U.S. patent application number 10/611838 was filed with the patent office on 2004-04-29 for method and apparatus employing ultrasound energy to treat body sphincters.
Invention is credited to Schaer, Alan.
Application Number | 20040082859 10/611838 |
Document ID | / |
Family ID | 32110801 |
Filed Date | 2004-04-29 |
United States Patent
Application |
20040082859 |
Kind Code |
A1 |
Schaer, Alan |
April 29, 2004 |
Method and apparatus employing ultrasound energy to treat body
sphincters
Abstract
Methods and apparatus for treating gastroesophageal reflex and
other luminal conditions provide for delivering acoustic energy to
a body lumen to remodel tissue surrounding the body lumen. In the
case of treating GERD, a catheter carrying an ultrasonic or other
vibrational transducer is introduced to the lower esophageal
sphincter, and acoustic energy is delivered to the sphincter in
order to tighten or bulk the sphincter such that reflex is
reduced.
Inventors: |
Schaer, Alan; (San Jose,
CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Family ID: |
32110801 |
Appl. No.: |
10/611838 |
Filed: |
June 30, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60419317 |
Oct 16, 2002 |
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60393339 |
Jul 1, 2002 |
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Current U.S.
Class: |
600/459 ;
600/462 |
Current CPC
Class: |
A61N 2007/0043 20130101;
A61N 2007/0091 20130101; A61B 18/18 20130101; A61N 7/022 20130101;
A61B 17/2202 20130101; A61N 2007/003 20130101; A61B 8/4281
20130101; A61N 2007/0095 20130101; A61N 7/02 20130101; A61B 18/1815
20130101; A61N 2007/0065 20130101; A61N 2007/0078 20130101; A61N
2007/0082 20130101; A61B 18/1492 20130101; A61B 2017/0046 20130101;
A61B 18/20 20130101 |
Class at
Publication: |
600/459 ;
600/462 |
International
Class: |
A61B 008/14 |
Claims
What is claimed is:
1. A method for remodeling luminal tissue, said method comprising:
positioning a vibrational transducer at a target site in a body
lumen of a patient; and energizing the vibrational transducer to
produce acoustic energy under conditions selected to induce tissue
remodeling in at least a portion of the tissue circumferentially
surrounding the body lumen.
2. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least shrink the tissue.
3. A method as in claim 1, wherein the acoustic energy is produced
under conditions which reduces the compliance of the tissue in
either or both the radial and longitudinal directions.
4. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least induce collagen formation in the
tissue.
5. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least cause cavitation in the tissue.
6. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least interrupt nerve pathways in the
tissue.
7. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least interrupt the reception and/or
production of biochemicals in the tissue.
8. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least interrupt the ability of the tissue
to absorb food.
9. A method as in claim 1, wherein the acoustic energy is produced
under conditions which at least selectively destroy intestinal
metaplasia in the esophagus.
10. A method as in claim 1, wherein the transducer is energized to
produce acoustic energy in the range from 10 W/cm.sup.2 to 100
W/cm.sup.2.
11. A method as in claim 1, wherein the transducer is energized at
a duty cycle from 10% to 100%.
12. A method as in claim 1, wherein the transducer is energized
under conditions which heat the tissue to a temperature in the
range from 55.degree. C. to 95.degree. C.
13. A method as in claim 1, further comprising cooling the luminal
surface tissue while tissue beneath the surface is heated.
14. A method as in claim 1, wherein positioning the vibrational
transducer comprises introducing a catheter which carries the
transducer into the body lumen.
15. A method as in claim 14, wherein positioning further comprises
inflating a balloon in the catheter to at least partly engage the
luminal wall and locate the transducer at a pre-determined position
relative to the target site.
16. A method as in claim 15, wherein the transducer is inside the
balloon and inflating the balloon with an acoustically transmissive
material which centers the transducer within the lumen and enhances
transmission of the acoustic energy to the tissue.
17. A method as in claim 15, wherein the transducer is located
between a pair of axially spaced-apart balloons and inflating the
balloon centers the transducer within the lumen, further comprising
introducing an acoustically transmissive medium between the
balloons to enhance transmission of the acoustic energy to the
tissue.
18. A method as in claim 15, further comprising moving the
transducer relative to the balloon(s) in order to focus or scan the
acoustic energy axially on the luminal tissue surface.
19. A method as in claim 16, wherein the acoustically transmissive
medium is cooled to cool the luminal tissue surface.
20. A method as in claim 1, further comprising monitoring
temperature at the luminal tissue surface.
21. A method as in claim 1, further comprising monitoring
temperature below the luminal tissue surface.
22. A method as in claim 1, wherein energizing comprises focusing
the acoustic energy beneath the luminal tissue surface.
23. A method as in claim 1, wherein energizing comprises focusing
the acoustic energy at or just before the luminal tissue
surface.
24. A method as in claim 27, wherein the vibrational transducer
comprised a phased array.
25. A method as in claim 24, wherein the phased array is
selectively energized to focus the acoustic energy at one or more
desired locations in the tissue surrounding the body lumen.
26. A method as in claim 1, wherein positioning the vibrational
transducer comprises: introducing a cannula to the target site;
expanding a balloon on the cannula at the target site with an
acoustically transmissive medium; and selectively directing the
vibrational transducer within the balloon to remodel targeted
tissue.
27. A method as in claim 26, further comprising viewing the target
tissue through a scope in or on the cannula while directing the
vibrational transducer.
28. A method as in claim 26, wherein selectively directing
comprises deflecting and/or rotating a beam transducer.
29. A method as in claim 26, wherein selectively directing
comprises axially translating a circumferential array
transducer.
30. A method as in claim 26, wherein selectively directing
comprises everting the transducer to direct energy against tissue
surrounding an opening to the body lumen.
31. A method as in claim 30, wherein the balloon is expanded over
the entire opening.
32. A method as in claim 31, wherein the balloon is expanded over a
location adjacent to the opening.
33. A method as in claim 26, wherein selectively directing
comprises pivoting at least one transducer from a fixed location
within the balloon.
34. A method as in claim 33, further comprising deflecting at least
one additional transducer from a fixed location within the
balloon.
35. A method as in claim 26, wherein selectively directing
comprises expanding a second balloon disposed over the vibrational
transducer, wherein the second balloon may be axially translated
within the first balloon.
36. A method as in claim 1, wherein positioning the vibrational
transducer comprises: expanding a balloon over an opening at one
end of the body lumen; filling the end of the lumen over the
balloon with an acoustically transmissive medium; and positioning
the vibrational transducer within the medium to direct acoustic
energy at the luminal tissue.
37. A method as in claim 1, wherein positioning the transducer
comprises: capturing luminal tissue between opposed elements,
wherein the transducer is disposed on one of the elements; and
directing energy from the transducer into the captured tissue.
38. A method as in claim 37, wherein capturing comprises clamping
with movable elements.
39. A method as in claim 37, wherein capturing comprises applying a
vacuum to the tissue to draw said tissue between the opposed
elements.
40. A method as in claim 1, wherein the body lumen is the esophagus
and the patient suffers from gastroesophageal reflux disease
(GERD).
41. A method as in claim 40, wherein the acoustic energy remodels
the tissue surrounding a lower esophageal sphincter.
42. A method as in claim 1, wherein the body lumen is the stomach
and the patient suffers from a hiatal hernia.
43. A method as in claim 42, wherein the acoustic energy remodels
the tissue surrounding a diaphragmatic sphincter.
44. Apparatus for remodeling the lower esophageal sphincter, said
apparatus comprising: a catheter adapted to be esophageally
introduced to the lower esophageal sphincter (LES); and a
vibrational transducer on the catheter adapted to deliver acoustic
energy to the tissue of the LES in order to lessen gastroesophageal
reflux.
45. Apparatus as in claim 44, further comprising an inflatable
balloon on the catheter, wherein said balloon is adapted when
inflated to position the catheter within the LES so that the
transducer can deliver energy to the LES.
46. Apparatus as in claim 45 wherein the transducer is positioned
coaxially with the balloon.
47. Apparatus as in claim 45, further comprising means for
inflating the balloon with an acoustically transmissive medium.
48. Apparatus as in claim 45 wherein the transducer is positioned
between a pair of spaced-apart balloons.
49. Apparatus as in claim 44, further comprising means for
delivering an acoustically transmissive medium between the
balloons.
50. Apparatus as in claim 44, further comprising means for cooling
the acoustically transmissive medium.
51. Apparatus as in claim 44, further comprising means for
measuring temperature at or beneath the luminal wall.
52. Apparatus as in claim 44, further comprising means to axially
translate the transducer relative to the catheter.
53. Apparatus as in claim 44, wherein the transducer comprises a
phased array.
54. A system comprising: apparatus as in claim 44; and a cannula
having a channel for receiving and deploying the catheter.
55. A system as in claim 54, further comprising a viewing scope
which is part of or introducable through the cannula.
56. A system as in claim 54, wherein the cannula further comprises
an inflatable balloon over a distal end, wherein the catheter is
extendible from the cannula into the balloon when the balloon is
inflated.
57. A system as in claim 56, wherein the vibrational transducer on
the catheter is deflectable and/or rotatable and/or evertable
within the balloon when inflated.
58. A system as in claim 56, wherein the vibrational transducer on
the catheter comprises a circumferential array and is axially
translatable within the balloon when inflated.
59. A system as in claim 56, wherein the transducer is pivotally
mounted on the catheter.
60. A system as in claim 56, wherein the transducer is mounted on
at least one of a pair of spaced-apart elements on the catheter
configured to receive target tissue therebetween.
61. A system as in claim 60, wherein the spaced-apart elements are
movable to clamp tissue therebetween.
62. A system as in claim 60, wherein a vacuum source is disposed on
the catheter to selectively draw tissue into the space between the
spaced-apart elements.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a non-provisional of U.S. Patent
Application Serial No. 60/419,317 (Attorney Docket No.
021574-000210), filed Oct. 16, 2002, which contained the entire
content of prior Provisional Application No. 60/393,339 (Attorney
Docket No. 21574-000200), filed on Jul. 1, 2002, with additional
material added, the full disclosures of which are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] In a general sense, the invention is directed to systems and
methods for treating interior tissue regions of the body. More
specifically, the invention is directed to systems and methods for
treating dysfunction in body sphincters and adjoining tissue, e.g.,
in and around the lower esophageal sphincter and cardia of the
stomach.
[0004] 2. Description of the Background Art
[0005] The gastrointestinal (GI) tract extends from the mouth to
the anus, and includes the esophagus, stomach, small and large
intestines, and rectum. Along the way, ring-like muscle fibers
called sphincters control the passage of food from one specialized
portion of the GI tract to another. The GI tract is lined with a
mucosal layer about 1-2 mm thick that absorbs and secretes
substances involved in the digestion of food and protects the
body's own tissue from self-digestion. The esophagus is a muscular
tube that extends from the pharynx through the esophageal hiatus of
the diaphragm to the stomach. Peristalsis of the esophagus propels
food toward the stomach as well as clears any refluxed contents of
the stomach.
[0006] The junction of the esophagus with the stomach is controlled
by the lower esophageal sphincter (LES), a thickened circular ring
of smooth esophageal muscle. The LES straddles the squamocolumnar
junction, or z-line--a transition in esophageal tissue structure
that can be identified endoscopically. At rest, the LES maintains a
high-pressure zone between 10 and 30 mm Hg above intragastric
pressures. The LES relaxes before the esophagus contracts, and
allows food to pass through to the stomach. After food passes into
the stomach, the LES constricts to prevent the contents from
regurgitating into the esophagus. The resting tone of the LES is
maintained by muscular and nerve mechanisms, as well as different
reflex mechanisms, physiologic alterations, and ingested
substances. Transient LES relaxations may manifest independently of
swallowing. This relaxation is often associated with transient
gastroesophageal reflux in normal people. Muscular contractions of
the diaphragm around the esophageal hiatus during breathing serve
as a diaphragmatic sphincter that offers secondary augmentation of
lower esophageal sphincter pressure to prevent reflux.
[0007] The stomach stores, dissolves, and partially digests the
contents of a meal, then delivers this partially digested food
across the pyloric sphincter into the duodenum of the small
intestine in amounts optimal for maximal digestion and absorption.
Feelings of satiety are influenced by the vagally modulated muscle
tone of the stomach and duodenum as well as through the reception
and production of biochemicals (e.g., hormones) therein,
particularly the gastric antrum.
[0008] Finally, after passage of undigested food into the large
intestine, it is passed out of the body through the anal sphincter.
Fluids unused by the body are passed from the kidneys into the
bladder, where a urinary sphincter controls their release.
[0009] A variety of diseases and ailments arise from the
dysfunction of a sphincter. Dysfunction of the lower esophageal
sphincter, typically manifest through transient, relaxations, leads
to reflux of stomach acids into the esophagus. One of the primary
causes of the sphincter relaxations is believed to be aberrant
vagally-mediated nerve impulses to the LES and cardia (upper part
of the stomach). This condition, called Gastroesophageal Reflux
Disease (GERD), creates discomfort such as heartburn and with time
can begin to erode the lining of the esophagus--a condition that
can progress to esophagitis and a pre-cancerous condition known as
Barrett's Epithelium. Complications of the disease can progress to
difficulty and pain in swallowing, stricture, perforation and
bleeding, anemia, and weight loss. Dysfunction of the diaphragmatic
sphincter, such as that caused by a hiatal hernia, can compound the
problem of LES relaxations. It has been estimated that
approximately 7% of the adult population suffers from GERD on a
daily basis. The incidence of GERD increases markedly after the age
of 40, and it is not uncommon for patients experiencing symptoms to
wait years before seeking medical treatment.
[0010] Treatment of GERD includes drug therapy to reduce or block
stomach acid secretions, and/or increase LES pressure and
peristaltic motility of the esophagus. Most patients respond to
drug therapy, but it is palliative in that it does not cure the
underlying cause of sphincter dysfunction, and thus requires
lifelong dependence. Invasive abdominal surgical intervention has
been shown to be successful in improving sphincter competence. One
procedure, called Nissen fundoplication, entails invasive, open
abdominal surgery. The surgeon wraps the gastric fundis about the
lower esophagus, to, in effect, create a new "valve." Less invasive
laparoscopic techniques have also been successful in emulating the
Nissen fundoplication. As with other highly invasive procedures,
antireflux surgery is associated with the risk of complications
such as bleeding and perforation. In addition, a significant
proportion of individuals undergoing laparascopic fundoplication
report difficulty swallowing (dysphagia), inability to vomit or
belch, and abdominal distention.
[0011] In response to the surgical risks and drug dependency of
patients with GERD, new trans-oral endoscopic technologies are
being evaluated to improve or cure the disease. One approach is the
endoscopic creation and suturing of folds, or plications, in the
esophageal or gastric tissue in proximity to the LES, as described
by Swain, et al, [Abstract], Gastrointestinal Endoscopy, 1994;
40:AB35. Another approach, as described in U.S. Pat. No. 6,238,335,
is the delivery of biopolymer bulking agents into the muscle wall
of the esophagus. U.S. Pat. No. 6,112,123 describes RF energy
delivery to the esophageal wall via a conductive medium. Also, as
described in U.S. Pat. No. 6,056,744, RF energy has been delivered
to the esophageal wall via discrete penetrating needles. The result
is shrinkage of the tissue and interruption of vagal afferent
pathways some believe to play a role in the transient relaxations
of the LES.
[0012] The above endoscopic techniques all require the penetration
of the esophageal wall with a needle-like device, which entails the
additional risks of perforation or bleeding at the puncture sites.
Special care and training by the physician is required to avoid
patient injury. Use of the plication technique requires many
operational steps and over time sutures have been reported to come
loose and/or the tissue folds have diminished or disappeared.
Control of the amount and location of bulking agent delivery
remains an art form, and in some cases the agent has migrated from
its original location. RF delivery with needles requires careful
monitoring of impedance and temperature in the tissue to prevent
coagulation around the needle and associated rapid increases in
temperature. Lesion size is also limited by the needle size.
Limitations of the design require additional steps of rotating the
device to achieve additional lesions. Physicians have to be careful
not to move the device during each of the multiple one-minute
energy deliveries to ensure the needles do not tear the tissue.
[0013] Dysfunction of the anal sphincter leads to fecal
incontinence, the loss of voluntary control of the sphincter to
retain stool in the rectum. Fecal incontinence is frequently a
result of childbearing injuries or prior anorectal surgery. In most
patients, fecal incontinence is initially treated with conservative
measures, such as biofeedback training, alteration of the stool
consistency, and the use of colonic enemas or suppositories.
Biofeedback is successful in approximately two-thirds of patients
who retain some degree of rectal sensation and functioning of the
external anal sphincter. However, multiple sessions are often
necessary, and patients need to be highly motivated. Electronic
home biofeedback systems are available and may be helpful as
adjuvant therapy. Several surgical approaches to fecal incontinence
have been tried, with varying success, when conservative management
has failed. These treatments include sphincter repair, gracilis or
gluteus muscle transposition to reconstruct an artificial
sphincter, and sacral nerve root stimulation. The approach that is
used depends on the cause of the incontinence and the expertise of
the surgeon. Surgical interventions suffer from the same
disadvantages discussed above with respect to GERD. An RF needle
ablation device, similar in design to that described above for
treatment of GERD, has been described in WO/01/80723. Potential
device complications and use limitations are similar to those
described for GERD.
[0014] Dysfunction of the urinary sphincter leads to urinary
incontinence, the loss of voluntary control of the sphincter to
retain urine in the bladder. In women this is usually manifest as
stress urinary incontinence, where urine is leaked during coughing,
sneezing, laughing, or exercising. It occurs when muscles and
tissues in the pelvic floor are stretched and weakened during
normal life events such as childbirth, chronic straining, obesity,
and menopause. In men, urinary incontinence is usually a result of
pressure of an enlarged prostate against the bladder.
[0015] U.S. Pat. No. 6,073,052 describes a method of sphincter
treatment using a microwave antennae and specific time and
temperature ranges, and 6,321,121 a method of GERD treatment using
a non-specific energy source, with limited enabling specifications.
The use of ultrasound energy for circumferential heating of the
pulmonary vein to create electrical conduction block has been
described in U.S. Pat. No. 6,012,457 and U.S. Pat. No. 6,024,740.
The use of ultrasound for tumor treatments has been described in
U.S. Pat. No. 5,620,479.
[0016] In view of the foregoing, and notwithstanding the various
efforts exemplified in the prior art, there remains a need for a
more simple, rapid, minimally invasive approach to treating
sphincters that minimizes risk to the patient.
SUMMARY OF THE INVENTION
[0017] The present invention seeks to heat sphincter tissues using
ultrasound energy. The preferred method is to use ultrasound energy
to heat tissue and thus create necrotic regions (lesions) in the
tissue. The lesions tighten the tissue by shrinking it (through
dessication, protein denaturation, and disruption of collagen
bonds), and/or bulking it (with new collagen formation). The
lesions also prevent or delay opening of the sphincter by reducing
the compliance of the tissue in either or both the radial and
longitudinal directions as the sphincter is forced to expand and
shorten when the internal pressure increases. The lesions also
interrupt nerve pathways responsible for sphincter relaxations. In
general, during the heating process, the invention employs means to
minimize heat damage to the mucosal layer of the sphincter.
However, in the case of Barrett's Esophagus, selective heating of
the intestinal metaplasia on the luminal surface of the esophagus
is preferred. Ultrasound may also be used (continuously or in
pulsed mode) to create shock waves that cause mechanical disruption
through cavitation that create the desired tissue effects. While
this invention relates broadly to many tissue sphincters in the
body, the focus of the disclosure will be on the treatment of a
dysfunctional lower esophageal sphincter (LES) responsible for
GERD.
[0018] The key advantage of an ultrasound ablation system over
others is that a uniform annulus of tissue can be heated
simultaneously. Alternatively, the transducers can be designed so
that only user-defined precise regions of the circumference are
heated. Ultrasound also penetrates tissue deeper than RF or simple
thermal conduction, and therefore can be delivered with a more
uniform temperature profile. Thus lesions can be created at deeper
locations than could be safely achieved with RF needles puncturing
the tissue. Similarly, the deeper heating and uniform temperature
profile also allow for an improved ability to create a cooling
gradient at the surface. Relatively low power can be delivered over
relatively long durations to maximize tissue penetration but
minimize surface heating. If only surface heating is desired, as in
the case of Barrett's Esophagus, the acoustic energy can be focused
at or just before the tissue surface. Another means to selectively
heat the tissue surface is to place a material against the tissue,
between the tissue and the transducer, that selectively absorbs
acoustic energy and preferentially heats at the tissue interface. A
device using ultrasound for ablation may also be configured to
allow diagnostic imaging of the tissue to determine the proper
location for therapy and to monitor the lesion formation
process.
[0019] In a first specific aspect of the present invention, methods
for remodeling luminal tissue comprise positioning a vibrational
transducer at a target site in a body lumen of a patient. The
vibrational transducer is energized to produce acoustic energy
under conditions selected to induce tissue remodeling in at least a
portion of the tissue circumferentially surrounding the body lumen.
In particular, the tissue remodeling may be directed at or near the
luminal surface, but will more usually be directed at a location at
a depth beneath the luminal surface, typically from 1 mm to 10 mm,
more usually from 2 mm to 6 mm. In the case of Barrett's Esophagus,
the first 1 to 3 mm of tissue depth is to be remodeled. In the most
preferred cases, the tissue remodeling will be performed in a
generally uniform matter on a ring or region of tissue
circumferentially surrounding the body lumen, as described in more
detail below.
[0020] The acoustic energy will typically be ultrasonic energy
produced by electrically exciting an ultrasonic transducer which
may optionally be coupled to an ultrasonic horn, resonant
structure, or other additional mechanical structure which can focus
or enhance the vibrational acoustic energy. In an exemplary case,
the transducer is a phased array transducer capable of selectively
focusing and/or scanning energy circumferentially around the body
lumen.
[0021] The acoustic energy is produced under conditions which may
have one or more of a variety of biological effects. In many
instances, the acoustic energy will be produced under conditions
which cause shrinkage of the tissue, optionally by heating the
tissue and inducing shrinkage of the collagen. Alternatively or
additionally, the acoustic energy may be produced under conditions
which induce collagen formation in order to bulk or increase the
mass of tissue present. Such collagen formation may in some cases,
at least, result from cavitation or other injury-producing
application of the vibrational energy. Thus, under some conditions,
the vibrational energy will be produced under conditions which
cause cavitation within the tissues. Additionally, the acoustic
energy may be produced under conditions which interrupt nerve
pathways within the tissue, such as the vagal nerves as described
in more detail hereinafter. Add info here relating to treating
intestinal metaplasia, interruption of biochemical reception and
production, and prevention of food absorption.
[0022] Preferred ultrasonic transducers may be energized to produce
unfocused acoustic energy from the transducer surface in the range
from 10 W/cm.sup.2 to 100 W/cm.sup.2, usually from 30 W/cm.sup.2 to
70 W/cm.sup.2. The transducer will usually be energized at a duty
cycle in the range from 10% to 100%, more usually from 70% to 100%.
Focused ultrasound may have much higher energy densities, but will
typically use shorter exposure times and/or duty cycles. In the
case of heating the tissue, the transducer will usually be
energized under conditions which cause a temperature rise in the
tissue to a tissue temperature in the range from 55.degree. C. to
95.degree. C., usually from 60.degree. C. to 80.degree. C. In such
instances, it will usually be desirable to cool the luminal
surface, which is a mucosal surface in the case of the esophagus
which may treated by the present invention, in order to reduce the
risk of injury.
[0023] Usually, the vibrational transducer will be introduced to
the body lumen using a catheter which carries the transducer. In
certain specific embodiments, the transducer will be carried within
an inflatable balloon on the catheter, and the balloon when
inflated will at least partly engage the luminal wall in order to
locate the transducer at a pre-determined position relative to the
luminal target site. In a particular instance, the transducer is
disposed within the inflatable balloon, and the balloon is inflated
with an acoustically transmissive material so that the balloon will
both center the transducer and enhance transmission of acoustic
energy to the tissue. In an alternative embodiment, the transducer
may be located between a pair of axially spaced-apart balloons. In
such instances, when the balloons are inflated, the transducer is
centered within the lumen. Usually, an acoustically transmissive
medium is then introduced between the inflated balloons to enhance
transmission of the acoustic energy to the tissue. In any of these
instances, the methods of the present invention optionally comprise
moving the transducer relative to the balloons, typically in an
axially direction, in order to focus or scan the acoustic energy at
different locations on the luminal tissue surface.
[0024] In specific embodiments, the acoustically transmissive
medium may be cooled in order to enhance cooling of the luminal
tissue surface. Additionally, the methods may further comprise
monitoring temperature of the luminal tissue surface and/or at a
point beneath the luminal tissue surface.
[0025] In other specific examples, methods of the present invention
further comprise focusing acoustic energy beneath the luminal
tissue surface. Or in the case of Barrett's Esophagus, acoustic
energy is focused at or just before the luminal tissue surface. In
such instances, focusing may be achieved using a phased array (by
selectively energizing particular elements of the array) and the
tissue may be treated at various locations and various depths.
[0026] The methods as described above are particularly preferred
for treating patients suffering from gastroesophageal reflex
disease (GERD) where the acoustic energy remodels the tissue
surrounding a lower esophageal sphincter (LES). In other instances,
the methods of the present invention may be used to treat patients
suffering hiatal hernias, where the acoustic energy is directed at
tissue surrounding a diaphragmatic sphincter above the LES, to
treat the anal sphincter for incontinent patients, to remodel
tissues of the bladder neck and surrounding endopelvic fascia for
urinary stress incontinence, etc. Further, the methods of the
present invention can be used to induce feelings of satiety in
obese patients, where acoustic energy is delivered to regions of
the stomach and small intestine to interrupt or modify vagal
mediation of muscle tone, or to block or modify the reception and
production of biochemicals that affect satiety. The acoustic energy
may also be used to selectively necrose or shrink tissue in the
pylorus to delay gastric emptying and prolong the sensation of
fullness. Acoustic energy may also be used to render regions of
tissue unable to absorb food.
[0027] The methods of the present invention may further comprise
introducing a cannula to the target site, expanding a balloon on
the cannula at the target site with an acoustically transmissive
medium, and selectively directing the vibrational transducer within
the balloon to remodel targeted tissue. The balloon can provide a
relatively large working space and optionally can seal an opening
to the body lumen, such as to the esophagus. Optionally, a viewing
scope or other viewing means can be introduced into the balloon on
the cannula to allow visualization of the tissue being treated. In
such cases, the acoustically transmissive medium should also be
transparent. Within the inflated balloon, the transducer on the
catheter may be manipulated in a variety of ways, including
deflecting, rotating, everting, and the like, in order to direct
the vibrational energy precisely where desired. Alternatively or
additionally, phased array and other circumferential array
transducers may be axially translated to otherwise selectively
positioned to achieve a desired therapy. When used at the end of
the esophagus or at another opening to a body lumen, the balloon on
the cannula may be expanded to cover the entire opening or
alternatively may be expanded over a location adjacent to the
opening.
[0028] In other embodiments, directing the transducer may comprise
selectively pivoting at least one transducer from a fixed location
on the catheter or otherwise within the balloon, optionally
comprising deflecting at least two catheters from spaced-apart
locations. In such cases, the two transducers may be used together
in order to focus energy at particular location(s) within the
target tissue.
[0029] In yet another aspect of the present invention, positioning
the transducer may comprise capturing luminal tissue between
opposed elements on the catheter where the transducer is disposed
on at least one of the elements. The energy may then be directed
from the transducer into the captured tissue. Capturing may
comprise clamping the tissue between moveable elements and/or
applying a vacuum to the tissue to draw tissue between the opposed
elements.
[0030] The present invention still further comprises apparatus for
remodeling the lower esophageal sphincter. Such apparatus comprise
a catheter or probe adapted to be esophageally introduced to the
lower esophageal sphincter and a vibrational transducer on the
catheter. The transducer is adapted to deliver acoustic energy to
the tissue of the LES in order to lessen gastroesophageal reflux.
Apparatus for treating other sphincters may also be provided for
certain sphincters such as the anal sphincter. The apparatus may
comprise a more rigid probe instead of a highly flexible
catheter.
[0031] Specific apparatus constructions include providing an
inflatable balloon on the catheter, where the balloon is adapted
when inflated to position the catheter within the LES so that the
transducer can deliver energy to the LES. The transducer is usually
positioned coaxially within the balloon, and means may be provided
for inflating the balloon with an acoustically transmissive
medium.
[0032] Alternatively, the transducer may be positioned between a
pair of axially-spaced-apart balloons, where the apparatus will
typically further comprise means for delivering an acoustically
transmissive medium between the balloons. In all instances, the
apparatus may further comprise means for cooling the acoustically
transmissive medium, and means for axially translating the
transducer relative to the catheter. In certain specific examples,
the transducer comprises a phased array transducer.
[0033] The present invention may further comprise systems including
apparatus as set forth above in combination with a cannula having a
channel for receiving and deploying the catheter of the apparatus.
Usually, the systems will further include a viewing scope or other
imaging component which is either part of the cannula or
introducable through the cannula.
[0034] In preferred embodiments, the cannula further comprises an
inflatable balloon formed over a distal end thereof, where the
catheter is extendable from the cannula into the balloon when the
balloon is inflated. In such embodiments, the vibrational
transducer on the catheter is preferably deflectable, rotatable,
and/or evertable within the balloon when inflated to allow a high
degree of selective positioning of the transducer. Alternatively,
the vibrational transducer may comprise a circumferential array
which is axially translatable or otherwise positionable on the
catheter when the balloon is inflated. Still further optionally,
the transducer(s) may comprise pivotally mounted transducers on the
catheter to permit separate or focused positioning of the
transducers. Still further alternatively, the transducer(s) may be
mounted on a pair of spaced-apart elements on the catheter, where
the elements are configured to receive target tissue therebetween.
Usually, the elements will be movable to clamp tissue therebetween
and/or a vacuum source will be provided on the catheter to
selectively draw tissue into the space between the spaced-apart
elements.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG. 1 is an illustration of the tissue structures
comprising the esophagus and stomach.
[0036] FIG. 2 is an Ultrasound Ablation System for GERD
Treatment.
[0037] FIG. 3 is an Ultrasound Ablation Catheter.
[0038] FIG. 4a illustrates the diagnostic endoscopic procedure used
to identify the target treatment area.
[0039] FIG. 4b illustrates the delivery of the tissue treatment
apparatus.
[0040] FIG. 5 illustrates the positioning of the ultrasound
transducer and balloon at the region of the lower esophageal
sphincter.
[0041] FIG. 6 illustrates the positioning of the "rear-directed"
ultrasound transducer and balloon distal to the lower esophageal
sphincter for delivering energy to the inferior aspect of the lower
esophageal sphincter and the cardia.
[0042] FIG. 7 is a preferred pattern of completely circumferential
lesions.
[0043] FIG. 8 is a preferred pattern of groups of discrete lesions
formed in circumferential groups.
[0044] FIG. 9 is a cylindrical PZT material.
[0045] FIG. 10 is an annular array of flat panel transducers and
the acoustic output from the array.
[0046] FIG. 11 is isolated active sectors of a transducer formed by
isolating the plated regions.
[0047] FIG. 12 is a selective plating linked with continuous
plating ring.
[0048] FIG. 13 is a cylindrical transducer with non-resonant
channels.
[0049] FIG. 14 is a cylindrical transducer with an eccentric
core.
[0050] FIG. 15 is a cylindrical transducer with curved
cross-section and resulting focal region of acoustic energy.
[0051] FIG. 16 is an illustration of acoustic output from conical
transducers.
[0052] FIG. 17 is a longitudinal array of cylindrical
transducers.
[0053] FIG. 18 is a transducer mounting configuration using metal
mounts.
[0054] FIG. 19 shows transducer geometry variations used to enhance
mounting integrity.
[0055] FIG. 20 is transducer plating variations used to enhance
mounting integrity.
[0056] FIG. 21 shows cooling flow through the catheter center
lumen, exiting the tip.
[0057] FIG. 22 shows cooling flow recirculating within the catheter
central lumen.
[0058] FIG. 23 shows cooling flow circulating within the
balloon.
[0059] FIG. 24 shows cooling flow circulating within a
lumen/balloon covering the transducer.
[0060] FIG. 25 shows cooling flow circulating between an inner and
an outer balloon.
[0061] FIG. 26 is an ultrasound ablation element bounded by tandem
occluding members.
[0062] FIG. 27 shows sector occlusion for targeted ablation and
cooling.
[0063] FIG. 28 shows thermocouples incorporated into proximally
slideable splines positioned over the outside of the balloon.
[0064] FIG. 29 shows thermocouples incorporated into splines fixed
to the shaft but tethered to the distal end with an elastic
member.
[0065] FIG. 30 shows thermocouples attached to the inside of the
balloon, aligned with the ultrasound transducer.
[0066] FIG. 31 shows thermocouples positioned on the outside of the
balloon, aligned with the ultrasound transducer, and routed across
the wall and through the inside of the balloon.
[0067] FIGS. 32a-32c show the use of a slit in the elastic
encapsulation of a thermocouple bonded to the outside of an elastic
balloon that allows the thermocouple to become exposed during
balloon inflation.
[0068] FIG. 33 shows thermocouples mounted on splines between two
occluding balloons and aligned with the transducer.
[0069] FIG. 34a is an Ultrasound Ablation System for GERD Treatment
that includes an ablation catheter with a tip controllable from a
member attached to the distal tip.
[0070] FIG. 34b is an Ultrasound Ablation System for GERD Treatment
that includes an ablation catheter with a tip optionally controlled
via an internal tensioning mechanism.
[0071] FIG. 35 illustrates the deployment of an overtube with
balloon over an endoscope.
[0072] FIG. 36 illustrates retraction of the endoscope within the
balloon of the overtube.
[0073] FIG. 37 illustrates inflation of the overtube balloon at the
region of the Lower Esophageal Sphincter (LES).
[0074] FIG. 38a illustrates advancement of the ablation catheter
out of the endoscope.
[0075] FIG. 38b illustrates manipulation of the tip of the ablation
catheter in order to direct the energy in a particular
direction.
[0076] FIG. 39 illustrates lesion formation from above the LES
using the preferred system.
[0077] FIG. 40 illustrates lesion formation from below the LES
using the preferred system.
[0078] FIG. 41 illustrates lesion formation during the forward
delivery of ultrasound from a transducer mounted on the tip of the
catheter.
[0079] FIG. 42 illustrates lesion formation using the preferred
catheter with one external pullwire routed through a second open
channel of the endoscope. A smaller, simper overtube balloon is
also used.
[0080] FIG. 43 illustrates lesion formation using a catheter
advanced through an endoscope channel. No overtube is used;
instead, a balloon is mounted on the catheter tip which inflates
outward from the tip of the shaft.
[0081] FIG. 44 illustrates lesion formation using a deflectable or
preshaped catheter advanced out on an endoscope channel. The
overtube has a member extending distally from the distal opening of
the overtube. The balloon is mounted at its distal end to the
distal end of the member. The member has one or more lumens for
fluid delivery and guide wire use.
[0082] FIG. 45 illustrates the deployment of an overtube having a
doughnut shaped balloon.
[0083] FIG. 46 illustrates the lesion formation from an ultrasound
ablation catheter positioned inside the doughnut shaped balloon of
the overtube.
[0084] FIG. 47 illustrates lesion formation from a catheter having
either or both distal and proximal ablation elements mounted within
a peanut shaped balloon.
[0085] FIGS. 48a-48d illustrate alternative means for changing the
orientation of the ultrasound transducer.
[0086] FIG. 49a illustrates lesion formation from an ablation
catheter while sealing the distal LES orifice with a balloon
catheter.
[0087] FIG. 49b illustrates lesion formation from an ablation
catheter while sealing the distal LES orifice with a balloon
catheter and sealing the esophagus proximal to the LES with a
balloon on an overtube.
[0088] FIG. 49c illustrates the use of a stasis valve between the
overtube and endoscope to prevent fluid from flowing out the lumen
between the two devices.
[0089] FIGS. 49d and 49e illustrate different embodiments of the
stasis valve mounted on the tip of the overtube.
[0090] FIG. 50 illustrates lesion formation from an ablation
catheter routed through 2 available channels in the endoscope while
sealing the distal LES orifice with a balloon catheter.
[0091] FIG. 51 illustrates lesion formation from an ablation
catheter having a membrane surrounding the transducer while a
balloon attached to the opposite side of the shaft forcing the
transducer against the tissue.
[0092] FIGS. 52a and 52b illustrate the use of an ablation device
that sucks tissue in the region of the LES into a chamber where
energy delivered into captured tissue.
[0093] FIGS. 53a and 53b illustrate the use of mechanical swivel
grips to draw tissue into and hold within an ablation chamber.
[0094] FIG. 53c illustrates the use of wire to press tissue into
and hold within an ablation chamber.
[0095] FIG. 53d illustrates the use of inflatable doughnuts to
press tissue into and hold within an ablation chamber.
DETAILED DESCRIPTION OF THE INVENTION
[0096] This Specification discloses various catheter-based systems
and methods for treating dysfunction of sphincters and adjoining
tissue regions in the body. The systems and methods are
particularly well suited for treating these dysfunctions in the
upper gastrointestinal tract, e.g., in the lower esophageal
sphincter (LES) and adjacent cardia of the stomach. For this
reason, the systems and methods will be described in this
context.
[0097] Still, it should be appreciated that the disclosed systems
and methods are applicable for use in treating other dysfunctions
elsewhere in the body, which are not necessarily sphincter-related.
For example, the various aspects of the invention have application
in procedures requiring treatment of hemorrhoids, or incontinence,
or restoring compliance to or otherwise tightening interior tissue
or muscle regions. The systems and methods that embody features of
the invention are also adaptable for use with systems and surgical
techniques that are not necessarily catheter-based.
[0098] In general, this disclosure relates to the ability of the
ultrasound to heat the tissue in order to cause it to acutely
shrink and tighten. It should also be noted that another
physiologic means by which the tissue may move inward after heating
is through the stimulation of new collagen growth during the
healing phase. Besides swelling the wall, it may also serve to
strengthen the wall. Further, by necrosing viable tissue, vagal
afferent pathways responsible for transient relaxations of the LES
are reduced or eliminated, leading to improved tonic contraction of
the LES.
[0099] For the purposes of stimulating collagen growth, it may be
sufficient to deliver shock waves to the tissue such that the
tissue matrix is mechanically disrupted (i.e, via cavitation), but
not necessarily heated. This is another means by which ultrasound
could be a more beneficial energy modality than others. The
ultrasound could be delivered in high-energy MHz pulses or through
lower energy kHz or "lithotriptic" levels.
[0100] As FIG. 1 shows, the esophagus 10 is an approximately 25 cm
long muscular tube that transports food from the mouth to the
stomach 12 using peristaltic contractions. Mucous is secreted from
the walls of the esophagus to lubricate the inner surface and allow
food to pass more easily.
[0101] The junction of the esophagus 10 with the stomach 12 is
controlled by the lower esophageal sphincter (LES) 18, a thickened
circular ring of smooth esophageal muscle. The LES straddles the
squamocolumnar junction, or z-line 14--a transition in esophageal
tissue structure that can be identified endoscopically. An upper
region of the stomach 12 that surrounds the LES 18 is referred to
as the cardia 20. After food passes into the stomach 12, the LES 18
constricts to prevent the contents from regurgitating into the
esophagus 10. Muscular contractions of the diaphragm 16 around the
esophageal hiatus 17 during breathing serve as a diaphragmatic
sphincter that offers secondary augmentation of lower esophageal
sphincter pressure to prevent reflux.
[0102] The LES 18 relaxes before the esophagus 10 contracts, and
allows food to pass through to the stomach 12. After food passes
into the stomach 12, the LES 18 constricts to prevent the contents
from regurgitating into the esophagus 10. The resting tone of the
LES 18 is maintained by muscular and nerve mechanisms, as well as
different reflex mechanisms, physiologic alterations, and ingested
substances. Transient LES relaxations may manifest independently of
swallowing. This relaxation is often associated with transient
gastroesophageal reflux in normal people.
[0103] Dysfunction of the LES 18, typically manifest through
transient relaxations, leads to reflux of stomach acids into the
esophagus 10. One of the primary causes of the sphincter
relaxations is believed to be aberrant vagally-mediated nerve
impulses to the LES 18 and cardia 20. This condition, called
Gastroesophageal Reflux Disease (GERD), creates discomfort such as
heartburn and other debilitating symptoms. Dysfunction of the
diaphragmatic sphincter (at the esophageal hiatus 17), such as that
caused by a hiatal hernia, can compound the problem of LES
relaxations.
[0104] It should be noted that the views of the esophagus and
stomach shown in FIG. 1 and elsewhere in the drawings are not
intended to be strictly accurate in an anatomic sense. The drawings
show the esophagus and stomach in somewhat diagrammatic form to
demonstrate the features of the invention.
[0105] As shown in FIG. 2, the present invention relates to an
ablation system 30 consisting of an ablation device 32 with an
acoustic energy delivery element (ultrasound transducer) 34 mounted
on the distal end of the catheter. The device is delivered
transorally to the region of the LES 18. The system 30 consists of
the following key components:
[0106] 1. A catheter shaft 36 with proximal hub 38 containing fluid
ports 40, electrical connectors 42, and optional central guidewire
lumen port 44.
[0107] 2. An ultrasound transducer 34 that produces acoustic energy
35 at the distal end of the catheter shaft 36
[0108] 3. An expandable balloon 46 operated with a syringe 48 used
to create a fluid chamber 50 that couples the acoustic energy 35 to
the tissue 60
[0109] 4. Temperature sensor(s) 52 in the zone of energy
delivery
[0110] 5. An energy generator 70 and connector cable(s) 72 for
driving the transducer and displaying temperature values
[0111] 6. A fluid pump 80 delivering cooling fluid 82.
[0112] As shown in FIG. 3, the preferred embodiment of the ablation
device consists of an ultrasound transducer 34 mounted within the
balloon 46 near the distal end of an elongated catheter shaft 36. A
proximal hub, or handle, 38 allows connections to the generator 70,
fluid pump 80, and balloon inflation syringe 48. In other
embodiments (not shown) the hub/handle 38 may provide a port for a
guidewire and an actuator for deflection or spline deployment. The
distal tip 39 is made of a soft, optionally preshaped, material
such as low durometer silicone or urethane to prevent tissue
trauma. The ultrasound transducer 34 is preferably made of a
cylindrical ceramic PZT material, but could be made of other
materials and geometric arrangements as are discussed in more
detail below. Depending on performance needs, the balloon 46 may
consist of a compliant material such as silicone or urethane, or a
more non-compliant material such as nylon or PET, or any other
material having a compliance range between the two. Temperature
sensors 52 are aligned with the beam of acoustic energy 35 where it
contacts the tissue. Various configurations of temperature
monitoring are discussed in more detail below. The catheter is
connected to an energy generator 70 that drives the transducer at a
specified frequency. The optimal frequency is dependent on the
transducer 34 used and is typically in the range of 7-10 MHz, but
could be 1-40 MHz. The frequency may be manually entered by the
user or automatically set by the generator 70 when the catheter is
connected, based on detection algorithms in the generator. The
front panel of the generator 70 displays power levels, delivery
duration, and temperatures from the catheter. A means of detecting
and displaying balloon inflation volume and/or pressure, and
cooling flow rate/pressure may also be incorporated into the
generator. Prior to ablation, the balloon 46 is inflated with a
fluid such as saline or water, or an acoustic coupling gel, until
it contacts the esophagus over a length exceeding the transducer
length. Cooling fluid 82 is used to minimize heat buildup in the
transducer and keep the mucosal surface temperatures in a safe
range. In the preferred embodiment shown, cooling fluid 82 is
circulated in through the balloon inflation lumen 51 and out
through the central lumen 53 using a fluid pump 80. As described
later, the circulation fluid may be routed through lumens different
than the balloon lumen, requiring a separate balloon inflation port
39. Also, it may be advantageous to irrigate the outer proximal
and/or distal end of the balloon to cool it and to ensure the
expulsion or air on the outer edges of the balloon that could
interfere with the coupling of the ultrasound into the tissue. The
path of this irrigating fluid could be from a lumen in the catheter
and out through ports proximal and/or distal to the balloon, or
from the inner lumen of a sheath placed over the outside of or
alongside the catheter shaft.
[0113] In other embodiments (not shown) of the catheter, the
central lumen 53 could allow passage of a guidewire (i.e., 0.035")
from a proximal port 44 out the distal tip 39 for atraumatic
placement into the body. Alternatively, a monorail guidewire
configuration could be used, where the catheter 30 rides on the
wire just on the tip section 39 distal to the transducer 34. A
central lumen with open tip configuration would also allow passage
of an endoscope for visualization during the procedure. The
catheter could also be fitted with a pull wire connected to a
proximal handle to allow deflection to aid in placement through the
mouth and down the esophagus. This could also allow deflection of
an endoscope in the central lumen. The balloon may also be designed
with a textured surface (i.e., adhesive bulbs or ribs) to prevent
movement in the inflated state. Finally, the catheter shaft or
balloon or both could be fitted with electrodes that allow pacing
and electrical signal recording within the esophagus.
[0114] The above ablation device 32 is configured as an elongated
catheter. Of course, depending on the sphincter being treated, the
ablation device may be configured as a probe, or a surgically
delivered instrument.
[0115] In use (see FIGS. 4a, 4b, 5 and 6), the patient lies awake
but sedated in a reclined or semi-reclined position. If used, the
physician inserts an esophageal introducer 92 through the throat
and partially into the esophagus 10. The introducer 92 is
pre-curved to follow the path from the mouth, through the pharynx,
and into the esophagus 10. The introducer 92 also includes a
mouthpiece 94, on which the patient bites to hold the introducer 92
in position. The introducer 92 provides an open, unobstructed path
into the esophagus 10 and prevents spontaneous gag reflexes during
the procedure.
[0116] The physician need not use the introducer 92. In this
instance, a simple mouthpiece 94, upon which the patient bites, is
used.
[0117] The physician preferably first conducts a diagnostic phase
of the procedure, to localize the site to be treated. As FIG. 4a
shows, a visualization device can be used for this purpose. The
visualization device can comprise an endoscope 96, or other
suitable visualizing mechanism, carried at the end of a flexible
catheter tube 98. The catheter tube 98 for the endoscope 96
includes measured markings 97 along its length. The markings 97
indicate the distance between a given location along the catheter
tube 98 and the endoscope 96.
[0118] The physician passes the catheter tube 98 through the
patient's mouth and pharynx, and into the esophagus 10, while
visualizing through the endoscope 96. Relating the alignment of the
markings 97 to the mouthpiece 94, the physician can gauge, in
either relative or absolute terms, the distance between the
patient's mouth and the endoscope 96 in the esophagus 10. When the
physician visualizes the desired treatment site (lower esophageal
sphincter 18 or cardia 20) with the endoscope 96, the physician
records the markings 97 that align with the mouthpiece 94.
[0119] The physician next begins the treatment phase of the
procedure. As shown in FIG. 4b, the physician passes the catheter
shaft 36 carrying the ultrasound transducer 34 through the
introducer 92. For the passage, the expandable balloon 46 is in its
collapsed condition. The physician can keep the endoscope 96
deployed for viewing the expansion and fit of the balloon 46 with
the tissue 60, either separately deployed in a side-by-side
relationship with the catheter shaft 36, or (as will be described
later) by deployment through a lumen in the catheter shaft 36 or
advancement of the catheter 32 through a lumen in the endoscope 96
itself and expansion of the balloon distal to the endoscope 96. If
there is not enough space for side-by-side deployment of the
endoscope 96, the physician deploys the endoscope 96 before and
after expansion of the balloon 46.
[0120] As illustrated in FIG. 4b, the catheter shaft 36 includes
measured markings 99 along its length. The measured markings 99
indicate the distance between a given location along the catheter
shaft 36 and the ultrasound transducer 34. The markings 99 on the
catheter shaft 36 correspond in spacing and scale with the measured
markings 97 along the endoscope catheter tube 98. The physician can
thereby relate the markings 99 on the catheter shaft 36 to gauge,
in either relative or absolute terms, the location of the
ultrasound transducer 34 inside the esophagus 10. When the markings
99 indicate that the ultrasound transducer 34 is at the desired
location (earlier visualized by the endoscope 96), the physician
stops passage of the ultrasound transducer 34. The ultrasound
transducer 34 is now located at the site targeted for
treatment.
[0121] In FIG. 5, the targeted site is shown to be the lower
esophageal sphincter 18. In FIG. 6, the targeted site is shown to
be the cardia 20 of the stomach 12.
[0122] Once located at the targeted site, the physician operates
the syringe 48 to convey fluid or coupling gel into the expandable
balloon 46. The balloon 46 expands to make intimate contact with
the mucosal surface, either with the sphincter (see FIG. 5) or the
cardia 20 (FIG. 6) over a length longer than where the acoustic
energy 35 impacts the tissue. The balloon is expanded to
temporarily dilate the lower esophageal sphincter 18 or cardia 20,
to remove some or all the folds normally present in the mucosal
surface, and to create a chamber 50 of fluid or gel through which
the acoustic energy 35 couples to the tissue 60. The expanded
balloon 46 also places the temperature sensors 52 in intimate
contact with the mucosal surface.
[0123] The physician commands the energy generator 70 to apply
electrical energy to the ultrasound transducer 34. The function of
the ultrasound transducer 34 is to then convert the electrical
energy to acoustic energy 35.
[0124] The energy heats the smooth muscle tissue below the mucosal
lining. The generator 70 displays temperatures sensed by the
temperature sensors 80 to monitor the application of energy. The
physician may choose to reduce the energy output of the generator
70 if the temperatures exceed predetermined thresholds. The
generator 70 may also automatically shutoff the power if
temperature sensors 80 or other sensors in the catheter exceed
safety limits.
[0125] Prior to energy delivery, it will most likely be necessary
for the physician to make use of a fluid pump 80 to deliver cooling
fluid 82 to keep the mucosal temperature below a safe threshold.
This is discussed in more detail later. The pump 80 may be
integrated into the generator unit 70 or operated as a separate
unit.
[0126] Preferably, for a region of the lower esophageal sphincter
18 or cardia 20, energy is applied to achieve tissue temperatures
in the smooth muscle tissue in the range of 55.degree. C. to
95.degree. C. In this way, lesions can typically be created at
depths ranging from one 1 mm below the mucosal surface to as far as
the outside wall of the esophagus 10. Typical acoustic energy
densities range 10 to 100 W/cm.sup.2 as measured at the transducer
surface. For focusing elements, the acoustic energy densities at
the focal point are much higher.
[0127] It is desirable that the lesions possess sufficient volume
to evoke tissue-healing processes accompanied by intervention of
fibroblasts, myofibroblasts, macrophages, and other cells. The
healing processes results in a contraction of tissue about the
lesion, to decrease its volume or otherwise alter its biomechanical
properties. Replacement of collagen by new collagen growth may also
serve to bulk the wall of the sphincter. The healing processes
naturally tighten the smooth muscle tissue in the sphincter 18 or
cardia 20. Ultrasound energy typically penetrates deeper than is
possibly by RF heating or thermal conduction alone.
[0128] With a full circumferential output of acoustic energy 35
from ultrasound transducer 34, it is possible to create a
completely circumferential lesion 100 in the tissue 60 of the LES
18. To create greater lesion density in a given targeted tissue
area, it is also desirable to create a pattern of multiple
circumferential lesions 102a spaced axially along the length of the
targeted treatment site in the LES 18 or cardia 20 (above and below
the z-line 14, as shown in FIG. 7. Preferably, a pattern of 4
circumferential lesions 102a is desired spaced 1 cm apart, with 2
above the z-line 14, and 2 below; however, the safe and effective
range may be just one or higher, depending on how the lesions form
and heal. As shown in FIG. 6, the use of a "rear directed"
ultrasound beam also allows treatment of the inferior aspect of the
LES 18 and the cardia 20.
[0129] To limit the amount of tissue ablated, and still achieve the
desired effect, it may be beneficial to spare and leave viable some
circumferential sections of the esophageal wall. To this end, the
ultrasound transducer 34 can be configured (embodiments of which
are discussed in detail below) to emit ultrasound in discrete
locations around the circumference. Various lesion patterns 102b
can be achieved. A preferred pattern (shown in FIG. 8 for the
esophagus 10) comprises several rings 104 of lesions 106 about 5 mm
apart, each ring 104 comprising preferably 8 (potential range 1-16)
lesions 106. For example, a preferred pattern 102b comprises six
rings 104, 3 above and 3 below the z-line 14, each with eight
lesions 106.
[0130] The physician can create a given ring pattern (either fully
circumferential lesions or discrete lesions spaced around the
circumference) 100 by expanding the balloon 46 with fluid or gel,
pumping fluid 82 to cool the mucosal tissue interface as necessary,
and delivering electrical energy from the generator 70 to produce
acoustic energy 35 to the tissue 90. The lesions in a given ring
(100 or 104) can be formed simultaneously with the same application
of energy, or one-by-one, or in a desired combination. Additional
rings of lesions can be created by advancing the ultrasound
transducer 34 axially, gauging the ring separation by the markings
99 on the catheter shaft 36. Other, more random or eccentric
patterns of lesions can be formed to achieve the desired density of
lesions within a given targeted site.
[0131] The catheter 32 can also be configured such that once the
balloon 46 is expanded in place, the distal shaft 36 upon which the
transducer 34 is mounted can be advanced axially within the balloon
46 that creates the fluid chamber 35, without changing the position
of the balloon 46. Preferably, the temperature sensor(s) 52 move
with the transducer 34 to maintain their position relative to the
energy beam 35.
[0132] The distal catheter shaft 36 can also be configured with
multiple ultrasound transducers 34 and temperature sensors 52 along
the distal axis in the fluid chamber 35 to allow multiple rings to
be formed simultaneously or in any desired combination. They can
also simply be formed one-by-one without having to adjust the axial
position of the catheter 32.
[0133] To achieve certain heating effects, it may be necessary to
utilize variations of the transducer, balloon, cooling system, and
temperature monitoring. For instance, in order to prevent ablation
of the mucosal lining of the esophagus 10, it may be necessary to
either (or both) focus the ultrasound under the surface, or
sufficiently cool the surface during energy delivery. To treat
Barrett's Esophagus, the ultrasound may be focused at or just
before the tissue surface. The balloon material, or an additional
material adjacent to the balloon between the tissue and the
transducer may be made of sufficient dimensions and acoustic
properties to selectively absorb energy at the tissue interface.
Materials having good acoustic absorption properties include
silicone and polyurethane rubbers, and oil suspensions. Increasing
the frequency of the transducer will also aid in confining acoustic
absorption at the surface. Temperature monitoring provides feedback
as to the how well the tissue is being heated and cooled.
[0134] The following sections describe various embodiments of the
ultrasound transducer 34 design, the mounting of the ultrasound
transducer 34, cooling configurations, and means of temperature
monitoring.
[0135] Ultrasound Transducer Design Configurations: In one
preferred embodiment, shown in FIG. 9, the transducer 34 is a
cylinder of PZT (i.e., PZT-4, PZT-8) material 130. The material is
plated on the inside and outside with a conductive metal, and poled
to "flip", or align, the dipoles in the PZT material 130 in a
radial direction. This plating 120 allows for even distribution of
an applied potential across the dipoles. It may also be necessary
to apply a "seed" layer (i.e., sputtered gold) to the PZT 130 prior
to plating to improve plating adhesion. The dipoles (and therefore
the wall of the material) stretch and contract as the applied
voltage is alternated. At or near the resonant frequency, acoustic
waves (energy) 35 emanate in the radial direction from the entire
circumference of the transducer. The length of the transducer can
be selected to ablate wide or narrow regions of tissue. The
cylinder is 5 mm long in best mode, but could be 2-20 mm long.
Inner diameter is a function of the shaft size on which the
transducer is mounted, typically ranging from 1 to 4 mm. The wall
thickness is a function of the desired frequency. An 8 MHz
transducer would require about a 0.011" thick wall.
[0136] In another embodiment of the transducer 34 design,
illustrated in FIG. 10, multiple strips 132 of PZT 130 or MEMS
(Micro Electro Mechanical Systems--Sensant, Inc., San Leandro,
Calif.) material are positioned around the circumference of the
shaft to allow the user to ablate selected sectors. The strips 132
generally have a rectangular cross section, but could have other
shapes. Multiple rows of strips could also be spaced axially along
the longitudinal axis of the device. By ablating specific regions,
the user may avoid collateral damage in sensitive areas, or ensure
that some spots of viable tissue remain around the circumference
after energy delivery. The strips 132 may be all connected in
parallel for simultaneous operation from one source, individually
wired for independent operation, or a combination such that some
strips are activated together from one wire connection, while the
others are activated from another common connection. In the latter
case, for example, where 8 strips are arranged around the
circumference, every other strip (every 90.degree.) could be
activated at once, with the remaining strips (90.degree. C. apart,
but 45.degree. C. from the previous strips) are activated at a
different time. Another potential benefit of this multi-strip
configuration is that simultaneous or phased operation of the
strips 132 could allow for regions of constructive interference
(focal regions 140) to enhance heating in certain regions around
the circumference, deeper in the tissue. Phasing algorithms could
be employed to enhance or "steer" the focal regions 140. Each strip
132 could also be formed as a curved x-section or be used in
combination with a focusing lens to deliver multiple focal heating
points 140 around the circumference.
[0137] The use of multiple strips 132 described above also allows
the possibility to use the strips for imaging. The same strips
could be used for imaging and ablation, or special strips mixed in
with the ablation strips could be used for imaging. The special
imaging strips may also be operated at a different frequency than
the ablation strips. Since special imaging strips use lower power
than ablation strips, they could be coated with special matching
layers on the inside and outside as necessary, or be fitted with
lensing material. The use of MEMs strips allows for designs where
higher resolution "cells" on the strips could be made for more
precise imaging. The MEMs design also allows for a mixture of
ablation and imaging cells on one strip. Phasing algorithms could
be employed to enhance the imaging.
[0138] In another embodiment of the transducer 34 design, shown in
FIG. 11, a single cylindrical transducer 34 as previously described
is subdivided into separate active longitudinal segments 134
arrayed around the circumference through the creation of discrete
regions of inner plating 124 and outer plating 126. To accomplish
this, longitudinal segments of the cylindrical PZT material 130
could be masked to isolate regions 127 from one another during the
plating process (and any seed treatment, as applicable). Masking
may be accomplished by applying wax, or by pressing a plastic
material against the PZT 130 surface to prevent plating adhesion.
Alternatively, the entire inner and outer surface could be plated
followed by selective removal of the plating (by machining,
grinding, sanding, etc.). The result is similar to that shown in
FIG. 10, with the primary difference being that the transducer is
not composed of multiple strips of PZT 130, but of one continuous
unit of PZT 130 that has different active zones electrically
isolated from one another. Ablating through all at once may provide
regions of constructive interference (focal regions 140) deeper in
the tissue. Phasing algorithms could also be employed to enhance
the focal regions 140.
[0139] As described above, this transducer 34 can also be wired and
controlled such that the user can ablate specific sectors, or
ablate through all simultaneously. Different wiring conventions may
be employed. Individual "+" and "-" leads may be applied to each
pair of inner 124 and outer 126 plated regions. Alternatively, a
common "ground" may be made by either shorting together all the
inner leads, or all the outer leads and then wiring the remaining
plated regions individually.
[0140] Similarly, it may only be necessary to mask (or remove) the
plating on either the inner 124 or the outer 126 layers. Continuous
plating on the inner region 124, for example, with one lead
extending from it, is essentially the same as shorting together the
individual sectors. However, there may be subtle performance
differences (either desirable or not) created when poling the
device with one plating surface continuous and the other
sectored.
[0141] In addition to the concept illustrated in FIG. 11, it may be
desirable to have a continuous plating ring 128 around either or
both ends of the transducer 34, as shown in FIG. 12 (continuous
plating shown on the proximal outer end only, with no
discontinuities on the inner plating). This arrangement could be on
either or both the inner and outer plating surface. This allows for
one wire connection to drive the given transducer surface at once
(the concept in FIG. 11 would require multiple wire
connections).
[0142] Another means to achieve discrete active sectors in a single
cylinder of PZT is to increase or decrease the wall thickness (from
the resonant wall thickness) to create non-resonant and therefore
inactive sectors. The entire inner and outer surface can be then
plated after machining. As illustrated in FIG. 13, channels 150 are
machined into the transducer to reduce the wall thickness from the
resonant value. As an example, if the desired resonant wall
thickness is 0.0110", the transducer can be machined into a
cylinder with a 0.0080" wall thickness and then have channels 150
machined to reduce the wall thickness to a non-resonant value
(i.e., 0.0090"). Thus, when the transducer 34 is driven at the
frequency that resonates the 0.0110" wall, the 0.0090" walls will
be non-resonant. Or the transducer 34 can be machined into a
cylinder with a 0.015" wall thickness, for example, and then have
selective regions machined to the desired resonant wall thickness
of, say, 0.0110". Some transducer PZT material is formed through an
injection molding or extrusion process. The PZT could then be
formed with the desired channels 150 without machining.
[0143] Another way to achieve the effect of a discrete zone of
resonance is to machine the cylinder such that the central core 160
is eccentric, as shown in FIG. 14. Thus different regions will have
different wall thicknesses and thus different resonant
frequencies.
[0144] It may be desirable to simply run one of the variable wall
thickness transducers illustrated above at a given resonant
frequency and allow the non-resonant walls be non-active. However,
this does not allow the user to vary which circumferential sector
is active. As a result, it may be desirable to also mask/remove the
plating in the configurations with variable wall thickness and wire
the sectors individually.
[0145] In another method of use, the user may gain control over
which circumferential sector is active by changing the resonant
frequency. Thus the transducer 34 could be machined (or molded or
extruded) to different wall thicknesses that resonate at different
frequencies. Thus, even if the plating 122 is continuous on each
inner 124 and outer 126 surface, the user can operate different
sectors at different frequencies. This is also the case for the
embodiment shown in FIG. 10 where the individual strips 132 could
be manufactured into different resonant thicknesses. There may be
additional advantages of ensuring different depths of heating of
different sectors by operating at different frequencies. Frequency
sweeping or phasing may also be desirable.
[0146] For the above transducer designs, longitudinal divisions are
discussed. It is conceivable that transverse or helical divisions
would also be desirable. Also, while the nature of the invention
relates to a cylindrical transducer, the general concepts of
creating discrete zones of resonance can also be applied to other
shapes (planar, curved, spherical, conical, etc.). There can also
be many different plating patterns or channel patterns that are
conceivable to achieve a particular energy output pattern or to
serve specific manufacturing needs.
[0147] Except where specifically mentioned, the above transducer
embodiments have a relatively uniform energy concentration as the
ultrasound propagates into the tissue. The following transducer
designs relate to configurations that focus the energy at some
depth. This is desirable to minimize the heating of the tissue at
the mucosal surface but create a lesion at some depth.
[0148] One means of focusing the energy is to apply a cover layer
"lens" 170 (not shown) to the surface of the transducer in a
geometry that causes focusing of the acoustic waves emanating from
the surface of the transducer 34. The lens 170 is commonly formed
out an acoustically transmissive epoxy that has a speed of sound
different than the PZT material 130 and/or surrounding coupling
medium. The lens 170 could be applied directly to the transducer,
or positioned some distance away from it. Between the lens 170 and
the transducer may be a coupling medium of water, gel, or similarly
non-attenuating material. The lens could be suspended over (around)
the transducer 34 within the balloon 46, or on the balloon
itself.
[0149] In another embodiment, the cylindrical transducer 34 can be
formed with a circular or parabolic cross section. As illustrated
in FIG. 15, this design allows the beam to have focal regions 140
and cause higher energy intensities within the wall of the
tissue.
[0150] In another embodiment shown in FIG. 16, angled strips or
angled rings (cones) allow forward and/or rear projection of
ultrasound (acoustic energy 35). Rearward projection of ultrasound
35 may be particularly useful to heat the underside of the LES 18
or cardia 20 when the transducer element 34 is positioned distal to
the LES 18. Each cone could also have a concave or convex shape, or
be used with a lensing material 170 to alter the beam shape. In
combination with opposing angled strips or cones (forward 192 and
rearward 194) the configuration allows for focal zones of heating
140.
[0151] In another embodiment, shown in FIG. 17, multiple rings
(cylinders) of PZT transducers 34 would be useful to allow the user
to change the ablation location without moving the catheter. This
also allows for regions of constructive/destructive interference
(focal regions 140) when run simultaneously. Anytime multiple
elements are used, the phase of the individual elements may be
varied to "steer" the most intense region of the beam in different
directions. Rings could also have a slight convex shape to enhance
the spread and overlap zones, or a concave shape to focus the beam
from each ring. Pairs of opposing cones or angled strips (described
above) could also be employed. Each ring could also be used in
combination with a lensing material 170 to achieve the same
goals.
[0152] Transducer Mounting: One particular challenge in designing
transducers that deliver significant power (approximately 10
acoustic watts per cm.sup.2 at the transducer surface, or greater)
is preventing the degradation of adhesives and other heat/vibration
sensitive materials in proximity to the transducer. If degradation
occurs, materials under or over the transducer can delaminate and
cause voids that negatively affect the acoustic coupling and
impedance of the transducer. In cases where air backing of the
transducer is used, material degradation can lead to fluid
infiltration into the air space that will compromise transducer
performance. Some methods of preventing degradation are described
below.
[0153] In FIG. 18, a preferred means of mounting the transducer 34
is to securely bond and seal (by welding or soldering) the
transducer to a metal mounting member 200 that extends beyond the
transducer edges. Adhesive attachments 202 can then be made between
the mounting member 200 extensions remote to the transducer 34
itself. The mounting member(s) can provide the offsets from the
underlying mounting structure 206 necessary to ensure air backing
between the transducer 34 and the underlying mounting structure
206. One example of this is shown in FIG. 18 where metal rings 200
are mounted under the ends of the transducer 34. The metal rings
200 could also be attached to the top edges of the transducer 34,
or to a plated end of the transducer. It may also be possible to
mechanically compress the metal rings against the transducer edges.
This could be accomplished through a swaging process or through the
use of a shape-memory material such as nitenol. It may also be
possible to use a single metal material under the transducer as the
mounting member 200 that has depressions (i.e. grooves, holes,
etc.) in the region under the transducer to ensure air backing. A
porous metal or polymer could also be placed under the transducer
34 (with the option of being in contact with the transducer) to
provide air backing.
[0154] In FIG. 19, another means of mounting the transducer 34 is
to form the transducer 34 such that non-resonating portions 210 of
the transducer 34 extend away from the central resonant section
212. The benefit is that the non-resonant regions 210 are integral
with the resonant regions 212, but will not significantly heat or
vibrate such that they can be safely attached to the underlying
mounting structure 206 with adhesives 202. This could be
accomplished by machining a transducer 34 such that the ends of the
transducer are thicker (or thinner) than the center, as shown in
FIG. 19.
[0155] As shown in FIG. 20, another option is to only plate the
regions of the transducer 34 where output is desired, or interrupt
the plating 122 such that there is no electrical conduction to the
mounted ends 214 (conductor wires connected only to the inner
plated regions).
[0156] The embodiments described in FIGS. 18-20 can also be
combined as necessary to optimize the mounting integrity and
transducer performance.
[0157] Cooling Design Configurations: Cooling flow may be necessary
to 1) Prevent the transducer temperature from rising to levels that
may impair performance, and 2) Prevent the mucosal lining of the
sphincter from heating to the point of irreversible damage. The
following embodiments describe the various means to meet these
requirements.
[0158] FIG. 21 shows cooling fluid 82 being passed through a
central lumen 53 and out the distal tip 37 to prevent heat buildup
in the transducer 34. The central column of fluid 82 serves as a
heat sink for the transducer 34.
[0159] FIG. 22 is similar to FIG. 21 except that the fluid 82 is
recirculated within the central lumen 53 (actually a composition of
two or more lumens), and not allowed to pass out the distal tip
37.
[0160] FIG. 23 (also shown a part of the preferred embodiment of
FIG. 2) shows the fluid circulation path involving the balloon
itself. The fluid enters through the balloon inflation lumen 51 and
exits through one or more ports 224 in the central lumen 53, and
then passes proximally out the central lumen 53. The advantage of
this embodiment is that the balloon 46 itself is kept cool, and
draws heat away from the mucosal lining of the sphincter. Pressure
of the recirculating fluid 82 would have to be controlled within a
tolerable range to keep the balloon 46 inflated the desired amount.
Conceivably, the central lumen 53 could be the balloon inflation
lumen, with the flow reversed with respect to that shown in FIG.
23. Similarly, the flow path does not necessarily require the exit
of fluid in the central lumen 53 pass under the transducer 34--
fluid 82 could return through a separate lumen located proximal to
the transducer.
[0161] In another embodiment (not shown), the balloon could be made
from a porous material that allowed the cooling fluid to exit
directly through the wall of the balloon. Examples of materials
used for the porous balloon include open cell foam, ePTFE, porous
urethane or silicone, or a polymeric balloon with laser-drilled
holes. It is also conceivable that if a conductive media, such as
saline is used for the cooling fluid, and a ground patch attached
to the patient, electrical RF energy from the outer plating of the
transducer could be allowed to pass into the tissues and out to the
ground patch, resulting in a combination of acoustic and RF heating
of the tissue.
[0162] FIG. 24 shows the encapsulation of the transducer 34 within
another lumen 240. This lumen 240 is optionally expandable, formed
from a compliant or non-compliant balloon material 242 inside the
outer balloon 46 (the lumen for inflating the outer balloon 46 is
not shown). This allows a substantial volume of fluid to be
recirculated within the lumen 240 without affecting the inflation
pressure/shape of the outer balloon 46 in contact with the
sphincter. Allowing a substantial inflation of this lumen decreases
the heat capacity of the fluid in the balloon in contact with the
sphincter and thus allows for more efficient cooling of the mucosal
lining. Fluid 82 could also be allowed to exit the distal tip. It
can also be imagined that a focusing lens material 170 previously
described could be placed on the inner or outer layer of the lumen
material 242 surrounding the transducer 34.
[0163] As is shown in FIG. 25, there can be an outer balloon 46
that allows circulation over the top of the inner balloon 242 to
ensure rapid cooling at the interface. To ensure flow between the
balloons, the inner balloon 242 can be inflated to a diameter less
than the outer balloon 46. Flow 82 may be returned proximally or
allowed to exit the distal tip. Another version of this embodiment
could make use of raised standoffs 250 (not shown) either on the
inside of the outer balloon 46 or the outside of the inner balloon
242, or both. The standoffs 250 could be raised bumps or splines.
The standoffs 250 could be formed in the balloon material itself,
from adhesive, or material placed between the balloons (i.e.,
plastic or metal mandrels). The standoffs 250 could be arranged
longitudinally or circumferentially, or both. While not shown in a
figure, it can be imagined that the outer balloon 46 shown in FIG.
25 may only need to encompass one side (i.e., the proximal end) of
the inner balloon, allowing sufficient surface area for heat
convection away from the primary (inner) balloon 242 that in this
case may be in contact with the tissue. In the case of treating
Barrett's Esophagus, the space between the two balloons may be
filled with an oil suspension or other fluidic or thixotropic
medium that has relatively high acoustic attenuation properties.
The medium does not necessarily need to recirculate. The intent is
that this space between the balloons will preferentially heat and
necrose the intestinal metaplasia lining the esophagus.
[0164] In another embodiment, illustrated in FIG. 26, occluding
members 260 are positioned proximal (260a) and distal (260b) to the
transducer element for occluding the sphincter lumen 270. The
occluding members 260 may also serve to dilate the sphincter region
to a desired level. The occluding members 260 are capable of being
expanded from a collapsed position (during catheter delivery) for
occlusion. Each occluding member 260 is preferably an inflatable
balloon, but could also be a self-expanding disk or foam material,
or a wire cage covered in a polymer, or combination thereof. To
deploy and withdraw a non-inflatable occluding member, either a
self-expanding material could be expanded and compressed when
deployed out and back in a sheath, or the occluding member could be
housed within a braided or other cage-like material that could be
alternatively cinched down or released using a pull mechanism
tethered to the proximal end of the catheter 30. It may also be
desirable for the occluding members 260 to have a "textured"
surface to prevent slippage of the device. For example, adhesive
spots could be applied to the outer surface of the balloon, or the
self-expanding foam could be fashioned with outer ribs.
[0165] With the occluding members 260 expanded against the
sphincter lumen, the chamber 278 formed between the balloons is
then filled with a fluid or gel 280 that allows the acoustic energy
35 to couple to the tissue 60. To prevent heat damage to the
mucosal lining ML of the tissue lumen 270, the fluid/gel 280 may be
chilled and/or recirculated. Thus with cooling, the lesion formed
within a target site T the tissue 60 is confined inside the tissue
wall and not formed at the inner surface. This cooling/coupling
fluid 280 may be routed into and out of the space between the
occluding members with single entry and exit port, or with a
plurality of ports. The ports can be configured (in number, size,
and orientation) such that optimal or selective cooling of the
mucosal surface is achieved. Note also that cooling/coupling fluid
280 routed over and/or under the transducer 34 helps keep the
transducer cool and help prevent degradation in performance.
[0166] The transducer element(s) 34 may be any of those previously
described. Output may be completely circumferential or applied at
select regions around the circumference. It is also conceivable
that other energy sources would work as well, including RF,
microwave, laser, and cryogenic sources.
[0167] In the case where only certain sectors of tissue around the
circumference are treated, it may be desirable to utilize another
embodiment, shown in FIG. 27, of the above embodiment shown in FIG.
26. In addition to occluding the proximal and distal ends, such a
design would use a material 290 to occlude regions of the chamber
278 formed between the distal and proximal occluding members 260.
This would, in effect, create separate chambers 279 around the
circumference between the distal and proximal occluding members
260, and allow for more controlled or greater degrees of cooling
where energy is applied. The material occluding the chamber could
be a compliant foam material or an inflatable balloon material
attached to the balloon and shaft. The transducer would be designed
to be active only where the chamber is not occluded.
[0168] Temperature Monitoring: The temperature at the interface
between the tissue and the balloon may be monitored using
thermocouples, thermistors, or optical temperature probes. Although
any one of these could be used, for the illustration of various
configurations below, only thermocouples will be discussed. The
following concepts could be employed to measure temperature.
[0169] In one embodiment shown in FIG. 28, one or more splines 302,
supporting one or more temperature sensors 52 per spline, run
longitudinally over the outside of the balloon 46. On each spline
302 are routed one or more thermocouple conductors (actually a pair
of wires) 306. The temperature sensor 52 is formed at the
electrical junction formed between each wire pair in the conductor
306. The thermocouple conductor wires 306 could be bonded straight
along the spline 302, or they could be wound or braided around the
spline 302, or they could be routed through a central lumen in the
spline 302.
[0170] At least one thermocouple sensor 52 aligned with the center
of the ultrasound beam 35 is desired, but a linear array of
thermocouple sensors 52 could also be formed to be sure at least
one sensor 52 in the array is measuring the hottest temperature.
Software in the generator 70 may be used to calculate and display
the hottest and/or coldest temperature in the array. The
thermocouple sensor 52 could be inside or flush with the spline
302; however, having the sensor formed in a bulb or prong on the
tissue-side of the spline 302 is preferred to ensure it is indented
into the tissue. It is also conceivable that a thermocouple placed
on a slideable needle could be used to penetrate the tissue and
measure the submucosal temperature.
[0171] Each spline 302 is preferably formed from a rigid material
for adequate tensile strength, with the sensors 52 attached to it.
Each individual spline 302 may also be formed from a braid of wires
or fibers, or a braid of the thermocouple conductor wires 306
themselves. The splines 302 preferably have a rectangular cross
section, but could also be round or oval in cross section. To
facilitate deployment and alignment, the splines 302 may be made
out a pre-shaped stainless steel or nitenol metal. One end of the
spline 302 would be fixed to the catheter tip 37, while the
proximal section would be slideable inside or alongside the
catheter shaft 36 to allow it to move with the balloon 46 as the
balloon inflates. The user may or may not be required to push the
splines 302 (connected to a proximal actuator, not shown) forward
to help them expand with the balloon 46.
[0172] The number of longitudinal splines could be anywhere from
one to eight. If the transducer 34 output is sectored, the splines
302 ideally align with the active transducer elements.
[0173] In a related embodiment, a braided cage (not shown) could be
substituted for the splines 302. The braided cage would be
expandable in a manner similar to the splines 302. The braided cage
could consist of any or a combination of the following: metal
elements for structural integrity (i.e., stainless steel, nitenol),
fibers (i.e., Dacron, Kevlar), and thermocouple conductor wires
306. The thermocouple sensors 52 could be bonded to or held within
the braid. For integrity of the braid, it may be desirable for the
thermocouple conductors 306 to continue distal to the thermocouple
junction (sensor) 52. The number structural elements in the braid
may be 4 to 24.
[0174] In another embodiment shown in FIG. 29, a design similar to
the embodiment above is used, except the distal end of the spline
302 is connected to a compliant band 304 that stretches over the
distal end of the balloon as the balloon inflates. The band 304 may
be formed out of a low durometer material such as silicone,
urethane, and the like. It may also be formed from a wound metal
spring. The spline 302 proximal to the balloon may then be fixed
within the catheter shaft 36. Of course the arrangement could be
reversed with the spline 302 attached to the distal end of the
balloon 46, and the compliant band 304 connected to the proximal
shaft 36.
[0175] In another embodiment shown in FIG. 30, the sensors 52 are
bonded with adhesive 308 to the inside of the balloon (in the path
of the ultrasound beam 35). The adhesive 308 used is ideally a
compliant material such as silicone or urethane if used with a
compliant balloon. It may also be a cyanoacrylate, epoxy, or UV
cured adhesive. The end of the conductor wire 306 at the location
of the sensor 52 is preferably shaped into a ring or barb or the
like to prevent the sensor from pulling out of the adhesive.
Multiple sensors 52 may be arranged both circumferentially and
longitudinally on the balloon 46 in the region of the ultrasound
beam 35. Thermocouple conductor wires 306 would have sufficient
slack inside the balloon 46 to expand as the balloon inflates.
[0176] In another embodiment (not shown), the thermocouple
conductor wires are routed longitudinally through the middle of the
balloon wall inside preformed channels.
[0177] In another embodiment shown in FIG. 31, the thermocouple
sensors 52 are bonded to the outside of the balloon 46, with the
conductor wires 306 routed through the wall of the balloon 46, in
the radial direction, to the inside of the balloon 46 and lumens in
the catheter shaft 36. The conductor wires 306 would have
sufficient slack inside the balloon to expand as the balloon
inflates. To achieve the wire routing, a small hole is punched in
the balloon material, the conductor wire routed through, and the
hole sealed with adhesive. The conductor wire could be coated in a
material that is bondable with the balloon (i.e., the balloon
material itself, or a compatible adhesive 308 as described for FIG.
30) prior to adhesive bonding to help ensure a reliable seal.
[0178] In another embodiment shown in FIGS. 32a-32c, the
thermocouple sensors 52 mounted on the outer surface of the balloon
(regardless of how the wires 306 are routed) are housed in raised
bulbs 310 of adhesive 308 (or a molded section of the balloon
material itself) that help ensure they are pushed into the tissue,
allowing more accurate tissue temperature measurement that is less
susceptible to the temperature gradient created by the fluid in the
balloon. For compliant balloons, a stiff exposed sensor 52 could be
housed in a bulb of compliant material with a split 312. As the
balloon 46 inflates, the split 312 in the bulb 210 opens and
exposes the sensor 52 to the tissue. As the balloon 46 deflates,
the bulb 310 closes back over the sensor 52 and protects it during
catheter manipulation in the body.
[0179] In another embodiment (not shown), an infrared sensor
pointed toward the heat zone at the balloon-tissue interface could
be configured inside the balloon to record temperatures in a
non-contact means.
[0180] For the embodiments described in either FIG. 26 or FIG. 27
above, it may also be desirable to monitor the temperature of the
tissue during energy delivery.
[0181] This would be best accomplished through the use of
thermocouples aligned with the ultrasound beam emanating from the
transducer. Each thermocouple would monitor the temperature of the
mucosal surface to ensure that the appropriate amount of power is
being delivered. Power can be decreased manually or though a
feedback control mechanism to prevent heat damage to the mucosa, or
the power can be increased to a predetermined safe mucosal
temperature rise to ensure adequate power is being delivered to the
submucosa.
[0182] As shown in FIG. 33, the thermocouple sensors 52 could be
mounted on splines 302 similar in design, construction, and
operation to those described previously. In this configuration, the
splines 302 are expanded against the tissue without the use of an
interior balloon. They are deployed before, during, or after the
occlusion members 260 are expanded. The braided cage configuration
described above may also be used.
[0183] In another embodiment (not shown), the splines 302 or
braided cage containing the thermocouple sensors 52 could span over
the top of either or both expandable occlusive members 260. If the
occlusive members 260 are balloons, the balloons act to expand the
cage outward and against the tissue. If the occlusive members 206
are made from a self-expanding foam or disk material, the cage can
be used to contain the occlusive material 206 during advancement of
the catheter by holding the individual components of the cage down
against the shaft under tension. Once positioned at the site of
interest, the cage can be manually expanded to allow the occlusive
members 260 to self-expand.
[0184] The direction of ultrasound delivery to this point has
mostly been described as moving radially into the tissues of the
esophagus, LES, and/or gastric cardia. Other system embodiments
described below may be employed to aid in using an ablation device
that delivers energy in a variety of directions into the tissue.
For example, the ablation device can be oriented such that the
energy is applied through the longitudinal axis of the sphincter
wall, as opposed to radially through the wall. This has the
advantage of preventing energy from passing through the outer wall
where surrounding structures, such as the vagal nerves, liver,
aorta, and mediastinum reside. In addition, longitudinal lesions
may help reduce the axial compliance of the sphincter, preventing
it from shortening and thus delaying how soon it opens as the
gastric pressure increases. The designs also lend themselves to use
of a planar or partial arc transducer that can be more reliably
fabricated into a thinner wall than a cylindrical (for
circumferential output) transducer. This allows for operation at
higher frequencies that increases energy attenuation in the tissue
and limits the depth of penetration of the ultrasound energy. In
this instance, radial direction of the energy is more feasible
without damage to collateral structures. Finally, particular
embodiments of this invention may make lesion formation in the
gastric cardia easier than is possible with a circumferential
system. Lesions created on the "underside" of the sphincter in the
region of the gastric cardia may help reduce the compliance of the
gastric sling fibers in this region. This may help delay opening of
the sphincter as the stomach expands due to increases in gastric
pressure. The region of the gastric cardia may also have more vagal
innervation responsible for transient relaxations of the sphincter;
the lesions would reduce this innervation.
[0185] As shown in FIG. 34a, the present invention relates to an
ablation system 400 consisting of an ablation catheter 32 with an
acoustic energy delivery element (ultrasound transducer) 34 mounted
on the distal end of the catheter. The device is delivered
transorally to the region of the LES 18. The system 400 consists of
the following key components:
[0186] 1. An overtube 500 having a balloon 502 attached to the
distal opening 503.
[0187] 2. An endoscope 96 having at least one therapeutic channel
518 greater than 2.8 mm.
[0188] 3. A catheter 32 having a shaft 36 and a proximal hub/handle
38 containing fluid ports 40, electrical connectors 42, and
optional central guidewire lumen port 44. The catheter also has an
ultrasound transducer 34 on a mounting 37 that produces acoustic
energy 35 at the distal end of the distal catheter shaft 520
[0189] 4. An energy generator 70 and connector cable(s) 72 for
driving the transducer and displaying temperature values
[0190] 5. A fluid pump 80 delivering cooling fluid 82.
[0191] FIG. 34b illustrates a similar system where the ablation
catheter 32 makes use of a transducer 34 designed to deliver
acoustic energy radially (either circumferentially or in one or
more discrete sectors) from the longitudinal axis. The catheter 32
can be moved with respect to the overtube balloon 502. The tip of
the catheter may also be deflectable from an actuator on the
proximal hub/handle 38.
[0192] While use of the catheter 32 through a channel in the
endoscope 96 is preferred, it is conceivable that the catheter 32
could be deployed through the overtube 500 without the use of the
endoscope 96.
[0193] The preferred method of ablation treatment is illustrated in
FIGS. 35-39. In FIG. 35, an overtube device 500 having a
peanut-shaped balloon 502 is preloaded over an endoscope 96. The
balloon 502 is preferably made of a compliant material such as
silicone or polyurethane, but could also be a material such as
polyethylene or PET. The wall thickness of the balloon is
preferably thicker in the middle of the "peanut" to limit the
degree of radial expansion compared to the proximal and distal
sections. Alternatively the middle of the balloon is simply blown
or molded to a smaller diameter. The tip of the overtube balloon
502 is fitted with a relatively rigid nipple-shaped dome 504 that
allows a snug fit with the tip of the endoscope. The dome 504 may
be an integral, thickened portion of the balloon itself, or a
separate component that the balloon is bonded to. It is conceivable
that to aid seating the endoscope 96 in the dome 504 and make later
release more reliable, the tip of the endoscope could be secured to
the dome with the aid of one of the available endoscope channels.
For instance, suction from a channel of the endoscope 96 could be
applied to hold the dome against the endoscope tip, or a screw or
barb or other grasping mechanism could be advanced through the
channel to secure the dome tip to the tip of the endoscope. Also,
vacuum may be applied to the balloon 502 using the lumen of the
overtube 500, or from a lumen of the endoscope 96, to fold the
balloon 502 down onto the endoscope. The proximal end of the
overtube 502 is fitted with appropriate stasis valves to prevent
leakage out the proximal end. The balloon 502 and/or the dome 504
should be transparent to allow visualization of tissue structures
through the balloon wall.
[0194] An optional embodiment (not shown) would be the use of a
vent tube alongside the overtube 500 and overtube balloon 520 to
allow air in the stomach to vent out of the patient. The tube could
be positioned completely separate from the overtube or advanced
through an optional lumen in the overtube, exiting just proximal to
the overtube balloon 520. The distal end of the vent tube would be
positioned in the stomach 20 distal to the overtube balloon 520.
The tube is preferably relatively stiff at the proximal end (for
push transmission), and floppy at the distal end so that it is
atraumatic and conforms well to the overtube balloon 520 as the
balloon entraps the vent tube against the tissue. While the inner
diameter of the vent tube needs to be only on the order of 0.005"
to vent air, larger inner diameters up to 0.042" may be used to
speed the aspiration of fluids or allow the passage of a guide wire
(for ease in placement). The wall thickness may be 0.003" to
0.010", preferably, 0.004". The wall of the tube may be a solid
material, or a composite of plastic and adhesives and/or stainless
steel or nitenol wires or Dacron fibers. The wall may consist of
stainless steel, nitenol, or a plastic such as polyurethane, pebax,
polyethylene, PET, polyimide, or PVC.
[0195] With the endoscope 96 seated in the dome 504 of the balloon
502, the overtube 500 and endoscope 96 are advanced down the
esophagus 10 to the region of the LES 18. As illustrated in FIG.
36, using endoscopy visualization, and retracting the endoscope as
necessary, the balloon is positioned so that the peanut shape
straddles the LES 18.
[0196] The balloon is then inflated with a fluid medium (water,
saline, contrast, etc.) as illustrated in FIG. 37. Inflation is
performed preferably through the lumen of the overtube, although an
available channel in the endoscope 96, or lumens in the ablation
catheter 32 may also be used. The shape of the balloon allows it to
conform to the contours of the esophagus at, and on either side of,
the LES. The shape also helps stabilize the balloon at the LES. The
balloon is inflated to a diameter that allows safe dilatation of
the folds in the esophagus. The nominal inflated diameter of the
proximal section 510 should be 20 mm, with a range of 15-30 mm. The
distal section 512 can be larger, nominally 40 mm and a range of
15-50 mm. Diameter may be assessed by fluid volume, pressure,
endoscopic visualization, or fluoroscopic visualization. The
balloon and the fluid inside form a "coupling chamber" that allows
ultrasound energy to be transmitted to the tissue from inside the
balloon. Addition of contrast to the fluid allows fluoroscopic
visualization of the shape and diameter.
[0197] With the balloon inflated, the distal shaft 520 of the
ablation catheter 32 is advanced out of the endoscope channel 518,
as shown in FIGS. 38a and 38b. Mounted on the distal shaft 520 is
an ultrasound transducer 34. The transducer 34 is preferably a
cylinder with only one segment of the circumference active. Other
transducers have been described in provisional patent application
60/393,339 and are incorporated by reference herein. An external
manipulation member (hereafter called pull wire) 530 is positioned
on the side of the distal shaft 520 opposite the active transducer
segment. The distal end of the pull wire 530 is attached to a hinge
(or weld-joint) 528 at the catheter tip, and the proximal end is
routed through a lumen orifice 532 in the distal catheter shaft 520
and out the proximal end of the catheter to an actuator on the
hub/handle 38. As the pull wire 530 is tensioned, a soft, kink
resistant section 522 of the distal shaft 520 forms a tight bend
that allows the transducer to be oriented at the desired angle
inside the balloon 502. Compression of the pull wire straightens
the distal shaft 520 and may also bend it in the opposite
direction. The endoscope and/or fluoroscope may be used to
determine the proper orientation of the transducer relative to the
tissue.
[0198] With the transducer 34 oriented towards the tissue, cooling
flow circulation is initiated as shown in FIG. 38b, to prevent
heating of the mucosa during subsequent energy delivery. Chilled
fluid 82 from the pump 80 is preferably routed through a lumen
under/behind the transducer, out the distal orifice 526 and back
through the proximal (to the transducer) orifice 524 to a separate
lumen returning to the pump 80 or other reservoir. Alternatively,
or in addition, chilled fluid may be circulated via the overtube
lumen or a lumen in the endoscope.
[0199] As shown in FIG. 39, energy from the generator 70 is applied
to the transducer 54, which creates a beam of acoustic energy 35
directed towards the LES tissue 18. The transducer frequency, power
level, and power duration are chosen to create a lesion 550a of a
desirable size. The catheter 32 may be torqued and the pullwire 530
adjusted to reorient the transducer to another location around the
circumference and/or the length of the LES region, where energy
delivery and lesion creation are repeated. Ideally, each lesion is
formed for about 5-10 mm down the axial length of the LES at a
radial depth of 3-8 mm. As shown in FIG. 40, the transducer can
also be directed towards the LES 18 from within the stomach 12.
Also, from the same position, the transducer can be oriented to
ablate the gastric cardia 20, just beyond the LES 18. Lesions in
the gastric cardia might be more effective in ablating vagal
afferent nerve fibers responsible for transient relaxations of the
LES and also reduce the compliance of the gastric sling fibers to
delay sphincter opening during gastric distension.
[0200] FIG. 41 shows another embodiment of the invention where the
transducer 34 is instead (or in addition to) positioned at the tip
of the ablation catheter to direct energy in the same direction as
the axis of the catheter.
[0201] FIG. 42 shows another embodiment where a smaller balloon
502' is fitted on the tip of the overtube 500 to contain the distal
portion of the ablation catheter 32. The distal end of the overtube
shaft 500 in this case is aligned with the distal end of the
endoscope 96 and may be deflected with the endoscope 96. Also as
shown in FIG. 42, the pull wire may be routed through a separate
channel of the endoscope (the wire would need to be back-loaded
through the endoscope before it is inserted into the overtube).
[0202] FIG. 43 shows another embodiment where the balloon 502" is
attached to the distal shaft 520 of the catheter 32, and no
overtube is used. The distal end of pull wire 530 may be attached
to the outside of the shaft proximal to the balloon, or fixed
inside the distal shaft.
[0203] FIG. 44 shows another embodiment of the overtube 500 where a
distal member 501 extends from the distal opening of the overtube
to the distal end of the balloon 502. The distal end of the balloon
502 is bonded to the distal end of the member 501. The member 501
may have one or more lumens to allow passage of a guide wire 400,
and for inflation/deflation of the balloon, and/or circulating
cooling fluid within the balloon. The distal opening of member 501
may also be used to vent air from the stomach. The endoscope 96
carrying catheter 32 may be advanced through the main channel of
the overtube 500 as described previously.
[0204] FIG. 45 shows another embodiment of the overtube 500
employing the use of a doughnut shaped balloon 502e attached to the
distal end of the overtube. The doughnut shape allows for a central
lumen in the balloon. This may be important to vent air from the
stomach 12 or allow passage of the endoscope distal to the balloon.
The doughnut shape also provides a good reference to the position
of the inferior LES when inflated in the stomach and pulled back
against the bottom of the LES.
[0205] FIG. 46 illustrates the use of the ablation catheter 32 with
the overtube having a doughnut shaped balloon. The distal end of
the ablation catheter 32 is advanced through the center of the
doughnut shaped balloon 502e. With the transducer 34 aligned in the
desired location, the ablation catheter balloon 46 is inflated
inside the overtube balloon 502e. With both the overtube balloon
and 502e and the ablation catheter balloon 46 filled with an
adequate coupling fluid (i.e., water), the ultrasound energy is
able to propagate relatively undamped until it reaches the tissue
of the LES 18 or gastric cardia 20. The fluid inside either or both
the overtube balloon 502e or the ablation catheter balloon 46 may
be recirculated and chilled to prevent overheating of the
transducer 34 or the mucosa. Conceivably, the overtube 500 could
have a window opening (not shown) proximal to the doughnut shaped
balloon 502e. This would allow the balloon 46 of the ablation
catheter to inflate out of the inner lumen of the overtube proximal
to the overtube balloon 502e.
[0206] FIG. 47 shows another embodiment where the peanut shaped
balloon 502 is mounted on the distal ablation catheter shaft 520,
and no overtube is used. The ablation catheter may or may not be
passed through an endoscope 96. If not passed through an endoscope,
an endoscope is advanced alongside the catheter shaft, or
positioned at the desired location and the distance noted before it
is removed and the ablation catheter inserted the same distance.
Transducers 34 are mounted on the distal shaft 520 under to balloon
at locations either or both distal and proximal to the LES 18 (the
sunken region of the peanut balloon 502). The transducers may be
hinged to the side of the shaft and at point 229, and hinged at the
other end 528 where a pull wire is attached. The pull wire 530 is
routed through the shaft 520 to an actuator on the proximal end of
the device. Push and pull of the pull wire 530 may allow swiveling
of the transducer to create lesions 551a-551d. The transducers may
also be driven simultaneously while angled to focus at an
intersection point within the wall of the LES 18.
[0207] Other embodiments focused on a means to change the angle of
the transducer are illustrated in FIGS. 48a-48d. In FIG. 48a, the
transducer is mounted on a shaft member 521, which is advanced out
of a lumen in the distal shaft 520 of the ablation catheter 32. The
shaft 521 may have a set curve or be deflectable with an internal
pull wire. It can be seated in a channel 525 in shaft 520 during
advancement and retraction. The transducer 34 can be uni- or
multidirectional. In FIG. 48b, the shaft 521 continues distal to
the transducer where it is fixed inside shaft 520. Pushing and
pulling on the proximal shaft 520 causes a prolapse proximal to the
transducer at a soft, kink-resistant point 523. In FIG. 48c, pull
wire 530 is attached to the proximal end of the transducer at hinge
528. The "pull wire" is pushed forward to increase the transducer
angle, and pulled back to reduce the angle. In FIG. 48d, the
transducer 34 is angulated by inflating a bladder 527 under the
transducer. A floppy tether 529 may be tensioned to fully seat the
transducer 34 and bladder 527 into groove 525 during insertion and
removal.
[0208] In another embodiment shown in FIG. 49a, an endoscope 96
with two available channels is advanced down the esophagus 10 to
the region of the LES 18. The distal shaft 520 of ablation catheter
is advanced out of one of the available channels of the endoscope
96 to the region of the LES 18 to be treated. Mounted on the distal
shaft 520 is an ultrasound transducer 34. The transducer 34 is
preferably mounted to deliver a beam of acoustic energy in the same
direction as the catheter's longitudinal axis, but could also be
designed to deliver energy at other angles to the axis. The
transducer is optionally surrounded distally by a coupling chamber
570, consisting of a rigid or flexible membrane 571 filled with an
acoustic coupling medium (e.g., water, saline, gel). The thickness
of the membrane 571 where the ultrasound energy passes is
preferably less than one-quarter the wavelength of the ultrasound
to prevent transmission loss. One or more temperature sensors 569
may be mounted on the tip of the membrane 571 in the path of the
ultrasound beam 35 to monitor temperature of the mucosa to prevent
overheating.
[0209] An occlusion balloon catheter 560 consisting of a catheter
shaft 561 and balloon 562 is advanced through another available
channel of the endoscope 96 and distal to the LES 18. The balloon
562 is inflated (with air or water via a lumen in the catheter,
exiting at port 563 inside the balloon) in the stomach 12 to a
diameter larger than the LES opening and then pulled back against
the LES to create a seal. Fluid 565 (e.g., water, saline) is
injected through a lumen in catheter 560, exiting from a port 564
proximal to the balloon, to fill the region of the esophagus 10
proximal to the LES 18. This provides a means of ensuring acoustic
energy is coupled to the tissue as well as providing a means of
cooling the mucosa to prevent heat damage. The fluid 565 may
alternatively or additionally be infused through a lumen in the
endoscope 96. Circulation of the fluid 565 may also be accomplished
through multiple lumens in shaft 561 of catheter 560, or endoscope
96.
[0210] As shown in FIG. 49b, an overtube 500 having a balloon 572
bonded to the distal portion of the overtube shaft may be used to
create a proximal seal to contain the fluid 565 infused in the
region of the LES 18 (the balloon catheter 560 would continue to be
used to contain the fluid 565 at the distal portion of the LES 18).
As illustrated in FIG. 49b and FIGS. 49c-e, a stasis valve 573 on
the tip of the overtube may be used to prevent fluid from migrating
up the space between the endoscope and overtube, as well as to
prevent scraping the mucosa when the overtube is moved relative to
the endoscope. The valve 573 is compressible (formed from silicone
rubber or polyurethane) to accommodate a range of endoscope outer
diameters. The proximal end of overtube 500 may be fitted with a
similar stasis valve, or o-ring 574 which may be manually
compressed by turning a threaded nut 575. A side port luer 576 may
be used to flush the lumen of the overtube 500.
[0211] Referring back to FIG. 49a, once the fluid 565 is infused,
the transducer 34 is energized to deliver ultrasound energy 35 to
the region of the LES 18. The energy 35 is delivered for a
sufficient time and energy to create a lesion 575a in the tissue in
the region of the LES 18. The process may be repeated multiple
times around the cicumference and/or axis of the LES 18 to create
additional lesions, such as 575b.
[0212] In another embodiment shown in FIG. 50, the ablation
catheter 32 is configured similar to that shown in FIG. 51. The
catheter 32 is designed to be preloaded in the endoscope 96 such
that an extended portion of the shaft 572 distal to the transducer
34 runs from the distal endoscope, out through the proximal end.
This allows manipulation of two shaft elements, 570 and 572,
proximal and distal to the transducer, respectively, to change the
orientation of the transducer 34. The transducer 34 in this
configuration is elongated such that its width is approximately the
same as the diameter of the catheter shaft, and the length is in
the range of 3-10 mm. An occlusion balloon catheter 560 is again
positioned distal to the LES, but runs alongside the endoscope 96,
not through it. An overtube 500 with balloon 572 may be used in a
manner similar to that of FIG. 49b. As described for FIGS. 49a and
49b, fluid 565 is infused into the region of the LES 18 and
acoustic energy 35 is delivered from the transducer 34 into the
tissue to form lesions in various locations such as 576a and
576b.
[0213] In another embodiment shown in FIG. 51, the distal shaft 520
of ablation catheter 32 is advanced out of an endoscope 96 in the
region of the LES 18. In this embodiment, the endoscope only
requires one free channel, that dedicated to the ablation catheter
32. The distal shaft 520 of the catheter 32 is fitted with a
transducer 34, mounted along the side of the of the catheter shaft.
The transducer is surrounded by a membrane 580 with features and
function similar to that described for FIG. 49a to aid in coupling
of the ultrasound energy to the tissue. The fluid or gel in the
membrane may be recirculated to keep the transducer and mucosa
cool. Mounted to the opposite side of the shaft 520 from the
transducer 34 is an expandable member 582 designed to force the
membrane 580 surrounding the transducer 34 securely against the
tissue. The expandable member 582 is preferably a balloon, but
could also consist of one or more moveable splines designed to bow
against the tissue. An internal pull wire mechanism (not shown)
connected to a proximal actuator could also be employed to aid in
deflecting the distal shaft 520 against the tissue in the region of
the LES 18. Once in position against the tissue, ultrasound energy
35 is delivered from the transducer 34 to form lesions in various
positions in proximity to the LES, such as 577a and 577b.
[0214] In another embodiment shown in FIG. 52a and FIG. 52b, an
ablation catheter 32 is advanced to the region of the LES. Accurate
positioning at the LES is accomplished by using markings on the
shaft corresponding to previous use of an endoscope, or placing an
endoscope alongside the shaft of the ablation catheter. Constructed
on the distal end of catheter shaft 520 is a tissue chamber 590
designed to accept a portion of the muscle wall in the region of
the LES 18. The tissue chamber may measure 5-25 mm long and 3-10 mm
deep. Constructed proximal to the tissue chamber 590 is a
transducer assembly chamber 592. Within chamber 592 a transducer
assembly 594 is slideable via a piston 596 connected to an actuator
on the proximal end of the catheter 32. The transducer assembly 594
consists of a transducer 34 mounted with proximal air backing and a
distal coupling chamber 598 formed by a membrane 599 (similar in
form and function to that described for FIG. 49). Cooling fluid 600
may be circulated in and out of the chamber 598. Using the piston
596 the assembly may be pushed down onto the tissue drawn into the
tissue chamber 590. To aid in drawing the tissue into the chamber
590 and securing it there, suction from a plurality ports 601 may
be employed. The use on an expandable member 602 (balloon or
splines) mounted opposite to the chamber may aid in forcing the
catheter into the tissue (and thus the tissue into the chamber
590).
[0215] At the distal end of the chamber is an optional chamber 604
that may also accept circulated cooling fluid 600 to keep the
distal end of the mucosa from overheating. Distal to optional
chamber 604 is an element 606 that can be configured to absorb
ultrasound energy not absorbed by the tissue. This may consist of a
highly attenuating material such as silicone or polyurethane
rubber. Alternatively, element 606 could be another transducer 34
that directs energy into the tissue towards that coming from the
transducer assembly 594 to increase the heating within the tissue.
An atraumatic tip 608 is attached to the distal tip of the catheter
32. Once the tissue is pulled into the coupling chamber 590, the
transducer assembly 594 pushed against the tissue and infused with
cooling fluid 600, ultrasound energy 35 is delivered into the
tissue to form a lesion 610.
[0216] An alternative embodiment of the device described in FIG. 52
would be to not require the transducer assembly 594 to be moveable,
and thereby eliminate the need for the piston 596. The push force
onto the tissue could be accomplished by designing the membrane 599
to be outward expandable. Also, an internal pull wire mechanism
(not shown) attached to the distal tip of the catheter and
connected to a proximal actuator could also be employed to aid in
deflecting the distal shaft 520 against the tissue in the region of
the LES 18. More specifically, the pull wire may be used to curl
the distal tip 608 (and attached segments 606 and 604 under and
against the LES tissue.
[0217] Other means may be used in addition to or in place of that
described for FIG. 52 to draw the tissue into the tissue chamber.
FIG. 53a illustrates grasping mechanisms 620 actuated by pull wires
622 connected to an actuator at the proximal end of catheter 32.
The grasping mechanisms 620 are formed from a metal or hard plastic
and contain frictional tread 624 to assist in holding the slippery
tissue. They are also contained within the chamber 590 and hollow
in the middle so as to not interfere with the ultrasound energy.
The grasping mechanisms 630 illustrated in FIG. 53b are similar to
FIG. 53a except that they swing out from the catheter shaft to help
pull more tissue into the chamber 590. Additional tread 632 on the
bottom (distal) end of the chamber would aid in holding the tissue
in place. FIG. 53c shows preformed wire (i.e., stainless steel or
nitenol) being advanced out of the catheter shaft to pinch the
tissue and help force it into the tissue chamber 590. In FIG. 53d,
two "partial doughnut" balloons are inflated to help pinch and push
the tissue into the tissue chamber.
* * * * *