U.S. patent application number 11/365056 was filed with the patent office on 2006-12-21 for devices, systems, and methods for supporting tissue and/or structures within a hollow body organ.
This patent application is currently assigned to Aptus Endosystems, Inc.. Invention is credited to Lee Bolduc, Andrew L. Chiang, Philip R. Houle, Gilbert S. Laroya.
Application Number | 20060287661 11/365056 |
Document ID | / |
Family ID | 35196695 |
Filed Date | 2006-12-21 |
United States Patent
Application |
20060287661 |
Kind Code |
A1 |
Bolduc; Lee ; et
al. |
December 21, 2006 |
Devices, systems, and methods for supporting tissue and/or
structures within a hollow body organ
Abstract
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.
Inventors: |
Bolduc; Lee; (Sunnyvale,
CA) ; Chiang; Andrew L.; (Fremont, CA) ;
Houle; Philip R.; (Sunnyvale, CA) ; Laroya; Gilbert
S.; (Santa Clara, CA) |
Correspondence
Address: |
RYAN KROMHOLZ & MANION, S.C.
POST OFFICE BOX 26618
MILWAUKEE
WI
53226
US
|
Assignee: |
Aptus Endosystems, Inc.
|
Family ID: |
35196695 |
Appl. No.: |
11/365056 |
Filed: |
March 1, 2006 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10808216 |
Mar 24, 2004 |
|
|
|
11365056 |
Mar 1, 2006 |
|
|
|
10307226 |
Nov 29, 2002 |
|
|
|
10808216 |
Mar 24, 2004 |
|
|
|
10271334 |
Oct 15, 2002 |
6960217 |
|
|
11365056 |
Mar 1, 2006 |
|
|
|
60333937 |
Nov 28, 2001 |
|
|
|
Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 2017/0441 20130101; A61F 2/2445 20130101; A61B
17/068 20130101; A61B 2017/048 20130101; A61B 2017/0454 20130101;
A61B 2017/0488 20130101; A61F 2/2466 20130101; A61B 17/0487
20130101; A61B 2017/00575 20130101; A61B 2017/00592 20130101; A61B
17/00234 20130101; A61F 2/2412 20130101; A61B 2017/0496 20130101;
A61B 2017/0646 20130101; A61F 2002/249 20130101; A61F 2/2487
20130101; A61B 17/0057 20130101; A61F 2/2478 20130101; A61B
2017/00606 20130101; A61B 17/0401 20130101; A61B 2017/0649
20130101; A61F 2/2481 20130101; A61B 17/064 20130101; A61B 17/12122
20130101; A61B 17/12172 20130101; A61B 2017/00783 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
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.
Description
RELATED APPLICATIONS
[0001] 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 INVENTION
[0002] The 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 INVENTION
[0003] Hollow 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
[0004] The heart (see FIG. 1) is slightly larger than a clenched
fist. It is a double (left and right side), self-adjusting muscular
pump, the parts of which work in unison to propel blood to all
parts of the body. The right side of the heart receives poorly
oxygenated ("venous") blood from the body from the superior vena
cava and inferior vena cava and pumps it through the pulmonary
artery to the lungs for oxygenation. The left side receives
well-oxygenation ("arterial") blood from the lungs through the
pulmonary veins and pumps it into the aorta for distribution to the
body.
[0005] 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.
[0006] 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.
[0007] The heart has four valves (see FIGS. 2 and 3) that ensure
that blood does not flow in the wrong direction during the cardiac
cycle; that is, to ensure that the blood does not back flow from
the ventricles into the corresponding atria, or back flow from the
arteries into the corresponding ventricles. The valve between the
left atrium and the left ventricle is the mitral valve. The valve
between the right atrium and the right ventricle is the tricuspid
valve. The pulmonary valve is at the opening of the pulmonary
artery. The aortic valve is at the opening of the aorta.
[0008] At the beginning of ventricular diastole (i.e., ventricular
filling)(see FIG. 2), the aortic and pulmonary valves are closed to
prevent back flow from the arteries into the ventricles. Shortly
thereafter, the tricuspid and mitral valves open (as FIG. 2 shows),
to allow flow from the atria into the corresponding ventricles.
Shortly after ventricular systole (i.e., ventricular emptying)
begins, the tricuspid and mitral valves close (see FIG. 3)--to
prevent back flow from the ventricles into the corresponding
atria--and the aortic and pulmonary valves open--to permit
discharge of blood into the arteries from the corresponding
ventricles.
[0009] 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
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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
[0014] 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.
[0015] 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 INVENTION
[0016] The 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] Other features and advantages of the invention shall be
apparent based upon the accompanying description, drawings, and
claims.
DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a perspective, anterior anatomic view of the
interior of a healthy heart.
[0025] FIG. 2 is a superior anatomic view of the interior of a
healthy heart, with the atria removed, showing the condition of the
heart valves during ventricular diastole.
[0026] FIG. 3 is a superior anatomic view of the interior of a
healthy heart, with the atria removed, showing the condition of the
heart valves during ventricular systole.
[0027] FIG. 4A is a perspective view of an implant for supporting
tissue within a hollow body organ.
[0028] FIG. 4B is a side view of an applier instrument for
implanting the implant shown in FIG. 4A in tissue.
[0029] FIG. 4C is a side view of the implant shown in FIG. 4A after
implantation in tissue.
[0030] FIGS. 5A and 5B are tissue support systems established
within a hollow body organ that comprises two or more of the
implants as shown in FIG. 4A placed and maintained in tension by a
clip element.
[0031] FIGS. 6A and 6B show the tissue supporting system shown in
FIG. 5 established in a left ventricle of a heart, FIG. 6A showing
the enlarged volume of the ventricle prior to establishment of the
system, and FIG. 6B showing the system reducing the volume of
ventricle.
[0032] FIGS. 7A to 7D show the steps in establishing the system
shown in FIG. 6B by use of intra-vascular tools and techniques.
[0033] FIGS. 8A and 8B show a tissue supporting system like that
shown in FIG. 5, established in a left ventricle of a heart in or
near the annulus of the aortic valve, FIG. 8A showing the dilated
condition of the aortic valve annulus prior to establishment of the
system, and FIG. 8B showing the system reshaping the annulus to
restore leafet coaption.
[0034] FIGS. 9A to 9D show the steps in establishing the system
shown in FIG. 8B by use of intra-vascular tools and techniques.
[0035] FIGS. 10A and 10B show a tissue folding system established
in a left ventricle of a heart, FIG. 10A showing the enlarged
volume of the ventricle prior to establishment of the system, and
FIG. 10B showing the system reducing the volume of ventricle.
[0036] FIGS. 11A to 11D show the steps in establishing the system
shown in FIG. 10B by use of intra-vascular tools and
techniques.
[0037] FIG. 12 shows another embodiment of a tissue folding system
possessing the features of the system shown in FIG. 10B.
[0038] FIGS. 13A to 13C show the steps in establishing, by use of
intra-vascular tools and techniques, another embodiment of a tissue
folding system possessing the features of the system shown in FIG.
10B.
[0039] FIGS. 14A and 14B show the steps in establishing, by use of
intra-vascular tools and techniques, another embodiment of a tissue
folding system possessing the features of the system shown in FIG.
10B.
[0040] FIG. 15A is a tissue folding system as shown in FIG. 10B,
with the including of an overlaying patch component that is secured
by fasteners over the tissue fold established by the tissue folding
system.
[0041] FIG. 15B is a catheter that deploys the patch component
shown in FIG. 15A by intra-vascular access.
[0042] FIG. 16A shows the establishment of a system that creates a
pattern of folds in a hollow body organ to isolate or seal one
region of the hollow body organ from another region of the hollow
body organ.
[0043] FIG. 16B is a plane view of the pattern of folds created by
the system shown in FIG. 16A, taken generally along line 16B-16B in
FIG. 16A.
[0044] FIGS. 17A and 17B show the establishment of a pattern of
multiple folds in the region between an atrial appendage and an
atrial septum using the system shown in FIGS. 16A and 16B, FIG. 17A
showing the atrium prior to establishment of the system, and FIG.
17B showing the atrium after establishment of the system to isolate
and/or seal the atrial appendage from the atrial septum.
[0045] FIG. 17C is a plane view of the pattern of folds created by
the system shown in FIG. 17B, taken generally along line 17C-17C in
FIG. 17B.
[0046] FIGS. 18A and 18B show the establishment of a pattern of
multiple folds to seal a perforation in a hollow body organ using
the system shown in FIGS. 16A and 16B, FIG. 18A showing the
perforation prior to establishment of the system, and FIG. 18B
showing the closing of the perforation after establishment of the
system.
[0047] FIGS. 19A to 19F show various embodiments of a prothesis
that can be installed in a hollow body organ to shape the organ and
prevent its enlargement.
[0048] FIG. 20A shows a prosthesis of a type shown in FIGS. 19A to
19F installed in the interior of a hollow body organ.
[0049] FIG. 20B shows a prosthesis of a type shown in FIGS. 19A to
19F installed about the exterior of a hollow body organ.
[0050] FIG. 21A shows a prosthesis of a type shown in FIGS. 19A to
19F installed in the interior of a heart chamber.
[0051] FIGS. 22A to 22D show the steps in establishing, by use of
intra-vascular tools and techniques, the prosthesis shown in FIG.
20A.
[0052] FIG. 23 shows a prosthesis of a type shown in FIGS. 19A to
19F installed about the exterior of a heart.
[0053] FIGS. 24A and 24B show a composite prosthesis having the
features of the prosthesis shown in FIGS. 19A to 19F, being formed
by an array of two or more patch components installed in a left
ventricle of a heart.
[0054] FIG. 25 shows a prosthesis having the features of the
prosthesis shown in FIGS. 19A to 19F, being formed in the form of a
ring for placement in or near a heart valve annulus.
[0055] FIG. 26A shows a prosthesis as shown in FIG. 25 installed in
or near an annulus of an aortic valve.
[0056] FIG. 26B shows a prosthesis as shown in FIG. 25 installed in
or near an annulus of a mitral valve.
[0057] FIG. 27 is a catheter that deploys the prosthesis shown in
FIG. 25 by intra-vascular access.
[0058] FIG. 28 shows a patch component having the features of the
patch component shown in FIG. 15A, being sized and configured for
repairing a septal defect in a heart.
[0059] FIGS. 29A and 29B show the patch component shown in FIG. 28
installed in a septal defect between the left and right ventricles
of heart.
[0060] FIGS. 30A and 30B show various embodiments of an elongated
implant that can be implanted in a hollow body organ to shape the
organ and prevent its enlargement, FIG. 30A showing an implant
having a generally linear shape, and FIG. 30B showing an implant
having a generally curvilinear shape.
[0061] FIG. 31 shows the elongated implant shown in FIGS. 30A and
30B implanted in a left ventricle of a heart.
[0062] FIG. 32 shows a heart valve assembly having many of the
features of the prosthesis shown in FIGS. 19A to 19F, being formed
for placement in or near a heart valve annulus.
[0063] FIG. 33 shows an assembly as shown in FIG. 32 installed in
or near an annulus of an aortic valve.
[0064] FIGS. 34A to 34C show the steps in installing, by use of
intra-vascular tools and techniques, the heart valve assembly shown
in FIG. 32 in or near an annulus of an aortic valve.
DETAILED DESCRIPTION
[0065] 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.
[0066] The technology disclosed in this specification is divided
for clarity of presentation into sections, as follows: [0067] I.
Implants for Externally Supporting Tissue in a Hollow Body Organ
[0068] A. Overview [0069] B. Systems and Methods for Supporting
Tissue in a Heart Chamber [0070] C. Systems and Methods to Support
Tissue In or Near a Heart Valve Annulus [0071] II. Implants for
Creating Tissue Folds [0072] A. Overview [0073] B. Systems and
Methods Defining Discrete Tissue Folds [0074] 1. Tissue Folding
with Overlaying Patch Component [0075] C. Systems and Methods
Defining Patterns of Tissue Folds [0076] 1. Overview [0077] 2.
Appendage Isolation and Sealing [0078] 3. Closing Perforations,
Holes, or Defects [0079] III. Prostheses for Externally Supporting
Tissue in a Hollow Body Organ [0080] A. Overview [0081] B. Systems
and Methods for Supporting Tissue in a Heart Chamber [0082] C.
Systems and Methods for Supporting Tissue In or Near a Heart Valve
Annulus [0083] IV. Implants for Internally Supporting Tissue in a
Hollow Body Organ
[0084] 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
[0085] A. Overview
[0086] FIG. 4A shows an implant 10 sized and configured for
placement in a hollow body organ. The implant includes a body 12
that can be made from a formed plastic or metal or ceramic material
suited for implantation in the body.
[0087] 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 FIG. 4C) sufficient to significantly resist release
and/or migration of the body 12 from tissue, once implanted.
[0088] 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 FIG. 4B) that applies a force to cause the implant 10 to
penetrate tissue.
[0089] As shown in FIG. 4A, the body 12 also includes a tether
element 18. In the illustrated embodiment, the tether element 18 is
carried on or near the proximal region 16 of the body 12. By virtue
of this, when the body 12 is implanted in a tissue wall in a vessel
or hollow body organ (see FIG. 4C), the tether element 16 extends
outside the tissue wall.
[0090] 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.
[0091] 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.
[0092] The body 12 of the implant 10 can take various forms. In the
illustrated embodiment (as FIG. 4A shows), the body 12 comprises an
open helical coil. In the arrangement, the distal region 14
comprises a sharpened leading tip. This type of body 12 and distal
region 14 can be deployed into tissue by rotational movement, which
the applier instrument 20 imparts to the implant 10.
[0093] Also, in the illustrated embodiment (as FIG. 4A shows), the
proximal region 16 comprises an L-shaped leg. The L-shape leg
desirably bisects the entire interior diameter of the coil body 12;
that is, the L-shaped leg 16 extends completely across the interior
diameter of the coil body 12. The L-shaped leg 16 serves as a stop
to prevent the coil body 12, when rotated, from penetrating too far
into tissue. Furthermore, as FIG. 4B generally shows, a rotatable
implant drive mechanism 22 on the applier instrument 20 is sized
and configured to engage the L-shaped leg 16 and impart rotation to
the coil body 12 to achieve implantation in tissue.
[0094] FIGS. 5A and 5B show a tissue shaping system 24 comprising
at least two implants 10 shown in FIG. 4A. The implants 10 are
implanted in a tissue wall within a hollow body organ or vessel
(shown generically in FIGS. 5A and 5B) in a spaced-apart
relationship or pattern. The number of tethered implants 10
deployed can vary according to the size and geometry of the
targeted tissue volume, as well as the tissue support
objectives.
[0095] The system 24 includes at least one clip element 26 joined
to the tether elements 18 of the implants 10. FIG. 5A shows a
single clip element 26. FIG. 5B shows multiple clip elements 26.
The clip element or elements 26 mutually couple the tether elements
18 together, and allow tension to be applied and maintained
external to the tissue, as the arrows in FIGS. 5A and 5B show. The
tension individually applied and maintained by each tether element
18 on its respective implant 10, in combination, draws the
surrounding tissue wall en masse inward toward the clip element 26,
to shape the hollow body organ or vessel. Conversely, the tension
applied and maintained by the tether elements 18 on each implant
10, in combination, resists movement of the tissue wall en masse
outward away from the clip element 26. The tension prevents
distension of tissue wall beyond the volume created by the tissue
support system 24. The tissue support system 24, however, desirably
does not interfere with contraction of the tissue wall toward a
lesser volume.
[0096] 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.
[0097] 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.
[0098] B. Systems and Methods for Supporting Tissue in a Heart
Chamber
[0099] FIG. 6A shows a heart afflicted with congestive heart
failure. The condition shown in FIG. 6A is characterized by an
enlarged internal volume of the left ventricle. FIG. 6B shows the
treatment and/or repair of the condition by the implantation of a
system 24 of tethered implants 10 within the left ventricle. The
tethers 18 of the implants 10 are placed and held in tension (shown
by arrows in FIG. 6B) by a clip 26. Multiple clips 26 could be
used, if desired. The tension applied by the system 24 shapes the
left ventricle, pulling the chamber walls laterally closer together
and thereby reducing the overall maximum internal volume. The
tension prevents or restricts expansion of the left ventricle
beyond the shape during ventricular diastole, which is better
suited to efficient ventricular pumping. The support system 24,
however, does not interfere with normal contraction of the left
ventricle during ventricular systole.
[0100] FIGS. 7A to 7D show the intra-vascular deployment of the
system 24 shown in FIG. 6B. Alternatively, the system 24 can be
established using conventional open heart surgical techniques or by
thoracoscopic surgery techniques.
[0101] In the intra-vascular approach shown in FIGS. 7A to 7D, a
guide component 28 is delivered over a guide wire (not shown)
through the aortic valve into the left ventricle. The guide
component 28 can be delivered through the vasculature under
fluoroscopic guidance, e.g., through either a retrograde arterial
route (via, e.g., the femoral artery or subclavian artery) (as
shown) or an antegrade venous then trans-septal route.
[0102] 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 FIG. 7A shows. FIG. 4B also
shows the deployment of the applier instrument 20 through the guide
component 28.
[0103] In this arrangement (see FIG. 4B), the applier instrument 20
comprises a catheter 30 that carries an implant drive mechanism 22
on its distal tip. The drive mechanism 22 carries at least one
tethered implant 10. An motor 32 in a handle 34, operated by the
physician, drives the mechanism 22 to rotate the implant 10. As a
result, the implant 10 is caused to penetrate the myocardium (as
FIG. 7A shows).
[0104] 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.
[0105] 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. FIG. 7A shows the guide component 28 braced against a
wall of the ventricle to apply a counterbalancing resolution force.
In addition, or alternatively, the guide component 28 and/or the
aopplier instrument 20 can include some form of stabilization means
for applying a counteracting force at or near the drive mechanism
22. Various types of stabilization means are disclosed in
co-pending U.S. patent application Ser. No. 10/669,881, filed Sep.
24, 2003, and entitled "Catheter-Based Fastener Implantation
Apparatus and Methods with Implantation Force Resolution."
[0106] 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
FIG. 7B), a desired spacing of implants 10 (such as a radial or
spiral-like pattern) is distributed within the left ventricle.
[0107] 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 FIG.
7B shows.
[0108] As FIG. 7C shows, a clip-applier instrument 36 is tracked
through the guide component 28 and over the bundle of tether
elements 18 into the left ventricle. The tether elements 18 act as
a composite guide wire to guide the clip-applier instrument 36 into
the left ventricle.
[0109] 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 FIG.
7C). As the individual tether elements 18 grow taut, they apply
tension on the individual implants 10, as FIG. 7C shows. This, in
turn, pulls the walls of the left ventricle inward towards the
clip-applier instrument 26 (as a comparison of the left ventricle
shown in FIG. 7B to the left ventricle shown in FIG. 7C
demonstrates). Once a desired ventricular volume is achieved (as
determined, e.g., through fluoroscopy), the clip-applier instrument
36 applies a clip 26 to the tether elements, attaching the tether
elements 18 together in tension (see FIG. 7D). The clip-applier 36
cuts the bundle of tether elements 18 proximal to the site where
the clip 26 was applied. The clip-applier instrument 36 and loose
tethers 18 are then withdrawn from the left ventricle through the
guide component 28, and the guide component is withdrawn, as FIG.
7D shows.
[0110] The system 24 has been established to support the left
ventricle to treat, in this instance, congestive heart failure.
[0111] 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.
[0112] C. Systems and Methods to Support Tissue at or Near a Heart
Valve Annulus
[0113] FIG. 8A shows a heart afflicted with congestive heart
failure. As shown in FIG. 8A this condition has resulted in an
enlarged internal volume of the left ventricle, leading to a
dilation or stretching the aortic heart valve annulus. As a result,
the aortic valve leaflets do not properly coapt during ventricular
systole. An undesired retrograde flow of blood from the left
ventricle into the aorta can occur during ventricular systole.
[0114] FIG. 8B shows the treatment and/or repair of this condition
by the implantation of a system 24 of tethered implants 10 in the
left ventricle near the aortic valve annulus. The tethers 18 of the
fasteners are placed and held in tension (shown by arrows in FIG.
8B) by a clip 26. Multiple clips 26 can be used, if desired. The
tension applied by the system 24 reshapes the aortic valve annulus,
pulling the leaflets closer together, so that coaptation during
ventricular systole occurs, and retrograde flow is prevented or
reduced.
[0115] FIGS. 9A to 9D show the intra-vascular deployment of the
system 24 shown in FIG. 8B. Alternatively, the system 24 can be
established using conventional open heart surgical techniques or by
thoracoscopic surgery techniques.
[0116] The intra-vascular approach shown in FIGS. 9A to 9D is the
essentially the same as that shown in FIGS. 7A to 7D, previously
described. Under fluoroscopic guidance, the guide component 28 is
delivered over a guide wire through either the aortic valve (via,
e.g., the femoral artery or subclavian artery) into the left
ventricle at or near the inferior region of the aortic valve
annulus or an antegrade venous then trans-septal route. The guide
wire is withdrawn, and the applier instrument 20 is introduced
through the guide component 28, as FIG. 9A shows.
[0117] 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. FIG. 9A shows the guide
component 28 braced against a wall of the ventricle to apply a
counterbalancing resolution force to the implantation force. In
this way (see FIG. 9B), a desired pattern of implants 10 is
distributed at or near the inferior region of the aortic valve
annulus. The tether elements of the implants 10 are gathered and
channeled through the guide component 28 to outside the body.
[0118] 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 FIG. 9C). The tether elements 18 act
as guide wires to guide the clip-applier instrument 36 into the
left ventricle.
[0119] 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 FIG.
9C show. This, in turn, pulls the walls of the left ventricle in
the region of the aortic valve annulus inward towards the
clip-applier instrument 36. The aortic valve leaflets are drawn
closer together, into a geometry better suited for coaptation. The
clip-applier instrument 36 applies a clip 26 to the tether elements
18, attaching the tether elements together in tension (see FIG.
9D). The clip-applier 36 cuts the bundle of tether elements 18
proximal to the site where the clip 26 was applied, and the
clip-applier instrument 36 and loose tethers 18 are withdrawn. The
guide component is then withdrawn, as FIG. 9D shows.
[0120] 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.
[0121] 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
[0122] A. Overview
[0123] FIG. 10B shows a tissue folding system 38 comprising at
least one tethered implant 10 shown in FIG. 4A. The implant 10 is
used in combination with another implant 40, which can take the
form of the implant shown in FIG. 4B, but need not include a tether
element 18. The implants 10 and 40 are implanted in a tissue wall
within a hollow body organ or vessel (shown to be within a left
ventricle in FIG. 10B) in a spaced-apart relationship. The tether
element 18 of the implant 10 is cinched through the implant 40 and
held in tension by a clip element 42, to form a fold or tuck 44 in
the tissue region between the implants 10 and 40. The presence of
the fold 44 reduces the overall interior volume of the hollow body
organ or vessel, as a comparison of the left ventricle shown in
FIG. 10A--before establishment of the tissue folding system 38--and
the left ventricle shown in FIG. 10B--after establishment of the
tissue folding system 38--demonstrates. The number of implants 10
and 40 and resulting folds 44 formed can vary according to the size
and geometry of the targeted tissue volume, as well as the volume
reduction objectives.
[0124] The tissue folding system 38 as just described can be
established in various parts of the body and for various
therapeutic purposes.
[0125] B. Systems and Methods Defining Discrete Tissue Folds
[0126] The embodiment shown in FIG. 10B contemplates the
establishment of one or more discrete folds 44, e.g., for the
treatment and/or repair of congestive heart failure. The tissue
folding system 38 can be implemented in various ways.
[0127] FIGS. 11A to 11D contemplate the intra-vascular deployment
of the system 38 in a left ventricle, as generally shown in FIG.
10B. Alternatively, the system 28 can be established using
conventional open heart surgical techniques or by thoracoscopic
surgery techniques. The system 38 can be deployed in other hollow
body organs or vessels within the body, either by open surgical
techniques or intra-vascular access.
[0128] In the intra-vascular approach into the left ventricle, as
shown in FIGS. 11A to 11D, an applier instrument 20 can be
introduced through a guide component 28 through either the aorta in
the manner shown in FIG. 7A (via, e.g., the femoral artery or
subclavian artery) or an antegrade venous then trans-septal route.
The applier instrument 20 deploys at least one tethered implant 10
(as FIG. 11A shows). The applier instrument 20 is withdrawn to
receive the implant 40, and then redeployed to an adjacent tissue
region, using the tether element 18 of the first implant 10 as a
guide wire as FIG. 11B shows. The tether element 18 of the implant
10 is slidably trapped or otherwise threaded through the implant 40
as the implant 40 is deployed, as FIG. 11B also shows. The applier
instrument 20 is withdrawn from the guide component 28, with the
tether element 18 of the implant 10 channeled through the guide
component 28.
[0129] As FIG. 11C shows, a clip-applier instrument 36 is tracked
through the guide component 28 and over the tether element 18 to
the tissue site. The clip-applier instrument 36 is held stationary,
while the tether element 18 is pulled taut through the clip-applier
instrument 36 (see FIG. 11C). The tether element 18 applies tension
between the implants 10 and 40, drawing the implants 10 and 40
together to cinch the intermediate tissue. The intermediate tissue
folds it upon itself, and the fold 44 is created, as FIG. 11C
shows. The clip-applier instrument 36 applies a clip element 42, to
maintain tension and the resulting fold 44 (see FIG. 11D). The clip
applier 36 cuts the tether element 18 proximal to the site where
the clip 42 was applied. The clip-applier instrument 36 is then
withdrawn through the guide component 28, and the guide component
is withdrawn, as FIG. 11D shows.
[0130] Alternatively, or in combination with the clip element 42,
the implants 10 and 40 can include interlocking structural
components 46 (see FIG. 12) that are brought into engagement by
pulling the tether element 18 taut. In an alternative embodiment
(not shown), a separate bridging element can be applied to
interlock elements 10 and 40 after they are brought into close
proximity by pulling the tether element taut. The engagement
between the components 46 that holds the relative positions of the
implants 10 and 40, to maintain the tissue tension and the
resulting fold 44. In this arrangement, the implant 40 can be
partially installed and tension applied to the tether element 18 to
draw the implants 10 and 40 toward one another, to create the
desired fold 44. Then installation of the implant 40 can be
completed to bring the components 46 into interlocking
engagement.
[0131] As shown in FIGS. 13A to 13C, the spacing between the
implants 10 and 40, after tension is applied to the tether element
18, can be controlled by use of a flexible, collapsible tube 48
between the implants 10 and 40. In this arrangement, the length of
the tube 48, when collapsed, is predetermined to reflect the
desired spacing between the implants 10 and 40 when in tension. As
FIG. 13A shows, the tube 48 is guided in an uncollapsed condition
over the tether element 18 after deployment of the implant 10. The
implant 40 is deployed by the applier instrument 20 in the manner
previously described, placing the tube 48 (uncollapsed) between the
implants 10 and 40, as FIG. 13B shows. Subsequent use of the
clip-applier instrument, as previously described, to draw the
tether element 18 taut, collapses the tube 48 to until its
predetermined length is assumed--resisting any further cinching--at
which point the clip element 42 is applied, resulting in the system
38 shown in FIG. 13C. Alternatively, a non-collapsible tube could
be used as a spacer between the two implants 10 and 40.
[0132] 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 FIGS. 14A and 14B, two implants 10, each
with its own tether element 18 can be deployed. In this embodiment,
the clip-applier instrument 36 is guided over both tether elements
18, so that tension can be applied individually to each tether
element 18. The clip-applier instrument 36 draws the tether
elements 18 taut (as FIG. 14B shows), creating the fold 44. The
clip-applier instrument 36 then applies the clip element 42, to
hold the two individual tether elements 18 in tension, forming the
system 38.
[0133] 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.
[0134] 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.
[0135] 1. Tissue Folding With Overlaying Patch Component
[0136] As shown in FIG. 15A, the tissue folding system 38 can
include a patch component 50 secured by implants 56 to span the
tissue fold 44. The patch component 50 distributes forces within
the system 28 to maintain the fold 44.
[0137] 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.RTM. wire. The patch material desirably possesses some
elasticity, e.g., by using stretchable materials and/or
weaves/knits, like Spandex.TM. 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.
[0138] 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.
[0139] 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.
[0140] FIG. 15B shows a representative embodiment for delivering
the patch component 50 by a catheter 58 deployed through
intra-vascular access. The catheter 58 carries the patch component
50 in a collapsed condition. Once positioned over the site of the
fold 44, the patch component 50 is released from the end of
catheter 58 on outwardly tapered guide elements 60.
[0141] 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.
[0142] 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 FIG. 15B shows. The patch component
50 placed over the fold 44. The periphery of the patch component 50
is attached to tissue using the fasteners 56. As FIG. 15B shows,
the applier instrument 20, previously described, may be deployed
over the guide elements 60 to apply the fasteners 56 to the patch
component 50. Alternatively, the applier instrument 29 may be
deployed independent of the guide elements 60.
[0143] 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.
[0144] C. Systems and Methods Defining Patterns of Tissue Folds
[0145] 1. Overview
[0146] As FIGS. 16A and 16B show, a tissue folding system 52 can
comprise a plurality of folds 44 arranged in a pre-established
pattern or array within a hollow body organ. The folds 44 are
arranged in an annular pattern about the circumference of a tissue
region. The folds 44 are formed by placement of at least one
tethered implant 10 (as shown in FIG. 4A) in association with a
plurality of other implants 40 (which need not be tethered). The
tether element 18 cinches tissue between adjacent implants, and a
clip element 54 holds tension in the tether element 18. As FIG. 16A
shows, the resulting pattern of adjacent folds 44 creates a tissue
region that is circumferentially drawn in, in purse string fashion.
As FIG. 16B shows, the system 52 can be used to establish within a
given hollow body organ a restriction that essentially isolates or
seals one region of a hollow body from another region.
[0147] 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.
[0148] 2. Appendage Isolation/Sealing
[0149] FIG. 17A shows for the purpose of illustration the two
native anatomic parts of an atrium (here, the left atrium)--namely,
the atrial appendage (also call the appendix auricilae) and the
remainder of the atrium (also called the sinus). FIG. 17B shows a
tissue folding system 52 that has been established within the
atrium. The system 52 comprises a plurality of annular folds 44
(see FIG. 17C), which essentially isolates or seals the left atrial
appendage from the atrial septum. In this arrangement, the system
52 can be used, e.g., to prevent the formation of blood stasis
regions in an atrial appendage that is subject to dysfunction as a
result of decreased contractility of the atrium following, e.g.,
treatment of atrial fibrillation.
[0150] As shown in FIGS. 17B and 17C, the system 52 comprises at
least one tethered implant 10 used in association with a plurality
of other implants 40 (which need not be tethered). The implants 10
and 40 are implanted at or near the relatively restricted, native
junction between the atrial appendage and the atrial sinus. The
implants 10 and 40 are implanted in a spaced-apart, annular
relationship about the circumference of this junction.
[0151] 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.
[0152] 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.
[0153] 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.
[0154] It should be appreciated that a patch component 50 like that
shown in FIG. 15A could be deployed over a pattern of folds 44
formed by the system 52. It should also be appreciated that one or
more implants 10 and/or 40 of the system 52 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 are not
inherently electrically conductive, so as not to interfere with
electrical conduction within the heart.
[0155] 3. Closing Perforations, Holes, or Defects
[0156] FIG. 18A shows for the purpose of illustration a tissue
region that has a perforation caused, e.g., by disease, injury, or
genetic defect. FIG. 18B shows a tissue folding system 52
established at or near the perforation in the tissue region. The
system 52 comprises a plurality of annular folds 44, which
essentially draw tissue together in a purse-string effect to close
the perforation. The system 52 can be used, e.g., to seal septal
defects in the atrium or ventricle, or in other regions of the body
where perforations, holes, or defects occur.
[0157] The system 52 shown in FIG. 18B is essentially the same as
shown 52 in FIGS. 17B and 17C. The system 52 comprises at least one
tethered implant 10 in association with a plurality of other
implants 40. The implants 10 and 40 are implanted in a
spaced-apart, circumferential relationship about the perforation.
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, creating a pattern of adjacent,
folds 44 about the perforation. 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 tissue surrounding the
perforation together, thereby closing it, or at least reducing its
native diameter.
[0158] 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.
[0159] It should be appreciated that, given the dimensions of the
perforation, hole, or defect, a discrete system 38 like that shown
in FIGS. 10B could be used to draw tissue together in the region of
the perforation, thereby repairing it. It should also be
appreciated that a patch component 50 like that shown in FIG. 15A
can be deployed over a tissue site repaired by the system 52 or
58.
[0160] In one embodiment (see FIG. 28), the patch component 50 can
be sized and configured to cover a discrete perforation, such as a
septal defect in the heart, without association with a tissue
folding system 52 or 58. In this arrangement (see FIG. 28), the
patch component 50 includes, e.g., a body portion 66 and a stem
portion 68. The stem portion 68, in use, occupies the perforation,
hole, or defect (e.g., as shown in FIGS. 29A and 29B), to plug the
site. The body portion 66 extends like "wings" from the stem
portion 68 to contact and seat against wall tissue adjacent the
site.
[0161] FIGS. 29A and 29B show the patch component 50 shown in FIG.
28 installed to cover a septal defect between the left and right
ventricles of a heart. As FIGS. 29A and 29B show, fasteners 56 are
desirably applied to anchor the body portion 66 to adjacent wall
tissue. The patch component 50 shown in FIGS. 29A and 29B 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.
[0162] 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
[0163] A Overview
[0164] FIGS. 19A to 19F show various illustrative embodiments of a
prosthesis 70 that is sized and configured for placement within an
interior of a hollow body organ or around the exterior of a hollow
body organ (see, e.g., FIGS. 20A and 20B, respectively). The
prosthesis 70 has a body 72 that is preformed in a desired size and
shape based upon the anatomy and morphology of the hollow body
organ. When placed in or around a hollow body organ, the size and
shape of the prosthesis body 72 constrains tissue, to regulate the
maximum size and shape of the hollow body organ in a way that
achieves a desired therapeutic result. However, the prosthesis body
72 desirably does not interfere with contraction of the hollow body
organ to a lesser size and shape.
[0165] The body 72 can comprise a fully formed, three dimensional
structure, as FIGS. 19A to 19D show. Alternatively, the body 72 can
comprise component parts (A, B, C), as FIG. 19E shows, that are
assembled in situ to form a composite body structure. The component
parts A, B, and C may be assembled end-to-end in an adjacent
relationship, or the component parts A, B, and C can be assembled
in an overlapping relationship. In FIG. 19E, the component parts A,
B, C comprise hoops, bowls, or truncated cylinders, which are
assembled axially. Alternatively, as will be described in greater
detail later, the components could comprise patch components (like
that shown in FIG. 15A) that are assembled together, either
end-to-end or in an overlaying relationship. Still alternatively,
the body 72 can comprise a sheet-like structure, as shown in FIG.
19F, that is wrapped in situ to form a composite, three dimensional
body structure. The body 72 could also include components that are
coupled together with interconnecting hinges or springs. It should
be appreciated that a multitude of structural configurations are
possible.
[0166] 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.TM. 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.
[0167] 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.
[0168] 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.
[0169] 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.RTM. 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.
[0170] 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 FIG. 19A.
Alternatively, the scaffold-like structure 76 can comprise zigzag
type stent rings (FIG. 19B), which can be independent or
interconnected one with the other, or combinations thereof; or a
helically wound stent support (FIG. 19C); or a woven or
crisscrossing pattern. The scaffold-like structure 76 need not be
present throughout the body 72; that is, the body 72 may include
regions that include a scaffold-like structure 76 and regions that
do not. The scaffold-like structure 76 can be, e.g., sewn onto
prosthetic material 74. Other attachment means could be utilized to
secure the scaffold-like structure 76 to the prosthetic material
74. These means include bonding; capturing the scaffold-like
structure 76 between two layers of prosthetic material 74; and
incorporating the scaffold-like structure 76 directly into the
prosthetic material 74. The scaffold-like structure 76 can be
present either inside the prosthesis body 72, or outside the
prosthesis body 72, or within the prosthesis body 72, or
combinations thereof. Desirably, the surface of the prosthesis 70
that is exposed to flow of blood or body fluids is relatively
smooth to minimize turbulence.
[0171] 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.
[0172] FIGS. 20A and 20B show the prosthesis 70 installed within a
targeted hollow body organ (FIG. 20A) or about a targeted hollow
body organ (FIG. 20B). At least part of the outer surface(s) of
prosthesis can be coated with substances, such as glue or drugs, or
structures, such as barbs or hooks, to promote adhesion or
connection to the hollow body organ.
[0173] 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.
[0174] Desirably, as FIGS. 20A and 20B show, the prosthesis body 72
accommodates the introduction of one or more fasteners 56 to anchor
the prosthesis 70 in place. For this purpose, regions of the
prosthesis body 72 can be specially sized and configured for the
receipt and retention of fasteners. For example, the size and
spacing of the scaffold-like structure 76 can be configured in the
regions to specially accommodate the placement of fasteners 56;
and/or woven fibers with an "X-pattern" or a "sinusoidal pattern"
can be used in the region to specially accommodate placement of
fasteners 56; and/or the prosthetic material can be folded-over to
form multiple layers, to reinforce the prosthesis in the regions
where fasteners 56 are placed; and/or denser weave patterns or
stronger fibers can be used, selected from, e.g., Kevlar.TM.
material or Vectran.TM. material or metallic wire woven alone or
interwoven with typical polyester fibers in the regions were
fasteners 56 are placed. It may also be desirable to
fluoroscopically indicate the regions with auxiliary radiopaque
markers on the prosthetic material 14, and/or scaffold-like
structure 76 to aid in positioning the fasteners 56.
[0175] The fasteners 56 can be variously constructed. They can,
e.g., comprise staples or (as shown) helical fasteners, like that
shown in FIG. 4A, but without the tether element 18.
[0176] 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.
[0177] B. Systems and Methods for Supporting Tissue in a Heart
Chamber
[0178] FIG. 21 shows the prosthesis 70 as described installed in a
left ventricle of a heart. The left ventricle has been enlarged due
to the effects of congestive heart failure. As FIG. 21 shows, the
prosthesis is desirably secured to the walls of the ventricle using
fasteners 56.
[0179] 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.
[0180] 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.
[0181] FIGS. 22A to 22D show the intra-vascular deployment of the
prosthesis 70 shown in FIG. 21. Alternatively, the prosthesis 70
can be installed using conventional open heart surgical techniques
or by thoracoscopic surgery techniques.
[0182] In the intra-vascular approach shown in FIGS. 22A to 22D, a
first catheter 78 is navigated over a guide wire 80 through the
aortic valve into the left ventricle (see FIG. 22A). The first
catheter 78 can be delivered through the vasculature under
fluoroscopic guidance, e.g., through either a retrograde arterial
route (via, e.g., the femoral artery or subclavian artery) (as
shown) or an antegrade venous then trans-septal route.
[0183] The first catheter 78 carries the prosthesis 70 in a
radially reduced or collapsed configuration. Once inside the left
ventricle (see FIG. 22B), the first catheter 70 releases the
prosthesis 70, which eventually expands radially into the
configuration shown in FIG. 21. The first catheter 78 is then
withdrawn over the guide wire 80.
[0184] The guide component 28 (previously described) is delivered
over the guide wire 80 (which is then withdrawn) (see FIG. 22C) and
maneuvered to each region where a fastener 56 is to be applied. The
applier instrument 20 (previously described) is introduced through
the guide component 28, as FIG. 22C shows and can also been seen in
FIG. 4B. In this embodiment, the applier instrument 20 carries a
helical fastener 56 generally of the type shown in FIG. 4A, but
without a tether element 18. The applier instrument 20 rotates the
fastener 56, causing it to penetrate the myocardium.
[0185] As FIG. 22D depicts, the guide component 28 is repositioned
in succession to each intended attachment site for the fastener 56.
At each site, the applier instrument 20 is actuated to place a
fastener 56. FIGS. 22C and 22D show the guide component 28 braced
against a wall of the ventricle to apply a counterbalancing
resolution force to the implantation force. In this way, a desired
pattern of fasteners 56 is applied, securing the prosthesis 70 to
the left ventricle, as FIG. 21 shows. The applier instrument 20 and
guide component 28 are then withdrawn.
[0186] The prosthesis 70 has been installed to shape the left
ventricle to treat, in this instance, congestive heart failure.
[0187] 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.
[0188] FIG. 23 shows an alternative embodiment, in which the
prosthesis 70 as described is installed around the exterior of the
ventricles of a heart afflicted with congestive heart failure. The
prosthesis 70 can be installed using conventional open heart
surgical techniques or by thoracoscopic surgery techniques.
[0189] As shown in FIG. 23, the prosthesis 70 is desirably secured
to the exterior walls of the ventricles using fasteners 56. The
fasteners 56 are applied from within the heart, using the
intra-vascular approach and technique just described. The presence
of the prosthesis 70 shapes the ventricles, reducing their overall
maximum internal volume. The presence of the prosthesis 70 also
resists further enlargement of the ventricles and provides a shape
is better suited to efficient ventricular pumping. The presence of
the prosthesis 70, however, desirably does not interfere with
contraction of the ventricles to a lesser volume.
[0190] FIGS. 24A and 24B show a prosthesis system 82 comprising an
array of two or more patch components 50, as previously described
with reference to FIG. 15A. In FIGS. 24A and 24B, the hollow body
organ comprises a left ventricle of a heart, but it should be
appreciated that the system 82 can be established in other body
organs, as well. In this embodiment, each patch component 50 is
individually attached by one or more fasteners 56 to a localized
tissue region in the hollow body organ. The patch components 50 are
shown to be placed in an overlapping array (see FIG. 24B), but the
array need not be overlapping. FIG. 24A shows the guide component
28 braced against a wall of the ventricle to apply a
counterbalancing resolution force to the implantation force. Using
a plurality of patch components 50, the system 82 can form a
composite prosthesis within the entire interior of the hollow body
organ, or, alternatively, the system 82 can form a prosthesis that
occupies only a portion of the entire interior to provide localized
tissue shaping. While not shown, it should also be appreciated that
the system 82 of patch components 50 can be installed on the
exterior of the hollow body organ.
[0191] 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.
[0192] 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 FIG. 21 or 23) can
be applied in association with an individual patch component 50,
with the patch component 50 in this arrangement serving to protect
the prosthesis 70 from abrasion due to the fastener 56, as well as
providing compliance between the fastener 56 and the prosthesis
70.
[0193] C. Systems and Methods for Support Tissue At or Near a Heart
Valve Annulus
[0194] FIG. 25 shows a prosthesis 70, in which the prosthesis body
72 is sized and configured as a ring, for placement in a heart
valve annulus. The prosthesis body 72 can be in the form of a
continuous ring or a discontinuous ring. In this way, the
prosthesis body 72 is preformed in a desired size and shape to
emulate the shape of a healthy, native annulus. The prosthesis body
72 thereby serves to shape an annulus that has experienced
dilation, as well as resist future dilation. The prosthesis body 72
desirably shapes the annulus so that so that normal leaflet
coaptation will occur, and/or so that retrograde flow through the
valve is prevented or reduced.
[0195] 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.
[0196] 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.
[0197] 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.
[0198] FIG. 26A shows for purposes of illustration the prosthesis
70 installed in or near the annulus of a mitral valve. FIG. 26B
shows for the purpose of illustration the prosthesis 70 installed
in or near the annulus of an aortic valve. The prosthesis 70 may be
attached either inside the ventricle in or near the aortic valve
(as FIG. 26B shows) or outside the ventricle within the aorta in or
near the aortic valve.
[0199] As FIG. 27 shows, the prosthesis body 72 can be delivered
through intra-vascular access by a catheter 58 like that shown in
FIG. 15B. The catheter 58 carries the prosthesis body 72 in a
collapsed condition. Once positioned in the targeted heart annulus,
the prosthesis body 72 can be released from the end of catheter 58
on guide elements 60. The guide elements 60 comprise wires with
eyes 62, which are releasably secured to the eyelet regions 84 of
the prosthesis body 72 by releasable sutures 64, as previously
described. Once the prosthesis body is deployed and positioned, the
prosthesis body can be attached to the annulus using the fasteners
56, and the sutures 64 then released to free the prosthesis body 72
from the catheter 58. As FIG. 15B shows, the applier instrument 20,
previously described, may be deployed over the guide elements 60,
or the applier instrument 20 may be deployed independent of the
guide elements (as FIG. 27 shows) to apply the fasteners 56 to the
eyelet regions.
[0200] 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 FIGS. 8 and 9.
[0201] FIG. 32 shows a heart valve assembly 100 having a generally
cylindrical shape formed by a collapsible scaffold-like structure
102. As shown, the scaffold-like structure 102 carries a prosthetic
material 104, although the structure 102 can be free of a
prosthetic material 104. As previously described with respect to
the prosthesis 70, the prosthetic material 104 and/or scaffold-like
structure 102 of the heart valve assembly 100 are sized and
configured to assume a compressed or collapsed, low profile
condition, to permit their intra-vascular introduction into a
hollow body organ by a catheter. Also as previously discussed, the
prosthetic material 104 and/or scaffold-like structure 102 are
sized and configured for expansion, and preferably self-expansion,
in situ from a collapsed condition into an expanded condition in
contact with tissue in the targeted region. For example, the
scaffold-like structure 102 can comprise a self-expanding plastic
or metal material (e.g., from Nitinol.RTM. wire) that can be
compressed in the presence of a force, but self-expands upon
removal of the compressive force. As illustrated, the scaffold-like
structure 102 comprises zigzag type stent rings.
[0202] 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.
[0203] In use (see FIG. 33), the valve assembly 100 is installed at
or near a heart valve annulus. In FIG. 33, the targeted heart valve
annulus is the aortic valve. Desirably, as FIG. 33 shows, the valve
assembly 100 accommodates the introduction of one or more fasteners
56 to anchor the assembly 100 in place either during or after its
installation.
[0204] 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 FIG. 4A, but without the tether
element 18.
[0205] 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.
[0206] Using an intra-vascular approach (see FIG. 34A), the
assembly 100 may be deployed by first folding and/or compressing
the assembly 100 into a lumen of a trans-vascular catheter 110 for
delivery. The catheter 110 may be advanced through the vasculature
into the heart through a retrograde arterial route (via, e.g., the
femoral artery or subclavian artery) (as FIG. 34A shows) or an
antegrade venous and then trans-septal route, if left heart access
is needed from a peripheral vessel access. Use of a standard
available guide wire 112 and/or guide sheath can assist the
operator in delivering and deploying the catheter 110 into
position.
[0207] The valve assembly 100 is then be pushed out of the lumen of
the catheter 110 (as FIG. 34B shows). The assembly 100 self-expands
into the desired shape and tension when released in situ (as FIG.
34C shows). After either partial or complete expansion of the valve
assembly 100, the catheter 110 is withdrawn, and the guide
component 28 (previously described) is delivered over the guide
wire 112. The guide component 28 is maneuvered to each region where
a fastener 56 is to be applied. The applier instrument 20
(previously described) is introduced through the guide component
28, as FIG. 34C shows.
[0208] The applier instrument 20 carries a helical fastener 56. The
applier instrument 20 rotates the fastener 56, causing it to
penetrate the myocardium. FIG. 34C shows the guide component 28
braced against a wall of the aorta to apply a counterbalancing
resolution force to the implantation force. The guide component 28
is repositioned in succession to each intended attachment site for
the fastener 56. At each site, the applier instrument 20 is
actuated to place a fastener 56. In this way, a desired pattern of
fasteners 56 is applied, securing the valve assembly 100 at or near
the targeted heart valve annulus. The applier instrument 20 and
guide component 28 are then withdrawn.
[0209] The valve assembly 100 has been installed to repair, or
replace, or supplement a native heart valve.
[0210] 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 FIGS. 8 and 9.
IV. Implants for Internally Supporting Tissue in A Hollow Body
Organ
[0211] FIGS. 30A and 30B show an implant 86 sized and configured
for placement in a hollow body organ. The implant 86 includes an
elongated body 88 that can be made from a formed plastic or metal
or ceramic material suited for implantation in the body.
[0212] The body 88 can possess a generally straight or linear
configuration, as FIG. 30A shows. Alternatively, the body 88 can
possess a curvilinear configuration, as FIG. 30B shows. As shown in
FIGS. 30A and 30B, the body 88 possesses a helical coil
configuration.
[0213] The body 88 includes a distal region 90. The distal region
90 is sized and configured to penetrate tissue.
[0214] The body 88 also includes a proximal region 92. As shown in
FIGS. 30A and 30B, the proximal region 92 comprises an L-shaped
leg. Like the L-shaped leg 16 shown in FIG. 4A, the L-shape leg 92
shown in FIGS. 30A and 30B desirably bisects the entire interior
diameter of the coil body 88. As before described, the L-shaped leg
92 serves as a stop to prevent the coil body 88, when rotated, from
penetrating too far into tissue. Furthermore, the rotatable implant
drive mechanism 22 on the applier instrument 20 (shown in FIG. 4B)
is sized and configured to engage the L-shaped leg 92 and impart
rotation to the coil body 88 to achieve implantation in tissue.
[0215] 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 FIG. 30A can run
either longitudinally or circumferentially within tissue, as FIG.
31 shows. The curvilinear body 88 shown in FIG. 30B exits tissue
and then re-enters tissue in a serpentine path, as FIG. 31 also
shows. When implanted, the implants 86 resist enlargement of the
interior of a hollow body organ. However, the implants 86 desirably
do not interfere with contraction of the hollow body organ to a
lesser interior volume.
[0216] FIG. 31 shows the implants 86 implanted, for the purpose of
illustration, in a left ventricle of a heart. The presence of the
implants 86 prevents enlargement of the heart chamber due to, e.g.,
congestive heart failure. Of course, the implants 86 can be
implanted in other hollow body organs and achieve a comparable
therapeutic effect.
[0217] Like the implants 10 previously described, the implants 86
shown in FIGS. 30A and 30B can be installed by intra-vascular
deployment using the instruments and techniques previously
described. Alternatively, the implants 86 can be installed using
conventional open heart surgical techniques or by thoracoscopic
surgery techniques.
[0218] 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.
[0219] 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.
* * * * *