U.S. patent application number 17/126066 was filed with the patent office on 2021-06-24 for apparatus for treating obesity.
The applicant listed for this patent is Peter Forsell. Invention is credited to Peter Forsell.
Application Number | 20210186508 17/126066 |
Document ID | / |
Family ID | 1000005432978 |
Filed Date | 2021-06-24 |
United States Patent
Application |
20210186508 |
Kind Code |
A1 |
Forsell; Peter |
June 24, 2021 |
APPARATUS FOR TREATING OBESITY
Abstract
A volume filling device for treatment of obesity is placed
outside the stomach wall of the patient to reduce the inner volume
of the stomach, thereby affecting the patient's appetite. By
providing the volume filling device outside the stomach wall,
contact with stomach acids is avoided, thereby increasing the life
of the device.
Inventors: |
Forsell; Peter; (Bouveret,
CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Forsell; Peter |
Bouveret |
|
CH |
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|
Family ID: |
1000005432978 |
Appl. No.: |
17/126066 |
Filed: |
December 18, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13123019 |
Apr 7, 2011 |
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PCT/SE09/00452 |
Oct 12, 2009 |
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17126066 |
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61228633 |
Jul 27, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/0069 20130101;
A61B 1/2736 20130101; A61F 2250/0004 20130101; A61B 2017/00827
20130101; A61F 5/0073 20130101; A61B 17/068 20130101; A61F 5/0036
20130101; A61F 5/0043 20130101; A61B 17/08 20130101; A61B
2017/00561 20130101; A61F 2002/045 20130101; A61B 1/04 20130101;
A61F 5/004 20130101; A61B 2017/081 20130101; A61B 2017/00818
20130101; A61B 2017/00278 20130101; A61F 5/0086 20130101; A61F 2/04
20130101; A61B 17/064 20130101; A61B 2017/308 20130101; A61B
2017/306 20130101; A61F 2005/0023 20130101; A61B 17/0469 20130101;
A61F 2250/0001 20130101; A61F 5/005 20130101; A61F 2005/002
20130101; A61F 2005/0016 20130101; A61B 1/3132 20130101; A61F 5/003
20130101; A61N 1/36007 20130101; A61B 17/320016 20130101; A61B
17/3474 20130101; A61F 5/0046 20130101; A61B 17/3423 20130101; A61F
5/0033 20130101; A61F 5/0089 20130101 |
International
Class: |
A61B 17/08 20060101
A61B017/08; A61B 17/04 20060101 A61B017/04; A61B 17/068 20060101
A61B017/068; A61F 2/04 20060101 A61F002/04; A61F 5/00 20060101
A61F005/00; A61N 1/36 20060101 A61N001/36; A61B 1/04 20060101
A61B001/04; A61B 1/273 20060101 A61B001/273; A61B 1/313 20060101
A61B001/313; A61B 17/064 20060101 A61B017/064; A61B 17/32 20060101
A61B017/32; A61B 17/34 20060101 A61B017/34 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 10, 2008 |
SE |
0802138-8 |
Jan 29, 2009 |
SE |
PCT/SE2009/000047 |
Claims
1-111. (canceled)
112. An apparatus for treating obesity of an obese patient having a
stomach with a food cavity, the apparatus comprising: at least one
biocompatible volume filling device adapted to be completely
invaginated by a stomach wall portion of the patient, wherein the
at least one biocompatible volume filling device is adapted to be
implanted in the abdominal cavity and invaginated in the stomach
wall from the outside thereof such that the volume of the food
cavity is reduced in size by a volume substantially exceeding the
volume of the volume filling device, and wherein the at least one
biocompatible volume filling device comprises a blind hole arranged
in an outer wall of the at least one biocompatible volume filling
device to allow the at least one biocompatible volume filling
device to be held by an instrument during implantation of the at
least one biocompatible volume filling device.
113. The apparatus according to claim 112, further comprising a
main volume filling device reservoir adapted to be inflatable, the
volume filling device further comprising an expandable structure,
adapted to expand, when the volume filling device is invaginated in
the stomach wall, wherein said structure comprises a bellow adapted
to take into account the fibrosis surrounding the volume filling
device when implanted, such that the movement of the bellow is
substantially un-affected by said fibrosis.
114. The apparatus according to claim 112, wherein the volume
filling device further comprises at least one of the following
materials; a bio-compatible material, an elastic material, a
flexible non-elastic material, a homogenous material, a gel, and a
material which is not destructible by acids of the stomach.
115. Tha apparatus according to claim 112, wherein the
circumference of the volume filling device as seen in a plane
perpendicular to an axis through the device increases and decreases
at least two times as the plane is displaced along said axis.
116. The apparatus according to claim 112, wherein the volume
filling device is further provided with at least one layer,
comprising at least one of: a polytetrafluoroethylene layer, a
polyurethane layer, a silicone layer, a metal layer, a metal layer
comprises any of gold, silver, and titanium, or a combination
thereof, a plurality of layers, a plurality of layers, with an
outer surface of at least one of; layer of polyurethane, or
polytetrafluoroethylene, Parylene, silicone, metal, or a
combination thereof, a plurality of layers, with an inner surface
layer of at least one of; polyurethane, or polytetrafluoroethylene,
Parylene, silicone, metal, or a combination thereof, a plurality of
layers, with an inner surface layer of polytetrafluoro ethylene and
an outer layer of silicone, a plurality of layers, with an inner
surface layer of polytetrafluoro ethylene, an intermediate layer of
silicone, and an outer layer of Parylene, a plurality of layers,
with an inner surface layer of polyurethane and an outer layer of
silicone, a plurality of layers, with an inner surface layer of
polyurethane, an intermediate layer of silicone, and an outer layer
of Parylene, and an outer layer that includes a biocompatible
material.
117. The apparatus according to claim 112, wherein the volume
filling device comprises a fluid comprising at least one of: a
fluid adapted to be transformed into solid state or fixed form; a
polyurethane liquid, an iso-tonic fluid, a fluid comprising large
molecules to prevent diffusion, and a fluid comprising iodine
molecules.
118. The apparatus according to claim 112, further comprising at
least one of: a holding device adapted to be held by an instrument
and simplify the implantation of the volume filling device, and two
or more holding devices adapted to be held by an instrument and
simplify the implantation of the volume filling device.
119. The apparatus according to claim 112, wherein
stomach-to-stomach sutures or staples are provided with fixation
portions exhibiting a structure adapted to be in contact with the
stomach wall to promote growth of human tissue to secure long term
placement of the volume filling device attached to the stomach
wall, wherein the structure comprises a net like structure.
120. The apparatus according to claim 112, wherein the volume
filling device is adapted to be non-invasively adjustable
postoperatively, comprising an external control unit for
controlling at least one of; the volume filling device according to
claim 1 and the stretching device according to claim 2 from the
outside of the patient's body, comprising a wireless remote control
adapted to control the device from the outside of the patient's
body.
121. The apparatus according to claim 112, wherein the volume
filling device is adapted to be non-invasively adjustable
postoperatively, comprising an external control unit for
controlling at least one of; the volume filling device and the
stretching device from the outside of the patient's body,
comprising a subcutaneously placed switch or reservoir adapted to
control the device from the outside of the patient's body.
122. The apparatus according to claim 112, comprising a sensor or
sensing device adapted to be implanted in the patient body, wherein
an implantable control unit is adapted to control the device from
the inside of the patient's body using information from said a
sensor or sensing device, adapted to sense, directly or indirectly,
the food intake of the patient, wherein the apparatus, comprising
an operation device for operating at least one of the volume
filling device, and the stretching device according, when implanted
to stretch the stomach wall portion such that satiety is
created.
123. The apparatus according to claim 112, wherein the volume
filling device comprises a stretching device adapted to be engaged
with a part of the stomach wall, including suturing or stapling the
stretching device to the stomach wall or invaginating the
stretching device in the stomach wall part, with stomach to stomach
sutures, wherein the stretching device is further adapted to
stretch a stomach wall portion controlling a force used for
stretching the stomach wall portion as well as, the time periods
the stretching is applied when the stretching is applied.
124. The apparatus according to claim 112, wherein the volume
filling device comprises a stretching device comprising two parts
engaged with different parts of the stomach wall, one part each,
wherein said engagement includes suturing or stapling the parts to
the stomach wall or invaginating the parts in the stomach wall
part, with stomach to stomach sutures, wherein the stretching
device further adapted to have different wall portions stretched
independently from each other controlling a force used for
stretching the stomach wall portion as well as the time periods the
stretching is applied when the stretching is applied.
125. The apparatus according to claim 112, further comprising a
fluid connection interconnecting the stretching device and the
volume filling device, wherein the stretching device comprises an
expandable stretching reservoir and an operation device for
operating the stretching device when implanted to stretch the
stomach wall portion, wherein the volume filling device is
inflatable and in fluid connection with said stretching reservoir,
and wherein said operation device comprises a pump for pumping
fluid between said main reservoir and said stretching reservoir to
stretch said stomach wall portion such that satiety is created,
comprising a control device for controlling said stretching device
including said pump.
126. The apparatus according to claim 112, further comprising a
fluid connection interconnecting the stretching device and the
volume filling device, wherein the volume filling device comprises
a main volume filling device reservoir, and a stretching device
comprising at least one operable stretching device implantable in
an obese patient and adapted to stretch a portion of the patient's
stomach wall, wherein said stretching device comprises an
expandable reservoir, adapted to be invaginated in the stomach wall
at the upper part of the stomach, higher up than the inflatable
main volume filling device when the patient is standing, wherein
the volume filling device is inflatable and in fluid connection
with said stretching reservoir, wherein normal contractions of the
stomach wall, related to food intake, cause fluid to flow from said
invaginated main volume filling reservoir lower placed onto the
stomach wall adapted to cause said stretching reservoir to stretch
said stomach wall portion such that satiety is created.
127. A system including the apparatus according to claim 112,
wherein wireless energy is transmitted inductively from a primary
coil in an external energy source to a comprised secondary coil
included in a comprised internal energy receiver, wherein the
internal energy receiver being connected to the implanted energy
consuming components of the apparatus for directly or indirectly
supplying received energy thereto, wherein the system further
comprising at least one of: a battery, a rechargeable battery, and
an energy transforming device.
Description
TECHNICAL FIELD
[0001] The present invention relates to an apparatus, a system, and
a method for treating obesity.
BACKGROUND
[0002] Obesity has been treated by gastric banding a band placed
around the stomach to create a stoma, a restricted opening, to
restrict the flow of food down to below the band. There has also
been tried to use electrical stimulation of the stomach wall to
cause the patient to feel satiety.
[0003] When the stomach gets distended the patient gets a feeling
that the stomach is full.
[0004] Another prior art way of treating obesity is to insert a
balloon-like object into the stomach of the patient. In this way,
the patient is given the feeling of satiety much more quickly when
eating, preventing excessive intake of food. However, these prior
art balloon-like objects are subject to stomach acids, leading to
their destruction within a couple of months of use.
[0005] An example of a prior art inflatable gastric device for
treating obesity is disclosed in U.S. Pat. No. 4,246,893 to Berson.
In this document, it is disclosed an abdominal method wherein an
inflatable balloon is surgically implanted in the abdominal cavity
of the patient adjacent to the stomach. An adjusting port is
provided subcutaneously and the balloon is subsequently inflated by
means of inserting a hypodermic needle through the skin of the
patient into the adjusting port and introducing a fluid under
pressure into the port for passage into the balloon to distend the
upper abdomen, compressing the stomach and thereby producing a
sense of satiety.
SUMMARY
[0006] The object of the present invention to provide obesity
treatment apparatus, system and methods with improved long term
properties.
[0007] This object and others are obtained by an apparatus
described in the appended claims. Thus, by providing an apparatus
comprising at least one volume filling device adapted to be at
least substantially invaginated by a stomach wall portion of the
patient, and
wherein the volume filling device is adapted to be placed outside
of the stomach wall with the outer surface of the volume filling
device resting against the outside of the stomach wall, such that
the volume of the food cavity is reduced in size by a volume
substantially exceeding the volume of the volume filling device,
the volume filling device having a maximum circumference of at
least 30 millimeters wherein said volume filling device has a
volume of less than 0.0002 m.sup.3 whereby an apparatus for
treating obesity is obtained.
[0008] The present invention is based on the realization that by
invaginating a volume filling device by the stomach wall on the
outside thereof this device is protected from the stomach acids and
will thus remain functioning for a very long time.
[0009] Preferably, the at least one volume filling device is
adapted to be at least substantially invaginated by a stomach wall
portion of the patient by suturing a first part of a stomach wall
serosa towards a second, different part of a stomach wall serosa,
the serosa being the outer layer of the stomach wall.
[0010] The stomach is mounted in two sails extending on the lesser
and greater curvature of the stomach, called the greater or majus
omentum and lesser or minus omentum, respectively. The lesser
omentum is also called the hepatogastric omentum including the
hepatogastric ligament. Preferably, the volume filling device has a
shape adapted for permitting the device to be invaginated without
penetrating the hepatogastric ligament of the patient.
[0011] Preferably, the volume filling device has an outer surface
that includes a biocompatible material.
[0012] Preferably, the volume filling device is adapted to be
completely invaginated by the stomach wall of the patient and to be
placed outside the stomach wall via a gastroscopic instrument. To
this end the volume filling device may comprise an attachment
device adapted to co-operate with a gripping instrument. Suitably,
the volume filling device is adapted to be non-invasively
adjustable postoperatively.
[0013] The apparatus may comprise a fixation device, suitably two
or more fixation devices, adapted to be involved in the fixation of
the volume filling device to the stomach wall. The volume filling
device may comprise a holding device adapted to be held by an
instrument, suitably two or more holding devices, to simplify the
implantation of the device.
[0014] At least a part of the volume filling device may be made of
a material which is not destructible by stomach acid. The volume
filling device may be destructible by acids, for example
hydrochloric acid.
[0015] In an embodiment, the volume filling device is inflatable to
an expanded state and comprises an enclosure wall defining a
chamber, wherein the volume filling device is inflated with a gel
or fluid supplied into the chamber. At least one tube may be
connected to the volume filling device for supplying gel or fluid
to the chamber. An injection port connectible with the tube may be
provided. Alternatively, the volume filling member may be provided
with an inlet port for a fluid or a gel connectible to a
gastroscopic instrument, wherein the inlet port comprises a fluid
connection adapted to interconnect the inflatable device and the
gastroscopic instrument.
[0016] The volume filling device may include a homogenous material,
such as gel having a shore value of less than 15. The device may
also be a solid body.
[0017] The volume filling device may comprise a rigid, elastic or
flexible outer surface. Where the outer surface is rigid, it is
rigid enough to maintain non-deformed when subject to forces
created by stomach movements. The volume filling device may
comprise a flexible non-elastic material.
[0018] In accordance with a first general design of the volume
filling device, the device has a maximum circumference as seen in a
plane perpendicular to an axis through the device. The
circumferences of the device as seen in other planes perpendicular
to said axis are equal to the maximum circumference or decrease as
seen along said axis in the direction from the maximum
circumference. For example, the device may be substantially egg
shaped, spherically shaped, or substantially shaped like an egg
with an indented middle section or like a bent egg.
[0019] In accordance with a second general design of the device,
the circumference of the device as seen in a plane perpendicular to
an axis through the device increases and decreases at least two
times as the plane is displaced along said axis, or decreases and
increases at least one time as the plane is displaced along said
axis. For example, the device may be substantially shaped like a
kidney.
[0020] The volume filling device preferably has an elongated,
rounded, bent and/or curved shape.
[0021] The volume filling device has a circumference of at least
60, 90, 120, 150, 180 or 220 mm.
[0022] By providing a volume filling device with a volume of less
than 0.0002 m.sup.3, several advantages are obtained. Such a volume
filling device is suitable for invagination with a good result
between the lesser and greater curvatures, including sails with
blood vessels and nerves, holding the stomach in place. The lesser
and greater curvatures have a mutual distance in the magnitude of 1
decimeter or slightly more. Taking into account that the
circumference of the device is 3.14 times the diameter, the full
distance between the lesser and greater curvature is occupied at
small sizes of the volume filling device. With current
biocompatible material it is more or less impossible to keep a gas
inside the volume filling device without losing gas to the
surroundings. Thus, the volume filling device is suitably filled
with a fluid, giving it substantial weight at large volumes. A
volume filling device comprised in the inventive apparatus, having
a volume of less than 0.0002 m.sup.3, can be carried by the stomach
wall without any problems.
[0023] The volume filling device may comprise at least two
interconnectable portions adapted to be placed inside the stomach
as separate portions.
[0024] The volume filling device may comprise an elastic or
flexible material, a bio-compatible material and/or silicone.
[0025] Suitably, the volume filling device is provided with at
least one layer. For example, a metal layer, a Parylene layer, a
polytetrafluoroethylene layer or a polyurethane layer. The layers
may comprise multiple layers in any order. Suitably, one of the
layers may be made of made of metal, silicon or PTFE. The volume
filling device may comprise an outer surface layer of polyurethane,
Teflon.RTM., or polytetrafluoroethylene, or a combination
thereof.
[0026] The volume filling device may comprise a fluid adapted to be
transformed into solid state or fixed form. Such a fluid may be
liquid polyurethane or iso-tonic. The fluid may comprises large
molecules, such as iodine molecules, to prevent diffusion.
[0027] Suitably, the volume filling device is deformable to a
maximum diameter, so as to be insertable into a laparoscopic
trocar.
[0028] Preferably, the volume filling device is adapted to be kept
in place by stomach-to-stomach sutures or staples to invaginate the
device in the stomach wall.
[0029] Advantageously, the volume filling device has varying
circumference to better be kept in place invaginated in the stomach
wall of the patient. The stomach-to-stomach sutures or staples may
be provided with fixation portions exhibiting a structure adapted
to be in contact with the stomach wall to promote growth in of
human tissue to secure long term placement of the volume filling
device attached to the stomach wall. The structure may comprise a
net like structure.
[0030] In embodiment of the invention, the apparatus comprises a
stretching device placed outside the stomach wall and adapted to
stretch a portion of the stomach wall, thereby affecting the
patient's appetite. Where the volume filling device is inflatable,
the apparatus may comprise a fluid connection interconnecting the
stretching device and the volume filling device.
[0031] In an embodiment, the apparatus comprises a stretching
device comprising at least one operable stretching device
implantable in an obese patient and adapted to stretch a portion of
the patient's stomach wall and an operation device for operating
the stretching device when implanted to stretch the stomach wall
portion such that satiety is created.
[0032] In an embodiment, the apparatus comprises at least one
operable stretching device implantable in the patient and adapted
to stretch a portion of the patient's stomach wall, and an
implantable control unit for automatically controlling the operable
stretching device, when the control unit and stretching device are
implanted, to stretch the stomach wall portion in connection with
the patient eating such that satiety is created.
[0033] In an embodiment, the apparatus comprises a stretching
device comprising at least one operable stretching device
implantable in an obese patient and adapted to stretch a portion of
the patient's stomach wall, wherein said stretching device
comprising an expandable stretching reservoir and an operation
device for operating the stretching device when implanted to
stretch the stomach wall portion, wherein the volume filling device
is inflatable and in fluid connection with said stretching
reservoir, wherein said operation device comprises a pump for
pumping fluid between said main reservoir and said stretching
reservoir to stretch said stomach wall portion such that satiety is
created. A control device may be provided for controlling said
stretching device including said pump. The control device may
comprise a wireless remote control adapted to control the
stretching device from the outside of the patient's body, or an
implantable control unit for controlling said stretching device.
Alternatively, the control device may comprise a subcutaneously
placed switch or reservoir adapted to control the stretching device
from the outside of the patient's body. A sensor or sensing device
to be implanted in the patient body may be provided, wherein the
implantable control unit is adapted to control the stretching
device from the inside of the patient's body using information from
said a sensor or sensing device, adapted to sense, direct or
indirect, the food intake of the patient.
[0034] In an embodiment, the volume filling device comprises a main
volume filling reservoir, a stretching device comprising at least
one operable stretching device implantable in an obese patient and
adapted to stretch a portion of the patient's stomach wall, wherein
said stretching device comprising an expandable reservoir, adapted
to be invaginated in the stomach wall at the upper part of the
stomach, higher up than the inflatable main volume filling device
when the patient is standing, wherein the volume filling device is
inflatable and in fluid connection with said stretching reservoir,
wherein normal contractions of the stomach wall, related to food
intake, cause fluid to flow from said invaginated main volume
filling reservoir lower placed onto the stomach wall adapted to
cause said stretching reservoir to stretch said stomach wall
portion such that satiety is created. The fluid connection between
the main volume filling device reservoir and the stretching
reservoir comprises a non-return valve. The fluid connection
between the main volume filling device reservoir and the stretching
reservoir comprises a release function adapted to release the
volume in the stretching reservoir back to the main volume filling
device reservoir. Said release function may comprise a fluid return
connection of a substantially smaller area than said fluid
connection, to slowly release back fluid to said main volume
filling device reservoir from the stretching reservoir to release
said stretching of the stomach wall portion. A further manual
control device comprising a subcutaneously placed reservoir adapted
to control the stretching device from the outside of the patient's
body may be provided to further affect the stretching device to
stretch the stomach wall portion.
[0035] In an embodiment, the a main volume filling device reservoir
adapted to be inflatable may be provided, wherein the volume
filling device further comprises an expandable structure, adapted
to expand, when the device is invaginated in the stomach wall,
wherein said structure comprising a bellow adapted to take into
account the fibrosis surrounding the device when implanted, such
that the movement of the bellow is substantially un-affected of
said fibrosis.
[0036] In an embodiment, the apparatus comprises a stretching
device comprising at least one operable stretching device
implantable in an obese patient and adapted to stretch a portion of
the patient's stomach wall and wherein the stretching device
comprising a expandable structure, adapted to expand and stretch
the stomach wall portion, when the device is invaginated in the
stomach wall, wherein said structure comprising a special bellow
adapted to take into account the fibrosis surrounding the device
when implanted, such that the movement of the bellow is
substantially un-affected of said fibrosis. An operation device for
operating the stretching device may be provided to stretch the
stomach wall portion such that satiety is created. The apparatus
may comprise an implantable control unit for automatically
controlling the operable stretching device, when the control unit
and stretching device are implanted, to stretch the stomach wall
portion in connection with the patient eating such that satiety is
created.
[0037] In an embodiment, the apparatus comprises a stretching
device comprising at least one operable stretching device
implantable in an obese patient and adapted to stretch a portion of
the patient's stomach wall such that satiety is created. The
control device may comprise a wireless remote control adapted to
control the stretching device from the outside of the patient's
body or an implantable control unit for controlling said stretching
device. Alternatively, said control device may comprise a
subcutaneously placed switch or reservoir adapted to control the
stretching device from the outside of the patient's body. A sensor
or sensing device adapted to be implanted in the patient body may
be provided, wherein the implantable control unit is adapted to
control the stretching device from the inside of the patient's body
using information from said sensor or sensing device, adapted to
sense, direct or indirect, the food intake of the patient.
[0038] In an embodiment, the apparatus is further adapted to treat
reflux disease. To this end, it further comprises an implantable
movement restriction device adapted to be at least partly
invaginated by the patient's stomach fundus wall and having an
outer surface that includes a biocompatible material, wherein a
substantial part of the outer surface of the movement restriction
device is adapted to rest against the stomach wall without injuring
the latter in a position between the patient's diaphragm and at
least a portion of the lower part of the invaginated stomach fundus
wall, such that movement of the cardiac notch of the patient's
stomach towards the patient's diaphragm is restricted, when the
movement restriction device is invaginated, to thereby prevent the
cardia from sliding through the patient's diaphragm opening into
the patient's thorax, so as to maintain the supporting pressure
against the patient's cardia sphincter muscle exerted from the
patient's abdomen, the movement restriction device having a size of
at least 125 mm3 and a circumference of at least 15 mm.
[0039] In another embodiment, the apparatus is further adapted to
treat reflux disease. To this end, it further comprises an
implantable movement restriction device having an outer surface
including a biocompatible material, wherein the movement
restriction device is adapted to rest with at least a part of its
outer surface against the patient's stomach fundus wall, in a
position between the patient's diaphragm and the fundus wall, such
that movement of the cardiac notch of the patient's stomach towards
the patient's diaphragm is restricted, when the movement
restriction device is implanted in the patient, to thereby prevent
the cardia from sliding through the patient's diaphragm opening
into the patient's thorax, so as to maintain the supporting
pressure against the patient's cardia sphincter muscle exerted from
the patient's abdomen, wherein the movement restriction device
having a size of at least 125 mm3 and a circumference of at least
15 mm, and an a fixation device adapted to secure the movement
restriction device in said position, when the movement restriction
device is implanted.
[0040] In another embodiment, the apparatus is further adapted to
treat reflux disease. To this end, it further comprises an
implantable movement restriction device adapted to be at least
partly invaginated by the patient's stomach fundus wall and having
an outer surface that includes a biocompatible material, wherein a
substantial part of the outer surface of the movement restriction
device is adapted to rest against the stomach wall without injuring
the latter in a position between the patient's diaphragm and at
least a portion of the lower part of the invaginated stomach fundus
wall, such that movement of the cardiac notch of the patient's
stomach towards the patient's diaphragm is restricted, when the
movement restriction device is invaginated, to thereby prevent the
cardia from sliding through the patient's diaphragm opening into
the patient's thorax, so as to maintain the supporting pressure
against the patient's cardia sphincter muscle exerted from the
patient's abdomen, the movement restriction device having a size of
at least 125 mm3 and a circumference of at least 15 mm, further
comprising a stretching device comprising at least one operable
stretching device implantable in the obese patient and adapted to
stretch a portion of the patient's stomach wall such that satiety
is created.
[0041] In another embodiment, the apparatus is further adapted to
treat reflux disease. To this end, it further comprises an
implantable movement restriction device having an outer surface
including a biocompatible material, wherein the movement
restriction device is adapted to rest with at least a part of its
outer surface against the patient's stomach fundus wall, in a
position between the patient's diaphragm and the fundus wall, such
that movement of the cardiac notch of the patient's stomach towards
the patient's diaphragm is restricted, when the movement
restriction device is implanted in the patient, to thereby prevent
the cardia from sliding through the patient's diaphragm opening
into the patient's thorax, so as to maintain the supporting
pressure against the patient's cardia sphincter muscle exerted from
the patient's abdomen, wherein the movement restriction device
having a size of at least 125 mm3 and a circumference of at least
15 mm, and a fixation device adapted to secure the movement
restriction device in said position, when the movement restriction
device is implanted, further comprising a stretching device
comprising at least one operable stretching device implantable in
the obese patient and adapted to stretch a portion of the patient's
stomach wall such that satiety is created.
[0042] In an embodiment, the apparatus further comprises a
stretching device comprising three or more mechanical parts engaged
with different parts of the stomach wall, one part each, wherein
said engagement includes suturing or stapling to the stomach wall
or invaginating the mechanical parts in the stomach wall part with
stomach to stomach sutures, wherein the three or more mechanical
parts are adapted to move in relation to each other adapted to
stretch three different wall portions, the stretching device
further adapted to having said wall portions stretched
independently from each other both regarding force used for
stretching the stomach wall portion as well as, time periods the
stretching is applied, and when the stretching is applied.
[0043] In an embodiment, the apparatus further comprises a
stretching device comprising two or more hydraulic parts engaged
with different parts of the stomach wall, one part each, wherein
said engagement includes suturing or stapling to hydraulic part to
the stomach wall or invaginating the hydraulic parts in the stomach
wall part, with stomach to stomach sutures, wherein the two or more
hydraulic parts are adapted to move in relation to each other
adapted to stretch three different wall portions, the stretching
device further adapted to having said wall portions stretched
independently from each other both regarding force used for
stretching the stomach wall portion as well as, time periods the
stretching is applied, and when the stretching is applied.
[0044] In an embodiment, the apparatus further comprises a
stretching device is engaged with a part of the stomach wall,
including suturing or stapling the stretching device to the stomach
wall or invaginating the stretching device in the stomach wall
part, with stomach to stomach sutures, wherein the stretching
device is further adapted to stretch a stomach wall portion
controlling force used for stretching the stomach wall portion as
well as, time periods the stretching is applied, and when the
stretching is applied.
[0045] In an embodiment, the apparatus further comprises a
stretching device comprising two parts engaged with different parts
of the stomach wall, one part each, wherein said engagement
includes suturing or stapling the parts to the stomach wall or
invaginating the parts in the stomach wall part, with stomach to
stomach sutures, wherein the stretching device further adapted to
have different wall portions stretched independently from each
other controlling force used for stretching the stomach wall
portion as well as, time periods the stretching is applied, and
when the stretching is applied.
[0046] In an embodiment, the apparatus further comprises an
external control unit for controlling the volume filling device
from the outside of the patient's body. The external control unit
may comprise a wireless remote control adapted to control the
device from the outside of the patient's body. Alternatively, the
external control unit may comprise a subcutaneously placed switch
or reservoir adapted to control the device from the outside of the
patient's body.
[0047] In an embodiment, the apparatus further comprises a sensor
or sensing device adapted to be implanted in the patient body,
wherein the implantable control unit is adapted to control the
device from the inside of the patient's body using information from
said a sensor or sensing device, adapted to sense, direct or
indirect, the food intake of the patient.
[0048] In accordance with another aspect of the present invention,
there is provided an apparatus for treating obesity of an obese
patient having a stomach with a food cavity, the apparatus
comprising at least one volume filling device adapted to be at
least substantially invaginated by a stomach wall portion of the
patient and having an outer surface that includes a biocompatible
material, wherein the volume filling device is adapted to be placed
inside the stomach with the outer surface of the volume filling
device resting against the inside of the stomach wall, such that
the volume of the food cavity is reduced in size by a volume
substantially exceeding the volume of the volume filling device,
the volume filling device having a maximum circumference of at
least 30 millimeters.
[0049] In a preferred embodiment, the system comprises at least one
switch implantable in the patient for manually and non-invasively
controlling the apparatus.
[0050] In another preferred embodiment, the system comprises a
wireless remote control for non-invasively controlling the
apparatus.
[0051] In a preferred embodiment, the system comprises a hydraulic
operation device for operating the apparatus.
[0052] In one embodiment, the system comprises a motor or a pump
for operating the apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0053] The present invention will now be described in more detail
by way of non-limiting examples and with reference to the
accompanying drawings, in which:
[0054] FIG. 1 is an overall view of a patient showing the outlines
of the stomach,
[0055] FIG. 2a is a view of a first embodiment of an apparatus for
treating obesity implanted in a human patient,
[0056] FIG. 2b is a sectional view taken along line IIb-IIb of FIG.
2a,
[0057] FIGS. 3a-k, 3m, 3n, 3p show different shapes and features of
a volume filling device comprised in an apparatus according to the
invention,
[0058] FIGS. 4a-d show a deflated inflatable volume filling device
comprised in an apparatus according to the invention and an
instrument for placing the volume filling device,
[0059] FIGS. 5a-i illustrate different steps of invaginating the
inflatable device of FIG. 4a on the outside of a stomach wall of a
patient,
[0060] FIGS. 6a, 6b, 7 and 8 show alternative embodiments wherein
the volume filling device is adapted to be non-invasively
adjustable postoperatively,
[0061] FIGS. 9 and 10 show embodiments wherein the volume filling
device is adapted to be invaginated in the fundus region of the
patient's stomach,
[0062] FIG. 11 shows an embodiment wherein the volume filling
device is also adapted to treat reflux,
[0063] FIG. 12 show an embodiment wherein the volume filling device
adapted also for treating reflux is combined with stretching
devices for stretching part of the stomach fundus wall,
[0064] FIGS. 13-16 show alternative embodiments wherein a
combination of a volume filling device and a stretching device is
used,
[0065] FIGS. 17a and 17b show an embodiment wherein the volume
filling device is provided on the inside of the stomach wall,
[0066] FIGS. 18a-h illustrate different steps of invaginating the
inflatable device of FIG. 4a on the inside of a stomach wall of a
patient,
[0067] FIGS. 19a-j illustrate different steps of invaginating the
inflatable device of FIG. 4a on the inside of a stomach wall of a
patient,
[0068] FIGS. 20a-f illustrate different steps of invaginating the
inflatable device of FIG. 4a on the inside of a stomach wall of a
patient,
[0069] FIGS. 21a and 21b show an instrument used in a method of
engaging a volume filling device.
[0070] FIG. 22 is an overall view of a patient with an implanted
apparatus for treating obesity,
[0071] FIGS. 23-41 show various ways of powering an apparatus for
treating obesity implanted in a human patient,
[0072] FIGS. 42-47 and 48a-48c show various ways of arranging
hydraulic or pneumatic powering of an apparatus for treating
obesity implanted in a human patient,
[0073] FIG. 49 illustrate the invagination of a plurality volume
filling devices, and
[0074] FIGS. 50a and 50b illustrate an abdominal method.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0075] Preferred embodiments of the invention will now be described
in detail with reference to the drawing figures.
[0076] FIG. 1 shows a human patent 1, who is being treated for
obesity. A volume filling device 10 is provided so that it reduces
the inner volume of the stomach 12--the food cavity of the stomach,
thereby affecting the patient's appetite. The function and the
operation of this volume filling device will be described and
explained in detail in the following description.
[0077] FIGS. 2a and 2b show in detail a first embodiment of an
apparatus to treat obesity according to the invention, wherein FIG.
2a show aside view of the stomach while FIG. 2b is a sectional view
taken along line IIb-IIb of FIG. 2a. The apparatus comprises a
volume filling device 10 implanted in a human patient. More
specifically, in the embodiment of FIG. 2a the volume filling
device 10 is invaginated in the wall 12a of the patient's stomach
12 on the outside of the stomach wall. The volume filling device
may be at least substantially invaginated by a stomach wall portion
of the patient by suturing a first part of a stomach wall serosa
towards a second, different part of a stomach wall serosa, the
serosa being the outer layer of the stomach wall. The volume
filling device has a volume of less than 0.0002 m.sup.3 (200 ml) to
allow invagination without penetrating the hepatogastric ligament.
The body of the volume filling device 10 is elongated and shaped to
rest against the wall 12a of the stomach 12 and further has an
outer surface suitable to rest against this wall.
[0078] By invaginating the volume filling device 10 in part of the
stomach wall, the size of the food cavity, generally designated 12b
in FIG. 2b, will be reduced, resulting in a more rapid feeling of
satiety after food intake.
[0079] The volume filling device 10 preferably comprises an elastic
or flexible material, such as silicone. In this way, the volume
filling device can adapt to the movements of the stomach, the
degree of food intake etc.
[0080] By providing the volume filling device from a bio-compatible
material, the risk of the patient's body rejecting the implant is
to a very large extent reduced.
[0081] The volume filling device 10 can be fixed to the wall 12a of
the stomach 12 in a number of different ways. In the embodiment
shown in FIG. 2b, the volume filling device 10 is invaginated in
the stomach wall 12a. After invagination, a number of
stomach-to-stomach sutures or staples 14 are applied to keep the
invagination in the short term. This allows growth of human tissue,
keeping the invagination in the long term.
[0082] The volume filling device 10 preferably has an essentially
round shape to not damage the stomach wall. An example thereof is
shown in FIG. 3a, wherein the volume filling device is essentially
egg-shaped. In another preferred embodiment, the volume filling
device is slightly bent, such as the embodiment shown in FIG. 3b.
However, since the stomach wall is strong many different shapes,
forms, and dimensions may be used. In one embodiment, the volume
filling device has a diameter of about 40 millimeters and a length
of about 120 millimeters, resulting in a volume that is about half
the volume of the patient's stomach. However, it is preferred that
the maximum circumference of the volume filling device is at least
30 millimeters, more preferably at least 80 millimeters, and even
more preferably at least 120 millimeters.
[0083] It is not necessary that the volume filling device is
elongated. In the embodiment shown in FIG. 3c, the volume filling
device 10 is essentially spherical or ball-shaped. In order to fill
out the stomach, two or more such volume filling devices may be
combined to achieve the desired decrease of the food cavity of the
patient's stomach.
[0084] It has been mentioned that the volume filling device is
secured by the stomach-to-stomach sutures or staples. In order to
further improve the fixation, the volume filling device may be
provided with a waist portion having smaller diameter that the
maximum diameter of the volume filling device. Such volume filling
device having a waist portion 10a is shown in FIG. 3d.
[0085] The volume filling device 10 may consist of at least two
interconnectable portions so that each portion is easier to insert
into the stomach and further through a hole in the stomach wall.
Thus, FIG. 3e shows a volume filling device comprising two more or
less spherical sub-parts 10b, 10c interconnected by a portion with
which preferably has smaller diameter. The portion with smaller
diameter may comprise an interconnection means with a reversible
function allowing subsequent disconnection of the two
interconnected sub-parts 10b, 10c. Such means may comprise a
bayonet socket, a screw connection or the like, designated 10d in
the figure. Alternatively, the portion with smaller diameter may
comprise a fixed interconnection, such as resilient locking hooks
provided on one of the sub-parts 10b, 10c and engaging the rim of a
hole provided in the other one of the sub-parts 10b, 10c.
[0086] The configuration of the volume filling device 10 is not
limited to one waist portion 10a. Thus, in FIG. 3f a volume filling
device with two waist portions is shown.
[0087] In order to facilitate positioning of the volume filling
device, an attachment means in the form of a handle or the like may
be provided on the outer surface of the volume filling device. One
example thereof is shown in FIG. 3g, wherein also a detail view of
a handle 10e is shown. In a preferred embodiment, the attachment
means is provide at an end portion of the volume filling device 10.
In order to avoid protruding portion on the surface of the volume
filling device 10, the handle 10e is provided flush with the outer
surface of the volume filling device 10 and a recess 10f is
arranged to allow a gripping tool or instrument (not shown in FIG.
3g) to achieve firm gripping around the handle 10e.
[0088] The volume filling device may comprise a tube for filling or
emptying the volume filling device of a fluid or gel. By injecting
fluid or gel into the volume filling device 10, the volume filling
device is inflated to an inflated state, as will be described
below. The size of the volume filling device can also be adjusted
by moving fluid or gel therefrom to a different reservoir.
[0089] A volume filling device 10 adapted for this is shown in FIG.
3h. A tube 10g is fixedly attached to the volume filling device.
This tube can be attached to a suitable instrument (not shown) or
an injection port, which will be explained in detail below.
[0090] Instead of having a fixedly attached tube, the volume
filling device 10 may comprise an inlet port 10h adapted for
connection of a separate tube, see FIG. 3i.
[0091] It is important that the implanted volume filling device is
firmly kept in place in the stomach wall in which it is
invaginated. To this end, the volume filling device can be provided
with one or more through holes adapted for receiving sutures or
staples used for fixation of the invagination. Such an embodiment
is shown in FIG. 3j, where the volume filling device 10 is provided
with a row of holes 10i provided on a protruding flange-like
protrusion on the volume filling device. In this embodiment, the
row of holes extends along the longitudinal axis of the volume
filling device.
[0092] FIG. 3k illustrates how sutures 14 are provided so that they
run through the stomach wall 12a and through the holes 10i. In this
way, the volume filling device is fixed in place in the pouch
created from the stomach wall and will thus be prevented from
sliding.
[0093] Although a plurality of holes is illustrated in the FIG. 3j,
it will be appreciated that one single hole is sufficient to obtain
improved fixation of the volume filling device 10.
[0094] FIG. 3m illustrates a volume filling device provided with an
inlet port 10h. The volume filling device is invaginated in the
stomach wall and the inlet port 10h is available for connection to
a tube or the like from the abdominal area of the patient.
[0095] FIG. 3n illustrates an invaginated volume filling device
wherein, instead of an inlet port, a fixed tube 10g extends into
the abdominal area of the patient.
[0096] FIG. 3p is a figure similar to FIG. 3m but also illustrating
tunneling of a connection tube 10g in the stomach wall between the
inlet port 10h and the volume filling device 10.
[0097] It has been shown that the shape of the volume filling
device can take many different forms. It will be appreciated that
also the material of the volume filling device can vary. It is
preferred that the volume filling device is provided with a coating
in the form of a layer, such as a Parylene, polytetrafluoroethylene
(PTFE), or polyurethane layer, or a combination of such layers,
i.e., a multi-layer coating. This layer or multi-layer coating
improves the properties of the volume filling device, such as its
resistance to wear.
[0098] In one embodiment, the volume filling device comprises an
inflatable device expandable to an expanded state. In this case,
the inflatable device is provided with an inlet port for a fluid
and is adapted to be connected to a gastroscopic instrument. This
embodiment will now be described in detail with reference to FIGS.
4a-4d.
[0099] An inflatable volume filling device in its non-expanded
state is shown in FIG. 4a. It is essentially a balloon-like,
deflated device 10 having an inlet port 10h. In this state, the
inflatable device has a diameter of a few millimeters at the most,
allowing it to be inserted into the stomach through the esophagus
of the patient by means of a gastroscopic, tube-like instrument
500, depicted in FIG. 4b. The instrument comprises an outer sleeve
500a and an inner sleeve 500b which can be displaced longitudinally
relatively to the outer sleeve. The inner sleeve is provided with a
cutter in the form of a cutting edge 515 at the distal end thereof.
This cutting edge can be used for cutting a hole in the stomach
wall, as will be explained in detail in the following.
[0100] When the instrument reaches a stomach wall, see FIG. 4c, the
inner sleeve is brought forward from its position in the outer
sleeve and into contact with the stomach wall 12a. The cutting edge
515 of the inner sleeve then cuts a hole in the stomach wall so as
to allow subsequent insertion of the volume filling device 10 into
and through this hole, see FIG. 4d. In order to push the volume
filling device through the hole, a piston 502 may be provided in
the instrument. Thus, the instrument further comprises a piston 502
adapted for pushing a deflated volume filling device 10 out from a
position in the inner sleeve, this position being shown in FIG. 4b,
to a position outside of the inner sleeve, this being shown in FIG.
4d.
[0101] In order to protect the deflated volume filling device 10
from the cutting edge 515 of the inner sleeve, a further protective
sleeve (not shown) can be provided around the volume filling
device.
[0102] An intraluminar method of invaginating a volume filling
device 10 on the outside of the stomach wall 12a will now be
described with reference to FIGS. 5a-i. Initially, an instrument
600, preferably a gastroscopic instrument, is inserted into the
mouth of the patient, see FIG. 5a. The instrument comprises an
injection device 601, 602 for injecting either fluid or a device
into the stomach of the patient. The instrument 600 further
comprises a control unit 606 adapted for controlling the operation
of the instrument. To this end, the control unit 606 comprises one
or more steering devices, in the embodiment shown in the figure in
the form of two joysticks 603 and two control buttons 604. A
display 605 is provided for displaying the image provided by an
optical device for viewing inside the stomach, such as a camera
(not shown) arranged at the outer end of the elongated member 607,
see FIGS. 5e-i. The camera, which may comprise connecting
electrical wires extending along the elongated member, may be
assisted by a light source (not shown) placed distally on the
elongated member for illuminating the inside of the stomach. The
optical device may also comprise optical fibers placed along the
elongated member and leading out from the patient's body for
external viewing of the inside of the stomach.
[0103] The instrument is further inserted into the esophagus and
into the stomach of the patient, see FIG. 5b. By means of the
instrument 600, a hole 12b is created in the wall of the stomach
12. To this and, the instrument is provided with one or more
cutters at the distal end thereof, for example in the way described
above with reference to FIGS. 4a-d. These cutters can of course be
designed in different ways, such as a toothed drum cutter rotating
about the center axis of the tube-like instrument.
[0104] After cutting a hole in the stomach wall, the distal end of
the instrument 600 is inserted into and through the hole 12b so
that it ends up outside the stomach wall 12a. This is shown in FIG.
5c, showing a side view of the stomach 12, and FIG. 5d, which is a
sectional view through the stomach of FIG. 5c taken along the lines
Vd-Vd.
[0105] The instrument 600 is adapted to create a "pocket" or
"pouch" on the outside of the stomach 12 around the hole 12b in the
stomach wall. Such an instrument and the method of providing the
pouch will now be described.
[0106] FIGS. 5e-i show a gastroscopic or laparoscopic instrument
for invaginating a volume filling device 10 in the stomach wall 12a
of the patient by creating a pouch of stomach wall 12a material in
which the volume filling device is placed. The instrument,
generally designated 600, and which may comprise the features
described above with reference to FIGS. 4a-d, comprises an
elongated member 607 having a proximal end and a distal end, the
elongated member 607 having a diameter less than that of the
patient's esophagus and being flexible such as to allow
introduction of the flexible elongated member 607 with its distal
end first through the patient's throat, esophagus and into the
stomach 12 to the stomach wall 12a.
[0107] The stomach penetration device or cutter 615 is provided on
the elongated member 607 at the distal en thereof for penetrating
the stomach wall 12a so as to create a hole in the stomach wall
12a, to allow introduction of the elongated member 607 through the
hole. The stomach penetration device 615 could be adapted to be
operable for retracting said stomach penetration device 615 after
the stomach fundus wall 12a has been penetrated, for not further
damaging tissue within the body. The instrument further comprises a
special holding device 609 provided on the elongated member 607 on
the proximal side to the penetration device 615.
[0108] The elongated member further comprises an expandable member
611 which is adapted to be expanded after the elongated member has
penetrated the stomach wall 12a and thereby assist in the creation
of a cavity or pouch adapted to hold the volume filling device 10.
The expandable member 611 may comprise an inflatable circular
balloon provided circumferentially around the distal end portion of
the flexible elongated member 607.
[0109] The method steps when invaginating the volume filling device
will now be described in detail. After the instrument 600 has been
inserted into the stomach 12, the stomach penetration device 615 is
placed into contact with the stomach wall 12a, see FIG. 5e. The
stomach penetration device or cutter 615 is then brought to create
the hole 12b in the stomach wall, whereafter at least the
expandable member 611 is brought through the hole 12b in the
stomach wall. The special holding device 609 is in this step
brought to a holding state wherein it expands radially so as to
form an essentially circular abutment surface to the stomach wall
12a, see FIG. 5f. In this way, the insertion of the stomach
penetration device 615 and the expandable member 611 through the
hole 12b in the stomach wall is limited to the position shown in
FIG. 5f.
[0110] The expandable member 611 is then expanded. In the case the
expandable member comprises a balloon or the like, air or other
fluid is injected into it.
[0111] The part of the elongated member 607 comprising the
expandable member 611 is then retracted in the proximal direction,
as indicated by the arrow in FIG. 5g, thereby pulling the stomach
wall 12a into a basket or cup like structure created by the special
holding device 609.
[0112] A suturing or stapling device 608 is further provided,
either as a device connected to the elongated member 607 or as a
separate instrument. The suturing or stapling member comprises a
suturing or stapling and 613 which is adapted to close the cavity
or pouch by means of stomach to stomach sutures or staples 14.
[0113] In a further step, illustrated in FIG. 5h, an inflatable
volume filling device 10 is placed in its deflated state in the cup
like structure. The volume filling device 10 is then inflated to
its inflated or expanded state, see FIG. 5i. This inflation of the
volume filling device 10 can be accomplished by injecting a fluid
or a gel into the deflated volume filling device. It can also be
accomplished by injecting a material which is allowed to cure,
thereby forming a solid device 10. Thus, the volume filling device
10 shown in FIGS. 5h and 5i can illustrate either a balloon-like
device which is subsequently filled with fluid or gel or
alternatively a material which is simply injected into the cup like
structure formed by the stomach wall 12a.
[0114] The fluid which is used to fill the volume filling device 10
could be any suitable fluid suitable to fill the inflatable device
10, such as a salt solution. In another embodiment, when this fluid
is a fluid which is adapted to be transformed into solid state, the
fluid could be liquid polyurethane.
[0115] In order to minimize or entirely eliminate leakage, the
fluid is iso-tonic, i.e., it has the same osmolarity as human body
fluids. Another way of preventing diffusion is to provide a fluid
which comprises large molecules, such as iodine molecules.
[0116] The stomach-to-stomach sutures or staples are preferably
provided with fixation portions exhibiting a structure, such as a
net like structure, adapted to be in contact with the stomach wall
to promote growth in of human tissue to secure the long term
placement of the volume filling device attached to the stomach
wall.
[0117] After the inflatable device 10 has been inflated, partly or
fully, the inlet port 10h (not shown in FIGS. 5h and 5i) of the
volume filling device 10, is sealed and the instrument 600 is
retracted from the hole 12b, which is subsequently closed in some
suitable way, such as by means of the instrument 600. The
instrument is then removed from the stomach 12 and the inflatable
device 10 in its inflated or expanded state is invaginated by a
stomach wall portion of the patient on the outside of the stomach
wall. This reduces the inner volume of the stomach, thereby
affecting the patent's appetite.
[0118] During one or more of the above described steps, the stomach
may be inflated with gas, preferably by means of the gastroscopic
instrument.
[0119] The volume filling device 10 described above with reference
to FIGS. 5a-i has been described as an inflatable volume filling
device. It will be appreciated that is also can be an elastic
volume filling device with an elasticity allowing compression so as
to be inserted into a gastroscopic instrument and which expands to
an expanded state after leaving the instrument.
[0120] An alternative embodiment of an apparatus for treating
obesity will now be described with reference to FIGS. 6a and 6b,
showing a sectional view of a stomach in which a volume filling
device is invaginated in the stomach wall on the outside thereof
together with a system for regulating the size of the volume
filling device. The volume filling device is an inflatable device
as described above with reference to FIGS. 5a-h and thus comprises
a fluid. The inflatable device 10 thus forms a fluid chamber, in
which fluid is allowed to flow. The inflatable device thereby forms
an expandable chamber that can change the volume it occupies in the
stomach wall, thereby forming a hydraulically or pneumatically
regulated inflatable device.
[0121] In FIG. 6a, an injection port 16 for fluids is connected to
the inflatable volume filling device 10 by means of a conduit 18 in
the form of a tube. The inflatable device 10 is thereby adapted to
be regulated, preferably non-invasively, by moving liquid or air
from the injection port 16 to the chamber formed by the inflatable
device. By using a hypodermic needle or the like, the amount of
fluid in the inflatable device 10 can thus be adjusted, thereby
adjusting the size of the adjustable device. The injection port 16
can also be used simply for refilling the volume filling device
10.
[0122] A similar embodiment is shown in FIG. 6b. However, in this
embodiment the injection port 16 has been replaced by an adjustable
regulation reservoir 17 in fluid connecting with the volume filling
device 10 via a conduit 18. When the regulation reservoir 17 is
pressed, the volume thereof decreases and hydraulic fluid is moved
from the reservoir to the chamber formed by the inflatable device
10 via the conduit or tube 18, enlarging or expanding the
inflatable device 10. In this way, the volume filling device is
non-invasively adjustable postoperatively.
[0123] The regulation reservoir 17 can be regulated in several
ways. In an alternative embodiment, the regulation reservoir 17 is
regulated by manually pressing a regulation reservoir. In other
words, the regulation reservoir is regulated by moving a wall of
the reservoir. It is then preferred that the regulation reservoir
is placed subcutaneously and non-invasive regulation is thereby
achieved.
[0124] It will be appreciated that instead of hydraulic operation,
pneumatic operation can be used, wherein air instead of hydraulic
fluid is moved between the regulation reservoir and the chamber
formed by the inflatable device 10. Preferable the regulation
reservoir has a locking position to keep it in the desired
position. If the patient compresses the reservoir it preferably
stays compressed and releases after pressing again.
[0125] Any kind of hydraulic solution may be used for the
inflatable device. The hydraulic solution may be driven by both
mechanically and be powered with any motor or pump as well as
manually.
[0126] In another embodiment, shown in FIG. 7, a motor 40 is
adapted to move a wall of the regulation reservoir 17. The powered
regulation reservoir 17 is then preferably placed in the abdomen of
the patient. In this embodiment, a wireless external remote control
unit forming part of an external energy transmission device 34 can
be provided to perform non-invasive regulation of the motor via an
energy transforming device 30, which is adapted to supply an energy
consuming operation device, in the present example the motor 40,
with energy via a power supply line 32.
[0127] The remote control may comprise a wireless energy
transmitter, whereby the non-invasive regulation is performed by
the energy transmitter. When the regulation is performed by means
of a remote control an internal power source for powering the
regulating device is provided. The internal energy source can for
example be a chargeable implanted battery or a capacitor or a
device for receiving wireless energy transmitted from outside the
body of the patient. Different ways of regulating the inflatable
device 10 will be described below with reference to FIGS.
22-41.
[0128] In yet an alternative embodiment, shown in FIG. 8, the
apparatus for treating obesity comprises a pump 44, wherein the
reservoir is regulated by the pump 44 pumping fluid or air from the
reservoir to the chamber formed by the inflatable device. Different
configurations of this pump will be described below with reference
to FIGS. 22-41.
[0129] Yet an alternative embodiment of an apparatus for treating
obesity will now be described with reference to FIG. 9, which shows
a stomach 12 of a patient who is treated for obesity. This
embodiment is similar to the one described above with reference to
FIG. 7 and the apparatus comprises a volume filling device in the
form of an inflatable device 10 which is invaginated in the wall
12a of the patient's stomach 12. However, in this case the
invagination has been performed in the fundus, i.e., the upper
portion of the stomach, where the number of receptors in the
stomach wall is large, and the inflatable device functions as a
stretching device for part of the stomach fundus wall.
[0130] A regulation reservoir 17 for fluids is connected to the
inflatable device by means of a conduit 18 in the form of a tube.
The inflatable device 10 is thereby adapted to be regulated,
preferably non-invasively, by moving liquid or air from the
regulation reservoir 17 to the chamber formed by the inflatable
device 10. The regulation of the inflatable device 10 preferably
comprises a reversed servo, i.e., a small volume is actuated for
example by the patient's finger and this small volume is in
connection with a larger volume, i.e., the regulation reservoir
17.
[0131] Thus, the inflatable device 10 is placed outside the stomach
wall and is adapted to stretch a part of the stomach fundus wall,
thereby affecting the patient's appetite. By enlarging the size of
the stretching device, the stomach fundus wall 12a surrounding the
inflatable stretching device 10 is stretched since the
circumference of the inflatable stretching device 10 is increased.
By this stretching, the receptors in the stomach wall indicate that
the stomach is full, thereby creating a feeling of satiety to the
patient. Correspondingly, when the stretching device 10 is
contracted, the receptors indicate that the stomach is not full,
thereby returning the feeling of hunger. It will be appreciated
that this embodiment combines the effects of both reducing the
volume of the stomach food cavity and stretching part of the
stomach wall, thereby increasing the treatment effect.
[0132] The expansion and contraction of the stretching device 10
can be performed under direct control of the patient.
Alternatively, the expansion and contraction can be performed
according to a pre-programmed schedule.
[0133] In a preferred embodiment, shown in FIG. 10, a sensor 19 is
provided at a suitable position, such as at the esophagus. The
volume filling device 10 in the form of the inflatable stretching
device is similar to the one shown in FIG. 9. By providing one or
more sensors, the apparatus for treating obesity can be automated
in that the size of the volume filling device 10 in the form of the
inflatable stretching device is adjusted depending on the amount of
food entering the food cavity of the stomach. The fluid is thereby
moved between the inflatable volume filling device 10 and a fluid
reservoir 15.
[0134] The apparatus for treating obesity can have the additional
functionality of treating reflux. An embodiment having this
function is shown in FIG. 11, wherein the volume filling device 10
is invaginated in the stomach wall close to and at least partially
above the patient's cardia 26 when the patient is in a standing
position and is fixed to a position above the cardia area 26 by a
fixation, such as sutures or staples 14a. For example a direct or
indirect fixation to the diaphragm muscle or associated muscles may
be provided. As an alternative a direct or indirect fixation to the
esophagus above and close to the angle of His can be provided. In
this alternative embodiment, the volume filling device 10 rests in
a position against stomach wall of the fundus when implanted and
which also fills a volume above the cardia area 26 between the
cardia and the diaphragm muscle so that the cardia is prevented
from slipping up into the thorax cavity, whereby reflux disease is
prevented.
[0135] Such a volume filling device 10 may be used for keeping
electronics and/or an energy source and/or hydraulic fluid.
Hydraulic fluid from that device may be distributed to several
smaller inflatable device areas to vary the stretching area from
time to time avoiding any possible more permanent stretching effect
of the stomach wall. Even mechanically several stretching areas may
be used.
[0136] In an alternative embodiment, which is shown in FIG. 12, the
volume of an inflatable volume filling device 10 may be in fluid
connection with one or more preferably smaller inflatable devices
or chambers that functions as adjustable stretching devices 50.
These chambers are adapted to communicate with fluid or air being
moved between the chambers.
[0137] Thus, the large chamber 10 is adapted to, with its main
volume to be a volume filling device for reducing the size of the
food cavity and for treating reflux disease and the one or several
small chambers are adapted to function as the inflatable devices to
treat obesity, wherein the main chamber is adapted to communicate
with fluid or air to the small chambers causing a stretching effect
in the stomach wall thereby further treating obesity.
[0138] In FIGS. 13-16, different embodiments embodying a
combination of a volume filling device invaginated in the central
or lower portion of the stomach and a stretching device invaginated
in the upper portion or fundus of the patient's stomach. Thus, in
FIG. 13 there is shown an adjustable volume filling device 10,
which is invaginated in the stomach wall of a patient's stomach 12.
Additionally, an adjustable stretching device 50 with the
previously described function is invaginated in the stomach fundus
wall of the patient. It is preferred that the volume filling device
10 is substantially larger than the stretching device 50.
[0139] The volume filling device 10 and the stretching device 50
are in fluid communication with each other via a fluid
communication device comprising a first fluid tube 52, in which a
pump 54 is provided. The pump 54 is under the control from an
energy transforming device 30, which is adapted to supply the pump
54 with energy via a power supply line 56. The energy transforming
device 30 is also connected to a sensor 19 provided in the
esophagus of the patient so that food intake can be detected.
[0140] The volume filling device 10 and the stretching device 50
are also in fluid communication with each other via a second fluid
tube 58, which preferably has a smaller cross-sectional area than
the first fluid tube 52.
[0141] The operation of this arrangement is as follows. The volume
filling device 10 functions as in the above described embodiments,
i.e., it reduces the size of the food cavity of the patient's
stomach 12. Additionally, when the stretching device 50 is enlarged
by pumping fluid from the volume filling device 10 and to the
stretching device 50 by means of the pump 54, the stomach fundus
wall is stretched, creating a feeling of satiety for the patient.
Thus, for example when food intake is detected by means of the
sensor 19, fluid is automatically pumped into the stretching device
50 to increase the feeling of satiety and thereby limit the food
intake.
[0142] When fluid has been injected into the stretching device 50,
the internal pressure therein is higher than the internal pressure
in the volume filling device 10. This difference in pressure will
create a flow of fluid in the second, preferably narrower tube 58
from the stretching device 50 to the volume filling device 10. The
flow rate will be determined by among other things the difference
in pressure and the cross-sectional area of the second tube 58. It
is preferred that the second tube is so dimensioned, that the
pressures in the volume filling device 10 and the stretching device
50 will return to equilibrium after 3 hours after fluid has been
injected into the stretching device 50 to create the feeling of
satiety.
[0143] In this embodiment, the function of the second tube 58 is to
allow fluid to return from the stretching device 50 to the volume
filling device 10. It will be appreciated that this function also
can be performed by the pump 54 in the first tube 52 and that the
second tube 58 then can be omitted.
[0144] FIG. 14 illustrates an embodiment similar to the one
illustrated in FIG. 13. Thus, there is provided an adjustable
volume filling device 10, which is invaginated in the stomach wall
of a patient's stomach 12. Additionally, an adjustable stretching
device 50 with the previously described function is invaginated in
the stomach fundus wall of the patient. It is preferred that the
volume filling device 10 is substantially larger than the
stretching device 50.
[0145] The volume filling device 10 and the stretching device 50
are in fluid communication with each other via a first fluid tube
52, and a second fluid tube, which preferably has a smaller
cross-sectional area than the first tube. However, instead of a
pump, them is provided a non-return valve 60 in the first fluid
tube 52 instead of an energized pump. This non-return valve 60
allows fluid to flow in the direction from the volume filling
device 10 and to the stretching device 10 but not vice verse. This
means that this embodiment may be entirely non-energized. Instead,
it operates according to the following principles.
[0146] When the food cavity of the stomach 12 is essentially empty,
there is a state of equilibrium between the internal pressure of
the volume filling device 10 and the stretching device 50. In this
state, the stretching device is in a non-stretch state, i.e., it
does not stretch a part of the stomach fundus wall and thus does
not create a feeling of satiety.
[0147] When the patient starts to eat, food will enter the food
cavity of the stomach 12. This will create increased pressure on
the stomach wall in which the volume filling device is invaginated
and the internal pressure therein will increase. Also, the stomach
wall muscles will begin to process the food in the food cavity by
contraction, which also contributes to an increased internal
pressure in the volume filling device 10.
[0148] Since the internal pressure in the stretching device 50 will
remain essentially unchanged, because it is located in the upper
part of the stomach 12 where no food is exerting a pressure on the
stomach wall, a fluid flow will be created through the first and
second fluid tubes 52, 58 in the direction from the volume filling
device 10 and to the stretching device 50. This in turn will
increase the volume of the stretching device 50, which, by
stretching the stomach fundus wall, will provide a feeling of
satiety to the patient.
[0149] A fluid flow from the stretching device 50 to the volume
filling device 10 through the second tube 58 will return the
pressure of these devices to equilibrium as described above with
reference to FIG. 13.
[0150] FIG. 15 illustrates an embodiment, which is similar to the
one shown in FIG. 14 but with the addition of an injection port 16,
which is used for refilling the fluid system comprising the volume
filling device 10 and the stretching device 50 or alternatively for
actively adjusting the size thereof.
[0151] Similarly, FIG. 16 illustrates an embodiment wherein the
stretching device 50 can be actively regulated by manually pressing
an adjustment reservoir which is provided subcutaneously below the
patient's skin, similar to the embodiment shown in FIG. 9. Thus, a
regulation reservoir 17 for fluids is connected to the inflatable
device by means of a conduit 18 in the form of a tube. The
stretching device 50 is thereby adapted to be regulated,
non-invasively, by moving liquid or air from the regulation
reservoir 17 to the chamber formed by the inflatable device. The
regulation of the stretching device 50 preferably comprises a
reversed servo, i.e., a small volume is actuated for example by the
patient's finger and this small volume is in connection with a
larger volume.
[0152] An alternative placement of the volume filling device 10 is
shown in FIGS. 17a and 17b, wherein FIG. 17b shows a sectional view
through the stomach shown in FIG. 17a along the line XVIIb-XVIIb.
There, the volume filling device 10 is adapted to be placed inside
the wall of the stomach 12, such as via a gastroscope or similar
intraluminar instrument, and resting against the inside of the
stomach wall 12a. The inflatable device can be kept invaginated by
means of sutures or staples 14, like in the embodiment of FIGS. 2a
and 2b. In this embodiment, no hole is required in the stomach
wall. Instead, a method of providing the volume filling device 10
can comprise the following steps, which will be explained with
reference to FIGS. 18a-i showing an invagination instrument
[0153] The invagination instrument, generally designated 630,
comprises an elongated tube member 632 similar to the elongated
member 607 described above with reference to FIGS. 5a-i. Thus, it
can be connected to a control unit 606, see FIG. 5a. The
invagination instrument 630 further comprises a perforated suction
portion 634, which preferably is elongated. The suction portion 634
exhibits a plurality of small holes 636, into which air will be
sucked by providing suction in the tube member 632. This suction
effect will be used to create a "pocket" or "pouch" in a part of a
stomach wall, generally designated 12a.
[0154] In other words, when the tip of the suction portion 634 is
pressed against the stomach wall 12a, see FIG. 18a, a small recess
will be formed therein. When the suction portion 634 is further
pressed against the stomach wall 12a, see FIG. 18b, a larger recess
will be formed. The part of the stomach wall 12a that forms the
recess will, due to the suction effect, adhere to the suction
portion 634 of the invagination instrument 630. As the suction
portion 634 is further pressed into the stomach wall 12a, see FIG.
18c, a deeper recess will be formed until the entire suction
portion 634 is embedded in the recess, see FIG. 18d.
[0155] The rim of the recess will at this stage be fixated by means
of fixation elements 638 and the suction portion be removed from
the instrument, see FIG. 18e. A compressed elastic volume filling
device 10 will subsequently be inserted into the recess, see FIG.
18f, for example in the way described above with reference to FIG.
4d. This compressed volume filling device is then expanded to its
final shape, see FIG. 18g, where after the pouch is sealed by
suturing or stapling by means of the fixations elements, see FIG.
18h.
[0156] All the alternatives described above with reference to FIGS.
2-16 are also applicable to the embodiment described with reference
to FIGS. 17 and 18, i.e., to the embodiment where the volume
filling device is invaginated on the inside of the stomach
wall.
[0157] FIGS. 19a-j show an instrument for use in a method of
engaging a volume filling device 10 to the stomach wall 12 of a
patient. The instrument is adapted to be inserted through a narrow
tube shaped object such as a gastroscope, used in an intraluminar
procedure, or a laparoscopic trocar used in a laparoscopic
procedure. The instrument comprises an elongated member 650 which
is adapted to be flexible by means of a construction comprising
multiple ring shaped members, however it is equally conceivable
that said elongated member 650 is adapted to be flexible by means
of said elongated member 650 being made of a flexible or adjustable
material. The elongated member 650 is inserted into the body and
placed in proximity to the stomach wall 12a of the patient, from
the outside or inside thereof. The elongated member 650 has a
special holding device 651 adapted to hold the stomach by means of
mechanical grabbing members or vacuum. The special holding device
651 comprises a first joint 652 and a second joint 653, which
enable the special holding device 651 be operable in relation to
the elongated member 650 and thereby place the part of the special
holding device comprising the mechanical grabbing members or vacuum
elements into contact with the stomach wall 12a of the patient.
FIG. 19b shows the special holding device 651 when placed in
contact with the stomach wall 12a of the human patient, after which
the special holding device 651 connects to the stomach wall 12, for
holding the stomach wall 12a. FIG. 19c shows the instrument when
the step of advancing a pushing rod 654 from the elongated member
650 is performed. The pushing rod 654 pushes the stomach wall 12 to
create a cavity or pouch thereof. FIG. 19d shows the instrument
turned 90.degree. in relation to FIGS. 19a-c.
[0158] This view shows the special holding devices 651a,b operably
attached to two sides of the elongated member 650 and being in
contact with the stomach wall 12a, holding the stomach wall 12 as
the pushing rod 654 pushes to create a cavity or pouch. When the
pushing rod 654 has pushed the stomach wall 12 to a desired
position the special holding devices 651a,b moves towards the
pushing rod 654 and thereby closes the cavity or pouch.
[0159] After the cavity or pouch has been created it needs to be
sealed. FIG. 19f shows the advancement of a suturing or stapling
device 655 from the elongated member 650. The suturing or stapling
device 655 is positioned in connection with the stomach wall after
which the suturing or stapling device commences with the suturing
or stapling of the stomach wall 12a, creating a seal of stomach to
stomach sutures or staples 14. The instrument is moved along the
stomach wall 12a of the patient and thereby a cavity or pouch is
created and sealed using the instrument, as shown in FIGS. 19g and
19h. When a cavity or pouch or desired size has been created and
sealed an inserting member 656 is advanced from the elongated
member 650. The inserting member 656 is adapted to insert a volume
filling device 10 being inflatable, as described earlier in this
application. After the inserting member 656 has been positioned in
the cavity or pouch the volume filling device 10 is inserted
through the inserting member 656 and into the cavity or pouch by
means of a pressurized fluid or gas, or a mechanical advancement
member pushing said inflatable volume filling device 10 into the
cavity or pouch. The insertion member then inflates the inflatable
volume filling device with a fluid or gas and seals of the final
section of the pouch using stomach to stomach sutures or staples
14. The embodiment described explains the process of inserting an
inflatable volume filling device, however it is equally conceivable
that the volume filling device 10 is expandable by means of the
volume filling device 10 being made of an elastic material.
[0160] FIGS. 20a-f show an instrument for use in a method of
engaging a volume filling device 10 to the stomach wall 12a of a
patient. The instrument is adapted to be inserted through a narrow
tube shaped object such as a gastroscope, used in an intraluminar
procedure, or a laparoscopic trocar used in a laparoscopic
procedure. The instrument comprises an elongated member 660 which
is adapted to be flexible by means of a construction comprising
multiple ring shaped members, however it is equally conceivable
that said elongated member 660 is adapted to be flexible by means
of said elongated member 660 being made of a flexible or adjustable
material. The elongated member 660 is inserted into the body and
placed in proximity to the stomach wall 12a of the patient, from
the outside or inside thereof. The elongated member 660 has
multiple special holding devices 661 adapted to hold the stomach by
means of mechanical grabbing members or vacuum. The special holding
devices 661 are locked in a position alongside the elongated member
660 by means of a locking ring 662. The special holding devices are
made of a flexible material end pro-bent to expand into a
funnel-shaped device when said locking ring 662 is removed. The
special holding device in its funnel shaped expandable state is
shown in FIG. 20b. FIG. 20b further shows the special holding
device 661 when placed in contact with the stomach wall 12a of the
human patient, after which the special holding device 661 connects
to the stomach wall 12a, for holding the stomach wall 12a. FIG. 20c
shows the instrument when the step of advancing a pushing rod 664
from the elongated member 660 is performed. The pushing rod 664
pushes the stomach wall 12a to create a cavity or pouch thereof.
When the pushing rod 664 has pushed the stomach wall 12a to a
desired position the special holding devices 661 moves towards the
pushing rod 664 and thereby closes the cavity or pouch.
[0161] After the cavity or pouch has been created it needs to be
sealed. FIG. 20d shows the advancement of a suturing or stapling
device 665 from the elongated member 660. The suturing or stapling
device 665 is positioned in connection with the stomach wall 12
after which the suturing or stapling device 665 commences with the
suturing or stapling of the stomach wall 12a, creating a seal of
stomach to stomach sutures or staples 14. Thereafter an inserting
member 666 is advanced from the elongated member 660 and the
special holding devices 661 are retracted. The inserting member 666
is adapted to insert a volume filling device 10 being inflatable,
as described earlier in this application. After the inserting
member 666 has been positioned in the cavity or pouch the volume
filling device 10 is inserted through the inserting member 666 and
into the cavity or pouch by means of a pressurized fluid or gas, or
a mechanical advancement member pushing said inflatable volume
filling device 10 into the cavity or pouch. The inserting member
656 then inflates the inflatable volume filling device with a fluid
or gas and seals of the final section of the pouch using stomach to
stomach sutures or staples 14. The embodiment described explains
the process of inserting an inflatable volume filling device 10,
however it is equally conceivable that the volume filling device 10
is expandable by means of the volume filling device 10 being made
of an elastic material. FIG. 20f shows the volume filling device 10
as the volume filling device 10 is invaginated in the stomach wall
12a, in a cavity or pouch sealed with stomach to stomach sutures or
staples 14.
[0162] FIG. 21a shows an instrument used in a method of engaging
the volume filling device according to any of the embodiments of
the application to the stomach wall 12a. The instrument comprises
an elongated member 670 which is adapted to be flexible by means of
a construction comprising multiple ring shaped members, however it
is equally conceivable that said elongated member 670 is adapted to
be flexible by means of said elongated member 670 being made of a
flexible or adjustable material. The elongated member 670 is
inserted into the body and placed in proximity to the stomach wall
12a of the patient, from the inside thereof. A stomach penetrating
member 672 is placed in the distal end of the elongated member 670,
retractably fixated to a protective sleeve 673 adapted to protect
the tissue of the body from the sharp penetrating member 672 or
cutter 672 after the cutting operation has been performed.
[0163] FIG. 21b shows the instrument comprising the elongated
member 670 after the cutting operation has been performed and the
stomach penetrating member or cutter 672 has been retracted into
the protective sleeve 673. A guiding wire 671 is pushed through the
elongated member 670, through the hole made in the stomach wall 12a
and out through the abdomen and placed on the inside of the
patients skin, which is penetrated from the outside to enable the
guiding wire 671 to exit the abdomen. The guiding wire 671 can then
be used to guide a conduit 18 or a lead attached to the volume
filling device 10 being placed in the stomach from the inside
thereof. The volume filling device 10 with the conduit 18 or
electrical lead being a volume filling device 10 according to any
of the embodiments of this application. The guiding of the conduit
18 or electrical lead enables the attachment of the conduit 18 or
electrical lead to a control unit 42 placed subcutaneously in the
patient from the outside of the abdomen.
[0164] FIGS. 20a-f show an instrument for use in a method of
engaging a volume filling device 10 to the stomach wall 12a of a
patient. The instrument is adapted to be inserted through a narrow
tube shaped object such as a gastroscope, used in an intraluminar
procedure, or a laparoscopic trocar used in a laparoscopic
procedure. The instrument comprises an elongated member 660 which
is adapted to be flexible by means of a construction comprising
multiple ring shaped members, however it is equally conceivable
that said elongated member 660 is adapted to be flexible by means
of said elongated member 660 being made of a flexible or adjustable
material. The elongated member 660 is inserted into the body and
placed in proximity to the stomach wall 12a of the patient, from
the outside or inside thereof. The elongated member 660 has
multiple special holding devices 661 adapted to hold the stomach by
means of mechanical grabbing members or vacuum. The special holding
devices 661 are locked in a position alongside the elongated member
660 by means of a locking ring 662. The special holding devices are
made of a flexible material end pre-bent to expand into a
funnel-shaped device when said locking ring 662 is removed. The
special holding device in its funnel shaped expandable state is
shown in FIG. 20b. FIG. 20b further shows the special holding
device 661 when placed in contact with the stomach wall 12a of the
human patient, after which the special holding device 661 connects
to the stomach wall 12a, for holding the stomach wall 12a. FIG. 20c
shows the instrument when the step of advancing a pushing rod 664
from the elongated member 660 is performed. The pushing rod 664
pushes the stomach wall 12a to create a cavity or pouch thereof.
When the pushing rod 664 has pushed the stomach wall 12a to a
desired position the special holding devices 661 moves towards the
pushing rod 664 and thereby closes the cavity or pouch.
[0165] After the cavity or pouch has been created it needs to be
sealed. FIG. 20d shows the advancement of a suturing or stapling
device 665 from the elongated member 660. The suturing or stapling
device 665 is positioned in connection with the stomach wall 12a
after which the suturing or stapling device 665 commences with the
suturing or stapling of the stomach wall 12a, creating a seal of
stomach to stomach sutures or staples 14. Thereafter an inserting
member 666 is advanced from the elongated member 660 and the
special holding devices 661 are retracted. The inserting member 666
is adapted to insert a volume filling device 10 being inflatable,
as described earlier in this application. After the inserting
member 666 has been positioned in the cavity or pouch the volume
filling device 10 is inserted through the inserting member 666 and
into the cavity or pouch by means of a pressurized fluid or gas, or
a mechanical advancement member pushing said inflatable volume
filling device 10 into the cavity or pouch. The inserting member
656 then inflates the inflatable volume filling device with a fluid
or gas and seals of the final section of the pouch using stomach to
stomach sutures or staples 14. The embodiment described explains
the process of inserting an inflatable volume filling device 10,
however it is equally conceivable that the volume filling device 10
is expandable by means of the volume filling device 10 being made
of an elastic material. FIG. 20f shows the volume filling device 10
as the volume filling device 10 is invaginated in the stomach wall
12a, in a cavity or pouch sealed with stomach to stomach sutures or
staples 14.
[0166] FIG. 21a shows an instrument used in a method of engaging
the volume filling device according to any of the embodiments of
the application to the stomach wall 12a. The instrument comprises
an elongated member 670 which is adapted to be flexible by means of
a construction comprising multiple ring shaped members, however it
is equally conceivable that said elongated member 670 is adapted to
be flexible by means of said elongated member 670 being made of a
flexible or adjustable material. The elongated member 670 is
inserted into the body and placed in proximity to the stomach wall
12a of the patient, from the inside thereof. A stomach penetrating
member 672 is placed in the distal end of the elongated member 670,
retractably fixated to a protective sleeve 673 adapted to protect
the tissue of the body from the sharp penetrating member 672 or
cutter 672 after the cutting operation has been performed.
[0167] FIG. 21b shows the instrument comprising the elongated
member 670 after the cutting operation has been performed and the
stomach penetrating member or cutter 672 has been retracted into
the protective sleeve 673. A guiding wire 671 is pushed through the
elongated member 670, through the hole made in the stomach wall 12a
and out through the abdomen and placed on the inside of the
patients skin, which is penetrated from the outside to enable the
guiding wire 671 to exit the abdomen. The guiding wire 671 can then
be used to guide a conduit 18 or a lead attached to the volume
filling device 10 being placed in the stomach from the inside
thereof. The volume filling device 10 with the conduit 18 or
electrical lead being a volume filling device 10 according to any
of the embodiments of this application. The guiding of the conduit
18 or electrical lead enables the attachment of the conduit 18 or
electrical lead to a control unit 42 placed subcutaneously in the
patient from the outside of the abdomen.
[0168] FIG. 22 illustrates a system for treating a disease
comprising an apparatus 10 comprising a volume filling device of
the present invention placed in the abdomen of a patient. An
implanted energy-transforming device 1002 is adapted to supply
energy consuming components of the apparatus with energy via a
power supply line 1003. An external energy-transmission device 1004
for non-invasively energizing the apparatus 10 transmits energy by
at least one wireless energy signal. The implanted
energy-transforming device 1002 transforms energy from the wireless
energy signal into electric energy which is supplied via the power
supply line 1003.
[0169] The implanted energy-transforming device 1002 may also
comprise other components, such as: a coil for reception and/or
transmission of signals and energy, an antenna for reception and/or
transmission of signals, a microcontroller, a charge control unit,
optionally comprising an energy storage, such as a capacitor, one
or more sensors, such as temperature sensor, pressure sensor,
position sensor, motion sensor etc., a transceiver, a motor,
optionally including a motor controller, a pump, and other parts
for controlling the operation of a medical implant.
[0170] The wireless energy signal may include a wave signal
selected from the following: a sound wave signal, an ultrasound
wave signal, an electromagnetic wave signal, an infrared light
signal, a visible light signal, an ultra violet light signal, a
laser light signal, a micro wave signal, a radio wave signal, an
x-ray radiation signal and a gamma radiation signal. Alternatively,
the wireless energy signal may include an electric or magnetic
field, or a combined electric and magnetic field.
[0171] The wireless energy-transmission device 1004 may transmit a
carrier signal for carrying the wireless energy signal. Such a
carrier signal may include digital, analogue or a combination of
digital and analogue signals. In this case, the wireless energy
signal includes an analogue or a digital signal, or a combination
of an analogue and digital signal.
[0172] Generally speaking, the energy-transforming device 1002 is
provided for transforming wireless energy of a first form
transmitted by the energy-transmission device 1004 into energy of a
second form, which typically is different from the energy of the
first form. The implanted apparatus 10 is operable in response to
the energy of the second form. The energy-transforming device 1002
may directly power the apparatus with the second form energy, as
the energy-transforming device 1002 transforms the first form
energy transmitted by the energy-transmission device 1004 into the
second form energy. The system may further include an implantable
accumulator, wherein the second form energy is used at least partly
to charge the accumulator.
[0173] Alternatively, the wireless energy transmitted by the
energy-transmission device 1004 may be used to directly power the
apparatus, as the wireless energy is being transmitted by the
energy-transmission device 1004. Where the system comprises an
operation device for operating the apparatus, as will be described
below, the wireless energy transmitted by the energy-transmission
device 1004 may be used to directly power the operation device to
create kinetic energy for the operation of the apparatus.
[0174] The wireless energy of the first form may comprise sound
waves and the energy-transforming device 1002 may include a
piezo-electric element for transforming the 23 sound waves into
electric energy. The energy of the second form may comprise
electric energy in the form of a direct current or pulsating direct
current, or a combination of a direct current and pulsating direct
current, or an alternating current or a combination of a direct and
alternating current. Normally, the apparatus comprises electric
components that are energized with electrical energy. Other
implantable electric components of the system may be at least one
voltage level guard or at least one constant current guard
connected with the electric components of the apparatus.
[0175] Optionally, one of the energy of the first form and the
energy of the second form may comprise magnetic energy, kinetic
energy, sound energy, chemical energy, radiant energy,
electromagnetic energy, photo energy, nuclear energy or thermal
energy. Preferably, one of the energy of the first form and the
energy of the second form is non-magnetic, non-kinetic,
non-chemical, non-sonic, non-nuclear or non-thermal.
[0176] The energy-transmission device may be controlled from
outside the patient's body to release electromagnetic wireless
energy, and the released electromagnetic wireless energy is used
for operating the apparatus. Alternatively, the energy-transmission
device is controlled from outside the patient's body to release
non-magnetic wireless energy, and the released non-magnetic
wireless energy is used for operating the apparatus.
[0177] The external energy-transmission device 1004 also includes a
wireless remote control having an external signal transmitter for
transmitting a wireless control signal for non-invasively
controlling the apparatus. The control signal is received by an
implanted signal receiver which may be incorporated in the
implanted energy-transforming device 1002 or be separate there
from.
[0178] The wireless control signal may include a frequency,
amplitude, or phase modulated signal or a combination thereof.
Alternatively, the wireless control signal includes an analogue or
a digital signal, or a combination of an analogue and digital
signal. Alternatively, the wireless control signal comprises an
electric or magnetic field, or a combined electric and magnetic
field.
[0179] The wireless remote control may transmit a carrier signal
for carrying the wireless control signal. Such a carrier signal may
include digital, analogue or a combination of digital and analogue
signals. Where the control signal includes an analogue or a digital
signal, or a combination of an analogue and digital signal, the
wireless remote control preferably transmits an electromagnetic
carrier wave signal for carrying the digital or analogue control
signals.
[0180] FIG. 23 illustrates the system of FIG. 22 in the form of a
more generalized block diagram showing the apparatus 10, the
energy-transforming device 1002 powering the apparatus 10 via power
supply line 1003, and the external energy-transmission device 1004,
The patient's skin 1005, generally shown by a vertical line,
separates the interior of the patient to the right of the line from
the exterior to the left of the line.
[0181] FIG. 24 shows an embodiment of the invention identical to
that of FIG. 23, except that a reversing device in the form of an
electric switch 1006 operable for example by polarized energy also
is implanted in the patient for reversing the apparatus 10. When
the switch is operated by polarized energy the wireless remote
control of the external energy-transmission device 1004 transmits a
wireless signal that carries polarized energy and the implanted
energy-transforming device 1002 transforms the wireless polarized
energy into a polarized current for operating the electric switch
1006. When the polarity of the current is shifted by the implanted
energy-transforming device 1002 the electric switch 1006 reverses
the function performed by the apparatus 10.
[0182] FIG. 25 shows an embodiment of the invention identical to
that of FIG. 23, except that an operation device 1007 implanted in
the patient for operating the apparatus 10 is provided between the
implanted energy-transforming device 1002 and the apparatus 10.
This operation device can be in the form of a motor 1007, such as
an electric servomotor. The motor 1007 is powered with energy from
the implanted energy-transforming device 1002, as the remote
control of the external energy-transmission device 1004 transmits a
wireless signal to the receiver of the implanted
energy-transforming device 1002.
[0183] FIG. 26 shows an embodiment of the invention identical to
that of FIG. 23, except that it also comprises an operation device
is in the form of an assembly 1008 including a motor/pump unit 1009
and a fluid reservoir 1010 is implanted in the patient. In this
case the apparatus 10 is hydraulically operated, i.e. hydraulic
fluid is pumped by the motor/pump unit 1009 from the fluid
reservoir 1010 through a conduit 1011 to the apparatus 10 to
operate the apparatus, and hydraulic fluid is pumped by the
motor/pump unit 1009 back from the apparatus 10 to the fluid
reservoir 1010 to return the apparatus to a starting position. The
implanted energy-transforming device 1002 transforms wireless
energy into a current, for example a polarized current, for
powering the motor/pump unit 1009 via an electric power supply line
1012.
[0184] Instead of a hydraulically operated apparatus 10, it is also
envisaged that the operation device comprises a pneumatic operation
device. In this case, the hydraulic fluid can be pressurized air to
be used for regulation and the fluid reservoir is replaced by an
air chamber.
[0185] In all of these embodiments the energy-transforming device
1002 may include a rechargeable accumulator like a battery or a
capacitor to be charged by the wireless energy and supplies energy
for any energy consuming part of the system.
[0186] As an alternative, the wireless remote control described
above may be replaced by manual control of any implanted part to
make contact with by the patient's hand most likely indirect, for
example a press button placed under the skin.
[0187] FIG. 27 shows an embodiment of the invention comprising the
external energy-transmission device 1004 with its wireless remote
control, the apparatus 10, in this case hydraulically operated, and
the implanted energy-transforming device 1002, and further
comprising a hydraulic fluid reservoir 1013, a motor/pump unit 1009
and an reversing device in the form of a hydraulic valve shifting
device 1014, all implanted in the patient. Of course the hydraulic
operation could easily be performed by just changing the pumping
direction and the hydraulic valve may therefore be omitted. The
remote control may be a device separated from the external
energy-transmission device or included in the same. The motor of
the motor/pump unit 1009 is an electric motor. In response to a
control signal from the wireless remote control of the external
energy-transmission device 1004, the implanted energy-transforming
device 1002 powers the motor/pump unit 1009 with energy from the
energy carried by the control signal, whereby the motor/pump unit
1009 distributes hydraulic fluid between the hydraulic fluid
reservoir 1013 and the apparatus 10. The remote control of the
external energy-transmission device 1004 controls the hydraulic
valve shifting device 1014 to shift the hydraulic fluid flow
direction between one direction in which the fluid is pumped by the
motor/pump unit 1009 from the hydraulic fluid reservoir 1013 to the
apparatus 10 to operate the apparatus, and another opposite
direction in which the fluid is pumped by the motor/pump unit 1009
back from the apparatus 10 to the hydraulic fluid reservoir 1013 to
return the apparatus to a starting position.
[0188] FIG. 28 shows an embodiment of the invention comprising the
external energy-transmission device 1004 with its wireless remote
control, the apparatus 10, the implanted energy-transforming device
1002, an implanted internal control unit 1015 controlled by the
wireless remote control of the external energy-transmission device
1004, an implanted accumulator 1016 and an implanted capacitor
1017. The internal control unit 1015 arranges storage of electric
energy received from the implanted energy-transforming device 1002
in the accumulator 1016, which supplies energy to the apparatus 10.
In response to a control signal from the wireless remote control of
the external energy-transmission device 1004, the internal control
unit 1015 either releases electric energy from the accumulator 1016
and transfers the released energy via power lines 1018 and 1019, or
directly transfers electric energy from the implanted
energy-transforming device 1002 via a power line 1020, the
capacitor 1017, which stabilizes the electric current, a power line
1021 and the power line 1019, for the operation of the apparatus
10.
[0189] The internal control unit is preferably programmable from
outside the patient's body. In a preferred embodiment, the internal
control unit is programmed to regulate the apparatus 10 according
to a pre-programmed time-schedule or to input from any sensor
sensing any possible physical parameter of the patient or any
functional parameter of the system.
[0190] In accordance with an alternative, the capacitor 1017 in the
embodiment of FIG. 28 10 may be omitted. In accordance with another
alternative, the accumulator 1016 in this embodiment may be
omitted.
[0191] FIG. 29 shows an embodiment of the invention identical to
that of FIG. 23, except that a battery 1022 for supplying energy
for the operation of the apparatus 10 and an electric switch 1023
for switching the operation of the apparatus 10 also are implanted
in the patient. The electric switch 1023 may be controlled by the
remote control and may also be operated by the energy supplied by
the implanted energy-transforming device 1002 to switch from an off
mode, in which the battery 1022 is not in use, to an on mode, in
which the battery 1022 supplies energy for the operation of the
apparatus 10.
[0192] FIG. 30 shows an embodiment of the invention identical to
that of FIG. 29, except that an internal control unit 1015
controllable by the wireless remote control of the external
energy-transmission device 1004 also is implanted in the patient.
In this case, the electric switch 1023 is operated by the energy
supplied by the implanted energy-transforming device 1002 to switch
from an off mode, in which the wireless remote control is prevented
from controlling the internal control unit 1015 and the battery is
not in use, to a standby mode, in which the remote control is
permitted to control the internal control unit 1015 to release
electric energy from the battery 1022 for the operation of the
apparatus 10.
[0193] FIG. 31 shows an embodiment of the invention identical to
that of FIG. 30, except that an accumulator 1016 is substituted for
the battery 1022 and the implanted components are interconnected
differently. In this case, the accumulator 1016 stores energy from
the implanted energy-transforming device 1002. In response to a
control signal from the wireless remote control of the external
energy-transmission device 1004, the internal control unit 1015
controls the electric switch 1023 to switch from an off mode, in
which the accumulator 1016 is not in use, to an on mode, in which
the accumulator 1016 supplies energy for the operation of the
apparatus 10. The accumulator may be combined with or replaced by a
capacitor.
[0194] FIG. 32 shows an embodiment of the invention identical to
that of FIG. 31, except that a battery 1022 also is implanted in
the patient and the implanted components are interconnected
differently. In response to a control signal from the wireless
remote control of the external energy-transmission device 1004, the
internal control unit 1015 controls the accumulator 1016 to deliver
energy for operating the electric switch 1023 to switch from an off
mode, in which the battery 1022 is not in use, to an on mode, in
which the battery 1022 supplies electric energy for the operation
of the apparatus 10.
[0195] Alternatively, the electric switch 1023 may be operated by
energy supplied by the accumulator 1016 to switch from an off mode,
in which the wireless remote control is prevented from controlling
the battery 1022 to supply electric energy and is not in use, to a
standby mode, in which the wireless remote control is permitted to
control the battery 1022 to supply electric energy for the
operation of the apparatus 10.
[0196] It should be understood that the electric switch 1023 and
all other switches in this application should be interpreted in its
broadest embodiment. This means a transistor, MCU, MCPU, ASIC, FPGA
or a DA converter or any other electronic component or circuit that
may switch the power on and off. Preferably the switch is
controlled from outside the body, or alternatively by an implanted
internal control unit.
[0197] FIG. 33 shows an embodiment of the invention identical to
that of FIG. 29, except that a motor 1007, a mechanical reversing
device in the form of a gear box 1024, and an internal control unit
1015 for controlling the gear box 1024 also are implanted in the
patient. The internal control unit 1015 controls the gear box 1024
to reverse the function performed by the apparatus 10 (mechanically
operated). Even simpler is to switch the direction of the motor
electronically. The gear box interpreted in its broadest embodiment
may stand for a servo arrangement saving force for the operation
device in favour of longer stroke to act.
[0198] FIG. 34 shows an embodiment of the invention identical to
that of FIG. 40 except that the implanted components are
interconnected differently. Thus, in this case the internal control
unit 1015 is powered by the battery 1022 when the accumulator 1016,
suitably a capacitor, activates the electric switch 1023 to switch
to an on mode. When the electric switch 1023 is in its on mode the
internal control unit 1015 is permitted to control the battery 1022
to supply, or not supply, energy for the operation of the apparatus
10.
[0199] FIG. 35 schematically shows conceivable combinations of
implanted components of the apparatus for achieving various
communication options. Basically, there are the apparatus 10, the
internal control unit 1015, motor or pump unit 1009, and the
external energy-transmission device 1004 including the external
wireless remote control. As already described above the wireless
remote control transmits a control signal which is received by the
internal control unit 1015, which in turn controls the various
implanted components of the apparatus.
[0200] A feedback device, preferably comprising a sensor or
measuring device 1025, may be implanted in the patient for sensing
a physical parameter of the patient. The physical parameter may be
at least one selected from the group consisting of pressure,
volume, diameter, stretching, elongation, extension, movement,
bending, elasticity, muscle contraction, nerve impulse, body
temperature, blood pressure, blood flow, heartbeats and breathing.
The sensor may sense any of the above physical parameters. For
example, the sensor may be a pressure or motility sensor.
Alternatively, the sensor 1025 may be arranged to sense a
functional parameter. The functional parameter may be correlated to
the transfer of energy for charging an implanted energy source and
may further include at least one selected from the group of
parameters consisting of; electricity, any electrical parameter,
pressure, volume, diameter, stretch, elongation, extension,
movement, bending, elasticity, temperature and flow.
[0201] The feedback may be sent to the internal control unit or out
to an external control unit preferably via the internal control
unit. Feedback may be sent out from the body via the energy
transfer system or a separate communication system with receiver
and transmitters.
[0202] The internal control unit 1015, or alternatively the
external wireless remote control of the external
energy-transmission device 1004, may control the apparatus 10 in
response to signals from the sensor 1025. A transceiver may be
combined with the sensor 1025 for sending information on the sensed
physical parameter to the external wireless remote control. The
wireless remote control may comprise a signal transmitter or
transceiver and the internal control unit 1015 may comprise a
signal receiver or transceiver. Alternatively, the wireless remote
control may comprise a signal receiver or transceiver and the
internal control unit 1015 may comprise a signal transmitter or
transceiver. The above transceivers, transmitters and receivers may
be used for sending information or data related to the apparatus 10
from inside the patient's body to the outside thereof.
[0203] Where the motor/pump unit 1009 and battery 1022 for powering
the motor/pump unit 1009 are implanted, information related to the
charging of the battery 1022 may be fed back. To be more precise,
when charging a battery or accumulator with energy feedback
information related to said charging process is sent and the energy
supply is changed accordingly.
[0204] FIG. 36 shows an alternative embodiment wherein the
apparatus 10 is regulated from outside the patient's body. The
system 1000 comprises a battery 1022 connected to the apparatus 10
via a subcutaneous electric switch 1026. Thus, the regulation of
the apparatus 10 is performed non-invasively by manually pressing
the subcutaneous switch, whereby the operation of the apparatus 10
is switched on and off. It will be appreciated that the shown
embodiment is a simplification and that additional components, such
as an internal control unit or any other part disclosed in the
present application can be added to the system. Two subcutaneous
switches may also be used. In the preferred embodiment one
implanted switch sends information to the internal control unit to
perform a certain predetermined performance and when the patient
press the switch again the performance is reversed.
[0205] FIG. 37 shows an alternative embodiment, wherein the system
1000 comprises a hydraulic fluid reservoir 1013 hydraulically
connected to the apparatus. Non-invasive regulation is performed by
manually pressing the hydraulic reservoir connected to the
apparatus. Alternatively, the hydraulic fluid reservoir 1013 is
adapted to work with an injection port for the injection of
hydraulic fluid, preferably for calibration of hydraulic fluid.
[0206] The system may include an external data communicator and an
implantable internal data communicator communicating with the
external data communicator. The internal communicator feeds data
related to the apparatus or the patient to the external data
communicator and/or the external data communicator feeds data to
the internal data communicator.
[0207] FIG. 38 schematically illustrates an arrangement of the
system that is capable of sending information from inside the
patient's body to the outside thereof to give feedback information
related to at least one functional parameter of the apparatus or
system, or related to a physical parameter of the patient, in order
to supply an accurate amount of energy to an implanted internal
energy receiver 1002 connected to implanted energy consuming
components of the apparatus 10. Such an energy receiver 1002 may
include an energy source and/or an energy-transforming device.
Briefly described, wireless energy is transmitted from an external
energy source 1004a located outside the patient and is received by
the internal energy receiver 1002 located inside the patient. The
internal energy receiver is adapted to directly or indirectly
supply received energy to the energy consuming components of the
apparatus 10 via a switch 1026. An energy balance is determined
between the energy received by the internal energy receiver 1002
and the energy used for the apparatus 10, and the transmission of
wireless energy is then controlled based on the determined energy
balance. The energy balance thus provides an accurate indication of
the correct amount of energy needed, which is sufficient to operate
the apparatus properly, but without causing undue temperature
rise.
[0208] In FIG. 38 the patient's skin is indicated by a vertical
line 1005. Here, the energy receiver comprises an
energy-transforming device 1002 located inside the patient,
preferably just beneath the patient's skin 1005. Generally
speaking, the implanted energy-transforming device 1002 may be
placed in the abdomen, thorax, muscle fascia (e.g. in the abdominal
wall), subcutaneously, or at any other suitable location. The
implanted energy-transforming device 1002 is adapted to receive
wireless energy E transmitted from the external energy source 1004a
provided in an external energy-transmission device 1004 located
outside the patient's skin 1005 in the vicinity of the implanted
energy-transforming device 1002.
[0209] As is well known in the art, the wireless energy E may
generally be transferred by means of any suitable Transcutaneous
Energy Transfer (TET) device, such as a device including a primary
coil arranged in the external energy source 1004a and an adjacent
secondary coil arranged in the implanted energy-transforming device
1002. When an electric current is fed through the primary coil,
energy in the form of a voltage is induced in the secondary coil
which can be used to power the implanted energy consuming
components of the apparatus, e.g. after storing the incoming energy
in an implanted energy source, such as a rechargeable battery or a
capacitor.
[0210] However, the present invention is generally not limited to
any particular energy transfer technique, TET devices or energy
sources, and any kind of wireless energy may be used.
[0211] The amount of energy received by the implanted energy
receiver may be compared with the energy used by the implanted
components of the apparatus. The term "energy used" is then
understood to include also energy stored by implanted components of
the apparatus. A control device includes an external control unit
1004b that controls the external energy source 1004a based on the
determined energy balance to regulate the amount of transferred
energy. In order to transfer the correct amount of energy, the
energy balance and the required amount of energy is determined by
means of a determination device including an implanted internal
control unit 1015 connected between the switch 1026 and the
apparatus 10. The internal control unit 1015 may thus be arranged
to receive various measurements obtained by suitable sensors or the
like, not shown, measuring certain characteristics of the apparatus
10, somehow reflecting the required amount of energy needed for
proper operation of the apparatus 10. Moreover, the current
condition of the patient may also be detected by means of suitable
measuring devices or sensors, in order to provide parameters
reflecting the patient's condition. Hence, such characteristics
and/or parameters may be related to the current state of the
apparatus 10, such as power consumption, operational mode and
temperature, as well as the patient's condition reflected by
parameters such as; body temperature, blood pressure, heartbeats
and breathing. Other kinds of physical parameters of the patient
and functional parameters of the device are described
elsewhere.
[0212] Furthermore, an energy source in the form of an accumulator
1016 may optionally be connected to the implanted
energy-transforming device 1002 via the control unit 1015 for
accumulating received energy for later use by the apparatus 10.
Alternatively or additionally, characteristics of such an
accumulator, also reflecting the required amount of energy, may be
measured as well. The accumulator may be replaced by a rechargeable
battery, and the measured characteristics may be related to the
current state of the battery, any electrical parameter such as
energy consumption voltage, temperature, etc. In order to provide
sufficient voltage and current to the apparatus 10, and also to
avoid excessive heating it is clearly understood that the battery
should be charged optimally by receiving a correct amount of energy
from the implanted energy-transforming device 1002, i.e. not too
little or too much. The accumulator may also be a capacitor with
corresponding characteristics.
[0213] For example, battery characteristics may be measured on a
regular basis to determine the current state of the battery, which
then may be stored as state information in a suitable storage means
in the internal control unit 1015. Thus, whenever new measurements
are made, the stored battery state information can be updated
accordingly. In this way, the state of the battery can be
"calibrated" by transferring a correct amount of energy, so as to
maintain the battery in an optimal condition.
[0214] Thus, the internal control unit 1015 of the determination
device is adapted to determine the energy balance and/or the
currently required amount of energy, (either energy per time unit
or accumulated energy) based on measurements made by the
above-mentioned sensors or measuring devices of the apparatus 10,
or the patient, or an implanted energy source if used, or any
combination thereof. The internal control unit 1015 is further
connected to an internal signal transmitter 1027, arranged to
transmit a control signal reflecting the determined required amount
of energy, to an external signal receiver 1004c connected to the
external control unit 1004b. The amount of energy transmitted from
the external energy source 1004a may then be regulated in response
to the received control signal.
[0215] Alternatively, the determination device may include the
external control unit 1004b. In this alternative, sensor
measurements can be transmitted directly to the external control
unit 1004b wherein the energy balance and/or the currently required
amount of energy can be determined by the external control unit
1004b, thus integrating the above-described function of the
internal control unit 1015 in the external control unit 1004b. In
that case, the internal control unit 1015 can be omitted and the
sensor measurements are supplied directly to the internal signal
transmitter 1027 which sends the measurements over to the external
signal receiver 1004c and the external control unit 1004b. The
energy balance and the currently required amount of energy can then
be determined by the external control unit 1004b based on those
sensor measurements.
[0216] Hence, the present solution according to the arrangement of
FIG. 38 employs the feedback of information indicating the required
energy, which is more efficient than previous solutions because it
is based on the actual use of energy that is compared to the
received energy, e.g. with respect to the amount of energy, the
energy difference, or the energy receiving rate as compared to the
energy rate used by implanted energy consuming components of the
apparatus. The apparatus may use the received energy either for
consuming or for storing the energy in an implanted energy source
or the like. The different parameters discussed above would thus be
used if relevant and needed and then as a tool for determining the
actual energy balance. However, such parameters may also be needed
per se for any actions taken internally to specifically operate the
apparatus.
[0217] The internal signal transmitter 1027 and the external signal
receiver 1004c may be implemented as separate units using suitable
signal transfer means, such as radio, IR (Infrared) or ultrasonic
signals. Alternatively, the internal signal transmitter 1027 and
the external signal receiver 1004c may be integrated in the
implanted energy-transforming device 1002 and the external energy
source 1004a, respectively, so as to convey control signals in a
reverse direction relative to the energy transfer, basically using
the same transmission technique. The control signals may be
modulated with respect to frequency, phase or amplitude.
[0218] Thus, the feedback information may be transferred either by
a separate communication system including receivers and
transmitters or may be integrated in the energy system. In
accordance with the present invention, such an integrated
information feedback and energy system comprises an implantable
internal energy receiver for receiving wireless energy, the energy
receiver having an internal first coil and a first electronic
circuit connected to the first coil, and an external energy
transmitter for transmitting wireless energy, the energy
transmitter having an external second coil and a second electronic
circuit connected to the second coil. The external second coil of
the energy transmitter transmits wireless energy which is received
by the first coil of the energy receiver. This system further
comprises a power switch for switching the connection of the
internal first coil to the first electronic circuit on and off,
such that feedback information related to the charging of the first
coil is received by the external energy transmitter in the form of
an impedance variation in the load of the external second coil,
when the power switch switches the connection of the internal first
coil to the first electronic circuit on and off. In implementing
this system in the arrangement of FIG. 38, the switch 1026 is
either separate and controlled by the internal control unit 1015,
or integrated in the internal control unit 1015. It should be
understood that the switch 1026 should be interpreted in its
broadest embodiment. This means a transistor, MCU, MCPU, ASIC FPGA
or a DA converter or any other electronic component or circuit that
may switch the power on and off.
[0219] To conclude, the energy supply arrangement illustrated in
FIG. 38 may operate basically in the following manner. The energy
balance is first determined by the internal control unit 1015 of
the determination device. A control signal reflecting the required
amount of energy is also created by the internal control unit 1015,
and the control signal is transmitted from the internal signal
transmitter 1027 to the external signal receiver 1004c.
Alternatively, the energy balance can be determined by the external
control unit 1004b instead depending on the implementation, as
mentioned above. In that case, the control signal may carry
measurement results from various sensors. The amount of energy
emitted from the external energy source 1004a can then be regulated
by the external control unit 1004b, based on the determined energy
balance, e.g. in response to the received control signal. This
process may be repeated intermittently at certain intervals during
ongoing energy transfer, or may be executed on a more or less
continuous basis during the energy transfer.
[0220] The amount of transferred energy can generally be regulated
by adjusting various transmission parameters in the external energy
source 1004a, such as voltage, current, amplitude, wave frequency
and pulse characteristics.
[0221] This system may also be used to obtain information about the
coupling factors between the coils in a TET system even to
calibrate the system both to find an optimal place for the external
coil in relation to the internal coil and to optimize energy
transfer. Simply comparing in this case the amount of energy
transferred with the amount of energy received. For example if the
external coil is moved the coupling factor may vary and correctly
displayed movements could cause the external coil to find the
optimal place for energy transfer. Preferably, the external coil is
adapted to calibrate the amount of transferred energy to achieve
the feedback information in the determination device, before the
coupling factor is maximized.
[0222] This coupling factor information may also be used as a
feedback during energy transfer. In such a case, the energy system
of the present invention comprises an implantable internal energy
receiver for receiving wireless energy, the energy receiver having
an internal first coil and a first electronic circuit connected to
the first coil, and an external energy transmitter for transmitting
wireless energy, the energy transmitter having an external second
coil and a second electronic circuit connected to the second coil.
The external second coil of the energy transmitter transmits
wireless energy which is received by the first coil of the energy
receiver. This system further comprises a feedback device for
communicating out the amount of energy received in the first coil
as a feedback information, and wherein the second electronic
circuit includes a determination device for receiving the feedback
information and for comparing the amount of transferred energy by
the second coil with the feedback information related to the amount
of energy received in the first coil to obtain the coupling factor
between the first and second coils. The energy transmitter may
regulate the transmitted energy in response to the obtained
coupling factor.
[0223] With reference to FIG. 39, although wireless transfer of
energy for operating the apparatus has been described above to
enable non-invasive operation, it will be appreciated that the
apparatus can be operated with wire bound energy as well. Such an
example is shown in FIG. 39, wherein an external switch 1026 is
interconnected between the external energy source 1004a and an
operation device, such as an electric motor 1007 operating the
apparatus 10. An external control unit 1004b controls the operation
of the external switch 1026 to effect proper operation of the
apparatus 10.
[0224] FIG. 40 illustrates different embodiments for how received
energy can be supplied to and used by the apparatus 10. Similar to
the example of FIG. 38, an internal energy receiver 1002 receives
wireless energy B from an external energy source 1004a which is
controlled by a transmission control unit 1004b. The internal
energy receiver 1002 may comprise a constant voltage circuit,
indicated as a dashed box "constant V" in the figure, for supplying
energy at constant voltage to the apparatus 10. The internal energy
receiver 1002 may further comprise a constant current circuit,
indicated as a dashed box "constant C" in the figure, for supplying
energy at constant current to the apparatus 10.
[0225] The apparatus 10 comprises an energy consuming part 10j,
which may be a motor, pump, restriction device, or any other
medical appliance that requires energy for its electrical
operation. The apparatus 10 may further comprise an energy storage
device 10k for storing energy supplied from the internal energy
receiver 1002. Thus, the supplied energy may be directly consumed
by the energy consuming part 10j, or stored by the energy storage
device 10k, or the supplied energy may be partly consumed and
partly stored. The apparatus 10 may further comprise an energy
stabilizing unit 101 for stabilizing the energy supplied from the
internal energy receiver 1002. Thus, the energy may be supplied in
a fluctuating manner such that it may be necessary to stabilize the
energy before consumed or stored.
[0226] The energy supplied from the internal energy receiver 1002
may further be accumulated and/or stabilized by a separate energy
stabilizing unit 1028 located outside the apparatus 10, before
being consumed and/or stored by the apparatus 10. Alternatively,
the energy stabilizing unit 1028 may be integrated in the internal
energy receiver 1002. In either case, the energy stabilizing unit
1028 may comprise a constant voltage circuit and/or a constant
current circuit.
[0227] It should be noted that FIG. 38 and FIG. 40 illustrate some
possible but non-limiting implementation options regarding how the
various shown functional components and elements can be arranged
and connected to each other. However, the skilled person will
readily appreciate that many variations and modifications can be
made within the scope of the present invention.
[0228] FIG. 41 schematically shows an energy balance measuring
circuit of one of the proposed designs of the system for
controlling transmission of wireless energy, or energy balance
control system. The circuit has an output signal centered on 2.5V
and proportionally related to the energy imbalance. The derivative
of this signal shows if the value goes up and down and how fast
such a change takes place. If the amount of received energy is
lower than the energy used by implanted components of the
apparatus, more energy is transferred and thus charged into the
energy source. The output signal from the circuit is typically feed
to an A/D converter and converted into a digital format. The
digital information can then be sent to the external
energy-transmission device allowing it to adjust the level of the
transmitted energy. Another possibility is to have a completely
analog system that uses comparators comparing the energy balance
level with certain maximum and minimum thresholds sending
information to external energy-transmission device if the balance
drifts out of the max/min window.
[0229] The schematic FIG. 41 shows a circuit implementation for a
system that transfers energy to the implanted energy components of
the apparatus of the present invention from outside of the
patient's body using inductive energy transfer. An inductive energy
transfer system typically uses an external transmitting coil and an
internal receiving coil. The receiving coil, L1, is included in the
schematic FIG. 24; the transmitting parts of the system are
excluded.
[0230] The implementation of the general concept of energy balance
and the way the information is transmitted to the external energy
transmitter can of course be implemented in numerous different
ways. The schematic FIG. 41 and the above described method of
evaluating and transmitting the information should only be regarded
as examples of how to implement the control system.
Circuit Details
[0231] In FIG. 41 the symbols Y1, Y2, Y3 and so on symbolize test
points within the circuit. The components in the diagram and their
respective values are values that work in this particular
implementation which of course is only one of an infinite number of
possible design solutions.
[0232] Energy to power the circuit is received by the energy
receiving coil L1. Energy to implanted components is transmitted in
this particular case at a frequency of 25 kHz. The energy balance
output signal is present at test point Y1.
[0233] Those skilled in the art will realize that the above various
embodiments of the system could be combined in many different ways.
For example, the electric switch 1006 of FIG. 24 could be
incorporated in any of the embodiments of FIGS. 27-33, the
hydraulic valve shifting device 1014 of FIG. 27 could be
incorporated in the embodiment of FIG. 26, and the gear box 1024
could be incorporated in the embodiment of FIG. 25. Please observe
that the switch simply could mean any electronic circuit or
component.
[0234] The embodiments described in connection with FIGS. 38, 40
and 41 identify a method and a system for controlling transmission
of wireless energy to implanted energy consuming components of an
electrically operable apparatus. Such a method and system will be
defined in general terms in the following.
[0235] A method is thus provided for controlling transmission of
wireless energy supplied to implanted energy consuming components
of an apparatus as described above. The wireless energy E is
transmitted from an external energy source located outside the
patient and is received by an internal energy receiver located
inside the patient, the internal energy receiver being connected to
the implanted energy consuming components of the apparatus for
directly or indirectly supplying received energy thereto. An energy
balance is determined between the energy received by the internal
energy receiver and the energy used for the apparatus. The
transmission of wireless energy B from the external energy source
is then controlled based on the determined energy balance.
[0236] The wireless energy may be transmitted inductively from a
primary coil in the external energy source to a secondary coil in
the internal energy receiver. A change in the energy balance may be
detected to control the transmission of wireless energy based on
the detected energy balance change. A difference may also be
detected between energy received by the internal energy receiver
and energy used for the medical device, to control the transmission
of wireless energy based on the detected energy difference.
[0237] When controlling the energy transmission, the amount of
transmitted wireless energy may be decreased if the detected energy
balance change implies that the energy balance is increasing, or
vice versa. The decrease/increase of energy transmission may
further correspond to a detected change rate.
[0238] The amount of transmitted wireless energy may further be
decreased if the detected energy difference implies that the
received energy is greater than the used energy, or vice versa. The
decrease/increase of energy transmission may then correspond to the
magnitude of the detected energy difference.
[0239] As mentioned above, the energy used for the medical device
may be consumed to operate the medical device, and/or stored in at
least one energy storage device of the medical device.
[0240] When electrical and/or physical parameters of the medical
device and/or physical parameters of the patient are determined,
the energy may be transmitted for consumption and storage according
to a transmission rate per time unit which is determined based on
said parameters. The total amount of transmitted energy may also be
determined based on said parameters.
[0241] When a difference is detected between the total amount of
energy received by the internal energy receiver and the total
amount of consumed and/or stored energy, and the detected
difference is related to the integral over time of at least one
measured electrical parameter related to said energy balance, the
integral may be determined for a monitored voltage and/or current
related to the energy balance.
[0242] When the derivative is determined over time of a measured
electrical parameter related to the amount of consumed and/or
stored energy, the derivative may be determined for a monitored
voltage and/or current related to the energy balance.
[0243] The transmission of wireless energy from the external energy
source may be controlled by applying to the external energy source
electrical pulses from a first electric circuit to transmit the
wireless energy, the electrical pulses having leading and trailing
edges, varying the lengths of first time intervals between
successive leading and trailing edges of the electrical pulses
and/or the lengths of second time intervals between successive
trailing and leading edges of the electrical pulses, and
transmitting wireless energy, the transmitted energy generated from
the electrical pulses having a varied power, the varying of the
power depending on the lengths of the first and/or second time
intervals.
[0244] In that case, the frequency of the electrical pulses may be
substantially constant when varying the first and/or second time
intervals. When applying electrical pulses, the electrical pulses
may remain unchanged, except for varying the first and/or second
time intervals. The amplitude of the electrical pulses may be
substantially constant when varying the first and/or second time
intervals. Further, the electrical pulses may be varied by only
varying the lengths of first time intervals between successive
leading and trailing edges of the electrical pulses.
[0245] A train of two or more electrical pulses may be supplied in
a row, wherein when applying the train of pulses, the train having
a first electrical pulse at the start of the pulse train and having
a second electrical pulse at the end of the pulse train, two or
more pulse trains may be supplied in a row, wherein the lengths of
the second time intervals between successive trailing edge of the
second electrical pulse in a first pulse train and leading edge of
the first electrical pulse of a second pulse train are varied.
[0246] When applying the electrical pulses, the electrical pulses
may have a substantially constant current and a substantially
constant voltage. The electrical pulses may also have a
substantially constant current and a substantially constant
voltage. Further, the electrical pulses may also have a
substantially constant frequency. The electrical pulses within a
pulse train may likewise have a substantially constant
frequency.
[0247] The circuit formed by the first electric circuit and the
external energy source may have a first characteristic time period
or first time constant, and when effectively varying the
transmitted energy, such frequency time period may be in the range
of the first characteristic time period or time constant or
shorter.
[0248] A system comprising an apparatus as described above is thus
also provided for controlling transmission of wireless energy
supplied to implanted energy consuming components of the apparatus.
In its broadest sense, the system comprises a control device for
controlling the transmission of wireless energy from an
energy-transmission device, and an implantable internal energy
receiver for receiving the transmitted wireless energy, the
internal energy receiver being connected to implantable energy
consuming components of the apparatus for directly or indirectly
supplying received energy thereto. The system further comprises a
determination device adapted to determine an energy balance between
the energy received by the internal energy receiver and the energy
used for the implantable energy consuming components of the
apparatus, wherein the control device controls the transmission of
wireless energy from the external energy-transmission device, based
on the energy balance determined by the determination device.
[0249] In one embodiment at least one battery may be a part of or
replace the energy-transforming device 1002 to supply energy to the
apparatus 10 over a power supply line. In one embodiment the
battery is not rechargeable. In an alternative embodiment the
battery is rechargeable. The battery supply may of course be placed
both remote to and incorporated in the device.
[0250] Further, the system may comprise any of the following:
[0251] A primary coil in the external energy source adapted to
transmit the wireless energy inductively to a secondary coil in the
internal energy receiver. [0252] A determination device adapted to
detect a change in the energy balance, wherein the control device
controls the transmission of wireless energy based on the detected
energy balance change [0253] A determination device adapted to
detect a difference between energy received by the internal energy
receiver and energy used for the implantable energy consuming
components of the apparatus, wherein the control device controls
the transmission of wireless energy based on the detected energy
difference. [0254] A control device controlling the external
energy-transmission device to decrease the amount of transmitted
wireless energy if the detected energy balance change implies that
the energy balance is increasing, or vice versa, wherein the
decrease/increase of energy transmission corresponds to a detected
change rate. [0255] A control device controlling the external
energy-transmission device to decrease the amount of transmitted
wireless energy if the detected energy difference implies that the
received energy is greater than the used energy, or vice versa,
wherein the decrease/increase of energy transmission corresponds to
the magnitude of said detected energy difference. [0256] An
apparatus wherein the energy used for the apparatus is consumed to
operate the apparatus, and/or stored in at least one energy storage
device of the apparatus. [0257] An apparatus where electrical
and/or physical parameters of the apparatus and/or physical
parameters of the patient are determined, the energy-transmission
device transmits the energy for consumption and storage according
to a transmission rate per time unit which is determined by the
determination device based on said parameters. The determination
device also determines the total amount of transmitted energy based
on said parameters. [0258] An apparatus wherein, wherein a
difference is detected between the total amount of energy received
by the internal energy receiver and the total amount of consumed
and/or stored energy, and the detected difference is related to the
integral over time of at least one measured electrical parameter
related to the energy balance, the determination device determines
the integral for a monitored voltage and/or current related to the
energy balance. [0259] An apparatus wherein the derivative is
determined over time of a measured electrical parameter related to
the amount of consumed and/or stored energy, the determination
device determines the derivative for a monitored voltage and/or
current related to the energy balance. [0260] An
energy-transmission device comprising a coil placed externally to
the human body, and an electric circuit provided to power the
external coil with electrical pulses to transmit the wireless
energy. The electrical pulses have leading and trailing edges, and
the electric circuit is adapted to vary first time intervals
between successive leading and trailing edges and/or second time
intervals between successive trailing and leading edges of the
electrical pulses to vary the power of the transmitted wireless
energy. As a result, the energy receiver receiving the transmitted
wireless energy has a varied power. [0261] An electric circuit
adapted to deliver the electrical pulses to remain unchanged except
varying the first and/or second time intervals. [0262] An electric
circuit having a time constant and being adapted to vary the first
and second time intervals only in the range of the first time
constant, so that when the lengths of the first and/or second time
intervals are varied, the transmitted power over the coil is
varied. [0263] An electric circuit adapted to deliver the
electrical pulses to be varied by only varying the lengths of first
time intervals between successive leading and trailing edges of the
electrical pulses. [0264] An electric circuit adapted to supply a
train of two or more electrical pulses in a row, said train having
a first electrical pulse at the start of the pulse train and having
a second electrical pulse at the and of the pulse train, and [0265]
the lengths of the second time intervals between successive
trailing edge of the second electrical pulse in a first pulse train
and leading edge of the first electrical pulse of a second pulse
train are varied by the first electronic circuit. [0266] An
electric circuit adapted to provide the electrical pulses as pulses
having a substantially constant height and/or amplitude and/or
intensity and/or voltage and/or current and/or frequency. [0267] An
electric circuit having a time constant, and being adapted to vary
the first and second time intervals only in the range of the first
time constant, so that when the lengths of the first and/or second
time intervals are varied, the transmitted power across the first
coil are varied. [0268] An electric circuit adapted to provide the
electrical pulses varying the lengths of the first and/or the
second time intervals only within a range that includes the first
time constant or that is located relatively close to the first time
constant, compared to the magnitude of the first time constant.
[0269] FIGS. 42-45 show in more detail block diagrams of four
different ways of hydraulically or pneumatically powering an
implanted apparatus according to the invention.
[0270] FIG. 42 shows a system as described above with. The system
comprises an implanted apparatus 10 and further a separate
regulation reservoir 1013, a one way pump 1009 and an alternate
valve 1014.
[0271] FIG. 43 shows the apparatus 10 and a fluid reservoir 1013.
By moving the wall of the regulation reservoir or changing the size
of the same in any other different way, the adjustment of the
apparatus may be performed without any valve, just free passage of
fluid any time by moving the reservoir wall.
[0272] FIG. 44 shows the apparatus 10, a two way pump 1009 and the
regulation reservoir 1013.
[0273] FIG. 45 shows a block diagram of a reversed servo system
with a first closed system controlling a second closed system. The
servo system comprises a regulation reservoir 1013 and a servo
reservoir 1050. The servo reservoir 1050 mechanically controls an
implanted apparatus 10 via a mechanical interconnection 1054. The
apparatus has an expandable/contactable cavity. This cavity is
preferably expanded or contracted by supplying hydraulic fluid from
the larger adjustable reservoir 1052 in fluid connection with the
apparatus 10. Alternatively, the cavity contains compressible gas,
which can be compressed and expanded under the control of the servo
reservoir 1050.
[0274] The servo reservoir 1050 can also be part of the apparatus
itself.
[0275] In one embodiment, the regulation reservoir is placed
subcutaneous under the patient's skin and is operated by pushing
the outer surface thereof by means of a finger. This system is
illustrated in FIGS. 46a-c. In FIG. 46a, a flexible subcutaneous
regulation reservoir 1013 is shown connected to a bulge shaped
servo reservoir 1050 by means of a conduit 1011. This bellow shaped
servo reservoir 1050 is comprised in a flexible apparatus 10. In
the state shown in FIG. 46a, the servo reservoir 1050 contains a
minimum of fluid and most fluid is found in the regulation
reservoir 1013.
[0276] Due to the mechanical interconnection between the servo
reservoir 1050 and the apparatus 10, the outer shape of the
apparatus 10 is contracted, i.e., it occupies less than its maximum
volume. This maximum volume is shown with dashed lines in the
figure.
[0277] FIG. 46b shows a state wherein a user, such as the patient
in with the apparatus is implanted, presses the regulation
reservoir 1013 so that fluid contained therein is brought to flow
through the conduit 1011 and into the servo reservoir 1050, which,
thanks to its bellow shape, expands longitudinally. This expansion
in turn expands the apparatus 10 so that it occupies its maximum
volume, thereby stretching the stomach wall (not shown), which it
contacts.
[0278] The regulation reservoir 1013 is preferably provided with
means 1013a for keeping its shape after compression. This means,
which is schematically shown in the figure, will thus keep the
apparatus 10 in a stretched position also when the user releases
the regulation reservoir. In this way, the regulation reservoir
essentially operates as an on/off switch for the system.
[0279] An alternative embodiment of hydraulic or pneumatic
operation will now be described with reference to FIGS. 47 and
48a-c. The block diagram shown in FIG. 47 comprises with a first
closed system controlling a second closed system. The first system
comprises a regulation reservoir 1013 and a servo reservoir 1050.
The servo reservoir 1050 mechanically controls a larger adjustable
reservoir 1052 via a mechanical interconnection 1054. An implanted
apparatus 10 having an expandable/contactable cavity is in turn
controlled by the larger adjustable reservoir 1052 by supply of
hydraulic fluid from the larger adjustable reservoir 1052 in fluid
connection with the apparatus 10.
[0280] An example of this embodiment will now be described with
reference to FIG. 48a-c. Like in the previous embodiment, the
regulation reservoir is placed subcutaneous under the patient's
skin and is operated by pushing the outer surface thereof by means
of a finger. The regulation reservoir 1013 is in fluid connection
with a bellow shaped servo reservoir 1050 by means of a conduit
1011. In the first closed system 1013, 1011, 1050 shown in FIG.
48a, the servo reservoir 1050 contains a minimum of fluid and most
fluid is found in the regulation reservoir 1013.
[0281] The servo reservoir 1050 is mechanically connected to a
larger adjustable reservoir 1052, in this example also having a
bellow shape but with a larger diameter than the servo reservoir
1050. The larger adjustable reservoir 1052 is in fluid connection
with the apparatus 10. This means that when a user pushes the
regulation reservoir 1013, thereby displacing fluid from the
regulation reservoir 1013 to the servo reservoir 1050, the
expansion of the servo reservoir 1050 will displace a larger volume
of fluid from the larger adjustable reservoir 1052 to the apparatus
10. In other words, in this reversed servo, a small volume in the
regulation reservoir is compressed with a higher force and this
creates a movement of a larger total area with less force per area
unit.
[0282] Like in the previous embodiment described above with
reference to FIGS. 46a-c, the regulation reservoir 1013 is
preferably provided with means 1013a for keeping its shape after
compression. This means, which is schematically shown in the
figure, will thus keep the apparatus 10 in a stretched position
also when the user releases the regulation reservoir. In this way,
the regulation reservoir essentially operates as an on/off switch
for the system.
[0283] One single volume filling device has been described as
invaginated in the stomach wall. Alternatively, two or more volume
filling devices 10 may be invaginated to obtain the desired
reduction of the food cavity. One such example is illustrated in
FIG. 49, wherein three ball-shaped volume filling devices 10 are
invaginated in the wall of the patent's stomach 12.
[0284] It has been described how the volume filling device 10 is
invaginated in the stomach wall by means of a gastroscopic
instrument. It will be appreciated that abdominal operation methods
can be used as well. Such methods will now be described in detail
with reference to FIGS. 50a and 50b.
[0285] In a first alternative embodiment, the volume filling device
is implanted using a laparoscopic method instead of the
intraluminar method described above. According to this embodiment,
a needle or a tube-like instrument is inserted into the abdomen of
the patient's body, and said needle or tube-like instrument is then
used to fill the patient's abdomen with gas. Subsequently, at least
two laparoscopic trocars are inserted into the patient's body; and
a camera is inserted through one of said at least two laparoscopic
trocars. Then, at least one dissecting tool through one of said at
least two laparoscopic trocars, and an area of the stomach is
dissected. The volume filling device is then introduced into the
abdominal cavity, and placed on the outside of the stomach wall. A
pouch in the stomach wall for the device is created, and the device
invaginated in said pouch by providing sutures or staples to the
stomach wall, thereby positioning the volume filling device so that
the volume of the food cavity is reduced in size by a volume
substantially exceeding the volume of the volume filling
device.
[0286] The above first alternative preferably further comprises
affixing the device to the stomach wall by providing sutures or
staples.
[0287] The above embodiment preferably further comprises providing
an apparatus for regulating the obesity treatment device from the
outside of the patient's body; and operating said apparatus to
regulate the obesity treatment device. Further, regulation of the
obesity treatment device includes changing the volume of a filling
body of the volume filling device when implanted.
[0288] The above embodiment preferably further comprises providing
an injection type syringe comprising a fluid for injection into an
implanted filling body; and injecting volume of fluid into said
filling body.
[0289] According to an embodiment, the device is enclosed in the
pouch or partially enclosed in that the pouch is left at least
partly open. Further, the pouch can be designed to exhibit only one
opening. Alternatively the pouch is designed to exhibit two
openings and to extend non-circumferentially around the
stomach.
[0290] Preferably the pouch has a volume of more than 15
milliliters.
[0291] In a second alternative, also using a laparoscopic method
instead of the intraluminar method, the initial steps are the same
as described in the first alternative, but following dissection of
the stomach, a hole is created in the stomach wall and a volume
filling device introduced into the abdominal cavity and through
said hole into the stomach. The device is placed on the inside of
the stomach wall, and a pouch is created on the outside of the
stomach cavity for the device placed on the inside of the stomach
wall, and the device is invaginated in the pouch by providing
sutures or staples to the stomach wall, thereby positioning the
volume filling device so that the volume of the food cavity is
reduced in size by a volume substantially exceeding the volume of
the volume filling device.
[0292] The above embodiment preferably further comprises affixing
the device to the stomach wall by providing sutures or staples.
According to one embodiment, the stomach wall is affixed to the
lower part of the patient's esophagus by providing sutures or
staples.
[0293] The above second alternative preferably further comprises
providing an apparatus for regulating the obesity treatment device
from the outside of the patient's body; and operating said
apparatus to regulate the obesity treatment device. Further,
regulation of the obesity treatment device includes changing the
volume of a filling body of the volume filling device when
implanted.
[0294] The above embodiment preferably further comprises providing
an injection type syringe comprising a fluid for injection into an
implanted filling body; and injecting volume of fluid into said
filling body.
[0295] According to an embodiment, the device is enclosed in the
pouch or partially enclosed in that the pouch is left at least
partly open. Further, the pouch can be designed to exhibit only one
opening. Alternatively the pouch is designed to exhibit two
openings and to extend non-circumferentially around the
stomach.
[0296] Preferably the pouch has a volume of more than 15
milliliters.
[0297] A third alternative involves a surgical incision instead of
the either the intraluminar or the laparoscopic method. Here, an
opening in the patient's abdominal wall is made by surgical
incision, and an area of the patient's stomach is dissected. The
volume filling device is introduced through said abdominal
incision, and attached to the stomach wall, thereby positioning the
volume filling device so that the volume of the food cavity is
reduced in size by a volume substantially exceeding the volume of
the volume filling device.
[0298] In an alternative embodiment of the above, third
alternative, the initial steps are the same including the
dissection of an area of the stomach. Following this, a pouch in
the stomach wall is created for the device, and the device
invaginated in the pouch by providing sutures or staples to the
stomach wall, thereby positioning the volume filling device so that
the volume of the food cavity is reduced in size by a volume
substantially exceeding the volume of the volume filling
device.
[0299] In yet another alternative embodiment of the above, third
alternative, the initial steps are the same including the
dissection of an area of the stomach. Following this, a hole in the
stomach wall is created and the volume filling device introduced
through the hole and into the stomach. The device is then placed on
the inside of the stomach wall, and a pouch on the stomach wall
created for the device. The device is then invaginated in the pouch
by providing sutures or staples to the stomach wall, thereby
positioning the volume filling device so that the volume of the
food cavity is reduced in size by a volume substantially exceeding
the volume of the volume filling device.
[0300] The above embodiments of the third alternative further
comprise affixing the device to the stomach wall by providing
sutures or staples.
[0301] The above embodiment preferably further comprises providing
an apparatus for regulating the obesity treatment device from the
outside of the patient's body; and operating said apparatus to
regulate the obesity treatment device. Further, regulation of the
obesity treatment device includes changing the volume of a filling
body of the volume filling device when implanted.
[0302] The above embodiment preferably further comprises providing
an injection type syringe comprising a fluid for injection into an
implanted filling body; and injecting volume of fluid into said
filling body.
[0303] According to an embodiment, the device is enclosed in the
pouch or partially enclosed in that the pouch is left at least
partly open. Further, the pouch can be designed to exhibit only one
opening. Alternatively the pouch is designed to exhibit two
openings and to extend non-circumferentially around the
stomach.
[0304] Preferably the pouch has a volume of more than 15
milliliters.
[0305] A fourth alternative embodiment is a method comprising the
steps of inserting a needle or a tube-like instrument into the
abdomen of the patient's body, using said needle or tube-like
instrument to fill the patient's abdomen with gas; placing at least
two laparoscopic trocars in the patient's body; inserting a camera
through one of said at least two laparoscopic trocars into the
patient's abdomen; inserting at least one dissecting tool through
one of said at least two laparoscopic trocars; dissecting an area
of the stomach; creating a pouch from the stomach wall for the
device; closing the pouch by providing sutures and staples;
introducing a injecting member comprising an injectable filling
material; and injecting the filling material into the pouch,
thereby creating a filling body that fills a volume in the
patient's stomach, reducing the food cavity in size by a volume
substantially exceeding the volume of the volume filling
device.
[0306] Instead of the above disclosed laparoscopic method, a
surgical incision or opening is cut in the skin to enter the
patients abdomen; an area of the stomach dissected; a pouch created
from the stomach wall for the device; and said pouch closed by
providing sutures and staples. An injecting member comprising an
injectable filling material is then introduced; and the filling
material injected into the pouch, thereby creating a filling body
that reduces the food cavity in size by a volume substantially
exceeding the volume of the volume filling device.
[0307] According to an alternative embodiment of the above, the
pouch is created on the outside of the stomach wall, with the
filling body placed against the inside of the stomach wall.
[0308] The method according to either of the two previous
embodiments comprises creating a hole in the stomach wall wherein
the pouch is created on the inside of the stomach wall, with the
filling body placed against the outside of the stomach wall.
[0309] The method according to either of the two previous
embodiments may further comprise affixing the stomach wall to the
lower part of the patient's esophagus by providing sutures or
staples or affixing the stomach wall to the patient's diaphragm
muscle or associated muscles.
[0310] Preferably the pouch has a volume of more than 15
milliliters.
[0311] In a method according to either of the two previous
embodiments the filling material is preferably capable of
undergoing a curing process from a fluid state to a semi-solid or
solid state. Preferably said curing process is triggered by an
increase in temperature from ambient temperature to body
temperature.
[0312] The invention also makes available a method of treating
obesity in a patient by implanting a volume filling device that,
when implanted in a patient, reduces the food cavity in size by a
volume substantially exceeding the volume of the volume filling
device, the method comprising the steps of: inserting a needle or a
tube-like instrument into the abdomen of the patient's body; using
said needle or tube-like instrument to fill the patient's abdomen
with gas; placing at least two laparoscopic trocars in the
patient's body; inserting a camera through one of said at least two
laparoscopic trocars into the patient's abdomen; inserting at least
one dissecting tool through one of said at least two laparoscopic
trocars; dissecting an area of the stomach; creating a hole in the
stomach wall; introducing a device into the abdominal cavity;
introducing the device through the hole and into the stomach;
placing the device on the outside of the stomach wall; fixating the
device placed on the outside of the stomach wall, and thereby
creating a filling body that reduces the food cavity in size by a
volume substantially exceeding the volume of the volume filling
device.
[0313] In the above method, the device is preferably affixed to the
stomach wall by providing sutures or staples.
[0314] The invention also comprises a laparoscopic instrument for
providing a volume filling device to be invaginated in the stomach
wall of a human patient to treat obesity, suitable for use with any
of the laparoscopic methods described above, the instrument
comprising: an elongated member having a proximal end and a distal
end, the elongated member having a diameter less than that of a
laparoscopic trocar to be introduced into the patients abdomen
during a laparoscopic operation; a stomach pushing device for
pushing the stomach wall to create a tube-like shaped portion of
the stomach wall protruding into the normal stomach cavity, said
pushing device comprising the volume filling device to be
invaginated by the stomach wall in the tube-like shaped portion
thereof, wherein the pushing device comprises a vacuum device to
suck the stomach fundus to assist the instrument in forming the
tube-like shaped portion of the stomach wall together with the
pushing device, and wherein the vacuum device comprises a vacuum
passageway leading from the proximal to the distal end of the
instrument and at the end portion of the instrument, which includes
the pushing device, said vacuum passageway is divided up in
multiple small openings adapted to suck the stomach wall portion to
become adherent to the pushing device to further form the tube-like
stomach wall portion; and wherein the instrument comprises an
insertion device adapted to introduce the volume filling device
into the tube-like shaped stomach portion.
[0315] This instrument preferably comprises at least one clamping
device for holding the opening of the tube-like portion
substantially closed by clamping together stomach to stomach in
said opening, wherein the instrument is adapted to place the at
least one clamping device at the opening in such a way that it
allows later suturing of the opening.
[0316] Further, the instrument preferably comprises an inflation
device for inflating the volume filling device before or after the
suturing. Further still, the instrument preferably comprises a
suturing device adapted to suture the opening of the tube-like
portion with stomach to stomach sutures for creating at least
partly a closed space enclosing the volume filling device, wherein
the instrument is adapted to be withdrawn leaving the volume
filling device at least partly invaginated in the stomach wall.
[0317] Said suturing device preferably comprises a first and second
suture positioning member provided on the elongated member situated
in the stomach at the distal end thereof, and wherein the
instrument further comprises an operation device adapted to adjust
the first and second suturing member in a position in which the
first and second suture positioning members are in front of each
other with the stomach wall on both sides of the open end of the
cup like portion, and adapted to suture the open end of the cup
like portion of the wall with a row of stomach to stomach
sutures.
[0318] Preferably said suturing device comprises an operable
re-loadable multi-suturing device, which is reloadable with sutures
from outside of the patient's body and which is adapted to suture
the open end of the cup like portion of the wall with said row of
stomach to stomach sutures, wherein the row of sutures comprises
two or more sutures or staples to be sutured simultaneously.
[0319] More preferably, said suturing device comprises multiple
sutures for suturing two or more sutures simultaneously.
[0320] It is understood that a skilled person is in the position of
combining steps, changing the order of steps, and combining
elements of the different embodiments of the invention without
inventive effort, and without departing from the scope of the
invention as defined in the description and claims.
* * * * *