Device for use in performing organ occlusions, especially an intrauterine tracheal occlusion in the treatment of a congenital fetal diaphragmatic hernia

Abstract

The present invention concerns a device for use during organ occlusions in humans or mammals, especially for the performing of an intrauterine tracheal occlusion in the course of the treatment of a congenital fetal diaphragmatic hernia, comprising a balloon body (1) which can be filled with a fluid with a balloon shell (2), forming a lumen to hold the fluid, and a balloon mouth (3) for introducing the fluid into the lumen, a separate auxiliary catheter for the placement of the balloon body (1) in the organ segment being treated and/or for the inflation of the balloon body (1) with the fluid, wherein the balloon body (1) is connected to a flexible, elongated prolongation element (4).

Claims

1. Device for use during organ occlusions in humans or mammals, especially for the performing of an intrauterine tracheal occlusion in the course of the treatment of a congenital fetal diaphragmatic hernia, comprising a balloon body (1) which can be filled with a fluid with a balloon shell (2), forming a lumen to hold the fluid, and a balloon mouth (3) for introducing the fluid into the lumen, a separate auxiliary catheter for the placement of the balloon body (1) in the organ segment being treated and/or for the inflation of the balloon body (1) with the fluid, characterized in that the balloon body (1) is connected to a flexible, elongated prolongation element (4).

2. Device according to claim 1, characterized in that the flexible elongated prolongation element (4) involves a filament, a thread, a fiber, a fiber blend, a cord, a hose, a yarn or a ribbon.

3. Device according to claim 1, characterized in that the flexible elongated prolongation element (4) is connected by force locking to the balloon mouth (3) or to the balloon shell (2).

4. Device according to claim 3, characterized in that the flexible elongated prolongation element (4) closes the balloon mouth (3).

5. Device according to claim 4, characterized in that the flexible elongated prolongation element (4) opens up the balloon mouth (3) when a pulling force of >0.5 N is applied.

6. Device according to claim 1, characterized in that a valve flap (5) is integrated in the balloon mouth (3).

7. Device according to claim 6, characterized in that the valve flap (5) integrated in the balloon mouth (3) is connected to the flexible elongated prolongation element (4) by force locking for the deflation of the balloon.

8. Device according to claim 1, characterized in that the balloon body (1) holds a volume between 0.25 and 9 ml, preferably between 1 and 3 ml, and/or the balloon mouth has an opening diameter between 1.0 and 6.0 mm, preferably between 1.5 and 3.0 mm, and/or the balloon body (1) comprises in its width and its length dimension a ratio between 710 mm and 70120 mm.

9. Device according to claim 1, characterized in that the flexible elongated prolongation element (4) comprises a channel (6) for at least one section, which is in fluidic communication with the lumen of the balloon body (1) and at its distal end an auxiliary catheter can be introduced via an opening (7).

10. Device according to claim 9, characterized in that the channel (6) is formed for the entire length of the flexible elongated prolongation element (4) and a valve flap (5) is arranged at the distal end of the prolongation element (4) in the channel (6).

11. Device according to claim 9, characterized in that the channel (6) is formed only through the proximal part of the flexible elongated prolongation element (4) and not at the distal part of the flexible elongated prolongation element (4) and a valve flap (5) is arranged at the distal end of the channel (6).

12. Device according to claim 1, characterized in that the flexible elongated prolongation element (4) in its lengthwise dimension corresponds at least to a multiple of the length of the balloon body (1) and the flexible elongated prolongation element (4) consists either of solid material or comprises a channel (6) for at least a section on the inside.

13. (canceled)

14. The method according to claim 17, characterized in that the organ occlusion involves an intrauterine tracheal occlusion during the treatment of a congenital fetal diaphragmatic hernia.

15. The method according to claim 17, characterized in that the organ occlusion involves an occlusion of the upper respiratory passages for staunching of bleeding, an occlusion of the esophagus or an occlusion of the auditory canals.

16. The method according to claim 17, characterized in that the occlusion device is designed for use in prevention or treatment of an organ constriction or scar formation.

17. A method of occluding an organ or organ cavity of a mammal comprising the steps of: positioning an occlusion device into a mammal in need of an organ occlusion at a location, said occlusion device having an inflation lumen sized and shaped for receiving an inflation fluid, and an identification or inflation fluid removal member extending from said inflation lumen; and inflating said inflation lumen.

18. The method according to claim 17 wherein said identification or inflation fluid removal member is a flexible, elongated prolongation element.

19. The method according to claim 17 wherein said identification or inflation fluid removal member is positioned within said mammal to allow said mammal, or a person independent of said mammal, to apply a force thereto and cause said inflation lumen to deflate or be removed from said inflated position.

20. The method according to claim 17 further including the step of using said identification or inflation fluid removal member to locate said inflated lumen positioned within said mammal, using said identification or inflation fluid removal member to cause said inflated lumen to deflate, or combinations thereof.

Description

FIGURES

[0034] FIG. 1 shows a first sample embodiment of the device according to the invention (without auxiliary catheter), consisting of a balloon body 1, a balloon shell 2 and a balloon mouth 3. On the balloon mouth 3 there is located a threadlike flexible prolongation element 4 in the form of a polypropylene thread, which is wound around the balloon mouth 3. The prolongation element 4 in the variant depicted is not connected to the lumen of the balloon body and not hollow on the inside.

[0035] FIG. 2 shows another variant embodiment, in which a channel 6 runs for a section inside the flexible elongated prolongation element 4 at its proximal end, being in fluidic communication with the lumen of the balloon body 1. At the distal end of the channel 6 there is provided a closure device, in order to prevent an escape of fluid from the balloon. The opening 7 of the channel 6 at the distal end furthermore serves for introducing the auxiliary catheter for the positioning and/or filling of the balloon.

[0036] FIG. 3 shows another variant embodiment, in which a channel 6 runs in the prolongation element 4 for the entire length of the prolongation element 4. At the distal end of the prolongation element a valve flap 5 is arranged in the channel 6. The emptying of the balloon is done for example by cutting off the distal end of the prolongation element 4 behind the valve flap 5.

CLINICAL TRIAL

[0037] In the context of a trial, patients with a sonographically diagnosed, pronounced fetal diaphragmatic hernia with an o/e LV ratio (observed/expected lung volume ratio, MRT finding) of 15% were subjected to a treatment with the device according to the invention. A balloon per FIG. 1, outfitted with a polypropylene thread, was used to perform an intrauterine tracheal occlusion. The balloon body 1 consists of a latex balloon with a volume of 2.5 ml and a size of 1228 mm. At the balloon mouth 3, a prolongation element 4 in the form of a polypropylene thread (monophil 2-0 polypropylene, 5/0) with a length of 7 cm was attached. Usually the closure of the fetal trachea was done intrauterine between week 26 and 28 of pregnancy (WP), whereupon the increased hydrostatic pressure in the bronchial system rises. The removal of the intratracheal balloon was done in the course of a second fetal surgery procedure between WP 34 and 35. After this, a fetal surgery treatment was performed after WP 28+4. The procedure was done with the aid of a 1.2 mm fetoscope under 3-D ultrasound control.

[0038] The fetus was intubated with no problems up to the point of the Bifurcatio trachae. The optics were temporarily removed and the balloon introduced into the fetal trachea with the aid of an auxiliary catheter under ultrasound control (Tchirikov M, Gatopoulos G, Strohner M, Puhl A, Steetskamp J. Two new approaches in intrauterine tracheal occlusion using an ultrathin fetoscope. Laryngoscope. 2010 Feb; 120(2):394-8). After the balloon with the threadlike flexible prolongation element 4 was put in place across the bifurcation, the deployment of the balloon body 1 was done with 2.5 ml of NaCl solution. During this process, the localization of the balloon outfitted with the prolongation element 4 and the condition of the fetus was monitored by sonography. Then the auxiliary catheter was removed and replaced with the optics. Sonographic imaging of the balloon in situ shows that the tracheal balloon with the prolongation element 4 was in the desired position.

[0039] In the further course, the observed/expected-LV ratio increased from 15% to 134%. Two months after the insertion, the removal of the tracheal balloon was done. In this process, it was easy to localize the polypropylene thread during the fetoscopic removal. The subsequent delivery was done per sectionem (Caesarian). The congenital diaphragmatic hernia was successfully operated upon the following day. After a period of one year, the child showed no permanent damage upon examination.

[0040] Thanks to the connection of the balloon body 1 to a threadlike flexible prolongation element 4, such as a polypropylene thread, the finding and the removal of the tracheal balloon can be greatly facilitated. In this way, the operation time was significantly reduced as compared to the classical method.

[0041] The connection of the balloon to a prolongation element 4 furthermore affords an intrauterine possibility of balloon removal by the fetus itself. In this variant embodiment, a second fetoscopic surgical procedure in WP 34 can be avoided entirely. The device according to the invention thus also enables an extending of the time of action of a tracheal occlusion on the growth of the lungs up to the time of delivery. Yet also with other indications calling for an organ occlusion, such as an occlusion of the upper respiratory passages for hemostasis or of other organs during organ bleeding, the patient can himself remove the balloon body 1 from the affected treatment area or the organ by pulling on the prolongation element 4. Thus, a removal of the balloon during these indications is much easier than was possible with traditional balloons.