DEVICE FOR TREATING UTERER BLEEDING AND METHOD OF USE THEREOF

Abstract

The present invention discloses a device 1 for treating uterine bleeding. The device 1 includes a shaft having a proximal end and a distal end with one or more lumens extending therethrough, a deployable sleeve 5 at the distal end, and / or an occlusion flange 7 between the proximal and distal ends. The device 1 is useful in a method for treating uterine bleeding, the method including inserting the distal end of the device 1 into a patient's uterus, deploying the sleeve 5 and / or deploying the flange 7 to engage against the cervix, and introducing a treatment fluid through the lumen in the shaft. Examples of treatment fluids include sclerotherapy agents or saline.

Description

[Technical field]

[0001] The present disclosure relates to the field of uterine or obstetric bleeding and to devices for treating and / or quantifying blood loss, and methods of treatment using these devices, as well as methods of quantifying blood loss. [Background technology]

[0002] Postpartum hemorrhage (PPH) is defined as cumulative blood loss of 1000 mL or more, or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after delivery. More conservative definitions of PPH may also define it as blood loss of more than 500 mL after vaginal delivery and more than 1000 mL after cesarean delivery. PPH is estimated to occur in approximately 1-3% of all deliveries, with blood loss estimated by visualization. Of note, when blood loss is measured quantitatively, the incidence of postpartum hemorrhage has increased to approximately 10% of all deliveries.

[0003] Postpartum hemorrhage is the leading cause of maternal mortality on the day of delivery. Mortality is estimated at up to 20% in some parts of the world, and common morbidities include blood transfusion, hysterectomy, thromboembolism, and postpartum anemia requiring blood or iron infusions. Risk of mortality or serious morbidity is significantly increased in black women, including risk of disseminated intravascular coagulation (DIC) and blood transfusion. Black women are more likely than non-black women to undergo hysterectomy due to postpartum hemorrhage.

[0004] Risk factors for postpartum hemorrhage include, but are not limited to, advanced maternal age, parity (multiple births), reproductive trauma, operative delivery, large for gestational age, and hypertensive syndrome. Although risk factors are predictive for some patients, abnormal bleeding can occur in patients with no known or apparent risk factors.

[0005] Abnormal uterine bleeding (AUB), also called irregular vaginal bleeding, is bleeding from the uterus that is abnormally frequent, excessively long-lasting, heavier than normal, and occurs irregularly. Symptoms include vaginal bleeding that occurs irregularly with abnormal frequency, lasts abnormally long, and is heavier than normal. The normal frequency of menstrual periods is 22-38 days. The variation in time between cycles is usually less than 21 days. Bleeding usually lasts less than 9 days and the total blood loss per cycle is less than 80 mL. Excessive blood loss of more than 80 mL can be defined as anything that adversely affects a person's quality of life. Also, bleeding for more than 6 months after menopause is considered abnormal uterine bleeding.

[0006] The underlying causes of AUB include, but are not limited to, ovulatory disorders, uterine fibroids, endometrial proliferation into the uterine wall, uterine polyps, underlying bleeding disorders, side effects from birth control, and cancer. More than one category of causes may apply in an individual case. A common classification system applied in medicine is the FIGO PALM COEIN classification system. This classification system includes nine main categories according to the acronym PALM-COEIN (pronounced "palm-koin"): polyps, adenomyosis, leiomyomas, malignancies, and hyperplasia, blood coagulation disorders, ovulatory dysfunction, endometrium, iatrogenic diseases, and unclassified. In general, members of the PALM group are distinct (i.e., structural) entities that can be diagnosed by physical or imaging techniques and / or histopathology, whereas the COEIN group relates to entities that are not defined by imaging or histopathology (i.e., nonstructural).

[0007] There is an urgent need for devices and methods that rapidly address and ameliorate postpartum hemorrhage and related conditions, as well as abnormal uterine bleeding. Summary of the Invention

[0008] The devices and methods disclosed herein fulfill these urgent needs. Thus, the present specification provides a method for rapidly stopping blood loss during postpartum hemorrhage and abnormal uterine bleeding (AUB) using the novel device described herein. The advantages include at least the following: the relative risk to the patient from the treatment process itself is minimal, the device is relatively low cost and can be easily shipped and stored where needed, any obstetric provider can easily learn to properly use the device, and no long term effects on normal uterine function are expected from the treatment methods disclosed herein.

[0009] One aspect of the disclosure includes steps 1) of providing a device including: a) a shaft having a proximal end and a distal end ("proximal" and "distal" being from the perspective of an operator of the device); b) a first lumen enclosed within the shaft having a first port at the proximal end for introducing a therapeutic fluid and a first opening at the distal end for dispensing the therapeutic fluid; c) a deployable sleeve at the distal end of the shaft; and d) an occlusion flange positioned between the proximal and distal ends of the shaft; and 2) providing a source of therapeutic fluid to the first port and 3) connecting the distal end of the device to one or more bleeding sites at or near a bleeding site. 3) inserting the deployable sleeve into a uterus of a subject suffering from postpartum hemorrhage characterized by blood vessels; 4) deploying the deployable sleeve to be positioned against a side wall of the uterus and retain the therapeutic fluid within the uterus; 5) locking the device in place by positioning the flange against the cervical fornix; and 6) introducing the therapeutic fluid through the first port, through the first lumen, out an opening in the distal shaft and into the uterus at a pressure effective to cause the therapeutic fluid to flow retrogradely into the one or more bleeding blood vessels.

[0010] Another aspect of the disclosure relates to a device for treating postpartum hemorrhage, comprising: a) a shaft having a proximal end and a distal end; b) a first lumen enclosed within the shaft, the first lumen having at the proximal end a first port for introducing a therapeutic fluid and a first valve operable to open and close the lumen, and at the distal end a first opening for dispensing the therapeutic fluid; c) a deployable sleeve at the distal end of the shaft configured for insertion through the cervix of a subject; and d) an occlusion flange positioned between the proximal and distal ends of the shaft. A syringe or other injection means can also function as the first valve. The device may further include a second lumen in the shaft having a second port at the proximal end and a second opening at the distal end for drainage.

[0011] Another related aspect of the disclosure relates to a method of treating postpartum hemorrhage comprising: 1) inserting the distal end of the device for treating postpartum hemorrhage into a uterus of a subject suffering from postpartum hemorrhage having one or more bleeding vessels; 2) providing a source of therapeutic fluid to the first port; 3) deploying the deployable sleeve to be positioned against a side wall of the uterus and to retain the therapeutic fluid within the uterus; 4) locking the device in place by positioning the flange against the cervical fornix; and 5) introducing the therapeutic fluid through the first port through the first lumen, out an opening in the distal shaft and into the uterus at a pressure effective to cause the therapeutic fluid to flow retrogradely into one or more bleeding vessels at or near a site of bleeding.

[0012] Yet another aspect of the present disclosure relates to a method of treating abnormal uterine bleeding comprising the steps of: 1) providing a device comprising: a) a shaft having a proximal end and a distal end; and b) a lumen enclosed within the shaft having a port at the proximal end for introducing a therapeutic fluid and an opening at the distal end for dispensing the therapeutic fluid; 2) providing a source of therapeutic fluid to the port; 3) inserting the distal end of the device into an external cervical os of a subject suffering from abnormal uterine bleeding characterized by one or more bleeding blood vessels at or near a bleeding site; and 4) introducing the therapeutic fluid through the port through the lumen and out the opening of the shaft at the distal end into the uterus at a pressure effective to cause the therapeutic fluid to flow retrogradely into the one or more bleeding blood vessels. The source of therapeutic fluid may be an injection means. The injection means may include a syringe.

[0013] Yet another aspect of the present disclosure relates to a device for treating abnormal uterine bleeding comprising: a) a shaft having a proximal end and a distal end, and b) a lumen enclosed within the shaft having at the proximal end a port for introducing a therapeutic fluid and a valve operable to open and close the lumen, and at the distal end an opening for dispensing the therapeutic fluid, the device may further include a conical gel tip at the distal end of the shaft.

[0014] A further related aspect of the present disclosure relates to a method of treating abnormal uterine bleeding comprising the steps of: 1) inserting the distal end of the device for treating abnormal uterine bleeding into an external cervical os of a subject suffering from abnormal uterine bleeding characterized by one or more bleeding vessels at or near a site of bleeding; 2) providing a source of therapeutic fluid to the port; and 3) introducing the therapeutic fluid through the port, through the lumen, out an opening in the shaft of the distal end and into the uterus, at a pressure effective to cause the therapeutic fluid to flow retrogradely into the one or more bleeding vessels.

[0015] Another aspect of the present disclosure includes steps 1) of providing a device including: a) a shaft having a proximal end and a distal end; b) a first lumen enclosed within the shaft having a first port at the proximal end for optionally introducing a therapeutic fluid and a first opening at the distal end for optionally dispensing the therapeutic fluid; c) a second lumen within the shaft having a second port at the proximal end and a second opening at the distal end for draining blood; d) a deployable sleeve at the distal end of the shaft; and e) an occlusion flange positioned between the proximal and distal ends of the shaft; and 3) providing a occlusion flange at the distal end of the device to produce a occlusion flange. The present invention relates to a method for determining quantitative blood loss (QBL) in obstetric bleeding, the method comprising the steps of: 2) inserting the deployable sleeve into a uterus of a subject suffering from obstetric bleeding, 3) deploying the deployable sleeve to be positioned against a side wall of the uterus and seal the uterine cavity, 4) locking the device in place by positioning the flange against the cervical vault, 5) draining blood through the second lumen in the shaft to a device configured to measure or weigh the drained blood, and optionally 6) introducing a therapeutic fluid through the first port. In the QBL method, the device may be configured to measure or weigh the drained blood and includes a receiving container, a measuring container, a weighing container, a receiving means, a measuring means or a weighing means.

[0016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure.

[0017] Further details and embodiments of the present disclosure are evident from the drawings. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a perspective view of a device for treating postpartum hemorrhage according to the present disclosure, comprising a non-deployed sleeve at the distal end of the shaft, a non-deployed and non-positioned occlusion flange at the central portion of the shaft, and means for deploying both the sleeve and the flange.

[0019] [Diagram 2] FIG. 2 is an exploded view of the device for treating postpartum hemorrhage shown in FIG. 1, illustrating the arrangement of the various components.

[0020] [Figure 3A] An external view of the device in Figure 1 is shown. [Figure 3B] FIG. 3B is a cross-sectional view of the device taken along the line indicated in FIG. 3A.

[0021] [Figure 4] 4A shows various perspective views of the device of FIG. 1, FIG. 4B shows a front view, FIG. 4C shows a rear view, FIG. 4D shows a top view, and FIG. 4E shows a bottom view.

[0022] [Diagram 5] 2 is a perspective view of the device for treating postpartum hemorrhage shown in FIG. 1 when both the deployable sleeve and the occlusion flange are expanded and deployed.

[0023] [Figure 6A] FIG. 6 shows an external view of the deployed device of FIG. [Figure 6B] 6B shows a cross-sectional view of the deployed device taken along the line identified in FIG. 6A.

[0024] [Figure 7] FIG. 2 is a schematic diagram of one embodiment of a method of the present disclosure, illustrating the step of inserting the device for treating postpartum hemorrhage shown in FIG. 1 into a patient's postpartum uterus.

[0025] [Figure 8] FIG. 1 is a schematic diagram of one aspect of the method of the present disclosure, showing a sleeve deployed against the interior sidewall of the postpartum uterus and an occlusion flange deployed and positioned against the cervical vault to lock the device in place.

[0026] [Figure 9] FIG. 3C shows a cross-sectional close-up of the distal end of the undeployed device shown in FIG. 3B.

[0027] [Figure 10] FIG. 6C shows a cross-sectional close-up of the distal end of the deployed device shown in FIG. 6B.

[0028] [Figure 11A] 1 shows a structural diagram of a non-deployed sleeve. [Figure 11B] 1 shows a view of the same undeployed sleeve including a surrounding outer cover. [Figure 11C] 13 shows a schematic diagram of a sleeve deployed to form multiple anchors. [Figure 11D] 1 shows a view of the same sleeve unfolded including a surrounding outer cover.

[0029] [Figure 12A] 1 shows a cross-sectional structural view of a non-deployed device including a non-deployed sleeve and associated slidable member with a hand grip. [Figure 12B] 1 shows a view of the same non-deployed device including an outer cover surrounding the non-deployed sleeve.

[0030] [Figure 13A] 1 shows a cross-sectional structural view of a deployed device including a deployed sleeve and associated slidable member with a hand grip. [Figure 13B] 1 shows a view of the same deployed device including an outer cover surrounding the deployed sleeve.

[0031] [Figure 14] FIG. 1 is a perspective view of a device for treating abnormal uterine bleeding (AUB) according to the present disclosure, comprising a shaft including a lumen and a conical gel tip at a distal end.

[0032] [Figure 15] FIG. 15 is an exploded view of the AUB apparatus shown in FIG. 14, showing the arrangement of the various components.

[0033] [Figure 16]16A shows various perspective views of the AUB treatment device of FIG. 14, with FIG. 16A showing an exterior view of the device, FIG. 16B showing a cross-sectional view of the device along the line identified in FIG. 16A, and FIG. 16C showing a detailed cross-sectional view of the distal end of the device.

[0034] [Figure 17] FIG. 15 is a schematic diagram of one embodiment of the method of the present disclosure, illustrating the step of inserting the AUB treatment device shown in FIG. 14 into the patient's vagina and positioning it to contact and seal the external cervical os.

[0035] [Figure 18] 13 illustrates an initial, undeployed configuration of an alternative AUB device having a balloon.

[0036] [Figure 19] 19 shows the device of FIG. 18 in a deployed configuration with the balloon inflated.

[0037] [Figure 20] 1 illustrates an initial, undeployed configuration of an alternative PPH device having a balloon.

[0038] [Figure 21] 21 shows the PPH device of FIG. 20 in a deployed configuration with the balloon inflated.

[0039] [Figure 22] FIG. 22 is another schematic diagram illustrating the relative movement of the movable handles of the device of FIGS. 20 and 21. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] As disclosed herein, several ranges of values ​​are provided. The recitation of a numerical range by endpoints includes all numbers and fractions contained in that range, as well as the recited endpoints. Unless the context dictates otherwise, it is understood that each intervening value between the upper and lower limits of that range is also specifically disclosed to the tenth of the unit of the lower limit. Each smaller range between any stated value or intervening value within a stated range and any other stated value or intervening value within that stated range is encompassed in the disclosure. The upper and lower limits of these smaller ranges may be independently included or excluded, and each range with either or both limits included is also encompassed in the disclosure, subject to the specifically excluded limit in the stated range. If one or both of the limits are included in a stated range, then ranges excluding either or both of those included limits are also included in the disclosure. The term "about" generally includes ±10% of the stated value. For example, "about 10%" indicates a range of 9% to 11%, and "about 20" means 18 to 22. Preferably, "about" includes ±6% of the stated value. Alternatively, "about" includes ±5% of the stated value. Other meanings of "about" may be apparent from the context, such as rounding, so that, for example, "about 1" may mean 0.5 to 1.4.

[0041] With respect to the device, the terms "proximal" and "distal" refer to the device from the perspective of the operator, with the distal end being the end that is inserted into the vagina and the proximal end being closest to the operator.

[0042] Unless otherwise defined, all terms used in the disclosure of this disclosure, including technical and scientific terms, have the meaning commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0043] One embodiment of the device of the present invention is shown in Figures 1-6 and 9-13. Thus, the postpartum hemorrhage treatment device 1 includes a shaft member 2 containing one or more lumens, an end cap member 3, an externally coated non-deployed sleeve member 5, a non-deployed occlusion flange member 7, a slidable segment member 9, a hand grip member 11, a proximal end cap member 12 having ports to the lumens, an injection line member 13 feeding a first lumen in the shaft, a drain line member 15 connected to a second lumen in the shaft for drainage, a pressure gauge member 17, an injection member 19 such as a syringe or bag, and a valve member 21 on the drain line, which may be a pinch clamp. See Figures 1, 2 and 4A-4E. Figures 9, 11A, 11B, 12A and 12B show detailed views of the components of the non-deployed postpartum hemorrhage treatment device. The structural diagram in Figure 11A shows the structural configuration 40 of the lower portion of the undeployed sleeve with the cover removed, and Figure 11B shows the undeployed sleeve with the cover added. The structural diagram in Figure 12A shows the configuration of the lower portion of the undeployed closure flange with the cover removed, and Figure 12B shows the undeployed closure flange with the cover. The structural diagram in Figure 11C shows the configuration of the lower portion of the deployed sleeve with the cover removed, and Figure 11D shows the deployed sleeve including the cover. The structural diagram in Figure 13A shows the configuration of the lower portion of the deployed flange with the cover removed, and Figure 13B shows the deployed flange with the cover.

[0044] The occlusion flange may further include an outer cover. The outer cover may include a flexible stretchable membrane, such as a silicone rubber membrane, and may further include gripping pads or gripping tabs 8 made of the same silicone rubber material. Alternatively, the gripping pads may include a different rubber material. These gripping pads allow the flange to contact the cervical tissue without irritating or damaging the cervical tissue. The flange's anchors may be deployed to lock the outer cover in place by gripping and sealing the outer cover against the cervix. In one embodiment, when the flange is deployed open, it resembles an inverted umbrella.

[0045] For the deployed configuration of the device, reference may be made to Figures 5, 6A and 6B. Figures 10, 11C, 11D, 13A and 13B show detailed views of the components of the deployed postpartum hemorrhage treatment device 10, in which the non-deployed sleeve 5 (including the outer cover) is deployed to form the deployed sleeve 50 (including the outer cover), and the non-deployed occlusion flange 7 (including the outer cover with grip pads 8) is deployed to form the deployed occlusion flange 70 (including the outer cover with grip pads 80).

[0046] Another embodiment of the device of the present invention is shown in Figures 14 to 16. Thus, a (non-pregnancy related) abnormal uterine bleeding (AUB) treatment device 1' includes a shaft member 2'' containing a single lumen, a conical gel tip member 3', a proximal end cap member 12' having a port to the lumen, an injection line member 13 feeding the lumen in the shaft, a pressure gauge member 17, and an injection member 19, such as a syringe.

[0047] The cone shape of the tip 3' is designed to form a seal with the external cervical os. The tip comprises an elastic gel that conforms to the external cervical os to provide a seal with manual pressure. The elastic gel is a molded gel that can conform to the size and shape of the cervix, form a watertight seal and provide a comfortable surface, and may comprise, for example, latex-free silicone rubber. Features identified in the drawings are labeled as follows: 1. The non-deployed device of the present disclosure 1' Another device of the present disclosure 2. A shaft containing one or more lumens 2' Shaft exposed after unfolding sleeve and / or closure flange 2'' shaft with single lumen 3 Distal End Cap 3' Distal Conical Gel Tip 4. Structural composition of non-deployable sleeves 4' Structural configuration of the non-deployed blocking flange 5 Non-deployed sleeve including outer cover 6. Bend points of non-deployable sleeve structure 6' Bend point of the structure of the non-deployed closure flange 7. Non-expanded occlusion flange 8 Grip pads (tabs) on non-deployed occlusion flange covers 9 Slidable member on shaft 10. Deployed Device of the Present Disclosure 11 Hand grip on slidable member 12 Proximal end cap with port to lumen 12' Proximal end cap with port to single lumen 13 Injection line supplying the first lumen in the shaft 15 Drainage line connected to a second lumen in the shaft for drainage 17 Pressure gauge 19 Injection means (syringe or bag) 21 Valve (pinch clamp) 30 Holes or holes in the distal end cap that allow flow out of and into the lumen of the shaft 40 Structural configuration of the deployed closure flange 50 Expanded sleeve including outer cover 70 Expanded occlusion flange including outer cover with grip pad 80 Grip pads on deployed occlusion flange cover 100 patient uteruses 110 Inner wall of uterus 120 Cervix AUB device with 200 balloons 202 Shaft of device 200 203 Distal end cap of device 200 212 Proximal end cap of device 200 213 First injection port of device 200 214 Second injection port of device 200 230 at least one lumen of the device 200 260 Balloon of device 200 261 Hollow tube of device 200 300 PPH device with balloon 302 Inner shaft of device 300 303 Distal end cap of device 300 309 Movable shaft of device 300 311 Ergonomic handle of device 300 312 Proximal end cap of device 300 313 First injection port of device 300 314 Second injection port of device 300 315 Drain port of device 300 330 At least one lumen of the device 300 350 Deformable cup of device 300 360 Balloon of device 300 361 Hollow tube of device 300 370 flange of device 300 371 Lower part of flange 370 372 End of flange 370

[0048] One embodiment of a method of using the device of the present disclosure is as follows. Thus, a postpartum hemorrhage treatment device according to the present disclosure is inserted into the vagina of a postpartum patient suffering from postpartum hemorrhage and actuated as follows: The distal end of the undeployed device 1 (FIG. 1) is inserted and positioned within the bleeding uterus of the postpartum patient as shown in FIG. 7. The deployable sleeve 5 is deployed against the uterine sidewall 110 to form the deployed sleeve 50 (FIG. 8), thereby sealing the interior of the uterus. The device is subsequently or simultaneously locked in place by deploying the occlusion flange 7 (FIG. 1) to form the deployed flange 70 (FIG. 8), and positioned against the cervix 120. In one embodiment, both the sleeve and flange are deployed and positioned simultaneously, for example, by moving the slidable member 9 toward the distal end of the device using the hand grip member 11. See FIGS. 5 and 8. FIG. 5 shows the exposed shaft segment 2′ after deployment of the sleeve and occlusion flange. Deployment is completed by bending the undeployed 5 and 7 at bending points 6 and 6', respectively (see Figs. 11A-11D, 12A, 12B, 13A and 13B) to form 50 and 70, locking the device in place (Fig. 8). Grip pads 80 on the deployed occlusion flange cover serve to hold the device in place without damaging or irritating the sensitive cervical tissue. Thereafter, an injection means 19, e.g., a syringe, introduces the therapeutic solution through the injection line 13 into the first lumen of the shaft 2, out the first opening at the distal end and into the uterus via the hole 30 in the end cap 3. The therapeutic solution is maintained at an appropriate pressure to flow back into one or more bleeding vessels, and the pressure is monitored by a pressure gauge 17.

[0049] After treatment, excess solution and any blood can be drained through holes 30 in end cap 3 and into a second lumen in shaft 2 back into drain line 15 for drainage and safe waste disposal. Drainage can be achieved naturally by opening a valve (pinch clamp 21) or by vacuum suction, or both. In at least one embodiment, suction is applied to drain line 15 by a suction valve or pump (not shown).

[0050] Preferably, gripping pads are applied to the occlusion flange cover in the area where the flange contacts the cervix. These gripping pads may comprise the same elastomer as the flexible stretchable membrane covering the occlusion flange, such as a silicone rubber elastomer, or alternatively, may comprise a different elastomer. Anchors on the padded flange deploy to seal the outer cover against the cervix, thereby locking the outer cover in place without irritating and damaging the cervical tissue. In one embodiment, when the covered occlusion flange is opened and deployed, the flange resembles an inverted umbrella.

[0051] Another embodiment of a method of using the device of the present disclosure is as follows. Thus, an AUB treatment device corresponding to the present disclosure is inserted into the vagina of a patient suffering from (non-pregnancy related) abnormal uterine bleeding and operated as follows: As shown in FIG. 17, the distal end of the device 1' (FIG. 14) is inserted into the vagina and positioned against the patient's external cervical os. The practitioner applies manual forward pressure with the shaft 2'' of the device to seal the conical gel tip against the external cervical os. Thereafter, an injection means 19, e.g., a syringe, introduces a treatment solution through the injection line 13 into the lumen of the shaft 2'', out the conical gel tip 3' through the cervical canal and into the uterine cavity. The treatment solution is maintained at an appropriate pressure to cause reflux into one or more bleeding vessels, while pressure is monitored by the pressure gauge 17.

[0052] After treatment is complete, the device is removed and the treatment solution and blood are allowed to drain naturally.

[0053] One aspect of the disclosure includes steps 1) of providing a device including: a) a shaft having a proximal end and a distal end; b) a first lumen enclosed within the shaft having a first port at the proximal end for introducing a therapeutic fluid and a first opening at the distal end for dispensing the therapeutic fluid; c) a deployable sleeve at the distal end of the shaft; and d) an occlusion flange positioned between the proximal and distal ends of the shaft; and 2) providing a source of therapeutic fluid, optionally including a sclerotherapy agent, to the first port; and 3) connecting the distal end of the device to a sclerotherapy vessel characterized by one or more bleeding blood vessels at or near a bleeding site. 3) inserting the deployable sleeve into the uterus of a subject suffering from postpartum hemorrhage; 4) deploying the deployable sleeve so as to be positioned against a side wall of the uterus and retain the therapeutic fluid within the uterus; 5) locking the device in place by positioning the flange against the cervical fornix; and 6) introducing the therapeutic fluid through the first port, through the first lumen, out an opening in the distal shaft and into the uterus at a positive pressure effective to cause the therapeutic fluid to flow retrogradely into the one or more bleeding blood vessels.

[0054] In the method of treating postpartum hemorrhage, the source of therapeutic fluid may be an injection means. The injection means may include a syringe. In the method of treating postpartum hemorrhage, the deployable sleeve may be configured to expand radially from the shaft upon deployment. The deployable sleeve may further include a number of anchors that expand circumferentially to seal the uterine cavity. The deployable sleeve may further include an outer cover. The outer cover may include a flexible stretchable membrane, such as a silicone rubber membrane. The anchors of the deployable sleeve may deploy to seal the outer cover within the uterine cavity. In one embodiment, the open deployment provides an umbrella-like opening. The deployable sleeve may be manually deployed or actuated by pressure of the therapeutic fluid.

[0055] In the method of treating postpartum hemorrhage, the occlusion flange may be slidable along the shaft of the device. The occlusion flange is a retention means that locks the device in place and retains the injected therapeutic fluid in the uterus at a desired positive pressure so that the therapeutic fluid penetrates the bleeding vessels. The flange may be ring-shaped or cone-shaped and may include two circular arcs. The flange may include a bendable member that bends with ribs that define a cone-shaped pattern when deployed by bending. Referring to the undeployed segment 7 in FIG. 1, this segment 7 is bent to become the deployed segment 70 in FIG. 5. The occlusion flange may further include an outer cover. The outer cover may include a flexible stretchable membrane, such as a silicone rubber membrane, and may include gripping pads or tabs made of the same or different silicone rubber material. These gripping pads allow the flange to contact and grip the cervical tissue without irritating or damaging the cervical tissue. The flange's anchors can deploy to lock the outer cover in place by sealing it against the cervix. In one embodiment, by unfolding and deploying, the anchor resembles an inverted umbrella.

[0056] In the method of treating postpartum hemorrhage, the device may further include a second lumen in the shaft having a second port at the proximal end and a second opening for drainage at the distal end. The shaft may include a second lumen in the shaft. The second lumen may be parallel to the first lumen. The second lumen may surround the first lumen.

[0057] When using the above device in the method for treating postpartum hemorrhage, an appropriate intrauterine positive pressure should be maintained. The intrauterine pressure is preferably maintained at about 10 to about 100 mmHg, or about 10 to about 60 mmHg, or about 15 to about 55 mmHg, or about 20 to about 50 mmHg, or about 25 to about 45 mmHg, or about 30 to about 40 mmHg, or about 30 to about 60 mmHg, or about 30 to about 100 mmHg, or about 50 to about 100 mmHg. The intrauterine pressure may be about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or about 100 mmHg. More preferably, an intrauterine pressure of at least about 30 mmHg is maintained. In most cases, the optimal pressure window for treatment is about 73 mmHg to about 88 mmHg. For some target applications, the practitioner may set a target pressure of about 80 mmHg with a variance of + / - 8 mmHg.

[0058] In the method of treating postpartum hemorrhage, the first lumen of the device may further include a first valve operable to open and close the lumen. A syringe or other injection means may also function as the first valve. The second lumen may further include a second valve operable to open and close the lumen. The second valve may include a pinch clamp.

[0059] In the above method, the sclerotherapy agent may be a vascular sclerosing agent. The sclerotherapy agent includes detergents such as sodium tetradecyl sulfate, polidocanol, sodium morrhuate, and ethanolamine oleate, osmotic agents such as hypertonic sodium chloride solution and sodium chloride solution containing dextrose, and chemical irritants such as chromated glycerin and polyiodine. The sclerotherapy agent preferably includes polidocanol.

[0060] Depending on the patient's condition and the extent of bleeding, an appropriate amount of sclerotherapy treatment solution is injected. The appropriate amount of sclerotherapy solution to be used may be determined based on the volume of the intrauterine cavity of a particular patient. The treatment dose will vary depending on the anatomy of a particular patient and the tone of the uterine muscle at the time of treatment. This amount may be determined by the attending practitioner based on observations during the course of treatment. In some patients, a second solution of about 0.9% saline may be injected into the patient after administration of the sclerotherapy solution to increase the dosage and completely fill the larger volume of the intrauterine cavity.

[0061] In the method of treating postpartum hemorrhage, the source of therapeutic fluid may further include a reservoir, which may be integral with the device or may be separate and connected to the device prior to dispensing of the therapeutic fluid.

[0062] The above method of treating postpartum hemorrhage may further include the step of administering a second therapeutic agent.

[0063] Another aspect of the present disclosure relates to a device for treating postpartum hemorrhage comprising: a) a shaft having a proximal end and a distal end; b) a first lumen enclosed within the shaft, the first lumen having at the proximal end a first port for introducing a therapeutic fluid and a first valve operable to open and close the lumen, and at the distal end a first opening for dispensing the therapeutic fluid; c) a deployable sleeve at the distal end of the shaft configured for insertion through a subject's cervix; and d) an occlusion flange positioned between the proximal and distal ends of the shaft. A syringe or other injection means can also function as the first valve.

[0064] The device for treating postpartum hemorrhage may further include a second lumen in the shaft. The second lumen may be parallel to the first lumen. The second lumen may surround the first lumen. The deployable sleeve may further include an external (membrane) cover. The external cover may include a silicone rubber membrane. The deployable sleeve may further include a plurality of anchors that expand circumferentially to seal the uterine cavity. The occlusion flange may be slidable along the shaft. The device may further include a second lumen in the shaft having a second port at the proximal end, a second opening at the distal end for drainage, and a second valve. The device may further include a source of therapeutic fluid, optionally including a sclerotherapy agent, which provides the therapeutic fluid to the first port. The sclerotherapy agent may be a vascular sclerotherapy agent. The sclerotherapy agent may include and / or be polidocanol.

[0065] One related aspect of the disclosure is a method of treating postpartum hemorrhage comprising steps 1) inserting the distal end of the device for treating postpartum hemorrhage into a uterus of a subject suffering from postpartum hemorrhage having one or more bleeding vessels, 2) providing a source of therapeutic fluid, optionally including a sclerotherapy agent, to the first port, 3) deploying the deployable sleeve to be positioned against a side wall of the uterus and to hold the therapeutic fluid within the uterus, 4) locking the device in place by positioning the flange against the cervical vault, and 5) introducing the therapeutic fluid through the first port through the first lumen, out an opening in the distal shaft and into the uterus at a positive pressure effective to cause the therapeutic fluid to flow retrogradely into one or more bleeding vessels at or near the site of bleeding, the method optionally further comprising the step of administering a second therapeutic agent.

[0066] Yet another aspect of the present disclosure relates to a method of treating abnormal uterine bleeding comprising the steps of: 1) providing a device comprising: a) a shaft having a proximal end and a distal end; and b) a single lumen enclosed within the shaft having a port at the proximal end for introducing a treatment fluid and an opening at the distal end for dispensing the treatment fluid, 2) providing a source of treatment fluid, optionally including a sclerotherapy agent, to the port; 3) inserting the distal end of the device into the cervical os of a subject suffering from abnormal uterine bleeding characterized by one or more bleeding blood vessels at or near a bleeding site; and 4) introducing the treatment fluid through the port through the lumen and out the opening of the shaft at the distal end into the uterus at a positive pressure effective to cause the treatment fluid to flow retrogradely into the one or more bleeding blood vessels. Preferably, the distal end of the shaft comprises a conical tip designed to form a seal with the cervical os. The conical tip preferably comprises a soft elastic gel that conforms to the cervical os to provide a seal with manual pressure. The elastic gel is a molded gel that can conform to the size and shape of the cervix, form a waterproof seal and provide a comfortable surface, and may include, for example, latex-free silicone rubber. The source of the therapeutic liquid may be an injection means. The injection means may include a syringe.

[0067] In the above method of treating abnormal uterine bleeding, the intrauterine positive pressure may be maintained at about 10 to about 100 mmHg, or about 10 to about 60 mmHg, or about 15 to about 55 mmHg, or about 20 to about 50 mmHg, or about 25 to about 45 mmHg, or about 30 to about 40 mmHg, or about 30 to about 60 mmHg, or about 30 to about 100 mmHg, or about 50 to about 100 mmHg. The intrauterine pressure may be about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or about 100 mmHg. In most cases, the optimal pressure window for treatment is about 73 mmHg to about 88 mmHg. In some target applications, the practitioner may set a target pressure of approximately 80 mmHg with a variance of + / - 8 mmHg.

[0068] In the method of treating abnormal uterine bleeding, the lumen may include a valve operable to open and close the lumen. A syringe or other injection means may also function as the first valve.

[0069] In the method of treating abnormal uterine bleeding, the sclerotherapy agent may be a vascular sclerosing agent. Sclerosing agents include detergents such as sodium tetradecyl sulfate, polidocanol, sodium morrhuate, and ethanolamine oleate, osmotic agents such as hypertonic sodium chloride solution, sodium chloride solution containing dextrose, and chemical irritants such as chromated glycerin and iodine polyiodide. The sclerotherapy agent preferably includes polidocanol. In the method of treating abnormal uterine bleeding, the source of therapeutic fluid may further include a reservoir configured to hold and contain the therapeutic fluid (sclerotherapy agent) until administration. The reservoir (not shown) may be integral with the device or may be separate so as to be connected to the device prior to dispensing the therapeutic fluid.

[0070] The above method of treating abnormal uterine bleeding may further include the step of administering a second therapeutic agent.

[0071] Yet another aspect of the present disclosure relates to a device for treating abnormal uterine bleeding comprising: a) a shaft having a proximal end and a distal end; and b) a lumen enclosed within the shaft having at the proximal end a port for introducing a therapeutic fluid and a valve operable to open and close the lumen, and at the distal end an opening for dispensing the therapeutic fluid. Preferably, the device may further include a conical gel tip at the distal end of the shaft.

[0072] A further aspect of the present disclosure relates to a method of treating abnormal uterine bleeding comprising steps 1) inserting the distal end of the device for treating abnormal uterine bleeding into a uterus of a subject suffering from abnormal uterine bleeding characterized by one or more bleeding vessels at or near a bleeding site; 2) providing a source of therapeutic fluid, optionally including a sclerotherapy agent, to the port; and 3) introducing the therapeutic fluid through the port, through the lumen, out an opening in the shaft of the distal end and into the uterus, at a positive pressure effective to cause the therapeutic fluid to flow retrogradely into the one or more bleeding vessels. The intrauterine pressure is preferably maintained at about 10 to about 100 mmHg, or about 10 to about 60 mmHg, or about 15 to about 55 mmHg, or about 20 to about 50 mmHg, or about 25 to about 45 mmHg, or about 30 to about 40 mmHg, or about 30 to about 60 mmHg, or about 30 to about 100 mmHg, or about 50 to about 100 mmHg. The intrauterine pressure may be about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or about 100 mmHg. In most cases, the optimal pressure window for treatment is about 73 mmHg to about 88 mmHg. In some target applications, the practitioner may set a target pressure of about 80 mmHg with a variation of + / - 8 mmHg.

[0073] Another aspect of the present disclosure includes steps 1) of providing an apparatus including: a) a shaft having a proximal end and a distal end; b) a first lumen enclosed within the shaft having a first port at the proximal end for optionally introducing a therapeutic fluid and a first opening at the distal end for optionally dispensing the therapeutic fluid; c) a second lumen within the shaft having a second port at the proximal end and a second opening at the distal end for draining blood; d) a deployable sleeve at the distal end of the shaft; and e) an occlusion flange positioned between the proximal and distal ends of the shaft; and 3) providing an occlusion flange positioned between the proximal and distal ends of the shaft and a first lumen enclosed within the shaft having a first port at the proximal end for optionally introducing a therapeutic fluid and a first opening at the distal end for optionally dispensing the therapeutic fluid. The present invention relates to a method for determining quantitative blood loss (QBL) in obstetric bleeding, the method comprising: 2) inserting a deployable sleeve into a uterus of a subject undergoing obstetric bleeding; 3) deploying the deployable sleeve to be positioned against the side wall of the uterus and seal the uterine cavity; 4) locking the device in place by positioning the flange against the vault of the cervix; 5) draining blood through the second lumen in the shaft to a device configured to measure or weigh the drained blood; and 6) optionally introducing a treatment fluid including a sclerotherapy agent through the first port. In the QBL method, the device may be configured to measure or weigh the drained blood and includes a receiving container, a measuring container, a weighing container, a receiving means, a measuring means or a weighing means. It should be understood that in some embodiments of the QBL method, the device may be inserted transvaginally / transcervically for the sole purpose of measuring gross blood loss. That is, in some embodiments, no treatment fluid is required since the only purpose is to quantify blood loss.

[0074] In those embodiments where a treatment liquid is applied, the source of treatment liquid for the method of determining QBL in obstetric bleeding may be an injection means. The injection means may include a syringe, and the treatment liquid does not necessarily require a specific drug, but rather may be a sterile solution such as saline, rather than a sclerotherapy agent. Nevertheless, a sclerotherapy agent may be used as a treatment liquid. The deployable sleeve of the device may be configured to expand radially from the shaft upon deployment. The deployable sleeve may include a number of anchors that expand circumferentially to seal the uterine cavity. The deployable sleeve may be manually deployed or actuated by pressure of the treatment liquid. The occlusion flange of the device may be slidable along the shaft. The second lumen of the device may be parallel to the first lumen. The second lumen of the device may surround the first lumen. The deployable sleeve of the device may further include an outer (membrane) cover. The outer membrane cover may include a silicone rubber membrane. Anchors of the device may deploy to seal the outer cover within the uterine cavity. The first lumen of the device may include a first valve operable to open and close the lumen. A syringe or other injection means may also function as the first valve. The second lumen may include a second valve operable to open and close the lumen. As mentioned above, a sclerotherapy agent for the QBL method may be a vascular sclerotherapy agent, although in some treatments, the administered drug may be a vascular sclerotherapy agent, and in some cases, no specific drug is required. The sclerotherapy agent may be a vascular sclerotherapy agent. The sclerotherapy agent may include polidocanol.

[0075] The QBL method may further comprise the step of administering a second therapeutic agent. EXAMPLES

[0076] The following examples are illustrative of the present disclosure and are not intended to limit its scope in any way.

[0077] < Example 1 Devices to treat postpartum hemorrhage> The device of FIG. 1 is assembled as shown in FIG. 2 and includes a shaft 2 including one or more lumens, a distal end cap 3, a non-deployable sleeve 5 including an outer covering, a non-deployable occlusion flange 7 having an outer covering, a slidable segment member 9, a hand grip 11 on the slidable segment, a proximal end cap 12 having ports to the lumens, an injection line 13 feeding a first lumen in the shaft, a drain line 15 connected to a second lumen in the shaft, a pressure gauge 17, a syringe 19, and a pinch clamp 21.

[0078] < Example 2 How to treat postpartum hemorrhage > As shown in FIG. 7, the device of Example 1 is inserted and positioned in the bleeding uterus of a postpartum patient. The expandable sleeve 5 is deployed against the side wall 110 of the uterus to form the deployed sleeve 50 (FIG. 8), thereby sealing the interior of the uterus. At the same time, the occlusion flange 7 is deployed to form 70 (FIG. 8) and positioned against the cervix 120 to lock the device in place. The treatment solution is then introduced by the syringe 19 through the injection line 13 into the first lumen of the shaft 2, out the first opening at the distal end, and through the end cap 3 into the uterus (see FIG. 6A). The treatment solution is maintained at an appropriate pressure, as measured by the pressure gauge 17, to reflux into one or more bleeding vessels. The intrauterine pressure is maintained at about 10 to about 100 mmHg. After treatment, excess treatment solution and any blood is discharged through the end cap 3 into the second lumen in the shaft 2 and into the drainage line 15 for drainage and safe waste disposal.

[0079] < Example 3 Devices to treat abnormal uterine bleeding> The AUB device of FIG. 14 is assembled as shown in FIG. 15 and includes a shaft 2″ containing a lumen, a distal conical gel tip 3′, a proximal end cap 12′ having a port to the lumen, an injection line 13 feeding the lumen in the shaft, a pressure gauge 17, and a syringe 19.

[0080] < Example 4How to Treat (Non-Pregnancy Related) Abnormal Uterine Bleeding > As shown in FIG. 17, the device of Example 3 is inserted and positioned in the vagina of a patient suffering from (non-pregnancy related) abnormal uterine bleeding. Thus, the distal end of the AUB device 1' is inserted into the vagina and positioned against the patient's external cervical os. The practitioner manually applies forward pressure with the shaft 2'' of the device to seal the conical gel tip against the external cervical os to provide a pressure seal. The treatment solution is then introduced by injection means 19, e.g., a syringe, through the injection line 13 into the lumen of the shaft 2'', out the conical gel tip 3' through the cervical canal and into the uterine cavity. The treatment solution is maintained at an appropriate pressure to reflux into one or more bleeding vessels, as monitored by the pressure gauge 17. The pressure should be maintained at about 10 to about 100 mmHg. After treatment is completed, the device is removed, allowing drainage of the treatment solution and blood to occur naturally.

[0081] < Additional Balloon Embodiments > 18 and 19 show another embodiment of the AUB device 200. The device 200 may be similar to the PPH device described above and shown in FIGS. 14-16C. The device 200 may have the same, similar, and / or substantially the same features, components, and functions as described above. Additionally, the device 200 may further include a means for deploying a balloon 260 within the patient's uterus 100. Accordingly, duplicated descriptions have been omitted or simplified, and the same reference numerals have been used wherever possible, e.g., the number 200 in the embodiment of the underlying device may be added to previously described components having similar structural characteristics and / or functions.

[0082] FIG. 18 illustrates an initial, undeployed configuration of the AUB device 200, and FIG. 19 illustrates a deployed configuration of the AUB device 200. Referring generally to FIGS. 18-19, the AUB device 200 may include a shaft member 202 having a generally elongated cylindrical shape. In various embodiments, the shaft member 202 may be a hollow tube that serves as a housing for various internal components, which will be described in more detail below. In one example, the shaft member 202 may serve as a housing for other components and / or a conduit for delivering therapeutic fluids to or draining fluids from the patient's uterus. The shaft member 202 may include a distal end cap 203 having at least one lumen 230 at its distal end, and a proximal end cap 212 at its proximal end. In this embodiment, the distal end cap 203 is a cone-shaped flexible member that functions to form a seal with the cervix and direct therapeutic fluids through the at least one lumen 230 and into the uterine cavity from the cervical canal. The distal end cap 203 may be formed of any suitable biocompatible material, such as a gel of material, such as silicone, an elastomeric material, or a substance having properties such as semi-fluid. These material properties facilitate and / or allow the end cap 203 to conform to various anatomical shapes of the external cervical os (opening). This structure and material properties can function to form a fluid-tight seal that allows treatment fluid to be introduced into the cavity at a desired pressure range, and to allow that pressure to be maintained for the duration of the treatment cycle, i.e., over an extended period of time.

[0083] In other embodiments, the multiple lumens 230 may be distributed around the exterior surface of the distal end cap 203. As shown, the distal end cap 203 has a maximum width at its portion coupled to the shaft member 202 that is close to the width of the shaft member 202. In other embodiments, the distal end cap 203 may have a maximum width at its portion coupled to the shaft member 202 that is greater than (or less than) the width of the shaft member (not shown). In that sense, it is contemplated that various embodiments according to the principles disclosed herein may include multiple different sizes of distal end caps 203 having sizes and shapes that generally correspond to a particular patient. For example, a younger patient who has not delivered a fetus may require a relatively smaller distal end cap 203 than an older patient who has delivered a fetus.

[0084] In use, a practitioner can deliver therapeutic fluid from the proximal end cap 212 through the end cap 203 by any of the means previously disclosed. In this embodiment, the proximal end cap 212 may include a first injection port 213 for delivering therapeutic fluid into the uterine cavity and a second injection port 214 for delivering fluid to the balloon 260. In various embodiments, the first injection port 213 may be used to deliver therapeutic fluid directly into the interior cavity of the shaft 202 and out of the at least one lumen 230. Alternatively, the first injection port 213 may be used to deliver therapeutic fluid to an internal delivery channel that is in fluid communication with the at least one lumen 230.

[0085] Unlike the previously described embodiments, a hollow tube 261 (also referred to as a pipe or channel) can extend through and / or from the distal end cap 203 and support the inflatable balloon 260 at its distal end. The hollow tube 261 can be a flexible member that is resistant to deformation during insertion. Alternatively, the hollow tube 261 can be a thin, substantially rigid member. In this embodiment, the hollow tube 261 is in fluid communication with the second injection port 214. For example, an internal tube extending longitudinally through the shaft 202 can be connected to the second injection port 214 and the hollow tube 261. In this manner, the practitioner can inflate the balloon 260 by injecting fluid through the second injection port 214 by any of the previously disclosed injection means, e.g., a syringe or pump.

[0086] In at least one exemplary method of use, the practitioner may use a syringe to inject saline into the balloon 260. Additionally, the practitioner may take care to inject an appropriate amount of saline to expand the balloon 260 to a particular volume, taking into account the relative intrauterine cavity volume of the particular patient being treated. Furthermore, the balloon 260 may be injected with saline before and / or after the therapeutic fluid is injected through the first injection port 213, but in either case, the balloon 260 is inflated after being positioned within the uterus. At least one advantage of this embodiment is that the inflated balloon 260 may reduce the amount of fluid required to fill the intrauterine cavity. For example, by reducing the void space within the uterine cavity, a relatively smaller amount of therapeutic fluid is required to fill the intrauterine cavity. This helps, among other things, to reduce the associated costs of the targeted therapeutic fluid. In some embodiments, the balloon 260 may serve a non-therapeutic purpose. For example, the balloon 260 may be inflated to such an extent that it does not push against the uterine wall (or at least only slightly contacts a very small portion of the uterine wall) and / or only slightly changes the internal pressure of the therapeutic fluid against the uterine wall. In other embodiments, the balloon 260 may be used for therapeutic purposes in that it is inflated to push against the uterine wall and directly affect the internal pressure of the therapeutic fluid against the uterine wall. In at least one therapeutic example method of use, the practitioner may selectively inflate and / or deflate the balloon 260 to maintain an ideal internal pressure within the uterine cavity over time. In at least some cases, this example may be performed simultaneously with the delivery of the therapeutic fluid into the uterine cavity.

[0087] Figures 20-22 show another embodiment of a PPH device 300. Figure 20 shows a first view of the PPH device in an undeployed configuration. Figure 21 shows a second view of the PPH device of Figure 19 when in a deployed configuration. Figure 22 shows another view that generally illustrates the relative movement of the movable handles of the device of Figures 20 and 21.

[0088] The device 300 may be similar to the PPH device previously described and shown in Figures 1-6 and 9-13. The device 300 may also be similar to the AUB device described above in Figures 18-19. The device 300 may have the same, similar, and / or substantially the same features, components, and functions as described above. Additionally, the device 300 may further include a means for deploying a balloon within the patient's uterus 100. Accordingly, duplicated descriptions are omitted or simplified, and the same reference numerals are used wherever possible, for example, the number 300 in the base embodiment may be added to the previously described components having similar functions.

[0089] 20-22, an alternative PPH treatment device 300 is disclosed. As shown, the device 300 may include an inner shaft 302 coupled to a distal end cap member 303 and a proximal end cap member 312. The inner shaft 302 may be a hollow tube that serves as a housing for various internal components, which will be described in more detail below. In one example, the shaft member 302 may serve as a housing for other components and a conduit for delivering and / or removing treatment fluids. The shaft member 302 may include a distal end cap 303 having at least one lumen 330 at its distal end and a proximal end cap 312 at its proximal end. In this embodiment, the distal end cap 303 is a hemispherical member having multiple lumens 330 for delivering treatment fluids to the patient. In some embodiments (not shown), the distal end cap 303 may further include at least one lumen 330 for removing fluids from the patient. For example, fluid may be removed from the patient by returning fluid to the hollow shaft member 302 via a dedicated lumen 330 and exiting through the exit port 315. In various embodiments, fluid may be removed by applying suction pressure to the exit port 315, for example, using a valve, vacuum, syringe, or the like. Applying suction or pressure to draw fluid from the patient's uterus is particularly advantageous when the patient's uterus is atonic. At least one example of having a dedicated drainage means may be to allow the practitioner to observe the amount of blood loss and / or therapeutic fluid being drained by the device 300. As shown, the distal end cap 303 has a maximum width at the portion coupled to the shaft member 302 that allows the distal end cap 303 to be at least partially inserted into the patient's cervix and / or uterus (see FIG. 7).

[0090] In an exemplary embodiment, a hollow tube 361 (also referred to as a pipe or channel) may extend from the evacuation port 315 to an inner surface of the deformable cup 350. In use, the deformable cup 350 may form a seal against the patient's cervix. The deformable cup 350 may be made of any biocompatible material, such as silicone or an elastomeric material. In use, the hollow tube 361 may be used to drain fluid from the patient's uterus. Additionally, as previously described, the clamping member 21 (see FIG. 2) may be used to prevent undesired fluid drainage from the patient's uterus, and the clamping member 21 may be opened to facilitate drainage of fluid from the patient's uterus. Alternatively, fluid may be removed from the patient via a dedicated lumen 330 back to a dedicated drainage line connected to the evacuation port 315 (not shown).

[0091] In use, a practitioner may deliver therapeutic fluid to the lumen 320 of the end cap 303 by any of the previously disclosed means, such as a syringe 19 (see FIG. 5 ) in fluid communication with the proximal end cap 212. In this embodiment, the proximal end cap 312 may include a first injection port 313 for delivering therapeutic fluid into the uterine cavity, a second injection port 314 for delivering fluid to the balloon 360, and an evacuation port 315 for selectively removing fluid from the patient's uterus. In various embodiments, the first injection port 313 may be used to deliver therapeutic fluid directly to the interior cavity of the shaft 302 to pressurize it, and fluid may be expelled from the at least one lumen 330 into the patient's uterus. Alternatively, the first injection port 313 may be used to deliver therapeutic fluid to an internal delivery channel and / or tube in fluid communication with the distal end cap 303 and the at least one lumen 330. In various embodiments, the balloon 360 may be coupled to the distal most point of the distal end cap 303. For example, a connection port or nipple may be provided on the distal end cap 303 suitable for connecting the balloon 360. In use, a practitioner may inflate the balloon 360 by injecting a fluid, such as saline or other suitable liquid, into the proximal end cap 312 at the second injection port 314. For example, a dedicated injection line may extend through the hollow shaft 302 (not shown). Alternatively, a dedicated injection line may extend along the outside of the hollow shaft 302, along the inside of an outer sleeve, such as the movable shaft 309.

[0092] Unlike the previously described embodiments, the movable outer shaft 309 may surround the hollow inner shaft 302. The inner diameter of the movable outer shaft 309 may substantially approximate the outer diameter of the hollow inner shaft 302 while allowing for tolerances to allow the movable outer shaft 309 to slide freely back and forth longitudinally of the inner shaft 302. Consistent with the disclosure herein, the movable outer shaft 309 may have various integral contours to allow for dedicated fluid delivery (to the lumen 330 or balloon 360) or fluid evacuation conduits (from the cup 350 and / or hollow tube 361) depending on the particular configuration. In an exemplary embodiment, an inner tube for inflating the balloon may extend longitudinally through the inner shaft 302 and / or the movable shaft 309. In this manner, the practitioner may inflate the balloon 360 by injecting fluid through the second injection port 214 by any of the previously disclosed injection means (see syringe 19 in FIG. 5).

[0093] 22, the movable shaft 309 may be able to move (slide) back and forth longitudinally along the inner shaft 302 (see arrow in FIG. 22). The movable shaft 309 may be configured to actuate against at least one flange 370, e.g., a deformable tongue, finger, or tab. In the illustrated embodiment, two flanges 370 are visible, but it should be understood that in various embodiments, multiple flanges 370 may be included, e.g., two, three, four, five, etc. In various embodiments, the flange 370 may be coupled to the movable shaft 309 or the inner shaft 302. In at least one embodiment, the flange 370 is coupled to an intermediate portion of the inner shaft 302. In an open position where the movable shaft 309 is positioned adjacent the proximal end cap 312, the flange 370 is in a neutral position where it does not contact the cup 350. In use, the practitioner may grasp the ergonomic handle 311 (see FIG. 21) and slide the movable shaft 309 forward toward the distal end cap 303. In doing so, a lower portion 371 of the corresponding flange 370 may be clamped and / or shifted toward the inner shaft 302. In doing so, an end 372 of the corresponding flange 370 may be moved inwardly and directly into contact with the cup 350. For example, in the closed position, the movable shaft 309 may be gripped by the handle 311 and moved toward the distal end cap 303 to clamp the flange 370 (or flanges 370) thereby bringing the corresponding end 372 into direct contact with the cup 350. In this manner, the movable shaft 309 and the handle 311 are configured to bring the at least one flange 370 into direct contact with the cup 350 such that the at least one flange 370 supports the cup 350 to form a pressure-tight seal with the patient's cervix.

[0094] In another embodiment, the at least one flange 370 may be directly coupled to the end of the movable shaft 309. In this manner, the practitioner may slide the movable shaft 309 toward the distal end cap 303 so that the at least one flange 370 directly contacts the cup 350. In doing so, the at least one flange 370 may support the cup 350, thereby forming a pressure-tight seal against the patient's cervix.

[0095] Preferred embodiments of the present disclosure are described herein, including the best mode known to the inventors for carrying out the disclosure. Variations of these preferred embodiments may become apparent to those skilled in the art upon reading the foregoing description. The inventors expect such variations to be applicable to those skilled in the art, and intend to practice the present disclosure other than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements of all possible variations of this disclosure is included in the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

[0096] Although certain embodiments of the present disclosure have been described in detail above, it should be understood that this description is merely for illustrative purposes and that the above description of the present disclosure is not exhaustive. Certain features of the present disclosure are shown in some drawings and not in others, and this is for convenience, and any feature can be combined with another feature according to the present disclosure. Some variations and alternatives will be apparent to those skilled in the art. Such alternatives and variations are intended to be included in the scope of the claims. Certain features presented in the dependent claims can be combined and included within the scope of the present disclosure. The present disclosure also includes embodiments as if the dependent claims were written alternatively in the form of multiple dependent claims with reference to other independent claims.

[0097] It should be understood that the various aspects disclosed herein may be combined in different combinations than those specifically set forth in the description, accompanying figures, and claims. For example, features, functions, and components of a particular embodiment may be combined with other embodiments, and vice versa, unless the context dictates otherwise. Similarly, features, functions, and components may be omitted, unless the context dictates otherwise. It should also be understood that, by way of example, certain acts or events of any of the processes or methods described herein may be performed in a different order, added, combined, or omitted entirely (e.g., not all acts or events described may be necessary to implement the techniques).

Claims

1. A device for use in a method for treating abnormal uterine bleeding, comprising: The device comprises: a) a shaft having a proximal end and a distal end; b) a lumen enclosed within the shaft having a port at the proximal end for introducing a therapeutic fluid and an opening at the distal end for dispensing the therapeutic fluid; The method comprises: 1) providing said device; 2) providing a source of therapeutic fluid containing a sclerotherapy agent to said port; 3) inserting the distal end of the device into the external cervical os of a subject suffering from abnormal uterine bleeding characterized by one or more bleeding vessels at or near the site of bleeding; 4) introducing the therapeutic fluid through the port, through the lumen, out an opening in the distal shaft and into the uterus at a pressure effective to cause the therapeutic fluid to flow retrograde into the one or more bleeding vessels; Device.

2. The device described in claim 1, wherein the method further includes a step of inflating a balloon positioned at the distal end of the device.

3. 3. The device of claim 2, wherein the source of therapeutic fluid is an injection means, the injection means comprising a syringe.

4. The device of claim 1 , further comprising a conical gel tip at the distal end of the shaft.

5. The device described in claim 1, wherein the method further includes maintaining an intrauterine pressure of about 10 to about 100 mmHg.

6. The device described in claim 5, wherein the method further includes maintaining an intrauterine pressure of at least about 30 mmHg.

7. The device of claim 1 , wherein the lumen includes a valve operable to open and close the lumen.

8. The device of claim 1 , wherein the sclerotherapy agent is a vascular sclerosing agent.

9. The device of claim 1 , wherein the sclerotherapy agent comprises polidocanol.

10. The device of claim 1 , wherein the source of therapeutic fluid further comprises a reservoir.

11. The device of claim 10 , wherein the reservoir is integral with the device or is connected to the device prior to dispensing the therapeutic liquid.

12. The device described in claim 1, wherein the method further includes a step of administering a second therapeutic agent.

13. a) a shaft having a proximal end and a distal end; b) a conical gel tip at the distal end of the shaft; c) a device for treating abnormal uterine bleeding, comprising: a lumen at the proximal end having a port for introducing a therapeutic fluid and a valve operable to open and close the lumen; and a lumen at the distal end having an opening for dispensing the therapeutic fluid, the lumen enclosed within the shaft.

14. The device of claim 13 for use in a method for treating abnormal uterine bleeding, comprising: The method comprises: 1) inserting the distal end of the device of claim 13 into the external cervical os of a subject suffering from abnormal uterine bleeding characterized by one or more bleeding vessels at or near the site of bleeding; 2) providing a source of therapeutic fluid containing a sclerotherapy agent to said port; and 3) introducing the therapeutic fluid through the port, through the lumen, out an opening in the distal shaft and into the uterus at a pressure effective to cause the therapeutic fluid to flow retrograde into the one or more bleeding vessels. Device.

15. A method of inserting a catheter into a subject's cervix, comprising: inserting a catheter into the subject's cervix; and inserting a catheter into the subject's cervix. The device of claim 13 further comprising an occlusion flange positioned between the proximal and distal ends of the shaft.

16. An inflatable balloon disposed at the distal end of the shaft; a balloon inflation lumen for introducing fluid into the inflatable balloon; 16. The device of claim 15, further comprising a second lumen in the shaft having a second port at the proximal end and a second opening at the distal end for drainage.

17. The deployable sleeve further comprises a plurality of anchors that expand circumferentially to seal the uterine cavity; or 17. The device of claim 15 or 16, wherein the deployable sleeve further comprises an outer cover, optionally the outer cover comprising a silicone rubber membrane.

18. The shaft includes a second lumen within the shaft; 17. The device of claim 15 or 16, optionally wherein the second lumen is parallel to, and optionally surrounds, the first lumen.

19. The apparatus further comprising a source of treatment fluid including a sclerotherapy agent, the source supplying the treatment fluid to the first port; 17. The device of claim 15 or 16, wherein the sclerotherapy agent is a vascular sclerosing agent, and optionally the sclerotherapy agent comprises polidocanol.

20. An apparatus as described in claim 15 or 16, wherein the occlusion flange is slidable along the shaft.

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