WO1999017708A1 - Gastro-intestinal tube with dissolvable support bolster - Google Patents

Gastro-intestinal tube with dissolvable support bolster Download PDF

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Publication number
WO1999017708A1
WO1999017708A1 PCT/US1998/020829 US9820829W WO9917708A1 WO 1999017708 A1 WO1999017708 A1 WO 1999017708A1 US 9820829 W US9820829 W US 9820829W WO 9917708 A1 WO9917708 A1 WO 9917708A1
Authority
WO
WIPO (PCT)
Prior art keywords
gastro
bolster
tube
set forth
intestinal
Prior art date
Application number
PCT/US1998/020829
Other languages
French (fr)
Inventor
Todd Snow
Original Assignee
Boston Scientific Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Corporation filed Critical Boston Scientific Corporation
Priority to AU96812/98A priority Critical patent/AU9681298A/en
Publication of WO1999017708A1 publication Critical patent/WO1999017708A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/60—General characteristics or adaptations biodegradable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

Definitions

  • the present invention relates generally to an
  • a gastro-intestinal device having a deformable
  • gastro-intestinal device One type of gastro-intestinal device, the gastro-
  • intestinal tube is widely used with patients who require
  • PEG Percutaneous Endoscopic Gastrostomy
  • Gastro-intestinal tubes like other gastro-.
  • intestinal tract typically have an internal bolster, or
  • the end having the bolster lies inside the stomach wall.
  • the tube is pulled from outside the abdomen until the
  • a stoma forms which runs from the stomach to the
  • the tubes are manipulated by medical
  • the tubes are also manipulated by
  • the tube to become misplaced within or removed from the gastro-intestinal tract.
  • bolster may also rupture the stomal tract as it is pulled
  • Tube migration refers to post-placement tube
  • tissue dies or is displaced, the bolster migrates into
  • the bolster may become misplaced within the peritoneal
  • the flexible internal bolster may be
  • gastrostomy relates to deliberate tube removal by medical personnel. Gastro-intestinal tubes often become occluded
  • Some tubes have rigid internal
  • the disk prevents premature traction removal
  • Adapter tube must then be removed by using an endoscopic snare, an invasive and often expensive medical procedure,
  • the stomal tract may be
  • the bolster retains its domed shape.
  • the present invention overcomes the deficiencies in
  • the invention comprises a
  • the invention furthermore is located at the distal end.
  • the support bolster is such that the support bolster
  • the stoma typically takes approximately
  • the internal bolster may be pulled into and
  • stomach may then fall away from the abdominal wall. Should that occur, a second surgical procedure would
  • the support bolster has a
  • shaft of the gastro-intestinal tube can be coated with
  • Fig. 1 shows an elevational view, partially in section
  • Fig. 2 is a top view of an embodiment of dissolvable
  • support bolster of the present invention where the support bolster is shaped as a disk.
  • Fig. 3 is a side view of the dissolvable support bolster
  • Fig. 4a is an elevational view, partially in section, of
  • Fig. 4b is an elevational view, partially in section, of
  • Fig. 5a is an elevational view, partially in section, of
  • Fig. 5b is an elevational view, partially in section, of the embodiment of gastro-intestinal tube having a
  • Fig. 6a is an elevational view, partially in section, of
  • Fig. 6b is an elevational view, partially in section, of
  • Fig. 7a is an elevational view, partially in section, of
  • Fig. 7b is an elevational view, partially in section, of
  • Fig. 8a is an elevational view, partially in section, of
  • internal bolster is convex, as viewed from a proximal
  • Fig. 8b is an end view of the gastro-intestinal tube
  • Fig. 9a is an elevational view, partially in section, of
  • Fig. 9b is an end view of the gastro-intestinal tube
  • Fig. 10a is an elevationai view, partially in section, of
  • Fig. 10b is an end view of the gastro-intestinal tube
  • Fig. 11a is an elevational view, partially in section, of
  • support bolster are concave, as viewed from a proximal
  • Fig. lib is an end view of the gastro-intestinal tube
  • Fig. 12a is an elevational view, partially in section, of
  • bolster- are concave, as viewed from a proximal vantage
  • Fig. 12b is an end view of the gastro-intestinal- tube
  • Fig. 13a is an elevational view, partially in section, of
  • bolster are concave, as viewed from a proximal vantage
  • Fig. 13b is an end view of the gastro-intestinal tube
  • Fig. 14a is an elevational view, partially in section, of
  • gastro-intestinal tube having a dissolvable support bolster according to the present
  • support bolster are convex, as viewed from a proximal
  • Fig. 14b is an end view of the gastro-intestinal tube
  • Fig. 15a is an elevational view, partially in section, of
  • bolster are convex, as viewed from a proximal vantage
  • Fig. 15b is an end view of the gastro-intestinal tube
  • Fig. 16a is an elevational view, partially in section, of
  • both the internal bolster and support bolster are convex, as viewed from a proximal vantage
  • Fig. 16b is an end view of the gastro-intestinal tube
  • Fig. 17a is an elevational view, partially in section, of
  • the support bolster has a convex distal
  • Fig. 17b is an end view of the gastro-intestinal tube
  • Fig. 18a is an elevational view, partially in section, of
  • the internal bolster is concave, as viewed from a proximal vantage point, and circular in
  • the support bolster has a convex distal
  • Fig. 18b is an end view of the gastro-intestinal tube
  • Fig. 19a is an elevational view, partially in section, of
  • the support bolster has a convex distal
  • Fig. 19b is an end view of the gastro-intestinal tube
  • the preferred embodiment of the present invention comprises a gastro-intestinal tube 1 having proximal and
  • FIG. 1 shows
  • Fig. 1 also shows an external bolster 4
  • Fig. 1 shows an elevational view of the preferred
  • gastro-intestinal tube 1 can be placed either transorally
  • the tube may be placed using either the push or
  • the dissolvable bolster 3 is adjacent to the
  • the tube 1 extends from inside the gastric wall 5 out
  • Figs. 2 and 3 show the support bolster 3 of the
  • the support bolster 3 is preferably a round disk with an outer diameter of approximately 2-3
  • gastro-intestinal tubes is typically between 14 fr. and
  • the support bolster is a disk with a
  • dissolvable support bolster 3 need only
  • the support bolster 3 can be pliant enough to
  • the support bolster 3 is made of a dissolvable
  • biocompatible material preferably an aliphatic
  • polyester such as the material used to make medical
  • the support bolster 3 can also be made
  • dissolvable polymers such as collagen, elastin, chitin.
  • other materials e.g. collagen, elastin, chitin.
  • dissolvable polymers include poly [phosphoesters] ,
  • poly [anhydrides] poly [orthoesters] , poly [phosphazenes] ,
  • biocompatible, dissolvable medical devices are biocompatible, dissolvable medical devices.
  • the dissolution time for the support bolster is
  • the dissolution time can be shorter than two
  • the gastro-intestinal tube shaft 7 can be made of any biocompatible copolymer such as a silicone elastomer,
  • the internal bolster 2 is made of a collap s ible
  • the tube can removed by traction pulling from
  • bolster 3 ' has a coating which contains a medicating
  • support bolster 3 1 is placed within the abdominal cavity
  • the support bolster 3 1 lies distally adjacent to the
  • the coating will include an
  • anti- inflammatory drug such as salicylic acid or
  • the coating may also include an antibiotic,
  • antiviral, antimicrobial, or antiencrustation agent or a
  • disinfecting agent such as a bacteriocidal or
  • Ciprofloxacin or gentamicin are examples of gentamicin.
  • Chlorhexadine and triclosan are examples of
  • Patent No. 5,366,505 describes the use of slime-
  • a medicating substance such as a substance
  • Dissolvable materials make good drug delivery agents, avoiding the need for a coating which
  • materials which can be coated with medication include:
  • aliphatic polyesters such as DecapeptylTM , Lupron
  • the rates at which the the support bolster dissolves and the medication is dispensed can be controlled with
  • tube may contain a medicating agent, as shown in Fig. 4b.
  • Medication, so located can be delivered directly to the
  • FIG. 4a shows a gastro-
  • Medication may also be located on or within the
  • tubular prosthesis having a drug incorporated within a
  • Fig. 4a shows a gastro-intestinal tube of present
  • That figure also shows a support bolster
  • FIGs. 5a and 7a show gastro-intestinal
  • Fig. 6a shows a support
  • a medicating substance can be delivered
  • 5b, 6b, and 7b show gastro-intestinal tubes of the
  • tube shaft are equipped with a medicating substance) .
  • Fig. 8a shows a gastro-intestinal tube of the present
  • Fig. 8b is an end view of the gastro-
  • Fig. 8a shows a gastro-intestinal tube of the
  • Fig. 10a shows a gastro-
  • intestinal tube of the present invention in which the
  • internal bolster 11 is proximally convex and oblong in
  • Fig. 11a shows a gastro-intestinal tube of the
  • bolster 18 are concave and circular in shape.
  • bolster 20 are concave and oblong in shape. Figs, lib,
  • Fig. 14a shows a gastro-intestinal tube of the present invention in which both the the internal bolster
  • support bolster 22 are convex and oval in shape.
  • Fig. 15a shows a gastro-
  • intestinal tube of the present invention in which both
  • Fig. 16a shows a gastro-
  • intestinal tube of the present invention in which both
  • FIGs. 14b, 15b and 16b show
  • Fig. 17a shows a gastro-intestinal tube of the
  • Fig. 18a shows a gastro-intestinal
  • bolster 31 is concave and circular in shape, and the
  • Fig. 19a shows a gastro-intestinal tube of the present invention, in which
  • the internal bolster 32 is concave and oblong in shape
  • the support bolster 33 has a concave distal surface

Abstract

A gastro-intestinal tube which provides rigid support during stomal formation, while allowing tube removal by pulling from outside the abdominal wall. The tube has proximal and distal ends, a deformable internal bolster attached to the distal end, and a dissolvable support bolster placed around the tube proximal to the internal bolster. The support bolster is made of a dissolvable material, such that the bolster provides a high degree of securement to the gastro-intestinal tube during formation of the stoma, and dissolves to allow tube removal after the stoma has formed. In an alternate embodiment, the bolster has a coating of a medicating agent.

Description

GASTRO-INTESTINAL TUBE WITH DISSOLVABLE SUPPORT BOLSTER
Field of the Invention
The present invention relates generally to an
apparatus for use in the placement of gastro-intestinal
devices. More specifically, the present invention
relates to a gastro-intestinal device having a deformable
internal bolster and a dissolvable support bolster.
Background of the Invention
Medical practitioners utilize a variety of gastro¬
intestinal devices to access the gastro-intestinal tract.
One type of gastro-intestinal device, the gastro-
intestinal tube, is widely used with patients who require
catheterization for the purposes of, for example,
delivering food or medication to the gastr-intestinal
tract, draining the tract, or creating a surgical port.
Patients with damage to their upper gastro-intestinal
tract, or with neurological or mental impairment often
need long-term cacheterization for these purposes. In
order to place catheters within the gastro-intestinal -
tract, medical practitioners often use Percutaneous Endoscopic Gastrostomy (PEG) techniques. These
techniques typically involve either placing a gastro-
intestinal tube in the patient's mouth and snaking it
down the esophagus, into the stomach, and out the
abdominal wall, or they involve inserting the tube into
the stomach from outside of the abdominal wall by sliding
the tube over a guidewire .
Gastro-intestinal tubes, like other gastro-.
intestinal devices which provide access to the gastro-
intestinal tract, typically have an internal bolster, or
anchoring device, at one end which secures the tube
within the stomach. When the tube is properly placed,
the end having the bolster lies inside the stomach wall.
The tube is pulled from outside the abdomen until the
internal bolster forces the stomach against the abdominal
wall; a process called "approximation." An additional
bolster is often placed on the outside of the abdominal
wall to hold the stomach in contact with the abdominal
wall. After the stomach and abdominal wall are held in
place for approximately two weeks, a fistulous tract,
called a stoma, forms which runs from the stomach to the
outer surface of the abdominal wall . When using percutaneous gastrostomy, practitioners
face several common complications, including: infection
at the stoma site, premature tube removal, and tube
migration. Peristomal infections, the most common post-
placement complication, result from introducing a gastro¬
intestinal tube into the sterile abdominal penetration,
after the tube has been dragged through non-sterile
locations such as the mouth, esophagus, and the -external
abdominal wall. Although prophylactic medication often
prevents infection, peristomal infection still occurs in
a small percentage of cases where prophylactic treatment
has been administered.
Most gastro-intestinal tubes used in long-term
catheterization remain in place for several months.
During that time, the tubes are manipulated by medical
practitioners who clean the stoma site, attach and detach
devices for delivering food and medicine, and otherwise
move the tubes. The tubes are also manipulated by
patients, some of whom suffer from mental or neurological
disorders and try to remove the tube by pulling it from
outside the abdominal wall. Such manipulation can cause
the tube to become misplaced within or removed from the gastro-intestinal tract.
If the tube is deliberately or inadvertently pulled
before the stoma forms, it may fall out of the stomach
wall and become misplaced either within the abdominal
wall or within the peritoneal cavity which is sterile and
susceptible to infection. Since peritoneal infection
often goes unnoticed until it has become severe,
misplacing the tube within that cavity can cause- serious
medical complications. If the tube is pulled after the
stoma has formed, it may be completely removed from the
stoma, requiring replacement procedures. The internal
bolster may also rupture the stomal tract as it is pulled
through, requiring subsequent medical procedures.
Tube migration refers to post-placement tube
movement within the stomach and abdominal walls.
Migration typically results from clamping the outer
bolster too tightly against the abdomen during
approximation. Excessive clamping pins the internal
bolster tightly against the stomach wall, often leading
to ulceration and necrosis of the gastric tissue. As the
tissue dies or is displaced, the bolster migrates into
the body tissue. Because PEG approximation is usually performed without endoscopic visualization, the excessive
clamping often goes undetected.
If migration occurs before the stomal tract forms,
the bolster may become misplaced within the peritoneal
cavity. Migration into the peritoneal c vi y . Jten leads
to severe infection and, where the tube is used for
feeding or medication delivery, to misdirected delivery
into the peritoneal cavity. Tube migration often goes
undetected until observable manifestations, such as
bleeding, occurs.
A high incidence of tube migration occurs where
flexible internal bolsters are used. Although such
bolsters enable tube removal by pulling the tube from
outside the abdominal wall, they are also more
susceptible to tube migration. When outer bolsters are
used in connection with flexible internal bolsters and
clamped tightly, the flexible internal bolster may be
pulled into the abdominal penetration. Due to their
flexible structure of these flexible bolsters, they often
migrate further into the penetration.
Another common complication from using percutaneous
gastrostomy relates to deliberate tube removal by medical personnel. Gastro-intestinal tubes often become occluded
or clogged and must be removed and replaced. They are
also periodically removed and replaced during normal
medical maintenance . Some tubes have rigid internal
bolsters which prevent removal by pulling from outside
the abdominal wall. These bolsters must be removed
either surgically or by endoscopic snare. Other tubes
have internal bolsters which detach when the tube is
traction pulled, and are left to be expelled from the
body through excretion. These additional invasive
procedures increase patient discomfort, risk of
infection, as well as medical expenses.
Applied Medical Technologies, Inc. of Independence,
Ohio markets a device called the "Secure Cath Adaptor"
having a rigid disk which fits over the tube shaft, up
against a more flexible internal bolster. The rigid disk
is designed to prevent removal by pulling the tube from
outside the abdominal wall; called removal by traction
pull or traction removal. Thus, in addition to
preventing premature traction removal, the disk prevents
traction removal for tube replacement. The "Secure Cath
Adapter" tube must then be removed by using an endoscopic snare, an invasive and often expensive medical procedure,
Practitioners may nevertheless attempt traction removal,
as such removal is often performed without internal
visualization. In the process, the stomal tract may be
damaged .
The prior art contains several gastro-intestinal
tubes which inhibit premature removal to some degree
while allowing deliberate removal by medical personnel.
U.S. Pat. No. 5,356,391 describes a tube with a
collapsible internal bolster. During normal operation,
the bolster retains its domed shape. During traction
pull, the dome collapses to a diameter which allows the
bolster to pass through the stoma. A similar device" is
described in U.S. Pat. No. 5,391,159. U.S. Pat. No.
5,248,302 describes an internal bolster which can be
removed through use of an obturator.
Summary of the Invention
The present invention overcomes the deficiencies in
the prior art by providing a gastro-intestinal device
which prevents premature traction removal, but allows certain deliberate traction removal, such as removal for
purposes of replacement . The invention comprises a
gastro-intestinal tube with a deformable internal bolster
located at the distal end. The invention further
comprises a dissolvable support bolster which is located
proximally adjacent to the internal bolster. The support
bolster provides rigid support to the internal bolster
prior to dissolution of the support bolster and -thereby
preventing premature tube removal. After the support
bolster dissolves, however, the tube can be removed by
traction pulling the tube through the penetration into
which it had been placed.
In the preferred embodiment, the dissolution titne of
the support bolster is such that the support bolster
provides rigid support during formation of a fistulous
tract connecting the stomach to the abdominal wall,
called a stoma. The stoma typically takes approximately
two weeks from initial tube placement to form. If the
tube is inadvertently or deliberately pulled before stoma
formation, the internal bolster may be pulled into and
become misplaced within the peritoneal cavity, and the
stomach may then fall away from the abdominal wall. Should that occur, a second surgical procedure would
likely be required to place another gastro-intestinal
tube .
In another embodiment, the support bolster has a
coating which contains a substance such as an anti-
inflammatory, antibiotic, antiviral, antiencrustation,
antimicrobial, or disinfecting agent. Additionally, the
shaft of the gastro-intestinal tube can be coated with
such a substance .
Brief Description of the Drawings
The invention will be more readily understood through the
following detailed description, with reference to the
accompanying drawings, in which:
Fig. 1 shows an elevational view, partially in section,
of a gastro-intestinal tube constructed according to the
principles of this invention, as placed within the
gastric cavity.
Fig. 2 is a top view of an embodiment of dissolvable
support bolster of the present invention, where the support bolster is shaped as a disk.
Fig. 3 is a side view of the dissolvable support bolster
shown in Fig. 2.
Fig. 4a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster constructed according to the
principles of this invention.
Fig. 4b is an elevational view, partially in section, of
the embodiment of gastro-intestinal tube having a
dissolvable support bolster shown in Fig. 4a, with both
the tube shaft and dissolvable support bolster coated
with a substance.
Fig. 5a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster constructed according to the
principles of the present invention.
Fig. 5b is an elevational view, partially in section, of the embodiment of gastro-intestinal tube having a
dissolvable support bolster shown in Fig. 5a, with both
the tube shaft and support bolster coated with a
substance .
Fig. 6a is an elevational view, partially in section, of
a gastro-intestinal tube with a dissolvable support
bolster having an extended lateral extent, constructed
according to the present invention, as placed within the
gastric cavity.
Fig. 6b is an elevational view, partially in section, of
the embodiment of gastro-intestinal tube with dissol-vable
support bolster having an extended lateral extent, with
both the tube shaft and the dissolvable support bolster
coated with a substance according to the principles of
the present invention.
Fig. 7a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster constructed according to the
principles of the present invention. Fig. 7b is an elevational view, partially in section, of
the embodiment of gastro-intestinal tube having a
dissolvable support bolster shown in Fig. 7a, with both
the tube shaft and dissolvable support bolster coated
with a substance according to the present invention.
Fig. 8a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a-
dissolvable support bolster constructed according to the
principles of the present invention, in which the
internal bolster is convex, as viewed from a proximal
vantage point, and oval in shape, as viewed from an end.
Fig. 8b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 8a.
Fig. 9a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which the internal bolster is convex, as
viewed from a proximal vantage point, and circular in
shape, as viewed from an end. Fig. 9b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 9a.
Fig. 10a is an elevationai view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which the internal bolster is convex, as
viewed from a proximal vantage point, and oblong in
shape, as viewed from an end.
Fig. 10b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 10a.
Fig. 11a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which both the the internal bolster and
support bolster are concave, as viewed from a proximal
vantage point, and oval in shape, as viewed from an end.
Fig. lib is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 11a. Fig. 12a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which both the internal bolster and support
bolster- are concave, as viewed from a proximal vantage
point, and circular in shape, as viewed from an end.
Fig. 12b is an end view of the gastro-intestinal- tube
having a dissolvable support bolster shown in Fig. 12a.
Fig. 13a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present"
invention, in which both the internal bolster and support
bolster are concave, as viewed from a proximal vantage
point, and oblong in shape, as viewed from an end.
Fig. 13b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 13a.
Fig. 14a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a dissolvable support bolster according to the present
invention, in which both the the internal bolster and
support bolster are convex, as viewed from a proximal
vantage point, and oval in shape, as viewed from an end.
Fig. 14b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 14a.
Fig. 15a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which both the internal bolster and support
bolster are convex, as viewed from a proximal vantage
point, and circular in shape, as viewed from an end.
Fig. 15b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 15a.
Fig. 16a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which both the internal bolster and support bolster are convex, as viewed from a proximal vantage
point, and oblong in shape, as viewed from an end.
Fig. 16b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 16a.
Fig. 17a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which the the internal bolster is concave,
as viewed from a proximal vantage point, and oval in
shape; and the support bolster has a convex distal
surface (as viewed from a proximal vantage point) and a
substantially planar proximal surface.
Fig. 17b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 17a.
Fig. 18a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which the the internal bolster is concave, as viewed from a proximal vantage point, and circular in
shape; and the support bolster has a convex distal
surface (as viewed from a proximal vantage point) and a
substantially planar proximal surface.
Fig. 18b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 18a.
Fig. 19a is an elevational view, partially in section, of
an embodiment of gastro-intestinal tube having a
dissolvable support bolster according to the present
invention, in which the the internal bolster is concave,
as viewed from a proximal vantage point, and oblong n
shape; and the support bolster has a convex distal
surface (as viewed from a proximal vantage point) and a
substantially planar proximal surface.
Fig. 19b is an end view of the gastro-intestinal tube
having a dissolvable support bolster shown in Fig. 19a.
Detailed Description of the Invention
The preferred embodiment of the present invention comprises a gastro-intestinal tube 1 having proximal and
distal ends, an internal bolster 2 attached to the distal
end, a dissolvable support bolster 3 which is located
proximally adjacent to the internal bolster. Fig. 1 shows
a dissolvable support bolster which is placed around the
tube shaft 7 of the tube 1, just proximal to the internal
bolster 2. Fig. 1 also shows an external bolster 4
placed around the tube shaft 7 just proximal to -the
abdominal wall 6.
Fig. 1 shows an elevational view of the preferred
embodiment as properly placed within the body. The
gastro-intestinal tube 1 can be placed either transorally
or percutaneously, using any of the methods for placing
gastro-intestinal devices known in the prior art. For
example, the tube may be placed using either the push or
pull PEG techniques known in the art. When properly
placed, the dissolvable bolster 3 is adjacent to the
inner gastric wall 5, proximal to the internal bolster 2.
The tube 1 extends from inside the gastric wall 5 out
through the external abdominal wall 6.
Figs. 2 and 3 show the support bolster 3 of the
present invention. The support bolster 3 is preferably a round disk with an outer diameter of approximately 2-3
cm, and an inner diameter sized to allow fitting the disk
around the outer diameter of the tube shaft 7, which, for
gastro-intestinal tubes, is typically between 14 fr. and
28 fr . (i .e 4.55 mm and 8.9 mm) . Although the thickness
of the support bolster 3 can vary, in the preferred
embodiment, the support bolster is a disk with a
thickness of 2-3mm. Generally, the support bolster need
only have a size and thickness sufficient to prevent
premature tube removal.
Further, the dissolvable support bolster 3 need only
be as rigid as necessary to prevent premature removal
through the penetration that eventually forms the stoma
tract . The support bolster 3 can be pliant enough to
allow compression or manipulation during tube insertion,
yet still rigid enough to prevent premature removal.
The support bolster 3 is made of a dissolvable
biocompatible material, preferably an aliphatic
polyester, such as the material used to make medical
suture. However, the support bolster 3 can also be made
of any biocompatible, dissolvable material known in the
art, such as dissolvable polymers or other materials (e.g. collagen, elastin, chitin) . Examples of
dissolvable polymers include poly [phosphoesters] ,
poly [anhydrides] , poly [orthoesters] , poly [phosphazenes] ,
poly [anhydrides] , polysaccharides, peptide-based
polymers, and poly [ -esters] . In addition, U.S. Pat. No.
5,085,629 (incorporated herein by reference for this
purpose) describes several compositions used to form
biocompatible, dissolvable medical devices.
The dissolution time for the support bolster is
preferably between two and four weeks, which is the
amount of time a stomal tract typically takes to form.
This allows the support bolster 3 to rigidly support the
internal bolster during stomal formation, yet permit"
traction removal of the tube 1 shortly thereafter.
However, the dissolution time can be shorter than two
weeks or longer than four weeks, and techniques for
varying the dissolution time of biocompatible compounds
are well-known in the art. Since gastro-intestinal tubes
are typically remain in vivo for less than six months,
the dissolution time of the support bolster 3 will not
usually be longer than six months.
The gastro-intestinal tube shaft 7 can be made of any biocompatible copolymer such as a silicone elastomer,
silicone copolymer or polyurethane . The use of
copolymers to form the shaft of a gastro-intestinal tube
is well-known in the art.
The internal bolster 2 is made of a collapsible
material such that, after the support bolster 3
dissolves, the tube can removed by traction pulling from
outside the abdominal wall 6. Several materials and
structures for collapsible internal bolsters exist in the
prior art. Examples can be found in U.S. Pat. No.
5,356,391 and U.S. Pat. No. 5,391,159 (the contents of
these patents are incorporated herein by reference for
these teachings) . Another example is the internal
bolster used with the device marketed as the "Secure Cath
Adapter" by Applied Medical Technologies.
In another embodiment of the present invention,
shown in Fig. 4b, the outer surface of the support
bolster 3 ' has a coating which contains a medicating
substance. When a gastro-intestinal tube having such a
support bolster 31 is placed within the abdominal cavity,
the support bolster 31 lies distally adjacent to the
gastric wall, as shown in Fig. 1. The coating of the support bolster 3 ' enables delivery of the medicating
substance from the support bolster 3 ' directly to the
gastric wall, where infection and inflammation is most
likely to occur. Typically, the coating will include an
anti- inflammatory drug, such as salicylic acid or
prednisone. The coating may also include an antibiotic,
antiviral, antimicrobial, or antiencrustation agent, or a
disinfecting agent such as a bacteriocidal or
bacteriostatic agent. Ciprofloxacin or gentamicin are
examples of antibiotics which can be used with this
embodiment . Chlorhexadine and triclosan are examples of
disinfecting agents which can be used. United States
Patent No. 5,366,505 describes the use of slime-
inhibiting compounds in connection with medical devices
to inhibit the growth of microorganisms thereon (the
contents of this patent is incorporated herein by
reference for these teachings) . Such compounds may be
used with the present invention.
As an alternative to coating the support bolster
with a medicating substance, such a substance may be
located, placed, or formed within the dissolvable support
bolster 3 ' . Dissolvable materials make good drug delivery agents, avoiding the need for a coating which
includes a medicating substance. The use of
biocompatible, dissolvable devices for medication
delivery is well known in the art. Typically, the device
is made with a porous structure. The medication is then
loaded into the pores of the device, which is placed
within the body. This method of dispensing medication is
described in U.S. Pat. No. 4,702,917. U.S. Pat. Nos.
3,887,699 and 4,148,871 also describe biocompatible
materials used to dispense medication (the contents of
these patents are incorporated herein by reference for
these teachings). United States Patent Nos. 5,234,457
and 5,464,450 also describe the use of dissolvable
materials for medication delivery (the contents of these
patents are incorporated herein by reference for these
teachings) . Examples of biocompatible, dissolvable
materials which can be coated with medication include:
aliphatic polyesters (such as Decapeptyl™ , Lupron
Depot™, Zoladex-rM, and Atrigelra) , poly [phosophesters} ,
poly [anhydrides] , poly [α-esters] , and polyalphahydroxy
acids .
The rates at which the the support bolster dissolves and the medication is dispensed can be controlled with
the use of a rate-limiting membrane with the support
bolster. The use of such a membrane is known in the art.
See Golomb et al, Journal of Biomedical Materials
Research, 25(8), 1991, 937-952.
Additionally, the shaft 7' of the gastro-intestinal
tube may contain a medicating agent, as shown in Fig. 4b.
Medication, so located, can be delivered directly to the
tissue of the penetration which forms the stoma tract,
thereby alleviating the risk of infection, inflammation,
or encrustation within that tract. For example, a distal
portion of the tube shaft 7, 9 cm. in length, can be
coated or otherwise equipped with a antibiotic or anti-
inflammatory medication. (Fig. 4a shows a gastro-
intestinal tube of the present invention in which neither
the shaft 7 of the tube nor the support bolster 3 have a
medicating substance coating.)
Medication may also be located on or within the
internal bolster 2, in a manner described above. The
degree to which the internal bolster 2 is in direct
contact with the gastric wall depends largely on the size
and configuration of the support bolster 3. Where portions of the internal bolster 2 are in direct contact
with the gastric wall, medication located on that bolster
can be delivered directly. Even where the internal
bolster 2 is not in direct contact, however, medication
located on or within the internal bolster 2 can be
released into the gastric lumen. In addition, as the
support bolster 3 dissolves, a greater portion of the
internal bolster 2 may come into direct contact with the
gastric wall.
United States Patent No. 5,366,504 describes a
tubular prosthesis having a drug incorporated within a
dissolvable coating. The contents of that patent are
incorporated herein for those teachings.
Fig. 4a shows a gastro-intestinal tube of present
invention with a internal bolster 2 having a flattened
bulbous shape. That figure also shows a support bolster
3 shaped as disk. However, these bolsters can vary
widely in shape. Figs. 5a and 7a show gastro-intestinal
tubes of the present invention with support bolsters 8
and 9, respectively, which are formed to partially
surround the internal bolster 2. Fig. 6a shows a support
bolster 34 with an extended lateral extent. Each of the support bolsters depicted in Figs. 5a, 6a, and 7a
provide a greater surface area than that provided by the
support bolster 3, shown in Fig. 4. With this increased
surface area, a medicating substance can be delivered
directly to a larger area of the gastric wall. (Figs.
5b, 6b, and 7b show gastro-intestinal tubes of the
present invention in which both the support bolster and
tube shaft are equipped with a medicating substance) .
It is within the scope of the invention to use a
variety of shapes for the internal bolster and the
support bolster, as variations in shape can affect, among
other things, the ease with which the gastro-intestinal
device can be placed or removed, and the area of the
gastric wall to which a substance can be directly
delivered. For example, the embodiment illustrated in
Fig. 8a shows a gastro-intestinal tube of the present
invention in which the internal bolster 11 is proximally
convex and oval in shape (as viewed from an end) . The
convex shape of of the internal bolster 11 facilitates
traction removal of the tube once the support bolster 10
has dissolved. Fig. 8b is an end view of the gastro-
intestinal tube shown in Fig. 8a. Fig. 9a shows a gastro-intestinal tube of the
present invention in which the internal bolster 11 is
convex and circular in shape. Fig. 10a shows a gastro-
intestinal tube of the present invention in which the
internal bolster 11 is proximally convex and oblong in
shape (as viewed from an end) . Figs. 9b and 10b show end
views of the gastro-intestinal tubes shown in Figs. 9a
and 10a, respectively.
Fig. 11a shows a gastro-intestinal tube of the
present invention in which both the the internal bolster
17 and support bolster 16 are concave and oval in shape.
With this concave shape, the internal bolster 17 is
resistant to migration and traction removal. Fig. 12a
shows a gastro-intestinal tube of the present invention
in which both the the internal bolster 19 and support
bolster 18 are concave and circular in shape. Fig. 13a
shows a gastro-intestinal tube of the present invention
in which both the the internal bolster 21 and support
bolster 20 are concave and oblong in shape. Figs, lib,
12b and 13b show end views of the gastro-intestinal tubes
shown in Figs. 11a, 12a, and 13a, respectively.
Fig. 14a shows a gastro-intestinal tube of the present invention in which both the the internal bolster
23 and support bolster 22 are convex and oval in shape.
With this proximally convex shape, the the support
bolster 22 can remain in greater contact with the gastric
wall, and the internal bolster 23 can be removed by
traction pull more easily. Fig. 15a shows a gastro-
intestinal tube of the present invention in which both
the the internal bolster 25 and support bolster 24 are
convex and circular in shape. Fig. 16a shows a gastro-
intestinal tube of the present invention in which both
the the internal bolster 27 and support bolster 26 are
convex and oblong in shape. Figs. 14b, 15b and 16b show
end views of the gastro-intestinal tubes shown in Figs.
14a, 15a, and 16a, respectively.
Fig. 17a shows a gastro-intestinal tube of the
present invention, in which the internal bolster 29 is
concave and oval in shape, and the support bolster 28 has
a concave distal surface and a substantially planar
proximal surface. Fig. 18a shows a gastro-intestinal
tube of the present invention, in which the internal
bolster 31 is concave and circular in shape, and the
support bolster 30 has a concave distal surface and a substantially planar proximal surface. Fig. 19a shows a gastro-intestinal tube of the present invention, in which
the internal bolster 32 is concave and oblong in shape,
and the support bolster 33 has a concave distal surface
and a substantially planar proximal surface .

Claims

What is claimed is:
1. A gastro-intestinal device comprising:
a tube having proximal and distal ends, an
internal bolster attached to the distal end of
the tube having a collapsible structure which
allows removal of the device; and
a support bolster which fits around the
tube at the distal end, proximal to the
internal bolster.
2. A gastro-intestinal tube as set forth in cl_rim 1,
wherein the support bolster is biocompatible and
dissolvable.
3. A gastro-intestinal tube as set forth in claim 1,
wherein the support bolster comprises one or more of:
a(n) aliphatic polyester, poly [phosphoester] ,
poly [anhydride] , poly [orthoester] , poly [phosphazene] ,
poly [anhydride] , polysaccharide, peptide-based polymer,
and poly [╬▒-ester] .
4. A gastro-intestinal tube as set forth in claim 1,
wherein the support bolster has an outer diameter of
approximately 2cm.
5. A gastro-intestinal tube as set forth in claim 1,
wherein the support bolster has a dissolution time of
between 2 and 4 weeks in vivo.
6. A gastro-intestinal tube as set forth in claim 1,
wherein the support bolster has a dissolution time of up
to 6 months in vivo .
7. A gastro-intestinal tube as set forth in claim 1,
wherein the support bolster has an external coating
comprising an anti-inflammatory agent.
8. A gastro-intestinal tube as set forth in claim 1,
wherein the support bolster has an external coating
comprising an antibiotic agent.
9. A gastro-intestinal tube as set forth in claim 1, wherein the support bolster has an external coating
comprising an antiviral agent.
10. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has an external coating
comprising an antimicrobial agent.
11. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has an external coating
comprising an antiencrustation agent.
12. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has an external coating
comprising a disinfecting agent.
13. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has a porous structure
capable of holding an anti-inflammatory agent within the
pores .
14. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has a porous structure capable of holding an antibiotic agent within the pores.
15. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has a porous structure
capable of holding an antiviral agent within the pores.
16. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has a porous structure
capable of holding an antimicrobial agent within the
pores .
17. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has a porous structure
capable of holding an antiencrustation agent within the
pores .
18. A gastro-intestinal tube as set forth in claim
1, wherein the support bolster has a porous structure
capable of holding an disinfecting agent within the
pores .
19. A gastro-intestinal tube as set forth in claim 1, wherein a portion of the tube shaft, proximally
adjacent to the internal bolster is coated with an anti-
inflammatory agent .
20. A gastro-intestinal tube as set forth in claim
16, wherein the coated portion of the tube has a length
of approximately 9 cm.
21. A gastro-intestinal tube as set forth in claim
1, wherein a portion of the tube, proximally adjacent to
the internal bolster, is coated with an antibiotic drug.
22. A gastro-intestinal tube as set forth in cl"aim
18, wherein the coated portion of the tube has a length
of approximately 9 cm.
23. A gastro-intestinal tube as set forth in claim
1, wherein a medicating agent is incorporated into the
support bolster.
24. A gastro-intestinal tube as set forth in claim
2, wherein a medicating agent is incorporated into the support bolster and dispensed therefrom.
25. A gastro-intestinal tube as set forth in claim
2, wherein a the support bolster has a membrane which
limits the rate of dissolution of the support bolster.
26. A gastro-intestinal tube as set forth in claim
22, wherein the support bolster has a membrane which
limits the rate at which the medicating agent is
dispensed.
27. A gastro-intestinal tube as set forth in claim
2, wherein the internal bolster is concave, as viewed
from a proximal vantage point .
28. A gastro-intestinal tube as set forth in claim
2, wherein the internal bolster is convex, as viewed from
a proximal vantage point .
29. A gastro-intestinal tube as set forth in claim
2, wherein the support bolster is concave, as viewed from
a proximal vantage point .
30. A gastro-intestinal tube as set forth in claim
2, wherein the support bolster is convex, as viewed from
a proximal vantage point .
31. A gastro-intestinal tube as set forth in claim
2, wherein the support bolster is shaped as a disk.
32. A gastro-intestinal tube as set forth in claim
2, wherein the support bolster has a convex distal
surface, , as viewed from a proximal vantage point, and a
substantially planar proximal surface.
33. A gastro-intestinal device comprising:
a tube shaft having proximal and distal
ends; an internal bolster attached to the
distal end of the tube, said internal bolster
having a collapsible structure which allows
traction removal of the tube from a stoma; and
a biocompatible, dissolvable support
bolster which fits around the tube shaft at the
distal end, proximal to the internal bolster, wherein the support bolster is made of a group
consisting of a(n) aliphatic polyester,
poly [phosphoester] , poly [anhydride] ,
poly [orthoester] , poly [phosphazene] ,
poly [anhydride] , polysaccharide, pep - de-based
polymer, and poly [╬▒-ester] .
34. A gastro-intestinal device comprising:
a tube having proximal and distal ends, a
tube shaft extending from said proximal end to
said distal end; an internal bolster attached
to the distal end of the tube having a
collapsible structure which allows traction
removal , and
a biocompatible, dissolvable support
bolster which fits around the tube shaft at the
distal end, proximal to the internal bolster,
wherein the support bolster is made of
biocompatible, dissolvable material, and said
support bolster further having a coating of
medicating agent.
PCT/US1998/020829 1997-10-03 1998-10-02 Gastro-intestinal tube with dissolvable support bolster WO1999017708A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU96812/98A AU9681298A (en) 1997-10-03 1998-10-02 Gastro-intestinal tube with dissolvable support bolster

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/943,918 1997-10-03
US08/943,918 US6186985B1 (en) 1997-10-03 1997-10-03 Gastro-intestinal tube with dissolvable support bolster

Publications (1)

Publication Number Publication Date
WO1999017708A1 true WO1999017708A1 (en) 1999-04-15

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US (1) US6186985B1 (en)
AU (1) AU9681298A (en)
WO (1) WO1999017708A1 (en)

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WO2008015337A2 (en) * 2006-08-02 2008-02-07 Eleph'ent Technology Sa Percutaneous gastrostomy probe including a single biodegradable internal flange
WO2008015336A2 (en) * 2006-08-02 2008-02-07 Eleph'ent Technology Sa Percutaneous gastrostomy probe with inflatable balloon and with biodegradable anchorage means
FR2904531A1 (en) * 2006-08-02 2008-02-08 Eleph Ent Technology PERCUTANEOUS GASTROSTOMY PROBE
WO2008015336A3 (en) * 2006-08-02 2008-04-17 Eleph Ent Technology Sa Percutaneous gastrostomy probe with inflatable balloon and with biodegradable anchorage means
WO2008015337A3 (en) * 2006-08-02 2008-05-15 Eleph Ent Technology Sa Percutaneous gastrostomy probe including a single biodegradable internal flange
FR2919497A1 (en) * 2007-07-31 2009-02-06 Lch Materiel Medical Sarl PERCUTANEOUS GASTROSTOMY PROBE WITH INTERNAL FLANGE AND BIODEGRADABLE TIP
WO2009027600A2 (en) 2007-07-31 2009-03-05 Eleph'ent Technology Sa Percutaneous gastrostomy probe with internal collar and biodegradable end piece
WO2009027600A3 (en) * 2007-07-31 2009-04-30 Eleph Ent Technology Sa Percutaneous gastrostomy probe with internal collar and biodegradable end piece
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