Body fluid conditioning device

Abstract

A body fluid conditioning device includes an inner tube disposed inside an outer tube with a gap therebetween, the inner tube being formed with a hole, the hole of the inner tube having a size larger than a size of a hole formed in the outer tube. A fluid adapter is sealingly coupled to the proximal portion of the inner tube. The fluid adapter includes a vacuum port adapted to be coupled to a vacuum source for generating a negative pressure in the inner tube. The outer tube is adapted to press uterine tissue against the outer tube. And the expansion plug is arranged on the outer pipe.

Description

Technical Field

[0001] The present invention relates to a body fluid regulation device, for example, for treating postpartum hemorrhage. Background Art

[0002] Obstetric hemorrhage is the most common and dangerous childbirth complication. Traditionally, postpartum hemorrhage (PPH) has been defined as an estimated blood loss greater than 500 mL associated with vaginal delivery or greater than 1000 mL associated with cesarean delivery. This was redefined by the American College of Obstetricians and Gynecologists in 2017, and the current definition is a cumulative blood loss greater than 1000 mL with signs and symptoms of hypovolemia within 24 hours of the birth process, regardless of the mode of delivery. Although this change was made knowing that blood loss during childbirth is often underestimated, blood loss greater than 500 mL during vaginal delivery should be considered abnormal and may require intervention. Primary postpartum hemorrhage occurs within the first 24 hours after childbirth, while secondary postpartum hemorrhage is characterized by bleeding that occurs from 24 hours to 12 weeks postpartum.

[0003] There are several causes of PPH, such as uterine atony, retained placenta, coagulation defects, and uterine inversion. The most common clinical cause is uterine atony, which results in inadequate contraction of the uterine myofibers and inadequate occlusion of the spiral arteries, leading to uncontrolled bleeding. Summary of the Invention

[0004] The present invention aims to provide a body fluid regulation device, for example, for treating postpartum hemorrhage. Although the present invention is described with reference to a uterine bleeding regulation device, the present invention can be used to regulate or stop other body fluids from other organs (such as the bladder and other organs).

[0005] The device includes means for grasping, holding, and retaining uterine cavity tissue (endometrium and / or myometrium) while applying negative pressure (vacuum) to the uterine cavity in order to drain blood clots and other debris from the uterus and to stop bleeding by contracting the uterus and forcing contact between the uterine walls. Additional features include, but are not limited to, injecting various fluids or other substances into the uterine cavity or directly into the endometrium / myometrium, such as substances that enhance uterine contractility.

[0006] The device includes an anchoring expansion plug or seal, such as a balloon. The expansion plug can be fixed or slidable and adjustable and can be placed in the cervix or vagina. When inflated, the plug occludes the opening of the uterus, thereby fixing the device in place and allowing a vacuum to be created in the uterine cavity.

[0007] The shaft of the device includes an inner tube inside the outer tube, with a gap between the two tubes. The diameter of the inner tube is smaller than that of the outer tube, and the inner tube is formed with holes that are larger in size than the holes formed in the outer tube. The size and shape of the holes in the inner and outer tubes can vary.

[0008] A vacuum source (such as a vacuum pump) is connected to the inner tube, and a negative pressure is generated in the inner tube. This negative pressure creates a pressure difference between the inner tube and the uterine wall via the holes in the inner tube, the gap between the inner and outer tubes, and the holes in the outer tube. Thus, the negative pressure sucks the uterine wall towards the outer tube. The tube - within - a - tube structure provides optimal conditions for continuously maintaining the vacuum. This is because the uterine wall presses against and surrounds the outer tube (multiple parts of the uterine wall press against each other to help stop bleeding), but does not press against or adjoin the inner tube, thereby maintaining the vacuum in the inner tube.

[0009] The outer tube can have elongated ribs that divide the outer tube into different compartments. These ribs maintain the gap between the outer and inner tubes and prevent the outer tube from collapsing onto the inner tube.

[0010] Another purpose of the structure of the inner and outer tubes is to form a blood clot filtration assembly. When the vacuum pump is activated, uterine debris (such as blood clots and tissue residues) and blood are sucked through the holes in the outer tube into the larger holes in the inner tube. Debris larger than the holes in the outer tube does not pass through the outer tube and remains on the outer tube or blocks the holes in the outer tube. As long as some of the holes in the outer tube remain open, the vacuum originating from the inner tube continues to collect debris and press the uterine wall against the outer tube and, where there is no overlap with the outer tube, against each other as well. (If all the holes in the outer tube are blocked, the device can be cleaned, for example, by applying positive pressure to remove the blockage or by removing and cleaning the device). The debris and clots can be collected in a collection container by the suction force. The collected fluid can undergo filtration and treatment for reinfusion.

[0011] The shape and size of the holes can be selected to optimally suck debris. For example, a conical shape (starting from larger on the outside to smaller on the inside) or an irregular shape can enable the application of negative pressure to suck in coagulated debris. The holes can be covered with or contain a mesh or net - like material that can cut or break the clots, thus minimizing the possibility of the clots completely blocking the holes.

[0012] In another non - limiting aspect of the present invention, a grasping member is provided that not only grasps uterine tissue but can also be used to deliver one or more drugs or other substances into the endometrium, myometrium, or uterine cavity. For example, an array of needles or loops containing curved and hidden hooks can be placed on the shaft of the device. Each loop is capable of independently deploying the hook. After inserting the device into the uterus, inflating the anchoring balloon in the vagina or cervix, turning on the vacuum and causing the uterine tissue to collapse around the device, the grasping mechanism is manually / automatically activated, allowing the hooks to be pulled out so that they embed into the adjacent uterine tissue (mechanical grasping). The gripper can hold the upper and lower walls in the correct positions facing each other and prevent the tissue from rotating and twisting during vacuum activation. Drugs for enhancing uterine contractility can be delivered via the grasping member, which has a hollow cavity through which the drug can be injected. The grasping member can protrude in a manner that will optimize the penetration of the tissue at that anatomical site with a relevant length.

[0013] The retractable grasping member can have a stop to enable precise depth penetration into the tissue.

[0014] Another option is to add a conical structure to the distal end of the device. The conical structure can include a fixing member that allows the conical structure to be attached to the basal tissue, such as by mechanical fixation, which can be rotated to grasp the base and rotated in the opposite direction to release the base. The conical structure can also be attached to the base by vacuum force (the same vacuum source as the inner tube or a second vacuum source). These retractable fixing members can also be used to inject drugs into the basal tissue or other tissues to enhance uterine contractility.

[0015] Another option is to have a trauma - free end at the end of the shaft (the shaft is an assembly of an inner tube and an outer tube) to minimize the likelihood of tissue trauma. (The material making up the tube can be flexible or semi - flexible and can be inert to further minimize the likelihood of tissue trauma). The trauma - free end can also assist in the corrective repositioning of uterine tissue, such as in the case of tissue inversion. The end can include one or more holes to enable distal aspiration of fluid and debris.

[0016] Another option includes a forceps - shaped device inserted into the uterine cavity. Inside the uterus, the forceps arms open until they physically contact the anterior and posterior uterine walls. The arms can be attached to the uterine walls by using both vacuum and grasping. The closing of the forceps causes the anterior and posterior uterine walls to fold and / or move towards each other, resulting in forced contraction of the uterus and cessation of bleeding. After that, the device can be removed. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present invention will be more fully understood and appreciated from the following detailed description in conjunction with the accompanying drawings, in which:

[0018] Figure 1 is a simplified view of a body fluid regulation device according to a non - limiting embodiment of the present invention.

[0019] Figure 2 is a more detailed view of the proximal portion of the body fluid regulation device.

[0020] Figure 3 is a more detailed view of the inflation plug of the body fluid regulation device.

[0021] Figure 4 is a more detailed view of the distal portion of the body fluid regulation device.

[0022] Figure 5 is a more detailed view of a type of grasping member of the body fluid regulation device, which is a needle through which a drug can be delivered.

[0023] Figure 5A is a simplified view of an outer tube with a longitudinal gap (i.e., the outer tube does not have a complete 360° perimeter) according to a non - limiting embodiment of the present invention.

[0024] Figure 6A and Figure 6B are a side view and an end view, respectively, of another type of grasping member of the body fluid regulation device, which includes a ring around the outer tube, and the ring has a needle through which a drug can be delivered.

[0025] Figure 7 is a simplified view of a conical structure coupled to the distal end of the body fluid regulation device, which includes a fixing member that allows the conical structure to be fixed to the basal tissue.

[0026] Figures 8A to 8E is a simplified view of a body fluid regulation device according to another non - limiting embodiment of the present invention.

[0027] Figure 9 is a detailed illustration of the distal portion of the body fluid regulation device, showing a stimulating electrode and a radiopaque marker.

[0028] Figure 10A and Figure 10B is a simplified view of an internal rib in the outer tube. Detailed Description

[0029] Now referring to Figure 1 , Figure 1 which shows a body fluid regulation device 10 according to a non - limiting embodiment of the present invention.

[0030] Device 10 may include an inner tube 12 inside an outer tube 14 (the two tubes together are also referred to as the intrauterine shaft or simply the shaft), with a gap 16 therebetween. A distal inner cap 18 may be mounted at the distal ends of inner tube 12 and outer tube 14, where cap 18 is located within gap 16 and rests on inner tube 12 and outer tube 14 (such as on the outer surface of inner tube 12 and the inner or outer surface of outer tube 14). Cap 18 thus helps to keep gap 16 unobstructed and serves as a protective front dome. Device 10 may include a proximal handle 17.

[0031] Gap 16 and the lumen of inner tube 12 may serve as working channels for tools, such as but not limited to fiber optic tools, hysteroscopy tools, graspers, biopsy tools, etc.

[0032] Inner tube 12 has a smaller diameter than outer tube 14 and is formed with holes 20 that are larger in size than holes 22 formed in outer tube 14. Holes 20 and 22 can have any size and shape, such as but not limited to circular, oval, polygonal, regular, irregular, etc. For example, but not limited to, the larger hole 20 can be oval in the range of 2 - 6 mm in width and 5 - 10 mm in length; the smaller hole 22 can be oval in the range of 1 - 5 mm in width and 3 - 7 mm in length. These holes 20 and 22 can be formed in any pattern around the circumferences of inner tube 12 and outer tube 14 and along the lengths of inner tube 12 and outer tube 14.

[0033] Optionally, outer tube 14 can be a mesh or porous covering or other kind of covering with one or more holes, and the term "outer tube" encompasses all such structures.

[0034] Reference Figure 10A and Figure 10B , it can be seen that outer tube 14 can have elongated ribs 95 that divide the outer tube into different compartments. Ribs 95 are positioned on the inner surface of outer tube 14 between the holes, so they do not interfere with the holes. Ribs 95 maintain the gap between the outer tube and the inner tube and prevent the outer tube from collapsing against the inner tube.

[0035] Now referring Figure 5A to one such exemplary structure. In this embodiment, outer tube 14 has a longitudinal gap 82 (i.e., the outer tube does not have a complete 360° circumference). Seals 84 may be provided along the edges of outer tube 14 along longitudinal gap 82 that sealably abut the outer profile of inner tube 12 to maintain a vacuum within inner tube 12.

[0036] Now additionally referring Figure 2 , Figure 2 shows the proximal portion of the body fluid regulation device 10. For simplicity, outer tube 14 and handle 17 are not shown in Figure 2shown in. The fluid adapter 24 is sealingly coupled to the proximal portion of the inner tube 12, for example, by one or more seals 25. It should be noted that the term "fluid" encompasses liquids and / or gases. The fluid adapter 24 may include a vacuum port 26, which may introduce negative pressure from a vacuum source 28 into the lumen of the inner tube 12.

[0037] The fluid adapter 24 (any kind of fluid inlet or connector) may include one or more catheter ports 30. In a non-limiting illustrative embodiment, there are two catheter ports 30, which are proximally coupled to a bifurcated manifold 32, and the proximal portion of the bifurcated manifold is coupled to a fluid connector 34, such as a Luer connector. A syringe 36 may be coupled to the fluid connector 34. The catheter ports 30 are coupled to one or more catheters 38 (in a non-limiting illustrative embodiment, there are two catheters 38. It should be noted that in Figure 2 , the catheter 38 is not connected to the vacuum port 26 or the vacuum source 28). Referring again to Figure 1 , the device 10 may include one or more grasping members 40, which, in this embodiment, are needles coupled to the catheters 38. As will be described in more detail below, the syringe 36 ( Figure 2 ) may introduce a drug into the hollow cavity of the grasping member 40 through the catheter 38 to introduce the drug into uterine tissue. The term "needle" as used throughout the specification and claims includes needles, hooks, spear-like implements, barbs, and any other sharp-tipped element.

[0038] Now referring to Figure 3 (for simplicity, the inner tube 12 is not shown in Figure 3 ). The device 10 may include an anchoring inflation plug 42, such as a balloon. The inflation plug 42 may be coupled to a collar 44, which may slide adjustably along the outer tube 14. A flexible member 45, such as a bellows, may be coupled to the proximal portion of the inflation plug 42 and the outer tube 14 to allow flexibility in the position of the inflation plug 42. Alternatively, the inflation plug 42 may be fixedly coupled to the outer tube 14. When inflated, the inflation plug 42 blocks the opening of the uterus, thereby fixing the device 10 in place and allowing a vacuum to be created in the uterine cavity.

[0039] The inflation plug 42 may include a balloon fluid port 46, which is coupled to a fluid source 50 via a valve or stopcock 48. In this way, the inflation plug 42 may be inflated by introducing fluid therein and may be deflated by removing fluid therefrom. The valve 48 may be embedded inside the device.

[0040] Figure 4 and Figure 5A more detailed view of the distal portion of the body fluid regulation device, which shows that the grasping member 40 includes a needle coupled to the catheter 38. The catheter 38 may be covered by a sheath 39. The lumen 37 of the catheter 38 ( Figure 5 ) is a passage for introducing, for example, a drug into the lumen of the needle to deliver the drug to the uterine tissue. Without limitation, the drug may be utrogestan, oxytocin, or a drug for enhancing uterine contractility, such as but not limited to ergot alkaloids and prostaglandins, such as meptazinol, carboprost, dinoprost, and misoprostol.

[0041] As Figure 5 shown, a fiducial marker 49 may be provided on the grasping member 40 to assist the surgeon in seeing the spatial and rotational orientation of the grasping member 40. Alternatively, the fiducial marker 49 may be provided on other parts of the device 10, such as but not limited to a part of the outer tube 14 (as Figure 1 seen). The fiducial marker can assist the user in controlling the orientation of the needle or other parts of the device and guiding the needle to the upper and lower walls of the uterus.

[0042] Figure 4 Another form of the body fluid regulation device of Figure 9 is shown. To stimulate muscle contraction, one or more stimulating electrodes 90 may be positioned along the outer tube 14 (axis) of the device (or any other suitable part of the device). The electrodes 90 are positioned to contact the organ tissue after operating the negative pressure (vacuum). The electrodes 90 stimulate muscle contraction by means of electrical pulses (muscle electrical stimulation or electromyostimulation). The electrodes 90 may be powered by a battery integrated in the device and are activated at the start of the surgical procedure.

[0043] Figure 9 Another optional feature of the present invention is also shown, namely, one or more radiopaque markers 92 (for example, to assist in visualizing the device using ultrasound, X-ray, etc.), such as but not limited to strips, rings, bands, etc., which may be positioned on the outer tube 14 (axis) of the device (or any other suitable part of the device).

[0044] Now refer to Figure 6A and Figure 6B , Figure 6A and Figure 6BShows another type of gripping member of the body fluid regulation device. In this embodiment, the gripping member includes a ring 52 around the outer tube 14, and the ring 52 has hooks, needles or blades 54 protruding outward from the ring 52. The needle 54 can optionally be coupled to the catheter 38 so that drugs can be delivered therethrough. One or more sensors 56 can be coupled to the needle 54 to provide an indication of whether the needle is engaged in the tissue. The sensor 56 can be, but is not limited to, a contact sensor (e.g., capacitance changes if in contact with or not in contact with tissue), a pH sensor (pH changes if in contact with or not in contact with tissue), a vacuum sensor or other sensors.

[0045] In the use of this device, a vacuum source (such as a vacuum pump) is coupled to the inner tube, and a negative pressure is generated in the inner tube, and this negative pressure creates a pressure difference between the inner tube and the uterine wall via the holes in the inner tube, the gap between these tubes, and the holes in the outer tube. Therefore, the negative pressure sucks the uterine wall towards the outer tube. The structure of the inner tube and the outer tube provides optimal conditions for continuously maintaining the vacuum. This is because the uterine wall presses against the outer tube and around the outer tube (multiple parts of the uterine wall press against each other to help stop bleeding), but does not press against or adjacent to the inner tube, whether there is the support of the elongated rib or not, and the elongated rib maintains the gap between the outer tube and the inner tube, so that the vacuum in the inner tube is maintained. After inserting the device into the uterus, inflating the anchoring balloon in the vagina, turning on the vacuum and collapsing the uterine tissue around the device, the gripping member can be activated manually or automatically, thereby allowing the hook or needle to be pulled out so that they are embedded in the adjacent uterine tissue (mechanical gripping). Drugs for enhancing uterine contractility can be delivered via the gripping member, where the gripping member has a hollow cavity through which the drug can be injected.

[0046] The structure of the inner tube and the outer tube has another purpose of forming a blood clot filtration assembly. When the vacuum pump is activated, uterine debris (such as blood clots and tissue residues) and blood are sucked into the larger holes of the inner tube through the holes of the outer tube. Debris larger than the holes of the outer tube does not pass through the outer tube and remains on the outer tube or blocks the holes of the outer tube. As long as some of the holes of the outer tube remain open, the vacuum generated in the inner tube continues to collect debris and press the uterine wall towards the outer tube. (If all the holes of the outer tube become blocked, the device can be cleaned (while in situ or after removal), for example, by applying positive pressure to remove the blockage). The debris can be collected into a collection container by suction. The collected blood can be filtered and processed for reinfusion.

[0047] Now refer to Figure 7Optionally, the conical structure 58 can be coupled to the distal end of the device 10, and the conical structure 58 can include a fixation member 60 (e.g., a hook or a needle, etc.), and the fixation member 60 allows the conical structure 58 to be fixed to the basal tissue, for example, by mechanical fixation, wherein the fixation member 60 can be retracted or rotated to grasp the substrate and rotated in the opposite direction to release the substrate. The conical structure 58 can also be attached to the substrate by a vacuum force (the same vacuum source as the inner tube or a second vacuum source).

[0048] Now referring to Figures 8A to 8E , Figures 8A to 8E there is shown a body fluid regulation device 70 according to another non-limiting embodiment of the present invention. The body fluid regulation device 70 includes two or more tweezer arms 72. Each tweezer arm 72 includes a vacuum port 74 ( Figure 8D ), which is connected to the vacuum source in the embodiment of Figure 1 . The tweezer arms 72 can be coupled to a trigger mechanism 75 disposed on a handle 76. The tweezer arms 72 can be moved radially inwards and outwards by the trigger mechanism 75. Each tweezer arm 72 may further include a grasping member 78 ( Figure 8D ), such as a needle or a hook.

[0049] Figure 8A and Figure 8B show the device 70 before and after insertion into the uterus, respectively.

[0050] Inside the uterus, the tweezer arms are opened until they are in physical contact with the anterior uterine wall and the posterior uterine wall. As Figure 8C shown, the lower tweezer arm 72 can be attached to the lower uterine wall (posterior wall) by vacuum, and the upper tweezer arm 72 can be attached to the upper uterine wall (anterior wall) by vacuum. The arms can be attached to the uterine wall by using both vacuum and grasping.

[0051] As Figure 8E shown, the closing of the tweezers causes the anterior uterine wall and the posterior uterine wall to move towards each other, thereby causing forced contraction of the uterus and cessation of bleeding. After that, the device can be removed (release the gripper and remove the device), as seen in Figure 8F .

[0052] As Figure 8E seen, the device can include one or more flow sensor probes 80 for measuring the bleeding level in real time.

Claims

1. A body fluid regulation device, comprising: An inner tube disposed inside an outer tube, with a gap between the inner tube and the outer tube. The inner tube is formed with holes, and the size of the holes in the inner tube is larger than the size of the holes formed in the outer tube; A fluid adapter sealingly coupled to the proximal portion of the inner tube. The fluid adapter includes a vacuum port adapted to be coupled to a vacuum source for generating negative pressure in the inner tube. Wherein, the outer tube is adapted to press uterine tissue against it; and An expansion plug disposed on the outer tube.

2. The body fluid regulation device according to claim 1, further comprising a grasping member arranged to protrude outward from the outer tube.

3. The body fluid regulation device according to claim 1 or claim 2, wherein, The fluid adapter includes one or more catheter ports coupled to one or more catheters disposed in the inner tube, and the grasping member is coupled to the distal portion of the one or more catheters.

4. The body fluid regulation device according to claim 3, wherein, The grasping member is arranged to protrude outward from the outer tube.

5. The body fluid regulating device according to claim 2, wherein, The grasping member includes a needle.

6. The body fluid regulation device according to claim 3, wherein, The grasping member includes a hollow needle, and drugs and other materials can flow through the one or more catheters and the hollow needle.

7. The body fluid regulation device according to any one of claims 1-6, wherein, The expansion plug is capable of sliding along the outer tube.

8. The body fluid regulation device according to any one of claims 2 - 6, further comprising a reference mark for indicating the spatial and rotational orientation of the grasping member.

9. The body fluid regulation device according to any one of claims 2-6 or claim 8, wherein, The grasping member is disposed around the outer tube.

10. The body fluid regulation device according to any one of claims 1-9, wherein, A cap is mounted at the distal ends of the inner tube and the outer tube, wherein the cap is located in the gap and rests on the inner tube and the outer tube.

11. The body fluid regulation device according to any one of claims 2 - 10, further comprising one or more sensors adapted to provide an indication of whether the grasping member is engaged in tissue.

12. The body fluid regulation device according to any one of claims 2 - 11, further comprising one or more stimulating electrodes operable to stimulate muscle contraction by means of electrical pulses.

13. The body fluid regulation device according to any one of claims 2 - 12, further comprising one or more radio - opaque markers.

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

15. A device, comprising: A shaft; A grasping member arranged to protrude outward from the distal portion of the shaft. Each grasping member among the grasping members is formed with a hollow cavity through which drugs can flow; An actuator coupled to the grasping member for controlling the movement of the grasping member; And An expansion plug disposed on the proximal portion of the shaft.

16. A body fluid regulation device, comprising: Two or more forceps arms, each forceps arm including a vacuum port adapted to be coupled to a vacuum source. The forceps arms are coupled to a trigger mechanism for radially moving the forceps arms inward and outward. Each forceps arm includes a grasping member.

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