U.S. patent application number 10/603587 was filed with the patent office on 2004-04-08 for device for protecting a cover, the use of a device for protecting a cover, a method of fitting a cover on a probe, and a method of making a device for protecting a cover.
Invention is credited to Hascoet, Gerard, Pechoux, Thierry.
Application Number | 20040068160 10/603587 |
Document ID | / |
Family ID | 9543303 |
Filed Date | 2004-04-08 |
United States Patent
Application |
20040068160 |
Kind Code |
A1 |
Hascoet, Gerard ; et
al. |
April 8, 2004 |
Device for protecting a cover, the use of a device for protecting a
cover, a method of fitting a cover on a probe, and a method of
making a device for protecting a cover
Abstract
The invention relates to a device for protecting a cover.
According to the invention, said cover is flexible and tubular in
shape being closed at one end and open at its other end, and said
cover is disposed at least in part inside a hollow tubular
protective element referred to as a protective tube, which element
is open at both ends. The device of the invention is particularly
suited for use in the medical field, in particular for covering,
preferably in sterile manner, a tool that is to be inserted in an
animal or a human being, in particular in a natural passage such as
the esophagus, the urethra, the rectum, or a blood vessel.
Inventors: |
Hascoet, Gerard; (Paris,
FR) ; Pechoux, Thierry; (Paris, FR) |
Correspondence
Address: |
Alan D. Miller
Amster, Rothstein & Ebenstein
90 Park Avenue
New York
NY
10016
US
|
Family ID: |
9543303 |
Appl. No.: |
10/603587 |
Filed: |
June 25, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10603587 |
Jun 25, 2003 |
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10021626 |
Dec 12, 2001 |
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6605034 |
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10021626 |
Dec 12, 2001 |
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09522516 |
Mar 10, 2000 |
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6350232 |
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Current U.S.
Class: |
600/124 |
Current CPC
Class: |
A61B 8/12 20130101; A61B
1/00144 20130101; A61B 8/06 20130101; A61B 1/00142 20130101 |
Class at
Publication: |
600/124 |
International
Class: |
A61B 001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 17, 1999 |
FR |
FR 99 03293 |
Claims
1/ A device for protecting a cover, the device comprising a hollow
tubular protective element which is open at both ends, referred to
as a protective tube, at least a portion of said cover being placed
inside the tube, the cover being flexible and in the form of a tube
that is closed at one end and open at its other end.
2/ A device according to claim 1, having means facilitating
insertion of the cover inside the protective tube.
3/ A device according to claim 2, wherein the means for
facilitating insertion comprise a flexible coupling mounted on that
one of the open ends of the protective tube which is adjacent to
the closed end of the cover, specifically so as to enable temporary
suction to be established in this region.
4/ A device according to claim 1, wherein the protective tube has a
plurality of means enabling localized regions to be established in
which the cover is not in contact with the inside wall of the
protective tube, and in particular internal ridges preferably
disposed substantially parallel to the longitudinal axis of the
protective tube.
5/ A device according to claim 4, wherein the ridges are
continuous, extending substantially from one end td the other of
the protective tube, thereby making it possible, for example, to
establish temporary suction between the cover and the inside wall
of the tube.
6/ A device according to claim 1, wherein the cover is flexible and
is folded back over the protective tube at its end remote from the
closed end of the cover.
7/ A device according to claim 1, in which the protective tube has
an inside wall, and wherein the protective tube has means for
holding the cover substantially against the inside wall of the
protective tube, e.g. means comprising a rod of appropriate
diameter.
8/ A device according to claim 1, wherein the cover contains an
impedance-matching medium, and in particular a gel, for matching
impedance between the cover itself and a measuring element for
insertion at least temporarily inside the flexible cover.
9/ A device according to claim 8, wherein the impedance-matching
medium is an acoustic impedance-matching medium, thus enabling
soundwaves to be transmitted substantially without disturbance.
10/ A device according to claim 8, wherein the impedance-matching
medium is disposed substantially at the closed end of the cover,
said impedance-matching medium, such as a gel, preferably being
biocompatible, and better still being edible.
11/ A device according to claim 1, the device being sterilized, in
particular packaged in a sterilizable sealed package which is
advantageously transparent, at least in part.
12/ A device according to claim 1, wherein the cover is of a length
that is sufficient to cover the outside surface of an
intracorporeal probe, preferably an intracorporeal probe having an
ultrasound type measuring element, e.g. for measuring the speed or
flow rate of a flowing body fluid, such as blood.
13/ A device according to claim 1, wherein the cover is made of a
sterilizable flexible material such as silicone or a natural or
synthetic rubber such as SEBS.
14/ A method of fitting a cover on a probe, the cover having an
opening and being contained at least in part inside a tube, a
device according to claim 1 being provided, wherein: a) the
protective tube is coupled to a vacuum pump; b) a vacuum is
established inside the tube adjacent to the closed end of the cover
within a closed space as defined between the cover, the vacuum
pump, and the protective element; c) the rod is withdrawn while the
vacuum is maintained; d) the probe is inserted into the cover; e)
the vacuum is eliminated; and f) the assembly comprising the probe
with the cover mounted thereon is withdrawn.
15/ A method of fitting a cover on a probe that is to be inserted
in an animal or a human being, in particular in a natural passage
such as the esophagus, the urethra, the rectum, or a blood vessel,
said cover being optionally sterile, the cover having an opening
and being contained at least in part inside a tube, a device
according to claim 1 being provided, wherein: a) the protective
tube is coupled to a vacuum pump; b) a vacuum is established inside
the tube adjacent to the closed end of the cover within a closed
space as defined between the cover, the vacuum pump, and the
protective element; c) the rod is withdrawn while the vacuum is
maintained; d) the probe is inserted into the cover; e) the vacuum
is eliminated; and f) the assembly comprising the probe with the
cover mounted thereon is withdrawn.
16/ A method of making a device according to claim 1, wherein: g)
the cover is prepared by cutting a portion of flexible tube from a
reel on which the tube is wound, which portion serves to constitute
the cover, and by sealing one end of the portion by means of a hot
press; h) the cover is inserted in the tube by means of a rod, and
a few millimeters of the cover is folded back over the tube; i) a
predetermined quantity of an impedance-matching medium is inserted
inside the cover, and then the plug rod is inserted into the cover;
and j) the device prepared in this way and accompanied by a cutting
tool is packaged individually.
17/ A method according to claim 16, wherein suction is established
outside the cover prior to inserting the impedance-matching medium
and the plug rod into the cover, after which the suction is
eliminated.
Description
[0001] The present invention relates to a device for protecting a
cover, to the use of a device for protecting a cover, to a method
of fitting a cover on a probe, and to a method of making a device
for protecting a cover.
BACKGROUND OF THE INVENTION
[0002] Patent FR-A-2 695 999=U.S. Pat. No. 5,479,928 describes an
intracorporeal probe for accurately determining the speed of a
liquid medium, and in particular blood flow rate in the aorta.
Other intracorporeal probes are known in the medical field for
humans and for animals.
[0003] Such a probe must be subjected to a sterilization operation
prior to be used on a patient. Such sterilization is lengthy,
expensive, and difficult to implement. It is necessary to apply
sterilization agents which are expensive, and in particular
pharmaceuticals, conscientiously to the probe. Care must be taken
of the probe while it is being handled in this way since such a
probe is fragile and the sterilization agents can be harmful. In
addition, it is necessary to renew the sterilization operation on
each occasion that the probe is used, thereby increasing the risk
of damaging the probe.
[0004] It is also possible to use a cover to protect the patient
from the transmission of pathogens when such a probe is used.
However, such a cover is not easy to fit onto the probe, and in
addition care must be taken to ensure that the cover is
sterile.
OBJECTS AND SUMMARY OF THE INVENTION
[0005] The invention seeks to resolve these problems by proposing a
device for protecting a cover that enables the cover to be fitted
easily on the probe and that guarantees that the cover is sterile.
Thus, the invention guarantees hygiene for the patient during use
of the probe without it being necessary to sterilize the probe on
each use. The invention thus proposes a solution which is simple,
low cost, and easy to implement.
[0006] The invention also provides the use of a device for
protecting a cover, a method of fitting a cover on a probe, and a
method of making a device for protecting a cover.
[0007] The device of the invention for protecting a cover can
advantageously be employed when using the probe known under the
name "DYNEMO 3000", produced by SOMETEC.
[0008] More precisely, the invention provides a device for
protecting a cover, the device comprising a hollow tubular
protective element which is open at both ends, referred to as a
protective tube, at least a portion of said cover being placed
inside the tube, the cover being flexible and in the form of a tube
that is closed at one end and open at its other end.
[0009] Such a device makes it possible to use a probe without it
being necessary to sterilize said probe. In addition, the cover
that is used is easy to fit and to handle.
[0010] Preferably, the device has means facilitating insertion of
the cover inside the protective tube.
[0011] Advantageously, the means for facilitating insertion
comprise a flexible coupling mounted on that one of the open ends
of the protective tube which is adjacent to the closed end of the
cover, specifically so as to enable temporary suction to be
established in this region.
[0012] Preferably, the protective tube has a plurality of means
enabling localized regions to be established in which the cover is
not in contact with the inside wall of the protective tube, and in
particular internal ridges preferably disposed substantially
parallel to the longitudinal axis of the protective tube.
[0013] Advantageously, the ridges are continuous, extending
substantially from one end to the other of the protective tube,
thereby making it possible, for example, to establish temporary
suction between the cover and the inside wall of the tube.
[0014] Preferably, the cover is flexible and is folded back over
the protective tube at its end remote from the closed end of the
cover.
[0015] Advantageously, the device is made in such a way that the
protective tube has an inside wall, and the protective tube has
means for holding the cover substantially against the inside wall
of the protective tube, e.g. means comprising a rod of appropriate
diameter.
[0016] Preferably, the cover contains an impedance-matching medium,
and in particular a gel, for matching impedance between the cover
itself and a measuring element for insertion at least temporarily
inside the flexible cover.
[0017] Advantageously, said impedance-matching medium is an
acoustic impedance-matching medium, thus enabling soundwaves to be
transmitted substantially without disturbance.
[0018] Preferably, said impedance-matching medium is disposed
substantially at the closed end of the cover, said
impedance-matching medium, such as a gel, preferably being
biocompatible, and better still being edible.
[0019] Advantageously, the device is sterilized, in particular
packaged in a sterilizable sealed package which is advantageously
transparent, at least in part.
[0020] Preferably, the cover is of a length that is sufficient to
cover the outside surface of an intracorporeal probe, preferably an
intracorporeal probe having an ultrasound type measuring element,
e.g. for measuring the speed or flow rate of a flowing body fluid,
such as blood.
[0021] Advantageously, the cover is made of a sterilizable flexible
material such as silicone or a natural or synthetic rubber such as
SEBS.
[0022] The invention also provides the use of a device of the kind
described in the medical field in particular for covering,
preferably in sterile manner, a tool that is to be inserted in an
animal or a human being, in particular in a natural passage such as
the esophagus, the urethra, the rectum, or a blood vessel.
[0023] The invention also provides a method of fitting a cover on a
probe, the cover having one opening and being contained at least in
part inside a tube, a device of the kind described being provided,
said method comprising the following steps:
[0024] the protective tube is coupled to a vacuum pump;
[0025] a vacuum is established inside the tube adjacent to the
closed end of the cover within a closed space as defined between
the cover, the vacuum pump, and the protective element;
[0026] the rod is withdrawn while the vacuum is maintained;
[0027] the probe is inserted into the cover;
[0028] the vacuum is eliminated; and
[0029] the assembly comprising the probe with the cover mounted
thereon is withdrawn.
[0030] The invention also provides a method of making a device of
the kind described, in which method:
[0031] the cover is prepared by cutting a portion of flexible tube
from a reel on which the tube is wound, which portion serves to
constitute the cover, and by sealing one end of the portion by
means of a hot press;
[0032] the cover is inserted in the tube by means of a rod, and a
few millimeters of the cover is folded back over the tube;
[0033] a predetermined quantity of an impedance-matching medium is
inserted inside the cover, and then the plug rod is inserted into
the cover; and
[0034] the device prepared in this way and accompanied by a cutting
tool is packaged individually.
[0035] Advantageously, suction is established outside the cover
prior to inserting the impedance-matching medium and the plug rod
into the cover, after which the suction is eliminated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] Other characteristics and advantages of the invention appear
from the following description of an embodiment that is given by
way of non-limiting example and with reference to the accompanying
figures, in which:
[0037] FIG. 1 is a perspective view of a device for protecting a
cover in a package, showing how the device is presented to a user
of a probe;
[0038] FIG. 2 is a longitudinal section view of a device for
protecting a cover;
[0039] FIG. 2A is a cross-section of the protective tube on IIA-IIA
in FIG. 2;
[0040] FIG. 3 shows a step during which a vacuum is established by
a vacuum pump and the rod is withdrawn from the cover, as explained
below;
[0041] FIG. 4 is a view analogous to the preceding figure but in
which the rod has been fully withdrawn, and furthermore FIG. 4
shows the probe that is to be used;
[0042] FIG. 5 shows the probe inserted inside the cover;
[0043] FIG. 6 shows the probe covered by the cover and ready for
use; and
[0044] FIG. 7 shows the step of cutting open the cover after a
probe fitted with the cover has been used, for the purpose of
removing a used cover so that it can be discarded.
MORE DETAILED DESCRIPTION
[0045] A protective device 1 is described below. It comprises a
tube 2 (FIG. 2) also referred to as a protective element or as a
protective tube or as a vacuum chamber. The tube 2 is hollow and
open at both ends. On its inside surface it has four ridges 12
constituted by rectilinear projecting portions extending over the
entire length of the tube. The four ridges 12 are uniformly
distributed over the inside surface of the tube (FIG. 2A). The tube
2 is for single use and it is delivered sterile.
[0046] The tube 2 contains a flexible cover 4 that is substantially
tubular in shape, being closed at one end and open at the other
end. At its closed end, the cover 4 is completely covered by the
tube 2. At its open end, the cover 4 is folded back over the
outside surface of the tube 2. The ridges 12 are means for enabling
localized areas to be created where the cover 4 does not come into
contact with the inside wall of the tube 2, thereby enabling
suction to propagate, as described below. The diameter of the cover
4 is suitable for enabling it to fit substantially closely against
the inside surface of the tube 2. The cover 4 is designed to cover
a plunger 42 of a probe 40 (FIG. 6). The probe itself is known and
it is not described in detail herein. The probe 40 has a guide
endpiece 44 for guiding a cradle 48 carrying transducers suitable
for performing measurements. The length of the cover 4 is
sufficient to ensure that, in use, only the cover 4 comes into
contact with the patient. The cover 4 is delivered sterile and is
for single use only. The cover 4 protects the patient from any risk
of being contaminated by pathogens carried by the probe 40. The
cover 4 is automatically tested individually for leakproofing while
it is being put into place.
[0047] The cover 4 contains an impedance-matching medium, in
particular an acoustic gel 8 (FIG. 2) which is delivered sterile,
for single use, biocompatible, nontoxic, and better still edible,
so as to avoid any risk in the event of the cover 4 rupturing while
it is inside the patient. The acoustic gel 8 is placed in the
closed end of the cover 4. The acoustic gel 8 should never come
into contact with the patient. Its function is to ensure that
ultrasound signals from the probe 40 are transmitted well and with
little refraction relative to the tissues.
[0048] A plug rod 6 is engaged in the cover 4. The plug rod 6
projects beyond the tube 2. The plug rod 6 is constituted by a long
tube which is closed at its end engaged inside the cover 4 and open
at its other end. The plug rod 6 serves to keep the acoustic gel 8
at the end of the cover 4. The plug rod 6 also constitutes means
for keeping the cover 4 in place substantially in contact with the
tube, in particular during transport. The plug rod 6 is never in
contact with the patient, it is for single use only, and it is
delivered sterile.
[0049] A flexible silicone coupling 10, for single use only and
delivered sterile, is mounted on the tube 2 adjacent to the closed
end of the cover 4. As described below, the coupling 10 constitutes
means for facilitating insertion of the envelope 4 inside the tube
2. The coupling 10 never comes into contact with the patient. The
coupling 10 is of a shape suitable for establishing a leakproof and
flexible connection between the tube 2 and a hand pump 16 (FIG.
3).
[0050] The hand pump 16 is a conventional vacuum pump which is not
described in detail herein. It has a trigger 18 for establishing
suction when in the position shown in FIG. 4 and for releasing
suction when in the position shown in FIG. 5. It never comes into
contact with the patient nor does it come into contact with the
cover 4, so it is not subject to sterility constraints, however it
can be decontaminated in a solution of glutaraldehyde, if
necessary. The hand pump 16 is not for single use only and it is
not sterile.
[0051] A cutting tool 20 (FIG. 1) has a handle 22 of plastics
material, more precisely of polycarbonate, and a crescent-shape
blade 24 made of stainless metal. For safety reasons, it is
difficult to gain access to the cutting edge of the blade 24. A cap
26 protects access to the blade 24. The cutting tool 20 is for
single use only and it is delivered sterile.
[0052] The protective device 1 is delivered together with the
cutting tool 20 in a transparent package 30, as shown in FIG.
1.
[0053] The dimensions and the materials of the device are given
below by way of specific example.
[0054] The tube 2 is 610 millimeters long, has an inside diameter
of 9 millimeters, and an outside diameter of 10 millimeters. The
tube 2 is made of polycarbonate.
[0055] The cover 4 is 560 millimeters long, has an inside diameter
6.5 millimeters, and an outside diameter of 6.9 millimeters. The
cover 4 is made of styrene ethylene butadiene styrene (SEBS); i.e.
it is made of a thermoplastic elastomer.
[0056] The plug rod 6 is 610 millimeters long, has an inside
diameter of 5.4 millimeters, and an outside diameter of 7
millimeters. The plug rod 6 is made of polyethylene.
[0057] The acoustic gel 8 is sterile and edible. The cover 4
contains about one cubic millimeter thereof.
[0058] The coupling 10 is 25 millimeters long, has an inside
diameter of 6.5 millimeters, and an outside diameter of 12.5
millimeters. The coupling 10 is made of silicone.
[0059] The use of the device is described below. The user seeks to
fit the cover 4 on the probe 40.
[0060] To do this, the user begins by verifying that the package 30
is intact, puts on sterile gloves, and cuts open one end of the
package 30. The protective device 1 is taken carefully out of the
package 30. The hand pump 16 is connected to the coupling 10. The
user holds the protective device 1 in the vertical position taking
care to position the acoustic gel 8 at the bottom, and then
establishes a vacuum in a closed space 14 defined by the coupling
10, the hand pump 16, the cover 4, and the tube 2. The vacuum is
established by actuating the trigger 18 of the hand pump 16. A few
strokes of the hand pump should suffice. The cover 4 becomes
separate from the plug rod 6. The purpose of the ridges 12 is to
facilitate transmission of the vacuum between the cover 4 and the
inside of the tube 2. The function of the hand pump is thus to
establish a gaseous vacuum inside the space 14 so as to inflate the
cover 4, thereby enabling the plug rod 6 to be withdrawn and then
the probe 40 to be inserted, as explained below.
[0061] The user carefully withdraws the plug rod 6 by hand, so as
to avoid entraining the cover 4 or any acoustic gel 8 in this
operation (FIG. 3).
[0062] The user then verifies that the vacuum is still present,
thus ensuring that the cover 4 is leakproof (FIG. 4).
[0063] While keeping the tube 2 vertical, the user then inserts the
plunger 42 of the probe 40 until the end of the probe dips into the
acoustic gel 8, and then verifies that the guide endpiece 44 has
reached the end of the cover 4. At this point the user gently
releases the suction by acting on the trigger 18 of the hand pump
16 (FIG. 5). The end of the cover 4 which was initially folded down
over the outside surface of the tube 2 is then slid onto the
plunger 42 of the probe 40.
[0064] Thereafter the probe 40 covered in the cover 4 is withdrawn
from the tube 2. The user then checks that there are no bubbles
around the transducer cradle 48. The probe 40 covered in this way
by the cover 4 is then ready to be inserted in the patient (FIG. 6)
and must be handled with the usual precautions required when
handling a sterile object. Once the probe 40 has been put into
place, the user can take measurements.
[0065] Since the time required for fitting the cover is very short,
the user does not put the cover 4 into place on the probe 40 until
the last moment, immediately prior to use. For insertion via the
mouth, it is advantageous to use a spacer between the teeth (not
shown) so as to protect the probe 40 from being bitten. In
addition, such a spacer can be of assistance in stabilizing the
depth to which the probe 40 is introduced, with internal rotation
being performed by means of the plunger 42. The acoustic gel 8 also
enables the transducer cradle 48 to rotate properly without
twisting the cover 4.
[0066] While the probe 40 is being withdrawn from the patient, it
is preferable to withdraw the cover 4 together with the probe 40
itself. After the probe 40 fitted with the cover has been
withdrawn, the user rinses the entire cover abundantly with
antiseptic soap, while taking care not to wet the handle of the
probe 40.
[0067] The user takes the sterile cutting tool 20 from its package
and uses the blade 24 of the tool to slit open the cover 4,
starting from its open end (FIG. 7). The cover 4 is thus cut along
its entire length. The cover 4 is cut lengthwise so as to avoid
running any risk of damaging the probe 40.
[0068] The user removes the used and cut-open cover from the probe
40 and discards the cover 4. The user disposes of the acoustic gel
8 present on the plunger 42 and rinses the plunger 42 of the probe
40 abundantly in water so as to eliminate all traces of the
acoustic gel 8.
[0069] The method of making the protective device 1 is described
below. To implement this method, the following items are used: a
syringe having a capacity of 50 cubic centimeters with a diameter
of 2 millimeters and a cannula having a length of 600 millimeters;
a polyethylene rod having a diameter of 4 millimeters and a length
of 650 millimeters; a hot press; and a vacuum pump; these items are
not shown.
[0070] Initially the cover 4 is prepared and inserted inside the
tube 2.
[0071] To do this, a reel is available having 500 meters to 1000
meters of flexible tube wound thereon, which tube is used to make
the cover. The tube is cut into portions that are 560 millimeters
long. One end of each portion is sealed by means of the hot press.
This makes the cover 4.
[0072] To make the coupling 10, a rolled-up hose is cut into
portions that are each 25 millimeters long. Thereafter, the
coupling 10 is inserted on the tube 2.
[0073] The polyethylene rod is used to insert the cover 4 inside
the tube 2 and the cover 4 is folded back onto the tube 2 over
about 4 millimeters.
[0074] Thereafter the acoustic gel 8 is inserted inside the cover
4. To do this, the syringe is filled with acoustic gel 8 while
ensuring that no bubbles form. Bubbles of air are eliminated via
the cannula. The vacuum pump is connected to the coupling 10.
Suction is established. Then about 1 cubic millimeter of acoustic
gel 8 is inserted in the inflated cover 4. Thereafter the plug, rod
6 is inserted above the acoustic gel 8. Suction is eliminated. The
device prepared in this way is packaged individually, accompanied
by a cutting tool 20. A label is stuck on the package. A parcel of
five packages is made up and a second label is placed on the parcel
which is ready to be sold.
* * * * *