POSTPARTUM BLOOD LOSS COLLECTION AND MEASUREMENT DEVICE, AND METHOD OF USE
20210369936 · 2021-12-02
Assignee
Inventors
Cpc classification
A61M1/69
HUMAN NECESSITIES
A61M2205/3379
HUMAN NECESSITIES
A61G13/102
HUMAN NECESSITIES
International classification
Abstract
Devices and methods for collecting and measuring postpartum blood loss of a patient are disclosed. The device generally includes a tray that may be positioned under a patient and a basin configured to collect blood. The basin can include gradation markings to facilitate accurate, real-time measurements of the amount of blood that the patient has lost to guide decision making of medical personnel.
Claims
1. A fluid collection device, comprising: a tray defining a proximal edge and a distal edge; and a basin connected to the proximal edge of the tray, the basin including an opening at a top perimeter edge and walls extending away from the tray towards a bottom, the walls and bottom defining an interior volume configured to receive fluid. The fluid collection device of claim 1, wherein the tray and basin are integrally formed as a single component.
2. The fluid collection device of claim 1, wherein the tray and basin are formed as independent components, and the basin is removably connected to the proximal edge of the tray.
3. The fluid collection device of claim 1, wherein the tray is configured to be at least partially positioned over a patient bed or beneath a patient.
4. The fluid collection device of claim 1, wherein the tray and the basin are fabricated from a flexible, rubber material.
5. The fluid collection device of claim 1, wherein the tray defines a substantially planar configuration including flat top and bottom surfaces extending between the proximal and distal edges.
6. The fluid collection device of claim 1, wherein the tray includes opposing side edges extending between the proximal and distal edges, and wherein at least a portion of the side edges tapers inwardly towards the proximal edge.
7. The fluid collection device of claim 1, wherein a width of the proximal edge of the tray is equal to a width of the basin.
8. The fluid collection device of claim 1, wherein the tray includes fluid guides extending from a top surface of the tray at opposing side edges of the tray.
9. The fluid collection device of claim 8, wherein the fluid guides extend substantially perpendicularly from the top surface of the tray and connect to the opening of the basin.
10. The fluid collection device of claim 1, wherein the tray includes fluid guides extending from a top surface of the tray in a central region of the tray between opposing side edges of the tray.
11. The fluid collection device of claim 1, wherein at least one of the walls of the basin includes gradations formed therein or marked thereon to indicate a level of fluid within the interior volume of the basin.
12. The fluid collection device of claim 1, wherein at least three of the walls of the basin taper inwardly towards the bottom.
13. The fluid collection device of claim 1, comprising a drain line extending from the bottom of the basin for selective drainage of the fluid from the basin.
14. The fluid collection device of claim 13, comprising a valve incorporated into the drain line for selectively draining the fluid from the basin.
15. A fluid collection system, comprising: a fluid collection device including (i) a tray defining a proximal edge and a distal edge, and (ii) a basin connected to the proximal edge of the tray, the basin including an opening at a top perimeter edge and walls extending away from the tray towards a bottom, the walls defining an interior volume configured to receive fluid; and an insert configured to be at least partially removably positioned within at least one of the opening or the interior volume of the basin, the insert including a filtration structure for filtering large particles from the fluid collected in the interior volume of the basin.
16. The fluid collection system of claim 15, wherein the insert includes a handle capable of being releasably engaged with a perimeter lip surrounding the basin.
17. The fluid collection system of claim 15, comprising a drain line extending from the bottom of the basin for selective drainage of the fluid from the basin.
18. A method of fluid collection, comprising: positioning a fluid collection device at least partially on a bed or beneath a patient, the fluid collection device including (i) a tray defining a proximal edge and a distal edge, and (ii) a basin connected to the proximal edge of the tray, the basin including an opening at a top perimeter edge and walls extending away from the tray towards a bottom, the walls defining an interior volume; allowing fluid to drain along the tray towards the basin; and collecting the fluid within the interior volume of the basin.
19. The method of claim 18, comprising positioning an insert including a filtration structure within at least one of the opening or the interior volume of the basin, capturing large particles from the fluid with the filtration structure, and removing the insert from the opening or the interior volume of the basin to dispose of the captured large particles.
20. The method of claim 18, comprising visually measuring a level of the fluid collected within the interior volume of the basin using gradations formed in or marked on at least one of the walls of the basin.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] To assist those of skill in the art in making and using the postpartum collection and measurement device, reference is made to the accompanying figures. While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
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DETAILED DESCRIPTION
[0050] With reference to
[0051] The tray 102 can include a grip section 106, a midsection 108, and a lip 110. The lip 110 can define a curved section that connects the tray 102 to the basin 104, thereby defining the proximal end of the tray 102. The grip section 106 can define the opposing distal end of the tray 102. The midsection 108 defines the structure of the tray 102 between the proximal and distal ends. The grip 106 permits manipulation or handling of the device 100, including placement and removal of device 100 relative to the hospital bed and/or patient. The midsection 108 couples or connects the grip 106 with the lip 110.
[0052] In some embodiments, the device 100 can be fabricated or formed as a single piece of material such that the tray 102 is integrally formed with the basin 104. For example, the tray 102 and basin 104 can be injection molded or cast together as a single structural component. In some embodiments, the device 100 can be formed as a single structural component using a three-dimensional plastic printer. In some embodiments, the device 100 can be fabricated or formed from two or more pieces of material, with such pieces of material coupled together structurally to ensure stability of the device 100 during use. The device 100 can be fabricated from rubber and/or plastic materials chosen to provide for sufficient stiffness for handling of the device 100 and for collection of fluids in the basin 104, while providing sufficient flexibility for ease of positioning the device at least partially underneath a patient.
[0053] As illustrated in
[0054] The grip section 106 can be configured for releasable attachment relative to a hospital bed. In some embodiments, the grip section 106 can be placed at an edge of the bed beneath the patient, with the patient weight maintaining the position of the device 100 relative to the patient and/or the bed without using any additional attachment mechanisms. In some embodiments, the device 100 (or at least the tray 102) can be fabricated from a rubber or silicone material to increase friction against the tray 102, reducing or preventing movement of the tray 102 relative to the patient and/or the bed. In some embodiments, the grip 106 can include one or more securing mechanisms configured to assist in placement, attachment or stabilization of the device 100 relative to the bed and/or patient. In some embodiments, such securing mechanisms can include, e.g., spring-loaded clips, raised edges, combinations thereof, or the like. In some embodiments, the device 100 can be maintained in the desired position by the weight of the patient resting at least partially over the tray 102 and/or grip 106.
[0055] In some embodiments, the tray 102 can include one or more indentations 112 formed in the midsection 108 and extending down the center of the midsection 108 (see, e.g.,
[0056] The basin 104 generally includes a top surface or edge 114 that is coupled or connected to the lip 110 of the tray 102 (see, e.g.,
[0057] As shown by
[0058] In some embodiments, the bottom 118 can include a nozzle 122 extending from the bottom 118. The nozzle 122 can be a tube (e.g., a substantially transparent tube or line) that is fluidly connected to the interior of the basin 104. The nozzle 122 can be selectively actuated into an open (e.g., flow) configuration and a closed (e.g., no flow) configuration that allows the basin 104 to be emptied without removal of the device 100 from the bed and/or patient. In some embodiments, the nozzle 122 can include a valve 126 capable of being selectively actuated for drainage of the basin 104. For example, the nozzle 122 can be fluidly coupled to an exterior drain line for draining the fluid from the basin 104. Such drainage of the basin 104 can be performed when the basin 104 is filled or nearly filled, but bleeding is still ongoing. In some embodiments, the top surface or edge 114 can be compatible with a removable lid (not shown) or other cover for the basin 104, e.g., to control any potential overflow of fluids from the basin 104.
[0059] As shown in
[0060] In some embodiments, the tray 102 can be dimensioned approximately 6 inches long (as measured between the lip 110 and the grip section 106) and approximately 0.25 inches thick (as measured between the top and bottom surfaces of the tray 102). In some embodiments, the grip section 106 can be dimensioned approximately 8 inches wide (as measured between the side edges of the tray 102), and the tray 102 can gradually taper to match the width of the lip 110. In some embodiments, the tray 102 can have alternative shapes or dimensions, such that the tray 102 is larger or smaller. The lip 110 can be configured to smoothly attach the tray 102 and the basin 104. In some embodiments, the edges or corners may be rounded (as shown) or may include sharper connections. In some embodiments, the basin 104 can be approximately 8 inches deep (as measured between the top surface or edge 114 and the bottom 118) and can a diameter of approximately 6 inches (as measured between the walls 116), such that the device 100 defines a total length of approximately 12 inches. Persons of skill in the art will recognize that these dimensions may be adjusted, and that not all embodiments will include the measurements provided by these exemplary embodiments.
[0061] In some embodiments, the device 100 can be formed or fabricated from a medical-grade plastic or other non-absorbent material(s) appropriate for medical use. In some embodiments, the device 100 can be formed or fabricated from a medical-grade plastic capable of repeated sterilization and re-use. In some embodiments, the device 100 can be disposable and formed of non-absorbent materials appropriate for one-time medical use. In some embodiments, the device 100 can be formed or fabricated from a combination of materials, or both reusable and disposable portions. For example, in some embodiments, the tray 102 can be formed or fabricated from disposable materials while the basin 104 is formed or fabricated from reusable materials.
[0062] The device 100 is configured to permit measuring the amount of fluid collected within the basin 104 without moving the device 100 until the basin 104 is full or substantially full. In some embodiments, the device 100 can formed or fabricated from transparent materials, opaque materials, or a combination of transparent and opaque materials to provide for improved visibility of the contents within the basin 104. For example, if the basin 104 is formed or fabricated from transparent materials, the gradation markings 124 may be visible on the inside of the wall 116 (e.g., similar to a urine “hat” placed in the toilet). In some embodiments, the gradation markings 124 can be on the outside of wall 116, the inside of the wall 116, or both. In some embodiments, if the device 100 is formed or fabricated from non-transparent materials, the wall 116 can be fabricated to define a sufficiently small thickness that would permit visualizing the level of fluid within the basin 104 through the wall 114 from the outside of the device 100. In some embodiments, at least the basin 104 and/or at least the wall 116 can be formed or fabricated from transparent materials, such as plastic, while the remaining sections of the device 100 are formed or fabricated from a non-transparent material.
[0063] In some embodiments, the basin 104 can be formed or fabricated from a medical-grade plastic configured to extend below the tray 102 and collect blood from the patient. In some embodiments, the basin 104 can be uniformly molded with the tray 102 or otherwise permanently coupled with the tray 102. In some embodiments, the basin 104 can be releasably attached to the tray 102 (e.g., in embodiments where the basin 104 is designed to be disposable and the tray 102 is designed to be reusable).
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[0065] In some embodiments, the devices discussed herein can be used during delivery (e.g., if a patient is hemorrhaging during or before labor), with the same method described for postpartum use. In such scenarios, the device may need to be removed for the birth of the baby and repositioned once the patient is no longer in labor.
[0066] With reference to
[0067] The device 200 includes a body 210 with a tray 212 and a basin 214. The tray 212 can define a substantially planar/flat, sheet-like form that extends along a single horizontal plane between proximal and distal edges 216, 218. In some embodiments, the proximal edge 216 can be curved towards the basin 214, providing space around the device 200 for medical professionals treating the patient. In some embodiments, the distal edge 218 can define a substantially linear edge. In some embodiments, the length of the tray 212 as measured between the basin 214 and the distal edge 218 can be, e.g., about 18 inches. In some embodiments, the width of the tray 212 as measured between side edges of the tray 212 can be about, e.g., 18 inches. The planar configuration of the tray 212 allows for positioning of the tray 212 on the top surface of the mattress 202 and at least partially underneath the patient, with the patient weight and/or friction maintaining the position of the device 200 relative to the mattress 202.
[0068] In the embodiment of
[0069] The basin 214 includes an opening 222 at or near the top surface of the tray 212. In some embodiments, the opening 222 can be substantially oval in shape. The opening 222 extends into the interior or cavity formed by the walls 220 of the basin 214, the interior or cavity capable of receiving a predetermined amount of fluid. The configuration of the basin 214 ensures that fluid flowing along the top surface of the tray 212 is guided into the basin 214 through the opening 222. The fluid flows downward to the bottom 224 of the basin 214, allowing the basin 214 to gradually fill with the fluid until the top edge of the basin 214 is reached. The walls 220 of the basin 214 can include graduations formed and/or marked thereon to indicate the level of fluid collected in the basin 214. The width and length of the basin 214 (and the opening 222) are dimensioned smaller than the width and length of the tray 212. In some embodiments, the device 200 can include a lid for covering the opening 222 of the basin 214, thereby preventing or reducing potential spillage of the fluid contained in the basin 214. In some embodiments, the basin 214 can include a drain nozzle extending from the bottom 224 to allow for selective draining of the basin 214 without removal of the device 200 from the hospital bed 204.
[0070] With reference to
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[0072] The device 200 can therefore be used to collect blood and other fluid(s) in the basin 214 during or post labor. The insert 226 can be used to filter out large particles that traditionally result in inaccurate measurement of blood loss. As such, only blood and other fluid(s) enter the basin 214 and the insert 226 can be removed to dispose of the larger particles prior to being replaced on the device 200. The graduations on the basin 214 can be used throughout the procedure to visually measure the amount of blood collected in the basin 214 in real-time. The drain valve or line at the bottom 218 of the basin 214 can be intermittently used to drain the basin 214. Alternatively, the device 200 can be removed from the bed 204 for draining of the basin 214, and subsequently replaced under the patient. In some embodiments, the basin 214 can be removable from the tray 212, allowing for removal of the basin 214 without removal of the tray 212. The device 200 therefore provides a convenient, accurate and cost-effective means for measuring blood loss of the patient.
[0073] With reference to
[0074] The basin 256 includes an opening 266 having a substantially linear side at the proximal edge 254, and a semi-circular or rounded opposing side that connects on either side of the proximal edge 254. The basin 256 includes walls 268 extending from the top edge formed by the opening 266 to a bottom 270 surface, defining a volume that can receive therein fluid(s) from the patient. In some embodiments, the tray 154 can be about 18 inches wide at or near the distal edge 258, and about 6 inches wide at or near the proximal edge 260. The basin 256 can similarly be about 6 inches wide, about 3 inches long, and about 6 inches deep. The wide tray 154 at the distal edge 258 allows for positioning of the device 250 under the patient, while the tapered proximal edge 260 results in a narrow basin 256 that provides sufficient volume to capture fluid without interfering with staff tasks in the surrounding area. In some embodiments, the basin 256 can include gradations 272 on the inner wall 268 with the outer wall 268 facing away from the mattress 202 being transparent, allowing for visualization of the gradations 272 through the wall 268.
[0075] With reference to
[0076] The basin 306 includes an opening 316 leading into the interior volume of the basin 306 formed by the walls 318 and bottom 320. The opening 316 can define a substantially rectangular configuration. In some embodiments, the width of the opening 316 can be about 18 inches, the length can be about 2 inches, and the depth can be about 3 inches. The narrow basin 306 prevents interference with staff tasks and the shallow depth of the basin 306 provides more stability when the device 300 is in use. The extended length provides the needed volume to capture fluid from the patient. The basin 306 can include gradations 322 formed or printed on the front surface of the wall 318, providing visibility of the level of fluid in the basin 306.
[0077] With reference to
[0078] The basin 356 includes an opening 368 leading into the interior volume of the basin 356 formed by the walls 370 and bottom 372. The opening 368 can define a substantially rectangular configuration. In some embodiments, the width of the opening 368 can be about 9 inches, the length can be about 2 inches, and the depth can be about 6 inches. The narrow basin 356 prevents interference with staff tasks and the shallow depth of the basin 356 provides more stability when the device 350 is in use.
[0079] In some embodiments, the tray 354 can include fluid guides 374 (e.g., tapered tray funnels, or the like) extending from the top surface of the tray 354 between the side edges. For example, as illustrated in
[0080] With reference to
[0081] The basin 406 includes an opening 416 leading into the interior volume of the basin 406 formed by the walls 418 and bottom 420. The opening 416 can define a substantially rectangular configuration. In some embodiments, the width of the opening 416 can be about 9 inches, the length can be about 2 inches, and the depth can be about 6 inches. The narrow basin 406 prevents interference with staff tasks and the shallow depth of the basin 406 provides more stability when the device 400 is in use. In some embodiments, the rear wall 418 can remain perpendicular relative to the upper perimeter edge of the basin 406, while the front and side walls 418 of the basin 406 can gradually taper towards the bottom 420. In some embodiments, the top perimeter edge surrounding the opening 416 can include fluid guides or a continuous raised lip extending or connecting with the fluid guides 412, 414 to prevent spillage of the fluid over the edge of the basin 406.
[0082] While exemplary embodiments have been described herein, it is expressly noted that these embodiments should not be construed as limiting, but rather that additions and modifications to what is expressly described herein also are included within the scope of the invention. Moreover, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations are not made express herein, without departing from the spirit and scope of the invention.