U.S. patent application number 10/260533 was filed with the patent office on 2004-04-01 for injection port.
Invention is credited to Forsell, Peter.
Application Number | 20040064110 10/260533 |
Document ID | / |
Family ID | 32029706 |
Filed Date | 2004-04-01 |
United States Patent
Application |
20040064110 |
Kind Code |
A1 |
Forsell, Peter |
April 1, 2004 |
Injection port
Abstract
An injection port and implantable pump for adding fluid to, or
withdrawing fluid from, a surgical implant inside a patient's body
is disclosed. Also disclosed is a surgical method for treating
diseases using the injection port and pump. The injection port and
implantable pump includes a rigid base member and an injection
membrane penetrable by an injection needle and attached to the base
member. The membrane and base member define a chamber for holding
fluid. The membrane is displaceable relative to the base member
between a first position in which the volume of the fluid chamber
is maximal and a second position, in which the volume of the
chamber is minimal. According to the method, the membrane is
manually displaced from time to time to distribute fluid between
the fluid chamber of the injection port and the implant to operate
the implant, which is typically a hydraulic restriction device. The
implant can be designed for treating reflux disease, urinary
incontinence, impotence, anal incontinence or obesity.
Inventors: |
Forsell, Peter; (Zug,
CH) |
Correspondence
Address: |
NIXON & VANDERHYE P.C.
8th Floor
1100 North Glebe Road
Arlington
VA
22201-4714
US
|
Family ID: |
32029706 |
Appl. No.: |
10/260533 |
Filed: |
October 1, 2002 |
Current U.S.
Class: |
604/288.01 |
Current CPC
Class: |
A61M 39/0208 20130101;
F04B 9/14 20130101; A61M 5/14276 20130101; A61M 2039/0054 20130101;
A61M 2039/0072 20130101; F04B 43/04 20130101; F04B 43/0063
20130101; A61M 5/1428 20130101 |
Class at
Publication: |
604/288.01 |
International
Class: |
A61M 031/00 |
Claims
What is claimed is:
1. An injection port for adding fluid to or withdrawing fluid from
a surgical implant inside a human body, the injection port
comprising a rigid base member, and an injection membrane attached
to said base member, said membrane and said base member defining a
chamber for fluid, wherein said membrane includes a first layer and
a second layer attached to each other, said first layer having
better strength properties than said second layer and said second
layer having better sealing properties than said first layer.
2. An injection port according to claim 1, wherein said first layer
is harder than said second layer.
3. An injection port according to claim 2, wherein said second
layer is situated between said first layer and said chamber.
4. An injection port according to claim 3, wherein said membrane
comprises a third layer harder than said second layer, said third
layer being situated between said second layer and said
chamber.
5. An injection port according to claim 2, wherein said second
layer is made of silicone having a hardness of less than 20
Shore.
6. An injection port according to claim 1, wherein said membrane is
displaceable relative to said base member between a first position,
in which a volume of said chamber is maximal, and a second
position, in which the volume of said chamber is minimal.
7. An injection port according to claim 6, wherein said membrane is
manually displaceable between said first and second positions.
8. An injection port according to claim 6, further comprising a
locking device adapted to releaseably lock said membrane in said
second position.
9. An injection port according to claim 6, wherein said membrane is
elastic and takes the shape of a semi-sphere, when it is in said
first position.
10. An injection port according to claim 9, wherein said membrane
is substantially flattened, when it is in said second position.
11. An injection port according to claim 10, further comprising a
locking device adapted to releaseably lock said membrane in said
second position, when said membrane is pushed from said first
position to said second position.
12. An injection port according to claim 11, wherein said a locking
device is adapted to release said membrane from said second
position upon pushing said membrane, whereby said membrane resumes
its semi-spherical shape in said first position.
13. An implantable pump for pumping fluid to and from a surgical
implant inside a human body, comprising a rigid base member, and an
injection membrane penetrable by an injection needle and attached
to said base member, said membrane and said base member defining a
chamber for fluid, wherein said membrane is displaceable relative
said base member between a first position, in which the volume of
said chamber is maximal, and a second position, in which the volume
of said chamber is minimal, whereby the amount of fluid that is to
be pumped between said chamber and the surgical implant can be
calibrated by inserting an injection needle through said injection
membrane and adding fluid to or withdrawing fluid from said
chamber.
14. An implantable pump according to claim 13, wherein said
membrane is manually displaceable between said first and second
positions.
15. An implantable pump according to claim 13, further comprising a
locking device adapted to releaseably lock said membrane in said
second position.
16. An implantable pump according to claim 13, wherein said
membrane is elastic and takes the shape of a semi-sphere, when it
is in said first position.
17. An implantable pump according to claim 16, wherein said
membrane is substantially flattened, when it is in said second
position.
18. An implantable pump according to claim 17, further comprising a
locking device adapted to releaseably lock said membrane in said
second position, when said membrane is pushed from said first
position to said second position.
19. An implantable pump according to claim 18, wherein said locking
device is adapted to release said membrane from said second
position upon pushing said membrane, whereby said membrane resumes
its semi-spherical shape in said first position.
20. An implantable pump according to claim 13, wherein said
membrane includes a first layer and a second layer attached to each
other, said first layer having better strength properties than said
second layer and said second layer having better sealing properties
than said first layer.
21. An implantable pump according to claim 20, wherein said first
layer is harder than said second layer.
22. An implantable pump according to claim 21, wherein said second
layer is situated between said first layer and said chamber.
23. An implantable pump according to claim 22, wherein said
membrane comprises a third layer that is harder than said second
layer, said third layer being situated between said second layer
and said chamber.
24. An implantable pump according to claim 21, wherein said second
layer is made of silicone having a hardness of less than 20
Shore.
25. A method for hydraulically operating a surgical implant
implanted in a patient, the method comprising: subcutaneously
implanting in the patient an injection port having a displaceable
injection membrane for changing the volume of a fluid chamber in
the injection port; hydraulically connecting the injection port to
the surgical implant; calibrating the amount of fluid in the fluid
chamber of the injection port by penetrating the patient's skin and
the membrane of the injection port with an injection needle and
adding fluid to or withdrawing fluid from the fluid chamber; and
from time to time, manually displacing the membrane of the
subcutaneously implanted injection port, in order to distribute
fluid between the fluid chamber of the injection port and the
implant to operate the implant.
26. A surgical method for treating a patient having a disease,
comprising the steps of: insufflating the patient's abdomen with
gas; placing at least two laparoscopical trocars in the human's
body; inserting at least one dissecting tool through the trocars
and dissecting a region of the patient; implanting an implant
designed for treating reflux disease, urinary incontinence,
impotence, anal incontinence or obesity, in the dissected area by
using surgical instruments through the trocars; subcutaneously
implanting in the patient an injection port having a displaceable
injection membrane for changing the volume of a fluid chamber in
the injection port; hydraulically connecting the injection port to
the surgical implant; calibrating the amount of fluid in the fluid
chamber of the injection port by penetrating the patient's skin and
the membrane of the injection port with an injection needle and
adding fluid to or withdrawing fluid from the fluid chamber; and
from time to time, manually displacing the membrane of the
subcutaneously implanted injection port, in order to distribute
fluid between the fluid chamber of the injection port and the
implant to operate the implant.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to an injection port and an
implantable pump for adding fluid to, or withdrawing fluid from, a
surgical implant inside a human body. The present invention also
relates to surgical methods for treating diseases using the
injection port and pump.
BACKGROUND
[0002] Traditional so called injection ports are used for
post-operation adjustments of hydraulic implants. The injection
port comprises a thick wall member of silicone mounted under
tension to create a membrane through which it is possible to inject
a specific type of needle for injecting hydraulic fluid into the
interior of the port, without afterwards creating leakage through
the membrane. The needle has a lateral opening and does not cut out
any remaining hole in the silicone membrane. It just moves the
silicone aside. The silicone membrane of traditional injection
ports comprises a relatively hard (typically a hardness of about 60
Shore) and thick solid silicone. Since the thickness of the
membrane normally is about 6 mm for a normal-sized injection port,
it is difficult to find a proper location in the patient for
subcutaneous implantation of the injection port. Besides,
traditional injection ports are not suited for hydraulically
adjustable implants that need to be adjusted frequently, i.e.,
several times a day.
SUMMARY OF THE INVENTION
[0003] An object of the present invention is to provide an
injection port and an implantable pump, which are thinner and
smaller than those of the prior art, and, therefore, more easily
implanted subcutaneously. Another object of the present invention
is to provide an injection port and an implantable pump, which are
more versatile than those of the prior art. A further object of the
present invention is to provide an injection port and an
implantable pump that are easy and cheap to manufacture. Yet
another object of the present invention is to provide surgical
methods by using an injection port.
[0004] Accordingly, in accordance with a first aspect of the
present invention, there is provided an injection port for adding
fluid to, or withdrawing fluid from, a surgical implant inside a
human body, the injection port comprising a rigid base member, and
an injection membrane attached to the base member, the membrane and
the base member defining a chamber for fluid, wherein the membrane
includes a first layer and a second layer attached to each other,
the first layer having better strength properties than the second
layer and the second layer having better sealing properties than
the first layer.
[0005] As a result, the thickness of the membrane may even be
halved in comparison to the membrane used in prior injection ports.
For example, the thickness of the membrane of the injection port of
the present invention may be as small as about 3 mm. Furthermore,
if the membrane is designed with a shorter diameter, it can be even
thinner. Thus, since the thickness of the membrane can be
substantially decreased in comparison to prior art, the injection
port of the present invention can also be designed to be small and
thin.
[0006] Another advantage obtained by the injection port of the
present invention is that it also works as a small pump, which can
be manually operated.
[0007] The membrane layers of the present invention may be made of
silicone, wherein the first silicone layer is harder than the
second silicone layer. The second layer silicone suitably has a
hardness less than 20 Shore. Generally, the second layer is
situated between the first layer and the chamber of the injection
port. Alternatively, the membrane may comprise a third layer harder
than the second layer, wherein the third layer is situated between
the second layer and the chamber.
[0008] The membrane is suitably displaceable, preferably manually,
relative to the base member between a first position, in which the
volume of the chamber is maximal, and a second position, in which
the volume of the chamber is minimal. The membrane is preferably
elastic and may take the shape of a semi-sphere, when it is in the
first position. Accordingly, when the membrane is displaced to the
second position it is substantially flattened and in a state of
tension.
[0009] The injection port may further comprise a locking device
adapted to releaseably lock the membrane in the second position.
Thus, the membrane may be displaced from the first position to the
second position by manually depressing the membrane. Moreover, the
locking device can be adapted to release the membrane from the
second position upon pushing the membrane, whereby the membrane
resumes its semi-spherical shape in the first position.
[0010] In accordance with a second aspect of the present invention,
there is provided an implantable pump for pumping fluid to and from
a surgical implant inside a human body, comprising a rigid base
member, and an injection membrane penetrable by an injection needle
and attached to the base member, the membrane and the base member
defining a chamber for fluid, wherein the membrane is displaceable
relative the base member between a first position, in which the
volume of the chamber is maximal, and a second position, in which
the volume of the chamber is minimal, whereby the amount of fluid
that is to be pumped between the chamber and the surgical implant
can be calibrated by inserting an injection needle through the
injection membrane and adding fluid to or withdrawing fluid from
the chamber.
[0011] The injection membrane of the implantable pump may be
designed as the membrane discussed above in connection with the
injection port of the invention
[0012] In accordance with a third aspect of the present invention,
there is provided a method for hydraulically operating a surgical
implant implanted in a patient, the method comprising:
subcutaneously implanting in the patient an injection port having a
displaceable injection membrane for changing the volume of a fluid
chamber in the injection port; hydraulically connecting the
injection port to the surgical implant; calibrating the amount of
fluid in the fluid chamber of the injection port by penetrating the
patient's skin and the membrane of the injection port with an
injection needle and adding fluid to or withdrawing fluid from the
fluid chamber; and from time to time, manually displacing the
membrane of the subcutaneously implanted injection port, in order
to distribute fluid between the fluid chamber of the injection port
and the implant to operate the implant.
[0013] In accordance with a fourth aspect of the present invention,
there is provided a surgical method for treating a patient having a
disease, comprising the steps of: insufflating the patient's
abdomen with gas; placing at least two laparoscopical trocars in
the human's body; inserting at least one dissecting tool through
the trocars and dissecting a region of the patient; implanting an
implant designed for treating reflux disease, urinary incontinence,
impotence, anal incontinence or obesity, in the dissected area by
using surgical instruments through the trocars; subcutaneously
implanting in the patient an injection port having a displaceable
injection membrane for changing the volume of a fluid chamber in
the injection port; hydraulically connecting the injection port to
the surgical implant; calibrating the amount of fluid in the fluid
chamber of the injection port by penetrating the patient's skin and
the membrane of the injection port with an injection needle and
adding fluid to or withdrawing fluid from the fluid chamber; and
from time to time, manually displacing the membrane of the
subcutaneously implanted injection port, in order to distribute
fluid between the fluid chamber of the injection port and the
implant to operate the implant.
[0014] The above described apparatuses and methods may also be
designed for treating reflux disease, urine incontinence,
impotence, anal incontinence or obesity or the like.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] A preferred embodiment of the present invention will now be
described by way of example, with reference to the attached
drawings, by no way restricting the present invention thereto,
wherein
[0016] FIG. 1 shows an injection port according to the prior
art.
[0017] FIG. 2 illustrates an injection port according to the
present invention, where a needle has been injected through the
membrane.
[0018] FIG. 3 shows the injection port of FIG. 2 working as a hand
driven pump.
[0019] FIG. 4 shows the injection port of FIG. 2 working as a hand
driven pump, where the membrane is in its lowest position.
[0020] FIG. 5 is a schematic view of an implantable hydraulic
restriction device for use together with the injection port of the
invention, designed for treating reflux disease, urine
incontinence, anal incontinence or obesity.
DETAILED DESCRIPTION OF THE INVENTION
[0021] FIG. 1 shows a traditional injection port 1 according to the
prior art, which has a housing 2 mounted on a base 3 and a membrane
4 made of solid silicone covering an opening in housing 2.
Typically, the silicone used to make membrane 4 has a hardness of
60 Shore or more. The thickness of membrane 4 is normally about 6
mm for a normal-sized injection port.
[0022] FIG. 2 shows an injection port 10 according to the present
invention, where a needle 12 of a syringe 14 has been injected
through a membrane 16 attached to a rigid base member 18 of the
injection port 10. According to the embodiment shown in FIG. 2,
membrane 16 has a semi-spherical shape in its initial,
"non-depressed" position, as shown in FIG. 2. In the embodiment
shown in FIGS. 2-4, membrane 16 is comprised of three layers
attached to each other: a first hard layer 20 having preferably a
hardness of more than 20 Shore; a second soft central layer 22
having a hardness of less than 20 Shore; and a third hard layer 24,
having a hardness suitably more than 20 Shore, but preferably about
60 Shore or more. Membrane 16 and base member 18 define a chamber
25 for fluid. However, in the most general embodiment of the
injection port of the present invention, it is sufficient if
membrane 16 comprises two layers, i.e., one first hard layer and
one second soft layer between chamber 25 and first layer 20. First
layer 20 has better strength properties than second layer 22, and
second layer 22 has better sealing properties than first layer 20.
Membrane 16's layers are suitably made of plastic or silicone, and
preferably of silicone. Suitable silicon materials are manufactured
by "Applied Silicone, Inc."
[0023] FIGS. 3 and 4 show injection port 10 of FIG. 2 working as a
hand driven pump. By using a core for membrane 16 that is very
soft, i.e., elastic silicone material of less than 20 shore, it is
possible to create a thinner and more elastic membrane that could
be pumped by hand and still not cause leakage when a needle 12 of a
syringe 14 penetrates the membrane. FIG. 3 illustrates a finger 26
pushing (actuated by one push) membrane 16 in a direction 28 from
above. Membrane 16 will then be substantially flattened, such that
the surface that is faced against the finger 26 will assume a
somewhat concave bowl-shape 30. Membrane 16 is then moved to a
lowest position, as shown in FIG. 4, where it is held by a locking
device 32 until it is manually pressed again. When membrane 16 is
actuated again, by a second push by the finger 26, the locking
device 32 (which functions similar to the locking mechanism for a
ballpoint pen) releases membrane 16, whereby membrane 16 is able to
return to its regular convex-shaped condition as shown in FIG.
2.
[0024] FIG. 5 shows an example of an implantable hydraulic
restriction device 41 comprising a band 40 formed into a loop
around a patient's rectum (not shown), so that restriction device
41 may function as an artificial sphincter. Band 40 includes a
cavity 42, which can be hydraulically connected to an injection
port 10 of the invention. By using injection port 10, hydraulic
fluid may be supplied to band 40 to inflate cavity 42, in order to
close the rectum, and be withdrawn from the band 40 to deflate the
cavity 42, to open the rectum. This type of restriction device,
when combined with injection port 10 of the present invention, may
also be used as an artificial sphincter for treating patients
suffering from heartburn and reflux disease or urinary
incontinence. Restriction device 41 may also be combined with
injection port 10 for the purpose of forming an adjustable
constricted stoma opening in the stomach or esophagus of an obese
patient to treat obesity or for restricting the penile exit blood
flow of an impotent patient.
[0025] According to the method of using injection port 10 to treat
various diseases, after injection port 10 is subcutaneously
implanted in the patient, displaceable injection membrane 16 is
used to pump fluid in fluid chamber 25 to surgical implanted
restriction device 41, which is hydraulically connected to
injection port 10. The amount of fluid in fluid chamber 25 capable
of being pumped to restriction device 41 using injection port 10 is
calibrated by penetrating the patient's skin and membrane 16 of
injection port 10 with injection needle 12 of syringe 14 to add or
withdraw fluid from chamber 25. Membrane 16 is manually displaced
from time to time to pump the fluid from chamber 25 of injection
port 10 to implant 41 to operate the implant.
[0026] To insert in a patient an implant-like hydraulic restriction
device 41, the patient's abdomen is insufflated with gas, after
which at least two laparoscopical trocars are placed in the
patient's body. At least one dissecting tool is then inserted
through the trocars to dissect a region of the patient to implant
in the dissected area using surgical instruments through the
trocars the particular implant that is designed for treating the
particular disease to be treated.
[0027] Although the present invention has been described in terms
of a particular embodiment and process, it is not intended that the
invention be limited to that embodiment. Modifications of the
embodiment and process within the spirit of the invention will be
apparent to those skilled in the art. The scope of the invention is
defined by the claims that follow.
* * * * *