Device for collecting fluid losses and system for quantifying fluid losses that comprises such a device
Patent Information
- Application Number
- EP2023722438
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-04-14
- Filing Date
- 2023-04-14
- Publication Date
- 2025-02-19
AI Technical Summary
Current methods for quantifying blood loss after childbirth are inaccurate, leading to underestimation of postpartum hemorrhage (PPH), which is a major cause of maternal mortality, as they fail to provide precise measurement of blood volume lost during the critical post-delivery period, especially in the lying position after vaginal deliveries and cesarean sections.
A fluid loss collection device with an asymmetrical flared section and a tubular body, made of flexible biocompatible material, designed to be inserted into the vagina to collect blood loss, which connects to a quantification container, minimizing siphon effects and ensuring precise fluid collection and measurement.
The device provides objective and precise quantification of blood loss, reducing the risk of underestimating PPH and enabling timely diagnosis and treatment, potentially preventing significant morbidity and mortality associated with undetected hemorrhages.
Smart Images
Figure 1.1
Abstract
Description
[0001] Fluid loss collection device and fluid loss quantification system comprising such a device
[0002] The invention relates to a device for collecting fluid losses and a system for quantifying fluid losses comprising such a device.
[0003] Childbirth naturally induces blood loss for the patient who has given birth.
[0004] But when blood loss is at least 500 mL within twenty-four hours of delivery, this blood loss is then called Post-Partum Hemorrhage (PPH).
[0005] PPH affects approximately 10% of births.
[0006] Among PPH, a PPH is considered "severe" when blood loss is at least 1000 mL within twenty-four hours of delivery. Severe PPH then affects approximately 1% to 2% of deliveries.
[0007] In recent years, PPH has been the leading cause of pregnancy-related maternal mortality in France, and even worldwide.
[0008] A report from the National Expert Committee on Maternal Mortality from 2007 to 2009, published in 2013, revealed a maternal mortality rate of 9.6 per 100,000 live births. Among obstetric causes of death, 18% are related to PPH.
[0009] The main known risk factors for hemorrhage do not allow for the selection with sufficient sensitivity and specificity of patients who should be subject to specific preventive measures before giving birth. The majority of PPHs occur without any clearly identified risk factors. Therefore, it is not possible, given the current state of knowledge, to recommend a PPH prevention strategy based on the identification of risk factors for a given patient before giving birth.
[0010] The first few hours following childbirth (typically between two and six hours) are therefore crucial in monitoring PPH.
[0011] Currently, for vaginal delivery, blood loss after delivery is assessed using a graduated collection bag that is placed under the patient's buttocks. The bag is left in place while the patient is in the gynaecological position, i.e., approximately 20 to 30 minutes after delivery, and is then removed when the patient is lying down. Patient monitoring in the delivery room continues until two hours after delivery, but accurate quantification of blood loss then becomes impossible in the lying position, because in this position, if the collection bag is left in place, blood flows into the patient's back and / or various protections, draw sheets and / or sheets. It is currently considered that quantification with the collection bag leads to a 30% underestimation of blood loss.
[0012] For a cesarean section, intraoperative blood loss is quantified by the volume of fluid collected in suction jars. However, this collected volume only partially reflects the blood lost during the intraoperative period, particularly because a significant portion of the aspirated fluid may be amniotic fluid, and a significant portion of the blood flows through the patient's vagina and along the surgical fields. After the cesarean section, the patient is monitored for approximately two hours in the post-intervention care room (PAC), but no means of quantifying blood loss is then put in place. Only blood flowing into the sheets can alert the monitoring team if the quantity appears excessive.
[0013] Thus, in all cases, there is only an estimate of the amount of blood lost over the crucial period of time after delivery, and no quantification is implemented, whereas the precision in measuring the volume of blood lost is crucial information for diagnosing PPH.
[0014] In the aforementioned report, approximately 74% of maternal deaths related to PPH had a diagnostic error due to two key factors: a failure to quantify blood loss, both for vaginal deliveries and cesarean sections, and a failure to monitor the patient's clinical parameters, including the exact volume of blood loss.
[0015] This lack of monitoring and exact knowledge of the blood volume lost by the patient leads professionals in the delivery room to have a lack of awareness of the situation.
[0016] However, not understanding that the patient has HPP is dangerous; HPP can quickly worsen and lead to significant morbidity (surgical procedures; hospitalization in intensive care, etc.), or even death. There is therefore a loss of time in making the diagnosis and, consequently, a loss of chance of treatment, or even survival, for the patient.
[0017] Many deaths from PPH could be avoided if blood loss could be better quantified. These hemorrhages account for the largest proportion of preventable deaths, at around 83.9%, according to a study by INSERM.
[0018] There is therefore a need for equipment to quantify blood loss in patients who have given birth, both naturally and by caesarean section.
[0019] For this purpose, a device for collecting fluid losses is proposed, comprising: a tubular body having a first open free end and a second open free end, the tubular body comprising at least:
[0020] - a conduit, having the second free end open, and
[0021] - a flared section, extending from the conduit and comprising the first open free end, the flared section having a diameter increasing from the conduit to the first open free end, and a part, called the upper part, of the first open free end being further radially spaced from the conduit than another part, called the lower part, of the first open free end, which is diametrically opposite the upper part.
[0022] The flared section is thus configured to be inserted, in particular into a patient's vagina after childbirth, for example near the external orifice of the cervix.
[0023] The flared section thus forms a collection cup which is asymmetrical and is configured to collect a flow of fluid.
[0024] 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.
[0025] The material includes, for example, an elastomer.
[0026] For example, it is a biocompatible material.
[0027] For example, the material has a hardness between 40 shore A and 80 shore A.
[0028] The first end thus forms, for example, a flow inlet end into the device, and the second open free end thus forms a flow outlet end out of the device.
[0029] The asymmetrical shape of the flared section improves fluid collection and contributes to a satisfactory flow of the stream through the device to evacuate fluid losses. This shape also helps to limit a siphon effect that can distort a quantification of losses.
[0030] The conduit here designates a tube, of regular section, in particular of circular or oval section. The conduit has, for example, a diameter which decreases significantly from the flared section towards the second open free end, which helps to facilitate the flow of fluid.
[0031] The asymmetrical portion of the flared section is shaped so that the conduit is at its lowest level when the device is placed in a patient who is generally lying on her back, reducing the step or siphon effect. Thus, any flow entering the flared portion flows into the conduit with minimal dead volume.
[0032] Such a fluid loss collection device is thus particularly configured to form a vaginal blood loss collection device.
[0033] For example, for the patient lying on their back, the upper portion is configured to be positioned in the vagina towards the patient's bladder while the lower portion is configured to be positioned towards the rectum.
[0034] For example, the flared section has a first side, called the upper side, which has the upper part of the first open free end.
[0035] For example, the flared section has a second side, called the lower side, which includes the lower part of the first open free end.
[0036] For example, the upper side of the flared section is then flared relative to the conduit at a larger average angle than the lower side of the flared section.
[0037] For example, 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.
[0038] For example, 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.
[0039] The flared section has, for example, the general shape of an oblique truncated cone, one base of which is formed by the first open free end.
[0040] For example, the first open free end has an oval or circular section.
[0041] For example, the conduit then extends from a top of the oblique truncated cone formed by the flared section.
[0042] For example, a center of the first open free end is eccentric relative to a center of the conduit, for example relative to a section of the conduit by which the flared section is connected to the conduit.
[0043] The center designates for example the geometric center.
[0044] For example, the lower side of the flared section has a substantially straight profile. For example, the lower side of the flared section is then aligned with the conduit. For example, a lower side of the device forms a straight line.
[0045] 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.
[0046] For example, a plane passing through the top side and the bottom side of the device constitutes a plane of symmetry, when the device is in a free state.
[0047] For example, the upper side of the flared section has a roughly "S" shaped profile.
[0048] Such an at least partially "S" shape appeared to provide better ergonomics for the device. In particular, the device is more easily held in place in the vagina, producing little or no discomfort for the patient.
[0049] For example, the collection device comprises an insertion retention system. Such an insertion retention system is configured to prevent the device from slipping out of the area into which it is inserted, 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.
[0050] Such a bead further provides a rounded shape to one edge of the first open free end, which also facilitates insertion of the device, particularly into the vagina, as well as its removal.
[0051] Such a bead helps to maintain the desired shape of the first open, gaping free end, especially when the flared section is in a vagina and may then be subject to stresses that could deform it.
[0052] In an exemplary embodiment, the collection device comprises a positioning indicator.
[0053] Such a positioning indicator makes it possible to check how the device is positioned and oriented.
[0054] In one exemplary embodiment, the positioning indicator comprises a rib which extends longitudinally over a portion of an upper side of the device.
[0055] 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 so, for example in a sagittal plane.
[0056] 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.
[0057] The rib extends, for example, longitudinally over at least part of the upper side of the duct, or even also over part of the upper side of the flared section.
[0058] 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 with respect to the conduit. Said line then forms a top line of the device.
[0059] Such a rib may also be configured to limit the possibility of rotation of the collection device, particularly when it is in place in the vagina, and thus help to maintain the desired orientation of the device once in place.
[0060] In an exemplary embodiment, the conduit, which extends the flared section, thus forming a pipe, comprises a connecting end piece configured to connect a quantification container, such as for example a graduated collection bag.
[0061] For example, the connecting tip has the second free end open. The connecting tip has, for example, a cannula.
[0062] The conduit then also includes, by definition, a flow section, arranged between the flared section and the connection end piece.
[0063] Also provided, according to another aspect of the invention, is 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.
[0064] Such a quantification system thus provides objective and precise information on the volume of fluid, particularly blood loss expressed in the hours following childbirth.
[0065] The invention, according to an exemplary embodiment, will be well understood and its advantages will appear better on reading the detailed description which follows, given for information purposes and in no way limiting, with reference to the appended drawings in which: Figure 1 illustrates in perspective a device for collecting fluid losses according to an exemplary embodiment of the invention; Figure 2 represents the device of Figure 1, respectively from 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); and Figure 3 represents the device of Figures 1 and 2 with a quantification container to be connected thereto. The identical elements represented in the aforementioned figures are identified by identical numerical references.
[0066] Figure 1 shows a fluid loss collection device 10 according to an exemplary embodiment of the invention.
[0067] The collection device 10 comprises a tubular body 11.
[0068] The tubular body 11 is mainly made up of an envelope wall 12 with variable sections.
[0069] The tubular body 11 has two open free ends, between which the envelope wall 12 extends.
[0070] The two open free ends comprise a first open free end 13 and a second open free end 14.
[0071] As shown in Figure 1, 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.
[0072] The flared section 20 is configured to be inserted, in particular, into a vagina, in particular of a patient after childbirth.
[0073] 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.
[0074] Thus, according to a preferred option, the conduit 30 comprises a connection end piece 31.
[0075] The connection tip 31 is therefore configured to connect a quantification container, such as for example a graduated collection bag, as illustrated in figure 3.
[0076] The connecting end piece 31 then comprises the second open free end 14. The connecting end piece 31 comprises, for example, a cannula.
[0077] The conduit 30 then comprises, by definition, a section called the flow section 32, arranged between the flared section 20 and the connection end piece 31.
[0078] In the present embodiment, the conduit 30 has a circular section.
[0079] In addition, the flow section 32 here has a diameter that decreases substantially from the flared section 20, at least up to the connecting end piece 31, which helps to facilitate the flow of fluid. In the present exemplary embodiment, the connecting end piece 31, on the contrary, has a section that increases substantially from the flow section, and here up to the second open free end 14, in order to facilitate the connection of the quantification container.
[0080] Furthermore, according to an interesting characteristic of the invention, the flared section 20 has a diameter increasing from the conduit 30 to the first open free end 13.
[0081] In the present example, the flared section 20 also has a circular section; it could however be oval or other, if necessary.
[0082] As shown in Figure 1, the flared section 20, however, extends relative to the conduit 30 in an asymmetrical manner.
[0083] In particular, a part, called the upper part 21 of the first open free end 13 is further radially spaced from the conduit 30 than another part, called the lower part 22 of the first open free end 13, which is diametrically opposite the upper part 21.
[0084] The flared section thus forms a collection cup, particularly intravaginal, which is asymmetrical and is configured to collect a flow of fluid, particularly blood loss.
[0085] The flared section 20 has, for example, the general shape of an oblique truncated cone, a base of which is formed by the first open free end 13, and a top of which is extended by the conduit 30.
[0086] A geometric center of the first open free end 13 is then eccentric relative to a geometric center of the conduit 30.
[0087] 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.
[0088] For example, the collection device 10 has a lower side 15 and an upper side 16 which are diametrically opposed.
[0089] The collection device 10 having a circular section, a side here designates a line extending longitudinally from one end to the other of the tubular body 11.
[0090] Thus, for example, the upper side 16 represents the maximum height line of the device 10 relative to the lower side 15.
[0091] 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 an 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).
[0092] An angle “a” (illustrated in Figure 2A) formed by the upper side 24 relative to the conduit 30 (in particular relative to the flow section 32 of the conduit) is considered positive, between 0° and 90° for example, preferably between 0° and 45°.
[0093] Similarly, an angle “b” (not shown) formed by the lower side 23 relative to the conduit 30 is considered positive, between 0° and 90° for example, preferably between 0° and 45°.
[0094] Further here, the upper side 24 of the flared section 20 comprises the upper part 21 of the first open free end 13, and the lower side 23 of the flared section 20 comprises the lower part 22 of the first open free end 13.
[0095] 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.
[0096] In particular, the upper part 21 of the first open free end 13 is here the part of the first open free end most eccentric with respect to the conduit 30, that is to say having a maximum radial offset (therefore corresponding to a maximum average angle “a”).
[0097] In the embodiment shown, the upper side 24 of the flared section 20 has a substantially “S”-shaped profile.
[0098] The upper side 24 of the flared section 20 and the upper side 36 of the flow section 32 then form a curved line, which is "S" shaped. In addition, 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 having a minimal radial offset.
[0099] In the embodiment shown here, this minimum radial offset is even zero. The angle “b” formed by the lower side 23 relative to the conduit 30 is then considered to be zero.
[0100] The lower side 23 of the flared section 20 also has a substantially straight profile.
[0101] The lower side 23 of the flared section 20 and the lower side 35 of the flow section 32 further form a straight line here.
[0102] In addition, the upper side 36 of the flow section 32 here has an increasing height from the connection end piece 31 relative to the lower side 35, corresponding to the increasing diameter.
[0103] However, this diameter, and therefore the height, could be constant. Figures 2C and 2D show the collection device 10 seen from above and below respectively.
[0104] These figures show that the device has symmetry with respect to a median plane (not shown), which corresponds for example to a sagittal plane of the patient when the device is in place.
[0105] Such a median plane then passes through the upper side 16 and the lower side 15 of the device 10.
[0106] Laterally, the flared section 20 therefore has a flared, symmetrical shape.
[0107] A right lateral portion of the first open free end 13 is then as far apart radially from the conduit 30 as a left lateral portion of the first open free end 13, which is diametrically opposite the right lateral portion.
[0108] Furthermore, as illustrated in Figures 1 and 2C in particular, the collection device 10 includes a positioning indicator 17.
[0109] The positioning indicator 17 makes it possible to check the desired positioning of the device.
[0110] In the present embodiment, the positioning indicator 17 is formed by a rib.
[0111] Such a rib is thus configured to limit a possibility of rotation of the collection device 10 once it has been put in place.
[0112] It also allows you to see if the device is not twisted.
[0113] In particular, in this example, the collection device 10 is configured so that the upper side 16 is positioned in the vagina in the direction of the bladder, i.e. upwards when the patient is lying on her back.
[0114] The rib here extends along a portion of an upper side 16 of the device 10.
[0115] The rib is therefore here in the plane of symmetry of the device 10.
[0116] In particular, the rib extends here over a portion of the upper side 34 of the conduit 30 and over a portion of the upper side 24 of the flared section 20.
[0117] In particular, the rib here extends along the entire upper side 36 of the flow section 32.
[0118] It thus covers a connection zone between the conduit 30 and the flared section 20, which contributes to maintaining the shape of the device 10 when it is in place. Furthermore, as illustrated in FIGS. 1 and 2, the collection device 10 comprises 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.
[0119] The insertion retention system 18 here consists of a bead formed on the outer periphery of the first open free end 13.
[0120] Such a bead further provides a rounded shape to the edge of the first free end 13 of the device 10, which also facilitates insertion of the device as well as its removal.
[0121] Such a bead also helps to maintain the open shape of the first open free end 13, in particular when the flared section 20 is in place, for example in the vagina.
[0122] Figure 3 shows 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.
[0123] The quantification container 40 comprises, for example, here mainly a graduated collection bag 41, and a pipe 42. The pipe 42 on the one hand opens into the bag 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.
[0124] Tip 43 is for example a conical fitting.
[0125] Thus, if the device 10 is in place in the vagina of a patient, the conduit allows a bag to be connected to it allowing collection and quantification of fluid losses, in particular postpartum blood losses, thus contributing to monitoring postpartum hemorrhages.
Claims
DEMANDS 1. Fluidic loss collection device (10) comprising: a tubular body (11) having a first open free end (13) and a second open free end (14), the tubular body (11) comprising at least: a conduit (30), comprising the second open free end (14), and a flared section (20), extending from the conduit (30) and comprising the first open free end (13), the flared section (20) having a diameter increasing from the conduit (30) to the first open free end (13), and a part (21), called upper, of the first open free end (13) being more radially distant from the conduit (30) than another part (22), called lower, of the first open free end (13), which is diametrically opposite to the upper part (21).
2. Device (10) according to claim 1, characterized in that the flared section (20) has a first side (24), called the upper side, which includes the upper part (21) of the first open free end (13), a second side (23), called the lower side, which includes the lower part (22) of the first open free end (13), and in that the upper side (24) of the flared section is flared with respect to the conduit (30) at a mean angle (a) greater than the lower side (23) of the flared section.
3. Device (10) according to claim 2, characterized in that the lower side (23) of the flared section has a substantially straight profile.
4. Device (10) according to any one of claims 2 or 3, characterized in that the lower side of the flared section (20) is aligned with respect to the conduit.
5. Device (10) according to any one of claims 2 to 4, characterized in that the upper side (24) of the flared section has a substantially "S" shaped profile.
6. Device (10) according to any one of claims 1 to 5, characterized in that the flared section (20) comprises a lateral side, referred to as the left lateral side, and a other lateral side, called right lateral side, which is diametrically opposite the left lateral side, and in that the left lateral side and the right lateral side are flared in relation to the conduit (30) at the same mean angle.
7. Device (10) according to any one of claims 1 to 6, characterized in that a geometric center of the first open free end (13) is eccentric with respect to a geometric center of the conduit (30).
8. Device (10) according to any one of claims 1 to 7, characterized in that it comprises an insertion retention system (18).
9. Device (10) according to claim 8, characterized in that the insertion retention system (18) comprises a bead formed on the outer periphery of the first open free end (13).
10. Device (10) according to any one of claims 1 to 9, characterized in that it comprises a positioning indicator (17).
11. Device (10) according to claim 10, characterized in that the positioning indicator (17) has a rib which extends longitudinally over a part of an upper side (16) of the device (10).
12. Device (10) according to claim 11, characterized in that the rib is configured to stiffen the collection device (10) in bending.
13. Device (10) according to any one of claims 11 or 12, characterized in that the rib extends longitudinally over at least a part of the upper side of the conduit, or even also over a part of the upper side (24) of the flared section (20).
14. Device (10) according to any one of claims 1 to 13, characterized in that the conduit (30) has a connecting end (31) configured to connect a quantification container.
15. Device (10) according to any one of claims 1 to 14, characterized in that the flared section (20) is made of a biocompatible material.
16. Device (10) according to claim 15, characterized in that the material has a hardness between 40 shore A and 80 shore A.
17. Device (10) according to any one of claims 1 to 16, characterized in that the flared section (20) is configured to be inserted into the vagina of a patient after childbirth, for example, near the external os of the cervix.
18. Device (10) according to claim 17, characterized in that it is configured to form a vaginal blood collection device.
19. Device (10) according to any one of claims 17 or 18, characterized in that the upper part (21) is configured to be positioned in the vagina towards the patient's bladder while the lower part (22) is configured to be positioned towards the rectum.
20. Fluid loss quantification system comprising a fluid loss collection device (10) according to any one of claims 1 to 19, and a quantification container (40) connected to the conduit (30) of the device (10).