U.S. patent application number 14/012328 was filed with the patent office on 2013-12-26 for implantable devices for controlling the size and shape of an anatomical structure or lumen.
This patent application is currently assigned to ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.. The applicant listed for this patent is St. Jude Medical, Cardiology Division, Inc.. Invention is credited to Richard G. Cartledge, James I. Fann, Josef L. Friedmann, James L. Greene, Leonard Y. Lee.
Application Number | 20130345802 14/012328 |
Document ID | / |
Family ID | 56290972 |
Filed Date | 2013-12-26 |
United States Patent
Application |
20130345802 |
Kind Code |
A1 |
Cartledge; Richard G. ; et
al. |
December 26, 2013 |
IMPLANTABLE DEVICES FOR CONTROLLING THE SIZE AND SHAPE OF AN
ANATOMICAL STRUCTURE OR LUMEN
Abstract
An implantable device system for controlling the dimensions of
internal anatomic passages corrects physiologic dysfunctions
resulting from a structural lumen which is either too large or too
small. Implantable devices are disclosed which employ various
mechanisms for adjusting and maintaining the size of an orifice to
which they are attached. Systems permit he implants to be implanted
using minimally invasive procedures and permit final adjustments to
the dimensions of the implants after the resumption of normal flow
of anatomic fluids in situ.
Inventors: |
Cartledge; Richard G.;
(Hollywood, FL) ; Lee; Leonard Y.; (New York,
NY) ; Fann; James I.; (Portola Valley, CA) ;
Friedmann; Josef L.; (Scotts Valley, CA) ; Greene;
James L.; (Ft. Lauderdale, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
St. Jude Medical, Cardiology Division, Inc. |
St. Paul |
MN |
US |
|
|
Assignee: |
ST. JUDE MEDICAL, CARDIOLOGY
DIVISION, INC.
St. Paul
MN
|
Family ID: |
56290972 |
Appl. No.: |
14/012328 |
Filed: |
August 28, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11802264 |
May 21, 2007 |
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14012328 |
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|
|
10651840 |
Aug 29, 2003 |
7297150 |
|
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11802264 |
|
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|
60406841 |
Aug 29, 2002 |
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60444005 |
Jan 31, 2003 |
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60447383 |
Feb 14, 2003 |
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60462435 |
Apr 12, 2003 |
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60801861 |
May 19, 2006 |
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Current U.S.
Class: |
623/2.11 ;
623/2.37 |
Current CPC
Class: |
A61F 2250/0029 20130101;
A61F 2/2448 20130101; A61B 6/12 20130101; A61B 17/0644 20130101;
A61F 2/2442 20130101; A61B 2017/00455 20130101; A61F 2/0031
20130101; A61B 5/061 20130101; A61B 17/068 20130101; A61B
2017/00783 20130101; A61F 2/2466 20130101; A61B 2017/00243
20130101; A61B 5/6885 20130101; A61F 2/2445 20130101; A61B
2017/0496 20130101; A61F 2002/30537 20130101; A61B 2017/0641
20130101; A61B 2090/062 20160201; A61B 17/00234 20130101; A61F
2250/0004 20130101 |
Class at
Publication: |
623/2.11 ;
623/2.37 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An implantable device system for controlling at least one of the
shape and size of an anatomical structure or lumen, comprising: an
implantable device adapted for attachment to an anatomical
structure or lumen, said implantable device having a first band and
a second band and an adjustable member configured to both increase
and decrease the dimensions of the implantable device, said
adjustable member configured to receive an adjustment tool; a
torqueable adjustment tool configured to provide adjustment of the
dimensions of the implantable device, wherein adjustment of said
adjustable member adjusts the size of the implant device generally
in a preferred dimension.
2. The system of claim 1, wherein the first band and the second
band are overlappable.
3. The system of claim 1, wherein the first band and the second
band are slidable relative to each other.
4. The system of claim 1, wherein the adjustable member is
configured to pull the first band and the second band towards and
away from each other.
5. The system of claim 1, wherein the at least one of said first
and second bands has portions of varying durometer.
6. The system of claim 1, wherein the implantable device comprise a
prosthetic heart valve.
7. The system of claim 6, wherein the prosthetic heart valve
comprises an annuloplasty ring.
8. An implantable device having an adjustable size or shape
comprising: a first band including a terminal end having a
plurality of first adjustment stops; a second band including a
terminal end having a plurality of second adjustment stops; an
adjustable member configured for engagement with the first and
second adjustment stops; wherein operation of the adjustable member
is effective for increasing or decreasing the spacial relationship
between the terminal ends of the first and second bands thereby
adjusting the size or shape of the implantable device.
9. The implantable device of claim 8, wherein the terminal ends of
the first and second bands are arranged overlapping one another,
and wherein operation of the adjustable member effects the degree
of overlap between the first and second bands.
10. The implantable device of claim 8, wherein the adjustable
member includes a plurality of protrusions for engagement with the
first and second adjustment stops.
11. The implantable device of claim 10, wherein the adjustable
member is contained within a housing and is configured for rotation
about an axis thereof, and further including a locking assembly to
prevent rotation of the adjustable member.
12. The implantable device of claim 11, wherein the locking
assembly comprises a plurality of first teeth on the adjustable
member opposing a plurality of second teeth on the housing, and a
spring urging the plurality of first and second teeth into
engagement to prevent rotation of the adjustable member.
13. The implantable device of claim 11, wherein the adjustable
member includes a docking port adapted for releasably coupling to
an adjustment tool for rotating the adjustable member.
14. The implantable device of claim 13, further including an
adjustment tool for operation of the adjustable member.
15. The implantable device of claim 8, wherein the first and second
bands have a different width.
16. The implantable device of claim 8, wherein the first and second
bands are connected together by a ridged portion.
17. The implantable device of claim 16, wherein the ridged portion
is connected to the first and second bands by a flexible zone.
18. A prosthetic heart valve system comprising: a prosthetic heart
valve having an adjustable size or shape, the prosthetic heart
valve including a pair of bands having terminal ends arranged in
overlapping relationship, at least one of the terminal ends having
a plurality of adjustment stops; a housing rotationally containing
an adjustable member, the adjustable member having a plurality of
protrusions for engagement with the plurality of adjustment stops;
and an adjustment tool configured to be releasably coupled to the
adjustable member to effect the rotation thereof; wherein rotation
of the adjustable member varies the extent of overlap of the
terminal ends of the first and second bands for varying the size or
shape of the implant device.
19. The system of claim 18, further including a locking assembly to
prevent rotation of the adjustable member.
20. The system of claim 19, wherein the locking assembly comprises
a plurality of first teeth on the adjustable member opposing a
plurality of second teeth on the housing, and a spring urging the
plurality of first and second teeth into engagement to prevent
rotation of the adjustable member.
21. The system of claim 18, wherein the adjustable member includes
a docking port adapted for releasably coupling the adjustment tool
thereto.
22. The system of claim 18, wherein each of the terminal ends of
the pair of bands include a plurality of adjustment stops.
23. The system of claim 18, wherein the adjustable member is
configured to pull the terminal ends of the pair of bands towards
and away from each other.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional, of U.S. patent
application Ser. No. 11/802,264, filed May 21, 2007, which is a
continuation-in-part of U.S. patent application Ser. No.
10/651,840, filed Aug. 29, 2003, which application claims priority
under 35 U.S.C. .sctn.119(e) from U.S. Provisional Patent
Application No. 60/406,841 filed Aug. 29, 2002; U.S. Provisional
Patent Application No. 60/444,005, filed Jan. 31, 2003; U.S.
Provisional Patent Application No. 60/447,383, filed Feb. 14, 2003;
and U.S. Provisional Patent Application No. 60/462,435, filed Apr.
12, 2003; all of which are incorporated herein by reference. This
application also claims priority under 35 U.S.C. .sctn.119(e) from
U.S. Provisional Patent Application No. 60/801,861, filed on May
19, 2006, which is also incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] This invention relates generally to implantable devices for
controlling at least one of shape and size of an anatomic structure
or lumen.
DESCRIPTION OF RELATED ART
[0003] There is often a need to reduce the internal circumference
of an orifice or other open anatomic structure to narrow or
increase 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 or widening
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 the narrowing or widening effect, such that the degree of
narrowing or widening could be changed after its implantation, and
after the resumption of normal flow in situ.
[0004] 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.
[0005] 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.
[0006] 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 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 normal 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] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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 GEjunction.
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.
[0021] 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.
[0022] The present invention and the methods for its use anticipate
many alternate embodiments in other potential applications in the
broad fields of medicine and surgery. Among the other potential
applications anticipated according to the present invention are
adjustable implants for use in the treatment of morbid obesity,
urinary incontinence, anastomotic strictures, arterial stenosis,
urinary incontinence, cervical incompetence, ductal strictures, and
anal incontinence. The preceding discussions are intended to be
exemplary embodiments according to the present invention and should
not be construed to limit the present invention and the methods for
its use in any way.
SUMMARY OF THE INVENTION
[0023] An object of the present invention is to provide an
implantable device for controlling at least one of shape and size
of an anatomical structure or lumen. These and other objects of the
present invention are achieved in an implantable device for
controlling at least on of shape and size of an anatomical
structure or lumen. An implantable device is provided that has an
adjustable member configured to adjust the dimensions of the
implantable device. In certain embodiments, a torqueable adjustment
tool is configured to provide adjustment of the dimensions of the
implantable device for a preferred dimension. In other embodiments
adjustments for a preferred dimension may be accomplished remotely
through activation of internal adjustment mechanisms.
[0024] In another embodiment of the present invention, an
implantable device is provided for controlling at least one of
shape and size of an anatomical structure or lumen that includes an
implantable device has an adjustable member configured to adjust
the dimensions of the implantable device, a particularly a
preferred dimension. An adjustment tool is configured to provide
adjustment of the dimensions of the implantable device, the
adjustment tool providing translated motion through rotation.
[0025] In another embodiment of the present invention, 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 and includes first and second bands. An
adjustment tool is configured to provide adjustment of the
dimensions of the implantable device for a preferred dimension.
[0026] In still another embodiment of the present invention, 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. The implantable device has an anterior
portion, a posterior portion and dual threads that provide
preferential adjustment of one side or the other of the implantable
device. An adjustment tool is configured to provide adjustment of
the dimensions of the implantable device.
[0027] In yet another embodiment of the present invention, an
implantable device controls 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 provide
adjustment of the dimensions of the implantable device. The
adjustment tool provides reciprocating action to provide for the
adjustment.
[0028] In another embodiment of the present invention, an
implantable device controls 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 provide
adjustment of the dimensions of the implantable device. The
adjustment tool provides both course adjustment and fine
adjustment.
[0029] Other features and advantages of the present invention will
become apparent upon reading the following specification, when
taken in conjunction with the drawings and the appended claims.
BRIEF DESCRIPTION OF DRAWINGS
[0030] FIG. 1 is a front view of a first embodiment of an implant
for reducing the circumference of an anatomic orifice.
[0031] 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.
[0032] 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 reduced the size of the heart valve opening.
[0033] 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.
[0034] 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."
[0035] 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.
[0036] FIG. 7 is a right side view of the adjustment means of FIG.
6.
[0037] FIG. 8 is a left side view of the adjustment means of FIG.
6.
[0038] 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.
[0039] FIG. 10 is a perspective view of a first alternate
embodiment of an attachment means for the implant of FIG. 1.
[0040] FIG. 11 is a perspective view of a second alternate
embodiment of an attachment means for the implant of FIG. 1.
[0041] FIG. 12 is a perspective view of a third embodiment of an
implant for reducing the circumference of an anatomic orifice.
[0042] FIG. 13 is a perspective view of one end of the implant of
FIG. 12 showing an optional keyed relationship between three
coaxial cannulae to prevent relative rotation between the three
components.
[0043] FIG. 14 is a perspective view of the implant of FIG. 12
showing the outer cannula extended to cover the implant.
[0044] FIG. 15 is a perspective view of the implant of FIG. 12
showing the outer cannula retracted to expose the implant.
[0045] FIG. 16 is a perspective view of the implant of FIG. 12
showing the middle cannula extended to unfold the implant
[0046] 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.
[0047] 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.
[0048] FIG. 20 is a perspective view of the lower end of the
touchdown sensor of FIG. 19, showing the sensor in a compressed
condition.
[0049] FIG. 21 is a perspective end view of a fourth embodiment of
an implant for reducing the circumference of an anatomic
orifice.
[0050] FIG. 22 is a side view of the implant of FIG. 21 with the
implant opened up to show its full length.
[0051] FIG. 23 is a side view of the adjustment mechanism of the
implant of FIG. 21.
[0052] FIG. 24 is a close-up view of two of the retention barbs of
the implant of FIG. 21.
[0053] 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
[0054] FIG. 26 is a front view of the implant of FIG. 25, with the
implant shown in its contracted configuration.
[0055] 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.
[0056] 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.
[0057] 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.
[0058] FIG. 30 is a schematic view showing the implant of FIG. 29
implanted to reduce the circumference of the gastroesophageal
opening.
[0059] FIG. 31 is a schematic view of an embodiment of an
implantable device of the present invention.
[0060] FIG. 32A is a schematic view of another embodiment of an
implantable device of the present invention.
[0061] FIG. 32B is a schematic view of a threaded member in an
embodiment of an implantable device of the present invention.
[0062] FIG. 33 is a schematic view of an embodiment of an
implantable device of the present invention with an outer tubing
and an inner tubing in a relative first position.
[0063] FIG. 34 is a schematic view of an embodiment of an
implantable device of the present invention with an outer tubing
and an inner tubing in a relative second position.
[0064] FIG. 35 is a schematic view of an embodiment of an
implantable device of the present invention with an outer tubing
and an inner tubing in a relative third position.
[0065] FIG. 36 is a schematic view of an embodiment of an
adjustable member of the present invention, with the distal tip of
the adjustment tool coupled to the adjustment member.
[0066] FIG. 37 is a schematic view of an embodiment of an
adjustment member of the present invention having an integrated
pinion gear.
[0067] FIG. 38 is a schematic view of an embodiment of a flexible
tube cover for an implant device.
[0068] FIG. 39 is a cross-section view of an assembled embodiment
of an adjustable implant device.
[0069] FIG. 40 is a schematic view of an embodiment of a seal
jacket for an adjustable member.
[0070] FIG. 41 is a schematic view of an embodiment of an
adjustment band in the implantable member of the present
invention.
[0071] FIG. 42 is a disassembled schematic view of part of the
adjustment band and adjustment member of FIG. 41
[0072] FIG. 43 is an assembled view of the adjustment band and
adjustment member of FIG. 42.
[0073] FIG. 44 is a schematic view of an embodiment of the gearbox
for the adjustment band of FIG. 41.
[0074] FIG. 45 is a schematic view of an embodiment of the
implantable device of the present invention with a sliding band
that can be opened and closed to effect a preferential shape
change.
[0075] FIG. 46 is a schematic view of an embodiment of the
implantable device of the present invention with two adjustable
screws used to achieve different pulling rates.
[0076] FIG. 47 is a schematic view of an embodiment of the
implantable device of the present invention with reciprocating
motion and a clover gear.
[0077] FIG. 48 is a schematic view of an embodiment of the
implantable device system of the present invention with an
adjustment tool having high column strength and stiffness.
[0078] FIG. 49 is a schematic view of an embodiment of the
implantable device of the present invention shown in vivo with an
adjustment tool having reduced column stiffness.
[0079] FIG. 50 is a cut-away view of an embodiment of the proximal
portion of an adjustment tool.
[0080] FIG. 51 is a schematic view of an embodiment of the
implantable device of the present invention with an articulated
shape.
DETAILED DESCRIPTION OF THE INVENTION
[0081] 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 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.
[0082] 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.
[0083] 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. 4, 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.
[0084] 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.
[0085] 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.
[0086] 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.
[0087] 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.
[0088] 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 230 to move
with respect to the second band 245 to adjust the circumference of
an implant.
[0089] 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 band 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.
[0090] 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.
[0091] 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.
[0092] FIGS. 12-18 show another embodiment of a percutaneous
annuloplasty device according to the present invention, in which 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 605 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.
[0093] 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.
[0094] 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.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] 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 implant function and safety.
[0099] 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 employing 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.
[0100] 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.
[0101] 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 second geared 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 head 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 closed 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.
[0102] 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 hook 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 hooks 775 grasping the surrounding tissue
(much like barbed fish hooks). The terminal hooks 775 thus ensure
the seating of the implant 700 into the surrounding tissue.
[0103] 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 head 850. The first geared head 850 mates
with a second geared head 855. The second geared head 855 is
attached to an adjustment stem 860 which is machined to receive a
screwdriver-like adjustment element.
[0104] 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 performed 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.
[0105] 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 element 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.
[0106] 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.
[0107] 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.
[0108] Other embodiments of the adjustable implant and methods
according to the present invention include gastrointestinal
disorders such as gastro-esophageal 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.
[0109] 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.
[0110] 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.
[0111] In various embodiments according to the present invention,
the adjustment means may include a mechanism which may be threaded
or non-threaded, 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.
[0112] 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.
[0113] 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.
[0114] 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 glues or similar adhesives.
[0115] 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.
[0116] 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.
[0117] 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.
[0118] In alternate embodiments according to the present invention,
micromotor 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 micromotor arrays.
[0119] 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 site
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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] 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.
[0124] 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.
[0125] 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. 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.
[0126] 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.
[0127] 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.
[0128] In one embodiment of the present invention, illustrated in
FIG. 31, an implantable device system 1000 for controlling at least
the size or shape of an anatomical structure or lumen includes an
implantable device 1002 and an adjustment tool 1006. The anatomical
structure or lumen is an anatomic site with dysfunction that can be
relieved by the implantable device 1002 to change a size or shape
of the anatomic site.
[0129] The implantable device 1002, in one exemplary embodiment,
has a diameter no larger than 3.5 mm. In another embodiment the
implantable device 1002 is configured to have variable size
relative to its placement at an annulus of a heart valve. The
implantable device 1002 has an adjustable member 1004 configured to
adjust the dimensions of the implantable device 1002. In one
embodiment, the torqueable adjustment tool 1006 provides adjustment
of the dimensions of the implantable device 1002. The adjustable
member 1004, in some embodiments, may be oriented to receive the
adjustment tool from a direction generally perpendicular to the
primary plane defined by the implant device 1002. Such an
orientation is advantageous for intravenous access of the tool and
in situ adjustment of the implant device 1002. The implantable
device 1002 can have a configuration where there are different
pulling rates at different sections of the implantable device 1002.
The implantable device 1002 may optionally include a flexible tube
(1032, FIG. 38) and an outer fabric sheath (810, FIGS. 25 and 26),
which are not shown in the subsequent figures for clarity. The
outer fabric sheath can be sutured, stapled, clipped, coiled, or
otherwise affixed to anatomic tissue in a desired location.
Generally the desired location is considered to be the internal
surface of the area to be controlled, such as (for example) an
interior wall of an organ, artery, or other internal anatomic
passage. Also, while the implantable device 1002 is generally shown
in the subsequent figures to have a "D"-shaped configuration, it
should be understood that other shapes can be used in accordance
with embodiments of the present invention.
[0130] Still referring to FIG. 31, in certain embodiments, the
adjustment tool 1006 is at least partially hollow, and in one
specific embodiment at least 50% hollow. The adjustment tool 1006
may be an elongated tool, which has a proximal end and a distal end
releasably attached to the adjustable member 1004 of implantable
device 1002. The adjustment tool 1006 may extend from its distal
end coupled to the adjustable member 1004 to a control interface
(e.g., handle) at the proximal end located preferably outside of
the patient's body. The adjustment tool 1006, when coupled to the
adjustable member 1004 of implantable device 1002, can provide a
preferential shape change of the implantable device 1002 in planar
and non-planar directions. The adjustment tool 1006 can adjust the
implantable device 1002 in terms of narrowing or widening the
dimensions of the implantable device 1002.
[0131] FIG. 32A is a schematic of the implant device 1002 without
showing an optional flexible outer tube and fabric sheath. The
implantable device includes an adjustable member 1004 and
adjustable tube portions 1013a and 1013b, which slide within hollow
tube portions 1014a and 1014b, and retaining tube 1015. FIG. 32B is
a schematic of a disassembled portion of implantable device 1002
with retaining tube 1015 removed. As shown in FIG. 32B, in various
embodiments, the implantable device 1002 includes a threaded rod
1008 threaded with right-hand helical grooves 1010 and left-hand
helical grooves 1012. Other embodiments may include a threaded rod
1008 with helical grooves in a single direction (e.g., all
right-hand grooves or all left-hand grooves). Threaded rod 1008 may
be a rigid material such as titanium, stainless steel, or a
polymer. Adjustable tube portions 1013a and 1013b enclose at least
a portion of grooves 1010 and 1012 so that pins 1016a, 1016b or
protuberances on the inside diameter of the adjustable tube
portions 1013a, 1013b are engaged by the grooves 1010 and 1012,
respectively. In other embodiments, pins 1016a, 1016b may be
replaced by threads along the inside diameter of the adjustable
tube portions 1013a, 1013b. Helical grooves 1010 and 1012 may be
single channels or multiple channels to engage single pins 1016a,
1016b or multiple pins. Hollow tube portions 1014a, 1014b are
relatively rigid to maintain curvature of the adjustable tube
portions 1013a, 1013b regardless of the adjustment position.
[0132] The implantable device 1002 can have a coating including,
but not limited to, heparin, and antibiotic, collagen, and an agent
that promotes tissue in growth, PGLA, a de-calcification agent and
the like. The implantable device 1002 can be made of a variety of
materials including, but not limited to, a shape memory alloy
(SMA), a shape memory polymer (SMP), titanium, stainless steel,
polymer, a suture-based material, a biological material and the
like.
[0133] In another embodiment of the present invention, illustrated
in FIGS. 33 through 37, the adjustable member 1004 provides
translated motion through rotation. FIGS. 33 through 35 illustrate
a theory of operation of an embodiment of the present invention,
while FIGS. 36 and 37 shown details of the adjustment member
1004.
[0134] Referring to now FIG. 33, adjustable member 1004 of
implantable device 1102 is shown including a docking port 1021 to
receive the distal tip of the adjustment tool 1006 (FIG. 31). In
this embodiment, implant device includes a set of inner tubing
1028a, 1028b and a set of outer tubing 1026a, 1026b that can move
relative to each other. The ends of the inner tubing 1028a, 1028b
that do not engage the outer tubing 1026a, 1026b are secured to a
set of hollow tubing 1014a, 1014b so that the inner tubing 1028a,
1028b does not move relative to the hollow tubing 1014a, 1014b.
Although hollow tube portions 1014a, 1014b may be separate pieces
that are permanently abutted when assembled, in some embodiments,
the hollow tube portions 1014a, 1014b may be formed from a single
tubing piece. An inner cable 1030 passes through the various
tubing. Thus, the rigidity of the hollow tubing can be used to
maintain the adjustable implant 1102 shape in certain dimensions so
that adjustment of the device can be restricted to a preferred
dimension, for example, an anterior-posterior dimension.
[0135] As shown in more detail in FIGS. 36 and 37, adjustable
member 1004 may also include a pinion gear 1022 (which may be
integral to a docking port 1021) and a crown gear 1024. FIG. 36
provides an isometric view of the adjustable member 1004, and FIG.
37 provides a cut-away view of the adjustable member 1004. As can
be seen in the figures, the pinion gear 1022 engages the crown gear
1024. In some embodiments, the pinion gear 1022 may be eliminated
from adjustable member 1004, and the distal tip of the adjustment
tool 1006 may serve as the pinion gear when the tool is coupled to
the docking port 1021. When coupled to the docking port 1021, the
adjustment tool 1006 can rotate the pinion gear 1022.
[0136] Referring back to FIG. 33, the implantable device 1102 is
shown generally at the middle of its adjustment range. Outer tubing
1026a, 1026b is affixed to the adjustable member 1004 and extends
along a portion of the circumference of implantable device 1102.
Inner tubing 1028a, 1028b is affixed to hollow tubing 1014a, 1014b,
respectively. Similar to the single threaded rod 1008 of FIG. 32B,
threaded rods 1018a, 1018b sit inside the hollow tubing 1014a,
1014b and are threadedly engaged therewith. Threaded rods 1018a,
1018b may be a rigid material such as titanium, stainless steel, or
a polymer. Hollow tube portions 1014a, 1014b enclose the threaded
rods 1018a, 1018b such that rotation of the threaded rods 1018a,
1018b causes them to move axially within the hollow tube portions
1014a, 1014b. The threaded rod 1018a may have right-handed threads,
and the threaded rod 1018b may have left handed threads. Other
embodiments may include threaded rods 1018a, 1018b with threads in
a single direction (e.g., all right-hand grooves or all left-hand
threads).
[0137] The crown gear 1024, and one end of each threaded rod 1018a,
1018b are all attached to an inner cable 1030. Inner cable 1030 may
be a cable or tube of any material with sufficient flexibility to
conform to a shape of the implantable device 1102 while translating
torque. For example, suitable material for inner cable 1030 may
include titanium or stainless steel. As shown more clearly in FIGS.
36 and 37, the rotation of crown gear 1024 imparts rotation to
cable 1030 in the same direction.
[0138] Referring to FIG. 34, when the handle of adjustment tool
1006 (not shown in this figure) is rotated clockwise in docking
port 1021, it causes clockwise rotation of the pinion gear 1022 (in
FIG. 36). Rotation of the pinion gear 1022 in turn rotates crown
gear 1024. The rotation of crown gear 1024 causes rotation of inner
cable 1030, which imparts rotational movement to each threaded rod
1018a, 1018b. The rotation applied to the threaded rods 1018a,
1018b causes them to advance into their respective hollow tubing
1014a, 1014b in the directions A1, A2 shown. As shown in FIG. 34,
when threaded rods 1018a, 1018b advance toward the middle of the
hollow tubing 1014a, 1014b the overall circumference of the implant
device 1002 is reduced. Advancing the threaded rods 1018a, 1018b
drives the inner cable 1030 into the hollow tubing 1014a, 1014b.
Translation of inner cable 1030 into the hollow tubing 1014a, 1014b
causes the hollow tubing 1014a, 1014b to move towards adjustable
member 1004 in the direction B1 shown. Inner tubing 1028a, 1028b
slides into outer tubing 1026a, 1026b to accommodate movement of
the inner cable 1030.
[0139] Referring to FIG. 35, the handle of adjustment tool 1006
(not shown in this figure) is rotated counter-clockwise in docking
port 1021 to cause counter-clockwise rotation of the pinion gear
1022 (FIG. 36). Rotation of the pinion gear 1022, in turn rotates
crown gear 1024. The rotation of crown gear 1024 causes rotation of
inner cable 1030, which imparts rotational movement to each
threaded rod 1018a, 1018b. The rotation applied to the threaded
rods 1018a, 1018b causes them to begin to withdraw from their
respective hollow tubing 1014a, 1014b in the directions A2, A1
shown. As shown in FIG. 35, as threaded rods 1018a, 1018b withdraw
from the middle of the hollow tubing 1014a, 1014b the overall
circumference of the implant device 1002 is increased. Withdrawal
of the threaded rods 1018a, 1018b pushes the inner cable 1030 out
of the hollow tubing 1014a, 1014b. Translation of inner cable 1030
out of the hollow tubing 1014a, 1014b causes the hollow tubing
1014a, 1014b to move away from adjustable member 1004 in the
direction B2 shown. Inner tubing 1028a, 1028b telescopes out of
outer tubing 1026a, 1026b to accommodate movement of the inner
cable 1030.
[0140] The inner tubing 1028a, 1028b, the outer tubing 1026a,
1026b, and the hollow tubing 1014a, 1014b may be covered by a
flexible tube 1032, such as a silicone tube, shown in FIG. 38. In
one embodiment, outer flexible tube 1032 is provided with no seam
in the axial direction of the tube to allow for better tissue
ingrowth after the implant procedure. In other embodiments inner
tubing 1028a, 1028b may be eliminated, as shown in FIG. 39.
[0141] FIG. 39 provides an assembled cross-section view of an
implantable device 1202 according to an embodiment of the
invention. The implant device includes the adjustable member 1004,
the outer tubing 1026a, 1026b, the hollow tubing 1014a, 1014b, the
inner cable 1030, and the threaded rods 1018a, 1018b as discussed
in relation to FIGS. 33-35. As shown in FIG. 39, hollow tubing
1014a, 1014b may extend further along the length of inner cable
1030 than shown in other embodiments of FIGS. 33-35 to better
maintain a preferred shape of the implant. Hollow tubing 1014a,
1014b may be threaded to receive the threaded rods 1018a, 1018b; or
hollow tubing may optionally include a threaded insert (spar 1019a,
1019b) affixed to the inner diameter of hollow tubing 1014a, 1014b.
In operation, as previously described, an adjustment tool may
impart motion to the adjustable member 1004. Gears in the
adjustable member translate motion to the inner cable 1030 that, in
turn translate motion to the attached threaded rods 1018a, 1018b.
Depending on the direction of rotation, rotation of threaded rods
1018a, 1018b causes the threaded rods 1018a, 1018b to be drawn
toward or away from the middle of the hollow tubing 1014a, 1014b,
thus reducing or increasing the overall circumference of the
implant device 1002. The flexible outer tube 1032 and a seal jacket
1100 (also shown in FIG. 40) encapsulate the device so that no
moving parts are exposed. The flexible outer tube 1032 provide
sufficient rigidity to maintain a generally planar dimension, while
allowing the device to adjust shape generally in a preferred
dimension, such as the anterior-posterior dimension. As shown in
FIG. 39, the flexible outer tube 1032 may be further covered by an
outer fabric sheath 1110 or thin sewing cuff. Elimination of the
inner tubing (1028a, 1028b of FIG. 35) eliminates the need for
telescoping parts and prevents the possibility of telescoping tubes
being sutured or clipped together during attachment of the
implant.
[0142] Referring to FIG. 40, the adjustable member 1004 can include
a seal jacket 1100. FIG. 40 shows an embodiment of the seal jacket
1100. The seal jacket 1100 may include a cover 1102 for the docking
port 1021 (FIG. 33) of the adjustable member 1004. The cover 1102
may be in the form of a slit septum, flaps, elastic material or the
like. The seal jacket cover 1102 may be included as part of a seal
jacket 1100 that covers the entire housing of the adjustable member
1004 or a separate piece. In one embodiment, the seal jacket 1100
may be secured to the flexible tube 1032. The seal jacket 1100 and
flexible tube 1032 may be secured by an adhesive bond, a wrap,
sutures, or the like. The cover 1102 provides access for an
adjustment tool to couple to the docking port, while reducing the
possibility of thrombus. In some embodiments, seal jacket cover
1102 and/or the seal jacket 1100 may be made of silicone, and
covered by a polyester sewing layer or fabric sheath (e.g., 1110 of
FIG. 39). In various embodiments, the seal jacket fits over the
housing of the adjustable member 1004 that includes a crown gear
coupled to a cable, can provide pinion access, and the like. In
operation, the distal tip of an adjustment tool passes through the
cover 1102 to engage the rotatable gear of adjustable member
1004.
[0143] FIG. 41 shows an embodiment of implantable device 1302
including a first adjustment band 1042a and a second adjustment
band 1042b. The first and second adjustment bands 1042a, 1042b can
be overlapped, and the amount of overlap is effected by how the
implantable device 1302 is sized. The first and second bands 1042a,
1042b can be slidable relative to each other. An adjustable member
1304 is coupled to the first band 1042a and the second band 1042b,
and pulls or pushes them toward or away from each other. The first
band 1042a and the second band 1042b can have flexible portions
1046a, 1046b configured to create a flexible zone at the primary
bend regions 1047a, 1047b. The flexible portions 1046a, 1046b can
have varying lengths and may also include one or more rigid
portions 1044. These rigid portions 1044 can include welded braids
or bands, or have a higher durometer material than the flexible
portions 1046a, 1046b. The flexible portions 1046a, 1046b and rigid
portions 1044 may be part of the same material as the first and
second bands 1042a, 1042b, or one or more portions may be separate
material that is joined to form continuous piece.
[0144] The first and second bands 1042a, 1042b can have different
sizes or the same sizes. In one specific embodiment, the first and
second bands 1042a, 1042b are about 0.5 to 3 mm in thickness and
about 5 to 10 mm in width. The first and second bands 1042a, 1042b
can be made of a variety of materials including, but not limited
to, an SMA, an SMP, titanium, stainless steel, polymer, a
suture-based material, a biological material and the like. In one
embodiment, the first and second bands 1042a, 1042b include a
plurality of band layers. At least a portion of the first and
second bands 1042a, 1042b may have superelastic properties. Implant
1302 may include a flexible, extruded outer layer (not shown) or
hollow tube, such as flexible tube 1032 of FIG. 38, to encase the
structure formed by the first and second bands 1042a, 1042b
flexible portions 1046a, 1046b, and rigid portions 1044. The parts
of the first and second bands 1042a, 1042b, that extend past
adjustable member 1304 can be contained within the hollow interior
of the outer layer.
[0145] FIG. 42 provides a more detailed schematic view of the
unassembled adjustment bands and adjustment member of FIG. 41. The
first and second bands 1042a, 1042b may include a series of
adjustment stops 1048. Adjustment stops may be in the form of
holes, detents, dimples, ridges, teeth, raised elements, other
mechanical features or the like. These holes 1048 on each of the
bands 1042a, 1042b are coupled to an adjustable member 1304. The
adjustable member 1304 may be generally cylindrical (such as a
spool) with a series of teeth 1050 or protrusions radially
positioned to engage the adjustment stops 1048. Adjustable member
1304 may also include a docking port 1320 to receive an adjustment
tool to trigger rotational movement of the adjustable member.
[0146] FIG. 43 provides an assembled view of the adjustment band
and adjustment member of FIG. 42. When mounted in a housing (not
shown in FIG. 43), the adjustable member 1304 may be mounted on an
axis to allow for rotational movement. The first and second bands
1042a, 1042b pass on either side of adjustable member 1304 so that
the teeth 1050 engage the adjustment stops 1048 in each of the
bands 1042a, 1042b. Rotating the adjustable member in turn tightens
or loosens the bands.
[0147] FIG. 44 is a cut-away view of an embodiment of the gearbox
for the adjustment band of FIG. 41. In this embodiment, the
adjustable member 1304 rests on a spring 1052 inside a housing 1040
for the adjustable member. The housing 1040 includes access and
guidance for the first and second bands (1042a, 1042b of FIG. 43)
to couple with the teeth 1050 of the adjustable member 1304. The
spring 1052 forces the adjustable member 1304 upward so that teeth
1056 on the top of the adjustable member 1304 engage with teeth
1058 on the inside upper surface of the housing 1040. Engagement of
the adjustable member teeth 1056 with the housing teeth 1058 locks
the adjustable member 1304 in place to prevent rotational movement.
Downward force, applied for example by an adjustment tool, against
the spring 1052 disengages the teeth 1056 and 1058 so that the
adjustable member 1304 can be rotated to adjust the size or shape
of implantable device 1302.
[0148] In another embodiment, FIG. 45 provides a schematic view of
an implantable device 1402 of the present invention with a
plurality of sliding bands that can be opened and closed to effect
a shape change. As with the previous embodiments of FIGS. 41-44,
the first and second bands 1042a, 1042b pass on either side of
adjustable member 1304 so that the teeth 1050 engage the adjustment
stops 1048 in each of the bands 1042a, 1042b. Additional bands
1042c may be incorporated to increase stiffness at different areas
of the implant device 1402 to provide preferential shape change.
The additional bands 1042c may be secured to the first and second
bands 1042a, 1042b using welds 1043, adhesive or other mechanical
techniques known in the art.
[0149] As illustrated in FIG. 46, in one embodiment, an implantable
device 1502 has an anterior portion 1060, a posterior portion 1062
and dual threads that provide preferential adjustment of one side
or the other of implantable device 1002. The implantable device
1502 has two independently adjustable threaded portions 1064a,
1064b used to achieve different pulling rates and/or lateral
dimensions. The adjustable threaded portions 1064a, 1064b can be
connected to one or more adjustable member 1004 of the implantable
device 1502 and positioned at either the posterior or anterior
portions of the implantable device 1502. In one embodiment, the
posterior portion 1062 may be a rigid member which includes
threaded hex screws 1066a, 1066b, internal threads or similar
structures. In one embodiment, the hex screws 1066a, 1066b are
attached in a manner that allows rotation of the hex screws so that
the threads may engage adjustable threaded portions 1064a, 1064b.
Rigid posterior portion 1062 may include one or more of adjustable
members 1004 that can receive a tool to impart rotational motion
through an inner tube or cable to one or more of hex screws 1066a,
1066b, as described above. Anterior portion 1060 may be a flexible
tube to accommodate shape change as the anterior and posterior
portions 1060, 1062 move relative to each other.
[0150] In another embodiment, differently pitched threads or other
mechanisms may be used to provide non-symmetrical shape change of
the implant device. For example, referring to FIG. 46, wider
threads on threaded portion 1064b, in relation to the threads of
threaded portion 1064a, would allow an adjustable member 1004 to
expand or contract the implant 1502 more rapidly on the side of
threaded portion 1064b to provide preferential shape change for a
selected region while using a single adjustable member.
[0151] FIG. 47 is a schematic view of an embodiment of an
adjustable member 1604 for an implantable device. An adjustment
tool may impart reciprocating motion to the adjustable member 1604
that includes a clover gear 1070 mounted in a housing 1072. The
inner cable 1030 (FIG. 33) of the implantable device, for example,
is affixed to the clover gear 1070 such that rotation of the clover
gear transmits torque through the inner cable 1030 to a screw or
other adjustable portion of the implantable device as previously
disclosed. In this embodiment, the adjustment tool can provide
reciprocating action to provide for adjustment. The adjustable
member takes an axial force applied to the control portion at the
proximal end of the adjustment tool and converts it to a rotational
force applied to the inner cable 1030 of the implantable device.
Reciprocating axial force may be provided from an adjustment tool
by using spring-mounted buttons pressed by the user. Pressing a
first button may transmit a downward axial motion to a first ribbon
1074 which engages the clover gear 1070 to cause clockwise rotation
of the clover gear 1070. A spring or other return force pushes the
first ribbon back to its original position after each click or
press of the button. Similarly, pressing a second button may
transmit a downward axial motion to a second ribbon 1076 that
engages the clover gear 1070 to cause counter-clockwise rotation of
the clover gear 1070.
[0152] In another embodiment, the adjustment tool provides coarse
adjustment and fine adjustment. This varied adjustment can be
achieved with the adjustment tool having screws with different
threads.
[0153] FIG. 48 provides a schematic view of an embodiment of the
implantable device system 1000 including an adjustment tool 1706
with high column strength and stiffness. The adjustment tool 1706
has a shaft 1794 and a handle 1096 with sufficient column strength
to ensure a downward axial force on the handle 1096 provides proper
engagement with the adjustable member 1004 of the implantable
device 1002. The handle 1096 may be a grip-like handle, as shown,
or a smaller pen-type handle. The adjustment tool 1706 can include
mechanical locking at the distal region 1782 to lock with the
adjustable member 1004. The mechanical locking is configured to
provide engagement and disengagement tactile feel to the
physician.
[0154] FIG. 49 is a schematic view of another embodiment of the
implantable device system 1000 including an adjustment tool 1806
with reduced column stiffness. The adjustment tool 1806 has a
handle 1096 a shaft 1080 with reduced column stiffness for greater
flexibility and easier articulation of the adjustment tool 1806.
The handle 1096 may be a grip-like handle, as shown, or a smaller
pen-type handle. The easier articulation offered by the this
embodiment may facilitate user positioning of the device in vivo
and clearing adjacent biological structures, particularly when it
is docketed to the adjustable member 1004 of the implant 1002.
Flexibility may be varied along the length of the adjustment tool
shaft 1080. Flexibility may be increased at the distal region 1082
of the adjustment tool shaft 1006, particularly in the region
immediately proximal to the gear/fitting at the distal tip of the
adjustment tool 1006. This gear/fitting is constrained orthogonally
to the adjustable member 1004, and it is important that the
adjustment tool 1006 be easy to insert/connect and remain clear of
biological structures.
[0155] FIG. 50 provides a view of an embodiment of the proximal end
of the adjustment tool 1006. Referring to FIG. 50, adjustment tool
1006 includes a flexible cable 1094 or similar structure that is
affixed to and rotates with a handle 1996. In other embodiments,
the adjustment tool 1006 can have cables, a band, tubes, rods, and
the like to impart rotational and/or axial motion from the proximal
end to the distal tip of the tool 1006. The flexible cable 1094 may
be enclosed by a flexible, low-friction cable jacket 1098 that
allows the cable 1094 to rotate freely within the jacket 1098. In
some embodiments, adjustment tool 1006 may also include a spring
release mechanism to allow disengagement of the distal tip of the
tool from the docking port 1021 (FIG. 33) with minimal force being
applied to the sutures (or other mechanisms) securing the implant
device to the tissue of an anatomic orifice or lumen. As shown in
FIG. 50, in some embodiments, an e-clip 1099 or similar device may
be used near the handle 1996 of the adjustment tool 1006 to secure
the release mechanism in the docking station until adjustments are
complete.
[0156] In one embodiment illustrated in FIG. 51, the adjustment
tool 1006 may be inserted inside a rigid sheath 1092 that reaches
the implantable device 1002. Thus, FIG. 51 is a schematic view of
an embodiment of the implantable device system 1000 of the present
invention with an articulated shape. The rigidness of the sheath
1092 provides the necessary column strength to support the flexible
adjustment tool 1006. An added benefit to this embodiment is that
the sheath may be left in place, docked to the implantable device
1002. The flexible adjustment tool 1006 may be removed and then
reinserted at some future time to engage with the adjustable member
1004 of implantable device 1002.
[0157] The adjustment tool 1006 can have a handle 1096 that can be
adjustable. The handle 1096 can have a length of at least 8 inches,
and in one embodiment at least 10 inches. Other embodiments may
have a shorter or longer handle length. The handle 1096 may be
thick to provide a hand-grip, or, in other embodiments, smaller to
provide a pen-like grip. The handle can have a device to quantify a
size change of the implantable device 1002. For example, a
half-turn of the adjustment tool handle can be correlated to a
distance of travel of the threaded rods 1018a, 1018b (FIG. 33) of
an implant 1002, thus allowing for measured adjustment of the
implant. The handle may include a click-counter or other known
device to measure rotational movement. In one embodiment, the
adjustment tool 1006 may be included in a percutaneous delivery
catheter.
[0158] A sensor, such as the touchdown sensor described in relation
to FIGS. 12-18 above, can be coupled to the implantable device
1002. A variety of different sensors can be utilized, including but
not limited to, sensors that measure pressure, temperature and flow
across the implantable device 1002. Pacing leads are coupled to the
sensor and the implantable device 1002, and in this embodiment, the
sensor is responsive to flow through the implantable device
1002.
[0159] In another embodiment the implantable device system may
include a micro-electromechanical motor system 1001 in conjunction
with or instead of a separate adjustment tool to commence
rotational movement in an adjustable member, see FIG. 31. Power and
control of the micro-electromechanical motor system can be provided
by electromagnetic radiation or through a direct wire connection
and previously described herein.
[0160] Finally, it will be understood that the preferred embodiment
has been disclosed by way of example, and that other modifications
may occur to those skilled in the art without departing from the
scope and spirit of the appended claims.
* * * * *