U.S. patent application number 12/751803 was filed with the patent office on 2010-07-29 for surgical instruments and techniques for treating gastro-esophageal reflux disease.
Invention is credited to John H. Shadduck.
Application Number | 20100191237 12/751803 |
Document ID | / |
Family ID | 22832483 |
Filed Date | 2010-07-29 |
United States Patent
Application |
20100191237 |
Kind Code |
A1 |
Shadduck; John H. |
July 29, 2010 |
SURGICAL INSTRUMENTS AND TECHNIQUES FOR TREATING GASTRO-ESOPHAGEAL
REFLUX DISEASE
Abstract
An apparatus to treat tissue in a selected wall region of an
esophagus is provided. In one embodiment the apparatus includes an
elongate member having a circumference and is sized to be deployed
in an esophagus. The apparatus further includes an energy delivery
element sized to apply electrical energy to tissue in the
esophagus, and to produce a pattern of treated tissue within a less
than 180.degree. circumferential portion of the esophagus. The
elongate member further includes an expandable structure to
stabilize the energy delivery element in physical and electrical
contact with tissue.
Inventors: |
Shadduck; John H.; (Tiburon,
CA) |
Correspondence
Address: |
SHAY GLENN LLP
2755 CAMPUS DRIVE, SUITE 210
SAN MATEO
CA
94403
US
|
Family ID: |
22832483 |
Appl. No.: |
12/751803 |
Filed: |
March 31, 2010 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12368943 |
Feb 10, 2009 |
|
|
|
12751803 |
|
|
|
|
11469816 |
Sep 1, 2006 |
7507239 |
|
|
12368943 |
|
|
|
|
11365943 |
Mar 1, 2006 |
|
|
|
11469816 |
|
|
|
|
10780027 |
Feb 17, 2004 |
7008419 |
|
|
11365943 |
|
|
|
|
09222501 |
Dec 29, 1998 |
6740082 |
|
|
10780027 |
|
|
|
|
60086068 |
May 20, 1998 |
|
|
|
Current U.S.
Class: |
606/41 |
Current CPC
Class: |
A61B 2018/00797
20130101; A61B 2018/126 20130101; A61B 2018/00482 20130101; A61B
2018/00791 20130101; A61N 1/326 20130101; A61B 2018/00821 20130101;
A61B 18/1485 20130101; A61B 2018/00726 20130101; A61B 2018/1253
20130101; A61B 2018/00553 20130101; A61B 2018/1467 20130101; A61B
2018/00875 20130101; A61B 2018/00285 20130101; A61B 2018/00678
20130101; A61B 2018/00047 20130101; A61B 2018/00494 20130101; A61B
90/39 20160201; A61B 2090/3782 20160201; A61B 2018/1861 20130101;
A61B 2218/002 20130101; A61B 18/1492 20130101; A61B 2018/00815
20130101 |
Class at
Publication: |
606/41 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1. An apparatus to treat tissue at a targeted site in an esophagus
comprising: an extension member sized with a central axis for
deployment in an esophagus; an expansion structure on the extension
member, and a radio frequency energy delivery element on the
extension member positioned at a radial position closer to the
central axis of the extension member than the expandable structure.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of Ser. No. 12/368,943,
filed Feb. 10, 2009, which is a continuation application of Ser.
No. 11/469,816, filed Sep. 1, 2006, which is a continuation
application of Ser. No. 11/365,943, filed Mar. 1, 2006, which is a
divisional of co-pending U.S. application Ser. No. 10/780,027,
filed Feb. 17, 2004 (now U.S. Pat. No. 7,008,419), which is a
divisional of co-pending U.S. application Ser. No. 09/222,501,
filed Dec. 29, 1998 (now U.S. Pat. No. 6,740,082), which claims the
benefit of provisional U.S. Application Ser. No. 60/086,068, filed
May 20, 1998, and entitled "Surgical Instruments and Techniques for
Treating Gastro-Esophageal Reflux Disease," each of which is
incorporated herein by reference in its entirety and to which
applications we claim priority under 35 USC .sctn.120.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD OF THE INVENTION
[0003] This invention relates to instruments and techniques for
thermally-mediated therapies of targeted tissue volumes in a
patient's LES (lower esophageal sphincter) to treat
gastro-esophageal reflux disease (GERD) in a minimally invasive
manner. The thermally-mediated treatment, in a low temperature
range, selectively injures cells and proteins within the (LES) to
induce a predictable wound healing response to populate the
targeted tissue with collagen matrices as a means of altering the
bio-mechanical characteristics of the LES. In a slightly higher
temperature range, an alternative thermally-mediated treatment is
used to shrink native collagen fibers within the LES to "model" the
dimensions and laxity of the LES. The novel treatment techniques
are preferably performed with a trans-esophageally introduced
bougie-type instrument and are adapted to take the place of more
invasive surgical methods for treating GERD (e.g., Nissen
fundoplications) in the treatment of the less severe GERD
cases.
BACKGROUND OF THE INVENTION
[0004] Gastro-esophageal reflux disease (GERD) is a digestive
disorder caused by dysfunction in a patient's lower esophageal
sphincter (LES). In normal swallowing, the LES progressively opens
to allow food to pass into the stomach and thereafter tightens to
prevent food and stomach acids from flowing back into the
esophagus. Gastro-esophageal reflux occurs when the stomach's
contents flow upwardly into the esophagus. Typically, such acid
reflux results from anatomic abnormalities in the LES and
surrounding structures, such as overly relaxed muscle tone within
the LES, a shortened esophageal length within the abdominal cavity,
insufficient intra-abdominal pressures, and/or from a contributory
factor such as a hiatal hernia.
[0005] Prolonged acid reflux can cause serious complications such
as esophagitis, erosions, esophageal bleeding or ulcers. In
addition, chronic scarring caused by acid reflux can cause
narrowing or stricture in the esophagus. Some patients develop
Barrett's esophagus which is a form of severe damage to the
esophageal lining. It is believed that Barrett's esophagus is a
precursor to esophageal cancer.
[0006] As many as 20 million American adults suffer from moderate
to severe GERD. For chronic GERD and heartburn, a physician may
prescribe medications to reduce acid in the stomach, such as
H2-blockers (cimetidine, famotidine, nizatidine and ranitidine).
Another form of drug therapy utilizes a proton pump inhibitor (PPI)
that inhibits an enzyme in the acid-producing cells of stomach from
producing acid (omeprezole, lansoprezole). Yet another form of drug
therapy includes motility drugs for quickening the emptying of
stomach contents (cisipride, bethanechol and metclopramide). The
above-described drug therapies will reduce acid reflux thus
reducing pain to the patient, but either have no impact on, or even
increase alkaline reflux which can cause severe erosions in the
esophagus. Further there exists increasing evidence that lifetime
drug therapies can result in atrophic gastritis in certain
patients, which is known precursor to Barrett's esophagus.
[0007] Since GERD us caused by an anatomic (mechanical) defect,
certain surgeries are well suited to correct the defect by
effectively lengthening the LES and/or increasing intraluminal
pressures within the LES to prevent acid reflux. The leading
surgical procedure is an endoscopic Nissen fundoplication, in which
the surgeon develops a fold (plication) in the fundus of the
stomach and then wraps and sutures the plication generally around
the LES to increase intra-esophageal pressures therein. An
endoscopic Nissen fundoplication is difficult to perform and
typically requires the use of several disposable surgical
instruments that are expensive. An open surgery to accomplish a
Nissen fundoplication also is possible but undesirable because it
requires lengthy postoperative recuperation and results in a long
disfiguring upper abdominal incision.
[0008] There is therefore a need for a new therapies for treating
GERD that offer mechanical or biomechanical solutions to the
anatomic defect that underlies gastro-esophageal reflux.
Preferably, such new approaches to alleviate acid reflux will not
rely on lifetime drug therapies which do not correct the anatomic
defect causing acid reflux.
OBJECTS AND SUMMARY OF THE INVENTION
[0009] The principal objects of this invention are to provide
instruments and techniques for least invasive delivery of thermal
energy through a tissue surface to a targeted tissue volume to
accomplish the controlled remodeling of the treated tissue, and may
also be referred to as bulking tissue. The targeted tissues that
can be treated in a "least invasive" manner include, but not
limited to, soft tissues in the interior of a body (in particular,
collagenous tissues such as fascia, ligamentous tissue),
collagen-containing walls of vessels and organs, and anatomic
structures having, supporting or containing an anatomic lumen
(e.g., esophagus, urethra) Such tissues hereafter may be referred
to as "targeted" tissue volumes or "target sites".
[0010] More particularly, the invention discloses techniques and
instruments that utilize radiofrequency (Rf) energy delivery to
selectively injure cells and extracellular compositions (e.g.,
proteins) in a target site to induce a biological response to the
injury--such biological response including cell reproduction to an
extent but more importantly the population of the extracellular
space with collagen fibers in a repair matrix. Thus, the controlled
alteration or modeling of the structural and mechanical
characteristics of a targeted tissue site is possible by synthesis
of new collagen fibers (or "bulking effects") therein. The
above-described objects of the invention are enhanced by controlled
manipulation of certain biophysical characteristics of the target
tissue prior to the delivery of Rf energy to induce the injury
healing process. Besides the synthesis of collagen matrices,
another object of the invention is the acute shrinkage of native
collagen fibers in the targeted tissue volume. Such acute collagen
shrinkage can cause tightening of a targeted tissue volume.
[0011] The injury healing process in a human body is complex and
involves an initial inflammatory response which in collagenous
tissues is followed by a subsequent response resulting in the
population of new (nascent) collagen in the extracellular space. A
mild injury may produce only an inflammatory reaction. More
extensive tissue trauma invokes what is herein termed the injury
healing response. Any injury to tissue, no matter whether
mechanical, chemical or thermal may induce the injury healing
response and cause the release of intracellular compounds into the
extracellular compartment of the injury site. This disclosure
relates principally to induction of the injury healing process by a
thermally-mediated therapy. The temperature required to induce the
response ranges from about 40.degree. C. to 70.degree. C. depending
on the targeted tissue and the duration of exposure. Such a
temperature herein may be referred to as Tncs (temperature that
causes "new collagen synthesis"). The temperature needed to cause
such injury and collagen synthesis is lower than the temperature
Tsc (temperature for acute "shrinkage of collagen") in another
modality of the method of the invention disclosed herein.
[0012] In order to selectively injure a target tissue volume to
induce the population of the extracellular compartment with a
collagen matrix, "control" of the injury to a particular tissue is
required. In this disclosure, a Rf energy source is provided to
selectively induce the injury healing process. (It should be
appreciated that other thermal energy devices are possible, for
example a laser). In utilizing an Rf energy source, a high
frequency alternating current (e.g., from 100,000 Hz to 500,000 Hz)
is adapted to flow from one or more electrodes into the target
tissue. The alternating current causes ionic agitation and friction
in the targeted tissue as the ions follow the changes in direction
of the alternating current. Such ionic agitation or frictional
heating thus does not result from direct tissue contact with a
heated electrode.
[0013] In the delivery of energy to a soft tissue volume, I=E/R
where I is the intensity of the current in amperes, E is the energy
potential measured in volts and R is the tissue resistance measured
in ohms. In such a soft tissue volume, "current density" or level
of current intensity is an important gauge of energy delivery which
relates to the impedance of the tissue volume. The temperature
level generated in the targeted tissue volume thus is influenced by
several factors, such as (i) Rf current intensity (ii) Rf current
frequency, (iii) tissue impedance levels within the targeted tissue
volume, (v) heat dissipation from the targeted tissue volume, (vi)
duration of Rf delivery, and (vii) distance of the targeted tissue
volume from the electrodes. A subject of the present invention is
the delivery of "controlled" thermal energy to a targeted tissue
volume with a computer controlled system to vary the duration of
current intensity and frequency together, based on sensor feedback
systems.
[0014] In the initial cellular phase of injury healing,
granulocytes and macrophages appear and remove dead cells and
debris. In the inflammation process, the inflammatory exudate
contains fibrinogen which together with enzymes released from blood
and tissue cells, cause fibrin to be formed and laid down in the
area of the tissue injury. The fibrin serves as a hemostatic
barrier and thereafter acts as a scaffold for repair of the injury
site. Fibroblasts migrate and either utilize the fibrin as
scaffolding or for contact guidance thus further developing a
fiber-like scaffold in the injury area. The fibroblasts not only
migrate to the injury site but also proliferate During this
fibroplastic phase of cellular level repair, a extracellular repair
matrix is laid down that is largely comprised of collagen.
Depending on the extent of the injury to tissue, it is the
fibroblasts that synthesize the collagen within the extracellular
compartment as a form of connective tissue (hereafter nascent
collagen), typically commencing about 36 to 72 hours after the
injury.
[0015] Thus, in the injury healing response, compound tissues or
organs are repaired by such fibrous connective tissue formation (or
matrix formation). Such fibrous connective tissue is the single
most prevalent tissue in the body and gives structural rigidity or
support to tissues masses or layers. The principal components of
such connective tissues are three fiber-like proteins-collagen,
reticulin and elastin along with a ground substrate. The
bio-mechanical properties of fibrous connective tissue and the
repair matrix are related primarily to the fibrous proteins of
collagen and elastin. As much as 25% of total body protein is
native collagen. In repair matrix tissue, it is believed that
nascent collagen is in excess of 50%.
[0016] The unique properties of collagen are well known. Collagen
is an extracellular protein found in connective tissues throughout
the body and thus contributes to the strength of the
musculo-skeletal system as well as the structural support of
organs. Numerous types of collagen have been identified that seem
to be specific to certain tissues, each differing in the sequencing
of amino acids in the collagen molecule.
[0017] It has been previously recognized that collagen (or collagen
fibers as later defined herein) will shrink or contract
longitudinally when elevated in temperature to the range of
60.degree. C. to 80.degree. C., herein referred to as Tsc. Portions
of this disclosure relate to techniques for controlled shrinkage of
collagen fibers in the soft tissue, and more generally to the
contraction of a collagen-containing tissue volume, (including both
native collagen and nascent collagen) for therapeutic purposes.
[0018] Collagen consists of a continuous helical molecule made up
of three polypeptide coil chains. Each of the three chains is
approximate equal length with the molecule being about 1.4
nanometers in diameter and 300 nm in length along its longitudinal
axis in its helical domain domain (medial portion of the molecule).
The spatial arrangement of the three peptide chains in unique to
collagen with each chain existing as a right-handed helical coil.
The superstructure of the molecule is represented by the three
chains being twisted into a left-handed superhelix. The helical
structure of each collagen molecule is bonded to together by heat
labile intermolecular cross-links (or hydrogen cross-links) between
the three peptide chains providing the molecule with unique
physical properties, including high tensile strength along with
moderate elasticity. Additionally, there exist heat stabile or
covalent cross-links between the individual coils. The heat labile
cross-links may be broken by mild thermal effects thus causing the
helical structure of the molecule to be destroyed with the peptide
chains separating into individual randomly coiled structures. Such
thermal destruction of the cross-links results in the shrinkage of
the collagen molecule along its longitudinal axis to up to
one-third of its original dimension, in the absence of tension.
[0019] A plurality of collagen molecules (also called fibrils)
aggregate naturally to form collagen fibers that collectively make
up the a fibrous matrix. The collagen fibrils polymerize into
chains in a head-to-tail arrangement generally with each adjacent
chain overlapping another by about one-forth the length of the
helical domain a quarter stagger fashion to form a collagen fiber.
Each collagen fiber reaches a natural maximum diameter, it is
believed because the entire fiber is twisted resulting in an
increased surface are that succeeding layers of fibrils cannot bond
with underlying fibril in a quarter-stagger manner.
[0020] Thus, the present invention is directed to techniques and
instruments for controlled thermal energy delivery to portions of a
patient's LES, in alternative therapies, either:
[0021] a) to selectively injury cells and proteins in walls of the
LES to induce an injury healing response which populates the
extracellular compartment with a collagen fiber matrix ("nascent
collagen") to bulk and alter the architecture and flexibility
characteristics of tissue volumes within walls of the LES; or
[0022] b) to, optionally, shrink either "native" collagen or
"nascent" collagen in tissue volumes within the wall of the LES to
further alter mechanical characteristics of the LES and increase
intra-esophageal pressures.
[0023] More in particular, the device of the present invention for
"modeling" a collagen matrix in targeted tissue (or "bulking"
targeted tissue) in walls of the patient's LES is fabricated as a
flexible bougie that carries thermal energy delivery means in its
distal working end. Typically an Rf source is connected to at least
one electrode carried in the working end. The working end may carry
a single electrode that is operated in a mono-polar mode or a
plurality of electrodes operated in either a mono-polar or bi-polar
manner, with optional multiplexing between various paired
electrodes. A sensor array of individual sensors also is carried in
the working end, typically including (i) thermocouples and control
circuitry, and/or (ii) impedance-measuring circuitry coupled to the
electrode array.
[0024] A computer controller is provided, together with the
feedback circuitry from the sensor systems, that is capable of full
process monitoring and control of: (i) power delivery; (ii)
parameters of a selected therapeutic cycle, (iii) mono-polar or
bi-polar energy delivery, and (iv) multiplexing Rf delivery. The
controller also can determine when the treatment is completed based
on time, temperature, tissue impedance or any combination
thereof.
[0025] In a first method of the invention, the device is introduced
through the patient's mouth until the working end and electrode
array is positioned within the LES. The therapeutic phase commences
and is accomplished under various monitoring mechanisms, including
but not limited to (i) direct visualization, (ii) measurement of
tissue impedance of the target tissue masses relative to the
device, and (iii) utilization of ultrasound imaging before or
during treatment. The physician actuates the pre-programmed
therapeutic cycle for a period of time necessary to elevate the
target tissue mass to Tncs (temperature of new collagen synthesis)
which is from 45.degree. C. to 60.degree. C. depending on duration
of energy delivery.
[0026] During the therapeutic cycle, the delivery of thermal energy
is conducted under full-process feedback control. The delivery of
thermal energy induces the injury healing response which thereafter
populates the mass with an extracellular collagen matrix and
reduces the flexibility of the LES over the subsequent several days
and weeks. The physician thereafter may repeat the treatment.
[0027] In a second method of the invention, (either the initial or
a subsequent therapeutic cycle) the delivery of Rf energy may be
elevated to shrink collagen fibers at a range between 60.degree. C.
to 80.degree. C. to reach Tsc. The effect of such collagen
shrinkage is to rigidify or bulk the treated tissue volumes in the
wall of the LES.
[0028] Following an initial therapeutic cycle, the treatment can be
repeated until the desired increase in intra-esophageal pressures
is achieved. It is believed that such periodic treatments (e.g.,
from 2 to 6 treatments over a period of several weeks) may be best
suited to treat the LES.
[0029] The above-described modalities of (i) induced synthesis of
collagen in collagenous tissues, and (ii) shrinkage of collagen in
collagenous tissues describe the effects on LES tissue volumes.
These methods of treating the LES are defined herein by a
particular temperature range that causes the exact
cellular/extracellular effects in the targeted tissue volumes, and
are intended to be inclusive of other descriptive terms that may be
used to more generally characterize treatments, such as tightening
tissue, bulking tissue, fusing or fusion of collagenous tissues,
creating scar tissue, sealing or welding collagen-containing
tissue, shrinking tissue and the like. The methods disclosed herein
are not defined to include ablating tissue, which occurs at higher
temperature levels.
[0030] In general, the present invention advantageously provides
least invasive thermally-mediated techniques for increasing
intraluminal pressures in a patient's LES to prevent
gastro-esophageal reflux.
[0031] The present invention provides novel devices and techniques
for thermally inducing an injury healing response to alter
cellular/extracellular architecture in the LES.
[0032] The present invention provides techniques for thermal
induction of bulking of tissue volumes around a sphincter in an
anatomic lumen.
[0033] The present invention advantageously provides an electrode
array fur delivering a controlled amount of Rf energy to a specific
targeted tissue volume in the LES having a particular shape or
pattern.
[0034] The present invention provides an electrode array for
delivering a controlled amount of Rf energy to a specific target
collagen-containing tissue volume to achieve a controlled
contraction of the collagen fibers therein.
[0035] The present invention provides a novel device and technique
for contraction of collagen fibers around the lumen of an anatomic
structure to reduce the dimension of the lumen.
[0036] The present invention also provides an instrument and method
in which a bougie-type member has a working channel to accommodate
an endoscope, an accessory instrument or for therapeutic agent
delivery or suction.
[0037] The present invention advantageously provides a device that
is inexpensive and disposable. Additional advantages and features
of the invention appear in the following description in which
several embodiments are set forth.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] FIG. 1 is a perspective view of a Type "A" device and Rf
energy source of the present invention.
[0039] FIG. 2 is transverse sectional view of the device of FIG. 1
taken along line 2-2 of FIG. 1.
[0040] FIG. 3 A is an enlarged perspective view of the working end
of the device of FIG. 1.
[0041] FIG. 3B is transverse sectional view of the working end of
FIG. 3 A taken along line 3B-3B of FIG. 3A.
[0042] FIG. 4 is a perspective view of an alternative embodiment of
working end similar to FIG. 3 A.
[0043] FIGS. 5A-5F are views of a portion of the wall of a lower
esophageal sphincter (LES) showing various patterns of
thermally-mediated treatments developed by various electrode
arrays.
[0044] FIG. 6A is a view of an alternative embodiment of working
end similar to that of FIG. 3A.
[0045] FIG. 6B is an alternative embodiment of working end showing
a working channel.
[0046] FIG. 6C is a block diagram of the Rf source of the invention
including a computer controller.
[0047] FIGS. 7A-7D are schematic views of a method of
thermally-mediated treatment of the LES utilizing the device of
FIG. 1; FIG. 7A being a view of positioning the working end in the
region of the LES; FIG. 7B being a view of expansion of an optional
balloon carried at the working end; FIG. 7C being a view of
sectional view of the working end taken along line 7C-7C of FIG. 7B
showing the targeted tissue region; and, FIG. 7D showing the tissue
dimensions following a thermally mediated therapy.
[0048] FIGS. 8A-8B are views of the working end of a Type "B" of
device for thermally-mediated therapies of the LES and its means of
capturing the wall of the LES for treatment.
[0049] FIG. 9 is a view of the working end of an alternative Type
"B" devices similar to the device FIGS. 8A-8B.
[0050] FIG. 10 is a view of a portion of the wall of the LES
showing a method of treatment with a Type "B" device.
[0051] FIG. 11A is a view of the working end of another alternative
Type "B" with rolling components.
[0052] FIG. 11B is a view of a portion of the wall of the LES
showing a method of treatment with the working end of FIG. 11A.
[0053] FIG. 12A is a view of the working end of yet another Type
"B" device.
[0054] FIG. 12B is a view of a portion of the wall of the LES
showing a method of treatment with the working end of FIG. 12A.
[0055] FIG. 13 A is a view of a Type "C" device system for
thermally-mediated treatments of the LES.
[0056] FIG. 13B is a view of the working end of a component of the
Type "C" system of FIG. 13A.
[0057] FIG. 13C is a views of an alternative working end similar to
that of FIG. 13B.
[0058] FIG. 14 is a view of the wall of the LES showing a method of
treatment with the Type "C" system of FIG. 13A.
[0059] FIG. 15 is a view of the working end of another Type "C"
device
DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION
1. Type "A" Device for Thermally-Mediated LES Therapy
[0060] By way of example, FIG. 1 depicts LES treatment device 5
that is to be utilized for a thermally-mediated alteration of the
cellular/extracellular architecture of a lower esophageal sphincter
(LES) while at the same time sizing or gauging the lumen of the
esophagus. More in particular, device 5 comprises elongate
extension member 10 with proximal end 11 and working end 15 with
distalmost tip 16. Referring to FIGS. 1 and 2, extension member 10
has a generally cylindrical shape along longitudinal axis 17 with
an overall length of approximately 60 to 90 centimeters. The
cross-sectional dimension of extension member 10 would typically
range in diameters from #40 to #60 French for various patients
having varied esophageal anatomies (but may be much smaller as
described below for introduction through a working channel of a
flexible gastroscope).
[0061] The extension member 10 preferably is capable of bending in
an approximately 1.0 cm radius (or less) and may comprise a
flexible plastic casing 18 with a high-density liquid, gel or other
suitable flexible core 19 inside the casing and the tapered tip.
The device may compare in size and flexibility to a commercially
available bougie that is adapted to push through an esophagus to
enlarge the lumen, such as a bougie manufactured by Pilling Week,
420 Delaware Drive, Fort Washington, Pa.
[0062] In this Type "A" variant, an Rf energy source 40 is provided
for delivering thermal energy to portions of the LES. The Rf energy
source 40 may alternatively be replaced with a microwave source, or
another known source of thermal energy such as a laser. It further
should be appreciated that other sources of energy such as
ultrasound or high-energy focused ultrasound (HEFU) that are known
in the art may be utilized to cause thermally-mediated treatments
of target sites in the LES. The Rf energy source 40 is detachably
connected to extension member 10 by power cable 42.
[0063] Referring to FIG. 3A, the working end 15 carries at least
one electrode in an electrode array 44, and preferably carries a
plurality of Rf electrodes 45a-45n that are positioned in the
surface 46 of working end 15. FIGS. 1 and 3A show two exemplary
electrodes 45a-45b arranged longitudinally in extension member 10
in a spaced relationship in surface 46. The electrodes 45a-45b
shown in FIG. 3 may be operated in a mono-polar mode (with
groundplate) but preferably are operated in a bi-polar mode to
provide controlled energy delivery to achieve a particular
temperatures between the adjacent paired electrodes 45a-45b in the
wall W of the LES proximate to the electrodes. The electrodes are
of any suitable biocompatible conductive material which conduct
current to and from tissue around the LES in direct contact with
electrodes 45a-45b.
[0064] Expansion means are preferably (but optionally) carried in
working end 15 for increasing the transverse dimension of the
working portion and for pressing any electrodes 45a-45n securely
against a wall of the lumen of the LES. Inflatable balloon 50 is
capable of collapsed and inflated conditions and is depicted in
FIG. 1 (phantom view of inflated condition) and FIGS. 3A and 3B in
an inflated condition. Balloon 50 is incorporated into the wall of
extension member 10 in this embodiment generally on the opposite
side from electrodes 45a-45b. Balloon 50 preferably is made of an
elastomeric material, for example silicone or latex and has chamber
52 that is inflatable to a maximum transverse dimension of
approximately 10 to 30 millimeters at low pressures (e.g., from 0.5
to 5 psi). A Luer-type fitting 53 is coupled to tube 54 that is
provided in core 19 of extension member and communicates with an
inflation source to inflate balloon 50, for example a syringe with
saline solution or air (FIG. 1). It should be appreciated that the
expansion means of the invention is shown as balloon 50 but such
expansion means also may comprise any type of suitable mechanical
expansion structure disposed within the core of working end 15 that
is adapted to expand the cross-section of the working portion that
is known in the art (e.g., flexible ribs that are actuated with a
pull cable).
[0065] Visible and/or radiopaque and markings 57 are shown in FIG.
1 and are used to both angularly and axially position the working
end 15 of the device within the patient's LES. The markings 57 in
the proximal portion of extension member 10 are useful to the
anesthesiologist or physician's assistant to gauge the depth of
insertion of the device as well as its rotational angle.
[0066] As shown in FIG. 3 A, this particular embodiment of device 5
has electrodes 45a-45b each with an elongate shape with the
electrodes being longitudinally oriented in relation to axis 17 of
extension member 10. Preferably, the electrodes 45a and 45b have a
length ranging from about 5.0 mm to 15.0 mm and a width ranging
from 0.25 mm to 2.5 mm. The spacing dimension d between the
electrodes may range from about 0.5 mm to 10.0 mm.
[0067] Although FIGS. 3A-3B show a variant of device 5 with two
electrodes 45a and 45b, it should be appreciated that a plurality
of greater than two electrodes may be carried in particular spaced
relationships along working end 15, as shown in FIG. 4. In FIG. 4,
the alternative embodiment is shown with six longitudinal
electrodes 45a-45f. The embodiment of FIG. 4 thus may be operated
in a mono-polar mode or in a bi-polar mode with a computer
controller 60 (see FIG. 1) operatively connected to the Rf source
40 and electrodes and temperature sensors to multiplex (of vector)
the current flow between and among various paired electrodes. (It
should be appreciated that working end 15 may carry only a single
electrode operated in a mono-polar mode and fall within the scope
of the invention).
[0068] In the preferred embodiment described above, the elongate
configuration of the electrodes and their longitudinal orientation
was selected because it is believed that Rf energy delivery to
elongate regions of the LES will prove optimal to accomplish the
objectives of methods of the invention. As will be described below,
functional portions of the lower esophageal sphincter extend as
much as several cm from the gastro-esophageal junction and it is
believed that the disclosed thermally-mediated treatments of
collagen synthesis should extend over a substantial axial dimension
of the LES. Still, another the objective may be collagen shrinkage
based on anatomic dimensions and motility studies of a particular
patient. Further, the diagnosis may indicate that such collagen
shrinkage is desired in a localized annular or part annular region.
Thus, other electrode patterns in a "Type A" device are possible
and fall within the scope of the invention to deliver particular
patterns of thermally-mediated treatment to the wall W of the LES.
FIG. 5A shows a singular annular (circumferential) pattern of
treated tissue indicated at T in the wall W of a lower esophageal
sphincter to shrink collagen and slightly reduce the dimension of
the lumen by creating bulk in region T. In FIGS. 5A-5F, treated
tissue patterns are shown in portions of wall W (member 10 in
phantom view) and it can be understood that electrodes may be of
particular configuration to deliver such treatment locations and
patterns. (E.g., a single electrode operated in a mono-polar mode
(with groundpad) can develop the targeted treatment band T of FIG.
5 A, or two parallel electrodes operated in a bi-polar mode may
cause the targeted treatment band T of FIG. 5 A by energy flow
therebetween). FIG. 5B shows multiple annular regions or bands of
treated tissue T. FIG. 5C illustrates a multiplicity of treatment
regions T as when the objective is the delivery of Rf energy in a
diffuse manner over a substantial portion of wall W. FIG. 5D
illustrates a plurality of helical treatment regions T which would
result in diffuse effects if the regions were close together. FIG.
5E illustrates a v-shaped or chevron-shaped treatment regions T.
FIG. 5F is a more greatly enlarged view of wall W with treated
regions T multiple electrodes 45a-45n in phantom view. FIG. 5F
shown various arrows A that indicate multiplexed vectors of current
delivery are possible to cause the thermally-mediated treatments of
regions T. Any of the elongate electrodes of FIG. 5A-5E may be
configured as multiple intermittently-spaced electrodes and
optionally may operate in a bi-polar and multiplexed mode with
varied possible vectors between various paired electrodes. Only
certain electrodes may delivery current, all for a controlled
periods of time. The multiplexer also may cause the Rf energy
delivery to switch between mono-polar and bi-polar during a
treatment.
[0069] In the embodiments shown, the electrodes are of any suitable
conductive material which is adapted to deliver Rf energy to soft
tissue in the walls W of the LES around the esophageal lumen
without ablating (and necrosing) any surface tissue to significant
degree. The electrode material may include gold, nickel titanium,
platinum, stainless steel, aluminum and copper. Each individual
electrode of the array is connected to Rf source 40 and controller
60 by a suitable current-carrying wires 61a-61n within introducer
member 10. The proximal portions of such current-carrying wires are
carried in power cable 42 that connects with Rf source 40.
[0070] Referring back to FIG. 3 A it can be seen that a sensor
array of individual sensors 65a-65b (an number of sensors are
possible) also is provided in a spaced relationship around working
end 15. The sensor array will typically include thermocouples or
thermisters to measure temperature levels of an electrode or of a
portion of the wall W in contact with the sensor. Further, the
sensor array includes impedance sensing capabilities (not shown)
that measures tissue impedance in a conventional manner between
particular electrode elements at the controller 60 as described
below. Current-carrying wires 66a-66b are shown in FIGS. 2-3A are
connected to sensors 65a-65b. Other wires (not shown) may be
provided in the device that could be dedicated specifically to
measuring tissue impedance. One or more such impedance monitoring
systems may be used to confirm prior to the therapeutic cycle that
a satisfactory coupling of energy will be accomplished. Impedance
is monitored between each electrode and a groundpad when operated
in a mono-polar mode, or between various electrodes when operated
in a bi-polar mode.
[0071] Another embodiment of a Type "A" device 5 is shown in FIG.
6A wherein an ultrasound source 70 may be coupled to one or more
ultrasound transducers 72 (collectively) in a spaced relationship
in working end 15 of extension member 10. An output of ultrasound
source 70, optionally in combination with Rf source 40, any be
adapted to deliver thermal energy to the LES. Each ultrasound
transducer 72 may be a piezoelectric crystal mounted on a suitable
substrate. A conventional ultrasound lens of electrically insulated
material is fitted between the exterior of surface 18 of working
end 15 and the piezoelectric crystal which is connected by
electrical leads in extension member to ultrasound source 70. Each
ultrasound transducer thus is capable of transmitting ultrasound
energy into the target tissue of the LES for imaging purposes or
high-energy ultrasound (HEFU) to deliver thermal energy.
Thermocouples can provide accurate temperature measurements of
surface temperatures at various points along the esophageal lumen.
Such thermal sensors are preferably adjacent to piezoelectric
crystals.
[0072] FIG. 6B shows another embodiment of device 5 with a working
channel 76, with an open proximal end in the proximal end 11 of the
device with a distal termination (not shown) at the distal end of
the device. The working channel 76 may be any suitable dimension,
for example from about 0.5 mm to 5.0 mm or more, to accommodate a
flexible shaft accessory instrument (e.g., an endoscope or
forceps). Working channel 76 also may be utilized to deliver
therapeutic agents to the patient's stomach or to suction air or
liquid secretions from the stomach.
[0073] Referring now to FIG. 6C, a block diagram of the Rf source
40 and controller 60 is shown. The controller 60 includes a CPU
coupled to the Rf source and multiplexer 80 through a bus.
Associated with the controller system may be a keyboard, disk drive
or other non-volatile memory system, along with displays that are
known in the art for operating such a system. The operator
interface may include various types of imaging systems for
observing the treatment such as thermal or infrared sensed
displays, ultrasonic imaging displays or impedance monitoring
displays. The multiplexer 80 is driven by controller 60 (digital
computer) which includes appropriate software 82.
[0074] In operation, current supplied to individual electrodes
45a-45n along with voltage may be used to calculate impedance.
Thermocouples 65 carried in a position proximate to the electrodes
together with additional thermal sensors positioned within the Rf
source or generator are adapted to measure energy delivery (current
and voltage) to each electrode at the site of targeted tissue
during a therapeutic cycle. The output measured by thermal sensors
is fed to controller 60 in order to control the delivery of power
to each electrode location. The controller 60 thus can be
programmed to control temperature and Rf power such that a certain
particular temperature is never exceeded at a targeted treatment
site. The operator further can set the desired temperature which
can be maintained. The controller 60 has a timing feature further
providing the operator with the capability of maintaining a
particular temperature at an electrode site for a particular length
of time. A power delivery profile may be incorporated into
controller 60 as well as a pre-set for delivering a particular
amount of energy. A feedback system or feedback circuitry can be
operatively connected to the impedance measuring system, and/or the
temperature sensing system or other indicators and to the
controller 60 to modulate energy delivery at Rf source 40.
[0075] The controller software and circuitry, together with the
feedback circuitry, thus is capable of full process monitoring and
control of following process variables: (i) power delivery; (ii)
parameters of a selected treatment cycle (time, temperature,
ramp-up time etc.), (iii) mono-polar or bi-polar energy, and (iv)
multiplexing between various electrode combinations. Further,
controller 60 can determine when the treatment is completed based
on time, temperature or impedance or any combination thereof. The
above-listed process variables can be controlled and varied as
tissue temperature is measured at multiple sites in contact with
the sensor array, as well as by monitoring impedance to current
flow at each electrode which indicates the current carrying
capability of the tissue during the treatment process. Controller
60 can provide multiplexing along various vectors as previously
described, can monitor circuit continuity for each electrode and
can determine which electrode is delivering energy.
[0076] In FIG. 6C, the amplifier 85 is a conventional analog
differential amplifier for use with thermisters and transducers.
The output of amplifier 85 is sequentially connected by analog
multiplexer 80 to the input of analog digital converter 86. The
output of amplifier 85 is a particular voltage that represents the
respective sensed temperatures. The digitized amplifier output
voltages are supplied to microprocessor 88. Microprocessor 88
thereafter calculates the temperature and/or impedance of the
tissue site in question. Microprocessor 88 sequentially receives
and stores digital data representing impedance and temperature
values. Each digital value received by microprocessor corresponds
to a different temperature or impedance at a particular site.
[0077] The temperature and impedance values may be displayed on
operator interface as numerical values. The temperature and
impedance values also are compared by microprocessor with
programmed temperature and impedance limits. When the measured
temperature value or impedance value at a particular site exceeds a
pre-determined limit, a warning or other indication is given on
operator interface and delivery of Rf energy to a particular
electrode site can be decreased or multiplexed to other electrodes.
A control signal from the microprocessor may reduce the power level
at the generator or power source, or de-energize the power delivery
to any particular electrode site. Controller 60 receives and stored
digital values which represent temperatures and impedance sent from
the electrode and sensor sites. Calculated skin surface
temperatures may be forwarded by controller 60 to display and
compared to a predetermined limit to activate a warning indicator
on the display.
2. Method of Use of Type "A" Device
[0078] Operation and use of the instrument shown in FIG. 1 (with
two electrode 45a-45b embodiment) in performing the method of the
present invention can be described briefly as follows (FIGS.
7A-7D). The physician or an assistant introduces working end 15 of
device 5 through the patient's mouth into lumen 100 of esophagus
102. Referring to FIG. 7A, the physician advances extension member
10 distally and rotationally until working end 15 and electrodes
45a and 45b are in a suitable position within the LES (see FIG.
7A). The physician also may advance and turn the instrument to a
correct angle by reference to markings 57 on the proximal portion
of the device (see FIG. 1). In the illustrations, it is assumed
that the targeted tissue is in a quadrant at the patient's left
side or at the anterior of the LES (see FIGS. 7A-7B). It is
believed the area of treatment will vary from patient to patient as
determined by motiliry studies and anatomic characteristics, and
probably most cases will involve treatments in several angular
positions within the LES.
[0079] Referring to FIG. 7B, the diameter of extension member 10
may fit somewhat loosely or snugly in esophageal lumen 100
depending on the diameter of device selected. As shown in FIG. 7C,
the physician preferably (but optionally) inflates balloon 50 with
an inflation medium, for example air or saline solution from a
syringe (not shown). Balloon 50 is inflated to a sufficient
dimension to press the surface of working end 15, and more
particularly electrodes 45a and 45b, into firm contact with surface
104 of targeted tissue in wall W of the LES. (It should be
appreciated that a flexible fiberscope 105 (phantom view) may
introduced through a optional working channel 76 to view the
gastro-esophageal junction 108 from inside the patient's stomach
110 which may be useful in positioning the device (see FIG. 7B)).
The physician selects the treatment site based on anatomical
knowledge of the LES and is thus capable of avoiding thermal energy
delivery to certain areas or sides of the LES if so desired.
[0080] Now referring to FIG. 7B, the physician commences the
therapeutic phase of Rf delivery under various monitoring
mechanisms, including but not limited to, (i) measurement of tissue
impedance of the target tissue to determine electrical conductivity
between the targeted tissue and the electrode arrangement of device
5, (ii) utilization of ultrasound imaging before and/or during
treatment to establish a baseline and duty-cycle tissue
characteristics for comparative measurements; and optionally (iii)
direct visualization via a fiberscope introduced through a working
channel into the stomach and articulated (FIG. 7B). Alternatively,
a small diameter flexible scope could be positioned within lumen
100 to view the location of working end 15. (Another similar
alternative of delivering the thermally-mediated treatment
disclosed herein is to have a small diameter extension member 10
(e.g., 2.0 mm, to 6.0 mm) that can be introduced through the
working channel of a flexible scope). All these approaches are
similar and can yield the same results in the targeted tissue.
[0081] Still referring still to FIG. 7B, the physician may actuate
the controller to perform a first modality of treatment described
above as a collagen synthesis modality. The controller actuates a
preprogrammed therapeutic cycle for a period of time necessary to
elevate the targeted tissue T to a particular time/temperature
range based on feedback from the sensor system. The cycle can
elevate temperatures in the tissue to a range between 40.degree. C.
to 70.degree. C. for a period of time ranging from 60 seconds to 10
minutes. More preferably, the therapeutic cycle would elevate
temperatures in wall W of the LES to a range between 45.degree. C.
and 65.degree. C. for a period of time ranging from 60 seconds to 5
minutes. Still more preferably, the therapeutic cycle would include
temperatures in a range between 50.degree. C. and 60.degree. C. for
a period of time ranging from 60 seconds to 3 minutes. At the
particular selected parameters, the thermal effects will
selectively injures cells in and below the surface 104 of wall W at
target sites T thus inducing the desired injury healing response.
The depth of thermal penetration into the target tissue sites T is
determined by the current intensity and duration, and most
importantly the thermal relaxation time of the tissue, to
preferably effect selective heating of tissue at a depth of about
0.5 mm to 2.5 mm from the surface 104 of the wall W of the lumen
100.
[0082] As can be seen in FIG. 7C, electrodes 45a and 45b are in
direct contact with tissue surface 104 of wall W along the
tissue-electrode interface. Preferably, the controller 60 will
sense temperatures along the tissue-electrode interface by means of
the sensor array and/or impedance monitoring system and maintain
temperature at the tissue surface 104 at a level below that which
ablate the surface, generally by lowering the current intensity or
making the energy delivery intermittent. The effect of elevating
the temperature of the interior of wall W of the LES without
surface ablation can be accomplished because of surface cooling
caused by conduction of heat into lumen 100 and the heat-absorbing
(heat-sink) characteristics of the working end 15 and extension
member 10.
[0083] During the therapeutic cycle, the delivery of energy is
preferably conducted under full-process feedback control, and in
fact the treatment phase may require little attention by the
physician ft should be appreciated that the target tissue can be
treated uniformly, or various discrete portions of the target
tissue can be treated selectively. (In embodiments with a greater
number of electrodes, different levels of current can be delivered
to different electrode elements, or current can be multiplexed
through various electrodes along different vectors as described
previously).
[0084] A follow-on portion of the therapeutic cycle may comprise a
diagnostic phase to gauge the success of the treatment. With energy
delivery terminated, diagnosis may be accomplished through (i)
direct visualization, (ii) ultrasound imaging, (iv) infrared
imaging, or (v) temperature measurements.
[0085] Following such a therapeutic cycle to cause collagen
synthesis or bulking of target tissue portions around the LES, the
patient can return to normal activities with periodic monitoring of
the intra-esophageal pressure of the LES as well as muscle response
of the LES in conventional motility studies. Thereafter, the same
treatment may be repeated until alterations in
cellular/extracellular architecture increases intraluminal
pressures within the LES to the desired level. It is believed that
periodic treatments (e.g., 1 week to 2 weeks between treatments) is
best suited to alter the mechanical characteristics of the LES. The
thermally-mediated treatment induces a bodily response which
includes populating the targeted tissue sites T with nascent
collagen in the extracellular spaces, which after periodic
treatments will make walls W of the LES to be bulked up or thicker
and which will cause a reduced cross-section of lumen 100 within
the LES.
[0086] If the physician elects to tighten the LES to a greater
extent, he may in an initial treatment or in subsequent treatment,
perform a different modality of thermally-mediated treatment
described above as the collagen shrinkage modality. In this case,
the physician elects to deliver elevated levels of Rf energy to
contract or shrink collagen fibers to further tighten or reduce the
flexibility of target tissue T within wall portions of the LES. The
delivery of Rf energy will shrink collagen fibers as described
above in the LES without significant modification of adjacent
tissue volumes. The temperature gradients described above can be
accomplished to achieve the temperature to contract collagen fibers
in the targeted tissue without increasing the temperature of the
surface 104 so that the surface tissue will not be ablated,
blistered or necrosed. The energy level is monitored and controlled
as to each individual electrode as detailed above by controller 60.
The energy delivery is continuously changed based on sensor inputs
which includes temperature data and impedance data from the sensors
provided in the device.
[0087] In the collagen shrinkage modality of treatment, a
pre-programmed therapeutic cycle is selected to achieve shrinkage
of native collagen. In this case, the delivery of energy is
controlled to elevate temperatures in target tissue T to a range
generally between 60.degree. C. to 80.degree. C. Preferably, the
therapeutic cycle can be controlled to attain temperatures in the
targeted tissue in a range from 60.degree. C. and 70.degree. C. for
a period of time ranging from 60 seconds to 5 minutes. Immediate
acute longitudinal shrinkage of collagen fibers and molecules will
occur in such a temperature range. Thus, the targeted tissue T
shrink generally in the direction of collagen fibers therein and
will make the walls around the lumen of the esophagus somewhat
tighter and resistant to radial extension (opening). Looking at the
thermally-mediated effects on such collagenous tissue from a
different perspective, the collagen fibers and molecules are
increased greatly in caliber, as described above, thus causing a
bulking up of the targeted tissue in the LES (see FIG. 7D). In
other words, the native collagen (and collagen matrices) will bulk
up and tighten the targeted tissue sites T as shown in FIG. 7D. If
the therapy is performed following a prior collagen synthesis
treatment at the lower temperature ranges described above, the
follow collagen shrinkage therapy can be enhanced since both the
nascent and native collagenous tissue will shrink within the target
tissue sites T. Each subsequent treatment not only will populate
the tissue sites T with additional nascent collagen fibers, but
also shrinks the nascent collagen fibers from the prior treatment
or treatments.
3. Type "B" Device for Thermally-Mediated LES Therapy
[0088] By way of example, FIGS. 8A-8B and 9 depict an alternative
type of LES treatment device that may be utilized for Rf energy
delivery to wall portions W of the LES to alter its
cellular/extracellular architecture. More in particular, the system
includes an embodiment of elongate device or member 205 with a
medial extending portion 206 that is substantially similar to the
Type "A" device described above, and elements common to both the
Type "A" and Type "B" embodiment will be described with the same
reference numerals. As shown in FIG. 8A-8B, the working end 215 of
this embodiment carries a tissue-engaging means known in the art
comprising an openable/closeable arm structure for engaging target
tissue in the wall of the LES (Cf. the openable/closeable arm
structure of related Provisional Application Ser. No. 60/024,974
filed on Aug. 30, 1996; and follow-on patent application Ser. No.
09/920,291 filed on Aug. 28, 1997, which disclosures are
incorporated herein in their entirety by this reference). FIG. 8A
shows a longitudinally-oriented arm structure with arm elements
216a and 216b that are rotatable around pivots 217a and 217b and
are optionally covered within a thin flexible sheath 218 that
carries longitudinal electrodes 245a and 245b. FIG. 8B shows that
arm elements 216a and 216b are articulatable from a proximal handle
of the device by cables and articulating means known in the art
thereby to capture tissue of wall W therebetween. It should be
appreciated that the electrodes may be carried directly on the arm
elements without a covering sheath. The sheath, however, is
preferred to make the instrument perform similar to a bougie for
ease of introduction into a patient's esophagus.
[0089] Referring to FIG. 9, the elongate device 205 further may
include an inflatable collar 220 that can be inflated with any
suitable medium, for example air or saline solution from a syringe
(not shown). Collar 220 is shown in phantom view in an inflated
condition and is position around a distal portion of the device.
Collar 220 is sufficiently large to prevent it from passing through
GE-junction as the device is lifted proximally and thus may serve
as a means of positioning electrodes 245a and 245b and the
articulating arm elements in the LES.
[0090] In operation, a portion of the wall of the LES is shown in
sectional view in FIG. 10 being captured and engaged by arm
elements 216a and 216b (phantom view) of working end 215. The
sectional view depicts the targeted tissue T as a hatched regions
in interiors of the wall W of the LES as when Rf energy is
delivered in a bi-polar manner between the paired electrodes
(mono-polar flow also is possible). The treatment may be in a
single location or repeated in a plurality of locations. In order
for the arm elements and sheath 218 to better engage the well of
the LES, gripping elements known in the art may be configured in
the sheath or arm elements to grip tissue (e.g., penetrating
elements; tissue gripping studs, or suction apertures communicating
with remote suction source) and are intended be encompassed by the
scope of the invention.
[0091] FIG. 11A illustrates another embodiment of Type "B" device
in which roller elements 250a and 250b are carried in arm elements
216a and 216b to progressively the engage the wall W of the LES and
delivery Rf energy between various paired electrodes 245a-245n in
the roller elements 250a and 250b. This manner of Rf energy
delivery was disclosed in Provisional Application Ser. No.
60/024,974 filed on Aug. 30, 1996 and follow-on patent application
Ser. No. 09/920,291 filed on Aug. 28, 1997, and incorporated
therein Provisional Application Ser. No. 60/022,790 filed on Jul.
30, 1996 titled Less Invasive Surgical Instruments and Techniques
for Treating Sleep Apnea and Snoring; all of which applications are
incorporated herein in their entirety by this reference. (In the
earlier disclosures, one of the applications of Rf energy delivery
was to model the flexibility of a patient's soft palate by means of
collagen synthesis and/or collagen shrinkage therein). FIG. 11B is
a sectional view of a small portion of the LES with a wall W
engaged between rollers 250a and 250b and targeted tissue T
receiving Rf energy as described above.
[0092] Another variant of Type "B" device is shown in FIG. 12A in
which articulating arm elements 252a and 252b are carried in a
manner to engage the wall W of the LES at 90.degree. to the
previously described embodiment. In other words, the articulating
elements 252a and 252b are adapted to capture a portion of wall W
treat tissue in a fold around a part of a circumference of the LES
rather than in a longitudinal fold described previously. Such a
manner of capturing tissue and delivering Rf energy to the wall W
of an organ was disclosed in Provisional Application Ser. No.
60/024,974 filed on Aug. 30, 1996 and follow-on patent application
Ser. No. 09/920,291 filed on Aug. 28, 1997 (incorporated herein by
reference). FIG. 12B is a view of a small portion of the LES with a
wall W engaged by articulating elements 252a and 252b and further
indicating targeted tissue T receiving Rf energy in any of the
manners described previously.
4. Type "C" System for Thermally-Mediated LES Therapy
[0093] By way of example, FIGS. 13A-13C depict an alternative of
LES treatment system that may be utilized for performing the
above-described methods of treating a lower esophageal sphincter,
but this time with the assistance of a separate device from the
exterior of the LES in an endoscopic procedure. At the same time,
an intraluminal device is used to size or gauge lumen 100 of the
esophagus 102. More in particular, the system includes intraluminal
esophageal device 305 which is substantially similar to the Type
"A" device described above, and hereafter will have similar
elements described with the same reference numerals as used above
in the Type "A" device. The intraluminal device 305 further
includes an inflatable collar 307 that can be inflated with any
suitable medium, for example air or saline solution from a syringe
(not shown). Collar 307 is shown in phantom view in an inflated
condition and is position around a distal portion of the device.
Collar 307 is sufficiently large to prevent it from passing through
the GE-junction as the device is lifted proximally as a means of
positioning electrodes 45a-45n in the LES.
[0094] Intraluminal device 305 cooperates with extraluminal device
310 also shown in FIG. 13A-13C. The extraluminal device 310 has
elongate introducer member with proximal end 310a and is adapted
for introduction in the interior of the body through a cannula
(e.g., a 5-20 mm trocar sleeve) working end 315 is carried in the
distal portion of introducer member 310a and comprises an
articulatable of flexible section 320 section that has a
esophagus-contacting surface portion 322. The esophagus-contacting
portion 322 may be substantially planar (see FIG. 13B) but
preferably has an at least partial circumferential receiving
surface 323 for fitting closely around the esophagus 102 when
intraluminal device 305 is positioned within lumen 100 of the
esophagus (see FIG. 13C).
[0095] As can be seen in FIG. 13A, the extraluminal device 310 has
at least one and preferable a plurality of electrodes 345a-345n
within working end 315. FIG. 14 shows in a (sectional) perspective
view that the electrodes 345a-345n of extraluminal device 310 are
adapted to cooperate with electrodes 45a-45b of intraluminal device
305. In use, the electrodes of the two devices, 305 and 310,
preferably are adapted to operate in a bi-polar manner with current
passing from the extraluminal device to the intraluminal device or
vice versa, or in a bi-polar manner between paired electrodes in
the extraluminal member with the intraluminal electrodes not
activated but facilitating current flow through wall W (or vice
versa). Further, the bi-polar operation of the device may be along
a various multiplexed vectors as described previously. The
extraluminal device may have all the temperature sensing
capabilities, impedance monitoring capabilities, and other feedback
capabilities of the Type "A" device described above.
[0096] Alternatively, another embodiment of extraluminal device may
be used to deliver a thermally-mediated treatment as described
above, but only from the exterior of the esophagus to targeted
tissue in the LES. In some cases, Rf energy delivery only from the
exterior of the LES may be preferred because it would then be
unnecessary to elevate the temperature of surface 104 or mucous
membrane of the esophageal lumen 100. As described above, the
exterior approach logically would be performed only when the
surgeon needed to endoscopically access the patient's abdominal
cavity for other reasons, e.g., to treat a hiatal hernia that
sometimes contributes to GERD. Since several ports are necessary to
endoscopically correct a hiatal hernia, the use of such an
extraluminal instrument would make such a procedure no more
invasive. In either a mono-polar or bi-polar operating mode, the
intraluminal device may simply be a conventional bougie to "stent"
the esophagus while performing the thermally-mediated Rf treatment
of the LES from its exterior with device 310. FIG. 14 shows the
positioning of the devices 305 and 310 in a manner of practicing a
method of the invention The extraluminal device may have an
articulatable working end so that the esophagus-contacting portion
may be easily oriented to lay against the LES. Such a working end
may be hinged or flexible by any suitable means (e.g., a pull wire
or reciprocating rod mechanism), with the specific articulation
characteristics partly dependent on the location of the port which
is used to introduce the device into the patient's body.
[0097] FIG. 15 depicts another embodiment of LES treatment device
335 that may be utilized for thermally-mediated treatment of the
LES from its exterior in an endoscopic procedure. This embodiment
of extraluminal device has any suitable closing mechanism for
closing the at least two esophagus-contacting portions 336a and
336b around the LES and esophagus. Such an embodiment would allow
the delivery of thermal energy at least partly around the
circumference of the LES, and even entirely around the
circumference of the LES if so desired. This embodiment would
require that the distal esophagus and LES be mobilized before
utilizing the device. Again, this device would find use in cases
that require repair of a hiatal hernia wherein mobilization of the
distal esophagus is required. As shown in FIG. 15, the two
esophagus-contacting portions 336a and 336b are actuated by
reciprocation of sleeve 340 over cam-type elements 342a and
342b.
[0098] It should be appreciated that the combination of
intraluminal and extraluminal devices are preferably indexable by
any suitable means, by which is meant that it would be desirable to
have electrodes of the intraluminal device and the electrodes of
the cooperating extraluminal device maintainable in a particular
alignment or registration, both axially and angularly. A preferable
means is to provide a fiber optic light source in the intraluminal
component of the system that will transilluminate the wall W of the
LES, thereby allowing the physician to position markings (or
apertures) on the extraluminal device relative to the points of
transillumination. The two esophagus-contacting portions of the
extraluminal instrument are preferably made of a transparent
plastic material.
[0099] It should be appreciated that the surface 18 of working end
15 may carry cooling means as known in the art, wherein cooling
lumens may circulate a coolant fluid within the extension member to
maintain the surface 104 of the esophageal lumen 100 at a cooled
temperature. Alternatively, the extension member may carry the
semiconductor Peltier cooling means disclosed in co-pending U.S.
patent application Ser. No. 09/110,065 filed Jul. 3, 1998 titled
Semiconductor Contact Lens Cooling System and Technique for
Light-Mediated Eye Therapies. It should also be appreciated that
variations on the thermally-mediated treatments disclosed herein
may be accomplished with penetrating needle-type electrodes in a
working end 15 as known in the art that can be actuated from a
handle portion of an elongate member although this is not a
preferred approach.
[0100] From the foregoing it can be seen that there are provided
techniques and instruments that will selectively accomplish
thermally-mediated treatments of targeted collagenous tissues in a
patient's LES without substantially necrosing or ablating the
surface 104 of the esophageal lumen 100. The device can be utilized
to selectively injure cells to induce a biological response to
populate target tissue site T with a collagen fiber matrix. The
device further can be utilized to contract collagen-containing
tissue volumes to reduce the diameter of the lumen of LES. It can
be readily understood that such techniques of tissue modeling may
be applied to other lumens of other anatomic structures in the
body. For example, a treatment for urinary incontinence can be
effected to shrink tissue, tighten tissue or rigidify tissue with a
collagen matrix around the urethra with a trans-urethral Rf
instrument. Similarly, tissues around a patient's soft palates can
be treated. Specific features of the invention are shown in some
figures and not in others, and this is for convenience only and any
feature may be combined with another in accordance with the
invention. While the principles of the invention have been made
clear in the exemplary Type "A" through Type "C" versions, it will
be obvious to those skilled in the art that modifications of the
structure, arrangement, proportions, elements, and materials may be
utilized in the practice of the invention, and otherwise, which are
particularly adapted to specific environments and operative
requirements without departing from the principles of the
invention. The appended claims are intended to cover and embrace
any and all such modifications, with the limits only of the true
purview, spirit and scope of the invention.
* * * * *