WO2020081692A1

WO2020081692A1 - Treatment of hemorrhage with a reusable device

Info

Publication number: WO2020081692A1
Application number: PCT/US2019/056551
Authority: WO
Inventors: Rachel Chan SEAY; Gavin Moore MISCHLER; Katherine HU; Maya Marie LAPINSKI
Original assignee: Seay Rachel Chan; Mischler Gavin Moore; Hu Katherine; Lapinski Maya Marie
Priority date: 2018-10-18
Filing date: 2019-10-16
Publication date: 2020-04-23

Abstract

A device and method for treating hemorrhage is described. A tube portion is a body of the device, and it includes at least one aperture. A fluid connector allows fluid to enter the tube portion of the device. A balloon component is secured to the tube portion by at least one fastener. A sheath covers at least a portion of the balloon component. A locking mechanism enables adjustment of the sheath. The fluid moves through the tube portion and exits the tube portion through the at least one aperture to fill up the balloon component. The balloon component expands when filled by the fluid and applies pressure to a hemorrhage area.

Description

Treatment of Hemorrhage with a Reusable Device

Technical Field

The presently disclosed subject matter relates to preventing or reducing maternal mortality by treating postpartum hemorrhage (PPH). In particular, the presently disclosed subject matter relates to reducing and stopping blood loss subsequent to delivery.

Background

Recent advancements in medical technology have contributed to a decline of maternal mortality, but the existing solutions are often unaffordable in lower-resource settings. As a result, in such contexts, maternal mortality remains high. One of the leading causes of maternal mortality is postpartum hemorrhage (PPH), i.e., excessive blood loss in the time period immediately following delivery. PPH is responsible for over 25% of maternal deaths annually, and causes up to 60% of maternal deaths in low-resource settings.

PPH is conventionally treated with the use of uterotonic agents, uterine massage and compression techniques, and other supportive measures. Refractory PPH is managed with uterine balloon tamponade, and then surgical intervention, in conjunction with blood transfusion. These resources are typically available at well-equipped facilities, but in low- resource contexts PPH remains a significant cause of maternal mortality as many births still take place without access to such measures.

One of the existing methods of hemorrhage control is placement of a uterine balloon tamponade. This method involves application of pressure to the surface of the intrauterine walls to stop blood flow, which can be accomplished via insertion of intrauterine packing such as sterile towels or surgical sponges. Risks of intrauterine packing include infection, difficult subsequent removal of packing, and retained foreign body.

Cook Medical’s Bakri Balloon is one of the currently available uterine tamponade devices. However, even in high-resource settings, the Bakri device is ineffective (i.e. cannot be placed correctly and/or does not provide adequate hemostasis) in 10-20% of cases.

Originally designed to apply pressure to the lower uterine segment placental bed after delivery of a low-lying or placenta previa, the Bakri often rests in the lower portion of the uterus without fully contacting the fundal portions of the uterus. Successful placement of the Bakri Balloon relies heavily on ultrasound guidance to ensure proper placement within the intrauterine cavity, which, in turn, is dependent on availability of ultrasonic equipment and personnel trained to used it properly. High cost and supply chain challenges diminish the practicality of the use of the Bakri device in lower-resource settings. Condom catheter devices have been well-described for uterine tamponade in lower- resource settings. However, the condom catheter can be quite difficult to place correctly and maintain in the optimal intrauterine position and can become displaced from the uterine cavity during placement or inflation, losing contact with the uterine walls and thus decreasing efficacy. Similar to the Bakri device, condom catheters also may require ultrasound guidance when available to verify the placement of the condom tamponade. When ultrasound capacity is limited or unavailable, which is the case in many low-resource settings, it is difficult for providers to ensure proper placement of the tamponade balloon device.

When uterine tamponade fails, the most common next step is invasive surgical management, or transport to a higher care facility, when available. Options for surgery include compression sutures, systematic devascularization, and ultimately, hysterectomy. These operations are associated with higher risks of morbidity and mortality in any environment, and may not even be available in low-resource settings.

What is needed is a device optimized for low-resource settings that is minimally invasive, reusable and relatively intuitive for providers trained in basic obstetric care.

Summary

An aspect of the presently disclosed subject matter relates to a device for treating a hemorrhage, the device comprising: a tube portion with at least one aperture; a fluid connector that permits fluid to enter the tube portion; and a balloon component secured to the tube portion by at least one fastener such that the fluid entering the tube portion through the fluid connector exits the tube portion through the at least one aperture to fill up the balloon component; and wherein the balloon component expands when filled by the fluid.

Another aspect of the presently disclosed subject matter relates to a method for building a device for treating a hemorrhage, the method comprising: providing a tube portion with at least one aperture; providing a fluid connector that permits fluid to enter the tube portion of the device; and providing a balloon component; secured the balloon component to the tube portion by at least one fastener; wherein tube portion, the fluid connector and balloon component are arranged such that the fluid entering the tube portion through the fluid connector exits the tube portion through the at least one aperture to fill up the balloon component; and wherein the balloon component expands when filled by the fluid.

Another aspect of the presently disclosed subject matter relates to a method of treating a hemorrhage with a device that includes: a tube portion with at least one aperture, a fluid connector, and a balloon component, the method comprising: securing the balloon component to the tube portion by at least one fastener; placing the device in a hemorrhage area; injecting fluid into the tube portion via fluid connector, wherein the fluid exits the tube portion through the at least one aperture to fill up the balloon component; and expanding the balloon component by filling it up with the fluid under pressure; wherein the expanded balloon component applies pressure in order to treat the hemorrhage area.

Another aspect of the presently disclosed subject matter relates to a device for treating postpartum hemorrhage, comprising: a tube portion that is a body of the device, and that includes at least one aperture, a fluid connector that allows fluid to enter the tube portion of the device, a balloon component secured to the tube portion by at least one fastener, a sheath that covers at least a portion of the balloon component, and a locking mechanism that enables adjustment of the sheath, wherein the fluid moves through the tube portion and exits the tube portion through the at least one aperture to fill up the balloon component, wherein the balloon component expands when filled by the fluid, and wherein the tube portion is made out of a rigid material that allows haptic feedback verifying proper placement of the device.

Another embodiment is a method of treating hemorrhage with a device that includes: a tube portion with at least one aperture, a fluid connector, a balloon component, a sheath, and a locking mechanism, the method comprising: securing the balloon component to the tube portion by at least one fastener, covering at least a portion of the balloon component with the sheath, adjusting the sheath with the locking mechanism, placing the device in a hemorrhaging area and verifying proper placement by obtaining haptic feedback from the tube portion that is made out of a rigid material, injecting fluid into the fluid connector to move through the tube portion, wherein the fluid exits the tube portion through the at least one aperture to fill up the balloon component, expanding the balloon component by filling it up with the fluid under pressure, and using the expanded balloon component to apply the pressure in order to treat the hemorrhage area.

Brief Description of the Drawings

FIG. 1 A shows an example of a device for treating hemorrhage prior to inflation of an elastic component.

FIG. 1B shows an example of a device for treating hemorrhage subsequent to inflation of an elastic component.

FIG. 2 shows a top view of 3-D printed uterine models used for pressure testing.

FIG. 3A shows an example of a force sensor used for pressure testing.

FIG. 3B shows an example of the testing setup used for pressure testing.

FIG. 4A shows test results when pressure is applied by a single condom in small, medium, and large uterine models. FIG. 4B shows test results when pressure is applied by a single and double condom configuration in the large model.

FIG. 4C shows test results when pressure is applied by a single condom configuration using three different condom thicknesses in the large uterine model.

While the present disclosure will now be described in detail, and it is done so in connection with the illustrative embodiments, it is not limited by the particular embodiments illustrated in the figures and the appended claims.

Detailed Description

Reference will be made in detail to certain aspects and exemplary embodiments of the application, illustrating examples in the accompanying structures and figures. The aspects of the application will be described in conjunction with the exemplary embodiments, including methods, materials and examples, such description is non-limiting and the scope of the application is intended to encompass all equivalents, alternatives, and modifications, either generally known, or incorporated here. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. One of skill in the art will recognize many techniques and materials similar or equivalent to those described here, which could be used in the practice of the aspects and embodiments of the present application. The described aspects and embodiments of the application are not limited to the methods and materials described, but are to be accorded the broadest possible scope consistent with the principles and features disclosed herein.

As used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictates otherwise.

Ranges may be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as "about" that particular value in addition to the value itself. For example, if the value "10" is disclosed, then "about 10" is also disclosed. It is also understood that when a value is disclosed that "less than or equal to "the value," greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "10" is disclosed the "less than or equal to 10" as well as "greater than or equal to 10" is also disclosed.

One aspect of the present application relates to a device for treating a hemorrhage, the device comprising: a tube portion with at least one aperture; a fluid connector that permits fluid to enter the tube portion; and a balloon component secured to the tube portion by at least one fastener such that the fluid entering the tube portion through the fluid connector exits the tube portion through the at least one aperture to fill up the balloon component; and wherein the balloon component expands when filled by the fluid.

In some embodiments, the tube portion is made out of a rigid material that permits haptic feedback verifying proper placement of the device.

In some embodiments, the device is for treating a postpartum hemorrhage in the uterus.

In another embodiment, the device further comprises a pump for pumping the fluid through the fluid connector into the tube portion. In some embodiments, the fluid is one of a liquid and a gas.

In some embodiments, the device further comprises a sheath that covers at least a portion of the balloon component. In another embodiment, the device further comprises a locking mechanism, wherein the locking mechanism locks the sheath into place to regulate the size of the balloon upon expansion. In some embodiments, the tube portion includes a plurality of grooves along the axial direction of the tube portion, and wherein the locking mechanism engages with at least one of the grooves when locking the sheath into place. In another embodiment, the tube portion has a first outer radius and the sheath has a second inner radius, and the second inner radius is larger than the first outer radius.

In some embodiments, the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 50-150 mmHg. In another embodiment, the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 70-110 mmHg. In another embodiment, the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 90 mmHg.

In some embodiments, the at least one fastener is a surgical suture.

Another aspect of the present application relates to a method for building a device for treating a hemorrhage, the method comprising: providing a tube portion with at least one aperture; providing a fluid connector that permits fluid to enter the tube portion of the device; providing a balloon component; and securing the balloon component to the tube portion by at least one fastener; wherein tube portion, the fluid connector and balloon component are arranged such that the fluid entering the tube portion through the fluid connector exits the tube portion through the at least one aperture to fill up the balloon component; and wherein the balloon component expands when filled by the fluid.

In some embodiments, the method further comprises providing a pump for pumping the fluid through the fluid connector into the tube portion. In another embodiment, the fluid is one of a liquid and a gas.

In some embodiments, the method further comprises providing a sheath that covers at least a portion of the balloon component. In some embodiments, the method further comprises providing a locking mechanism, wherein the locking mechanism locks the sheath into place to regulate the size of the balloon upon expansion. In another embodiment, the tube portion includes a plurality of grooves along the axial direction of the tube portion, and wherein the locking mechanism engages with at least one of the grooves when locking the sheath into place. In some embodiments, the tube portion has a first outer radius and the sheath has a second inner radius, and the second inner radius is larger than the first outer radius.

In some embodiments, the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the balloon component is about 50-150 mmHg. In some embodiments, the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the balloon component is about 70-110 mmHg. In another embodiment, the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the balloon component is about 90 mmHg.

In some embodiments, the at least one fastener is a surgical suture.

Another aspect of the present application relates to a method of treating a hemorrhage with a device that includes: a tube portion with at least one aperture, a fluid connector, and a balloon component, the method comprising: securing the balloon component to the tube portion by at least one fastener; placing the device in a hemorrhage area; injecting fluid into the tube portion via fluid connector, wherein the fluid exits the tube portion through the at least one aperture to fill up the balloon component; and expanding the balloon component by filling it up with the fluid under pressure; wherein the expanded balloon component applies pressure in order to treat the hemorrhage area.

In some embodiments, the method further comprises receiving haptic feedback verifying proper placement of the device.

In some embodiments, the device further comprises a sheath, and the method further comprises moving the sheath so that it covers at least a portion of the balloon component. In some embodiments, the device further comprises a locking mechanism, and the method further comprises locking the sheath into place with the locking mechanism to regulate the size of the balloon upon expansion. In another embodiment, the tube portion further includes a plurality of grooves along the axial direction of the tube portion, and wherein the locking mechanism engages with at least one of the grooves when locking the sheath into place. In another embodiment, the tube portion has a first outer radius and the sheath has a second inner radius, and the second inner radius is larger than the first outer radius.

In some embodiments, the method further comprises using a pump for pumping the fluid through the fluid connector into the tube portion. In some embodiments, the fluid is one of a liquid and a gas.

In other embodiments, the pressure provided by the expanded balloon component is about 50-150 mmHg. In some embodiments, the pressure provided by the expanded balloon component is about 70-110 mmHg. In another embodiment, the pressure provided by the expanded balloon component is about 90 mmHg.

In some embodiments, the at least one fastener is a surgical suture.

The presently disclosed subject matter provides equipment and methods for stopping hemorrhage, such as postpartum hemorrhage (PPH). One example of a device insertable to stop hemorrhage is illustrated in Figs. 1(a) and (b).

As shown in Fig. 1(a), device 100 may include a fluid connector 1 that allows fluid to enter the inner shaft of the device 100. The fluid may flow from external fluid pumping mechanism, through the connector 1, and into the device 100. The connector 1 could connect to large syringe-style pumps, or to inflow tubing carrying liquid or gas from other sources. In one embodiment, the connector 1 may be a plastic Luer lock. The connector 1 may be made out of a material that is sterilizable and reusable, such as metal or plastic. The device 100 may further include a hollow tube 2 that is a body for the device 100. The tube 2 may be connected to the fluid connector 1 on the proximal end and it may include a tip that provides haptic feedback to a user upon contact. The hollow tube 2 can be composed of multiple segments which can each be disconnected and sterilized. The tube 2 allows fluid to escape near the distal end to inflate the elastic material. The tube 2 may be made of a solid, sturdy material that provides haptic feedback to the user when the device 100 contacts the wall of a uterine cavity.

In one embodiment, the tube 2 is assembled by screwing together at the center two pieces of the tube. This modularity may allow the device 100 to be disassembled into two smaller pieces in order to enable easier sterilization. The tube 2 may have a solid cap at the distal end. Other modularity with more than two pieces may also be used.

One example of the device 100 has an adjustable outer sheath 3 which may be used to cover a portion of an elastic balloon-like component 6. By covering a certain amount of the balloon 6, a user can restrict the portion of the balloon 6 that can expand, thus varying the size of the balloon 6. Accordingly, the device 100 may be customizable and adjustable to different uterine sizes. The sheath 3 may include a locking mechanism, which enables the user to lock it in place once the appropriate size is determined. In certain embodiments, the sheath 3 is made of a material sufficiently rigid to prevent the balloon 6 from expanding beneath it, e.g., a metal or plastic material. One example of the sheath 3 is a thin, hollow, metal tube which has a slightly larger radius than outer radius of the inner tube 2 it surrounds.

Moreover, one or more incremental locks 4a may be added to the device 100 and may connect to a locking mechanism 4 of the outer sheath 3, thus enabling for adjustments of the sheath 3. The locking mechanism 4 can be one of many types of locks, and it may allow the sheath 3 to smoothly move up and down the body 2 of the device 100 and then be fixed and/or locked at a specific location. The locking mechanism 4 of the device 100 may be a set of regularly spaced, 3D-printed locks 4a, which may be grooves that occur at predetermined intervals in the axial direction of the device’s main tube body 2. In one example, the grooves/locks 4a fit a matching male hook which may be machined on the inside of the sheath 3. The shape of the locks 4a may follow the shape of the device’s body 2. For example, a set of incremental grooves may be circumferential around the device's cylindrical body 2, as depicted in Fig. 1(a).

There may be a main groove created which is substantially parallel to the axis of the device 100, and perpendicular to the rest of the grooves/locks 4a. The main groove may act as a main channel for the movement of the male hook of the sheath 3. In one embodiment, the sheath 3 is in the unlocked position with its hook sliding through the main groove, when the sheath 3 is moved up or down the length of the body 2 of the device 100 to the desired location. Once a specific groove/lock 4a is chosen, the sheath 3 and hook may be twisted out of the main channel and into the selected groove, thereby locking the sheath 3 in place and preventing further movement of the sheath 3 in the axial direction of the body 2.

The selection of a specific lock 4a may be a function of the size of a cavity treated for hemorrhage. For example, the greater the cavity that the balloon 6 must press against, the farther the selected lock 4a may be from the distal end of the device 100. Accordingly, the sheath 3 may cover the lesser portion of the balloon 6, and therefore, the remaining uncovered portion of the balloon 6 would be larger, resulting in a larger volume of the balloon 6 when eventually filled with liquid, as illustrated in Fig. 1(b).

In one example of the device 100, the locking mechanism 4 is composed of 3D printed parts which surround the inner rod. In another example, the locking mechanism 4 is made out of a material that can be sterilized. Fig. 1(b) shows an example of the assembled and engaged device 100, with the expanded balloon 6 and the sheath 3 locked in place.

The elastic material 6 may be secured to the body 2 by fasteners 5, which may be used for adjustment of the effective elastic area between the body 2 and the elastic material 6. In one embodiment, the fasteners 5 are surgical sutures tied around the balloon 6. The balloon 6 may be capable of expanding when filled with a substance taking up space, such as liquid or gas, due to its elasticity. The balloon 6 may be made out of a material allowing it to stretch radially, longitudinally, or both, to grow larger when filled with a substance taking up space, such as liquid or gas. The balloon 6 may be incorporated over the top of the distal end of the device 100 and may be connected to the tube 2, such as by tying on both sides. The balloon 6 may be comprised of a condom. When expanded, the balloon 6 may apply pressure outward.

The body 2 of the device 100 may contain one or more holes 7 for a gas or a liquid

(“fluid”) to flow under pressure and inflate the balloon component 6. The fluid substance can travel from the fluid connector 1 through the tube 2 and exit through the holes 7. When the fluid connector 1 is disassembled after product use, the fluid is able to travel back into the holes 7 and then through the metal tube 2, exiting from the proximal end. In one

embodiment, the holes 7 are apertures created in the distal body piece used to fill the balloon 6 with sterile liquid (e.g. sterile water, sterile saline solution, etc.).

One of the objectives of the device 100 is to provide haptic feedback to the user regarding proper placement of the device 100 at the uterine fundus and ensure continued fundal contact during and after inflation. This haptic feedback may reduce or eliminate the need for ultrasound guidance to ensure proper placement of the device. To attain hemorrhage cessation, the device 100 must apply adequate pressure to as much of the surface area of the uterine cavity as possible. To achieve hemostasis, it may not always be necessary to meet the mean arterial pressure (MAP). As hemodynamic parameters vary in the immediate postpartum period, an average pressure goal may be determined to be necessary for achieving hemorrhage cessation in most patients, such as about 50-150 mmHg. In certain examples, the average pressure goal of the device 100 is about 70-110 mmHg, and in a specific example, presented in Table 1, the average pressure goal of the device 100 is about 90 mmHg. In some embodiments, 90 mmHg may be higher than the required pressure, since some uterine bleeding comes from small vessels which have low intravascular pressures.

Adjustable balloon size allows for maximum coverage and optimal pressure applied to varying sizes of uterine cavities. In the immediate postpartum period, the uterus displays considerable variability in dimension. Its length, anteroposterior dimension, and intrauterine cavitary volume may vary depending on gestational age, time since delivery, and anatomic variance including structural anomalies (for example, but not limited to, presence of uterine myomas). Variable balloon-size allows for optimal usage of a greater range of post evacuation uterine sizes.

In some embodiments, the variable balloon-size may range from about 200-1 OOOmL, and in other embodiments, the variable balloon-size may range from about 250-750mL. In a specific example, presented in Table 1, the balloon-size of the device about 100 is 500mL. In some embodiments, the shape of the balloon may be varied for individualized alignment. Changes in size and shape of the balloon may allow for different surface area contact in different contours and sizes of post-evacuation uteri.

In some embodiments, the device 100 diameter may range from l-5cm, and in other embodiments, the diameter of the device 100 may range from about 2-4cm. In a specific example, presented in Table 1, the diameter of the device 100 is about 3cm. For ease of use and patient safety and comfort, the device 100 should be as light and compact as possible.

The total diameter of the device should not exceed a value adequate to prevent cervical injury, such as being no greater than the diameter of the cervix, and to allow for safe removal within 24 hours.

By meeting these criteria, the device 100 is optimized to help stop PPH. Personnel with basic training in obstetrical care will be able to place the device 100 safely with appropriate training. The device 100 will involve readily available components and may not require radiologic capacity. Manufacturing Method:

Various methods for manufacturing the described subject matter may be used. In one instance, a device may be created by using metal components, 3-dimensional (3-D) printed polylactic acid (PLA) pieces, a suture, and an expandable balloon. The rigidity of the device allows it to provide haptic feedback to the user upon contact with the uterine fundus, allowing it to be used effectively without the use of ultrasound guidance in a low-resource setting.

Two separate rigid tubes, such as metal pipes, with threaded ends may be connected with a female threaded straight pipe connector to create a solid body that could be easily split up for small-scale sterilization. A threaded pipe cap may be screwed onto the end of one of the tube segments to function as a solid tip of the device which could safely make contact with the uterine fundus. Two holes may be formed in the distal end of the tube, just below the cap, so that sterile water or saline solution could flow through the pipe and into the balloon which would surround the end. An expandable balloon is first stretched around the blunt end of the device and then tied with biodegradable suture at the top and base of the condom to enclose a balloon shape. In another embodiment, an expandable balloon may be stretched around the distal end of the device and sealed by wrapping sutures tightly around the condom and tying them off to press it against the solid body. To prevent the expandable balloon from expanding vertically past the end of the device during inflation, the cap features a protruding rim under which sterile surgical suture can be easily tied.

In order to properly fit the various uterine sizes encountered in the postpartum period, the inner tube is surrounded by a sliding metal sheath, which can be repositioned at certain points along the pipe so that it blocks the inflation of the condom below that point. In one embodiment, the sheath is designed to cover the expandable balloon to the level of the external cervical os. The user can use either haptic or visual feedback to verify placement, although visual confirmation is not required. Other embodiments may also be used. The sheath may be locked into place by first sliding the sheath towards the tip of the device until the distal end of the sheath is flush with the external cervical os, and then twisting the notch at the base of the sheath into the grooves circumscribing the inner pipe at 1 cm increments, for example. When locked in place, the sheath covers any excess condom extending distal to the external cervical os and prevents that portion of the condom from inflating within the vagina, ensuring that only the proximal (intrauterine) portion of the balloon inflates and contacts the uterine walls.

Measuring the exact distance from the uterine fundus to the level of the external cervical os may be unnecessary for device use. If the user cannot correctly determine the distance, the sliding sheath can be extended to the longest distance and the condom can still be inflated within the uterus and possibly vagina. Inability to vary the size of the condom does not preclude use of the device.

To ensure an easy connection with syringes for condom balloon inflation, the lower end of the device is fit with a Luer lock attachment so that a standard syringe can be used for instillation of sterile water or saline solution to inflate the condom.

The present application is further illustrated by the following examples that should not be construed as limiting. The contents of all references, patents, and published patent applications cited throughout this application, as well as the Figures and Tables, are incorporated herein by reference.

Test Example:

To assess the ability of the device to apply adequate pressure to stop hemorrhage, tests are conducted to measure the pressure exerted at different locations within a model uterus. A 3-D uterine model is custom-designed and 3-D printed in PCL on the Stratasys Dimension l200es. In one embodiment, the balloon pressure matches or exceeds this MAP goal.

Table 1: Design Specifications

In one instance, a device may be created by using metal components, such as those purchased from McMaster, 3-dimensional (3-D) printed polylactic acid (PLA) pieces, an Ethibond Excel polyester suture, and a condom. Other constructions may also be used. All data analysis was done using Matlab R20l7b.

Testing Adaptabili ty

In order to determine the ability of the device to perform in a variety of post evacuation uterine sizes, adaptability tests are conducted. Three differently sized models - a large (20cm length, l740mL volume), medium (l6cm, 670mL), and small (lOcm, l70mL) version - are used to investigate potential variations in pressure exerted by the device, as shown in Fig. 2. Using these models to assess the pressure exerted by the device, pressure is defined as force, which is easily measured, per unit area, which is easily controlled. Each model contains holes at eight locations around its surface, distributed distally and proximally on both sides of the model. These locations are chosen to obtain measurements of pressure distribution in varying locations. The rods of the force gauges were inserted through these holes and square inch acrylic pads were attached to the rod tips, as illustrated in Fig. 3A. These gauges measure a force in Newtons over the square inch, which is then converted into a pressure reading in mmHg.

In the testing setup, the force gauges are positioned perpendicular to the model’s surface, as shown in Fig. 3B. One gauge is placed in the proximal uterine region, and the other is placed in the fundal region. A single Trojan-ENZ^® lubricated condom is rolled onto the body of the device and sutured in place at the top and bottom. The device is then inserted into the uterine model through the cervical opening until fundal contact is achieved, as determined through haptic feedback. The outer sheath is then adjusted so that it covers any excess condom outside of the model cervical opening. This adjustment varies for each model, according to its size.

When the inflated condom makes contact with the pads attached to the force gauges, it pushes against them with the pressure that the balloon would exert against the walls of the uterus. With a syringe, the device is inflated with water until it begins to expand out of the model’s cervix, at which point, the force readings are recorded. Nine trials are performed in each model.

Testing Versatility

Further tests are conducted to determine versatility and ability to apply successful pressure in different configurations. This is done by fitting the device with two, rather than one, Trojan-ENZ^® Lubricated condoms. An initial, single condom is placed over the device and tied at its base with suture. A second condom is then placed over it, adding another suture to both the top and bottom. Nine trials identical to those described above are performed. The largest model is used because it is at that size that the device experienced the initially observed failure. Testing is performed under the same assumptions as before.

Testing Condom Parameters

In order to further optimize the device’s performance and account for potential variation, varying condom thicknesses are also tested. The device is fit with three different condoms, each of the same brand but with a different thickness: Trojan^® Sensitivity Bareskin Lubricated condoms (0.046mm), Trojan-ENZ^® Lubricated condoms (0.07mm), and Trojan^® Ultra-Ribbed Lubricated condoms (0. l2lmm).

Initial Usability Testing of Fundal Placement with Haptic Feedback

An initial usability study was performed where 20 participants were asked to place two devices such that the tip reached the fundus of the uterine model (defined as the tip being held within a 2-inch radius of the exact fundus). One device was a condom catheter as might be used in a developing world setting, while the other was one of the present application.

To verify that potential observed differences in efficacy result from the altered condom thickness, each variation is tested in the same sized uterine model. The largest model is chosen, under the assumption that pressure readings obtained in the largest model would necessarily be less than than those obtained in the smaller models, based on previous results. This assumption allows for the likely conclusion that success in stopping hemorrhage in a larger uterus would indicate the device’s ability to also stop hemorrhage in a smaller uterus where less surface area contact and less pressure would be required.

The device is tested using the same procedure as outlined above, and nine trials were performed for each condom thickness.

Results

The results of pressure testing in the large, medium, and small uterine models with a single condom are shown in Fig. 4A. To further extend the results, a double condom setup and different condom thicknesses are tested in the large uterine model, and the results are shown in Figs. 4B and 4C. The red line indicates the goal of 90 mmHg.

Pressure testing results for the large, medium, and small uterine models are shown in Fig. 4A. In the small uterine model, at the proximal region, the device applies an average pressure of 104 mmHg, while the average pressure in the fundal region is 92 mmHg. In the medium uterine model, the device applies an average of 94.4 mmHg and 97.3 mmHg at the proximal and fundal regions, respectively. In the large uterine model, the device with a single normal condom applies an average pressure of 71.7 mmHg in the proximal region, and at the fundal region, the device reaches an average pressure of 76.3 mmHg. Further tests are done in the large model to determine other factors that would raise the pressure above the 90 mmHg goal.

Results for the double condom test in the large uterine model are shown in Fig. 4B. The double condom configuration is able to apply more pressure than the single condom configuration in the large model. The device fitted with two condoms applies an average pressure of 113 mmHg in the proximal region, and an average pressure of 125 mmHg in the fundal region - compared to the previous results of 71.7 mmHg in the proximal region and 76.3 mmHg in the fundal region for a single condom in the large model.

The results of condom thickness testing in the large uterine model are shown in Fig. 4B. The thin condom applies an average pressure of 52.9 mmHg and 57.3 mmHg at the proximal and fundal regions of the large model, respectively. The normal condom applies the previously stated average pressures of 71.7 mmHg and 76.3 mmHg. The thick condom applies an average pressure of 86.8 mmHg at the proximal region and 84.2 mmHg at the fundal region. This data demonstrates a clear distinction in the performances of the three thicknesses, which is confirmed with paired t-tests.

After the conduction of pressure testing with varying uterine model size, condom configuration, and condom thicknesses, it has been demonstrated that the device can reach the goal pressure threshold of 90 mmHg, all while offering haptic feedback to the user.

The terms and descriptions used herein are set forth by way of illustration only and are not meant as limitations. Those skilled in the art will recognize that many variations are possible within the spirit and scope of the invention as defined in the following claims, and their equivalents, in which all terms are to be understood in their broadest possible sense unless otherwise indicated.

Although the various systems, functions, or components of the present invention may be described separately, in implementation, they do not necessarily exist as separate elements. The various functions and capabilities disclosed herein may be performed by separate units or be combined into a single unit. Further, the division of work between the functional units can vary. Furthermore, the functional distinctions that are described herein may be integrated in various ways.

While various embodiments have been described above, it should be understood that such disclosures have been presented by way of example only and are not limiting. Thus, the breadth and scope of the subject compositions and methods should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

The foregoing description and examples have been set forth merely to illustrate the invention and are not intended to be limiting. Each of the disclosed aspects and embodiments of the present invention may be considered individually or in combination with other aspects, embodiments, and variations of the invention. Modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to persons skilled in the art and such modifications are within the scope of the present invention.

Claims

WHAT IS CLAIMED IS:

1. A device for treating a hemorrhage, the device comprising:

a tube portion with at least one aperture;

a fluid connector that permits fluid to enter the tube portion; and

a balloon component secured to the tube portion by at least one fastener such that the fluid entering the tube portion through the fluid connector exits the tube portion through the at least one aperture to fill up the balloon component; and

wherein the balloon component expands when filled by the fluid.

2. The device according to claim 1, wherein the tube portion is made out of a rigid material that permits haptic feedback verifying proper placement of the device.

3. The device according to claims 1 or 2, wherein the device is for treating a postpartum hemorrhage in the uterus.

4. The device according to claim 1, further comprising a pump for pumping the fluid through the fluid connector into the tube portion.

5. The device according to claims 1 or 4, wherein the fluid is one of a liquid and a gas.

6. The device according to claim 1, further comprising a sheath that covers at least a portion of the balloon component.

7. The device according to claim 6, further comprising a locking mechanism, wherein the locking mechanism locks the sheath into place to regulate the size of the balloon upon expansion.

8. The device according to claim 7, wherein the tube portion includes a plurality of grooves along the axial direction of the tube portion, and wherein the locking mechanism engages with at least one of the grooves when locking the sheath into place.

9. The device according to claim 6, wherein the tube portion has a first outer radius and the sheath has a second inner radius, and the second inner radius is larger than the first outer radius.

10. The device according to claim 1, wherein the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 50-150 mmHg.

11. The device according to claim 1 , wherein the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 70-110 mmHg.

12. The device according to claim 1, wherein the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 90 mmHg.

13. The device according to claim 1, wherein the at least one fastener is a surgical suture.

14. A method for building a device for treating a hemorrhage, the method comprising: providing a tube portion with at least one aperture;

providing a fluid connector that permits fluid to enter the tube portion of the device; providing a balloon component; and

securing the balloon component to the tube portion by at least one fastener;

wherein tube portion, the fluid connector and balloon component are arranged such that the fluid entering the tube portion through the fluid connector exits the tube portion through the at least one aperture to fill up the balloon component; and

wherein the balloon component expands when filled by the fluid.

15. The method according to claim 14, wherein the tube portion is made out of a rigid material that permits haptic feedback verifying proper placement of the device.

16. The method according to claims 14 or 15, wherein the device is for treating a postpartum hemorrhage in the uterus.

17. The method according to claim 14, further comprising providing a pump for pumping the fluid through the fluid connector into the tube portion.

18. The method according to claims 14 or 17, wherein the fluid is one of a liquid and a gas.

19. The method according to claim 14, further comprising providing a sheath that covers at least a portion of the balloon component.

20. The method according to claim 19, further comprising providing a locking mechanism, wherein the locking mechanism locks the sheath into place to regulate the size of the balloon upon expansion.

21. The method according to claim 20, wherein the tube portion includes a plurality of grooves along the axial direction of the tube portion, and wherein the locking mechanism engages with at least one of the grooves when locking the sheath into place.

22. The method according to claim 19, wherein the tube portion has a first outer radius and the sheath has a second inner radius, and the second inner radius is larger than the first outer radius.

23. The method according to claim 14, wherein the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 50-150 mmHg.

24. The method according to claim 14, wherein the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 70-110 mmHg.

25. The method according to claim 14, wherein the expanded balloon component provides pressure to the hemorrhage and the pressure provided by the expanded balloon component is about 90 mmHg.

26. The method according to claim 14, wherein the at least one fastener is a surgical suture.

27. A method of treating a hemorrhage with a device that includes: a tube portion with at least one aperture, a fluid connector, and a balloon component, the method comprising: securing the balloon component to the tube portion by at least one fastener;

placing the device in a hemorrhage area;

injecting fluid into the tube portion via fluid connector, wherein the fluid exits the tube portion through the at least one aperture to fill up the balloon component; and

expanding the balloon component by filling it up with the fluid under pressure; wherein the expanded balloon component applies pressure in order to treat the hemorrhage area.

28. The method of claim 27, further comprising receiving haptic feedback verifying proper placement of the device.

29. The method according to claims 27 or 28, wherein the device is for treating a postpartum hemorrhage in the uterus.

30. The method of claim 27, wherein the device further comprises a sheath, and the method further comprises moving the sheath so that it covers at least a portion of the balloon component.

31. The method according to claim 30, wherein the device further comprises a locking mechanism, and the method further comprises locking the sheath into place with the locking mechanism to regulate the size of the balloon upon expansion.

32. The method according to claim 31, wherein the tube portion further includes a plurality of grooves along the axial direction of the tube portion, and wherein the locking mechanism engages with at least one of the grooves when locking the sheath into place.

33. The method according to claim 30, wherein the tube portion has a first outer radius and the sheath has a second inner radius, and the second inner radius is larger than the first outer radius.

34. The method according to claim 34, further comprising using a pump for pumping the fluid through the fluid connector into the tube portion.

35. The method according to claims 27 or 34, wherein the fluid is one of a liquid and a gas.

36. The method according to claim 27, wherein the pressure provided by the expanded balloon component is about 50-150 mmHg.

37. The method according to claim 27, wherein the pressure provided by the expanded balloon component is about 70-110 mmHg.

38. The method according to claim 27, wherein the pressure provided by the expanded balloon component is about 90 mmHg.

39. The method according to claim 27, wherein the at least one fastener is a surgical suture.