U.S. patent application number 16/767037 was filed with the patent office on 2021-02-04 for occlusive cuff and implantable occlusive system comprising such a cuff.
The applicant listed for this patent is UROMEMS. Invention is credited to Hamid LAMRAOUI, Christopher MASRI.
Application Number | 20210030522 16/767037 |
Document ID | / |
Family ID | 1000005196150 |
Filed Date | 2021-02-04 |
United States Patent
Application |
20210030522 |
Kind Code |
A1 |
LAMRAOUI; Hamid ; et
al. |
February 4, 2021 |
OCCLUSIVE CUFF AND IMPLANTABLE OCCLUSIVE SYSTEM COMPRISING SUCH A
CUFF
Abstract
The invention relates to an occlusive cuff (1) for selectively
occluding an anatomical duct (2), comprising: a band (10) suited to
surrounding said anatomical duct (2), provided with a closing
device suited to maintaining the band wound upon itself over a
determined length (L.sub.10), and an inflatable reservoir (11)
arranged on an inner face of the band (10), said cuff being
characterised in that the inflatable reservoir (11) extends over
only a part (L.sub.11) of the length (L.sub.10) of the band (10),
another part (L.sub.13) of said length (L.sub.10) defining a free
inner surface (13) of the band configured to form a bearing zone
for the anatomical duct, such that when the band (10) is maintained
wound upon itself by the closing device, the inflatable reservoir
(11) is opposite said free inner surface (13) of the band.
Inventors: |
LAMRAOUI; Hamid; (Grenoble,
FR) ; MASRI; Christopher; (Grenoble, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
UROMEMS |
Grenoble |
|
FR |
|
|
Family ID: |
1000005196150 |
Appl. No.: |
16/767037 |
Filed: |
November 27, 2018 |
PCT Filed: |
November 27, 2018 |
PCT NO: |
PCT/FR2018/052985 |
371 Date: |
May 26, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/004 20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 28, 2017 |
FR |
1761287 |
Claims
1. An occlusive cuff for selectively occluding an anatomical duct,
comprising: a band suited to surrounding said anatomical duct,
provided with a closing device suited to maintaining the band wound
upon itself over a determined length, and an inflatable reservoir
arranged on an inner face of the band, wherein the inflatable
reservoir extends over only a part of the length of the band,
another part of said length defining a free inner surface of the
band configured to form a bearing zone for the anatomical duct,
such that when the band is maintained wound upon itself by the
closing device, the inflatable reservoir is opposite said free
inner surface of the band.
2. The cuff of claim 1, wherein the length of the reservoir is
chosen such that when the band is wound upon itself around the
anatomical duct and when the reservoir is inflated, the anatomical
duct is compressed between the wall of the reservoir and the free
surface of the band, the reservoir exerting a push force of the
anatomical duct against said free surface of the band.
3. The cuff of claim 1, wherein the inflatable reservoir and the
free inner surface of the band are configured to be in direct
contact with the anatomical duct when the band is wound around said
anatomical duct.
4. The cuff of claim 1, wherein the inflatable reservoir extends
over a length less than or equal to 75% of the length of the
band.
5. The cuff of claim 1, wherein the length of the band is comprised
between 30 and 110 mm, preferably between 70 and 110 mm.
6. The cuff of claim 1, wherein the band is formed of a textile
coated with a biocompatible elastomer.
7. The cuff of claim 1, wherein the reservoir is made of a
biocompatible elastomer.
8. The cuff of claim 6, wherein said biocompatible elastomer is
silicone.
9. The cuff of claim 1, further comprising a connector arranged at
one end of the band to ensure a fluid connection between the
reservoir and a tubing.
10. The cuff of claim 9, wherein the closing device comprises an
opening formed at one end of the band and able to engage around the
connector to maintain the band wound upon itself.
11. The cuff of claim 1, wherein the closing device comprises a
surface provided with teeth at one end of the band and an
attachment device comprising a slot for the insertion of said end,
configured to block the teeth against an extraction force of said
end.
12. The cuff of claim 11, wherein the teeth are arranged on the
outer face of the band.
13. An implantable occlusive system comprising an implantable
housing comprising a pump, and an occlusive cuff according to claim
1, in fluid connection with the pump to vary the volume of fluid in
the inflatable reservoir.
14. The system of claim 13, consisting of an artificial urinary
sphincter.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to an occlusive cuff intended
to selectively occlude an anatomical duct, such as a urethra or a
bladder neck, as well as an implantable occlusive system comprising
such a cuff.
PRIOR ART
[0002] Implantable occlusive systems exist intended to selectively
occlude an anatomical duct, for example to remedy incontinence
(case of artificial urinary or anal sphincters) or to limit intake
of food into the stomach (case of gastric bands). The occlusion of
the anatomical duct is brought about by the compression exerted by
a cuff wound around said duct.
[0003] Among cuffs, the present text focuses on those based on
fluid technology (the cuff comprising an inflatable reservoir
coupled to a fluid circuit making it possible to fill or to empty
selectively said reservoir, depending on the compression to exert
on the anatomical duct).
[0004] Among occlusive systems, some are manual, that is to say
that it is a user (for example the patient himself) who controls
the compression applied by the cuff. Other systems are automatic,
that is to say that they comprise one or more sensors, an actuator
and a control unit for controlling the actuator to impose a
determined compression of the anatomical duct by the cuff, without
any intervention of a user being necessary.
[0005] The document WO 2016/083428 describes an automatic
implantable occlusive system. This system comprises a fluid circuit
comprising: [0006] an inflatable occlusive cuff containing a
variable volume of fluid, intended to surround at least a part of a
natural duct to occlude, [0007] a recipient of variable volume
filled with a fluid, said recipient comprising a fixed part and a
movable part, [0008] a fluid connection between the recipient and
the occlusive cuff.
[0009] Furthermore, this system comprises an actuator mechanically
coupled with the movable part of the recipient so as to displace
said movable part linearly with respect to the fixed part to adjust
the volume of the recipient.
[0010] The actuator and the recipient of variable volume are
arranged in a leak tight housing containing a gas.
[0011] FIGS. 1A and 1B are views of an occlusive cuff 1' that can
be used in this system, respectively in the free state (before
implantation), and once implanted around the anatomical duct 2 to
occlude.
[0012] Said cuff comprises a band 10 suited to surrounding said
anatomical duct, and an inflatable reservoir 11' arranged on one
face of the band 10, substantially over the entire length thereof.
The inflatable reservoir 11 comprises at one of its ends a
connector 12 making it possible to ensure a fluid connection
between the inside of the reservoir 11 and a tubing 3 connected to
the recipient.
[0013] At its end opposite to said connector 12, the band has an
oblong opening 14, which is intended to be engaged on the connector
12 in order to maintain the cuff in position wound around the
anatomical duct 2.
[0014] In the present text, "length" of the cuff is taken to mean
the inner circumference of the cuff when said cuff is in its closed
position. This length is noted L.sub.10 in FIG. 2A. Depending on
the closing device of the cuff, this length is thus generally less
than the total length of the band.
[0015] Cuffs of different lengths exist, depending on the targeted
applications and patients.
[0016] The length of the occlusive cuff is chosen by the surgeon,
as a function of the circumference of the anatomical duct at the
location planned for the cuff.
[0017] In the case of artificial urinary sphincters, the cuff is
generally implanted in women around the bladder neck, which has a
large circumference. Typically, the length of the cuff for such an
application is of the order to ten or so centimetres.
[0018] However, the use of a cuff of this dimension poses a certain
number of problems for the implantation of the system and the
operation thereof.
[0019] A first drawback of such a cuff is its bulkiness. Yet, the
implantation of such a cuff around the bladder neck of women is
awkward because there is little space around the bladder neck to
insert the cuff. Moreover, the location of the cuff is very close
to the vaginal wall, which the surgeon must take care not to
perforate during the implantation.
[0020] On the one hand, the volume of the cuff being important, the
fluid recipient must be dimensioned as a consequence to provide
sufficient compression of the anatomical duct by the cuff. This
implies an increase in the bulkiness of the housing containing said
recipient.
[0021] Furthermore, the variation in volume of the recipient, which
is implemented with a considerable amplitude, also leads to a
reduction in the autonomy of the energy source which supplies the
actuator, when said actuator is also arranged in the housing.
[0022] Consequently, the use of a cuff of large dimension implies
at one and the same time great complexity of the implantation
operation, an increase in the volume of the implantable housing and
a decrease in the autonomy of the system.
DESCRIPTION OF THE INVENTION
[0023] An aim of the invention is thus to design an occlusive cuff
that can be easily implanted around an anatomical duct having a
large circumference, without causing the aforementioned
problems.
[0024] To this end, the invention proposes an occlusive cuff for
selectively occluding an anatomical duct, comprising: [0025] a band
suited to surrounding said anatomical duct, provided with a closing
device suited to maintaining the band wound upon itself over a
determined length, and [0026] an inflatable reservoir arranged on
an inner face of the band.
[0027] Said cuff is characterised in that the inflatable reservoir
extends over only a part of the length of the band, another part of
said length defining a free inner surface of the band configured to
form a bearing zone for the anatomical duct, such that when the
band is maintained wound upon itself by the closing device, the
inflatable reservoir is opposite said free inner surface of the
band.
[0028] In accordance with its common meaning, the term "free"
signifies in the present text that the inner surface of the band
does not support any additional element, which could be capable of
being interposed between the band and the anatomical duct.
[0029] In the present text, the term "inner" designates the face of
the cuff which, when the cuff is in closed position, is intended to
come into direct contact with the anatomical duct. The term "outer"
designates the opposite face.
[0030] In a particularly advantageous manner, the length of the
reservoir is chosen such that when the band is wound upon itself
around the anatomical duct and when the reservoir is inflated, the
anatomical duct is compressed between the wall of the reservoir and
the free surface of the band, the reservoir exerting a push force
of the anatomical duct against said free surface of the band.
[0031] The inflatable reservoir preferably extends over a length
less than or equal to 75% of the length of the band.
[0032] The length of the band may be comprised between 30 and 110
mm, preferably between 70 and 110 mm.
[0033] According to an embodiment, the band is formed of a textile
coated with a biocompatible elastomer. The inflatable reservoir may
be made of a biocompatible elastomer. According to an embodiment,
said biocompatible elastomer is silicone.
[0034] Advantageously, the cuff further comprises a connector
arranged at one end of the band to ensure a fluid connection
between the reservoir and a tubing.
[0035] According to an embodiment, the closing device comprises an
opening formed at one end of the band and able to engage around the
connector to maintain the band wound upon itself.
[0036] Alternatively, the closing device comprises a surface
provided with teeth at one end of the band and an attachment device
comprising a slot for the insertion of said end, configured to
block the teeth against an extraction force of said end.
Preferably, these teeth are arranged on the outer face of the
band.
[0037] The invention also relates to an implantable occlusive
system comprising a cuff such as described above and an implantable
housing comprising a pump in fluid connection with the cuff to vary
the volume of fluid in the inflatable reservoir.
[0038] According to a particular application of the invention, the
occlusive system is an artificial urinary sphincter.
DESCRIPTION OF THE FIGURES
[0039] Other characteristics and advantages of the invention will
become clear from the detailed description that follows, with
reference to the appended drawings among which:
[0040] FIG. 1A is a schematic view of an occlusive cuff of known
type, such as supplied to the surgeon with a view to
implantation;
[0041] FIG. 1B is a schematic view of the cuff of FIG. 1A, after
implantation around the anatomical duct (represented as not
exerting any compression on said duct);
[0042] FIG. 2A is a schematic view of an occlusive cuff according
to an embodiment of the invention, such as supplied to the surgeon
with a view to implantation;
[0043] FIG. 2B a schematic view of the cuff of FIG. 2A, after
implantation around the anatomical duct (represented as not
exerting any compression on said duct);
[0044] FIG. 2C is a schematic view of the cuff of FIG. 2A, after
implantation around the anatomical duct, in configuration of
obturation of said duct;
[0045] FIG. 3 illustrates an alternative of the system for closing
the occlusive cuff;
[0046] FIG. 4A illustrates a simulation by finite elements of the
compressive stress generated in a bladder neck by the compression
exerted by a cuff such as illustrated in FIG. 1A;
[0047] FIG. 4B illustrates a simulation by finite elements of the
compressive stress generated in the bladder neck by the compression
exerted by a cuff according to an embodiment of the invention;
[0048] FIG. 5 illustrates an implantable occlusive system
comprising a cuff according to an embodiment of the invention.
[0049] Identical reference signs from one figure to the other
designate elements that are identical or at least fulfil the same
function.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0050] Compared to known occlusive cuffs, the invention proposes
reducing the length of the inflatable reservoir.
[0051] FIGS. 2A-2C schematically illustrate a cuff 1 according to
an embodiment of the invention, respectively in the free state, in
the closed state without exerting compression on the duct and in a
configuration of occlusion of said duct.
[0052] The inflatable reservoir 11 extends over less than 75% of
the length L.sub.10 of the band, preferably less than 60% of the
length of the band, and in an even more preferred manner less than
50% of the length of the band. The length of the inflatable
reservoir is noted L.sub.11.
[0053] Thus, for example, for a cuff 10 cm long, the length of the
inflatable reservoir is 4.5 cm.
[0054] In other words, the inner face of the band 10 is broken down
into a region of length L.sub.11 on which is arranged the reservoir
11, and a region of length L.sub.13 which forms a free surface,
that is to say devoid of reservoir, and which constitutes a bearing
zone for the anatomical duct.
[0055] When the cuff is in closed position, the wall of the
reservoir 11 thus lies facing the free surface 13 of the band (the
anatomical duct 2 being interposed between these two surfaces, as
shown in FIG. 2B).
[0056] To the contrary, in a cuff of known type such as represented
in FIGS. 1A and 1B, the two ends of the reservoir are flush when
the cuff is closed. Even if a slight play may subsist between these
two ends, notably to take account of the variation in volume of the
reservoir when it is inflated, the corresponding zone of the band
does not constitute a bearing zone for the anatomical duct.
[0057] Returning to the invention, when the reservoir 11 is
inflated, it pushes the anatomical duct against the free surface 13
of the band, thus progressively occluding the duct (cf. FIG. 2C).
Thus, the anatomical duct is compressed between, on the one hand,
the reservoir 11 and, on the other hand, the free surface 13.
[0058] Advantageously, a panoply of cuffs of different lengths is
made available to the surgeon, from which the surgeon will chose
the most suitable for the patient and for the location planned for
the implantation. In this panoply, the length of the band is
generally comprised between 3 and 11 cm.
[0059] For cuffs of small length (that is to say typically less
than 7 cm), the inflatable reservoir may be arranged over the
entire length of the cuff.
[0060] From a certain length of cuff (for example 7 cm), the length
of the inflatable reservoir may be fixed (for example of the order
of 4.5 cm). Thus, it is possible to use the same pump for all cuff
dimensions, which avoids multiplying the housing references.
[0061] Such a cuff may be manufactured in the following manner.
[0062] On the one hand, the band is formed of a textile coated with
a biocompatible elastomer. Advantageously, the textile is a
biocompatible polyester fabric, known notably by the name of
DACRON.TM. and the elastomer is silicone. The band may be cut, for
example by water jet, from a sheet of large dimensions. The band
thus formed has the advantage of being smooth, of not setting into
the anatomical tissues (thus allowing potential explantation of the
cuff) and of not being stretchable.
[0063] On the other hand, the reservoir is made of a biocompatible
elastomer, for example silicone, preferably by dipping so as to
ensure a perfectly smooth surface state in order to ensure a
flexible contact with the anatomical duct.
[0064] The reservoir is bonded onto the band.
[0065] The connector is for its part moulded and bonded onto the
face of the band opposite to the reservoir while passing through
said band to ensure a fluid connection between the reservoir and
the tubing which is sleeved on the connector.
[0066] According to an embodiment, illustrated in FIG. 2A, the
closing device of the cuff 1 comprises an oblong opening 14
intended to engage on the connector 12.
[0067] According to another embodiment, illustrated in FIG. 3, the
band has at a first end a plurality of teeth 15 and at its other
end, preferably at the level of the connector 12, an attachment
device 16 comprising a slot suited to enabling the insertion of the
first end and provided with a retaining system only allowing a
displacement of the band 10 in the direction of the insertion (the
teeth opposing a traction movement aiming to make the band come out
of the slot). Advantageously, the teeth 15 lie on the outer face of
the band 10, in order not to risk eroding the compressed part of
the duct. The teeth may form an integral part of the band or be
manufactured by moulding then bonded onto the band.
[0068] Naturally, those skilled in the art could choose any other
closing device without however going beyond the scope of the
present invention.
[0069] The reduction in the length of the inflatable reservoir has
three main advantageous effects.
[0070] A first effect is a decrease in the bulkiness of the cuff,
which facilitates its implantation in zones where the available
space is limited. In the deflated state prior to implantation, the
cuff is in the form of a band having a small thickness, which can
thus be inserted relatively easily into the zone dissected around
the bladder neck, unlike the cuff described in the document WO
2013/165563, which uses the cooperation of an anvil integral with
the inner surface of the band and a hammer integral with the
reservoir to compress the anatomical duct. The anvil and hammer
being relatively rigid, they have a non-negligible bulkiness in the
implantation zone. Conversely, in the present invention, as is
clearly shown in FIGS. 2B and 2C, when the cuff is implanted around
the anatomical duct, said duct is in direct contact with the
reservoir 11 and with the free surface 13 of the band which are
flexible parts, which makes it possible to minimise the thickness
of the cuff and reduce the risk of erosion of body tissues.
[0071] A second advantageous effect of the invention is a reduction
in the volume of fluid necessary to swell the reservoir in order to
occlude the anatomical duct.
[0072] Consequently, the volume of the recipient of variable volume
contained in the housing remains limited, and the autonomy of the
energy source is not penalised.
[0073] A third effect is a modification of the mode of action of
the cuff on the anatomical duct.
[0074] FIG. 4A shows the result of a simulation by finite elements
of the compressive stresses applied to the bladder neck by a cuff
according to the prior art, such as illustrated in FIG. 1A, for a
fluid pressure in the cuff of 120 cm H.sub.2O. It may be observed
that the curvature of the cuff combined with a swelling of the
reservoir has the effect of dividing the reservoir 11' into four
pockets which each extend over around one quarter of the inner
circumference of the cuff. Yet, the bladder neck is pinched between
two adjacent pockets, and is subjected, in these pinch zones P, to
local mechanical stresses well above the stresses to which the
remainder of the neck is subjected. These localised stresses are
liable to damage the bladder neck, for example atrophying it.
[0075] In FIGS. 4A and 4B, the stress levels represented by dark
colours correspond to high stresses on the colour scale shown on
the right of each simulation.
[0076] FIG. 4B shows the result of a simulation by finite elements
of the compressive stresses applied to the bladder neck by a cuff
according to an embodiment of the invention, such as illustrated in
FIG. 2A, for a fluid pressure in the cuff of 120 cm H.sub.2O. It
may be observed that the reduction in the length of the inflatable
reservoir 11 has the effect of eliminating the pinch zones of the
bladder neck, and consequently eliminating the excess stresses
undergone locally by the bladder neck. The bladder neck is thus
less likely to be damaged.
[0077] FIG. 5 illustrates an implantable occlusive system
comprising an implantable housing comprising a pump, and an
occlusive cuff such as described above, in fluid connection with
the pump. The pump is advantageously one of the devices described
in the document WO 2016/083428.
[0078] The housing 4 contains the recipient of variable volume, the
actuator as well as said electronic module(s) and, if need be, the
energy source. The housing contains a gas, for example air. Said
housing must be leak tight to avoid any transfer of fluid or gas
from or to the intracorporal medium. The housing is made of a
biocompatible material and may for example be made of implantable
titanium and sealed by laser welding. A control of the leak
tightness may notably be carried out with helium (for example,
leakage rate less than 10.sup.-9 mbarl/s of helium) to ensure the
total leak tightness of the housing for the period for which the
system is implanted.
[0079] The recipient of variable volume is connected to the cuff 1
by the tubing 3.
[0080] Advantageously, the housing comprises, in a wall delimiting
the recipient of variable volume, a puncture port 5 perforable by a
needle and able to close in a leak tight manner after removal of
the needle, making it possible to inject or to remove fluid from
the recipient.
REFERENCES
[0081] WO 2016/083428 [0082] WO 2013/165563
* * * * *