U.S. patent application number 13/410281 was filed with the patent office on 2012-11-15 for methods, devices, kits and systems for defunctionalizing the cystic duct.
Invention is credited to J. Craig Milroy, R. Matthew Ohline, Jacques Van Dam.
Application Number | 20120289880 13/410281 |
Document ID | / |
Family ID | 40676480 |
Filed Date | 2012-11-15 |
United States Patent
Application |
20120289880 |
Kind Code |
A1 |
Van Dam; Jacques ; et
al. |
November 15, 2012 |
Methods, Devices, Kits and Systems for Defunctionalizing the Cystic
Duct
Abstract
The application discloses devices, systems, kits and methods for
treating biliary disease. Devices comprise, for example, a
component configurable for deployment between within a cystic duct
of a patient which has a proximal end and a distal end. In some
embodiments, a lumen may also extend therethrough.
Inventors: |
Van Dam; Jacques; (San
Carlos, CA) ; Milroy; J. Craig; (Palo Alto, CA)
; Ohline; R. Matthew; (Redwood City, CA) |
Family ID: |
40676480 |
Appl. No.: |
13/410281 |
Filed: |
March 1, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12959264 |
Dec 2, 2010 |
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13410281 |
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12277338 |
Nov 25, 2008 |
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12959264 |
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60991682 |
Nov 30, 2007 |
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61033368 |
Mar 3, 2008 |
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Current U.S.
Class: |
604/9 ; 604/8;
606/213 |
Current CPC
Class: |
A61F 2/24 20130101; A61M
25/1002 20130101; A61M 29/02 20130101; A61M 2025/1072 20130101;
A61B 2017/00278 20130101; A61F 2/2493 20130101; A61F 2220/0008
20130101; A61F 2250/0039 20130101; A61B 2017/1139 20130101; A61F
2/064 20130101; A61M 27/008 20130101; A61F 2002/041 20130101; A61B
17/1114 20130101; A61B 17/11 20130101; A61F 2/04 20130101; A61M
2025/0233 20130101 |
Class at
Publication: |
604/9 ; 604/8;
606/213 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61B 17/03 20060101 A61B017/03 |
Claims
1. A device for treating biliary disease comprising: a component
configurable for placement within a cystic duct of a biliary system
of a patient, the component further comprising a proximal end and a
distal end, an exterior surface, one or more external
configurations adapted and configured to secure the component
within the cystic duct, and a diameter sized to fit within the
cystic duct, wherein the device is adapted and configured to be
implanted within the cystic duct to defunctionalize the duct and to
at least one of control and prevent fluid communication between a
gallbladder and a common bile duct.
2. The device of claim 1 further comprising a delivery mechanism
for delivering a substance.
3. The device of claim 1 wherein the device is formed from at least
one of a bioresorbable material or an activatable material.
4. The device of claim 1 wherein the device is at least one of
removable and expandable.
5. The device of claim 1 further comprising one or more
configurations selected from a deployment configuration, a delivery
configuration and a final configuration.
6. The device of claim 5 further comprising a variable profile.
7. The device of claim 1 wherein a cross-sectional area of the
device is variable along a length.
8. The device of claim 1 wherein the device is configurable for
deployment by at least one of an endoscope and guidance
element.
9. The device of claim 1 further comprising a lumen extending
therethrough wherein the lumen is configurable to provide
restrictable fluid flow.
10. The device of claim 9 further comprising one or more fluid
control components.
11. The device of claim 1 further comprising a valve.
12. The device of claim 11 wherein the valve is at least one of a
flow-restrictor or one-way valve.
13. The device of claim 1 wherein the device is flexible.
14. The device of claim 1 wherein the external configuration is one
or more of threads, ridges and steps.
15. A biliary disease treatment device comprising: an implant
configurable for placement within a cystic duct of a biliary system
of a patient, the implant further comprising a proximal end and a
distal end, an exterior surface, and a diameter sized to fit within
the cystic duct wherein the implant is adapted to be delivered by
an endoscopic guidance element to the cystic duct.
16. A method of delivering a device to treat biliary disease
comprising: a. using an endoscope to place a guidance element
between an access lumen and a gallbladder; b. inserting a delivery
catheter over the guidance element and into the gallbladder; c.
delivering a cystic duct defunctionalizing device comprising a
proximal end and a distal end, an exterior surface, and a diameter
sized to fit within the cystic duct, to the cystic duct via the
guidance element; and d. positioning the cystic duct
defunctionalizing device within the cystic duct.
17. A kit for treating biliary disease comprising: a. a device
comprising a proximal end and a distal end, an exterior surface,
and a diameter sized to fit within the cystic duct wherein the
device is configurable to be positioned within a cystic duct; and
optionally b. a compound for delivery to a tissue.
18. A method of treating biliary disease comprising: a. accessing a
natural lumen associated with a gallbladder; b. defunctionalizing a
cystic duct.
19. A device for treating biliary disease comprising a plug adapted
and configured to be positioned within a lumen of a cystic duct of
a patient wherein the device has a proximal end, a distal end and a
diameter less sized to fit within the cystic duct and is
configurable either internally or externally to seat within the
lumen after deployment.
Description
CROSS-REFERENCE
[0001] This application is a CONTINUATION of application Ser. No.
12/959,264 filed Dec. 2, 2010, which is a CONTINUATION of
application Ser. No. 12/277,338, filed Nov. 25, 2008, which claims
the benefit of U.S. Provisional Application No. 60/991,682, filed
Nov. 30, 2007, and Application No. 61/033,368 filed Mar. 3, 2008,
which applications are incorporated herein by reference.
[0002] This application has related subject matter to U.S. Utility
patent application Ser. No. 12/277,443 filed Nov. 25, 2008,
entitled "Methods Devices, Kits and Systems for Defunctionalizing
the Gallbladder" by Jacques Van Dam, J. Craig Milroy, and R.
Matthew Ohline and U.S. Utility patent application Ser. No.
12/277,491, filed Nov. 25, 2008, entitled, "Biliary Shunts,
Delivery Systems, Methods of Using the Same, and Kits Therefor" by
Jacques Van Dam, J. Craig Milroy, and R. Matthew Ohline, which
applications are incorporated herein by reference.
FIELD OF THE INVENTION
[0003] The invention described in this patent application addresses
challenges confronted in the treatment of biliary disease. Biliary
disease includes conditions affecting the gallbladder, cystic duct,
and common bile duct.
BACKGROUND OF THE INVENTION
Biliary System Function and Anatomy:
[0004] Bile is a greenish-brown digestive fluid produced by the
liver 10 illustrated in FIG. 1, and is vital for the digestion of
fatty foods. Bile is secreted by liver cells and collected by a
network of ducts that converge at the common hepatic duct 12. While
a small quantity of bile drains directly into the lumen of the
duodenum 30 (the section of small intestine immediately downstream
of the stomach), most travels through the common hepatic duct 12
and accumulates in the lumen of the gallbladder 14. Healthy
gallbladders are pear-shaped sacs with a muscular wall that, on
average, measure 10 cm in length and can store approximately 50 ml
of fluid within its lumen. When fatty foods are ingested, the
hormone cholecystokinin is released, which causes the gallbladder
14 to contract. Contraction of the gallbladder 14 forces bile to
flow from the gallbladder 14, through the cystic duct 16, into the
common bile duct 18, out the papilla 28, and finally into the
duodenum 30 of the small intestine. Here, it mixes and reacts with
the food that exits the stomach. The Sphincter of Oddi 26 controls
secretions from the liver, pancreas 24, and gallbladder 14 into the
duodenum 30 of the small intestine. The opening on the inside of
the descending duodenum 30 after the Sphincter of Oddi 26 is called
the major duodenal papilla 28 (of Vater). Together, the biliary
ducts, the gallbladder 14, the cystic duct 16 and the common bile
duct 18 comprise the biliary system (FIG. 1).
[0005] The pancreas 24 is a gland organ in the digestive and
endocrine system of vertebrates. It is both an endocrine gland
(producing several important hormones, including insulin, glucagon,
and somatostatin), as well as an exocrine gland, secreting
pancreatic juice containing digestive enzymes that pass to the
small intestine. These enzymes help in the further breakdown of the
carbohydrates, protein, and fat in the chyme. The pancreatic duct
22, or duct of Wirsung, is a duct joining the pancreas 24 to the
common bile duct 18 to supply pancreatic juices which aid in
digestion provided by the exocrine pancreas. The pancreatic duct 22
joins the common bile duct 18 just prior to the major duodenal
papilla 28, after which both ducts perforate the medial side of the
second portion of the duodenum 30 at the major duodenal
papilla.
Biliary Disease:
[0006] The most common problem that arises in the biliary system is
the formation of gallstones, a condition called cholelithiasis.
Approximately 20 million Americans have gallstones, and about 1-3%
will exhibit symptoms in any given year. In the U.S., gallstones
are more common among women, with 25% of women having gallstones by
the age of 60 and 50% by the age of 75. Pregnancy and hormone
replacement therapy increase the risk of forming gallstones.
Prevalence is lower for American men: approximately 25% will
develop gallstones by the age of 75. In the U.S., gallstones are
responsible for the highest number of hospital admissions due to
severe abdominal pain.
[0007] Gallstones 20, 20' are most often composed of cholesterol,
but may also be formed from calcium bilirubinate, in which case
they are called pigment stones. They range in size from a few
millimeters to several centimeters, and are irregularly shaped
solids resembling pebbles. They can form in the gallbladder 14,
cystic duct 16, and/or the common bile duct 18 (FIG. 2). By
themselves, gallstones 20 do not necessarily result in disease
states. This is the case 90% of the time. However, stones can cause
infection and inflammation, a condition known as cholecystitis,
which is generally the result of restricting or blocking the flow
of bile from the gallbladder 14 and common bile duct 18, or the
fluids secreted by the pancreas 24.
[0008] Gallbladder disease may be chronic, and patients who suffer
from this may periodically experience biliary colic. Symptoms
include pain in the upper right abdomen near the ribcage, nausea,
and/or vomiting. The pain may resolve within an hour of onset, may
prove unresponsive to over-the-counter medicines, and may not
decrease with changes of position or the passage of gas. Recurrence
is common, with pain often recurring at the same time of day, but
with frequency of less than once per week. Fatty or large meals may
cause recurrence several hours after eating, often awakening the
patient at night. Patients may elect to suffer from these symptoms
for very long periods of time, such as years or even decades.
[0009] Patients with chronic cholecystitis have gallstones and
low-grade inflammation. Untreated, the gallbladder 14 may become
scarred and stiff over time, leading to a condition called
dysfunctional gallbladder. Patients who have chronic cholecystitis
or dysfunctional gallbladder may experience gas, nausea, and
abdominal discomfort after meals, and chronic diarrhea.
[0010] Acute cholecystitis (a surgical emergency) develops in 1-3%
of those with symptomatic gallstone disease, and is due to
obstruction of the common bile duct 18 or cystic duct 16 by stones
or sludge. Symptoms are similar to biliary colic, though they are
more severe and persistent. Pain in the upper right abdomen can be
constant and severe, the intensity may increase when drawing
breath, and it may last for days. Pain may radiate to the back,
under the breastbone or the shoulder blades, and it may be
perceived on the left side of the abdomen. In addition to nausea
and vomiting, one third of patients experience fever and chills.
Complications from acute cholecystitis can be serious and life
threatening, and include gangrene, abscesses, perforation of the
gallbladder 14 which can lead to bile peritonitis, pus in the
gallbladder wall (empyema), fistulae, and gallstone ilius (when a
gallstone creates a blockage in the small intestine).
[0011] When gallstones 20' become lodged in the common bile duct 18
(FIG. 2), the condition is known as choledocholithiasis. Symptoms
for this condition include pain, nausea and vomiting, and some
patients develop jaundice, have dark urine and/or lighter stools,
rapid heartbeat, and experience an abrupt drop in blood pressure.
These symptoms can also be accompanied by fever, chills, and/or
severe pain in the upper right abdomen. Complications from
choledocholithiasis can also be very serious, and include infection
of the common bile duct 18 (cholangitis) and inflammation of the
pancreas 24 (pancreatitis).
[0012] A smaller patient population suffers from gallbladder
disease that occurs in the absence of gallstones. This condition,
called acalculous gallbladder disease, can also be chronic or
acute. Chronic acalculous gallbladder disease, also called biliary
dyskinesia, is thought to be caused by motility disorders that
affect the gallbladder's ability to store and release bile. Acute
acalculous gallbladder disease occurs in patients who suffer from
other serious illnesses which can lead to inflammation of the
gallbladder 14 because of a reduction in the supply of blood to the
gallbladder 14 or a reduced ability to contract and empty bile into
the duodenum 30.
[0013] Cancer can also develop in the gallbladder 14, though this
condition is rare. Gallstones have been found in 80% of patients
with gallbladder cancer. Gallbladder cancer typically develops from
polyps, which are growths inside the gallbladder 14. When polyps 15
mm across or larger are observed, the gallbladder is removed as a
preventive measure. Polyps smaller than 10 mm are widely accepted
as posing low risk and are not generally removed. When detected
early, before the cancer has spread beyond the mucosa (inner
lining) of the gallbladder, the 5-year survival rate is
approximately 68%. However, gallbladder cancer is not usually
detected until patients are symptomatic, by which time the disease
is more advanced.
Treatment of Biliary Disease:
[0014] The most effective treatment for biliary disease has been
surgical removal of the gallbladder 14, a procedure called
cholecystectomy. Surgical removal of the gallbladder 14 is
indicated for patients who experience a number of less severe
gallstone attacks, cholecystitis, choledocholithiasis,
pancreatitis, acalculous biliary pain with evidence of impaired
gallbladder 14 emptying, those at high risk for developing
gallbladder cancer, and those who have previously undergone
endoscopic sphincterotomy for common bile duct stones. Other
treatment modalities exist and are frequently used, but gallbladder
disease tends to recur in the majority of patients who forgo
cholecystectomy and pursue alternatives. Removal of the gallbladder
14 is highly successful at permanently eliminating biliary disease.
Cholecystectomy is one of the most commonly performed procedures on
women. The gallbladder 14 is not an essential organ, and after a
period of adjustment post surgery, patients tend to return to more
or less normal digestive function.
[0015] Cholecystectomy can be performed either as open surgery,
which requires a single larger incision in the upper right abdomen,
or laparoscopic surgery, in which several small instruments are
inserted through much smaller incisions in the abdomen.
Approximately 80% of cholecystectomies are performed
laparoscopically. The primary benefits of this minimally invasive
approach are faster recovery for the patient, and a reduction in
overall healthcare costs. Patients who receive laparoscopic
cholecystectomy are usually released the same day. By contrast,
patients receiving open cholecystectomies typically spend 5-7 days
in a hospital before release. 5-10% of laparoscopic procedures
convert to open procedures when difficulties arise, such as injury
to major blood vessels, inadequate access, inadequate
visualization, previous endoscopic sphincterotomy, and thickened
gallbladder wall. Complications from cholecystectomy (open or
laparoscopic) include bile duct injuries (0.1-0.5% for open, 0.3-2%
with a declining trend for laparoscopic), pain, fatigue, nausea,
vomiting, and infection. In up to 6% of cases, surgeons fail to
identify and remove all gallstones present.
[0016] In some cases, the degree of infection and inflammation
prevents patients from undergoing immediate cholecystectomy. In
these cases, the gallbladder 14 must be treated with antibiotics
and anti-inflammatory agents, and drained through a tube into a
reservoir outside the abdomen. Placement of this tube occurs in a
procedure called percutaneous cholecystostomy, in which a needle is
introduced to the gallbladder 14 through the abdomen, fluid is
withdrawn, and a drainage catheter is inserted. This catheter
drains into an external bag which must be emptied several times a
day until the tube is removed. The drainage catheter may be left in
place for up to 8 weeks. In cases where no drainage catheter is
inserted, the procedure is called gallbladder aspiration. Since no
indwelling catheter is placed, the complication rate for
gallbladder aspiration is lower than that of percutaneous
cholecystostomy.
[0017] Treatment methodologies other than cholecystectomy include
expectant management, dissolution therapy, endoscopic retrograde
cholangiopanctreatograpy (ERCP) with endoscopic sphincterotomy, and
extracorporeal shockwave lithotripsy (ESWL).
[0018] Expectant management is appropriate for patients who have
gallstones but no symptoms, and for non-emergency cases with less
severe symptoms. This approach is not recommended when patients are
in high risk categories (e.g. high risk for gallbladder cancer) or
have very large gallstones (e.g. greater than 3 cm).
[0019] Oral dissolution therapy involves the administration of
pills containing bile acids that can dissolve gallstones. This
approach is only moderately effective, and the rate of recurrence
of gallstones after completion of treatment is high. It is not
appropriate for patients with acute inflammation or stones in the
common bile duct (more serious conditions). Dissolution therapy
tends to be more effective for patients with cholesterol stones,
and is sometimes used in conjunction with lithotripsy. Despite its
relative ineffectiveness, it is costly: treatment can last up to 2
years and the drugs cost thousands of dollars per year.
[0020] Related to oral dissolution therapy is contact dissolution,
a procedure that involves injection of a solvent such as methyl
tert-butyl ether (MTBE) directly into the gallbladder 14. This
approach is highly effective at dissolving gallstones, but patients
may experience severe burning pain.
[0021] ERCP (endoscopic retrograde cholangiopancreatograpy) is a
procedure in which an endoscope is introduced through the mouth of
a patient, past the stomach to the papilla 28, where the common
bile duct 18 empties into the duodenum 30. The overall goal of the
procedure is to insert instruments and tools into the common bile
duct 18 via the papilla 28 in order to treat biliary disease.
Typically, endoscopic sphincterotomy is performed, which is a
procedure that enlarges the opening of the papilla 28 in the small
intestine. This can be accomplished surgically or via balloon
dilation. Contrast agent is introduced into the common bile duct 18
to visualize the biliary tree fluoroscopically. Tools for clearing
blockages, such as mechanical lithotripsy devices, can be deployed
to crush gallstones and remove the resulting debris. Drainage
catheters and stents may also be inserted to facilitate the
drainage of bile past obstructions. Complications from this
challenging procedure occur at a rate of 5-8%, and include
recurrence of stone formation, pancreatitis, infection, bleeding,
and perforation.
[0022] Extracorporeal shockwave lithotripsy (ESWL) is a technique
in which focused, high-energy ultrasound is directed at the
gallbladder 14. The ultrasound waves travel through the soft body
tissue and break up the gallstones. The resulting stone fragments
are then usually small enough to pass through the bile duct into
the small intestine. Oral dissolution therapy is often used in
conjunction with ESWL. This treatment is not in common use, as less
than 15% of the patient population are good candidates. However,
ESWL is used to treat patients who are not candidates for surgery.
Complications from ESWL include pain in the gallbladder area,
pancreatitis, and failure of the gallstone fragments to pass into
the small intestine.
SUMMARY OF THE INVENTION
[0023] Devices for treating biliary disease are disclosed. Suitable
devices comprise, for example, a component configurable for
placement within a cystic duct of a biliary system of a patient
which has a proximal end 102 and a distal end 104. In some aspects,
a means adaptable for positioning within a lumen of a cystic duct
of a biliary system of a patient is provided which has a proximal
end and a distal end. Devices can further comprise a delivery
mechanism for delivering a substance, such as bioresorbable
materials or activatable materials. The means for positioning
within a lumen can further provide, for example, a means for
delivering a substance, such as bioresorbable materials or
activatable materials. In some instances, the devices are adaptable
and configurable to be removable. Additionally, or alternatively
the device are adaptable and configurable to be expandable.
Moreover, the devices can be configurable such that the device can
achieve one or more configurations, such as a deployment
configuration, a delivery configuration and a final configuration.
In some embodiments, devices comprise a variable profile, for
example, the device can be configurable to be variable along a
cross-sectional area of the device. In some aspects, the devices
are configurable for deployment by, for example, an endoscope, or
by a guidance element such as a guidewire or guidance catheter. In
other aspects a lumen can be provided that is configurable to
provide restrictable fluid flow, for example by using one or more
fluid control components. Devices can also be configured to
comprise a valve. Suitable valves include, for example, a
flow-restrictor valve or a one-way valve. Moreover, a means for
controlling a material can be provided, such as a valve, including,
for example, a flow-restrictor valve or a one-way valve. In some
configurations of the device it may be desirable for the device to
be flexible.
[0024] Still another aspect is directed to a biliary disease
treatment device comprising: an implant adapted to be delivered by
an endoscope, or guidance element such as a guidewire or guidance
catheter to a gastrointestinal site in proximity to a gallbladder,
and further adapted to form a conduit between the gastrointestinal
site and the gallbladder. Devices can further comprise a delivery
mechanism for delivering a substance, such as bioresorbable
materials or activatable materials. In some instances, the devices
are adaptable and configurable to be removable. Additionally, or
alternatively the device are adaptable and configurable to be
expandable. Moreover, the devices can be configurable such that the
device can achieve one or more configurations, such as a deployment
configuration, a delivery configuration and a final configuration.
In some embodiments, devices comprise a variable profile, for
example, the device can be configurable to be variable along a
cross-sectional area of the device. In some aspects, the devices
are configurable for deployment by, for example, an endoscope, or
by a guidance element such as a guidewire or guidance catheter. In
other aspects the lumen is configurable to provide restrictable
fluid flow, for example by using one or more fluid control
components. Devices can also be configured to comprise a valve.
Suitable valves include, for example, a flow-restrictor valve or a
one-way valve. In some configurations of the device it may be
desirable for the device to be flexible.
[0025] Yet another aspect is directed to a biliary disease
treatment device comprising: an implant adaptable to be delivered
by percutaneous means, to a gastrointestinal site in proximity to a
gallbladder, and further adapted to form a conduit means between
the gastrointestinal site and the gallbladder. Percutaneous means
includes, for example, guidewire, guiding catheter or
endoscope.
[0026] Aspects of the invention also include methods of delivering
a device to treat biliary disease. The methods of device delivery
comprise, for example, using an endoscope to place guidance
element, such as a guidewire or guidance catheter, between an
access lumen and a gallbladder; inserting a delivery catheter over
the guidance element and into the gallbladder; delivering a cystic
duct defunctionalizing device on the guidance element; and
positioning the cystic duct defunctionalizing device within a
cystic duct. Additional method steps can include the step of
passively retaining a distal end of the guidewire in the
gallbladder while the guidewire is used to deliver additional
elements. Moreover, the method can include the step of retaining a
distal end of the guidewire within the gallbladder, retaining a
distal end of the guidewire within the cystic duct, and/or
retaining a distal end of the guidewire within the common bile
duct. Additionally, gallstones can be removed through the created
lumen, if desired. Additionally, in some instances, the method can
include the step of localizing the gallbladder via endoscopic
ultrasound and/or altering or altering and removing gallstones. It
will be appreciated by those skilled in the art, that in some
instances, it may be desirable to clear obstructions within the
gallbladder. Moreover, it will be appreciated that the methods
involved herein facilitated treatment of biliary disease without
removal of the gallbladder. In still other methods, it may be
desirable to also visualize a treatment area, before, during, or
after any of the other method steps. In still other methods, a
biological duct can be formed in situ from a patient's tissue.
Moreover, the cystic duct defunctionalizing device can be changed,
if desired, from a delivery configuration to a deployment
configuration, from a delivery configuration to a final
configuration, and/or from a deployment configuration to a final
configuration. In still other aspects of the method, a
cross-sectional profile of the cystic duct defunctionalizing device
can be reduced. In other aspects, a valve can be operated to
restrict fluid flow. In some instances it may be desirable to
defunctionalize the cystic duct in situ. Such defunctionalizing can
be achieved by, for example, delivering a substance into a space
within the cystic duct. As will be appreciated by those skilled in
the art, a wide range of substances can be delivered, including,
for example, gels, foams, sclerosing agents, adhesives,
bioadhesives, anti-inflammatory and inflammatory agents. Moreover,
some substances can be selected that are capable of activation in
situ. The amount of substance delivered can vary, as desired, and
can include delivering an amount sufficient to fill, or
substantially fill, the lumen of the cystic duct, or in the case of
an activatable substance, an amount sufficient to result in an
activated substance amount sufficient to fill, or substantially
fill, the lumen of the cystic duct. In other aspects of the method,
the step of defunctionalizing the cystic duct is achievable by
delivering a plug or device into a space, or lumen, within the
cystic duct. Suitable plugs may be configurable either internally
or externally to seat within the lumen of the cystic duct. Moreover
plugs or devices can further comprise one or more thread profiles,
ridges or steps about its exterior surface adapted to aid in
seating the device within the lumen of the duct. The plugs or
devices can further comprise a valve.
[0027] Another aspect of the invention is directed to a kit for
treating biliary disease. Kits include, for example, one or more
devices configurable to be positioned within a cystic duct; and
optionally a compound for delivery to a tissue. Other components of
the kit include, one or more of, a catheter, a guidewire, an
ablation device, a sclerosing agent, antibiotic agents,
inflammatory agents, anti-inflammatory agents, biocompatible gels,
biocompatible foams, activatable materials, scissors, scalpels,
swabs, syringes, hemostats, lubricants, needles, snares,
antiseptics, and anesthetics.
[0028] Still another aspect of the invention is directed to a
method of treating biliary disease comprising: accessing a lumen
associated with a gallbladder; defunctionalizing a cystic duct. An
aspect of the method enables the gallbladder to be left in situ.
Additionally, the step of defunctionalizing the cystic duct can
further comprise the step of delivering a substance to at least one
of the cystic duct or the gallbladder. An amount of substance can
be delivered such that it occupies, or substantially occupies the
lumen, or is activated to occupy or substantially occupy the lumen
of the cystic duct. One or more suitable substances can be
delivered including, for example, antibiotics, inflammatory agents,
and anti-inflammatory agents. In some instances, the method
includes the step of preventing bile from entering the gallbladder
lumen. Additionally, the method can include the step of localizing
the gallbladder via endoscopic ultrasound. In other aspects of the
method, the step of accessing the gallbladder is achieved via the
gastrointestinal tract, such as by accessing the gastrointestinal
tract at a duodenum. Additional aspects of the method include, for
example, one or more of sclerosing, necrotizing or ablating tissue.
Ablation techniques can, for example, be selected from the group
comprising cryoablation, thermal ablation, chemical ablation, radio
frequency ablation, ultrasound ablation, and microwave ablation. In
some instances, a fluid can be delivered wherein the fluid is
delivered, for example, with an angular orientation, moreover fluid
can be delivered with at least one of a 360 degree radial pattern,
a sharp stream, and a cone shape. Still further, the fluid can be
delivered with a device comprising an articulating member or a
means for articulating. In some aspects of the method it may be
desirable to apply a vacuum to a lumen of the cystic duct or the
gallbladder, and/or apply an adhesive to the lumen of the cystic
duct. Additionally, in some instances the step of defunctionalizing
the cystic duct may further comprise physically blocking a lumen of
the cystic duct, such as with a plug, device, means for blocking or
means for plugging.
[0029] Yet another aspect of the invention is directed to a device
for treating biliary disease comprising a plug, device, means for
blocking or means for plugging, adaptable and configurable to be
positioned within a cystic duct of a patient having a proximal end
and a distal end and is configurable either internally or
externally to seat within a lumen of the cystic duct after
deployment. The external configuration of the plug, device, or
plugging means can be configurable to have one or more of threads,
ridges, steps, or means for securing. Moreover, the ridges, steps
or means for securing can be fixed or activatable. Additionally,
the plug, device or plugging means can further comprise a valve,
such as a one-way valve, or means for controlling or restricting a
flow of fluid or flowable material. In some aspects the plug,
device or plugging means can be positioned within or proximal to
the cystic duct.
[0030] Another aspect of the invention is directed to the use of
any of the devices disclosed herein for use in the treatment of
biliary disease.
INCORPORATION BY REFERENCE
[0031] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The novel features of the invention will be set forth with
particularity in any claims presented based on this application. A
better understanding of the features and advantages of the present
invention will be obtained by reference to the following detailed
description that sets forth illustrative embodiments, in which the
principles of the invention are utilized, and the accompanying
drawings of which:
[0033] FIG. 1 illustrates an overview of the biliary system;
[0034] FIG. 2 illustrates the biliary system with gallstones;
[0035] FIG. 3 illustrates an endoscope accessing the biliary system
via the intestinal system;
[0036] FIGS. 4A-E illustrate cystic duct defunctionalization
devices;
[0037] FIG. 5 illustrates a cystic duct defunctionalization device
in combination with a guidewire; and
[0038] FIG. 6 illustrates a cystic duct plug with 1-way valve.
DETAILED DESCRIPTION OF THE INVENTION
[0039] Devices, systems, methods and kits provided herewith can
obviate the need for a plurality of procedures, including, for
example: 1) percutaneous cholecystostomy, 2) cholecystectomy, 3)
percutaneous trans-hepatic cholangiography (PTHC), and 4)
endoscopic retrograde cholangiopancreatography (ERCP).
Additionally, disclosed treatment modalities enable treatment of a
distal common bile duct 18 obstruction, e.g. secondary to
pancreatic carcinoma, cholagiocarcinoma, and/or ampullary
carcinoma. As will be appreciated by those skilled in the art, the
conventional standard of care for treating biliary disease has been
surgical removal of the gallbladder 14 and closure of the cystic
duct 16. While this has proven to be an effective mechanism for
permanently eliminating biliary disease and its recurrence, the
present invention seeks to accomplish the same end in a less
invasive and less costly way. This may be achieved by treating
biliary disease without requiring the removal of the gallbladder
14. Methods and apparatus are described in this application that
are intended to effectively treat biliary disease with the
gallbladder 14 and cystic duct 16 left in situ by defunctionalizing
the cystic duct.
Defunctionalization of the Cystic Duct:
[0040] In order to treat gallbladder 14 disease while leaving the
gallbladder 14 in situ, it may be desirable to defunctionalize the
cystic duct 16. The cystic duct 16 connects the gallbladder 14 and
the common bile duct 18 (see FIG. 1), and is the flow path for bile
into and out of the gallbladder 14. An objective of
defunctionalizing the cystic duct 16 is to prevent bile from
reaching the gallbladder 14. The gallbladder 14 may be otherwise
unaltered, or it may be altered--e.g. a conduit or shunt may be
placed for access and/or drainage, the gallbladder 14 may be
defunctionalized, etc. When bile is unable to enter the cystic duct
16, and therefore the gallbladder 14, the gallbladder 14 will also
be effectively defunctionalized, whether or not any other treatment
is performed. Gallstones may form anywhere that bile is present in
the biliary system, so preventing bile from flowing in the cystic
duct 16 may prevent the formation of gallstones in the cystic duct
16 and gallbladder 14. Defunctionalization of the cystic duct 16
may be long- or short-term, temporary or permanent. The entire
length of the cystic duct 16 may be defunctionalized, or it may be
performed at one or more discrete locations. The treatment may be
applied anywhere along the length of the cystic duct 16, from the
point where it joins the common bile duct 18 to the point where it
interfaces with the gallbladder 14. However, the preferred
treatment location for defunctionalizing the cystic duct 16 is as
close to the junction with the common bile duct 18 as possible
without substantially affecting the function of the common bile
duct 18.
[0041] In holding with the other methods and apparatus described in
this application, it is most desirable to effect
defunctionalization of the cystic duct 16 from within the
gallbladder 14, inside the cystic duct 16, and/or inside the common
bile duct 18. This eliminates the need for external, surgical
access to these anatomical structures. Optionally,
defunctionalization of the cystic duct 16 is achieved by the use of
implements delivered endoscopically or means for accessing the
cystic duct percutaneously. In some instances, directly visualizing
the devices and navigational devices used may also be desirable,
and may facilitate control and treatment. Visualization may be
achieved by any suitable mechanism known in the art, including, for
example, endoscopic ultrasound (EUS), or by using a small daughter
endoscope (e.g. a cystoscope), or by using catheters incorporating
small imaging sensors at the distal end (e.g. Avantis' Third Eye)
and fiber optic imaging bundles (e.g. Boston Scientific's
SpyGlass). Visualization and guidance may also be achieved via
external imaging methods, such as fluoroscopy (with or without the
use of contrast agent), ultrasound, X-ray, etc.
[0042] Defunctionalization of the cystic duct 16 may be
accomplished by a variety of mechanisms, including, but not limited
to, ablation methods (e.g. cryo-, thermal-, RF, microwave,
ultrasound, etc.) and mechanical methods (e.g. plugs, stoppers,
sutures, staples, clamps, clips, adhesives, bioadhesives, vacuum
with adhesives/bioadhesives, vacuum without adhesives/bioadhesives,
etc.). Regardless of the method used, it may be helpful to begin
the process by inserting a guidance element 530, such as a
guidewire, guidance catheter or any suitable means for accessing
the cystic duct 16 from within the gallbladder 14, though a conduit
that connects the gallbladder 14 lumen to the access lumen, e.g. at
or near the duodenum 30, or from within the common bile duct 18, as
may be done during ERCP. A guidance element 530 (FIG. 5) (e.g. a
guidewire, guidance catheter, etc.) may be useful for inserting and
navigating items into the cystic duct 16, such as ablation
catheters, visualization catheters, mechanisms of treating
gallstones within the cystic duct 16, devices 520 for
defunctionalizing the cystic duct 16, and other mechanisms of
defunctionalizing the cystic duct 16. Since the cystic duct 16 is
funnel-shaped (with a larger diameter at the opening into the
gallbladder 14 than at the junction with the common bile duct 18),
and spirals as it progresses (an anatomical feature called the
valves of Heister), it may be easily traversed with a guidance
element 530, such as a guidewire or guidance catheter, from within
the gallbladder 14 simply by pushing. However, the guidance element
530 may be configured or configurable to facilitate advancement.
Moreover, alternate shapes of the guidance element 530 may
facilitate advancement, such as a cork-screw shape, spiral shape,
or a tip that is preferentially bent to one side. In these cases,
successfully advancing the guidance element 530 into the cystic
duct 16 may be achieved by pushing, torquing (rotating), or a
combination of pushing and torquing.
[0043] If defunctionalization is achieved by physically blocking
the cystic duct 16, a cystic duct defunctionalization device 420
serving a similar function as, for example, a bottle stopper may be
used (FIG. 4A). The defunctionalization device 420 has a proximal
end and a distal end. Such a device 420 may be inserted into the
cystic duct 16 from the gallbladder 14, through a conduit that
connects the gallbladder 14 to an access lumen such as the duodenum
30. The plug 420 may be inserted before, during, or after other
treatments for inflammation, infection, gallstones, etc. have been
administered or completed. The plug 420 may be left in place for a
limited period of time, or permanently. The plug 420 or means for
plugging the cystic duct may be comprised of any suitable
biocompatible material, such as silicone, polytetrafluroethylene
(PTFE), stainless steel, titanium, shape memory materials (e.g.
Nitinol), etc. The device 420 may be configured or configurable to
provide a means for blocking the cystic duct.
[0044] Devices 420 may optionally incorporate features that aid in
retaining and securing the device in place. Such features may be
inactive (that is, fixed and integral to or incorporated into the
devices), e.g. a spiral thread pattern 422 (in which case, the
devices should be rotated into position in the cystic duct 16 at
installation, FIG. 4B), one or more ridges 423 (FIG. 4C), and/or
one or more backward-facing steps 424 resembling a hose barb (FIG.
4D). Each of these one or more threads 422, ridges 423, and steps
424 features enable the device 420 to be secured within the cystic
duct 14. Alternately, the retaining features may be active 425 so
that they may be activated once the device is in the desired
position, e.g. with shape memory alloys (e.g. Nitinol) or with
mechanically triggered movable elements (FIG. 4E).
[0045] Additionally, a plug or stopper device 620 may have one or
more flow control elements, such as 1-way valves 640 which allow
flow out of the gallbladder 14 and cystic duct 16, but does not
allow flow into the cystic duct 16 or gallbladder 14 (FIG. 6). This
may be useful in cases where drainage of the gallbladder 14 and/or
cystic duct 16 is desired, and provides either a primary or
secondary flow path for fluids. Additionally, activatable materials
can be delivered to the cystic duct. Suitable activatable materials
include, for example, sclerosing substances, gels, foams,
adhesives, bioadhesives. Any of such activatable materials may be
selected so that they are absorbed or break down within the body
over a desired period of time. Additionally, a vacuum may be
applied to the cystic duct in order to close or substantially close
it. This may be done in combination with the use of any of the
other techniques described herein.
[0046] Since stones 20 may be present in the cystic duct 16 at the
time of treatment, it may be necessary to eliminate them before,
during, or after defunctionalization. This may be achieved using
mechanical lithotripsy, snares, chemical/contact dissolution with
substances such as methyl tertiary-butyl ether (MTBE), ultrasound
energy, or any other useful or effective mechanism of breaking up
and/or removing gallstones. Removal of gallstones through a conduit
placed in the gallbladder 14 allows clinicians to access the cystic
duct 16 from the reverse direction, which is not possible with
conventional techniques. This may dramatically facilitate the
process of treating gallstones 20 in the cystic duct 16 and common
bile duct 18, which can be difficult using conventional
techniques.
[0047] A method of treating biliary disease involves using an
endoscope 310 to access a region in the gastrointestinal (GI) tract
to which the cystic duct 16 is in close proximity, locating the
cystic duct 16, accessing the cystic duct 16, and then treating the
underlying condition that led to the need for intervention (FIG.
3). Treatments may also include, but are not limited to: providing
for drainage of the gallbladder 14 and/or the biliary tree,
delivering antibiotics, inflammatory, anti-inflammatory agents (any
of which may be short-term acting, fast acting, or time release),
and/or other substances (e.g. adhesives, bioadhesives, etc.) and/or
activatable materials to the gallbladder 14 and/or biliary tree,
removing gallstones 20, facilitating the destruction and subsequent
removal of gallstones, clearing obstructions, delivering catheters,
delivering stents (drug coated or not drug coated), temporarily or
permanently defunctionalizing the cystic duct 16, temporarily or
permanently defunctionalizing the gallbladder 14. Devices and
therapies can be delivered in a single treatment, with minimal
likelihood of or necessity for follow-up or repeat procedures.
[0048] Localization of the gallbladder 14 can be performed via
endoscopic ultrasound (EUS) by accessing the wall of the GI tract
with an endoscope 310 as shown in FIG. 3. Localization may also be
achieved by any other method that visualizes anatomical features,
such as fluoroscopy, x-rays, magnetic resonance imaging (MRI),
computed axial tomography (CT) scans, ultrasound imaging from
outside the body, or any method of anatomical imaging and
visualization.
[0049] Once the gallbladder 14 has been located, it may be accessed
and/or treated through the wall of the GI tract 350 (or any lumen
in proximity to the gallbladder 14) with tools and devices (e.g.
needles, guidewires, guidance catheters, shunts, dilators, etc.)
delivered through, for example, an endoscope 310. Such tools and
devices may be inserted down the length of the endoscope's working
channel 312, or loaded onto or near the distal end of the endoscope
310. Alternately, tools and other devices may be used that do not
require the aid of the endoscope for navigation or delivery. Direct
visualization may be provided by the endoscope 310 during the
procedure, as well as irrigation, suction, and insufflation.
[0050] Though the preferred location for accessing the gallbladder
lumen is the duodenum 30, it may also be readily achieved through
the wall of other regions of the GI tract, such as the stomach or
the jejunum, for example. Thus, any lumen in close proximity to the
gallbladder 14 is a candidate for access to and treatment of the
gallbladder 14 and other members of the biliary system.
[0051] The devices and methods disclosed herein facilitate
defunctionalizing the cystic duct without the need for surgery.
Kits:
[0052] All of the devices required to deliver and install a
conduit, treat and/or defunctionalize the cystic duct 16, may be
packaged in a kit. Bundling all devices, tools, components,
materials, and accessories needed to perform these procedures into
a kit may enhance the usability and convenience of the devices, and
also improve the safety of the procedure by encouraging clinicians
to use the items believed to result in the best outcomes. The kit
may be single-use or reusable, or it may incorporate some
disposable single-use elements and some reusable elements. The kit
may contain, but is not limited to, the following: implantable
and/or non-implantable devices; delivery devices (e.g., needles,
guidewires, guidance catheters, dilators, etc.); balloon
inflation/deflation accessories; syringes; fluid flow, temperature,
and pressure measurement instruments; scissors; scalpels; clips;
ablation catheters; endoscopic tools (e.g. lithotripsy devices,
snares, graspers, clamps, forceps, etc.). The kit may be supplied
in a tray, which organizes and retains all items so that they can
be quickly identified and used.
Description of Other Uses:
[0053] The techniques and devices described in this application may
prove beneficial in applications beyond their initial use in the
treatment of biliary disease.
[0054] For example, they may prove to be an effective mechanism of
treating cholangitis (infection of the common bile duct 18). This
condition is usually bacterial, and occurs when the bile duct is
blocked by gallstones 20' or a tumor. Traditional treatment
involves the insertion of a stent or drainage catheter into the
common bile duct 18 to allow bile to drain into the duodenum 30
from locations above the obstruction. Placement of a conduit into
the gallbladder 14 may allow for an alternate method of draining
bile and/or other fluids into the duodenum 30. Any blockage in the
common bile duct 18 between the entrance of the cystic duct 16 and
the duodenum 30 may be treated in this way. See FIG. 2.
[0055] Another use of the devices and techniques described
elsewhere in this application may be to create anastomoses between
any body lumens in proximity to one another. This may include, but
is not limited to: small bowel to small bowel anastomoses, small
bowel to large bowel anastomoses, large bowel to large bowel
anastomoses, and stomach to small bowel anastomoses. Additionally,
creating a conduit between the stomach and other body lumens may be
useful and effective for treating and/or managing obesity.
[0056] Another use of the devices and techniques described herein
is for drainage of any body lumen into another body lumen in
proximity, for example, the drainage of pancreatic pseudocysts.
[0057] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *