described in foregoing FIGS. 25 to 27 can be used alone or in combination with the tissue support systems described and shown in
The valve assembly 100 includes a flexible valve member 106. In the illustrated embodiment, the valve member comprises three, coapting leaflets 108, although the number of leaflets 108 can vary, e.g., between two and four.
In use (see
As previously described with respect to the prosthesis 70, regions of the scaffold-like structure 102 and/or prosthetic material 104 can be specially sized and configured for the receipt and retention of fasteners 56. The fasteners 56 can be variously constructed. They can, e.g., comprise staples or (as shown) helical fasteners, like that shown in
The valve assembly 100 as just described can be installed in the region of a heart valve annulus by intra-vascular approach. However, it should be appreciated that the assembly 100 can be installed using an open surgical procedure.
Using an intra-vascular approach (see
The valve assembly 100 is then be pushed out of the lumen of the catheter 110 (as
The applier instrument 20 carries a helical fastener 56. The applier instrument 20 rotates the fastener 56, causing it to penetrate the myocardium.
The valve assembly 100 has been installed to repair, or replace, or supplement a native heart valve.
The valve assembly 100 shown and described in foregoing FIGS. 32 to 34 can be used alone or in combination with the tissue support systems described and shown in
IV. Implants for Internally Supporting Tissue in A Hollow Body Organ
The body 88 can possess a generally straight or linear configuration, as
The body 88 includes a distal region 90. The distal region 90 is sized and configured to penetrate tissue.
The body 88 also includes a proximal region 92. As shown in
The body 88 and its distal region 90 are sized and configured to be implanted within or partially within tissue in a hollow body organ. The linear body 88 shown in
Like the implants 10 previously described, the implants 86 shown in
In the many catheter-based implantation techniques described above, the catheter used to place a given prosthesis in contact with tissue is usually manipulated to be detached from the prosthesis prior to the placement of fasteners. If desired, the catheter and prosthesis can remain coupled together during the fastening procedure. In this way, control of the prosthesis can be maintained up to and during the fastening procedure.
Other embodiments and uses of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples should be considered exemplary and merely descriptive of key technical; features and principles, and are not meant to be limiting. The true scope and spirit of the invention are defined by the following claims. As will be easily understood by those of ordinary skill in the art, variations and modifications of each of the disclosed embodiments can be easily made within the scope of this invention as defined by the following claims.
Claims
1. A system for supporting tissue within a hollow body organ comprising
- a first implant sized and configured to penetrate a first region of tissue in the hollow body organ,
- a second implant sized and configured to penetrate a second region of tissue in the hollow body organ spatially distinct from the first region, and
- at least one tension element to apply tension on the first and second implants and thereby draw tissue inward, thereby defining a reduced interior volume within the hollow body organ.
2. A system according to claim 1
- wherein the tension element folds tissue between the first and second implants.
3. A system according to claim 2
- further including a patch element fastened to tissue and overlaying the fold between the first and second implants.
4. A system according to claim 1
- wherein the first and second implants are part of an array of implants that penetrates spatially distinct regions of tissue in the hollow body organ, and
- wherein the tension element applies tension on the array of implants and thereby draw tissue inward.
5. A system according to claim 1
- wherein at least one of the implants comprises a helical fastener.
6. A system according to claim 1
- wherein the tension element includes first and second tether elements joined, respectively, to the first and second implants, and
- at least one clip element gathering the first and second tether elements together in a taut condition.
7. A method of supporting tissue in a hollow body organ comprising the step of using a system as defined in claim 1.
8. A method of supporting tissue in a heart chamber comprising the step of using a system as defined in claim 1.
9. A system for forming a tissue fold within a hollow body organ comprising
- a first implant sized and configured to penetrate a first region of tissue in the hollow body organ,
- a second implant sized and configured to penetrate a second region of tissue in the hollow body organ spatially distinct from the first region,
- at least one tension element extending between the first and second implants to apply tension on the first and second implants and thereby create a tissue fold between the first and second implants.
10. A system according to claim 9
- further including a patch element fastened to tissue and overlaying the tissue fold.
11. A system according to claim 9
- wherein the first and second implants are part of an array of implants that penetrates spatially distinct regions of tissue in the hollow body organ, and
- wherein the tension element extends among the array of implants to apply tension between adjacent implants and thereby create a pattern of tissue folds.
12. A system according to claim 11
- further including a patch element fastened to tissue and overlaying the pattern of tissue folds.
13. A system according to claim 9
- wherein at least one of the implants comprises
- a helical fastener.
14. A system according to claim 9
- wherein the tension element includes a tether element extending between the first and second implants in a taut condition.
15. A method of folding tissue in a hollow body organ comprising the step of using a system as defined in claim 9.
16. A method of folding tissue in a heart chamber comprising the step of using a system as defined in claim 9.
17. A method of folding tissue to close an atrial appendage comprising the step of using a system as defined in claim 9.
18. A method of folding tissue to close a perforation, hold, or defect comprising the step of using a system as defined in claim 9.
19. A system for supporting tissue in a hollow body organ comprising
- a prosthesis sized and configured for placement within an interior of the hollow body organ to regulate a size and/or shape of the hollow body organ, and
- at least one fastener securing the prosthesis to tissue in the hollow body organ.
20. A system according to claim 19
- wherein the fastener comprises a helical fastener.
21. A system according to claim 19
- wherein the prosthesis comprises an array of prosthetic patches.
22. A system according to claim 19
- wherein the prosthesis includes a formed body.
23. A system according to claim 19
- wherein the prosthesis includes an assembly of prosthesis sections.
24. A method of supporting tissue in a hollow body organ comprising the step of using a system as defined in claim 19.
25. A method of supporting tissue in a heart chamber comprising the step of using a system as defined in claim 19.
26. A system for supporting tissue around a hollow body organ comprising
- a prosthesis sized and configured for placement on an exterior of the hollow body organ to regulate a size and/or shape of the hollow body organ, and
- at least one fastener securing the prosthesis to tissue on the hollow body organ.
27. A system according to claim 26
- wherein the fastener comprises a helical fastener.
28. A system according to claim 26
- wherein the prosthesis comprises an array of prosthetic patches.
29. A system according to claim 26
- wherein the prosthesis includes a formed body.
30. A system according to claim 26
- wherein the prosthesis includes an assembly of prosthesis sections.
31. A method of supporting tissue around a hollow body organ comprising the step of using a system as defined in claim 26.
32. A method of supporting tissue around a heart chamber comprising the step of using a system as defined in claim 26.
33. A system for supporting tissue within a hollow body organ comprising
- an elongated implant sized and configured to penetrate tissue and extend along a curvilinear path within or partially within a tissue wall to regulate a size and/or shape of the hollow body organ.
34. A system according to claim 33
- wherein the elongated implant comprises a helical shape.
35. A method of supporting tissue in a hollow body organ comprising the step of using a system as defined in claim 33.
36. A method of supporting tissue in a heart chamber comprising the step of using a system as defined in claim 33.
37. A system for reducing volume within a hollow body organ comprising
- a prosthesis sized and configured for placement within the hollow body organ, the prosthesis including an expandable segment to regulate a size and/or shape of the hollow body organ, and
- at least one fastener securing the prosthesis to tissue in the hollow body organ.
38. A system according to claim 37 wherein the expandable segment is sized and configured to expand in response to receipt of fluid.
39. A method of reducing volume within a hollow body organ comprising the step of using a system as defined in claim 37.
40. A method of reducing volume within a heart chamber comprising the step of using a system as defined in claim 37.
41. A prosthesis for reducing volume within a hollow body organ comprising
- a prosthesis body sized and configured for placement within the hollow body organ, the prosthesis body including an expandable segment to regulate a size and/or shape of the hollow body organ, the expandable segment being sized and configured to expand in response to receipt of fluid.
42. A method of reducing volume within a hollow body organ comprising the step of using a prosthesis as defined in claim 41.
43. A method of reducing volume within a heart chamber comprising the step of using a prosthesis as defined in claim 41.
Type: Application
Filed: Mar 1, 2006
Publication Date: Dec 21, 2006
Applicant:
Inventors: Lee Bolduc (Sunnyvale, CA), Andrew Chiang (Fremont, CA), Philip Houle (Sunnyvale, CA), Gilbert Laroya (Santa Clara, CA)
Application Number: 11/365,056
International Classification: A61B 17/08 (20060101);