U.S. patent application number 17/652628 was filed with the patent office on 2022-06-09 for methods and devices for treating sphincter disorders.
The applicant listed for this patent is Eschara Medical, LLC. Invention is credited to Ryan Timothy Balko, Gabriel L. Ganz, Robert A. Ganz, Justin James Herbert, Brett Allyn Williams.
Application Number | 20220175512 17/652628 |
Document ID | / |
Family ID | 1000006213155 |
Filed Date | 2022-06-09 |
United States Patent
Application |
20220175512 |
Kind Code |
A1 |
Ganz; Robert A. ; et
al. |
June 9, 2022 |
METHODS AND DEVICES FOR TREATING SPHINCTER DISORDERS
Abstract
Devices and methods for treatment of bodily lumens and
sphincters are disclosed. Some embodiments include methods and
devices for inducing an inflammatory response and development of
fibrosis, collagen, and/or scar tissue. In some embodiments,
scaffolds may be composed of a matrix of filaments. Application of
the methods and devices disclosed herein to treat Gastroesophageal
Reflux Disease (GERD) and other sphincter disorders are discussed.
Biodegradable scaffolds configured to induce an inflammatory
response are also disclosed.
Inventors: |
Ganz; Robert A.;
(Minnetonka, MN) ; Ganz; Gabriel L.; (Minnetonka,
MN) ; Balko; Ryan Timothy; (Rogers, MN) ;
Herbert; Justin James; (Osseo, MN) ; Williams; Brett
Allyn; (North Oaks, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Eschara Medical, LLC |
Minnetonka |
MN |
US |
|
|
Family ID: |
1000006213155 |
Appl. No.: |
17/652628 |
Filed: |
February 25, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2020/047831 |
Aug 25, 2020 |
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17652628 |
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62891803 |
Aug 26, 2019 |
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62895306 |
Sep 3, 2019 |
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62932260 |
Nov 7, 2019 |
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62978083 |
Feb 18, 2020 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2210/0004 20130101;
A61F 2002/044 20130101; A61F 2/04 20130101 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1.-189. (canceled)
190. A scaffold for inducing an inflammatory response, the scaffold
comprising: a matrix comprising a plurality of bioabsorbable
filaments wherein the matrix is configured to be disposed adjacent
a sphincter within a patient.
191. The scaffold of claim 190, wherein the matrix is configured to
be disposed circumferentially around the sphincter.
192. The scaffold of claim 190, wherein the matrix is configured to
be disposed hemicircumferentially or partially circumferentially
around the sphincter.
193. The scaffold of claim 190, wherein the matrix is configured to
be disposed around portions of the sphincter in piecemeal
fashion.
194. The scaffold of claim 190, wherein the scaffold is configured
to induce the formation of a tissue collar adjacent the
sphincter.
195. The scaffold of claim 190, wherein the scaffold comprises a
flat woven shape or a tubular shape.
196. The scaffold of claim 190, wherein the matrix comprises a
constant filament density along the length of the scaffold.
197. The scaffold of claim 190, wherein the matrix comprises
synthetic bioabsorbable filaments.
198. The scaffold of claim 197, further comprising one or more
nonbioabsorbable materials.
199. The scaffold of claim 190, wherein the matrix comprises
polymeric bioabsorbable filaments at least partially coated with at
least one the following: a metal material, a ceramic material, a
composite material, or a glass material.
200. The scaffold of claim 190, wherein the matrix comprises
polymeric bioabsorbable filaments.
201. The scaffold of claim 200, further comprising gold particles
disposed in or on a portion of the scaffold.
202. The scaffold of claim 190, wherein the matrix is composed a
first plurality of filaments comprising a first material and a
second plurality of filaments comprising a second material.
203. The scaffold of claim 202, wherein an expected time for the
first material to be bioabsorbed differs from an expected time for
the second material to be bioabsorbed.
204. A method of reinforcing a sphincter comprising: disposing a
scaffold of bioabsorbable material adjacent a body organ or lumen
containing the sphincter to induce the development of a tissue
collar around a portion of the periphery of the sphincter.
205. The method of claim 204, wherein the scaffold of bioabsorbable
material is disposed adjacent the body organ or lumen containing
the sphincter such that the scaffold does not compress the
sphincter.
206. The method of claim 204, comprising disposing the scaffold of
bioabsorbable material adjacent the gastro-esophageal junction
and/or the esophagus and below the diaphragm to induce formation of
the tissue collar adjacent the esophagus and the underside of the
diaphragm.
207. The method of claim 206, wherein the tissue collar maintains a
position of at least a portion of the gastro-esophageal junction
distal to the diaphragm.
208. The method of claim 206, wherein the tissue collar directly
fixes the esophagus to the diaphragm.
209. The method of claim 206, further comprising repairing and/or
maintaining a repair of a hernia by inducing growth of the tissue
collar adjacent the crus muscles of the diaphragm to couple
portions of the crus muscles to each other.
Description
RELATED CASES
[0001] This application is a continuation of PCT Application No.
PCT/US2020/047831, filed on Aug. 25, 2020 a titled, "Methods and
Devices for Treating Sphincter Disorders," which, in turn, claims
priority to the following applications: U.S. Provisional
Application No. 62/891,803, filed on Aug. 26, 2019 and titled,
"Method and Device to treat Gastroesophageal Reflux Disease (GERD)
and other Sphincter Disorders"; U.S. Provisional Application No.
62/895,306, filed on Sep. 3, 2019 and titled, "Method and Device to
treat Gastroesophageal Reflux Disease (GERD) and other Sphincter
Disorders"; U.S. Provisional Application No. 62/932,260, filed on
Nov. 7, 2019 and titled, "Method and Device to treat
Gastroesophageal Reflux Disease (GERD) and other Sphincter
Disorders"; and U.S. Provisional Application No. 62/978,083, filed
on Feb. 18, 2020 and titled, "Method and Device to treat
Gastroesophageal Reflux Disease (GERD) and other Sphincter
Disorders." Each priority application listed above is hereby
incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] The present disclosure relates generally to the field of
implantable medical devices and associated methods. More
particularly, some embodiments relate to biodegradable implantable
devices and methods for reinforcement of a sphincter, such as the
lower esophageal sphincter (LES), including devices and methods for
reinforcing a sphincter through inducing a biologic response to an
implantable device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] The written disclosure herein describes illustrative
embodiments that are non-limiting and non-exhaustive. Reference is
made to certain of such illustrative embodiments that are depicted
in the figures, in which:
[0004] FIG. 1A is an illustration of a portion of an esophagus and
stomach of a patient and the lower esophageal sphincter (LES)
between the stomach and esophagus.
[0005] FIG. 1B is an illustration of the portion of the esophagus
and stomach of FIG. 1A, illustrating gastric reflux through the
LES.
[0006] FIG. 2A illustrates a biodegradable scaffold around a
portion of an esophagus, stomach, and LES.
[0007] FIG. 2B is a cross sectional view of a portion of the
esophagus, stomach, and LES of FIG. 2A depicting sphincter and
scaffold function during swallowing of a food bolus (note the
scaffold is not in cross section).
[0008] FIG. 2C is a cross sectional view of the portion of the
esophagus and stomach of FIG. 2A with the LES in a different state
than that of FIG. 2B depicting sphincter and biodegradable scaffold
function in closed state (note the scaffold is not in cross
section).
[0009] FIG. 2D illustrates the portion of the esophagus, stomach,
and LES of FIG. 2A showing tissue growth in response to the
scaffold of FIG. 2A after bioabsorption of the scaffold.
[0010] FIG. 2E is a cross sectional view of a portion of the
esophagus, stomach, and LES of FIG. 2A with a scaffold disposed
around the esophagus (note the scaffold is not in cross
section).
[0011] FIG. 2F is a portion of the esophagus, stomach, and LES of
FIG. 2E showing tissue growth in response to the scaffold of FIG.
2E after bioabsorption of the scaffold.
[0012] FIG. 2G is a view of the inferior aspect of the diaphragm,
specifically the crus muscles and diaphragmatic hiatus, through
which the esophagus exits, the esophagus and tissue growth of FIG.
2F.
[0013] FIG. 3A illustrates one embodiment of a biodegradable
tubular scaffold.
[0014] FIG. 3B illustrates another embodiment of a tubular
scaffold.
[0015] FIG. 3C illustrates another embodiment of a tubular
scaffold.
[0016] FIG. 3D illustrates an embodiment of a flat woven
scaffold.
[0017] FIG. 3E illustrates the tubular scaffolds of FIGS. 3A and 3B
disposed in a coaxial arrangement.
[0018] FIG. 3F illustrates another embodiment of a tubular
scaffold.
[0019] FIG. 3G illustrates yet another embodiment of a tubular
scaffold.
[0020] FIG. 4A illustrates the tubular scaffold of FIG. 3A disposed
in a circumferential loop.
[0021] FIG. 4B illustrates a tubular scaffold disposed to define
multiple helical loops.
[0022] FIG. 4C illustrates the flat woven scaffold of FIG. 3D
disposed in overlapping loops.
[0023] FIG. 4D illustrates the flat woven scaffold of FIG. 3D
disposed around a portion of the esophagus, stomach, and LES.
[0024] FIG. 4E illustrates the scaffold of FIG. 3D, shown with
tongue and groove coupling features on opposite ends of the
scaffold.
[0025] FIG. 5A illustrates a portion of an esophagus, stomach, and
LES with a needle for introducing bioabsorbable material.
[0026] FIG. 5B illustrates the portion of the esophagus, stomach,
and LES of FIG. 5A showing tissue growth in response to the
material of FIG. 5A after bioabsorption of the material.
[0027] FIG. 6A illustrates a portion of a colon, rectum, and anal
sphincter with a biodegradable scaffold shown around the anal
sphincter.
[0028] FIG. 6B illustrates a portion of the colon, rectum, and anal
sphincter of FIG. 6A with a tissue collar shown around the
sphincter after bioabsorption of the scaffold.
[0029] FIG. 6C illustrates a portion of a bladder, urethra, and
urethral sphincter with a biodegradable scaffold shown around the
urethral sphincter.
[0030] FIG. 6D illustrates a portion of the bladder, urethra, and
urinary sphincter of FIG. 6C with a tissue collar shown around the
urethral sphincter after bioabsorption of the scaffold.
DETAILED DESCRIPTION
[0031] The components of the embodiments as generally described and
illustrated in the figures herein can be arranged and designed in a
wide variety of different configurations. Thus, the following more
detailed description of various embodiments, as represented in the
figures, is not intended to limit the scope of the present
disclosure but is merely representative of various embodiments.
While various aspects of the embodiments are presented in drawings,
the drawings are not necessarily drawn to scale unless specifically
indicated.
[0032] The phrase "coupled to" is broad enough to refer to any
suitable coupling or other form of interaction between two or more
entities, including mechanical and fluidic interaction. Two
components may be coupled to each other even though they are not in
direct contact with each other. The phrases "attached to" or
"attached directly to" refer to interaction between two or more
entities which are in direct contact with each other and/or are
separated from each other only by a fastener of any suitable
variety (e.g., an adhesive). The phrase "fluid communication" is
used in its ordinary sense, and is broad enough to refer to
arrangements in which a fluid (e.g., a gas or a liquid) can flow
from one element to another element when the elements are in fluid
communication with each other.
[0033] As used herein, "biodegradable" and "bioabsorbable" are used
to describe materials that break down when implanted in the body.
Examples of biodegradable and/or bioabsorbable materials include
suture materials that are molecularly broken down when implanted in
the body. Materials within the scope of this definition include
materials that break down within a few days of implantation as well
as materials that break down over a time period of days to years,
including materials that break down in the body over several days,
materials that break down in the body over several weeks, materials
break down in the body over several months, and materials that
break down in the body over years.
[0034] As used herein, a "tissue collar" refers to any tissue
genesis, neogenesis, growth, or thickening induced by an
inflammatory response to the introduction of a bioabsorbable
material, including tissue growth comprising an acute and/or
chronic cellular response, foreign body reaction, granuloma
formation, giant cell formation, fibrosis, collagen, and/or scar
tissue.
[0035] Placement of a foreign material within the human body
generally results in an inflammatory response to the foreign body.
This response can be characterized as an initial acute inflammation
(neutrophils), followed by chronic inflammation (monocytes,
lymphocytes), then granuloma formation/granulation tissue, followed
by giant foreign body cell formation, and finally the formation of
fibrosis, collagen, and/or scar tissue. Treatments within the scope
of this disclosure include the deliberate inducement of an
inflammatory response, and the formation of the fibrosis, collagen,
and/or scar tissue that follows to support or reinforce a
sphincter.
[0036] Sphincters are rings of muscle tissue that surround lumens,
passages, openings, and/or portions of organs within the body.
Sphincters in a human body are typically tonically contracted, and
such contraction of a sphincter may close or narrow the sphincter
in order to control passage of gas, fluids, food, stool, urine, or
other materials through the sphincter, in either direction (for
example oral or aboral with reference to the esophagus). In some
instances, a sphincter may lose the ability to close off or control
material passage. For example, a sphincter may be stretched, be
injured or deteriorate with age and thus lose efficacy, or the
ability to control material passage through the sphincter.
[0037] The esophagus extends along the gastrointestinal tract to
the upper portion of the stomach. The lower esophageal sphincter
(LES) is a sphincter disposed between the esophagus and the stomach
and controls flow between those two organs. The gastroesophageal
junction (GEJ) refers to the area or zone of transition between the
esophagus and the stomach. The GEJ can be understood as including a
small distal portion of the esophagus, a small proximal portion of
the stomach, and the transition area between these portions. The
LES is disposed in the region of the GEJ.
[0038] The LES is one example of a sphincter that may lose efficacy
in humans. For example, the LES may fail to close, or only be able
to close partially, or the sphincter may close but be too easily
opened when subjected to increased gastric volume or increased
gastric or intra-abdominal pressure.
[0039] Gastroesophageal reflux disease (GERD) refers to pathologic
reflux or regurgitation of gastric content into the esophagus from
the stomach. Gastric content refers to materials present in the
stomach such as acid, bile, pepsin, pancreatic enzymes, partially
digested food, and so forth. GERD may result from failure of the
LES in closing off the opening between the esophagus and the
stomach, i.e., the sphincter can be lax, hypotensive or patulous,
or the LES can close but can be forced open too easily by excess
gastric volume or pressure or increased intra-abdominal pressure.
While small amounts of reflux occur in healthy individuals, GERD
refers to conditions where the refluxed material is large enough or
frequent enough to cause damage to the esophagus, cause heartburn,
regurgitation, other chest discomfort, or other symptoms. Damage to
the esophagus may be associated with conditions such as reflux
esophagitis, Barrett's esophagus, esophageal stricture, ulceration,
and bleeding, for example, while other symptoms of GERD include
heartburn, regurgitation, and chest discomfort. Various factors
including age, stress to the LES from overeating, obesity, trauma,
and various anatomical changes such as hiatal hernia, may lead to
shortening of the overall sphincter length, or intra-abdominal LES
length, or loss of sphincter pressure, leading to sphincter
dysfunction and subsequent GERD. The sphincter can weaken or fail
because it is too weak or too short to maintain adequate closure,
or the sphincter becomes excessively compliant and can be forced
open too easily.
[0040] GERD is a common condition affecting various populations. In
the United States, there are at least 60 million individuals with
GERD with at least 20 million cases severe enough to require daily
treatment by medication. Treatments for GERD include lifestyle
changes such as weight loss and elevation of the head of the bed,
and medications, including anti-acids or antisecretory medications,
and anti-reflux surgery or anti-reflux endoscopic techniques.
[0041] Medications for treatment of GERD include antisecretory
medications such as H2 receptor antagonists (Tagamet and Zantac,
etc.) as well as proton pump inhibitors (PPIs) such as Prilosec and
Nexium, etc. H2 receptor antagonists and PPIs partially or
completely block gastric acid secretion, helping to improve GERD
symptoms and facilitate healing of esophagitis. However,
antisecretory medications fail to control symptoms at least 30% of
the time, are expensive, do not address the reflux pathophysiology,
and can be associated with side effects such as vitamin and mineral
malabsorption, kidney disease, osteoporosis, increased diarrhea,
etc.
[0042] Surgical and endoscope treatments for GERD include
permanently positioning the proximal portion of the stomach around
the LES (i.e., Nissen fundoplication), or implantation of permanent
materials or devices configured to augment, support, or extend the
effective length of the LES, and/or augment the sphincter to
decrease compliance (e.g., LINX magnetic augmentation). These
techniques can be effective in treating the symptoms of GERD and
can help address GERD pathophysiology, however they are frequently
associated with side effects related to the permanent nature of the
implanted materials, including dysphagia, gas-bloat syndrome, vagal
nerve damage, and device migration.
[0043] Methods of treatment within the scope of this disclosure
include methods of inducing an inflammatory response and/or
inducing the formation of a tissue collar adjacent a sphincter
location, to reinforce the sphincter or otherwise favorably affect
sphincter mechanics. Tissue collars adjacent may be adjacent to the
sphincter in various patterns (such as circumferential, hemi
circumferential, piecemeal, and so forth) including embodiments
wherein the tissue collar is adjacent and/or around a body lumen or
organ that includes the sphincter. The tissue collar may be
adjacent the sphincter in a position where the tissue collar is
external to the sphincter and/or external to lumen or organ tissue
around the sphincter. Embodiments of bioabsorbable devices
configured to induce such an inflammatory and/or tissue response
are also within the scope of this disclosure. Methods of treatment
wherein a bioabsorbable device is completely bioabsorbed and only a
tissue cuff remains to reinforce a sphincter, as well as methods
where a portion of an otherwise bioabsorbable device remains
adjacent the sphincter along with the tissue cuff are within the
scope of this disclosure. One of ordinary skill in the art, having
the benefit of this disclosure, will recognize that a variety of
structures and devices may be designed and configured to induce a
desired inflammatory and/or tissue response and the present
disclosure is not limited to the specifically disclosed examples of
implantable devices.
[0044] In some embodiments, the present disclosure relates to
devices and methods for introducing a bioabsorbable material into
the body to stimulate an inflammatory response and/or tissue growth
adjacent a sphincter. The bioabsorbable material may be adjacent to
the sphincter in various patterns (such as circumferential, hemi
circumferential, piecemeal, and so forth) including embodiments
wherein the bioabsorbable material adjacent and/or around a body
lumen or organ that includes the sphincter. The bioabsorbable
material may be adjacent the sphincter in a position where the
bioabsorbable material is external to the sphincter and/or external
to lumen or organ tissue around the sphincter, including instances
wherein there is a gap between the bioabsorbable material and a
wall of lumen or organ containing the sphincter. In some
embodiments, a bioabsorbable material introduced adjacent to,
and/or around the wall of a body lumen or organ adjacent a
sphincter will induce a biologic response around said wall of the
body lumen as the material bioabsorbs. This biologic response may,
in turn, result in development of acute inflammation, chronic
inflammation, granuloma formation, foreign body giant cell
formation, fibrosis, collagen, and/or scar tissue at the treatment
site. In other words, the bioabsorbable material may induce
formation of a tissue collar. This tissue may tend to stabilize and
reinforce the lumen wall adjacent the sphincter, decreasing wall
compliance, increasing functional sphincter length, and augmenting
sphincter performance at the sphincter site and restoring sphincter
functionality. Devices wherein a bioabsorbable device is completely
bioabsorbed and only a tissue cuff remains to reinforce a
sphincter, as well as methods where a portion of an otherwise
bioabsorbable device remains adjacent the sphincter along with the
tissue cuff are within the scope of this disclosure.
[0045] As compared to implantation of permanent devices into a
patient, use of bioabsorbable materials reduces or eliminates
adverse issues and side effects related to permanent devices such
as infection, migration, dysphagia, gas-bloat syndrome, vagal nerve
damage, etc.
[0046] Though certain specific applications, such as treatment of
the LES, may be described herein, application and adaptation of the
devices and methods discussed herein to any sphincter is within the
scope of this disclosure. Discussion of specific examples does not
limit the application of these concepts to those examples.
[0047] In some embodiments the present disclosure includes
implantation of a bioabsorbable scaffold around a portion of the
esophagus, stomach, and GEJ in the region of the LES. Development
of fibrosis, collagen, and/or scar tissue adjacent to, and/or
around, the esophageal wall may tend to reinforce the esophageal
wall adjacent the LES and, in turn, augment, stabilize and restore
functionality to the LES.
[0048] As further detailed herein, devices and methods within the
scope of this disclosure may induce a tissue response in a variety
of ways using a variety of bioabsorbable materials. It is within
the scope of this disclosure to modify parameters such as surface
area of a bioabsorbable implant, rate of bioabsorption (including
use of multiple materials with different bioabsorption rates),
porosity of the implant, shape of the implant, height and width of
the implant, location of the introduction of the bioabsorbable
material, pattern of introduction of the bioabsorbable material,
tensile strength of the materials implanted, and so forth to affect
the treatment.
[0049] FIG. 1A is an illustration of a portion of an esophagus 10
and a stomach 20 of a patient. A lower esophageal sphincter (LES)
30 is also shown in a partial cutaway view. As shown in FIG. 1A,
the LES 30 is in a baseline, closed state. In this position, the
LES 30 reduces or prevents reflux of the contents of the stomach 20
into the esophagus 10. In healthy individuals, the LES 30 is
further configured to intermittently relax and open to allow
passage of food from the esophagus 10 into the stomach 20 while
limiting reflux.
[0050] As noted above, age, persistent overeating with stretching
of the LES, obesity and other conditions can effectively decrease
sphincter pressure or loosen and/or shorten the LES 30. In such
instances, the ability of the LES 30 to limit reflux may be
compromised, resulting in excess reflux or regurgitation of stomach
contents into the esophagus 10 and, potentially, result in
GERD.
[0051] FIG. 1B is an illustration of the portion of the esophagus
10 and the stomach 20 of FIG. 1A. As compared to FIG. 1A, however,
in FIG. 1B, the LES 30 is partially open, allowing reflux material
40 to travel from the stomach 20 to the esophagus 10. Thus, in
patients where the LES 30 frequently or permanently fails to fully
close, and/or can be more easily forced open, said gastric reflux
may lead to GERD and other conditions.
[0052] Introduction of a foreign material within the human body
will provoke an inflammatory response as described above, whether
the foreign material is permanent or bioabsorbable. Additionally,
foreign material breaking down and being absorbed by the body will
further invoke an inflammatory response. As bioabsorbable foreign
material is broken down within the human body, among other
substances, lactic acid can build up in the area around the
bioabsorbed material, which induces a local decrease in pH, and an
additional inflammatory response. In other words, the inflammatory
response to a bioabsorbable material is driven by both the physical
presence of the material itself (and the body's reaction thereto)
and chemical changes that result as the material is broken down
during bioabsorbtion, which also can trigger an additional
response.
[0053] Accordingly, as detailed herein, the inflammatory response
to devices within the scope of this disclosure may vary over time.
For example, a device may be comprised of two or more materials
with different rates of bioabsorbtion, including materials that
bioabsorb relatively rapidly at first resulting in a "burst" of
bioabsorbtion, and thus a burst of inflammatory response, then
followed by a material with relatively slower bioabsorption and a
more delayed inflammatory response. A single device may be
comprised of two, three, four, or more materials, each configured
to invoke a burst of inflammatory response at different times.
Materials with different expected rates or time periods of
bioabsorption may be used to create devices within the scope of
this disclosure.
[0054] FIG. 2A illustrates a bioabsorbable scaffold 100 around a
portion of an esophagus 10 at the gastroesophageal junction (GEJ),
in the region of the LES, between the esophagus 10 and the stomach
20. As noted above, introduction of a foreign material, such as the
scaffold 100, induces an inflammatory response around the tissue of
the wall of the esophagus 10.
[0055] FIG. 2B is a cross sectional view of a portion of the
esophagus 10 of FIG. 2A. FIG. 2B also illustrates the scaffold 100
disposed around the wall of the esophagus 10, at the GEJ and in the
region of the LES 30. For clarity in illustration, the scaffold 100
is not shown in cross section. As noted above, the muscular LES 30
is within the GEJ between the stomach 20 and the esophagus 10. In
the illustrated configuration, a bolus of food 45 is shown passing
from the esophagus 10, through the LES 30, and into the stomach
20.
[0056] FIG. 2C is a cross sectional view of the portion of the
esophagus 10 of FIG. 2A with the LES 30 in a closed state, as
compared to the open state of FIG. 2B. For clarity in illustration,
the scaffold 100 is not shown in cross section.
[0057] With reference to FIGS. 2A-2C, the scaffold 100 may be
disposed around the esophagus 10 such that it approximates and/or
is contiguous to the esophagus, but does not exert a compressive
force on the esophagus 10 when the esophagus 10 and LES 30 are in a
closed state. For example, the scaffold 100 may be sized such that
when food is not disposed within the esophagus 10, the scaffold 100
is loosely disposed around the esophagus 10. The scaffold 100 may
also be sized such that is it configured to match the size of the
esophagus 10 in a relaxed state, that is, it does not compress the
esophagus 10, but also has limited slack around the circumference
of the esophagus 10. As shown in FIG. 2B, passage of food through
the esophagus 10, the LES 30, and the scaffold 100 may tend to
enlarge the esophagus 10, leading to a tighter interaction with the
scaffold 100. In some embodiments, the scaffold 100 may be
configured to flexibly expand and contract in such instances with
the passage of food.
[0058] Embodiments wherein the scaffold 100 is more tightly coupled
to the esophagus 10 are also within the scope of this disclosure.
For instance, depending on the weakness of the LES 30 and the
degree to which the LES 30 is excessively compliant or damaged, a
practitioner may elect to more tightly constrain the GEJ to better
support the LES 30. Thus, embodiments wherein the scaffold 100 is
tightly coupled to the esophagus in the region of the GEJ and LES,
embodiments wherein the scaffold 100 is loosely disposed around the
esophagus in the region of the GEJ and LES, and embodiments wherein
the scaffold 100 is configured to contact but not compress the
esophagus in the region of the GEJ and LES are all within the scope
of this disclosure. Furthermore, any such arrangement of the
scaffold 100 with respect to the esophagus 10 may induce an
inflammatory response. Treatments within the scope of this
disclosure include reinforcing a sphincter only with
scaffold-induced tissue growth, not necessarily requiring
compressive or supportive pressure to be exerted by the scaffold
100.
[0059] As noted above, and further discussed below, the scaffold
100 may be comprised of a bioabsorbable material. As the
bioabsorbable scaffold material breaks down, the scaffold 100 is
ultimately completely bioabsorbed by the body and ultimately
disappears completely, leading to a condition where only the tissue
generated by the inflammatory response remains at the treatment
location. The induced tissue growth, which can be understood as a
tissue collar or collar of fibrosis, collagen, and/or scar tissue,
may thus continue to reinforce the sphincter after the scaffold 100
is no longer present. As also noted above, a "tissue collar" as
used herein refers to any tissue genesis, neogenesis, growth or
thickening induced by an inflammatory response to the introduction
of a bioabsorbable material, including tissue growth comprising
fibrosis, collagen, and/or scar tissue.
[0060] FIG. 2D depicts the portion of the esophagus 10 of FIG. 2A
showing tissue growth as a tissue collar 150 in response to the
scaffold 100 of FIG. 2A. Thus, FIG. 2D illustrates the state where
the scaffold 100 of FIGS. 2A-2C has been completely broken down and
absorbed by the body and only the tissue collar 150 remains to
reinforce and support the LES 30.
[0061] The tissue collar 150 may augment and reinforce the wall of
the esophagus 10, in the region of the GEJ/LES, augmenting the
sphincter via increasing functional sphincter length and reducing
compliance adjacent the LES 30. This, in turn, may make the LES 30
less likely to allow reflux, thus treating reflux symptoms and GERD
and promoting healing of injuries to the esophagus 10 caused by the
frequent presence of reflux material. The tissue collar 150 may be
disposed adjacent to the outside surface of the esophagus 10 and
thus may not constrict or narrow the lumen of the esophagus 10.
[0062] Treatments wherein a sphincter is treated by reinforcing the
corresponding body organ and/or lumen along a length of the organ
and/or lumen extending from a position along and also beyond the
sphincter on one or both ends of the sphincter are also within the
scope of this disclosure. In other words, treatments may be
configured to induce the growth of a tissue collar (such as tissue
collar 150) that begins at a location along a body organ or lumen
along, proximal, and/or distal of the location of the sphincter
along the body organ or lumen. Treatments configured to induce
growth of a continuous tissue collar along the treatment length as
well as treatments comprising discrete circumferential bands at two
or more positions along the treatment length are likewise within
the scope of this disclosure.
[0063] Methods of treatment of organ wall, lumen and sphincter may
thus comprise methods of inducing inflammation and/or the formation
of a tissue collar to reinforce body organ, lumen or tissue along
or adjacent the sphincter location. Additionally, in some
embodiments, treatment methods may additionally or alternatively
comprise inducing an inflammatory response and/or the formation of
a tissue collar to anchor the organ itself and or the lumen to
other body structures adjacent the organ or the lumen. In one
potential example, referring back to FIGS. 2E-2G, treatment of the
LES 30 may comprise anchoring the esophagus 10 to the diaphragm 50.
FIG. 2E is a cross sectional view of a portion of the esophagus 10
with a scaffold 100' disposed around the esophagus 10 in two loops.
For clarity in illustration, the scaffold 100' is not shown in
cross section. FIG. 2F is a portion of the esophagus 10 showing
tissue growth 150' in response to the scaffold 100' from FIG. 2E.
FIG. 2G is an inferior view of the diaphragm and diaphragmatic crus
muscles 51 and diaphragmatic hiatus 52 where the esophagus 10
passes through the diaphragm 50, and tissue growth 150' from the
scaffold 100' of FIG. 2E. The stomach 20 and LES 30 are also shown
in these figures. Though FIG. 2F illustrates a single tissue collar
150' formed from both loops of the scaffold 100', treatments where
any number of scaffolds are spaced such as to form discrete tissue
collar rings are likewise within the scope of this disclosure.
[0064] As shown FIGS. 2E to 2G, the esophagus 10 may pass through
the diaphragm 50 near or adjacent the LES 30. Placement of the
scaffold 100 may be configured to induce formation of a tissue
collar that tends to couple the esophagus 10 and/or the stomach 20,
and/or the GEJ to the diaphragm 50. For example, the scaffold 100
may be placed in contact with or in proximity to the diaphragm 50
as well as the esophagus 10 and/or the stomach 20. The induced
tissue collar (150 of FIG. 2D) may extend between the esophagus 10
and/or the stomach 20 to the diaphragm 50, coupling the diaphragm
50 to the esophagus 10 to further reinforce the esophageal
sphincter by keeping it in physiologic position within the
diaphragmatic hiatus and/or distal to the diaphragm. By scarring
the GEJ/LES in this position, the LES is buttressed by the
diaphragm restoring sphincter competency.
[0065] Such a treatment may also comprise a treatment for a hiatal
hernia, a condition where a portion of the stomach 20 extends
proximally through a weakened portion of the diaphragm 50 (such as
at or adjacent the diaphragmatic hiatus 52), i.e., an area where
the diaphragmatic crus muscles have separated (see, for example,
the view of FIG. 2G illustrating the relationship of the esophagus
10 and the crus muscles 51 of the diaphragm 50). Still further,
methods and devices within the scope of this disclosure may be
utilized to reinforce a hernia repair. For example, a practitioner
may repair a hernia by approximating and suturing the crus muscles
of the diaphragm 50 together, restoring the diaphragm to normal
function. Oftentimes, especially in elderly patients there is a
lack of collagen tissue in the region of the crus repair, and the
repair will fall apart post-operatively. By adding a bioabsorbable
scaffold in the region of the GEJ positioned to buttress the LES
but also impact the underside of the diaphragm, a practitioner can
add collagen and scar tissue to the crus muscles concurrently with
reinforcing the LES; this then will also reinforce a hiatal hernia
repair, often done in conjunction with anti-reflux surgery by
inducing formation of a tissue collar in the region of the crus
muscles between the diaphragm and esophagus to support the repair.
Thus by positioning the bioabsorbable material in the region of the
GEJ/LES and simultaneously on the underside of the diaphragm, in
the region of the crus muscles, as the material bioabsorbs and
collagen and scar tissue forms, the practitioner can augment the
LES, and also aid the longevity of a hiatal hernia repair by
helping anneal the crus muscles together, and can also scar the
GEJ/LES in appropriate physiologic position relative to the
diaphragmatic hiatus and/or below the diaphragm in the abdomen.
[0066] Various scaffold designs are within the scope of this
disclosure. Scaffolds within the scope of this disclosure may
comprise various weaves or webbing of filaments, including
monofilaments and/or braided filaments, alone or in combination.
Scaffolds may also comprise continuous materials, strips of porous
materials, and so forth. Scaffolds may be configured to be applied
as multiple wraps around a body lumen, such as wrapped helically
around and along a longitudinal length of the lumen. Scaffolds may
be configured with multiple layers and may be applied in multiple
layers. Scaffolds within the scope of this disclosure may include
markings denoting length along the longitudinal length of the
scaffold.
[0067] Additionally, scaffolds within the scope of this disclosure
may be comprised of multiple materials, including materials with
different rates of bioabsorption. For example, a scaffold may
comprise a matrix of filaments or fibers (such as a braid or
lattice of filaments) where some filaments are made of a first
material that bioabsorbs quickly and other filaments are made of a
material that bioabsorbs more slowly. Scaffolds may also be
comprised of three, four, five, or more materials with different
bioabsorption rates and or different weave patterns or combinations
of weave patterns, material of different porosities, etc.
[0068] Furthermore, the biodegradation or the bioabsorbable
materials may tend to induce an inflammatory response, as the
material breaks down and interacts with the body. In some
embodiments a first material may be configured to provide a burst
of inflammatory response as the material breaks down relatively
quickly (for example over a period of a few days to several weeks)
at a first time period and a second material may be configured to
provide a second burst of inflammatory response as the material
breaks down more slowly (for example over a period of months to
years), defining a second, delayed time period. In some
embodiments, a scaffold within the scope of this disclosure may be
comprised of a first material that bioabsorbs over a period of 10
to 30 days, a second material that bioabsorbs over a period of 30
to 60 days, a third material that bioabsorbs over a period of 60 to
120 days, a fourth material that bioabsorbs over a period of 120
days to a year, and a fifth material that bioabsorbs over a period
of time greater than one year. Any subset of such materials and any
range of rates of bioabsorbtion, including the use of
nonbioabsorbable materials in connection with bioabsorbable
materials, is within the scope of this disclosure.
[0069] Materials may further be configured such that the material
breaks down relatively slowly at first, then the rate of
bioabsorbtion increases over time. For example, a material or
filament may be coated with a material that bioabsorbs slowly, but
have a core of material that bioabsorbs quickly. As the coating
breaks down, the core may be exposed and deliver a burst of
inflammatory response as the core bioabsorbs. Likewise, a material
or filament may be coated with a material that bioabsorbs quickly,
but have a core of material that bioabsorbs slowly. This may
deliver a burst of inflammatory response upon initial implantation
while providing a slower and lasting inflammatory response as the
coating breaks down. Scaffolds with three, four, five, or more
materials so configured are likewise within the scope of this
disclosure. Still further, any combination of materials that
bioabsorb at different rates and/or provide bursts of inflammatory
responses at different time periods are within the scope of this
disclosure.
[0070] As noted above, the material comprising the scaffold may
affect the degree and timing of the inflammatory response.
Additionally, the structure of the scaffold may affect the
inflammatory response. For woven or braided scaffolds, for
instance, the filament size, surface roughness, and filament
spacing may all affect the inflammatory response. In some
embodiments, scaffold filaments may comprise barbs, hooks, or other
features along the length of the filament. For braided, woven,
porous, and continuous scaffolds, surface area, surface roughness,
porosity, weave and or fiber density, and overall shape may also
affect the inflammatory response. In some embodiments, scaffolds
with more surface area may interact with bodily tissues at more
locations and thus induce a greater inflammatory response.
Furthermore, scaffolds configured with greater surface area may
tend to break down or bioabsorb more quickly, or cause more
inflammation and tissue reaction, as more bioabsorbable material is
exposed to the body. As noted above, higher rates of bioabsorbtion
may induce higher rates of inflammatory response (such as related
to the presence of lactid acid, or other acids and breakdown
materials), thus scaffolds may be configured with more or varied
surface area to induce a greater inflammatory response.
[0071] Various parameters of the scaffold may be adjusted to adjust
the expected inflammatory response of a scaffold. In some
embodiments, scaffolds comprised of woven or braided filaments may
be tuned to adjust the expected inflammatory response of the
scaffold. Again, such parameters may include filament size,
tightness of the braid and/or density of the filaments, shape of
the braided filaments (e.g., tubular, flat, layered), porosity of
the weave, and so forth.
[0072] In some embodiments, scaffolds within the scope of this
disclosure may comprise tubular braids of filaments. FIG. 3A
illustrates one embodiment of a tubular scaffold 100A comprising
filaments 101A braided relatively tightly together. A relatively
tight braid such as that of scaffold 100A may be understood as
having a high filament density, meaning the number of filaments
101A disposed in a certain amount of area along the braid is high.
FIG. 3B illustrates another embodiment of a tubular scaffold 100B
comprising filaments 101B more loosely braided together as compared
to the braid of scaffold 100A. FIG. 3C illustrates another
embodiment of a tubular scaffold 100C comprising filaments 101C
even more loosely braided together. The filament density of
scaffolds 100B and 100C is thus lower than that of scaffold
100A.
[0073] In addition to tubular braided scaffolds as shown in FIGS.
3A-3C, a variety of shapes and configurations of scaffolds are
within the scope of this disclosure. FIG. 3D illustrates an
embodiment of a flat woven scaffold 100D, for example. Flat
scaffolds such as 100D may have a variety of filament densities,
sizes, and heights and may be made of a single weave layer of
filaments 101D, may be made of filaments 101D woven together in
multiple layers to increase the thickness of the scaffold 100D, or
may be comprised of singly woven layers stacked on each other.
[0074] Scaffolds within the scope of this disclosure may comprise
multiple layers, including flat scaffolds with multiple sublayers
(such as a scaffold formed by placing two or more scaffolds in the
form of scaffold 100D on top of each other), tubular scaffolds
disposed coaxially with each other, and so forth. The layers may be
coupled or fixed to each other or may be configured as displaceable
with respect to each other. Various layers may be comprised of
different materials and may have different structures. For example,
FIG. 3E shows a tubular scaffold comprised of the scaffold 100A of
FIG. 3A and the scaffold 100B of FIG. 3B in a coaxial
arrangement.
[0075] Scaffolds with multiple layers, whether arranged in a tube
within a tube or coaxial arrangement such as shown in FIG. 3E, a
multilayered flat scaffold, or any other shape may be configured
with various material properties in each layer. In other words,
each layer of a multilayered scaffold may comprise a different
material from others and any layer can comprise any combination of
materials (for example a braided layer of filaments of a plurality
of materials). Multilayered scaffolds where one or more layers have
the same properties are also within the scope of this
disclosure.
[0076] Additionally or alternatively, tubular scaffold structures
can be non-woven or non-braided, such as hollow tubular shapes
defined by a wall of helically wound filaments, such as in the form
of a hollow torque cable. The tubular shapes can also be completely
solid, including solid forms made of filaments disposed directly
adjacent each other, continuous solid materials such as extruded or
molded polymers, three dimensional matrices of filaments that
define cells and openings in the matrix but no central hollow
section, and so forth. Scaffold shapes can also be combinations of
tubular structures in various combinations with flat structures, or
layers of flat inner or outer structures, combined with inner or
outer tubular structures.
[0077] FIG. 3F illustrates an embodiment of a tubular scaffold 100E
comprised of four filaments 101E helically wound around a hollow
core. FIG. 3G illustrates another embodiment of a tubular scaffold
100F comprising two layers of helically wound filaments 101F also
with a hollow core. In some embodiments the filaments 101E, 101F of
either embodiment may all be of the same material, or multiple
materials may be used for filaments of either scaffold 100E,
100F.
[0078] Scaffolds within the scope of this disclosure may be
comprised of a variety of materials. Any number of bioabsorbable
materials including polymers, collagens, metals, ceramics,
composites, glasses, plastics, nanoparticles, vegetables and
vegetable oils, soaps, gels, and other materials, both natural and
synthetic, are within the scope of this disclosure. Examples of
polymers that are bioabsorbable and induce fibrosis include
polyamides, esters, anhydrides, acetals, carbonates, amides,
urethanes, and phosphates.
[0079] Other examples of biodegradable polymers or plastics include
Polyhydroxyalkanoates (PHAs), poly-3-hydroxybutyrates (PHBs),
polyhydroxyvalerates (PHVs), polyhyrdroxyhexanoates (PHHs),
polyactic acid, starch blends or thermoplastic polymers,
starch/polyactic acid, starch/polycaprolactone,
starch/polybutylene-adipate-co-terephthalate, cellulose esters,
cellulose acetate, nitrocellulose, biodegradable petroleum-based
plastics, such as polyglycolic acid (PGA), polybutylene succinate
(PBS), polypropylene, polycaprolactone, polyvinyl alcohol (PVA),
polybutylene adipate terephthalate (PBAT), n-alkanes, branched
alkanes, low molecular weight aromatics, cyclic alkanes, high
molecular weight aromatics, polar polymers, lignins, biodegradable
conducting polymers (CPs), carbon or noncarbon nanoparticles,
oligomer-based biodegradables, hydrolyzed esters, hydrazones,
poly-paradioxanone (PPD), etc. Other bioabsorbable polymers in
addition to these examples can be used.
[0080] As grouped by chemical families, additional bioabsorbable
polymers within the scope of this disclosure include poly(ester
urethanes), poly(anhydrides) (including poly(carboxy phenoxy
propane-co-sebacic acid)), poly(orthoesters), poly(propylene
fumarate), poly(pseudo amino acids), poly(ester amides), poly(alkyl
cyanacrylates), poly(phosphazenes), poly(phosphoesters), and
poly(.alpha.-esters).
[0081] Some examples of bioabsorbable metals within the scope of
this disclosure include iron-based, zinc-based, and magnesium-based
alloys, either coated or uncoated; pure metals; metal alloys; metal
matrix composites; and metal ceramic composites. Other
bioabsorbable metals in addition to these examples can be used.
[0082] Some examples of biodegradable ceramics within the scope of
this disclosure include dicalcium-based phosphates, etc. Other
bioabsorbable ceramics in addition to these examples can be
used.
[0083] Natural materials including catgut (chromatised or
non-chromatised) are likewise within the scope of this
disclosure.
[0084] Treatment materials within the scope of this disclosure may
comprise combinations of the example materials discussed above. For
example, a polymeric suture could be coated or partially coated
with metal, ceramic particles, or other particles to change the
inflammatory response profile of the treatment material. For
example, in some embodiments, gold may be disposed on a portion of
a scaffold to increase an inflammatory response, barium may be
disposed on a portion of a scaffold for radiopacity, and/or other
particles and or nanoparticles may be disposed on a portion of a
scaffold to affect other properties of the scaffold.
[0085] Various suture materials may be used to create scaffolds
within the scope of this disclosure. For example, commercially
available bioabsorbable suture materials may be used to create
braided or woven scaffolds. Caprosyn.TM. (glycolide, caprolactone,
trimethylene carbonate, and lactide) and Biosyn.TM. (glycolide and
trimethylene carbonate, and dioxanoneare) are two commercially
available examples of such sutures, though any other bioabsorbable
suture material is within the scope of this disclosure.
Caproysn.TM. and Biosyn.TM. are examples of materials with
different bioabsorption rates; in some potential embodiments a
braided or woven scaffold may comprise filaments of each material.
Other commercially available bioabsorbable sutures within the scope
of this disclosure include Maxon.TM. (copolymer of glycolicacid and
trimethylene carbonate), Polysorb.TM. (glycolide and lactide),
Velosorb.TM. (glycolide and lactide), and V-Loc.TM. (glycolide,
dioxanone, and trimethylene carbonate or a copolymer of glycolic
acid and trimethylene carbonate). These examples of suture
materials may bioabsorb in as short a time as 40 days or as long a
time as six months or more.
[0086] In addition to the rate of bioabsorption, suture or other
filament materials may be utilized based on the time period over
which the material loses its tensile strength. For example, a
suture that fully bioabsorbs over 40 days may lose its tensile
strength in as little as five days or less. Thus, materials may be
utilized that continue to induce an inflammatory response as the
material bioabsorbs, but the ability of the material to constrain
or compress the body lumen may quickly dissipate.
[0087] Other suture materials within the scope of this disclosure
include polypropylenes, poly L-lactide/glycolides, polyesters,
polybutilates, silks, vicryls, coated vicryls, polygalactins,
polydiaxonones, Monocryl, and Vicryl Rapide.
[0088] Suture materials used for scaffolds within the scope of this
disclosure may be monofilament, braided, multistrand, coated,
natural, synthetic, and so forth. Sutures of various sizes and
diameters are within the scope of this disclosure. For example, in
some embodiments sutures with a cross sectional diameter of between
0.001 mm and 1 mm, including between 0.001 mm and 0.800 mm are
within the scope of this disclosure. Sutures within this size range
correspond to sutures ranging from USP size 12-0 to 2-0 and from 0
to 5. Sutures or other filaments as used herein may include
markings denoting length along the suture.
[0089] Scaffolds within the scope of this disclosure may also
comprise permanent or nonbioabsorbable materials. For example,
scaffolds within the scope of this disclosure may contain permanent
filaments as well as bioabsorbable filaments. In some embodiments,
the majority of scaffold may comprise bioabsorbable material while
a smaller portion comprises permanent material. Embodiments of
scaffolds wherein greater than 80%, greater than 90%, greater than
95%, and greater than 99% of the material of the scaffold (by
weight or by volume) is bioabsorbable are within the scope of this
disclosure. Embodiments wherein a single filament comprises a
nonbioabsorbable material and embodiments wherein two, three, or
four filaments of a scaffold are nonbioabsorbable are likewise
within the scope of this disclosure.
[0090] Scaffolds of various sizes are within the scope of this
disclosure. Tubular woven scaffolds (such as scaffolds 100A, 100B,
and 100C of FIGS. 3A-3C) may range from 0.25 cm to 10 cm in
diameter, including from 0.5 cm to 6 cm and from 2 cm to 4 cm and
have a wall thickness between 0.05 mm to 10 mm, including from 0.05
mm to 5 mm and from 0.05 mm to 3 mm. Flat woven scaffolds such as
scaffold 100D of FIG. 3D may range from 0.5 cm to 10 cm in height,
including from 0.5 cm to 6 cm and from 2 cm to 4 and from 0.05 mm
to 10 mm in wall thickness, including from 0.05 mm to 5 mm and from
0.5 mm to 3 mm.
[0091] During use and treatment, scaffolds within the scope of this
disclosure may be disposed around a body lumen adjacent a sphincter
location. The scaffold may be wrapped around the body lumen a
single time or wrapped around multiple times with or without
overlapping wraps.
[0092] As also noted above, scaffolds within the scope of this
disclosure may comprise a variety of materials. For example, a
scaffold may be comprised of a plurality of filaments comprising a
first material and a plurality of filaments comprising a second
material. Scaffolds comprising three, four, five, or more materials
are likewise within the scope of this disclosure. The different
plurality of materials can be configured with different material
properties such as strength, elasticity, rate of bioabsorption,
thickness, surface finish, the presence or absence of barbs along
the filament, and so forth. V-Loc.TM. sutures, also discussed
above, are one example of a barbed suture.
[0093] While any combination of any number of materials disclosed
herein are within the scope of this disclosure, as noted above, in
some embodiments a scaffold may be comprised of two or more
materials each with different bioabsorption rates. Such scaffolds
may be configured to induce different amounts of inflammatory
response at different time periods and/or sustain an inflammatory
response over a certain time period. One such example is a scaffold
comprised partially of Caprosyn.TM., which bioabsorbs completely in
40 to 50 days, and Biosyn.TM., which bioabsorbs in 90 to 110 days.
In some embodiments two-thirds of the filaments of a scaffold may
comprise Caprosyn.TM. and one-third Biosyn.TM., though any ratio of
materials is within the scope of this disclosure. In another
embodiment a scaffold may be comprised of two-thirds Caprosyn.TM.
filaments and one-third V-Loc.TM. filaments. In another example, a
scaffold may be partially of fully comprised of polydioxanone
including embodiments wherein the polydioxanone is combined with
polyethylene glycol and/or barium sulfate. Further embodiments
wherein a scaffold is partially or fully comprised of polydioxanone
combined with poly lactide cocaprolactonecotrimethylene carbonate
and/or barium sulfate are likewise within the scope of this
disclosure. In some instances, polydioxanone materials, or
co-polymers of glycolic acid and lactic acid (e.g Vicryl Rapide)
may bioabsorb in about 7-12 days.
[0094] For example, FIG. 4A illustrates the tubular scaffold 100C
of FIG. 3C disposed in a circumferential loop. To form a loop such
as shown in FIG. 4A, a tubular scaffold (such as 100C) may be
wrapped once around a body lumen and the two ends of the scaffold
coupled together. Various methods of coupling the ends are within
the scope of this disclosure, including tying the loose ends to
each other with a knot, passing a suture around filaments 101C of
both ends to stitch the ends together, coupling the ends with a
fastener such a staple or clip, and so forth. The ends could also
be sutured separately to structures within the body of the patient,
such as the external wall of the lumen to be treated. Such a method
could be utilized to join the ends of the scaffold and attach the
scaffold to the body. Still further, in some tubular embodiments,
one end of the device may be configured with a tapered nose cone
configured to fit into the inside diameter of the opposite end to
couple the ends together.
[0095] A flat woven scaffold such as scaffold 100D of FIG. 3D may
also be disposed in a circumferential loop similar to the
arrangement of scaffold 100C in FIG. 4A. As with a tubular
scaffold, a flat woven scaffold such as 100D may be wrapped around
the lumen to be treated and the two ends coupled to each other
and/or to the lumen or other bodily structure. The ends could be
tied together, stitched together with a suture that passes around
the filaments 101D of the scaffold 100D, and/or coupled with a
fastener such as a staple or clip. Analogous to the nose cone
arrangement of a tubular scaffold as noted above, a flat woven
scaffold such as 100D may be configured with tongue and groove
features on opposite ends configured to couple to each other.
[0096] Tubular, flat, and other scaffold shapes may be wrapped
around the lumen to be treated multiple times. FIG. 4B illustrates
a tubular scaffold 100C' disposed to define multiple helical loops.
Any number of loops in such an arrangement are within the scope of
this disclosure. When wrapped in non-overlapping loops, the ends of
the scaffold 100C' may each be coupled to the lumen to be treated,
for example by running a suture around filaments 101C' and
stitching them to the surface of the lumen to be treated.
[0097] Furthermore, tubular, flat, or other scaffold shapes, or
combinations of tubular or flat shapes, may be wrapped around the
lumen to be treated in overlapping loops. FIG. 4C illustrates the
flat woven scaffold 100D of FIG. 3D disposed in overlapping loops.
While the arrangement shown in FIG. 4C overlaps completely,
arrangements where such loops partially overlap are within the
scope of this disclosure as well. The ends of the scaffold 100D may
be coupled to the lumen to be treated, for example by suturing the
filaments 101D to the body lumen. FIG. 4D illustrates the flat
woven scaffold 100D disposed around the esophagus 10 adjacent the
LES 30 and the stomach 20. FIG. 4D illustrates an example of how
the two ends of the flat woven scaffold 100D may be butted together
and coupled (e.g., via a suture, a tongue and groove arrangement,
or other coupling methods).
[0098] FIG. 4E illustrates one embodiment of a shape or structure
for coupling the ends of scaffold together. FIG. 4E illustrates the
scaffold 100D of FIG. 3D, shown with tongue 102D and groove 103D
features on opposite ends of the scaffold 100D. The tongue 102D and
groove 103D features can be configured to mate together to couple
the ends of the scaffold 100D together. These features can be
further coupled via a suture, clip, or other fastener. Embodiments
wherein other portions of one end are configured to mate with the
other are also within the scope of this disclosure, including
embodiments where the tongue and groove portions are formed along
the length of edges or at other points along the scaffold 100D.
Though the tongue and groove design in shown with a flat scaffold,
similar concepts can be applied to tubular scaffolds and scaffolds
of other shapes. Tubular scaffolds wherein one end is configured to
fit within the other end are also within the scope of this
disclosure.
[0099] Additionally, scaffolds with different shapes or structures
along the length of the scaffold are within the scope of this
disclosure. For example, a scaffold may have a tubular cross
section for a portion of its length and a flat woven structure
along a different portion. Any shape or structure of scaffold can
be used with any other. Embodiments where a scaffold is configured
with a plurality of treatment sections coupled together by smaller
linking elements (such as a single filament) may be utilized to
create a non-continuous pattern of inflammation around a lumen.
Stated another way, scaffolds within the scope of this disclosure
may define a plurality of zones along the length of the scaffold
wherein the filament density of the zones may or may not differ.
Still further, scaffolds within the scope of this disclosure may
define zones wherein any parameter, for example, cross sectional
shape or structure, filament density, filament diameter, use of
woven or continuous materials, number of materials comprising the
zone, surface characteristics of the scaffold, and so forth may or
may not vary between zones. Scaffolds may be circumferential, or
configured to be disposed about the circumference of a sphincter
(or tissue adjacent a sphincter), hemi-circumferential, partially
circumferential, piecemeal, or other configurations. Braided
scaffolds, non-woven scaffolds formed of filaments, scaffolds of
porous materials, and so forth are within the scope of this
disclosure. Filaments may be monofilament or may be comprised of
twisted or braided sub-filaments.
[0100] Scaffolds within the scope of this disclosure may be
implanted via surgical processes including laparoscopic procedures.
In some embodiments, a practitioner may surgically implant the
scaffold around the outside surface of an organ or lumen adjacent a
sphincter location. As also noted above, a practitioner may wrap
the scaffold around the organ or lumen any number of times,
including one, two, three, four, five, or more wraps. (See FIG. 2E
for an example of a scaffold 100' wrapped twice around the
esophagus 10.) Such wraps may be longitudinally separated from each
other (such that the scaffold helically winds along the lumen with
spaces between the loops), helically wound such that adjacent loops
touch but do not overlap, helically wound such that adjacent loops
partially overlap, or wound such that the loops directly overlap.
Any combination of these arrangements may be created along a
treatment length of the organ and/or lumen (e.g., overlapping along
a longitudinal portion and spaced along another longitudinal
portion).
[0101] The scaffold may be wrapped around the organ or lumen such
that portions of the scaffold extend beyond the sphincter to be
treated. For example, when placing a scaffold around the esophagus
adjacent the LES, the scaffold may be disposed around the region of
the GEJ/LES, and extending one, two, three, four, or more
centimeters along the esophagus and extending one, two, three, or
more centimeters onto the proximal portion of the stomach. Thus,
the scaffold may partially surround and extend beyond the LES.
[0102] As also noted above, during a procedure to implant a
scaffold, a practitioner may dispose the scaffold around the body
organ or lumen to be treated such that the scaffold contacts but
does not compress the body organ or lumen. Additionally, it is
within the scope of this disclosure to more loosely dispose the
scaffold around the body organ or lumen such that there is slack on
the scaffold as it extends around the organ or lumen or to dispose
the scaffold more tightly such that it partially compresses a
portion of the body organ or lumen. Scaffolds may be disposed
around bodily tissue adjacent a sphincter without directly fixing
the scaffold to the tissue, or scaffolds may be coupled to bodily
tissue (for example via bioabsorbable sutures, permanent sutures,
stapes, clips, and so forth). Scaffolds disposed adjacent a
sphincter may be disposed in contact with tissue that surrounds the
sphincter or may be disposed adjacent but not in contact with
tissue surrounding the sphincter. In some embodiments a scaffold
adjacent a sphincter may be disposed in contact with the sphincter,
in contact with tissue (such as the wall of a body lumen or organ)
that is in direct contact with the sphincter, and/or disposed such
that there is a gap between the scaffold and the wall of a body
lumen or organ containing the sphincter. Gaps between the external
wall of a body lumen or organ containing a sphincter and a scaffold
from 0 to 5 cm, 0 to 3 cm, and 0 to 1 cm are within the scope of
this disclosure.
[0103] Methods of treatment within the scope of this disclosure
include methods of inducing an inflammatory response and/or
inducing the formation of a tissue collar around a body organ or
lumen adjacent a sphincter location. In some instances, such
treatments comprise surgically disposing a scaffold at or adjacent
the organ or lumen to be treated. Methods wherein a scaffold is
disposed completely around the body organ or lumen as well as
methods wherein the scaffold is disposed only partially around the
body organ or lumen are within the scope of this disclosure. For
example, a scaffold may extend partially around the external wall
of the organ or lumen and be sutured to the external wall of the
organ or lumen at the ends of the scaffold. Embodiments wherein the
scaffold extends 180 degrees around the organ or lumen and
embodiments wherein the scaffold extends more or less than this are
within the scope of this disclosure.
[0104] Furthermore, embodiments wherein the scaffold comprises
wider treatment portions (such as braided or woven matrices of
filaments) coupled together by narrower surface area coupling
portions (such as a single suture or group of sutures with less
surface area than the treatment portions) are within the scope of
this disclosure. Thus, in some treatments a single scaffold may be
applied to induce an inflammatory response and/or tissue collar
along discontinuous segments around or along a lumen to be treated.
Embodiments where discrete portions of a scaffolding material are
coupled to the lumen as patches to induce areas of inflammation are
likewise within the scope of this disclosure.
[0105] Treatments within the scope of this disclosure may be
performed via open surgery; laparoscopic surgery; endoscopic
surgery; fluoroscopic surgery; needle access, including guided
needle access; radiologically, via peroral endoscopic myotomy
(POEM), and so forth. In some embodiments, a scaffold may be
implanted around the organ or lumen to be treated, while in other
embodiments the scaffold may be implanted into the tissue of the
organ or lumen to be treated. For example, a scaffold or portion of
a scaffold may be inserted into a portion of the wall of an organ
or lumen to be treated. Such procedures may be done through
endoscopy or endoscopic surgery entering the wall of the lumen from
the inside of the lumen or injecting material endoscopically via
the inside of a lumen or radiologically via extrinsic injection via
a needle. These injections can be done piecemeal,
circumferentially, hemi-circumferentially into the wall of the
organ or adjacent to the wall, including injections adjacent but
external to the wall. Procedures where biodegradable materials are
disposed directly against the tissue of a sphincter (for example
via an endoscopic or radiologic procedure) to induce inflammation
of the sphincter are likewise within the scope of this disclosure.
Biodegradable material can be placed externally via accessing the
wall internally, via endoscopy for example, penetrating the wall
from the inside out with an endoscopic needle for example,
extending the needle through the wall and depositing material
external or adjacent to the wall. The external portion of the organ
adjacent to the sphincter can also be directly reached by
percutaneous penetration of a needle via radiologic guidance for
example, to the external aspect of the organ adjacent to the
sphincter, and depositing of material via needle injection for
example.
[0106] For example, FIG. 5A illustrates a portion of the esophagus
10 and the stomach 20 with a percutaneous needle 60 for introducing
bioabsorbable material 201A, 201B, 201C, 201D adjacent to the
external wall of the esophagus 10. During some treatments, a
bioabsorbable material may be injected via a needle into the wall
of an organ or lumen to be treated. The bioabsorbable material
201A, 201B, 201C, 201D could also be injected directly into the
mucosa and/or submucosa, muscle layers, adventitia, and so forth of
the esophagus 10 in some treatments.
[0107] The bioabsorbable material 201A, 201B, 201C, 201D may be
injected as a continuous band, and injected in discrete segments or
portions around the circumference of the lumen to be treated, such
as the esophagus 10. The bioabsorbable material 201A, 201B, 201C,
201D can extend longitudinally along a length of the organ or lumen
to be treated and may extend beyond the sphincter location at
either longitudinal end.
[0108] Injections of materials into the wall of the esophagus, or
into the wall of another body organ or lumen adjacent a sphincter,
or external to a sphincter, may be performed percutaneously,
endoscopically, radiologically, laparoscopically, fluoroscopically,
via POEM, and so forth.
[0109] As the bioabsorbable material 201A, 201B, 201C, 201D breaks
down in the body, an inflammatory response may lead to the
formation of fibrosis, collagen, and/or scar tissue. FIG. 5B
illustrates the portion of the esophagus 10 and the stomach 20 of
FIG. 5A showing tissue growth in response to the bioabsorbable
material 201A, 201B, 201C, 201D of FIG. 5A. Thus, tissue collars
250A, 250B, 250C, 250D may be disposed externally around the
esophagus 10 in any pattern as discussed above or directly into the
wall of esophagus 10 in any pattern as discussed above. Any number
of treatment sites and locations are within the scope of this
disclosure.
[0110] The bioabsorbable material 201A, 201B, 201C, 201D injected
or placed external to, or in the wall of the lumen may comprise a
liquid, gel, suspension, plugs or pledgets of solid materials, and
so forth. As compared to injection of permanent materials into the
wall of a lumen, use of bioabsorbable materials reduces or
eliminates issues related to infection, or migration of the
permanent material to other areas of the body.
[0111] As noted above, the devices, concepts, and procedures
disclosed herein may be configured to treat a variety of sphincters
in a variety of body lumens. As discussed above, though this
disclosure may be applied to treat the LES and GERD, the
application of this disclosure is not limited to such treatments.
FIGS. 6A-6D illustrate examples of additional treatment locations.
These examples are not meant to constitute a complete list of
treatment locations; rather, they are meant as additional examples
of treatments within the scope of this disclosure. FIG. 6A
illustrates a portion of a colon 70 with a scaffold 300 shown
around the anal sphincter. FIG. 6B illustrates a portion of the
colon 70 with a tissue collar 350 shown around the anal sphincter
area of the rectum and anus. FIG. 6C illustrates a portion of a
bladder 80 and urethra 82 with a scaffold 400 shown around the
urinary sphincter of the urethra. FIG. 6D illustrates a portion of
the bladder 80 with a tissue collar 450 shown around the urinary
sphincter of the urethra 82. Analogous to the discussion of the LES
and GERD above, an inflammatory response may be induced adjacent
the anal or urinary sphincter to reinforce the sphincter and treat
disorders of the sphincter. Thus, the devices and methods disclosed
herein may be configured for treatment of a variety of conditions
(including fecal and urinary incontinence as well as other
disorders of these or other sphincters) in an analogous manner to
treatment of the LES for GERD. Additional applications include, but
are not limed to, analogous cardiac, neurological, renal, and
orthopedic treatments. For example, treatments may be used to
reinforce a cardiac valve, an aneurysm, bones, ligaments, tendons,
or other portions of the body.
[0112] It is noted that this disclosure recites certain features
and applications in connection with certain drawings or examples of
treatments for conciseness and clarity, though such disclosure may
be applied to other figures and examples throughout the disclosure.
In the figures, like features are designated with like reference
numerals, with the leading digits incremented, letters added
following the digits, and/or the addition of prime "'" markers. For
example, the embodiment depicted in FIGS. 2A-2D includes a scaffold
100 that may, in some respects, resemble the scaffolds 100A, 100B,
100C, 100D, 100C' of FIGS. 3A-4C and the embodiment depicted in
FIGS. 2A-2D includes a tissue collar 150 that may resemble the
tissue collars 250A, 250B, 250C, 250D, 350, 450 of FIGS. 5B-6B.
Relevant disclosure set forth above regarding similarly identified
features thus may not be repeated for each embodiment. Moreover,
specific features and related components shown in some embodiments
may not be shown or identified by a reference numeral in the
drawings or specifically discussed in connection with each
embodiment. However, such features may clearly be the same, or
substantially the same, as features depicted in other embodiments
and/or described with respect to such embodiments. Accordingly, the
relevant descriptions of such features apply equally to the
features of each embodiment. Any suitable combination of the
features, and variations of the same, described with respect one
embodiment can be employed with the components of the other
embodiments, and vice versa.
[0113] Any methods disclosed herein include one or more steps or
actions for performing the described method. The method steps
and/or actions may be interchanged with one another. In other
words, unless a specific order of steps or actions is required for
proper operation of the embodiment, the order and/or use of
specific steps and/or actions may be modified. Moreover,
sub-routines or only a portion of a method described herein may be
a separate method within the scope of this disclosure. Stated
otherwise, some methods may include only a portion of the steps
described in a more detailed method.
[0114] Reference throughout this specification to "an embodiment"
or "the embodiment" means that a particular feature, structure, or
characteristic described in connection with that embodiment is
included in at least one embodiment. Thus, the quoted phrases, or
variations thereof, as recited throughout this specification are
not necessarily all referring to the same embodiment.
[0115] Similarly, it should be appreciated by one of skill in the
art with the benefit of this disclosure that in the above
description of embodiments, various features are sometimes grouped
together in a single embodiment, figure, or description thereof for
the purpose of streamlining the disclosure. This method of
disclosure, however, is not to be interpreted as reflecting an
intention that any claim requires more features than those
expressly recited in that claim. Rather, as the following claims
reflect, inventive aspects lie in a combination of fewer than all
features of any single foregoing disclosed embodiment. Thus, the
claims following this Detailed Description are hereby expressly
incorporated into this Detailed Description, with each claim
standing on its own as a separate embodiment. This disclosure
includes all permutations of the independent claims with their
dependent claims.
[0116] Recitation in the claims of the term "first" with respect to
a feature or element does not necessarily imply the existence of a
second or additional such feature or element. It will be apparent
to those having skill in the art and the benefit of this
disclosure, that changes may be made to the details of the
above-described embodiments without departing from the underlying
principles of the present disclosure.
[0117] Example of a Biodegradable Scaffold for the Treatment of
GERD:
[0118] In one example, a Caprosyn.TM. monofilament size 1 material
was used to construct a scaffold that was implanted in a porcine
model as a treatment for GERD as described below. Specifically, a
scaffold was created that was comprised of 0.020'' diameter
Caprosyn monofilament in a braided configuration with 8 filaments.
The tubular braided scaffold had an inner diameter of 0.125'' and
between 10-20 picks per inch.
[0119] Prototype Testing
[0120] The hollow Caprosyn.TM. braided suture was then implanted
360 degrees around the esophagus of a Yorkshire swine in the region
of the GEJ/LES below the diaphragm. The implant was sutured to the
esophagus wall in three spots with Prolene to secure it in
place.
[0121] The animal was survived for 12 weeks post implant for follow
up testing and histology.
[0122] Follow Up Studies
[0123] Dysphagia Test
[0124] The animal survived 12 weeks and showed no signs of
dysphagia, being able to maintain appetite, eat consistently and
swallow food without difficulty. A barium swallow test was
conducted to ensure that there was no stenosis or stricture in the
region of the lower esophageal sphincter (LES). Several swallows
were viewed with fluoroscopic imaging and no dysphagia was
observed.
[0125] LES Yield Pressure (Force Required to Open the LES from the
Gastric Aspect):
[0126] A custom balloon catheter was used to measure the LES yield
pressure (LES opening force) prior to the implant, directly after
implant and at 12-week follow up. The custom balloon catheter was
inserted into the empty stomach of the animal, filled with 15 cc of
fluid and connected to a pressure sensor. The balloon was gradually
pulled from the stomach through the LES and into the esophagus
recording the pressure through the transition. The results of the
balloon pull-through test are in table 1 below.
TABLE-US-00001 TABLE 1 Baseline Delta in Percent (mmHg) Peak Value
Pressure Increase/Decrease Time Point Pre-Pull Through (mmHg)
(mmHg) from Baseline Pre-Implant - Open 26.9 164.7 137.8 0 Abdomen
Post Implant - 32.0 194.3 162.3 18% Immediately - Open Abdomen Post
Implant - 12 weeks - 53.2 201.9 148.7 8% Closed Abdomen Post
Implant - 12 weeks - 43.3 249.1 205.8 49% Open Abdomen
[0127] As seen from the LES yield pressure results, immediately
after implant the LES yield pressure was increased by approximately
18%. Additionally, 12-week follow up testing showed similar results
with an increase of approximately 49% which is likely due to the
collagen band induced by the bioabsorbable suture augmenting the
LES.
[0128] Scar Formation/Pathology
[0129] The esophagus, LES and stomach were explanted post testing
for further analysis of fibrosis/collagen band location and
thickness. Initial observations illustrated a collagen band 2/3 of
the way around the circumference of the esophagus directly in-line
with the Prolene securement sutures used at implant and directly
below the diaphragm.
[0130] Macroscopic observations: The serosal surface of the stomach
surrounding the gastroesophageal junction exhibited semi-firm to
firm red to tan adhesions, comprising .about.15-20% of the gastric
serosa. Fibrosis expanded the cardia serosa pars oesophagea and
there were no other abnormalities noted.
[0131] Microscopic observations: The serosal surfaces of the
esophagus and stomach within the tissue sections were minimally to
moderately expanded by irregular and papilliform streams of
fibrosis.
[0132] Observations
[0133] The initial feasibility prototypes demonstrated that a braid
of Caproysn.TM. monofilament suture can be heat set it to create a
stable hollow braided suture implant. The implant itself has shape
memory allowing the braid to stretch as food is ingested through
the esophagus and rebounds to augment the sphincter post
swallowing. The hollow suture was easy to slide around the
esophagus and was easy to suture in place. Analysis of the LES
yield pressure (LES opening force) demonstrated that at
baseline/pre-implant, the pressure increase during the balloon LES
pull-through was 137.8 mmHg. Immediately post-implant, the pressure
measurement was 162.3 mmHg resulting in an .about.18% increase in
LES yield pressure (opening force), demonstrating LES augmentation
which should help reduce/prevent GERD. The animal survived the
implant and abdominal closure. There was no sign of dysphagia
during the 12-week survival as well as during fluoroscopic imaging
of the barium sulfate swallow. The pressure measurement for the LES
balloon pull through test at the 12-week follow up was 205.8 mmHG
resulting in a 49% increase from pre-implant. The explant of the
esophagus illustrated collagen/fibrosis formation in the region of
the completely absorbed implant.
[0134] Based on these results, initial feasibility testing was
remarkably successful. A braided bioabsorbable suture with shape
memory was produced and implanted around the esophagus, increasing
the LES yield pressure immediately, without causing dysphagia.
Additionally, the device induced a fibrotic response/collagen band
that increased the LES yield pressure and decreased GEJ compliance
on a chronic basis, once the implant was fully absorbed.
* * * * *