Body fluid regulation device

Abstract

The fluid regulating device includes an inner tube disposed within an outer tube, with a gap between the inner tube and the outer tube, and an opening formed in the inner tube that is larger in size than the opening formed in the outer tube. A fluid adapter is sealingly coupled to a proximal portion of the inner tube. The fluid adapter includes a vacuum port adapted to be coupled to a vacuum source to generate negative pressure within the inner tube. The outer tube is adapted to be pressed against uterine tissue. An inflatable plug is disposed in the outer tube.

Description

[Technical Field]

[0001] The present invention relates to a body fluid regulating device used for treating postpartum hemorrhage and the like. [Background technology]

[0002] Obstetric hemorrhage is the most common and dangerous complication of childbirth. Traditionally, postpartum hemorrhage (PPH) has been defined as an estimated blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section. This definition was redefined by the American College of Obstetricians and Gynecologists in 2017, and is now defined as cumulative blood loss of more than 1000 mL accompanied by signs or symptoms of hypovolemia within 24 hours after delivery, regardless of route of delivery. This change recognizes that blood loss during delivery is routinely underestimated; however, blood loss exceeding 500 mL after vaginal delivery should be considered abnormal and may require intervention. Primary postpartum hemorrhage is characterized as bleeding occurring within 24 hours after delivery, while secondary postpartum hemorrhage is characterized as bleeding occurring between 24 hours and 12 weeks after delivery.

[0003] Causes of PPH include uterine atony, retained placenta, coagulation disorders, and uterine inversion. Clinically, the most common cause is uterine atony, which causes insufficient contraction of uterine muscle fibers and insufficient occlusion of the spiral arteries, resulting in uncontrollable bleeding. Summary of the Invention

[0004] The present invention aims to provide a fluid regulating device for use, for example, in the treatment of postpartum hemorrhage. Although the invention will be described in relation to a uterine bleeding regulating device, the invention can be used to regulate or stop other fluids from other organs, such as the bladder.

[0005] The device includes means for grasping, gripping, and holding uterine cavity tissue (endometrium and / or myometrium) while applying negative pressure (vacuum) to the uterine cavity, thereby evacuating blood clots and other debris from the uterus and halting bleeding by contracting the uterus and forcing contact between the uterine walls. Additional features include, but are not limited to, the injection of various fluids or other substances directly into the uterine cavity or endometrium / myometrium, including substances that enhance the force of uterine contractions.

[0006] The device includes a fixed, inflatable plug or seal, such as a balloon. The inflatable plug may be fixed or adjustable in a sliding manner and may be placed within the cervix or vagina. When inflated, the plug occludes the uterine opening, thereby securing the device in place and creating a vacuum within the uterine cavity.

[0007] The shaft of the device includes an inner tube within an outer tube with a gap between the two tubes. The inner tube has a smaller diameter than the outer tube and has an opening formed therein that is larger than the opening formed in the outer tube. The openings in the inner and outer tubes may be different in size and shape.

[0008] A vacuum source (such as a vacuum pump) is coupled to the inner tube and generates a negative pressure within the inner tube, creating a pressure differential between the inner tube and the uterine wall through the inner tube's opening, the gap between the tubes, and the outer tube's opening. This negative pressure draws the uterine wall toward the outer tube. This tube-in-tube configuration provides optimal conditions for maintaining a continuous vacuum because the uterine wall presses against the outer tube around it (portions of the uterine wall press against each other to help with hemostasis), but does not press against or abut the inner tube, thereby maintaining the vacuum within the inner tube.

[0009] The outer tube may have elongated ribs that divide the outer tube into different sections, which maintain a gap between the outer and inner tubes and prevent the outer tube from collapsing against the inner tube.

[0010] The inner and outer tube structures also serve another purpose: to form a clot filtration assembly. When the vacuum pump is activated, uterine debris, such as clots and tissue debris, and blood are drawn through the openings in the outer tube and into the larger openings in the inner tube. Debris larger than the openings in the outer tube does not pass through the outer tube and remains on or clogs the openings. As long as some openings in the outer tube remain open, the vacuum generated by the inner tube continues to collect debris, forcing the uterine wall against the outer tube and, where not overlapping, against each other. (If all openings in the outer tube become clogged, the device can be cleaned by applying positive pressure to clear the clogs or by removing and flushing.) The debris and clots are collected by suction into a collection container. This collected fluid can then be filtered and processed for reinfusion.

[0011] The shape and size of the opening can be selected to optimize debris aspiration. For example, a conical shape (larger outside to smaller inside) or an irregular shape can apply negative pressure to aspirate thrombus debris. The opening can be covered by or include a mesh or mesh-like material, which can cut or disrupt the thrombus, minimizing the chance of the thrombus completely clogging the opening.

[0012] Another non-limiting aspect of the present invention provides a gripping member that can be used not only to grip uterine tissue but also to deliver one or more drugs or other substances into the endometrium, myometrium, or uterine cavity. For example, an array of needles or rings containing curved, hidden hooks can be disposed on the shaft of the device. Each ring can independently deploy its hook. After inserting the device into the uterus and inflating the fixation balloon within the vagina or cervix and applying a vacuum to contract the uterine tissue around the device, the gripping mechanism can be manually or automatically activated to withdraw and implant the hooks into the adjacent uterine tissue (mechanical gripping). The gripping tool can fix the upper and lower walls in the correct position facing each other and prevent rotation or twisting of the tissue during vacuum activation. Drugs that enhance uterine contractility can be delivered through the gripping member, which in this case has a hollow lumen through which the drug can be injected. The gripping member can protrude to a length suitable for penetration into tissue at this anatomical location.

[0013] The retractable gripping members can have stops that allow for precise depth penetration into tissue.

[0014] Another option is to add a conical structure to the distal tip of the device, which can include a fixation member that can secure the conical structure to the fundal tissue, such as by mechanical fixation, which can be rotated to grasp the fundal portion and rotated in the opposite direction to release the fundal portion. The conical structure can also be secured to the fundal portion by vacuum, either from the same vacuum source as the inner tube or from a second vacuum source. These retractable fixation members can also be used to inject drugs into the fundal tissue or other tissues to enhance uterine contraction.

[0015] Another option is to have an atraumatic tip at the end of the shaft (the shaft is the assembly of the inner and outer tubes) to minimize the potential for tissue trauma. (The material from which the tube is made can be flexible, semi-flexible, or inert to further minimize the potential for tissue damage.) An atraumatic tip may be useful for corrective repositioning of uterine tissue, such as in cases of tissue inversion. The tip can include one or more openings to allow distal aspiration of fluids and debris.

[0016] Another option is a forceps-like instrument that is inserted into the uterine cavity. Once inside the uterus, the forceps arms are opened until they physically contact the anterior and posterior uterine walls. The arms can be secured to the uterine walls using both suction and grasping. When the forceps are closed, the anterior and posterior uterine walls fold and / or move closer together, which forces the uterus to contract and stop the bleeding. The instrument can then be removed. [Brief explanation of the drawings]

[0017] The present invention will be more fully understood and appreciated from the following detailed description when read in conjunction with the drawings. [Figure 1] FIG. 1 is a simplified diagram of a body fluid regulating device according to one non-limiting embodiment of the present invention. [Figure 2] FIG. 2 is a more detailed view of the proximal portion of the fluid regulating device. [Figure 3] FIG. 3 is a more detailed view of the inflatable plug of the fluid regulating device. [Figure 4] FIG. 4 is a more detailed view of the distal portion of the fluid regulating device. [Figure 5] Figure 5 is a more detailed view of one type of gripping member of a fluid regulating device, a needle capable of delivering a drug. Figure 5A is a simplified diagram of an outer tube having a longitudinal gap (i.e., not having a full 360° circumference) according to one non-limiting embodiment of the present invention. [Figure 6]6A and 6B are side and end views, respectively, of another type of gripping member of a fluid regulating device, which includes a ring around an outer tube having a needle capable of delivering a drug. [Figure 7] FIG. 7 is a simplified diagram of a conical structure coupled to the distal tip of a fluid regulating device, including a fixation member that allows the conical structure to be fixed to the underlying tissue. [Figure 8] 8A-8E are simplified diagrams of a bodily fluid regulating device according to another non-limiting embodiment of the present invention. [Figure 9] FIG. 9 is a detailed view of the distal portion of the fluid regulating device, showing the stimulation electrodes and radiopaque markers. [Figure 10] 10A and 10B are simplified diagrams of the internal ribs of the outer tube. DETAILED DESCRIPTION OF THE INVENTION

[0018] Referring to FIG. 1, a body fluid regulating device 10 according to one non-limiting embodiment of the present invention is shown.

[0019] The device 10 can include an inner tube 12 within an outer tube 14 (the two tubes together are also referred to as the intrauterine shaft or simply the shaft), with a gap 16 between the two tubes. A distal inner cap 18 is attached to the distal ends of the inner tube 12 and the outer tube 14, with the cap 18 positioned within the gap 16 and resting on the inner tube 12 and the outer tube 14 (e.g., on the outer surface of the inner tube 12 and the inner or outer surface of the outer tube 14). The cap 18 thus helps to maintain the patency of the gap 16 and functions as a protective front dome. The device 10 can include a proximal handle 17.

[0020] The gap 16 and lumen of the inner tube 12 can be used as a working channel for tools such as, but not limited to, fiber optic tools, hysteroscopic tools, graspers, biopsy tools, and the like.

[0021] The inner tube 12 has a smaller diameter than the outer tube 14 and has openings 20 formed therein that are larger than the openings 22 formed in the outer tube 14. The openings 20, 22 may be of any size and shape, including, but not limited to, circular, elliptical, polygonal, regular, and irregular. For example, the larger opening 20 may be elliptical with a width ranging from 2 to 6 mm and a length ranging from 5 to 10 mm, and the smaller opening 22 may be elliptical with a width ranging from 1 to 5 mm and a length ranging from 3 to 7 mm, but is not limited thereto. The openings 20, 22 may be formed in any pattern around the outer periphery of the inner tube 12 and the outer tube 14 and along the length of each tube.

[0022] Optionally, outer tube 14 may be a mesh or porous covering or other type of covering with one or more openings, and the term "outer tube" encompasses all of these structures.

[0023] 10A and 10B, it can be seen that the outer tube 14 can have elongated ribs 95 that divide the outer tube into different sections. The ribs 95 are located on the inner surface of the outer tube 14 between the openings so as not to interfere with the openings. The ribs 95 maintain a gap between the outer tube and the inner tube and prevent the outer tube from collapsing against the inner tube.

[0024] One such exemplary structure is described with reference to Figure 5A. In this embodiment, the outer tube 14 has a longitudinal gap 82 (i.e., the outer tube does not have a full 360° circumference). The edge of the outer tube 14 along the longitudinal gap 82 may be provided with a seal 84 that abuts and seals against the outer contour of the inner tube 12 to maintain a vacuum within the inner tube 12.

[0025] With further reference now to FIG. 2, the proximal portion of the fluid regulating device 10 is shown. For simplicity, the outer tube 14 and handle 17 are not shown in FIG. 2. A fluid adapter 24 is sealingly coupled to the proximal portion of the inner tube 12, such as with one or more seals 25. Note that the term "fluid" encompasses liquids and / or gases. The fluid adapter 24 may include a vacuum port 26 that can introduce negative pressure into the lumen of the inner tube 12 from a vacuum source 28.

[0026] The fluid adapter 24 (any type of fluid inlet or connector) can include one or more catheter ports 30. In the non-limiting illustrated embodiment, there are two catheter ports 30, proximally connected to a branching manifold 32, with a fluid connector 34, such as a Luer connector, coupled to the proximal portion of the branching manifold. A syringe 36 can be coupled to the fluid connector 34. The catheter ports 30 are coupled to one or more catheters 38 (in the non-limiting illustrated embodiment, there are two catheters 38; note that in FIG. 2, the catheters 38 are not connected to the vacuum port 26 or vacuum source 28). Referring again to FIG. 1, the device 10 can include one or more gripping members 40, which in this embodiment are needles coupled to the catheters 38. As described in more detail below, a syringe 36 (FIG. 2) can introduce an agent through the catheter 38 and into the hollow lumen of the gripping member 40 for delivery of the agent to the uterine tissue. The term "needle" as used in the specification and claims includes needles, hooks, lances, barbs and other sharp-pointed elements.

[0027] Referring now to FIG. 3 (for simplicity, the inner tube 12 is not shown in FIG. 3), the device 10 can include a secure inflatable plug 42, such as a balloon. The inflatable plug 42 can be coupled to a collar 44, which can be adjustably slid along the outer tube 14. A flexible member 45, such as a bellows, can be coupled to a proximal portion of the inflatable plug 42 and the outer tube 14, allowing for flexible adjustment of the position of the inflatable plug 42. Alternatively, the inflatable plug 42 can be fixedly coupled to the outer tube 14. When inflated, the inflatable plug 42 occludes the uterine opening, thereby securing the device 10 in place and creating a vacuum within the uterine cavity.

[0028] The inflatable plug 42 may include a balloon fluid port 46 that is coupled to a fluid source 50 via a valve or stopcock 48. This allows the inflatable plug 42 to be inflated by introducing fluid thereto and deflated by removing fluid therefrom. The valve 48 may be incorporated within the device.

[0029] 4 and 5 are more detailed views of the distal portion of the fluid regulating device, showing a needle-containing gripping member 40 coupled to a catheter 38. The catheter 38 may be covered by a sheath 39. The inner lumen 37 (FIG. 5) of the catheter 38 provides a passageway for introducing, for example, a drug into the needle lumen for drug delivery to the uterine tissue. The drug may be a uterotonic agent, oxytocin, or a drug used to enhance uterine contractility, such as, but not limited to, ergot alkaloids, prostaglandins, methergine, carboprost, dinoprostone, and misoprostol.

[0030] As shown in Figure 5, fiducial marks 49 may be placed on the gripping member 40 to assist the surgeon in visualizing the spatial and rotational orientation of the gripping member 40. Alternatively, the fiducial marks 49 may be placed on other portions of the apparatus 10, such as, but not limited to, a portion of the outer tube 14 (as shown in Figure 1). The fiducial marks may assist the user in controlling the orientation of the needle or other portions of the device and guiding the needle to the superior and inferior walls of the uterus.

[0031] FIG. 9 shows another version of the fluid regulating device of FIG. 4. One or more stimulation electrodes 90 can be positioned along the outer tube 14 (shaft) of the device (or on other suitable portions of the device) to stimulate muscle contractions. The electrodes 90 are positioned so that they come into contact with organ tissue after application of negative pressure (vacuum). The electrodes 90 stimulate muscle contractions via electrical impulses (electrical muscle stimulation or myoelectric stimulation). The electrodes 90 are powered by a battery built into the device and can be activated at the start of treatment.

[0032] FIG. 9 also illustrates another optional feature of the present invention: one or more radiopaque markers 92, such as (but not limited to) stripes, rings, bands, etc., disposed on the outer tube 14 (shaft) of the device (or any other suitable portion of the device) (e.g., to aid in visualization of the device using ultrasound, x-ray, etc.).

[0033] 6A and 6B, another type of gripping member of a fluid regulating device is shown. In this embodiment, the gripping member includes a ring 52 around the outer tube 14 having a hook, needle, or lancet 54 protruding outwardly therefrom. The needle 54 may optionally be coupled to the catheter 38 through which a medication may be delivered. One or more sensors 56 may be coupled to the needle 54 to provide an indication of whether the needle is engaged with tissue. The sensor 56 may be, but is not limited to, a contact sensor (e.g., a capacitance change depending on whether or not it is in contact with tissue), a pH sensor (a pH change depending on whether or not it is in contact with tissue), a vacuum sensor, or other sensor.

[0034] During use, a vacuum source (e.g., a vacuum pump) is connected to the inner tube and generates negative pressure within the inner tube, creating a pressure differential between the inner tube and the uterine wall through the inner tube's opening, the gap between the tubes, and the outer tube's opening. This negative pressure draws the uterine wall toward the outer tube. The tube-in-tube design provides optimal conditions for sustained vacuum maintenance. This is because the uterine wall presses against the outer tube around itself (portions of the uterine wall press against each other to aid in hemostasis), but does not press against or abut the inner tube, regardless of the support of the elongated ribs that maintain the gap between the outer and inner tubes. After inserting the device into the uterus and inflating the fixation balloon in the vagina to apply a vacuum and contract the uterine tissue around the device, the grasping element can be manually or automatically activated to withdraw the hooks or needles and embed them in the adjacent uterine tissue (mechanical grasping). The agent for enhancing uterine contractility may be delivered through the gripping member, in which case the gripping member has a hollow lumen through which the agent may be injected.

[0035] The inner and outer tube configuration also serves another purpose: to form a clot filtration assembly. When the vacuum pump is activated, uterine debris, such as clots and tissue debris, and blood are drawn through the opening in the outer tube and into the larger opening in the inner tube. Debris larger than the opening in the outer tube does not pass through the outer tube and remains on the outer tube or clogs the opening. As long as some openings in the outer tube remain open, the vacuum generated by the inner tube continues to collect debris, pressing the uterine wall against the outer tube. (If all openings in the outer tube become clogged, the device can be washed (either while in place or after removal), for example by applying positive pressure to clear the clogs.) Debris is collected by suction in a collection container. The collected blood can then be filtered and processed for reinfusion.

[0036] Referring now to Figure 7, a conical structure 58 can optionally be coupled to the distal tip of device 10 and can include a fixation member 60 (e.g., a hook or needle) that can secure conical structure 58 to the underlying tissue, such as by mechanical fixation, where fixation member 60 is retractable or rotated to grasp the base and rotated in the opposite direction to release the base. Conical structure 58 can also be secured to the base by vacuum force, either from the same vacuum source as the inner tube or from a second vacuum source.

[0037] 8A-8E, a bodily fluid regulating device 70 according to another non-limiting embodiment of the present invention is shown. The bodily fluid regulating device 70 includes two or more forceps arms 72. Each forceps arm 72 includes a vacuum port 74 (FIG. 8D) coupled to a vacuum source, similar to the embodiment of FIG. 1. The forceps arms 72 may be coupled to a trigger mechanism 75 provided on a handle 76. The forceps arms 72 may be moved radially inward and outward by the trigger mechanism 75. Each forceps arm 72 may also include a grasping member 78 (FIG. 8D), such as a needle or hook.

[0038] 8A and 8B show the device 70 before and after insertion into the uterus.

[0039] Once inside the uterus, the forceps arms are opened until they physically contact the anterior and posterior uterine walls. As shown in Figure 8C, the lower forceps arm 72 is secured to the lower (posterior) uterine wall by vacuum, and the upper forceps arm 72 is secured to the upper (anterior) uterine wall by vacuum. The arms can be secured to the uterine walls using both vacuum and gripping.

[0040] As shown in Figure 8E, closing the forceps brings the anterior and posterior uterine walls closer together, forcing the uterus to contract and stopping the bleeding. The device can then be removed (the graspers can be released and the device can be removed) as shown in Figure 8F.

[0041] As shown in FIG. 8E, the device can include one or more flow sensor probes 80 for measuring the level of bleeding in real time.

Claims

1. 1. A body fluid regulating device comprising: an inner tube disposed inside the outer tube, a gap being provided between the inner tube and the outer tube, and an opening formed in the inner tube that is larger in size than the opening formed in the outer tube; a fluid adapter sealingly coupled to a proximal portion of the inner tube, the fluid adapter including a vacuum port adapted to be coupled to a vacuum source to create a negative pressure within the inner tube, the outer tube adapted to allow uterine tissue to be pressed against the outer tube; and an inflatable plug disposed on said outer tube.

2. 2. The body fluid regulating device of claim 1, A bodily fluid regulating device, further comprising a gripping member configured to protrude outward from the outer tube.

3. The body fluid regulating device according to claim 1 or 2, A body fluid regulating device characterized in that the fluid adapter comprises one or more catheter ports coupled to one or more catheters disposed within the inner tube, and the gripping member is coupled to distal portions of the one or more catheters.

4. 4. The body fluid regulating device according to claim 3, A body fluid regulating device, wherein the gripping member is configured to protrude outward from the outer tube.

5. 3. The body fluid regulating device according to claim 2, A bodily fluid regulating device, wherein the gripping member comprises a needle.

6. 4. The body fluid regulating device according to claim 3, A fluid regulating device, wherein the gripping member includes a hollow needle, and wherein drugs and other substances are passable through the catheter(s) and the hollow needle.

7. The body fluid regulating device according to any one of claims 1 to 6, A fluid regulating device, wherein the inflatable plug is slidable along the outer tube.

8. The body fluid regulating device according to any one of claims 2 to 6, The body fluid regulating device further comprising reference marks for indicating spatial and rotational orientation of the gripping member.

9. The body fluid regulating device according to any one of claims 2 to 6 and 8, The body fluid regulating device, wherein the gripping member is disposed around the outer tube.

10. The body fluid regulating device according to any one of claims 1 to 9, A body fluid regulating device, characterized in that caps are attached to the distal ends of the inner tube and the outer tube, the caps being positioned in the gap and resting on the inner tube and the outer tube.

11. The body fluid regulating device according to any one of claims 2 to 10, A fluid regulating device, further comprising one or more sensors adapted to provide an indication of whether the gripping members are engaging tissue.

12. The body fluid regulating device according to any one of claims 2 to 11, A fluid regulating device further comprising one or more stimulation electrodes operable to stimulate muscle contraction with electrical impulses.

13. The body fluid regulating device according to any one of claims 2 to 12, A fluid regulating device further comprising one or more radiopaque markers.

14. The body fluid regulating device according to any one of claims 2 to 13, A fluid regulating device further comprising one or more elongated ribs formed on the interior surface of the outer tube.

15. 1. An apparatus comprising: A shaft, gripping members configured to protrude outward from a distal portion of the shaft, each of the gripping members having a hollow lumen formed therein through which a drug can flow; an actuator coupled to the gripping member for controlling movement of the gripping member; an inflatable plug disposed in the proximal portion of the shaft.

16. 1. A body fluid regulating device comprising: A fluid regulating device comprising two or more forceps arms, each of the forceps arms comprising a vacuum port adapted to be coupled to a vacuum source, the forceps arms coupled to a trigger mechanism for moving the forceps arms radially inward and outward, and each of the forceps arms comprising a gripping member.

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