U.S. patent application number 14/326883 was filed with the patent office on 2014-11-13 for methods and apparatus for controlling the internal circumference of an anatomic orifice or lumen.
The applicant listed for this patent is StJude Medical, Cardiology Division, Inc.. Invention is credited to Richard G. Cartledge, James I. Fann, Leonard Y. Lee.
Application Number | 20140336756 14/326883 |
Document ID | / |
Family ID | 37054006 |
Filed Date | 2014-11-13 |
United States Patent
Application |
20140336756 |
Kind Code |
A1 |
Lee; Leonard Y. ; et
al. |
November 13, 2014 |
METHODS AND APPARATUS FOR CONTROLLING THE INTERNAL CIRCUMFERENCE OF
AN ANATOMIC ORIFICE OR LUMEN
Abstract
An implantable device is provided for controlling at least one
of shape and size of an anatomical structure or lumen. An
implantable device has an adjustable member configured to adjust
the dimensions of the implantable device. An adjustment tool is
configured to actuate the adjustable member and provide for
adjustment before, during and after the anatomical structure or
lumen resumes near normal to normal physiologic function.
Inventors: |
Lee; Leonard Y.; (New York,
NY) ; Fann; James I.; (Portola Valley, CA) ;
Cartledge; Richard G.; (Hollywood, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
StJude Medical, Cardiology Division, Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
37054006 |
Appl. No.: |
14/326883 |
Filed: |
July 9, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11390984 |
Mar 27, 2006 |
|
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14326883 |
|
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|
|
60665296 |
Mar 25, 2005 |
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Current U.S.
Class: |
623/2.37 |
Current CPC
Class: |
A61B 2017/086 20130101;
A61F 2/2472 20130101; A61F 2250/0082 20130101; A61F 2230/0015
20130101; A61F 2220/0025 20130101; A61F 2220/0075 20130101; A61F
2250/001 20130101; A61F 2/2466 20130101; A61F 2220/0016 20130101;
A61F 2230/0006 20130101; A61F 2/2445 20130101; A61F 2210/0014
20130101; A61B 17/12013 20130101; A61F 2230/0095 20130101; A61F
2/2442 20130101; A61F 2230/0008 20130101 |
Class at
Publication: |
623/2.37 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An adjustable prosthetic implant for controlling at least one of
a shape and size of an anatomical structure or lumen, comprising: a
ring shaped member having an opening; a first draw string extending
within the opening and having an end extending outwardly of the
opening for engagement therewith; a second draw string extending
within the opening and having an end extending outwardly of the
opening for engagement therewith; and a first plurality of wedge
shaped shaping members disposed within the ring shaped member;
whereby tensioning of the first and second draw string by
engagement of their ends causes the ring shaped member to assume a
predetermined configuration.
2. The adjustable prosthetic implant of claim 1, wherein the
shaping members adjust the ring shaped member into a
three-dimensional shape.
3. The adjustable prosthetic implant of claim 1, wherein the
plurality of shaping members include a right most shaping member
and a left most shaping member; wherein the first draw string
comprises a right draw string and the second draw string comprises
a left draw string, and wherein the right draw string is attached
to the left most shaping member and the left draw string is
attached to the right most shaping member.
4. The adjustable prosthetic implant of claim 1, further including
a second plurality of shaping members disposed within the opening
of the ring shaped member, wherein the first plurality of shaping
members is spaced apart from the second plurality of shaping
members.
5. The adjustable prosthetic implant of claim 4, wherein the first
and second draw strings are attached to the first plurality of
shaping members, and further including third and fourth draw
strings attached to the second plurality of shaping members.
6. The adjustable prosthetic implant of claim 5, wherein the first
and third draw strings extend clockwise through the opening in the
ring shaped member and the second and fourth draw strings extend
counter clockwise through opening.
7. The adjustable prosthetic implant of claim 1, further including
a third and fourth draw string, wherein the shaping members have a
top and bottom, the top being narrower than at the bottom, whereby
the ring shaped member has a saddle-shaped configuration upon
tensioning the first, second, third and fourth draw strings.
8. The adjustable prosthetic implant of claim 1, wherein the
plurality of shaping members have a top and a bottom, wherein the
shaping members are arranged in alternating groups of shaping
members being narrower at their top than at their bottom and
narrower at their bottom than at their top, whereby the ring shaped
member has a three-dimensional configuration upon tensioning the
first and second draw strings.
9. The adjustable prosthetic implant of claim 1, wherein the ring
shaped member is configured to lie in a common plane when the first
and second draw strings are tensioned.
10. The adjustable prosthetic implant of claim 1, wherein the ring
shaped member has a circular shape, oval shape, polygonal shape,
d-shape or c-shape.
11. The adjustable prosthetic implant of claim 1, wherein the
prosthetic implant comprises a prosthetic annuloplasty ring.
12. The adjustable prosthetic implant of claim 1, wherein the
predetermined configuration comprises a complex three dimensional
configuration.
13. An adjustable prosthetic implant for controlling at least one
of a shape and size of an anatomical structure or lumen,
comprising: a ring shaped member having a first plurality of wedge
shaped shaping members arranged adjacent one another and configured
to adjust the configuration of the ring shaped member between a
first configuration and a second configuration; and an adjustment
member configured to actuate the plurality of wedge shaped shaping
members between the first and second configurations, wherein the
ring shaped member has a planar arrangement when the plurality of
wedge shaped shaping members are arranged in the first
configuration and have a three dimensional arrangement when the
plurality of wedge shaped shaping members are arranged in the
second configuration.
14. The adjustable prosthetic implant of claim 13, wherein the ring
shaped member comprises a prosthetic annuloplasty ring member.
15. The adjustable prosthetic implant of claim 13, further
including a first draw string coupled to one of the shaping
members, and a second draw string coupled to another one of the
shaping members, whereby tensioning of the first and second draw
strings causes the ring shaped member to assume the second
configuration.
16. The adjustable prosthetic implant of claim 15, further
including a third and fourth draw string, wherein the shaping
members have a top and bottom, the top being narrower than at the
bottom, whereby the ring shaped member has a saddle-shaped
configuration upon tensioning the first, second, third and fourth
draw strings.
17. The adjustable prosthetic implant of claim 13, wherein the
shaping members have a top and a bottom, wherein the shaping
members are arranged in alternating groups of shaping members being
narrower at their top than at their bottom and narrower at their
bottom than at their top.
18. The adjustable prosthetic implant of claim 15, further
including a second plurality of shaping members spaced apart from
the first plurality of shaping members.
19. The adjustable prosthetic implant of claim 18, wherein the
first and second draw strings are attached to the first plurality
of shaping members, and further including third and fourth draw
strings attached to the second plurality of shaping members.
20. The adjustable prosthetic implant of claim 19, wherein the
first and third draw strings extend clockwise about the ring shaped
member and the second and fourth draw strings extend counter
clockwise about the ring shaped member.
21. The adjustable prosthetic implant of claim 13, wherein the
plurality of wedge shaped shaping members lie in a single plane
when in first configuration and lie in a plurality of planes when
in the second configuration.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation, of U.S. patent
application Ser. No. 11/390,984, filed Mar. 27, 2006 which claims
the benefit of U.S. Provisional Patent Application No. 60/665,296
filed Mar. 25, 2005, the disclosures of which are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to surgical
procedures and relates more specifically to surgical procedures for
controlling the internal circumference of an anatomic orifice or
lumen.
[0003] Many anatomic structures in the mammalian body are hollow
passages in which walls of tissue define a central lumen, which
serves as a conduit for blood, other physiologic fluids, nutrient
matter, or waste matter passing within the structure. In many
physiologic settings, dysfunction may result from a structural
lumen which is either too large or too small. In most such cases,
dysfunction can be relieved by interventional changes in the
luminal size.
[0004] Thus in surgery, there is often a need to reduce the
internal circumference of an orifice or other open anatomic
structure to narrow the size of the orifice or opening to achieve a
desired physiologic effect. Often, such surgical procedures require
interruption in the normal physiologic flow of blood, other
physiologic fluids, or other structural contents through the
orifice or structure. The exact amount of the narrowing required
for the desired effect often cannot be fully appreciated until
physiologic flow through the orifice or structure is resumed. It
would be advantageous, therefore, to have an adjustable means of
achieving this narrowing effect, such that the degree of narrowing
could be changed after its implantation, but after the resumption
of normal flow in situ.
[0005] One example of a dysfunction within an anatomic lumen is in
the area of cardiac surgery, and specifically valvular repair.
Approximately one million open heart surgical procedures are now
performed annually in the United States, and twenty percent of
these operations are related to cardiac valves.
[0006] The field of cardiac surgery was previously transformed by
the introduction of the pump oxygenator, which allowed open heart
surgery to be performed. Valvular heart surgery was made possible
by the further introduction of the mechanical ball-valve
prosthesis, and many modifications and different forms of
prosthetic heart valves have since been developed. However, the
ideal prosthetic valve has yet to be designed, which attests to the
elegant form and function of the native heart valve. As a result of
the difficulties in engineering a perfect prosthetic heart valve,
there has been growing interest in repairing a patient's native
valve. These efforts have documented equal long-term durability to
the use of mechanical prostheses, with added benefits of better
ventricular performance due to preservation of the subvalvular
mechanisms and obviation of the need for chronic anticoagulation.
Mitral valve repair has become one of the most rapidly growing
areas in adult cardiac surgery today.
[0007] Mitral valve disease can be subdivided into intrinsic valve
disturbances and pathology extrinsic to the mitral valve ultimately
affecting valvular function. Although these subdivisions exist,
many of the repair techniques and overall operative approaches are
similar in the various pathologies that exist.
[0008] Historically, most valvular pathology was secondary to
rheumatic heart disease, a result of a streptococcal infection,
most commonly affecting the mitral valve, followed by the aortic
valve, and least often the pulmonic valve. The results of the
infectious process are mitral stenosis and aortic stenosis,
followed by mitral insufficiency and aortic insufficiency. With the
advent of better antibiotic therapies, the incidence of rheumatic
heart disease is on the decline, and accounts for a smaller
percentage of valvular heart conditions in the developed world of
the present day. Commissurotomy of rheumatic mitral stenosis was an
early example of commonly practiced mitral valve repair outside of
the realm of congenital heart defects. However, the repairs of
rheumatic insufficient valves have not met with good results due to
the underlying valve.cndot.pathology and the progression of
disease.
[0009] Most mitral valve disease other than rheumatic results in
valvular insufficiency that is generally amenable to repair.
Chordae rupture is a common cause of mitral insufficiency,
resulting in a focal area of regurgitation. Classically, one of the
first successful and accepted surgical repairs was for ruptured
chordae of the posterior mitral leaflet. The technical feasibility
of this repair, its reproducible good results, and its long-term
durability led the pioneer surgeons in the field of mitral valve
repair to attempt repairs of other valve pathologies.
[0010] Mitral valve prolapse is a fairly common condition that
leads over time to valvular insufficiency. In this disease, the
plane of coaptation of the anterior and posterior leaflets is
"atrialized" relative to a no mal valve. This problem may readily
be repaired by restoring the plane of coaptation into the
ventricle.
[0011] The papillary muscles within the left ventricle support the
mitral valve- and aid in its function. Papillary muscle
dysfunction, whether due to infarction or ischemia from coronary
artery disease, often leads to mitral insufficiency (commonly
referred to as ischemic mitral insufficiency). Within the scope of
mitral valve disease, this is the most rapidly growing area for
valve repair. Historically, only patients with severe mitral
insufficiency were repaired or replaced, but there is increasing
support in the surgical literature to support valve repair in
patients with moderate insufficiency that is attributable to
ischemic mitral insufficiency. Early aggressive valve repair in
this patient population has been shown to increase survival and
improve long-term ventricular function.
[0012] In addition, in patients with dilated cardiomyopathy the
etiology of mitral insufficiency is the lack of coaptation of the
valve leaflets from a dilated ventricle. The resultant
regurgitation is due to the lack of coaptation of the leaflets.
There is a growing trend to repair these valves, thereby repairing
the insufficiency and restoring ventricular geometry, thus
improving overall ventricular function.
[0013] The two essential features of mitral valve repair are to fix
primary valvular pathology (if present) and to support the annulus
or reduce the annular dimension using a prosthesis that is commonly
in the form of a ring or band. The problem encountered in mitral
valve repair is the surgeon's inability to fully assess the
effectiveness of the repair until the heart has been fully closed,
and the patient is weaned off cardiopulmonary bypass. Once this has
been achieved, valvular function can be assessed in the operating
room using transesophageal echocardiography (TEE). If significant
residual valvular insufficiency is then documented, the surgeon
must re-arrest the heart, re-open the heart, and then re-repair or
replace the valve. This increases overall operative, anesthesia,
and bypass times, and therefore increases the overall operative
risks.
[0014] If the prosthesis used to reduce the annulus is larger than
the ideal size, mitral insufficiency may persist. If the prosthesis
is too small, mitral stenosis may result. The need exists,
therefore, for an adjustable prosthesis that would allow a surgeon
to adjust the annular dimension in situ in a beating heart under
TEE guidance or other diagnostic modalities to achieve optimal
valvular sufficiency and function.
[0015] Cardiac surgery is but one example of a setting in which
adjustment of the annular dimension of an anatomic orifice in situ
would be desirable. Another example is in the field of
gastrointestinal surgery, where the Nissen fundoplication procedure
has long been used to narrow the gastro-esophageal junction for
relief of gastric reflux into the esophagus. In this setting, a
surgeon is conventionally faced with the tension between creating
sufficient narrowing to achieve reflux control, but avoiding
excessive narrowing that may interfere with the passage of nutrient
contents from the esophagus into the stomach. Again, it would be
desirable to have a method and apparatus by which the extent to
which the gastro-esophageal junction is narrowed could be adjusted
in situ to achieve optimal balance between these two competing
interests.
[0016] Aside from the problem of adjusting the internal
circumference of body passages in situ, there is often a need in
medicine and surgery to place a prosthetic implant at a desired
recipient anatomic site. For example, existing methods proposed for
percutaneous mitral repair include approaches through either the
coronary sinus or percutaneous attempts to affix the anterior
mitral leaflet to the posterior mitral leaflet. Significant
clinical and logistical problems attend both of these existing
technologies. In the case of the coronary sinus procedures,
percutaneous access to the coronary sinus is technically difficult
and time consuming to achieve, with procedures which may require
several hours to properly access the coronary sinus. Moreover,
these procedures employ incomplete annular rings, which compromise
their physiologic effect. Such procedures are typically not
effective for improving mitral regurgitation by more than one
clinical grade. Finally, coronary sinus procedures carry the
potentially disastrous risks of either fatal tears or catastrophic
thrombosis of the coronary sinus.
[0017] Similarly, percutaneous procedures which employ sutures,
clips, or other devices to affix the anterior mitral leaflets to
the posterior mitral leaflets also have limited reparative
capabilities. Such procedures are also typically ineffective in
providing a complete repair of mitral regurgitation. Furthermore,
surgical experience indicates that such methods are not durable,
with likely separation of the affixed valve leaflets. These
procedures also fail to address the pathophysiology of the dilated
mitral annulus in ischemic heart disease. As a result of the
residual anatomic pathology, no ventricular remodeling or improved
ventricular function is likely with these procedures.
[0018] The need exists, therefore, for a delivery system and
methods for its use that would avoid the need for open surgery in
such exemplary circumstances, and allow delivery, placement, and
adjustment of a prosthetic implant to reduce the diameter of such a
mitral annulus in a percutaneous or other minimally invasive
procedure, while still achieving clinical and physiologic results
that are at least the equivalent of the yields of the best open
surgical procedures for these same problems.
[0019] The preceding cardiac applications are only examples of some
applications according to the present invention. Another exemplary
application anticipated by the present invention is in the field of
gastrointestinal surgery, where the aforementioned Nissen
fundoplication procedure has long been used to narrow the
gastro-esophageal junction for relief of gastric reflux into the
esophagus. In this setting, a surgeon is conventionally faced with
the tension between creating sufficient narrowing to achieve reflux
control, but avoiding excessive narrowing that may interfere with
the passage of nutrient contents from the esophagus into the
stomach. Additionally, "gas bloat" may cause the inability to
belch, a common complication of over-narrowing of the GE junction.
An adjustable prosthetic implant according to the present invention
could allow in situ adjustment in such a setting under physiologic
assessment after primary surgical closure. Such an adjustable
prosthetic implant according to the present invention could be
placed endoscopically, percutaneously, or with an endoscope placed
within a body cavity or organ, or by trans-abdominal or
trans-thoracic approaches. In addition, such an adjustable
prosthetic implant according to the present invention could be
coupled with an adjustment means capable of being placed in the
subcutaneous or other anatomic tissues within the body, such that
remote adjustments could be made to the implant during physiologic
function of the implant. This adjustment means can also be
contained within the implant and adjusted remotely, i.e., remote
control adjustment. Such an adjustment means might be capable of
removal from the body, or might be retained within the body
indefinitely for later adjustment.
[0020] There is a need for an implantable device for controlling at
least one of shape and size of an internal structure or lumen.
There is a further need for an implantable device that an
adjustable member configured to adjust the dimensions of the
implantable device. There is still a further need for an
implantable device configured to be coupled to an adjustment tool
device that provides for adjustment before, during and after the
organ resumes near normal to normal physiologic function. A further
need exists for an implantable device configured to be coupled to
an adjustment tool that can be attached and re-attached to the
implantable device.
BRIEF SUMMARY OF THE INVENTION
[0021] Accordingly, an object of the present invention is to
provide an implantable device for controlling at least one of shape
and size of an internal structure or lumen.
[0022] Another object of the present invention is to provide an
implantable device that an adjustable member configured to adjust
the dimensions of the implantable device.
[0023] Yet another object of the present invention is to provide an
implantable device configured to be coupled to an adjustment tool
device that provides for adjustment before, during and after the
organ resumes near normal to normal physiologic function.
[0024] A further object of the present invention is to provide an
implantable device configured to be coupled to an adjustment tool
that can be attached and re-attached to the implantable device.
[0025] Still another object of the present invention is to provide
an implantable device and adjustment tool that is adjustable in at
least two dimensions.
[0026] Another object of the present invention is to provide an
implantable device for an internal structure or lumen with
dysfunction that is relieved by the implantable device by changing
the size or shape of the internal structure or lumen.
[0027] These and other objects of the present invention are
achieved in, an implantable device for controlling at least one of
shape and size of an internal structure or lumen. An implantable
device has an adjustable member configured to adjust the dimensions
of the implantable device. An adjustment tool is configured to
actuate the adjustable member and provide for adjustment before,
during and after the internal structure or lumen resumes near
normal to normal physiologic function.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 is a front view of a first embodiment of an implant
for reducing the circumference of an anatomic orifice.
[0029] FIG. 2 is a front view of the implant of FIG. 1 secured to
the annulus of a mitral valve, with the implant in an expanded
position.
[0030] FIG. 3 is a front view of the implant of FIG. 1 secured to
the annulus of a mitral valve, with the implant in a contracted
position to reduce the size of the heart valve opening.
[0031] FIG. 4 is a perspective view of a second embodiment of an
implant for reducing the circumference of an anatomic orifice,
inserted through an open operative cardiac incision and secured
around the mitral valve.
[0032] FIG. 5 is a perspective view of the implant of FIG. 4,
showing the cardiac incision closed, an adjustment tool extending
through the closed incision, and adjustment of the implant possible
after the patient has been taken "off pump."
[0033] FIG. 6 is a perspective view of a first embodiment of an
adjustment means for adjusting the circumference of an implant for
reducing the circumference of an anatomic orifice.
[0034] FIG. 7 is a right side view of the adjustment means of FIG.
6.
[0035] FIG. 8 is a left side view of the adjustment means of FIG.
6.
[0036] FIG. 9 is a right side view of a second embodiment of an
adjustment means for adjusting the circumference of an implant for
reducing the circumference of an anatomic orifice.
[0037] FIG. 10 is a perspective view of a first alternate
embodiment of an attachment means for the implant of FIG. 1.
[0038] FIG. 11 is a perspective view of a second alternate
embodiment of an attachment means for the implant of FIG. 1.
[0039] FIG. 12 is a perspective view of a third embodiment of an
implant for reducing the circumference of an anatomic orifice.
[0040] FIG. 13 is a perspective view of one end of the implant of
FIG. 12 stowing an optional keyed relationship between three
coaxial cannulae to prevent relative rotation between the three
components.
[0041] FIG. 14 is a perspective view of the implant of FIG. 12
showing the outer cannula extended to cover the implant.
[0042] FIG. 15 is a perspective view of the implant of FIG. 12
showing the outer cannula retracted to expose the implant.
[0043] FIG. 16 is a perspective view of the implant of FIG. 12
showing the middle cannula extended to unfold the implant.
[0044] FIGS. 17 and 18 are schematic views illustrating how
extension of the middle cannula causes the implant to unfold, where
FIG. 17 shows the implant in the folded position, and FIG. 18 shows
the implant in the unfolded position.
[0045] FIG. 19 is a perspective view of the lower end of a
touchdown sensor of the implant of FIG. 12, showing the sensor in
an uncompressed condition.
[0046] FIG. 20 is a perspective view of the lower end of the
touchdown sensor of FIG. 19, showing the sensor in a compressed
condition.
[0047] FIG. 21 is a perspective end view of a fourth embodiment of
an implant for reducing the circumference of an anatomic
orifice.
[0048] FIG. 22 is a side view of the implant of FIG. 21 with the
implant opened up to show its full length.
[0049] FIG. 23 is a side view of the adjustment mechanism of the
implant of FIG. 21.
[0050] FIG. 24 is a close-up view of two of the retention barbs of
the implant of FIG. 21.
[0051] FIG. 25 is a front view of a fifth embodiment of an implant
for reducing the circumference of an anatomic orifice, with the
implant shown in its expanded configuration.
[0052] FIG. 26 is a front view of the implant of FIG. 25, with the,
implant shown in its contracted configuration.
[0053] FIG. 27 is an enlarged view of the area indicated by the
circle 27 in FIG. 25, with the outer body removed to show interior
detail.
[0054] FIG. 28 is a schematic view showing the implant of FIG. 12
anatomically positioned at the mitral annulus in a heart with the
implant in a fully expanded state.
[0055] FIG. 29 is a schematic view showing the implant of FIG. 12
anatomically positioned at the gastroesophageal opening with the
implant in a fully expanded state.
[0056] FIG. 30 is a schematic view showing the implant of FIG. 29
implanted to reduce the circumference of the gastroesophageal
opening.
[0057] FIG. 31 is a plan view of a first embodiment of a drawstring
implant in its normal state.
[0058] FIG. 32 is a plan view of the implant of FIG. 31 in a
cinched state.
[0059] FIG. 33 is a plan view of a second embodiment of a
drawstring implant in its normal state.
[0060] FIG. 34 is a plan view of a third embodiment of a drawstring
implant in its normal state.
[0061] FIG. 35 is a plan view of a fourth embodiment of a
drawstring implant in its normal state.
[0062] FIG. 36 is a plan view of a fifth embodiment of a drawstring
implant in its normal state.
[0063] FIG. 37 is a plan view of a sixth embodiment of a drawstring
implant in its normal state.
[0064] FIG. 38 is a plan view of a seventh embodiment of a
drawstring implant in its normal state.
[0065] FIG. 39 is a plan view of an eighth embodiment of a
drawstring implant in its normal state.
[0066] FIG. 40 is a schematic view of the drawstring implant of
FIG. 31 showing the drawstring and internal attachment
locations.
[0067] FIG. 41 is a schematic view of the drawstring implant of
FIG. 40 in a cinched state.
[0068] FIG. 42 is a schematic view of a variation on the drawstring
implant of FIG. 31 showing the drawstring and internal attachment
locations.
[0069] FIG. 43 is a schematic view of the drawstring implant of
FIG. 42 in a cinched state.
[0070] FIG. 44 is a schematic view of the drawstring implant of
FIG. 34 showing the drawstring and internal attachment
locations.
[0071] FIG. 45 is a schematic view of the drawstring implant of
FIG. 44 in a cinched state.
[0072] FIG. 46 is a schematic view of a variation on the drawstring
implant of FIG. 34 showing the drawstring and internal attachment
locations.
[0073] FIG. 47 is a schematic view of the drawstring implant of
FIG. 46 in a cinched state.
[0074] FIG. 48 is a schematic view of a first embodiment of a
drawstring implant comprising internal shaping members depicting
the implant in its normal state.
[0075] FIG. 49 is a schematic view of the drawstring implant of
FIG. 48 depicting the implant in its cinched state.
[0076] FIG. 50 is a schematic view of a second embodiment of a
drawstring implant comprising internal shaping members depicting
the implant in its normal state.
[0077] FIG. 51 is a schematic view of the drawstring implant of
FIG. 50 depicting the implant in its cinched state.
[0078] FIG. 52 is a schematic view of a third embodiment of a
drawstring implant comprising internal shaping members depicting
the implant in its normal state.
[0079] FIG. 53 is a schematic view of the drawstring implant of
FIG. 52 depicting the implant in its cinched state.
[0080] FIG. 54 is a schematic view of a fourth embodiment of a
drawstring implant comprising internal shaping members depicting
the implant in its normal state.
[0081] FIG. 55 is a schematic view of the drawstring implant of
FIG. 54 depicting the implant in its cinched state.
[0082] FIG. 56 is an isometric view of an implant and associated
apparatus for adjusting the circumference of the implant from a
remote location.
[0083] FIG. 57 is an isometric view of the implant of FIG. 56.
[0084] FIG. 58 is an isometric view of the implant of FIG. 56
partially cut away to reveal interior detail.
[0085] FIG. 59 is an isometric view of the implant of FIG. 56 in a
cinched condition.
[0086] FIG. 60 is a partial isometric view of a drive shaft of the
apparatus of FIG. 56 for adjusting the circumference of an
implant.
[0087] FIG. 61 is a partial isometric view of an inner tube of the
apparatus of FIG. 56 for adjusting the circumference of an
implant.
[0088] FIG. 62 is a partial isometric view of the drive shaft of
FIG. 60 telescopically received within the inner tube of FIG.
61.
[0089] FIG. 63 is a side view of a spindle of a winch of the
implant of FIG. 56.
[0090] FIG. 64 is a top view of the spindle of FIG. 63.
[0091] FIG. 65 is an isometric view of the spindle of FIG. 63
[0092] FIG. 66 is an isometric view of the spindle of FIG. 63
showing a section of a band of the implant wrapped around the
spindle.
[0093] FIG. 67 is an exploded isometric view of the implant of FIG.
56.
[0094] FIG. 68 is an isometric view of the winch and band of the
implant of FIG. 56.
[0095] FIG. 69 is a side cut away view of the drive unit of the
apparatus positioned to engage the winch of the implant of FIG.
56
[0096] FIG. 70 is a side cut away view of the drive unit and winch
FIG. 69 depicting the drive unit engaged with the winch.
[0097] FIG. 71 is a top view of a second embodiment of a
winch-adjustable implant.
[0098] FIG. 72 is a top view of a third embodiment of a
winch-adjustable implant.
[0099] FIG. 73 is an isometric view of an alternate embodiment of a
drive unit for rotating the winch on a winch-adjustable
implant.
[0100] FIG. 74 is a side view of the drive shaft of the drive unit
of FIG. 73.
[0101] FIG. 75 is a bottom view of the drive shaft of FIG. 74.
[0102] FIG. 76 is a side view of the actuator button of the drive
unit of FIG. 73.
[0103] FIG. 77 is a bottom view of the actuator button of FIG.
76.
[0104] FIG. 78 is a side view of the inner cam sleeve of the drive
unit of FIG. 73.
[0105] FIG. 79 is a bottom view of the inner cam sleeve of FIG.
78.
[0106] FIG. 80 is a side view of the outer cam sleeve of the drive
unit of FIG. 73.
[0107] FIG. 81 is a bottom view of the outer cam sleeve of FIG.
80.
[0108] FIG. 82 is an exploded view of the drive unit of FIG.
73.
[0109] FIG. 83 is a side view of the drive unit of FIG. 73 showing
the actuator button in its normal position.
[0110] FIG. 84 is a side view of the drive unit of FIG. 83 showing
the actuator button in its depressed condition.
[0111] FIGS. 85-89 illustrate various embodiments of the present
invention with the deployment of anchoring clips for affixing the
implant to the tissue.
DETAILED DESCRIPTION
[0112] Referring now to the drawings, in which like numerals
indicate like elements throughout the several views, an exemplary
implant 10 comprising an implant body 15 is shown in FIG. 1. The
implant body 10 may be provided in a shape and size determined by
the anatomic needs of an intended native recipient anatomic site
within--a mammalian patient. Such a native recipient anatomic site
may be, by way of illustration and not by way of limitation, a
heart valve, the esophagus near the gastro-esophageal junction, the
anus, or other anatomic sites within a mammalian body that are
creating dysfunction that might be relieved by an implant capable
of changing the size and shape of that site and maintaining a
desired size and shape after surgery: In various embodiments, the
implant can be used for positioning an aortic valve, a triple A
device positioning, aortic stent grafting applications, aortic
endograph applications, aortic triple A stent graphs, ascending
aortic aneurysm repair, for stomach applications to control obesity
and the like.
[0113] The implant 10 of FIG. 1 comprises a circular implant body
15 which is provided with adjustable corrugated sections 20
alternating with intervening grommet-like attachment means 25
having narrowed intermediate neck portions. As can be seen in FIGS.
2 and 3, the implant body 15 may be secured to the annulus of a
heart valve 30 by a fixation means such as a suture 35 secured over
or through the attachment means 25. The corrugated sections 20 fold
and unfold as the circumference of the implant body 15 shortens or
lengthens. Adjustment of the implant 10 in situ may decrease the
overall size of the heart valve 30, increasing the coaptation of
the valve leaflets 40, and changing the configuration from that
shown in FIG. 2 to that shown in FIG. 3.
[0114] An additional exemplary embodiment 100 of the present
invention is shown in FIGS. 4 and 5, with an open operative cardiac
incision 105 in a heart 110 shown in FIG. 4, and closure of the
cardiac incision 105 in FIG. 5. As shown in FIG. 49 the exemplary
adjustable implant 100 according to the present invention comprises
an implant body 115 with attachment means 120 that allows fixation
to the annulus of a mitral valve 125. The exemplary adjustable
implant 100 is further provided with an adjustment means 130 that
is controlled by an attached or coupled adjustment tool 135. After
closure of the myocardial incision 105 in FIG. 5, the adjustment
tool 135 remains attached or coupled to the adjustment means 130,
so that the size and shape of the implant 100 may further be
affected after physiologic flow through the heart 110 is resumed,
but with the chest incision still open. Once the desired shape and
function are achieved, the adjustment tool 135 may be disengaged
from the adjustment means 130 and withdrawn from the myocardial
incision 105. In various embodiments according to the present
invention, the adjustment means 130 may be configured and placed to
allow retention by or re-introduction of the adjustment tool 135
for adjustment following closure of the chest incision.
[0115] To use the implant 100 of FIGS. 4 and 5, the physician makes
the open operative incision 105 in the heart 110, as shown in FIG.
4, in the conventional manner. The implant 100, mounted at the
forward end of adjustment tool 135, is then advanced through the
incision 105 and sutured to the annulus of the mitral valve 125.
The adjustment tool 135 is then manipulated, e.g., rotated,
depending upon the design of the adjustment means 130, to cause the
adjustment means to reduce the size of the implant body 115, and
hence the underlying mitral valve 125 to which it is sutured, to an
approximate size. The myocardial incision 105 can now be closed, as
shown in FIG. 5, leaving the adjustment tool extending through the
incision for post-operative adjustment.
[0116] Once the patient has been taken "off pump" and normal flow
of blood through the heart 110 has resumed, but before the chest
incision has been closed, further adjustments to the size of the
mitral valve 125 can be made by manipulating the adjustment tool
135.
[0117] FIGS. 6-8 show an exemplary adjustment means 200 for
adjusting the circumference of an annular implant such as the
implant 100 previously described. The adjustment means 200
comprises a rack and pinion system in which a first cam 205 with
geared teeth 210 and an engagement coupler 215 turns on a first
axel 220. In this example, the first cam 205 engages a geared rack
225 on one or more surfaces of a first band 230. The first band 230
passes between the first cam 205 and a second cam 235 that turns on
a second axel 240 that is joined to a second band 245. As shown in
FIG. 8, the first .and second axels 220, 240 are maintained in
suitable spaced-apart relation by means of a bracket 250 formed at
the end of the second band 245.
[0118] The adjustment means 200 is preferably set within a hollow
annular implant 100 of the type previously described, though it is
possible to use the adjustment means in a stand-alone configuration
wherein the first and second bands 230, 245 are opposing ends of
the same continuous annular. structure. In either event to adjust
the length of an implant comprising the adjustment means 200, a
tool such as a hex wrench engages the engagement coupler 215 on the
first cam 205 and rotates the first cam in a counterclockwise
direction as shown in FIG. 7, as indicated by the arrow 255.
Rotation of the first cam 205 causes the teeth 210 to drive the
rack 225 to move the first band 230 toward the right, as indicated
by the arrow 260 in FIG. 7. This movement of the first band
tightens the circumference of the annular implant. If the physician
inadvertently adjusts the implant too tight, reversing direction of
the engagement coupler 215 will loosen the implant.
[0119] In various embodiments according to the present invention,
the first and second bands 230, 245 may be separate structures, or
they may be opposing ends of the same continuous structure. In such
an embodiment, when motion is imparted to the engagement coupler
215, the first cam 205 is rotated, causing the geared teeth 210 to
engage the geared rack 225 and causing the first band 239 to move
with respect to the second band 245 to adjust the circumference of
an implant.
[0120] FIG. 9 shows a somewhat different configuration of an
exemplary engagement means 300 according to the present invention,
in which there is no engagement coupler, and a bracket 350 is
provided on both sides of the cams to maintain the first cam 315
and the second cam 320 in close approximation. In one proposed
embodiment, the bracket is designed with close tolerances so as to
press the first band 330 closely against the second band 345,
thereby to hold the bands in fixed relative position by friction.
In another proposed embodiment, the brackets 350 are fabricated
from an elastic material such that the cams 315, 320 can be spread
apart to insert the first band 330 between the cams, whereupon the
cams are pulled back together with sufficient force to hold the
bands 330, 345 in fixed relative position by friction. In still
another proposed embodiment involving an elastic mounting
arrangement between the cams 315, 320, the lower edge of the first
band 330 and the upper edge of the second and 345 have mating
frictional or mechanical surfaces, whereby the cams 315, 320 can be
spread apart to permit relative movement between the bands or
released to clamp the bands together in fixed relation.
[0121] FIG. 10 shows an exemplary attachment means 400 for an
implant according to the present invention. The attachment means
400 could be used, for example, in place of the attachment means 25
of the implant 10. The attachment means 400 takes the form of a
grommet 410 comprising a wall 415 defining a lumen 420 and an
attachment surface 425. Such an attachment means would be used with
the implant body extending through the lumen 420 and with fixation
devices such as sutures or wires either tied over or affixed
through the attachment surface 425.
[0122] FIG. 11 shows another alternate embodiment of an attachment
means 500 for an implant according to the present invention. The
attachment means 500 could also be used, for example, in place of
the attachment means 25 of the implant 10. FIG. 11 shows an
attachment means 500 in the form of a hollow tube or tube segment
510 comprising a wall 515 defining a lumen 520, an outer surface
525, and an attachment tab 530. Such an attachment means would be
used with the implant body extending through the lumen 520 and with
fixation devices such as sutures or wires either tied or otherwise
affixed over or through the attachment tab 530. Such fixation
devices might be placed through holes 535 provided in the
attachment tab 530. Alternately a solid attachment tab 530 might be
provided, and the fixation devices might be passed through the
solid tab. Modifications of these attachment means may be used in
conjunction with a sutureless attachment system.
[0123] FIGS. 12-18 show another embodiment of a percutaneous
annuloplasty device according to the present invention, in which a
delivery device in the nature of an implant/delivery system array
600 includes a housing sheath 605 (not seen in FIG. 12), an
actuating catheter 610 coaxially slidably mounted within the
housing sheath 605, and a core catheter 615 coaxially slidably
mounted within the actuating catheter 610. The core catheter has a
central lumen 616 (FIG. 13). The actuating catheter 610 and core
catheter 615 may be round tubular structures, or as shown in FIG.
13, either or both of the actuating and core catheters may be
provided with one or more keyed ridges 618, 620 respectively to be
received by one or more reciprocal slots 622, 624 within the inner
lumen of either the housing sheath 665 or the actuating catheter
610, respectively. Such keyed ridges 618, 620 would limit internal
rotation of an inner element within an outer element, should such
restriction be desirable to maintain control of the inner contents
from inadvertent displacement due to undesired rotational motion
during use.
[0124] The implant/delivery system array 600 includes a distal tip
625 at the forward end of the core catheter 615. One or more radial
implant support arms 630 have their distal ends 632 pivotably or
bendably mounted to the core catheter 615 adjacent its distal tip
625. The proximal ends 634 of the radial implant support arms 630
normally extend along the core catheter 615 but are capable of
being displaced outward away from the core catheter.
[0125] One or more radial support struts 636 have their proximal
ends 638 pivotably or bendably mounted to the distal end of the
actuating catheter 610. The distal end 640 of each radial support
strut is 636 pivotably or bendably attached to a midpoint of a
corresponding radial implant support arm 630. As the actuating
catheter 610 is advanced with respect to the core catheter 615, the
radial support struts 636 force the radial implant support arms 630
upward and outward in the fashion of an umbrella frame. Thus the
actuating catheter 610, core catheter 615, radial support struts
636, and radial support arms 630 in combination form a deployment
umbrella 642.
[0126] A prosthetic implant 645 is releasably attached to the
proximal ends 634 of the radial implant support arms 630. Around
the periphery of the prosthetic implant 645 and extending
proximally therefrom are a plurality of retention barbs 646. In
addition, one or more of the radial implant support arms 630
comprise touchdown sensors 648 whose proximal ends extend proximal
to the implant 645. Extending through the central lumen 616 (FIG.
13) of the core catheter 615 in the exemplary embodiment 600 and
out lateral ports 650 (FIG. 12) spaced proximally from the distal
tip 625 are one or more release elements 660, which serve to
release the implant 645 from the delivery system, and one or more
adjustment elements 665 which serve to adjust the implant's
deployed size and effect. Because the release elements 660 and
adjustment elements 665 extend through the proximal end of the core
catheter 615, as seen in FIGS. 14-16, these elements can be
directly or indirectly instrumented or manipulated by the
physician. A delivery interface 670 (FIGS. 12, 16) is defined in
this example by the interaction of the deployment umbrella 642, the
release elements 660, and the implant 645. In the disclosed
embodiment, the release elements 660 may be a suture, fiber, or
wire in a continuous loop that passes through laser drilled bores
in the implant 645 and in the radial implant support arms 630, and
then passes through the length of the core catheter 615. In such an
embodiment, the implant 645 may be released from the delivery
system at a desired time by severing the release element 660 at its
proximal end, outside the patient, and then withdrawing the free
end of the release element 660 through the core catheter 610.
[0127] FIGS. 14-16 show the operation of the implant/delivery
system array 600, in which an umbrella-like expansion of the
prosthetic implant 645 is achieved by sliding movement of the
housing sheath 605, the actuating catheter 610, and the core
catheter 615. Referring first to FIG. 14, the housing sheath 605 is
extended to cover the forward ends of the actuating catheter 610
and core catheter 615 for intravascular insertion of the
implant/delivery system array 600. From this starting position, the
housing sheath 605 is retracted in the direction indicated by the
arrows 662. In FIG. 15 the housing sheath 605 has been retracted to
expose the forward end of the actuating catheter 610 and the
collapsed deployment umbrella 642. From this position the actuating
catheter 610 is advanced in the direction indicated by the arrows
664. This will cause the deployment umbrellas to expand in the
directions indicated by the arrows 666. FIG. 16 shows the expansion
of the deployment umbrella 642 produced by distal motion of the
actuating catheter 610 relative to the core catheter 615. After the
implant 645 has been positioned and adjusted to the proper size,
the housing sheath 605 is advanced in the direction indicated by
the arrows 668 to collapse and to cover the deployment umbrella 642
for withdrawal of the device from the patient.
[0128] FIGS. 17 and 18 are schematic views illustrating the radial
implant support arms 630 and the radial support struts 636 of the
implant/delivery system array 600. In FIG. 17, a radial support
strut 636 is pivotably attached at its proximal end 638 at a first
pivotable joint 670 to the actuation catheter 610. The radial
support strut 636 is attached at its distal end 640 to a second
pivotable joint 672 at an intermediate point of a corresponding
radial implant support arm 630. The radial implant support arm 630
is attached at its distal end 632 by a third pivotable joint 674 to
the core catheter 620. FIG. 17 shows the assembly in a closed
state. When the actuation catheter 610 is advanced distally over
the core catheter 615, as shown by the arrows 676, the radial
support strut 636 and the radial implant support arm 630 are
extended by the motion at the first pivotable joint 670, the second
pivotable joint 672, and the third pivotable joint 674, as shown by
the arrow 678. This motion has the effect of expanding the
deployment umbrella and folded implant (not shown in FIGS. 17 and
18), allowing it to achieve its greatest radial dimension, prior to
engagement and implantation as previously discussed with reference
to FIGS. 12-16.
[0129] FIGS. 19 and 20 show further details of the touchdown
sensors 648 shown previously in FIG. 12. The touchdown sensor 648
of FIGS. 19 and 20 includes a distal segment 680, an intermediate
segment 682, and a proximal segment 684. The distal segment 680 is
spring-mounted, so that it is capable of slidable, telescoping
displacement over the intermediate segment 682 to achieve a
seamless junction with the proximal segment 684 upon maximal
displacement. When the touchdown sensor 648 is in its normal
condition, the spring extends the proximal segment such that the
sensor assumes the orientation shown in FIG. 19. When the implant
645 (FIG. 12) is seated against the periphery of an anatomical
opening, the proximal segment 684 of the sensor 648 is compressed
against the distal segment 680, as shown in FIG. 20. The distal
segment 680 and the proximal segment 684 are both constructed of,
are sheathed by, or otherwise covered with a radio-opaque material.
However, the intermediate segment 682 is not constructed or coated
with such a radio-opaque material. Therefore, when the distal
segment 680 is at rest, it is fully extended from the proximal
segment 684, and the gap represented by the exposed intermediate
segment 682 is visible on radiographic examination. However, when
the distal segment 680 is brought to maximum closeness with the
proximal segment 684, no such radio-opaque gap is radiographically
visible, and the touchdown sensor is said to be "activated". This
embodiment allows radiographic monitoring of the position of the
touchdown sensor 648 with respect to the degree of extension of the
distal catheter segment 680. In the embodiment according to the
present invention as shown, one or more touchdown detectors 648 are
employed to ascertain that the delivery system for the prosthetic
device is located in the proper position to deploy the implant into
the mitral annulus. As this anatomic structure cannot be directly
identified on fluoroscopy or standard radiographic procedures, such
precise location could be otherwise difficult. At the same time,
precise localization and engagement of the mitral annulus is
critical for proper m implant function and safety.
[0130] Touchdown detectors within the embodiments according to the
present invention can have a multiplicity of forms, including the
telescoping, spring-loaded, radio-opaque elements joined by a
non-radio-opaque element as in the aforementioned examples. In
embodiments efllploying magnetic resonance imaging, touchdown
detectors according to the present invention may utilize metallic
segments interposed by nonmetallic segments in a similar
telescoping, spring-loaded array. Other embodiments include a
visually-evident system with telescoping, spring-loaded elements
with color-coded or other visual features for procedures in which
direct or endoscopic observation would be possible. Still other
embodiments of touchdown detectors according to the present
invention include touchdown detectors provided with microswitches
at their tips, such that momentary contact of sufficient pressure
completes an electrical circuit and signals the activation of the
touchdown detector to the operator. Still other touchdown detectors
according to the present invention are provided with fiberoptic
pathways for Rahmen laser spectroscopy or other spectral analytical
techniques which are capable of detecting unique tissue qualities
of the tissue at the desired site for implantation. In addition,
still other embodiments according to the present invention include
touchdown detectors containing electrodes or other electronic
sensors capable of detecting and signaling the operator when a
desired electrophysiologic, impedance, or other measurable quality
of the desired tissue is detected for proper implantation. Such
electrophysiologic touchdown detectors may include electrical
circuits that produce visual, auditory, or other signals to the
operator that the detectors are activated and that the implant is
in the proper position for attachment.
[0131] In yet other embodiments according to the present invention,
other intracardiac or extracardiac imaging techniques including,
but not limited to, intravascular ultrasound, nuclear magnetic
resonance, virtual anatomic positioning systems, or other imaging
techniques may be employed to confirm proper positioning of the
implant, obviating the need for the touchdown sensors as previously
described.
[0132] FIGS. 21-24 show an implant 700 according to one embodiment
of the present invention. In this embodiment, the implant body 705
is bandlike and flexible. Through much of its length, the implant
body 705 is provided with a series of retention barbs 710 which are
oriented to facilitate placement, retention, and removal of the
device. The implant body 705 is also provided with an adjustable
section 715, which is provided in this example with a series of
adjustment stops 720. The adjustment stops 720 may be slots, holes,
detents, dimples, ridges, teeth, raised elements, or other
mechanical-features to allow measured adjustment of the implant 700
in use. In the embodiment shown in FIGS. 21-24, the adjustment
stops 720 are engaged by a geared connector 725. FIG. 21 is an end
view, showing the implant body 705 curved on itself, with the
retention barbs 710 to the exterior, and with the adjustable
section 715 passing through its engagement with the geared
connector 725 and curving internally within the implant body 705 to
form a closed, round structure. FIG. 23 shows details of an
exemplary geared connector 725, in which a housing 730 is connected
to the implant body 705. The housing 730 contains and supports a
mechanical worm 740 with an attached first geared head 750 which
mates with a second geared head 755. The econgeared head 755 is
attached to an adjustment stem 760 which is machined to receive a
screwdriver-like adjustment element. The various embodiments
according to the present invention may require a number of forms of
adjustment elements. In the present example, the adjustment element
is provided as a finely coiled wire with a distal tip machined to
be received by a receiving slot in the adjustment stem 760 (not
shown). The relationship between the distal tip of the adjustment
element and the adjustment stem 760 is mechanically similar to a
screwdriver bit and screwhead, such that torsion imparted to the
adjustment means by the operator will result in the turning of the
adjustment stem 760 and second geared bead 755 allows motion of the
first geared head 750 and worm 740, which creates motion of the
adjustable implant section 715 as the worm engages with the series
of adjustment tops 725. Excess length of the adjustable section 715
passes through a band slot 735 (FIG. 23), thus allowing the band to
move concentrically inside the dosed implant body 705. The
adjustment element in this embodiment may be designed to remain in
place after the deployment umbrella has been retracted and
withdrawn. The connection between the adjustment element's distal
tip and the adjustment stem 760 may be a simple friction
connection, a mechanical key/slot formation, or may be magnetically
or electronically maintained.
[0133] As further shown in FIG. 21, the exemplary embodiment
employs unidirectional retention barbs 710 which are attached to
the outer perimeter of the implant body 705. The retention barbs
710 are oriented in a consistent, tangential position with respect
to the implant body 705 such that rotational motion of the implant
body will either engage or release the retention barbs 710 upon
contact with the desired tissue at the time of deployment. This
positioning of the retention barbs 710 allows the operator to
"screw in" the implant 700 by turning the implant 700 upon its
axis, thus engaging the retention barbs 710 into the adjacent
tissue. As shown in FIG. 24, the retention barbs 710 may each be
further provided with a terminal book 775 at the end which would
allow for smooth passage through tissue when engaging the retention
barbs 710 by rotating the implant 700, without permitting the
implant 700 to rotate in the opposite direction, because of the
action of the terminal books 775 grasping the surrounding tissue
(much like barbed fish books). The terminal books 775 thus ensure
the seating of the implant 700 into the surrounding tissue.
[0134] FIGS. 25-27 illustrate another embodiment of an implant 800
as contemplated according to the present invention. The implant 800
includes a band 805 (FIG. 27), but the retention barbs of the
previous example have been eliminated in favor of an outer fabric
implant sheath 810. The fabric sheath 810 can be sutured or
otherwise affixed to the anatomic tissue in a desired location. The
circumference of the implant body 800 is adjusted through a geared
connector 825 similar to the geared connector of the bandlike
implant array shown in FIG. 23. More specifically, adjustment stops
820 on the band are engaged by a mechanical worm 840 with an
attached first geared bead 850. The first geared head 850 mates
with a second geared head 855. The second geared bead 855 is
attached to an adjustment stem 860 which is machined to receive a
screwdriver-like adjustment element.
[0135] FIG. 28 illustrates an example of the method of use of an
implant/delivery system array 600 for positioning an implant 645 in
a patient with ischemic annular dilatation and mitral
regurgitation. Peripheral arterial access is obtained via
conventional cutdown, arterial puncture, or other standard access
techniques. After access to the arterial system is attained;
guidewire placement is per-formed and intravascular access to the
heart, 900 is obtained using fluoroscopic, ultrasound,
three-dimension ultrasound, magnetic resonance, or other real-time
imaging techniques. The guidewire, deployment device, and implant
are passed through the aortic valve in a retrograde fashion into
the left ventricle 905 and then into the left atrium 910. At this
point, the operator retracts the housing sheath 605, thus
unsheathing the collapsed deployment umbrella 642 and implant 645.
The deployment umbrella 642 is then distended by the distal motion
of the actuation catheter, causing the radial support arms and
struts to fully distend. At this point, the touchdown detectors 648
are not in contact with any solid structures, and are fully
extended with their radiolucent gaps visible on the imaging system.
Once the deployment umbrella is distended, the entire assembly is
pulled back against the area of the mitral valve 915. At least two
touchdown detectors 648 are employed in a preferred embodiment
according to the present invention. When all touchdown detectors
show the disappearance of their intermediate, non-opaque,
intermediate segments and are thus activated, then the deployment
umbrella must be in contact with the solid tissue in the region of
the mitral annulus/atrial tissue, and further implant deployment
and adjustment may proceed. However, if any one touchdown sensor is
not activated, and a radiolucent gap persists, then the device is
not properly positioned, and must be repositioned before further
deployment. Thus, the touchdown sensor system may assist in the
deployment and adjustment of prosthetic devices by the delivery
system according to the present invention. Once properly
positioned, the operator rotates the actuation catheter in a
prescribed clockwise or counterclockwise manner to engage the
retention barbs on the implant into the tissue in the region of the
mitral annulus/atrial tissue. Should re-positioning be required, a
reverse motion would disengage the retention barbs from the
annular/atrial tissue, and repositioning may be performed, again
using the touchdown detectors for proper placement. Once firmly
seated, the adjustment element(s) are operated to achieve the
desired degree of annular reduction. Real-time trans esophageal
echocardiography, intravascular echocardiography, intracardiac
echocardiography, or other modalities for assessing mitral function
may then be employed to assess the physiologic effect of the repair
on mitral function, and additional adjustments may be performed.
Once a desired result has been achieved, the release elements are
activated to detach the implant from the deployment umbrella. The
operator then retracts the actuation catheter and extends the
housing sheath, collapsing the deployment umbrella, and covering
the components for a smooth and atraumatic withdrawal of the device
from the heart and vascular system.
[0136] If desired, the adjustment elements may be left in position
after the catheter components are withdrawn for further physiologic
adjustment. In yet other embodiments according to the present
invention, a catheter-based adjustment elements may subsequently be
re-inserted through a percutaneous or other route. Such an
adjustment element may be steerably operable by the operator, and
may be provided with magnetic, electronic, electromagnetic, or
laser-guided systems to allow docking of the adjustment element
with the adjustable mechanism contained within the implant. In
still other embodiments, the adjustment mechanism may be driven by
implanted electromechanical motors or other systems, which may be
remotely controlled by electronic flux or other remote
transcutaneous or percutaneous methods.
[0137] In the case of pulmonic valve-repair, initial catheter
access is achieved through a peripheral or central vein. Access to
the pulmonary valve is also achieved from below the valve once
central venous access is achieved by traversing the right atrium,
the tricuspid valve, the right ventricle, and subsequently reaching
the pulmonic valve.
[0138] In yet other embodiments according to the present invention,
catheter access to the left atrium can be achieved from cannulation
of central or peripheral veins, thereby achieving access to the
right atrium. Then a standard atrial trans-septal approach may be
utilized to access the left atrium by creation of an iatrogenic
atrial septal defect (ASD). In such a situation, the mitral valve
may be accessed from above the valve, as opposed to the retrograde
access described in Example 1. The implant and a reversed
deployment umbrella may be utilized with implant placement in the
atrial aspect of the mitral annulus, with the same repair technique
described previously. The iatrogenic ASD may then be closed using
standard device methods. Access to the aortic valve may also be
achieved from above the aortic valve via arterial access in a
similar retrograde fashion.
[0139] Other embodiments of the adjustable implant and methods
according to the present invention include gastrointestinal
disorders such as gastroesophageal reflux disease (GERD), a
condition in which the gastro-esophageal (GE) junction lacks
adequate sphincter tone to prevent the reflux of stomach contents
into the esophagus, causing classic heartburn or acid reflux. This
not only results in discomfort, but may cause trauma to the lower
esophagus over time that may lead to the development of
pre-cancerous lesions (Barrett's esophagus) or adenocarcinoma of
the esophagus at the GE junction. Surgical repair of the GE
junction has historically been achieved with the Nissen
Fundoplication, an operative procedure with, generally good
results. However, the Nissen procedure requires general anesthesia
and a hospital stay. Utilizing the devices and methods according to
the present invention, an adjustable implant would obviate the need
for a hospital stay and be performed in a clinic or
gastroenterologist's office. Referring now to FIGS. 29 and 30, an
umbrella deployment device 600 with implant 645 is passed under
guidance of an endoscope 1000, through the patient's mouth,
esophagus 1005, and into the stomach 1010, where the deployment
device 600 is opened with expansion of the implant 645 and
touchdown detectors 648 with a color-coded or otherwise visible
gap. The touchdown detectors are then engaged onto the stomach
around the gastroesophageal junction 1015 under direct endoscopic
control until all touchdown detectors 648 are visually activated.
The implant is then attached to the stomach wall, 1020 the umbrella
642 is released and withdrawn, leaving behind the implant 645 and
the adjustment elements. The implant is then adjusted until the
desired effect is achieved, i.e., minimal acid reflux either by
patient symptoms, pH monitoring of the esophagus, imaging studies,
or other diagnostic means. If the patient should suffer from gas
bloat, a common complication of gastroesophageal junction repair in
which the repair is too tight and the patient is unable to belch,
the implant can be loosened until a more desirable effect is
achieved.
[0140] In various embodiments anticipated by the present invention,
the implant body may be straight, curved, circular, ovoid,
polygonal, or some combination thereof. In various embodiments
anticipated by the present invention the implant may be capable of
providing a uniform or non-uniform adjustment of an orifice or
lumen within the body. The implant body may further completely
enclose the native recipient anatomic site, or it may be provided
in an interrupted form that encloses only a portion of the native
recipient anatomic site. In still other embodiments of the present
invention, the implant body may be a solid structure, while in yet
other embodiments the implant body may form a tubular or otherwise
hollow structure. In one embodiment of the present invention, the
body may further be a structure with an outer member, an inner
member, and optional attachment members. In such an embodiment, the
outer member of the implant body may serve as a covering for the
implant, and is designed to facilitate and promote tissue ingrowth
and biologic integration to the native recipient anatomic site. The
outer member in such an embodiment may be fabricated of a
biologically compatible material, such as Dacron, PTFE, malleable
metals, other biologically compatible materials or a combination of
such biologically compatible materials in a molded, woven, or
non-woven configuration. The outer member in such an embodiment
also serves to house the inner member. In this embodiment, the
inner member provides an adjustment means that, when operated by an
adjustment mechanism, is capable of altering the shape and/or size
of the outer member in a defined manner.
[0141] In alternate embodiments according to the present invention,
the adjustment means may be located external to or incorporated
within the outer member. In yet additional alternate embodiments
contemplated by the present invention, the implant body may consist
of an adjustment means without a separate outer member covering
said adjustment means.
[0142] In various embodiments according to the present invention,
the adjustment means may include a mechanism which may be threaded
or nonthreaded; and which may be engaged by the action of a screw
or worm screw, a friction mechanism, a friction-detent mechanism, a
toothed mechanism, a ratchet mechanism, a rack and pinion
mechanism, or such other devices to permit discreet adjustment and
retention of desired size a desired position, once the proper size
is determined.
[0143] In yet other embodiments according to the present invention,
the adjustment means may comprise a snare or purse string-like
mechanism in which a suture, a band, a wire or other fiber
structure, braided or non-braided, monofilament or multifilament,
is capable of affecting the anatomic and/or physiologic effects of
the implant device on a native anatomic recipient site upon varying
tension or motion imparted to said wire or fiber structure by a
surgeon or other operator. Such an adjustment means may be provided
as a circular or non-circular structure in various embodiments.
Changes in tension or motion may change the size and/or shape of
the implant.
[0144] In various embodiments according to the present invention,
the adjustment means may be a metallic, plastic, synthetic,
natural, biologic, or any other biologically-compatible material,
or combination thereof. Such adjustment means may further be
fabricated by extrusion or other molding techniques, machined, or
woven. Furthermore, in various embodiments of the present
invention, the adjustment means may be smooth or may include slots,
beads, ridges, or any other smooth or textured surface.
[0145] In various embodiments of the present invention, the implant
body may be provided with one or more attachment members such as
grommets or openings or other attachment members to facilitate
attachment of the implant to the native recipient site. In
alternate embodiments, the implant body may attach to or
incorporate a mechanical tissue interface system that allows a
sutureless mechanical means of securing the implant at the native
recipient site. In still other alternate embodiments, sutures or
other attachment means may be secured around or through the implant
body to affix the implant body to the native recipient site. In yet
other embodiments of the present invention, mechanical means of
securing the implant body to the native recipient site may be
augmented or replaced by use of fibrin or other
biologically-compatible tissue gives or similar adhesives.
[0146] In additional various embodiments according to the present
invention, the adjustable implant may be employed to adjustably
enlarge or maintain the circumference or other dimensions of an
orifice, ostium, lumen, or anastomosis in which a disease process
tends to narrow or constrict such circumference or other
dimensions.
[0147] In various embodiments according to the present invention,
an adjustment mechanism may be provided to interact with the
adjustment means to achieve the desired alteration in the size
and/or position of the adjustment means. Such an adjustment
mechanism may include one or more screws, worm-screw arrays
rollers, gears, frictional stops, a friction-detent system,
ratchets, rack and pinion arrays, micro-electromechanical systems,
other mechanical or electromechanical devices or some combination
thereof.
[0148] In some embodiments as contemplated by the present
invention, an adjustment tool may be removably or permanently
attached to the adjustment mechanism and disposed to impart motion
to the adjustment mechanism and, in turn, to the adjustment means
to increase or decrease the anatomic effect of the implant on the
native recipient site.
[0149] In alternate embodiments according to the present invention,
micrometer arrays with one or more micro-electromechanical motor
systems with related electronic control circuitry may be provided
as an adjustment means, and may be activated by remote control
through signals convey by electromagnetic radiation or by direct
circuitry though electronic conduit leads which may be either
permanently or removably attached to said micrometer arrays.
[0150] In still other various embodiments according to the present
invention, the adjustment mechanism may be provided with a locking
mechanism disposed to maintain the position of the adjustment means
in a selected position upon achievement of the optimally desired
anatomic and/or physiologic effect upon the native recipient sit
and the bodily organ to which it belongs. In other embodiments, no
special locking mechanism may be necessary due to the nature of the
adjustment means employed.
[0151] In yet other alternate embodiments according to the present
invention, the adjustment means and/or the outer member structure
may be a pliable synthetic material capable of rigidification upon
exposure to electromagnetic radiation of selected wavelength, such
as ultraviolet light. In such embodiments, exposure to the desired
electromagnetic radiation may be achieved by external delivery of
such radiation to the implant by the surgeon, or by internal
delivery of such radiation within an outer implant member using
fiberoptic carriers placed within said outer member and connected
to an appropriate external radiation source. Such fiberoptic
carriers may be disposed for their removal in whole or in part from
the outer implant member after suitable radiation exposure and
hardening of said adjustment means.
[0152] The present invention also provides methods of using an
adjustable implant device to selectively alter the anatomic
structure and/or physiologic effects of tissues forming a
passageway for blood, other bodily fluids, nutrient fluids,
semi-solids, or solids, or wastes within a mammalian body. Various
embodiments for such uses of adjustable implants include, but are
not limited to, open surgical placement of said adjustable implants
at the native recipient site through an open surgical incision,
percutaneous or intravascular placement of said implants under
visual control employing fluoroscopic, ultrasound, magnetic
resonance imaging, or other imaging technologies, placement of said
implants through tissue structural walls, such as the coronary
sinus or esophageal walls, or methods employing some combination of
the above techniques. In various embodiments as contemplated by the
present invention, adjustable implants may be placed and affixed in
position in a native recipient anatomic site by trans-atrial,
trans-ventricular, trans-arterial, trans-venous (i.e., via the
pulmonary veins) or other routes during beating or non-beating
cardiac surgical procedures or endoscopically or percutaneously in
gastrointestinal surgery.
[0153] Furthermore, alternate methods for use of an adjustable
implant device may provide for the periodic, post-implantation
adjustment of the size of the anatomic structure receiving said
implant device as needed to accommodate growth of the native
recipient site in a juvenile patient or other changes in the
physiologic needs of the recipient patient.
[0154] Adjustment of the adjustable implants and the methods for
their use as disclosed herein contemplates the use by the surgeon
or operator of diagnostic tools to provide an assessment of the
nature of adjustment needed to achieve a desired effect. Such
diagnostic tools include, but are not limited to, transesophageal
echocardiography, echocardiography, diagnostic ultrasound,
intravascular ultrasound, virtual anatomic positioning systems
integrated with magnetic resonance, computerized tomographic, or
other imaging technologies, endoscopy, mediastinoscopy,
laparoscopy, thoracoscopy, radiography, fluoroscopy, magnetic
resonance imaging, computerized tomographic imaging, intravascular
flow sensors, thermal sensors or imaging, remote chemical or
spectral analysis, or other imaging or quantitative or qualitative
analytic systems.
[0155] In one aspect, the implant/delivery system of the present
invention comprises a collapsible, compressible, or distensible
prosthetic implant and a delivery interface for such a prosthetic
implant that is capable of delivering the prosthetic implant to a
desired anatomic recipient site in a collapsed, compressed, or
non-distended state, and then allowing controlled expansion or
distension and physical attachment of such a prosthetic implant by
a user at the desired anatomic recipient site. Such a system
permits the delivery system and prosthetic implant to be introduced
percutaneously through a trocar, sheath, via Seldinger technique,
needle, or endoscopically through a natural bodily orifice, body
cavity, or region and maneuvered by the surgeon or operator to the
desired anatomic recipient site, where the delivery system and
prosthetic implant may be operably expanded for deployment. When
desirable, the implant/delivery system according to the present
invention is also capable of allowing the user to further adjust
the size or shape of the prosthetic implant once it has been
attached to the desired anatomic recipient site. The delivery
system according to the present invention is then capable of
detaching from its interface with the prosthetic implant and being
removed from the anatomic site by the operator. The delivery system
and prosthetic implant may be provided in a shape and size
determined by the anatomic needs of an intended native recipient
anatomic site within a mammalian patient. Such a native recipient
anatomic site may be a heart valve, the esophagus near the
gastro-esophageal junction, the anus, or other anatomic sites
within a mammalian body that are creating dysfunction that might be
relieved by an implant capable of changing the size and shape of
that site and maintaining a desired size and shape after
surgery.
[0156] In various embodiments contemplated by the present
invention, the delivery system may be a catheter, wire, filament,
rod, tube, endoscope, or other mechanism capable of reaching the
desired recipient anatomic site through an incision, puncture,
trocar, or through an anatomic passageway such as a vessel,
orifice, or organ lumen, or trans-abdominally or
trans-thoracically. In various embodiments according to the present
invention, the delivery system may be steerable by the operator.
The delivery system may further have a delivery interface that
would retain and convey a prosthetic implant to the desired
recipient anatomic site. Such a delivery interface may be operably
capable of distending, reshaping, or allowing the independent
distension or expansion of such a prosthetic implant at the desired
recipient anatomic site. Furthermore, such a delivery interface may
provide an operable means to adjust the distended or expanded size,
shape, or physiologic effect of the prosthetic implant once said
implant has been attached in situ at the desired recipient anatomic
site. In various embodiments according to the present invention,
such adjustment may be carried out during the procedure in which
the implant is placed, or at a subsequent time. Depending upon the
specific anatomic needs of a specific application, the delivery
interface and the associated prosthetic implant may be straight,
curved, circular, helical, tubular, ovoid, polygonal, or some
combination thereof. .cndot. In still other embodiments of the
present invention, the prosthetic implant may be a solid structure,
while in yet other embodiments the prosthetic implant may form a
tubular, composite, or otherwise hollow structure. In one
embodiment of the present invention, the prosthetic implant may
further be a structure with an outer member, an inner member, and
optional attachment members. In such an embodiment, the outer
member of the prosthetic implant may serve as a covering for the
implant, and is designed to facilitate and promote tissue ingrowth
and biologic integration to the native recipient anatomic site. The
outer member in such an embodiment may be fabricated of a
biologically compatible material; such as Dacron, PTFE, malleable
metals, other biologically compatible materials or a combination of
such biologically compatible materials in a molded, woven, or
non-woven configuration. The outer member in such an embodiment
also serves to house the inner member. In this embodiment, the
inner member provides an adjustment means that, when operated by an
adjustment mechanism, is capable of altering the shape and/or size
of the outer member in a defined manner.
[0157] In some embodiments according to the present invention, at
least some portions of the adjustable inner or outer member may be
elastic to provide an element of variable, artificial muscle tone
to a valve, sphincter, orifice, or lumen in settings where such
variability would be functionally valuable, such as in the
treatment of rectal incontinence or vaginal prolapse.
[0158] In various embodiments according to the present invention,
the delivery interface would have an attachment means to retain and
convey the prosthetic implant en route to the native anatomic
recipient site and during any in situ adjustment of the prosthetic
implant once it has been placed by the operator. Such an attachment
means would be operably reversible to allow detachment of the
prosthetic implant from the delivery interface once desired
placement and adjustment of the prosthetic implant has been
accomplished.
[0159] FIGS. 31-39 illustrate various embodiments of a ring in its
relaxed condition. FIG. 31 illustrates a circular ring 1110 having
drawstrings 1111, 1112 extending from a lower portion thereof. FIG.
32 illustrates an oval ring 130 having drawstrings 1121, 1122. FIG.
33 depicts a hexagonal ring 1130. FIG. 34 illustrates a ring 1140
in the shape of a partial circle 1145 with a straight leg 1146
connecting the two ends of the partial circle. FIG. 35 shows a ring
1150 comprising an arcuate portion 1154 and three-straight leg
portions 1155-1157 connecting the two ends of the arc. FIG. 36
shows a curvilinear ring 1160 having a convex portion 1164 on one
side and a concave portion 1166 on the other. FIG. 37 depicts a
curvilinear ring 1170 which is concave on both sides 1174, 1176.
FIG. 38 illustrates a ring 1180 which is generally circular in
shape and has an opening 1184 in its upper end. FIG. 39 shows a
ring comprising an arcuate portion 1194 and straight legs 1195,
1196 extending toward one another but leaving an opening 1197
therebetween.
[0160] FIGS. 40 and 41.cndot. show the ring 1110 cut away to show
the drawstrings 1111, 1112. The drawstrings 1111, 1112 or anchored
at a location 1113 opposite the exit location 1114 of the
drawstrings. When the drawstrings are tensioned, as shown in FIG.
41, the entire ring 10 is adjusted smaller.
[0161] (Optionally, the drawstrings 1111, 1112 can be freely
slidable within the ring 1110, rather than anchored, with largely
the same effect).
[0162] In contrast to the fully adjustable ring 1110 of FIGS. 40
and 41, the ring 1110A of FIGS. 42 and 43 is only partially
adjustable. The ends of the drawstrings 1111A, 1112A do not meet
but rather are anchored at locations 1113A, 1113B around the ring
1110A. When the drawstrings 1111A, 1112A are tensioned, the
segments 1117A, 1117B through which the drawstrings extend are the
sections which are most adjusted. In contrast, the section 1118A,
through which no portion of either drawstring extends, receives
relatively little adjustment.
[0163] FIGS. 44-47 illustrate the effect of internal reinforcement
on the adjustability of a ring. In FIGS. 1144 and 1145, a ring 1140
has no internal reinforcement. Consequently, when the drawstrings
1141, 1142 are tensioned, the entire ring 1140 adjusts. In
contrast, the ring 1140A of FIGS. 46 and 47 has a reinforcing
element 1144A extending through the straight leg 1146A of the ring.
In the disclosed embodiment the reinforcing element 1144A is a
hollow tube. However, it will be appreciated that the reinforcing
element 1144A can assume other configurations, including a solid
rod of suitable cross-section. Also, in the disclosed embodiment
the drawstrings 1141A, 1142A are anchored to the ends of the
reinforcing .cndot. element 1144A. However, it will be understood
that the drawstrings can extend through the tube, either to be
anchored at a common location inside the tube or to be freely
slidable within the tube. In the alternative, the drawstrings can
extend alongside the reinforcing element 1144A, either to be
anchored at a common location alongside the reinforcing element or
to be freely slidable alongside the reinforcing element.
[0164] FIGS. 48-51 illustrate the use of internal shaping members
operatively associated with the drawstrings such that when the
drawstrings are tensioned, the shaping members cause the ring to
assume a predetermined configuration. Referring first to FIGS. 48
and 49, a generally circular ring 1200 has a plurality of
wedge-shaped shaping members 1201 disposed within the ring. The
left drawstring 1202 is connected to the right-most shaping number
1201A, and the right drawstring 1203 is connected to the left-most
shaping number 1201B. When the drawstrings 1202, 1203 are
tensioned, the right-most shaping member 1201A and the left-most
shaping member 1201 Bare drawn toward one another. This movement of
the outermost shaping members causes the wedge surfaces of each
shaping number 1201 to confront the wedge surfaces of the adjacent
shaping members, forcing the group of shaping members to assume the
concave configuration illustrated in FIG. 49.
[0165] While the shaping members 1201 of the embodiment of FIGS. 48
and 49 are configured to assume a concave configuration when the
drawstrings are cinched, it will be appreciated that the
configuration of the shaping members may be designed such that the
group forms a convex configuration, a straight line, a serpentine
configuration with both convex and concave portions, or any other
desired geometric shape.
[0166] Referring now.cndot. to FIGS. 50 and 51, a generally
circular ring 1210 has two groups 1212, 1213 of wedge-shaped
shaping members 1211. The ring 1210 comprises four drawstrings, a
pair of drawstrings being associated with each of the two groups
1212, 1213 of wedge-shaped shaping members 1211. The first
drawstring 1214 extends around the ring 1210 in a clockwise
direction and is connected to the uppermost member 1211A of the
first group 1212 of shaping members 1211. The second drawstring
1215 extends around the ring 1210 in a counterclockwise direction
and is connected to the lowermost member 1211B of the first group
1212 of shaping members 1211. Similarly, the third drawstring 1216
extends around the ring 1210 in a clockwise direction and is
connected to the lowermost member 1211C of the second group 1213 of
shaping members 1211, while the fourth drawstring 1217 extends
around the ring in a counterclockwise direction and is connected to
the uppermost member 1211D of the second group 1213 of shaping
members.
[0167] When the four drawstrings 1214-1217 are cinched, the first
group 1212 of shaping members 1211 is drawn together, and the
second group 1213 of shaping members is drawn together. The two
groups 1212, 1213 of members 1211 assume predetermined geometric
shapes, causing the ring 1210 to assume the ovoid configuration
shown in FIG. 51.
[0168] While the two groups of shaping members in the embodiment of
FIGS. 50 and 51 form identical geometric shapes, it will be
understood that the configuration of the shaping members may be
designed such that each group forms a different shape. Similarly,
while the two groups of shaping members in the embodiment of FIGS.
50 and 51 form convex geometric shapes, it will be appreciated that
the shaping members can be configured to assume a concave shape, a
straight line, or a serpentine shape comprising both convex and
concave sections, or any combination of these and other shapes.
[0169] All of the devices of FIGS. 31 through 51 lie in essentially
a single plane when in their relaxed state and further lie in
essentially a single plane when the drawstrings are tensioned.
FIGS. 52 through 55 illustrate embodiments in which internal
shaping members are configured to adjust the ring to a more
three-dimensional shape.
[0170] Looking first at FIG. 52, a ring 1220 comprises a.cndot.
plurality of shaping members 1221 formed into two group 1222, 1223.
With the ring lying flat, the shaping members are narrower at the
top than at the bottom. Thus, when the drawstrings 1224-1227 are
cinched, the ring bows upward into the saddle-shaped configuration
depicted in FIG. 53.
[0171] FIGS. 54 and 55 illustrate an embodiment of a ring 1230
comprising a variety of differently configured shaping members
1231. Only some of the shaping members 1231 are shown in FIGS. 54
and 55 for clarity of illustration. The shaping members 1231 are
arranged in alternating groups 1232 of shaping members narrower at
the top than at the bottom and groups 1233 of shaping members
narrower at the bottom than at the top. Utilizing the principles
previously explained, it will be seen that, by having some shaping
members narrower at the top that the bottom and some shaping
members narrower at the bottom than at the top, complex
three-dimensional configurations can be achieved.
[0172] From the foregoing examples it will be apparent that the
rings can be, curvilinear (FIGS. 31, 32, and 36-38), rectilinear
(FIG. 33); or a combination of straight and curved segments (FIGS.
34, 35, and 39). The ring can be either entirely closed (FIGS.
31-37) or partially closed (FIGS. 38 and 39). The rings can be
fully adjustable (FIGS. 40, 41, 44, and 45) or partially adjustable
(FIGS. 42, 43, 46, and 47). The rings can be unreinforced (FIGS.
31-45) or reinforced (FIGS. 46 and 47). The rings can contain
shaping members that assume a specific geometric configuration in
two dimensions (FIGS. 48-51) or three dimensions (FIGS. 52-55).
[0173] The embodiments of FIGS. 31-55 all employ drawstrings as a
means for adjusting the circumference of the implants. A different
approach is taken in the embodiment of FIGS. 56-70, in which an
adjustable implant employs a winch to take up or to let out the
circumference of the ring. Looking first at FIG. 56, a system 1300
for adjusting the configuration of a mitral valve annulus includes
an adjustable ring 1310, a drive unit 1312 in the nature of an
adjustment tool, and a winch 1314 (largely hidden within the lower
end of the drive unit 1312 in FIG. 56). Each of these components
will now be discussed in more detail.
[0174] Referring to FIG. 57, the ring 1310 is at its maximum
circumference and is coupled to the winch 1314 at each end. The
ring 1310 comprises an outer layer 1320 of Dacron. In FIG. 58, the
ring 1310 is cut away to reveal an intermediate layer 1322 and a
continuous band 1324 of nitinol or other suitable flexible,
nonextensible material, i.e., a flexible member. FIG. 59 shows the
ring 1310 in a contracted state.
[0175] FIG. 60 illustrates the distal portion of a drive shaft 1330
of the drive unit 1310. The drive shaft 1330 is of indeterminate
length but is advantageously long enough to extend to a location
outside the patient, while at the same time being as short as
possible to facilitate transmission of torque along the length of
the shaft 1330. The drive shaft 1330 is preferably a solid,
flexible rod of circular cross-section, but it will be understood
that other suitable shapes, including hollow tubes, or rods of
cross-section other than circular, can be employed.
[0176] The drive shaft has a winch-engaging member 1332 at its
distal end 1334. In the disclosed embodiment the wench-engaging
member 1332 takes the form of a flat-blade screwdriver tip.
However, it will be understood that other suitable tip
configurations can be used to cooperatively engage the wench 1314,
including, but not limited to, a Philips head tip, a hex head tip,
a wrench socket, and the like. Spaced proximally up the drive shaft
1330 from the distal end 1334 is a circumferential groove 1336.
[0177] FIG. 61 depicts the distal portion of an inner tube 1340 of
the drive unit 1310. The inner tube at 1340 is comprised of a
flexible material. The inner tube 1340 has a lumen 1342 slightly
larger than the outer diameter of the drive shaft 1330 such that
the drive shaft can rotate freely within the inner tube 1340. At
the distal end 1344 of the inner tube 1340 are a pair of openings
1346 dimensioned to clear portions of the winch 1314. Also at the
distal end 1344 of the inner tube 1340 are a pair of
axially-extending slots 1348, which permit the distal end 1344 of
the inner tube 1340 to expand slightly.
[0178] Spaced around the periphery of the lumen, 1342 just proximal
of the distal end 1344 of the inner tube 1340 are a plurality of
inwardly projecting protrusions 1350. Just proximal of the proximal
ends of the slots 1348 is an inwardly extending annular ring 1352
(not shown in FIG. 61; see FIGS. 69, 70).
[0179] FIG. 62 shows the drive shaft 1330 disposed within the inner
tube 1340. The distal end of the drive shaft 1330 is recessed
within the distal end of the inner tube 1340. The annular ring 1352
(FIGS. 69, 70) of the inner tube 1340 engages the circumferential
groove 1336 of the drive shaft 1330 to retain the drive shaft and
inner tube in predetermined.cndot. axial relation.
[0180] The final component of the drive unit 1310 is an outer tube
1360 (FIGS. 69, 70) of a flexible, resilient material. The outer
rube 1360 has a lumen dimensioned to receive the inner tube 1340
therewithin, for a purpose which will be explained hereinbelow.
[0181] FIGS. 63-65 illustrate a spindle 1370 of the winch 1320. The
spindle 1370 has an upper end 1372, a lower end 1374, and a disk
1376 intermediate the upper and lower ends. The upper end 1372 of
the spindle 1370 comprises a drive-shaft engagement assembly 1378,
which in the disclosed embodiment comprises a pair of transverse
slots 1380 dimensioned to receive the flat-blade screwdriver tip
1332 of the drive shaft 1330 (FIG. 60). The portions of the spindle
1370 between the slots 1380 are beveled to form facets 1382 which
direct the flat-blade screwdriver tip 1332 of the drive shaft into
the slots.
[0182] Below the disk is a generally cylindrically shaped body
1384. In the disclosed embodiment the cylindrical body 1384 is
hollow to save material, but it will be understood that a solid
cylindrical body is also suitable. At the lower end 1374 of the
spindle 1370, slots 1386 are formed to extend in a generally axial
direction.
[0183] The upper surface of the disk 1376 comprises a plurality of
recesses 1398, the purpose of which will be explained below.
[0184] FIG. 66 shows a section of the band 1324 of the ring 1310
received within the slots 1386 and wrapped around the cylindrical
body 1384 of the spindle 1370.
[0185] The winch 1312 will now be described with reference to FIGS.
67 and 68. The winch 1312 comprises a housing 1390 consisting of
upper and lower housing halves 1390A, 1390B. The upper and lower
housing halves 1390A, 1390B are preferably formed with cooperating
pins and holes to facilitate in aligning and mating the housing
halves. In the upper end 1392 of the upper housing half 1390A, a
circular opening 1394 is formed. Surrounding the circular opening
1394 and protruding downward from the inner surface of the upper
housing half 1390A are a plurality of teeth 1396. The edges 1397 of
the upper surface 1392 are beveled. The upper and lower housing
halves 1390A, 1390B each comprise a generally cylindrical portion
1398A, 1398B and tangentially extending sleeve portions 1400A,
1400B.
[0186] The outer periphery of the lower housing half 13908 has a
plurality of dimples 1402 formed therein. Seated within the lower
housing half 1390B is a wave spring 1404. A washer 1406 with an
annular recess 1408 formed in its upper surface sits atop the wave
spring 1404. A portion of the band 1324 of the ring 1310 is
received within the slots 1386 in the lower end 1374 of the spindle
1370, and the lower end 1374 of the spindle rests within the
annular recess 1408 in the upper surface of the washer 1406.
Portions 1410, 1412 of the band 1324 adjacent the spindle 1370 are
seated within the tangentially extending-sleeve portions 1400B of
the lower housing half. The upper housing half 1390B is then
assembled onto the lower housing half 1390B. As can be seen in FIG.
68, the upper end 1372 of the spindle 1370 extends through the
circular opening 1394 in the upper housing half 1390A such that the
drive-shaft engagement assembly 1378 resides outside the housing
1390. The band 1324 exits the housing 1390 through the tangentially
extending sleeves 1400 such that the major portion of the band
resides outside the winch housing.
[0187] FIGS. 69 and 70 illustrate the engagement of the drive unit
1312 with the winch 1314. Referring first to FIG. 69, the winch
1314 is in a self-locked state. This state is achieved by the wave
spring 1404 urging the washer 1406 upward, which in turn forces the
spindle 1370 upward against the top interior surface of the winch
housing 1390. In this position, the teeth 1396 extending downward
from the top interior surface of the housing engage the recesses
1386 in the upper surface of the disk 1376 of the spindle 1370,
preventing rotation of the spindle.
[0188] As the drive unit 1312 is advanced down over the winch, the
inner edges of the distal end 1344 of the inner tube 1340 confront
the beveled outer edges of the upper end 1392 of the housing 1390
and spread the distal end of the inner tube. As the drive unit 1312
is advanced further, the tangential sleeves 1400 (FIG. 68) of the
winch housing 1390 are received within the openings 1346 (FIG. 61)
in the distal end 1344 of the inner tube 1340. Finally, the
inwardly projecting protrusions 1350 within the distal end 1344 of
the inner tube engage the dimples 1402 in the lower outer portion
of the winch housing 1390 to lock the drive unit 1312 to the winch
1314.
[0189] Referring now to FIG. 70, as the drive unit 1312 engages the
winch 1314, the blade 1332 of the drive shaft 1330 confronts the
beveled facets 1382 and is directed into one of the slots 1380. As
the drive unit 1312 is locked into position, the spindle 1370 is
forced downward, flattening the wave spring 1404 and disengaging
the recesses 1386 in the upper surface of the disk 1376 of the
spindle from the teeth 1396 on the interior upper surface of the
winch housing 1390. The spindle can now be turned. The band (not
shown in FIGS. 69-70) wraps around the spindle 1370 as the drive
shaft 1330 is turned, shortening the length of the band outside the
winch housing 1390.
[0190] When the band 1370 has been adjusted to the desired length,
the drive unit 1312 is disengaged from the winch 1314. The outer
tube 1360 is advanced until it confronts the tangential sleeves
1400 (FIG. 68) of the winch housing 1390. The outer tube 1360 is
then used to hold the winch 1314 and ring 1310 in place while the
inner tube 1340 is retracted. The protrusions 1350 within the
distal end 1344 of the inner tube disengage from the dimples 1,402
in the lower outer portion of the winch housing 1390.
Simultaneously, the drive shaft 1330 releases its downward pressure
on the spindle 1370. The wave spring 1404 returns to its normal,
uncompressed condition, biasing the spindle 1370 upward so that the
teeth 1396 on the interior upper surface of the winch housing 1390
once again engage the cooperating recesses 1386 in the upper
surface of the disk 1376. The spindle 1370 is now prevented from
rotating, thereby locking the winch 1314 and fixing the exposed
length of the ring 1310.
[0191] With the mechanics of the winch 1314, ring 1310, and drive
unit 1312 having thus been explained, the use of the device 1300 to
reconfigure a mitral valve annulus will now be described. With the
patient on bypass, the heart is opened, and the ring 1310 is
sutured around the mitral valve annulus, placing stitches through
the fabric outer layer 1320 and the adjacent tissue. Once the ring
1310 has been sutured in place, the drive unit 1312 is coupled to
the winch 1314, and preliminary adjustment of the ring is affected.
Leaving the drive unit engaged with the winch, the heart is now
closed, and the patient is taken off bypass. With the heart
beating, final adjustment of the ring can be effected via the drive
unit, checking for reflux by suitable medical visualization means.
Once final adjustment of the ring has been achieved, the drive unit
is uncoupled from the winch, without having to reopen or access the
anatomical structure or lumen and removed without having to once
again place the patient on bypass.
[0192] .cndot. FIG. 71 illustrates an alternate embodiment of a
winch-adjustable ring 1410 which is O-shaped. The ring 1410 is
partially adjustable and consists of a combination of straight and
curved sections. In the ring 1410, a band 1470 is split, and a
straight, relatively rigid section 1455 interconnects the free ends
of the band. The band 1470 is wound around the winch 1314 and is
taken up and let out in the same manner described above.
[0193] FIG. 72 illustrates another alternate embodiment of a
winch-adjustable ring 1510 which is partially adjustable and which
is concave on one side. Again, a band 1570 is split, and a curved,
relatively rigid section 1555 is connected between the free ends of
the band. The band 1570 is wound around the winch 1314 and is taken
up and let out in the same manner described above.
[0194] FIG. 73 illustrates a drive unit 1600 in the nature of an
adjustment tool for remotely rotating the winch 1314 of the rings
1310, 1410, and 1510. Whereas the drive unit 1312 previously
described transmits rotational force exerted by the user to the
winch, the drive unit 1600 converts axial movement of the user into
rotational movement of the winch. As shown in FIG. 73, the drive
unit 1600 includes a drive shaft 1610, an actuator button 1612, an
inner cam sleeve 1614, and an outer cam sleeve 616. Each of these
components will now be discussed in more detail.
[0195] Referring first to FIGS. 74 and 75, the drive shaft 1610
includes an elongated shaft member 1620 having an upper end 1622
and a lower end 1624. A winch-engaging member 1626 in the form of a
flat-head screwdriver blade is formed at the lower end 1624 of the
shaft 1620. At the upper end 1622 of the shaft 1620 a plurality of
longitudinally extending ribs 1628 are formed. In the disclosed
embodiment there are four ribs 1628 spaced equidistant around the
perimeter of the shaft 1620.
[0196] Referring now to FIGS. 76 and 77, the actuator button 1612
has a rounded upper end 1630 and a lower end 1632. Adjacent the
lower end 1632 of the actuator button, a plurality of pins project
radially outward. The pins 1634 are preferably wider at their outer
ends, tapering inwardly as the pins approach the body of the
actuator button 1612. In the disclosed embodiment there are four
pins 1634 spaced equidistant around the periphery of the actuator
button 1612.
[0197] A plurality of downwardly extending protrusions 1636 are
formed on the lower end 1632 of the actuator button 1612. In the
disclosed embodiment, there are eight such protrusions 1636 spaced
equidistant around the perimeter of the button 1612. As can be seen
in FIG. 77, the protrusions 1636 are slightly angularly offset with
respect to the pins 1634.
[0198] FIGS. 78 and 79 illustrate the inner cam sleeve 1614. The
inner cam sleeve 1614 has ari upper end 1640, a lower end 1642, and
a vertical bore 1644. The bore 1644 is dimensioned to receive the
upper end of the drive shaft 1610 and the lower end of the actuator
button .cndot. slidably therewithin.
[0199] A plurality of generally vertical slots 1646 are formed in
the wall of the sleeve 1614 and extend through the lower end 1642
of the sleeve. In the disclosed.cndot. embodiment there are four
such slots 1646 formed at 90* intervals around the sleeve. Also at
the lower end 1642 of the sleeve 1614, a plurality of angled teeth
1648 are formed. In the disclosed embodiment, the teeth 1648 are
generally vertical on the right side and slanted on the left side.
There are eight such teeth 1648 in the disclosed embodiment, spaced
equidistant around the perimeter of the sleeve 1614.
[0200] FIGS. 80 and 81 illustrate the outer cam sleeve 1616, which
is similar in configuration to the inner cam sleeve 1614 except the
teeth 1652 are angled in the opposite direction, that is, the left
side of each tooth 1652 is generally vertical and the right side of
each tooth 1652 is slanted. The bore 1654 of the outer cam sleeve
1616 is dimensioned to receive the inner cam sleeve 1614 slidably
therewithin. The outer cam sleeve 1616 has a plurality of generally
vertical slots 1656 formed in the wall of the sleeve at 90.degree.
intervals.
[0201] Assembly of the drive unit 1600 will now be explained with
reference to the exploded view of FIG. 82. The inner and outer cam
sleeves 1614, 1616 are nested and rotated relative to one another
so that the vertical slots 1646, 1656 are aligned. The actuator
button 1612 is then inserted into the inner cam sleeve 1614 from
the lower end 1642, with the pins 1634 of the actuator button 1612
riding within the vertical slots 1646, 1656 of the inner and outer
cam sleeves 1614, 1616. The upper end 1622 of the drive shaft 1610
is then inserted into the lower end 1642 of the inner cam sleeve
1614 with the ribs 1628 at the upper end 1622 of the shaft 1620
fitting within the vertical slots 1646, 1656 of the inner and outer
cam sleeves 1614, 1616.
[0202] Operation of the drive unit 1600 will now be explained with
reference to FIGS. 83 and 84, in which the outer cam sleeve 1616
has been removed for clarity of illustration. Referring first to
FIG. 83, the actuator button 1612 is in the "up" position. The pins
1634 of the actuator button 1612 are located within the upper
portions of the vertical slots 1646 of the inner cam sleeve 1614.
The drive shaft is in its upper or "retracted" position, with the
ribs 1628 at the upper end 1622 of the shaft 1620 fitting within
the vertical slots 1646 of the inner cam sleeve 1614.
[0203] As the user presses down on the actuator button 1612, the
lower end 1632 of the actuator button bears against the upper end
1622 of the drive shaft 1610, forcing it downward. The protrusions
1636 (FIGS. 76 and 77) on the lower end 1632 of the actuator button
1612 bear against the upper ends of the ribs. However, since the
protrusions are angularly offset, they tend to bias the ribs toward
the left (as seen in FIGS. 82 and 83). Thus, as the actuator button
1612 is depressed sufficiently for the ribs 1628 at the upper end
1622 of the shaft 1620 to clear the lower end of the slots 1646,
the ribs are biased to the left. When the actuator button is
released, the drive.cndot.shaft 1610 is biased upward by a spring.
The upper ends of the ribs 1628 engage the angled surface of the
corresponding teeth 1648 and ride along the angled surface until
confronting the vertical surface of the adjacent teeth.
[0204] The effect of this interaction between the ribs 1628 at the
upper end of the drive shaft 1610 and the slots 1646 and teeth 1648
at the lower end of the inner cam sleeve 1614 is that the drive
shaft is extended and rotated one-eighth of a turn in the clockwise
direction (as viewed from the upper end of the drive unit 1600).
The extension of the drive shaft 1610 depresses the spindle 1370 of
the winch 1314 (similar to FIG. 70), disengaging the teeth 1396 in
the roof of the winch housing 1390 from the recesses 1386 in the
spindle. The spindle 1370 is then rotated one-eighth of a turn in
the clockwise direction, taking up the band 1324.
[0205] Subsequent depression of the actuator button 1612 moves the
ribs into contact with the next adjacent teeth, rotating the
spindle 1370 another one-eighth of a turn. This time, as the ribs
1628 move up the angled surface of the corresponding teeth 1648,
the ribs are directed back into the slots 1646 in the 5 wall of the
inner cam sleeve 1614.
[0206] To take in the band 1324, the inner cam sleeve 1614 is
advanced down the shaft 1610 until the teeth 1648 in the lower end
of the inner cam sleeve clear the lower end of the outer cam sleeve
1616. Thus, as the actuator button 1612 is depressed and released,
the ribs 1628 interact with the lower end of the inner cam sleeve
1614. To let out the band, the outer cam sleeve 1616 is advanced
with respect to the inner cam sleeve until the teeth 1652 clear the
lower end of the inner cam sleeve 1614. Thus, as the actuator
button 1612 is depressed and released, the ribs 1628 interact with
the lower end of the outer cam sleeve 1616. Since the teeth 1652 at
the lower end of the outer cam sleeve 1616 are angled in the
opposite direction from the teeth 1648 at the lower end of the
inner cam sleeve 1614, rotational movement of the drive shaft 1610
is reversed, and the spindle rotates in a counterclockwise
direction (as seen from the top). Thus, with the lower end of the
outer cam sleeve 1616 extended, the winch 1370 is loosened
one-eighth of a turn for every actuation of the button 1612.
[0207] The drive unit 1600 makes possible the adjustment of an
implant 1310, 1410, 1510 from a location spaced apart from the
implant. This feature makes it possible to effect open-heart
surgery to place the implant, close the heart, go "off pump,"
restart the heart, and then adjust the circumference of the implant
(and thereby the mitral valve annulus) while the heart is actually
beating.
[0208] While this approach presents great strides over current
methods of adjusting the circumference of a mitral valve annulus,
it suffers one drawback in that the patient's heart rate and blood
pressure are lower as a result of the anesthesia. Thus while the
implant may be adjusted so that no reflux occurs at this lower
heart rate and blood pressure, it is possible that leaks may occur
once the heart rate and blood pressure have returned to normal.
[0209] To overcome this drawback, it is possible to bring the
patient's heart rate and blood pressure back up to normal while
still in the operating room by using well-accepted drugs, for
example, epinephrine. Once the patient's heart rate and blood
pressure have been brought up to normal levels, the circumference
of the implant can be adjusted.
[0210] Referring now to FIGS. 85-89, an implant 1710 comprises
deployable anchoring clips for affixing the implant to the tissue
surrounding an annulus whose circumference is desired to be
adjusted. The implant 1710 comprises a plurality of fastening
devices such as clips 1712 of nitinol or other resilient, shape
memory material. In the case of an implant for adjusting the
circumference of a mitral valve annulus, the clips may be from
approximately 4 mm to approximately 10 mm in length. In their
retracted state as shown in FIG. 84, the clips 1712 are straight
and lie flush against (or possibly recessed within) the lower face
1714 of the implant 1710. The center of each clip 1712 is anchored
to the underlying implant by stitching, adhesive, heat fusion,
eyelets, by being woven into the implant, or by other suitable
means. When released from their retracted state, the clips 1712
assume their normal configuration as shown in FIG. 85, that is, the
free ends of the clips curve into overlapping barbs.
[0211] FIGS. 87-89 illustrate the deployment of the clips 1712. The
clips 1712 are initially straight and lie flush against the
underlying lower face 1714 of the implant 1710. Referring first to
FIG. 86, a deployment suture 1720 extends upward through one free
end of a first clip, along the clip, and then downward through the
opposite free end of the first clip and into the underlying
substrate. The suture 1720 then extends upward through the first
free end of a second clip, .cndot.etc., until all clips are secured
to lie flush against the bottom face of the implant 1710.
[0212] As shown in FIG. 89, to deploy the clips, the deployment
suture 1720 is pulled. As the suture releases the first clip, the
clip assumes its normal configuration of overlapping barbs,
anchoring itself into the underlying tissue..cndot. As the suture
is pulled further, the second clip is release, curling itself into
overlapping barbs and anchoring itself into the underlying tissue.
This procedure is continued until all clips are released and have
anchored themselves into the underlying tissue.
[0213] Expected variations or differences in the results are
contemplated in accordance with the objects and practices of the
present invention. It is intended, therefore, that the invention be
defined by the scope of the claims which follow and that such
claims be interpreted as broadly as is reasonable.
[0214] Although the invention herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
invention as defined by the appended claims.
* * * * *