Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/02042—Determining blood loss or bleeding, e.g. during a surgical procedure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150045—Source of blood for blood from vagina, placenta, colon or mouth
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150366—Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag

Definitions

• Device for collecting fluidic losses and system for quantifying fluidic losses comprising such a device
• the invention relates to a device for collecting fluidic losses and a system for quantifying fluidic losses comprising such a device.
• PPH Postpartum Hemorrhage
• a PPH affects approximately 10% of deliveries.
• a PPH is said to be “serious” when the blood loss is at least 1000 mL in the twenty-four hours following delivery. Serious PPH then affects approximately 1% to 2% of deliveries.
• the first hours following delivery (typically between two and six hours) are therefore crucial in monitoring PPH.
• intraoperative blood loss is quantified by the volume of liquid collected in suction jars. This volume collected, however, only partially reflects the blood lost during the intraoperative period, in particular because a significant part of the liquid aspirated may be amniotic fluid, and a significant part of the blood flows through the vagina of the patient, and along the operating fields.
• the patient is monitored for approximately two hours in the post-interventional care room (SSPI), but no means of quantifying blood loss is then put in place. Only blood flowing into the sheets can alert the surveillance team if the quantity seems too large.
• SSPI post-interventional care room
• a fluid loss collection device comprising: a tubular body having a first open free end and a second open free end, the tubular body comprising at least:
• flared section extending from the conduit and comprising the first open free end, the flared section having an increasing diameter from the conduit to the first open free end, and a part, called upper, of the first free end open being more spaced radially from the conduit than another part, called lower, of the first open free end, which is diametrically opposite to the upper part.
• the flared section is thus configured to be inserted, in particular into a vagina of a patient after childbirth, for example near the external orifice of the uterine cervix.
• the flared section thus forms a collection cup which is asymmetrical and is configured to collect a flow of fluid.
• At least the flared section, forming the collection cup is for example made of a relatively flexible and deformable material to be easily introduced, for example into a vagina.
• the material comprises, for example, an elastomer.
• it is a biocompatible material.
• the material has, for example, a hardness of between 40 shore A and 80 shore A.
• the first end thus forms, for example, a flow inlet end into the device, and the second open free end thus forms an outlet end of the flow out of the device.
• the asymmetrical shape of the flared section improves fluid collection and contributes to satisfactory flow of flow through the device to evacuate fluid losses. This shape also makes it possible to limit a siphon effect which could distort the quantification of losses.
• the conduit here designates a tube, of regular section, in particular of circular or oval section.
• the conduit has, for example, a substantially decreasing diameter from the flared section towards the second open free end, which contributes to facilitating the flow of fluid.
• the asymmetrical part of the flared section has a shape such that the conduit is at a lowest level, when the device is placed in a patient who is generally lying on her back, making it possible to reduce the effect of walking or siphon. Thus any flow entering the flared part flows into the conduit with minimal dead volume.
• Such a fluid loss collection device is thus particularly configured to form a vaginal blood loss collection device.
• the upper portion is configured to be positioned in the vagina toward the patient's bladder while the lower portion is configured to be positioned toward the rectum.
• the flared section has a first side, called the upper side, which includes the upper part of the first open free end.
• the flared section has a second side, called the lower side, which includes the lower part of the first open free end.
• the upper side of the flared section is then flared relative to the conduit at an average angle greater than the lower side of the flared section.
• the flared section has a lateral side, called the left lateral side, and another lateral side, called the right lateral side, which is diametrically opposite the left lateral side; and the left lateral side and the right lateral side are flared relative to the conduit at the same average angle.
• a plane passing through the upper side and the lower side of the flared section constitutes a plane of symmetry, when the device is in a free state.
• the flared section has, for example, the general shape of an oblique truncated cone, a base of which is formed by the first open free end.
• the first open free end has an oval or circular section.
• the conduit then extends from a vertex of the oblique truncated cone formed by the flared section.
• a center of the first open free end is eccentric with respect to a center of the conduit, for example with respect to a section of the conduit through which the flared section is connected to the conduit.
• the center designates for example the geometric center.
• the lower side of the flared section has a substantially straight profile.
• the lower side of the flared section is then aligned with the conduit.
• a lower side of the device forms a straight line.
• the lower side of the device here comprises the lower side of the flared section and a lower side of the conduit located in an extension of the lower side of the flared section.
• a plane passing through the upper side and the lower side of the device constitutes a plane of symmetry, when the device is in a free state.
• the upper side of the flared section has a substantially “S” shaped profile.
• the device holds more easily in place in the vagina while producing little or no discomfort for the patient.
• the collection device includes an insertion retention system.
• an insertion retention system is configured to prevent the device from sliding out of the area into which it is introduced, in particular out of the vagina, and thus contributes to maintaining the flared section in position, for example in the vagina.
• the insertion retention system comprises, for example, a bead formed on the outer periphery of the first open free end.
• Such a bead also provides a rounded shape to one edge of the first open free end, which also facilitates insertion of the device, particularly in the vagina, as well as its removal.
• Such a bead helps to maintain the desired shape of the first open, gaping free end, particularly when the flared section is in a vagina and can then be subjected to stresses which could deform it.
• the collection device includes a positioning indicator.
• Such a positioning indicator makes it possible to check how the device is positioned and oriented.
• the positioning indicator comprises a rib which extends longitudinally over part of an upper side of the device.
• Such a rib makes it possible to ensure the alignment of the device when it is in place, for example in the patient's vagina, and to monitor that it remains thus, for example in a sagittal plane.
• Such a rib is for example also possibly configured to stiffen the collection device in bending.
• the upper side of the device, opposite the lower side of the device, here comprises an upper side of the conduit and the upper side of the flared section.
• the rib extends for example longitudinally over at least part of the upper side of the conduit, or even over part of the upper side of the flared section.
• the collection device being for example of round or oval section, the upper side then designates a line extending longitudinally from the upper part of the first open free end which has a maximum spacing relative to the conduit. Said line then forms a top line of the device.
• Such a rib can also be configured to limit the possibility of rotation of the collection device, particularly when it is in place in the vagina, and thus contribute to maintaining the desired orientation of the device once in place.
• the conduit which extends the flared section thus forming a pipe, comprises a connection end configured to connect a quantification container, such as for example a graduated collection bag.
• connection end has the second free end open.
• the connection tip includes, for example, a cannula.
• the conduit then also includes, by definition, a flow section, arranged between the flared section and the connection end.
• a fluid loss quantification system comprising a fluid loss collection device as described above and a quantification container connected to the conduit of the collection device.
• Such a quantification system thus makes it possible to have objective and precise information on the volume of fluid, in particular blood loss externalized in the hours following childbirth.
• Figure 1 illustrates in perspective a device for collecting fluidic losses according to an exemplary embodiment of the invention
• Figure 2 represents the device of Figure 1, respectively in left and right profiles (Figures 2A and 2B), from above (Figure 2C), from below (Figure 2D), from the front (Figure 2E) and from behind ( Figure 2F )
• Figure 3 represents the device of Figures 1 and 2 with a quantification container to be connected to it.
• the identical elements represented in the aforementioned figures are identified by identical numerical references.
• Figure 1 shows a fluid loss collection device 10 according to an exemplary embodiment of the invention.
• the collection device 10 comprises a tubular body 11.
• the tubular body 11 is mainly made up of an envelope wall 12 with variable sections.
• the tubular body 11 has two open free ends, between which the envelope wall 12 extends.
• the two open free ends comprise a first open free end 13 and a second open free end 14.
• the tubular body 11 comprises two major sections: a flared section 20 which comprises the first open free end 13, and a conduit 30, here comprising the second open free end 14, and which extends from the flared section 20.
• the flared section 20 is configured to be inserted, in particular, into a vagina, in particular of a patient after childbirth.
• the conduit 30, which extends the flared section 20, is configured to guide a flow, preferably into a container connected to the conduit 30 for this purpose.
• the first open free end 13 forms a flow inlet end and the second open free end 14 forms a flow outlet end.
• the conduit 30 includes a connection end 31.
• connection tip 31 is therefore configured to connect a quantification container, such as for example a graduated collection bag, as illustrated in Figure 3.
• a quantification container such as for example a graduated collection bag, as illustrated in Figure 3.
• connection tip 31 then includes here the second open free end 14.
• the connection tip 31 includes for example a cannula.
• the conduit 30 then comprises, by definition, a section called a flow section 32, disposed between the flared section 20 and the connection end 31.
• the conduit 30 has a circular section.
• the flow section 32 here has a substantially decreasing diameter from the flared section 20, at least to the connection tip 31, which contributes to facilitating the flow of fluid.
• the connection end 31 has, on the contrary, a substantially increasing section from the flow section, and here up to the second open free end 14, in order to facilitate the connection of the quantification container .
• the flared section 20 has an increasing diameter from the conduit 30 to the first open free end 13.
• the flared section 20 also has a circular section; however, it could be oval or other, if necessary.
• the flared section 20 however extends relative to the conduit 30 in an asymmetrical manner.
• a part, called the upper part 21 of the first open free end 13 is more spaced radially relative to the conduit 30 than another part, called the lower part 22 of the first open free end 13, which is diametrically opposite to the upper part 21.
• the flared section thus forms a collection cup, in particular intra-vaginal, which is asymmetrical and is configured to collect a flow of fluid, in particular blood loss.
• the flared section 20 has for example a general shape of an oblique truncated cone, a base of which is formed by the first open free end 13, and a vertex of which is extended by the conduit 30.
• a geometric center of the first open free end 13 is then eccentric with respect to a geometric center of the conduit 30.
• the asymmetrical shape of the flared section 20 is for example more visible in Figures 2A and 2B which show the collection device 10 in profile.
• the collection device 10 has a lower side 15 and an upper side 16 which are diametrically opposed.
• the collection device 10 having a circular section, one side here designates a line extending longitudinally from one end to the other of the tubular body 11.
• the upper side 16 represents the maximum height line of the device 10 in relation to the lower side 15.
• the lower side 15 of the device is therefore here composed of a lower side 23 of the flared section 20 and a lower side 33 of the conduit 30 (including a lower side 35 of the flow section 32), and the upper side 16 of the device is then composed of a upper side 24 of the flared section 20 and an upper side 34 of the conduit 30 (including an upper side 36 of the flow section 32).
• An angle “a” (illustrated in Figure 2A) formed by the upper side 24 with respect to the conduit 30 (in particular with respect to the flow section 32 of the conduit) is considered positive, comprised in 0° and 90° for example, preferably between 0° and 45°.
• an angle "b" (not illustrated) formed by the lower side 23 with respect to the conduit 30 is considered positive, comprised in 0° and 90° for example, preferably between 0° and 45°.
• the upper side 24 of the flared section 20 comprises the upper part 21 of the first open free end 13
• the lower side 23 of the flared section 20 comprises the lower part 22 of the first open free end 13.
• the upper side 24 is then flared relative to the conduit 30 at an average angle “a” greater than the average angle “b” of the lower side 23.
• the upper part 21 of the first free open end 13 is here the part of the first free open end most eccentric with respect to the conduit 30, that is to say presenting a maximum radial offset (therefore corresponding to a maximum average angle “a”).
• the upper side 24 of the flared section 20 has a substantially “S”-shaped profile.
• the upper side 24 of the flared section 20 and the upper side 36 of the flow section 32 then form here a curved line, which is in the shape of an “S”.
• the lower part 22 of the first open free end 13 is here the part of the first open free end which is the least eccentric with respect to the conduit 30, that is to say presenting a minimal radial offset.
• this minimal radial offset is even zero.
• the angle “b” formed by the lower side 23 with respect to the conduit 30 is then considered to be zero.
• the lower side 23 of the flared section 20 also has a substantially straight profile.
• the lower side 23 of the flared section 20 and the lower side 35 of the flow section 32 also form a straight line here.
• the upper side 36 of the flow section 32 here has an increasing height from the connection end 31 relative to the lower side 35, corresponding to the increasing diameter.
• Figures 2C and 2D show the collection device 10 seen from above and below respectively.
• Such a median plane then passes through the upper side 16 and the lower side 15 of the device 10.
• the flared section 20 therefore has a flared, symmetrical shape.
• a right lateral part of the first open free end 13 is then spaced radially from the conduit 30 as much as a left lateral part of the first open free end 13, which is diametrically opposite to the right lateral part.
• the collection device 10 includes a positioning indicator 17.
• the positioning indicator 17 makes it possible to check the desired positioning of the device.
• the positioning indicator 17 is formed by a rib.
• Such a rib is thus configured to limit the possibility of rotation of the collection device 10 once it has been put in place.
• the collection device 10 is configured so that the upper side 16 is positioned in the vagina towards the bladder, that is to say upwards when the patient is lying on her back.
• the rib extends here along a part of an upper side 16 of the device 10.
• the rib is therefore here in the plane of symmetry of the device 10.
• the rib extends here over part of the upper side 34 of the conduit 30 and over part of the upper side 24 of the flared section 20.
• the rib extends here all along the upper side 36 of the flow section 32.
• the collection device 10 includes an insertion retention system 18.
• Such an insertion retention system 18 is configured to prevent the device 10 from sliding out of its insertion zone and thus contributes to maintaining the flared section 20 in position in said zone.
• the insertion retention system 18 here consists of a bead formed on the outer periphery of the first open free end 13.
• Such a bead also provides a rounded shape at the edge of the first free end 13 of the device 10, which also facilitates insertion of the device as well as its removal.
• Such a bead also contributes to maintaining the open shape of the first open free end 13, particularly when the flared section 20 is in place, for example in the vagina.
• Figure 3 presents an example of a fluid loss quantification system 100 comprising a fluid loss collection device 10 as shown in Figures 1 and 2, and a quantification container 40, ready to be connected to the conduit 30 of the device 10 .
• the quantification container 40 comprises for example here mainly a graduated collection pocket 41, and a pipe 42.
• the pipe 42 on the one hand opens into the pocket 41 and on the other hand is terminated by a tip 43 configured to connect to the cannula 31 of the conduit 30 of the device 10, for example by inserting itself therein.
• the end piece 43 is for example a conical connector.
• the conduit makes it possible to connect a bag allowing collection and quantification of fluid losses, in particular postpartum blood loss, thus contributing to monitoring postpartum hemorrhage.

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• 2022
  • 2022-04-14 FR FR2203470A patent/FR3134514B1/fr active Active
• 2023
  • 2023-04-14 US US18/727,040 patent/US20240415394A1/en active Pending
  • 2023-04-14 EP EP23722438.1A patent/EP4507577A1/de active Pending
  • 2023-04-14 WO PCT/FR2023/050538 patent/WO2023199003A1/fr not_active Ceased

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