U.S. patent application number 12/352826 was filed with the patent office on 2009-05-14 for device for packaging and folding a flexible material part, in particular a parietal reinforcement.
This patent application is currently assigned to Sofradim Production. Invention is credited to Pierre Bailly, Bernard Detruit, Michel Therin.
Application Number | 20090120037 12/352826 |
Document ID | / |
Family ID | 8869446 |
Filed Date | 2009-05-14 |
United States Patent
Application |
20090120037 |
Kind Code |
A1 |
Detruit; Bernard ; et
al. |
May 14, 2009 |
DEVICE FOR PACKAGING AND FOLDING A FLEXIBLE MATERIAL PART, IN
PARTICULAR A PARIETAL REINFORCEMENT
Abstract
The invention concerns a device comprising: a packaging box for
the flexible material part, dimensioned to hold said part flat;
folding means for folding said part without direct handling, and a
reception tube for receiving said folded flexible material part.
The invention is characterized in that the reception tube is not
longitudinally slit, and the folding means comprise; a traction
suture connected to the flexible material part, which passes
through the tube, and, walls forming a funnel whereof the base
emerges proximate to the opening of the tube through which the
flexible material part is designed to be inserted into said tube,
said funnel being designed, when a traction is exerted on the
traction suture, to gradually fold down the zones of the part
located laterally relative to the tube towards the zone of the part
located opposite the opening of said tube, to enable the part to be
inserted into the tube.
Inventors: |
Detruit; Bernard;
(Saint-Cloud, FR) ; Therin; Michel; (Lyon, FR)
; Bailly; Pierre; (Caluire, FR) |
Correspondence
Address: |
CARTER, DELUCA, FARRELL & SCHMIDT, LLP
445 BROAD HOLLOW ROAD, SUITE 420
MELVILLE
NY
11747
US
|
Assignee: |
Sofradim Production
Trevoux
FR
|
Family ID: |
8869446 |
Appl. No.: |
12/352826 |
Filed: |
January 13, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11824628 |
Jul 2, 2007 |
7475776 |
|
|
12352826 |
|
|
|
|
10491715 |
Apr 10, 2004 |
7243791 |
|
|
PCT/FR02/03826 |
Nov 7, 2002 |
|
|
|
11824628 |
|
|
|
|
Current U.S.
Class: |
53/167 |
Current CPC
Class: |
A61F 2/0063 20130101;
A61F 2/0095 20130101 |
Class at
Publication: |
53/167 |
International
Class: |
B65B 61/00 20060101
B65B061/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 15, 2001 |
FR |
FR 01/014804 |
Claims
1-36. (canceled)
37. A package for a flexible material, comprising: a base adapted
to receive a flexible material in an unfolded configuration; a
tubular member having a proximal opening, a distal opening and a
lumen extending therethrough, the lumen being configured to receive
the flexible material in a folded configuration, said tubular
member being disposed in a tray; and a folding mechanism formed in
the tray, the folding mechanism configured to fold the flexible
material prior to introduction into the tubular member.
38. The package according to claim 37, further including: a suture
operatively connected to the flexible material; and wherein the
folding mechanism has a funnel configured to fold the flexible
material for passage of the flexible material into the tubular
member.
39. The package according to claim 38, wherein the funnel is
positioned adjacent to the distal opening of the tubular
member.
40. The package according to claim 37, further comprising a cover
such that said cover and tray combine to form a compartment for the
tubular member.
41. The package according to claim 37, further comprising a suture
disposed through the tubular member and extending through the
proximal opening thereof.
42. The package according to claim 37, wherein the tubular member
includes a proximal gas-tight valve.
43. The package according to claim 38, wherein the funnel comprises
at least two spaced apart walls defining a gap therebetween, the
gap configured to receive the flexible material.
44. The package according to claim 43, wherein the gap has a width
less than a width of the distal opening of the tubular member.
45. The package according to claim 43, wherein the at least two
spaced apart walls are formed by at least two side walls of at
least two cylindrical blocks connected to the base.
46. The package according to claim 37, wherein the tray comprises a
notch positioned substantially coaxial with a longitudinal axis
defined by the tubular member.
47. The package according to claim 46, wherein the notch of the
tray is substantially shaped as an inverted "V."
48. The package according to claim 37, further comprising a lid
covering the base.
49. The package according to claim 37, wherein tray is formed of a
thermoformed synthetic material.
50. A package for a flexible material, comprising: a base adapted
to receive a flexible material in an unfolded configuration; a
tubular member having a proximal opening, a distal opening and a
lumen extending therethrough, the lumen being configured to receive
the flexible material in a folded configuration, said tubular
member being disposed in a tray; and a means for folding the
flexible material before introduction into the tubular member,
wherein the means for folding is formed in the tray.
51. The package according to claim 50, further including: a suture
operatively connected to the flexible material; and wherein the
means for folding includes a funnel configured to Told the flexible
material for passage of the flexible material into the tubular
member.
52. The package according to claim 51, wherein the funnel is
positioned adjacent to the distal opening of the tubular
member.
53. The package according to claim 50, further comprising a cover
such that said cover and tray combine to form a compartment for the
tubular member.
54. The package according to claim 50, further comprising a suture
disposed through the tubular member and extending through the
proximal opening thereof.
55. A method comprising: receiving a package comprising a base
adapted to receive a flexible material in an unfolded
configuration; a tubular member having a lumen disposed in a tray,
the flexible material having a suture operatively connected thereto
and extending through the lumen; and a folding mechanism formed in
the tray, the folding mechanism configured to fold the flexible
material prior to introduction into the tubular member; and pulling
the suture to move the flexible material into contact with the
folding mechanism to introduce the flexible material into the lumen
of the tubular member in a folded configuration.
56. The method according to claim 55, further comprising the step
of placing the flexible material inside a patient by pulling the
suture to move the flexible material through the lumen of the
tubular member until the flexible material exits the tubular
member.
Description
[0001] The present invention relates to a device for packaging and
folding a flexible material part, especially a parietal
reinforcement.
[0002] Certain flexible material parts have to be stored flat in
their protective packagings in order to avoid any alteration of
their flat shape following prolonged folding or rolling up, in
particular the formation of creases, then, at the point of use,
have to be folded longitudinally or rolled up in such a way as to
have a compact cross-sectional shape.
[0003] This is particularly the case with a parietal reinforcement
designed to be fitted by means of a coelioscopy method. The
reinforcement must, in fact, be arranged flat in its packaging,
otherwise irreversible creases might be formed in its material,
subsequently preventing the reinforcement from being placed in
intimate contact with the wall to be treated, with a view to a cell
colonization. At the moment of its implantation, the reinforcement
must be folded for insertion into a trocar so as to be introduced
into the body of the patient through a small orifice.
[0004] According to an existing method, the reinforcement is simply
placed in a parallelepipedal box of suitable dimensions. This box
is opened at the moment of the fitting of the reinforcement and the
practitioner folds this reinforcement manually prior to inserting
it into a previously fitted trocar.
[0005] This method has the drawback of involving a handling of the
reinforcement and hence of generating a risk of its becoming
contaminated by the gloves of the practitioner. Moreover, the
reinforcement rubs against the wall of the trocar as it is inserted
into the latter, which likewise risks contamination of the
reinforcement if the wall of the trocar is contaminated.
[0006] French patent No. 94/12700 proposes inserting a traction
suture through the reinforcement, along a crenellated or wavy path.
Pulls on the ends of the suture allow a "concertina-type" folding
of the reinforcement to be achieved.
[0007] This method has the advantage of avoiding direct handling of
the reinforcement for achievement of the folding, of ensuring a
minimum bulk size of the reinforcement prior to introduction into
the trocar, and of producing a concertina-type folding, which
allows the reinforcement to be unfolded as it is extracted from the
trocar. On the other hand, this method still involves handlings of
the reinforcement at the moment of collection from its packaging
box and its introduction into the trocar. Nor does this method
eliminate the risk of contamination of the reinforcement by rubbing
against the wall of the trocar.
[0008] Another method likewise consists in equipping the packaging
box of the reinforcement with a roll-up key connected to one of the
edges of the reinforcement and with a longitudinally slit tube into
which the roll-up key is placed. At the moment of fitting of the
reinforcement, the key is rotated, enabling the reinforcement to be
rolled up and engaged in the slit tube. This slit tube is used to
introduce the reinforcement into the trocar.
[0009] This method has the advantage of eliminating all handling of
the reinforcement during folding and of protecting the
reinforcement from all contamination by rubbing against the wall of
the trocar. On the other hand, the slit in the tube has the
drawback of making the trocar non-impervious to gas when this tube
is engaged through the valve provided in the proximal end of the
trocar. The result is that, upon the insertion of this tube into
the trocar, there is an escape of the carbon dioxide used to raise
the abdominal wall of the patient in order to free the zone of
implantation of the reinforcement. The latter has therefore to be
introduced "blind", which is undoubtedly a constraint. The slit
tube, moreover, has a relatively large outer diameter, 12 mm in
size, resulting from the use of the roll-up key. This large
diameter entails the use of a trocar of corresponding inner
diameter, not always suited to the surgical conditions. In
addition, the reinforcement is rolled up upon itself, such that it
has to be fully released from the trocar in order to be able to be
opened out at the implantation site; this release is a marked
constraint as compared to a concertina-type folding as mentioned
above, which allows the reinforcement to be opened out as it is
extracted from the trocar.
[0010] The present invention aims to eliminate precisely these
drawbacks.
[0011] The device concerned comprises, in a manner which is known
per se: [0012] a packaging box for the flexible material part,
dimensioned so as to hold this part flat, [0013] folding means
allowing this part to be folded without direct handling, and [0014]
a receiving tube, designed to receive the flexible material part in
the folded state.
[0015] According to the invention, [0016] the receiving tube is not
longitudinally slit, and [0017] the folding means comprise: [0018]
a traction suture connected to the flexible material part, which
passes through the tube, and [0019] walls forming a funnel, the
base of which emerges close to the opening in the tube through
which the flexible material part is designed to be introduced into
this tube, this funnel being fit, when a traction is applied to the
traction suture, to progressively fold down those zones of the part
which are situated laterally relative to the tube toward that zone
of the part which is situated opposite the opening in this tube, to
allow the part admission to the tube.
[0020] The engagement of the flexible material part in the tube is
thus realized by simple traction on said traction suture, hence
without any direct contact or handling of this part. The
funnel-forming walls cause those zones of the part situated
laterally relative to the tube to be folded toward that zone of the
part which is situated opposite the opening in this tube and
therefore allow the achievement of a more or less "concertina-type"
folding-up of this part in this tube.
[0021] The packaging and folding device can be produced with
standard materials for a packaging, at very low cost price. It can
especially be produced by the assembly of parts made of
thermoformed synthetic material.
[0022] The flexible material part, once inserted in the tube, is
perfectly protected from contaminations upon its introduction into
a trocar. This tube forms, moreover, a particularly convenient
means for achieving this introduction in optimal conditions. The
tube can have a relatively small diameter, especially eight
millimetres, which allows it to be used with trocars of
corresponding small diameters; it thus avoids recourse to a special
trocar in order to realize said introduction, thereby substantially
simplifying the operation. Furthermore, since it is not slit, the
tube is gas-tight and does not give rise to an escape of carbon
dioxide when introduced through the valve fitted to the trocar.
[0023] This tube, moreover, can itself be equipped with a proximal
gas-tight valve and can, therefore, itself be used as a trocar.
This possibility, apart from the simplification which it brings,
helps to reduce the cost of the procedure.
[0024] Advantageously, said funnel-forming walls comprise two
rounded walls defining between them a pass-through gap for the
flexible material part having a width less than that of this
opening in the tube.
[0025] These rounded walls prove to allow the flexible material
part to be folded up perfectly. They can especially be constituted
by side walls of two cylindrical blocks connected to the packaging
box.
[0026] The flexible material part could, in this box, extend in the
horizontal extension of the tube, which would have the drawback,
however, of conferring large dimensions upon the device and of
involving an increase in material. For this reason, according to a
preferred embodiment of the invention, the device comprises a tray
which delimits, with the packaging box, a bottom receptacle for
receiving the flexible material part, comprises said funnel-forming
walls on its face opposite that delimiting this receptacle, and has
a rounded side edge, extending back from the box, around which the
flexible material part is designed to slide when the aforesaid
traction is applied to the traction suture.
[0027] This tray can comprise wedging means allowing the receiving
tube to be immobilized until the flexible material part is fully
engaged in this tube.
[0028] Advantageously, the device additionally comprises a cover
configured such as to grip the receiving tube tightly between it
and the aforesaid tray.
[0029] This cover, in conjunction with the tray, allows the
receiving tube to be perfectly immobilized throughout the operation
for inserting the flexible material part in this tube.
[0030] This cover can be separable from said tray to allow
extraction of the receiving tube. Preferably, it comprises a hinged
flap, allowing access to the receiving tube with a view to such
extraction.
[0031] Advantageously, said tray or said cover, or both, can
comprise a zone in the shape of an inverted "V", the base of which
is situated substantially coaxially to the axis of said receiving
tube, this zone being designed to be passed through by the traction
suture.
[0032] This zone thus allows that portion of the traction suture
which is engaged in the receiving tube to be held perfectly coaxial
to this tube, whatever the angle at which the traction is applied
to this suture.
[0033] For a good understanding thereof, the invention is
re-described below with reference to the appended diagrammatic
drawing representing, by way of non-limiting example, a preferred
embodiment of the device to which it relates.
[0034] FIG. 1 is an exploded perspective view of the parts which
make it up, prior to configuration of one of these parts with a
view to its assembly;
[0035] FIG. 2 is a view, similar to that of FIG. 1, of these same
parts, after said configuration;
[0036] FIG. 3 is a side view of the device, in longitudinal
section;
[0037] FIG. 4 is a sectional view along the line IV-IV of FIG.
6;
[0038] FIG. 5 is a top view during folding of a parietal
reinforcement which it contains; and
[0039] FIG. 6 is a view similar to FIG. 5, after this parietal
reinforcement has been fully folded.
[0040] FIGS. 1 to 4 represent a device 1 for packaging and folding
a parietal reinforcement 2, this reinforcement 2 being designed to
be fitted by means of a coelioscopy method.
[0041] The reinforcement 2 is of the traditional type, especially
realized in the form of a woven fabric or a knitted fabric of
synthetic fibres, with openwork structure. In the example
represented in the drawing, it has a substantially rectangular
general form, such that it defines an end side edge 2a having a
medial zone.
[0042] The device 1 comprises a packaging box for the reinforcement
2, a tray 3, a receiving tube 4 for receiving the reinforcement 2
in the flat state, a cover 5 and a traction suture 6. A
supplementary packaging box (not represented), receiving the whole
of the device 1, is provided so as to ensure the perfect sterility
of the device.
[0043] The packaging box for the reinforcement 2 is formed by a
base 7 and a lid 8.
[0044] The base 7 comprises side walls 10 delimiting a cavity 11
and an outer peripheral rim 12 situated level with the opening in
the cavity 11.
[0045] The lid 8 is sealed on the rim 12 such that it can be peeled
off.
[0046] The cover 5 is constituted by a part made of thermoformed
synthetic material. It has walls 15, allowing it to be fitted
tightly into the opening in the base 7, and a peripheral rim 16,
designed to come to bear against the rim 12 upon completion of this
fitting.
[0047] The cover 5 is sub-divided into a main portion 5a and a
marginal portion 5b, the latter being connected to the main portion
5a along a transverse fold line 17. This line 17 forms a hinge,
which allows the portion 5b to be folded upward relative to the
portion 5a.
[0048] The portion 5a has six oblong blocks 18 and two cylindrical
blocks 19 delimiting, on the bottom face of the cover 5, cavities
designed to tightly receive corresponding respective blocks 42, 46
(cf. FIGS. 2 and 3), contained in the tray 3, so as to allow the
assembly of the cover 5 and of the tray 3.
[0049] This portion 5a likewise has an elongate depression 20,
which delimits a semi-cylindrical receptacle emerging on the bottom
face of the cover 5, this receptacle being designed to tightly
receive the tube 4, as shown in FIGS. 3 to 6. On the side opposite
the portion 5b, the portion 5a has a raised wall 21.
[0050] The portion 5b has a boss 25 delimiting, on the bottom face
of the cover 5, a receptacle designed to receive a widened proximal
portion 4a of the tube 4. This boss 25 is bounded, on the side
opposite the portion 5a, by a wall 26 perpendicular to the axis of
the receptacle delimited by the depression 20 (cf. FIG. 3).
[0051] This portion 5b additionally has side cavities 27 and, on
the side opposite the portion 5a, two rounded zones which delimit
cavities 28. These cavities 27 and 28 are fit to receive the
fingers of a user, as will become apparent later.
[0052] In addition, as shown by FIG. 4, the portion 5b has, on the
side opposite the portion 5a, a notch 29 in the form of an inverted
"V", the base of which aligns substantially with the axis of the
receptacle delimited by the depression 20 when the portion 5b is
placed in the extension of the portion 5a.
[0053] The tray 3 is likewise made of a thermoformed synthetic
material. It has a main portion 3a and a marginal portion 3b
mutually connected by a transverse fold line 35. This line 35
allows the portion 3b to be folded over onto the portion 3a, as can
be seen by comparing FIGS. 1 and 2. This line 35 is bordered by two
grooves having rounded bases, such that the folding-over of the
portion 3b onto the portion 3a forms a relatively broad rounded
flange 36.
[0054] It can be seen in FIGS. 1 and 2 that the portions 3a and 3b
have blocks 34 and corresponding recesses 38, as well as ribs and
snap-lock depressions 39, which allow the tight fitting and
retention of the portion 3b on the portion 3a.
[0055] The portion 3a has a peripheral rim 37, which allows it to
be positioned, with wedging, in the base 7. This portion 3a is
dimensioned in such a way that the flange 36 is located back from
the corresponding wall 10 of the base 7. When the tray 3 is placed
in the base 7, a passage 40 therefore exists between this flange 36
and this wall 10, fit to allow the reinforcement 2 to slide through
it.
[0056] The portion 3a comprises a raised central zone 41, defining
a bottom receptacle for receiving the reinforcement 2. This zone 41
comprises four blocks 42, a semi-cylindrical receptacle 43 emerging
in the top face of the tray 3, dimensioned so as to tightly receive
the tube 4, a flared receptacle 44 dimensioned to tightly receive
the portion 4a of the tube 4, and two cavities 45 designed to
receive the walls delimiting the cavities 27.
[0057] For its part, the portion 3b comprises two blocks 42 and two
cylindrical blocks 46, as well as a semi-cylindrical depression 47
which delimits a receptacle entering the extension of the
receptacle 43 when the portion 3b is folded over onto the portion
3a. This receptacle is fit, with the receptacle delimited by the
depression 20, to tightly receive the tube 4, as is shown by FIG.
2.
[0058] It can be seen, more particularly in FIGS. 5 and 6, that the
two blocks 46 are arranged at a distance apart less than the inner
diameter of the tube 4, such that they form a stop against which
the end of the tube 4 comes to be positioned when this tube 4 is
placed in the aforesaid receptacles of the tray 3 and cover 5.
FIGS. 3 and 5 show, for their part, that the length of the tube 4
is such that the other end of this tube 4 reaches the immediate
proximity of the wall 26. This tube 4 is thus tightly imprisoned
between the cover 5 and the tray 3 when the blocks 42 and the top
part of the blocks 46 are engaged in the cavities delimited by the
blocks 18 and 19 and is axially jammed when the portion 5b is held
applied to the tray 3. The raising of this portion 5b allows, on
the other hand, the removal of the stop formed by the wall 26, so
that the tube 4 can be withdrawn, by sliding, from between the
cover 5 and the tray 3.
[0059] The portion 4a of the tube 4 accommodates a gas-tight
shutter, of the traditional type. This shutter is fit to resist the
pressure of the carbon dioxide gas used to raise the patient's
abdominal wall during the procedure, which raising offers freedom
of access to the site of implantation of the reinforcement 2.
[0060] The suture 6 comprises two strands forming a loop. It is
connected to the medial zone of the aforesaid side edge 2a of the
reinforcement 2 and passes through the tube 4. Its length is such
that it can be grasped in order to apply a traction capable of
making the reinforcement 2 penetrate the tube 4, as described
below.
[0061] In practice, the user grasps the suture 6 by one hand and,
with his other hand, applies pressure to the portion 5b, engaging
his thumb and his index finger of this other hand in the cavities
27.
[0062] A traction is applied to the suture 6, causing the
reinforcement 2 to pass around the flange 36 before coming into
contact with the side walls of the blocks 46. This contact, as
illustrated in FIG. 5, produces a gradual folding-down of the side
zones of the reinforcement 2 toward the medial zone of this
reinforcement, and hence a more or less concertina-type-folding of
the reinforcement 2.
[0063] Continuation of this traction effects the complete
introduction of the reinforcement 2 into the tube 4.
[0064] In the course of this traction, the suture 6 comes to bear
against the base of the notch 29, thereby ensuring that that
portion of the suture 6 situated in the tube 4 is held in a
position substantially coaxial to this tube 4, whatever the angle
at which the user applies said traction.
[0065] Once the reinforcement 2 is fully engaged in the tube 4, the
cavities 28 are utilized to raise the portion 5b of the cover 5 and
thus free the tube 4, which is able to be withdrawn, by sliding,
from between the cover 5 and the tray 3.
[0066] The tube 4 can then be used as a trocar for introducing the
reinforcement 2 into the body of the patient.
[0067] As is evident from the above-stated, the invention provides
a device for packaging and folding a flexible material part,
especially a parietal reinforcement 2, which device offers the
following decisive advantages: [0068] "concertina-type" folding of
the reinforcement 2, without any manual contact with the
reinforcement and according to a simple movement; [0069] insertion
of the reinforcement 2 into a tube 4 of relatively small diameter,
allowing the reinforcement to be protected as it is fed through a
trocar; [0070] gas-impermeability of the tube 4 and possibility of
use of this tube as a trocar; [0071] possibility of producing the
device with standard packaging materials, at a very low cost
price.
[0072] The invention is not, of course, limited to the embodiment
described above by way of example, but instead embraces all the
construction variants within the scope of the protection defined by
the attached claims.
* * * * *