Abstract
A vacuum sponge system, comprising: a sponge having an outer surface, a proximal end and a distal end, spaced from the proximal end in an axial direction of the sponge; a drainage tube disposed partially in the sponge, and is in fluid communication with the sponge; the drainage tube is connectable with a vacuum pump such that a pressure is applicable to the outer surface of the sponge; and a delivery member having an outer surface and extending in an axial direction of the sponge and adapted to establish a fluid communication between a region from the distal end of the sponge and region from the proximal end of the sponge. The pressure provided by the pump via the drainage tube is applied to a vicinity of the outer surface of the delivery member and the outer surface of the sponge. The delivery member is disposed partially radially outside of the sponge.
Claims
1. A vacuum sponge system, comprising: a sponge having an open-pore structure, an outer surface, a proximal end and a distal end, spaced from the proximal end in an axial direction of the sponge; a drainage tube disposed at least partially in the sponge, wherein the drainage tube is in fluid communication with the sponge; wherein the drainage tube is connectable with a vacuum pump such that a pressure generated by the vacuum pump is applicable to the outer surface of the sponge via the drainage tube; and a delivery member having an outer surface and extending in an axial direction of the sponge and adapted to establish a fluid communication between a region distal from the distal end of the sponge and region proximal from the proximal end of the sponge in a condition where the pressure provided by the vacuum pump via the drainage tube is applied to a vicinity of the outer surface of the delivery member and the outer surface of the sponge, wherein the delivery member is disposed at least partially radially outside of the sponge, wherein the vacuum sponge system is to be used in gastro-intestinal lumens of human bodies that are a deeper than 10 cm as seen from a body orifice inside a human body.
2. The vacuum sponge system of claim 1, wherein the pressure applied to the vicinity of the outer surface of the delivery member and the outer surface of the sponge is reduced compared to atmospheric pressure and comprises a range between 0.01 and 0.99 atm.
3. The vacuum sponge system of claim 2, further comprising a cover member disposed on at least a portion of the outer surface of the delivery member and in contact with the sponge, wherein the cover member is configured to transmit the pressure from the sponge to the outer surface of the delivery member.
4. The vacuum sponge system according to claim 1, wherein the delivery member comprises an enteral feeding device that is extendable distally from the sponge into a stomach or a small intestine of the human body when the sponge is positioned in an esophagus.
5. The vacuum sponge system of claim 4, wherein the enteral feeding device is disposed in the drainage tube.
6. A method for treatment of esophageal defects, comprising: inserting a sponge of a vacuum sponge system into an intestinal lumen of a human body over an esophageal defect in an esophagus, the sponge having an open-pore structure, an outer surface, a proximal end, and a distal end, spaced from the proximal end in an axial direction of the sponge, and a channel that extends from the proximal end of the sponge to the distal end of the sponge, wherein the vacuum sponge system further includes a drainage tube disposed at least partially in the sponge to be in fluid communication with the sponge, wherein the drainage tube is connectable with a vacuum pump such that a pressure generated by the vacuum pump is applicable to the sponge via the drainage tube; and a delivery member having an outer surface and extending in an axial direction of the sponge, wherein the delivery member comprises an enteral feeding devices and is disposed within the channel that extends from the proximal end of the sponge to the distal end of the sponge; extending the enteral feeding device distally of the sponge into a stomach or a small intestine of the human body; and applying pressure to the sponge, including applying the pressure provided by the pump via the drainage tube in a vicinity of the outer surface of the delivery member and the outer surface of the sponge, to provide for a closure of a lumen of the esophagus and establishing a fluid communication between a region distal from the distal end of the sponge and a region proximal from the proximal end of the sponge, in order to enable performance of enteral nutrition via the enteral feeding device.
7. The method of claim 6, further comprising: performing enteral nutrition via the enteral feeding device.
8. The vacuum sponge system of claim 6, wherein the pressure applied to the vicinity of the outer surface of the delivery member and the outer surface of the sponge is reduced compared to atmospheric pressure and comprises a range between 0.01 and 0.99 atm.
9. A method for the treatment of defects in a large intestine or a small intestine of a human body, wherein the method comprises: inserting the sponge of the vacuum sponge system of claim 11 into an intestinal lumen orally or anally over a defect; and placing the sponge under pressure to provide for a collapse of the intestinal lumen in a vicinity of a defect in the large or small intestine, allowing for intestinal gases and/or stool exit via the additional tube of the vacuum sponge system.
10. A vacuum sponge system, comprising: a sponge having an open-pore structure, an outer surface, a proximal end, and a distal end, spaced from the proximal end in an axial direction of the sponge, and a channel that extends from the proximal end of the sponge to the distal end of the sponge; a drainage tube disposed at least partially in the sponge, wherein the drainage tube is in fluid communication with the sponge, to provide for exit of a fluid out of the sponge; wherein the drainage tube is connectable with a vacuum pump such that a pressure generated by the vacuum pump is applicable to the outer surface of the sponge via the drainage tube; and a delivery member having an outer surface and extending in an axial direction of the sponge, and adapted to establish a fluid communication between a region distal from the distal end of the sponge and a region proximal from the proximal end of the sponge when the pressure provided by the pump via the drainage tube is applied in a vicinity of the outer surface of the delivery member and the outer surface of the sponge, wherein the delivery member is disposed within the channel that extends from the proximal end of the sponge to the distal end of the sponge, wherein the vacuum sponge system is to be used in gastro-intestinal lumens of human bodies that are a deeper than 10 cm as seen from a body orifice inside a human body.
11. The vacuum sponge system of claim 10, wherein the pressure applied to the vicinity of the outer surface of the delivery member and the outer surface of the sponge is reduced compared to atmospheric pressure and comprises a range between 0.01 and 0.99 atm.
12. The vacuum sponge system of claim 10, wherein the drainage tube is accommodated within the channel.
13. The vacuum sponge system of claim 10, wherein the sponge comprises a fluid collecting member and is disposed along the channel, wherein the channel is parallel to a longitudinal axis of the fluid collecting member.
14. The vacuum sponge system of claim 4, wherein the drainage tube extends along an entire length of the fluid collecting member.
15. The vacuum sponge system of claim 10, wherein the drainage tube is fixedly connected to the sponge.
16. The vacuum sponge system of claim 10, wherein the drainage tube has a plurality of openings in the a portion of the tube to be disposed in the sponge.
17. The vacuum sponge system of claim 10, further comprising an overtube to enclose at least a portion of the sponge, drainage tube, and one or both of a guide member and the delivery member.
18. The vacuum sponge system according to claim 10, wherein the delivery member comprises an enteral feeding device that is extendable distally from the sponge into a stomach or a small intestine of the human body when the sponge is positioned in an esophagus.
19. The vacuum sponge system of claim 18, wherein the enteral feeding device is disposed in the drainage tube.
20. The vacuum sponge system of claim 10, wherein the delivery member comprises an additional tube, to allow gases or stool to exit, and to further allow a large intestine of the human body to be decompressed when the sponge is positioned anally in the large intestine and the pressure is applied to the sponge to effect a collapse of an intestinal lumen onto the sponge.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0075] Preferred embodiments of the invention shall now be described with reference to Figures, in which
[0076] FIGS. 1-7 show an insertion system;
[0077] FIGS. 8-15 show an overtube;
[0078] FIGS. 16-21 show a sponge suction attachment;
[0079] FIGS. 22-26 show a sponge drainage unit;
[0080] FIGS. 27-32 show a drainage system; and
[0081] FIGS. 33-37 show another drainage system.
[0082] FIG. 38 shows a vacuum sponge system;
[0083] FIG. 39 shows another vacuum sponge system;
[0084] FIG. 40 shows still another vacuum sponge system;
[0085] FIG. 41 shows a still further vacuum sponge system;
[0086] FIG. 42 shows a still further embodiment of a vacuum sponge system,
[0087] FIG. 43 shows a flow diagram illustrating an inventive method and
[0088] FIG. 44 shows a flow diagram illustrating a further inventive method.
DETAILED DESCRIPTION
[0089] An embodiment according to the invention is shown in FIGS. 1-7. FIG. 1 is a view showing the arrangement of the complete insertion system. The compressed sponge 10, which is connected to drainage line 20, is received at the distal end of guide sleeve 8. A positioning sleeve 7 is likewise inserted into the guide sleeve via drainage line 20 and can be moved in relation to both the guide sleeve and the drainage line.
[0090] Guide wire 3 is located inside the drainage line. Said guide wire is initially placed endoscopically over a defect, and the entire insertion system can then be advanced over the wire into position. The sponge has an X-ray-proof marker, so that positioning can be carried out and monitored under X-ray surveillance.
[0091] FIG. 2 shows the commencement of sponge 10 being released. Positioning sleeve 7 and guide sleeve 8 are moved towards each other, thus causing the sponge to emerge from the distal end of the guide sleeve. FIG. 3 shows continued release of the sponge. FIG. 4 shows complete release of the sponge. FIG. 5 shows the released sponge after retraction of the guide sleeve, positioning sleeve and guide wire.
[0092] FIG. 6 shows a cross-section through the insertion system when the sponge has been released. Reference sign 21 marks the perforation openings of the drainage line in the sponge. FIG. 7 shows a cross-section through the insertion system, with sponge 10 compressed in the distal end of guide sleeve 8.
[0093] Another embodiment according to the invention is shown in FIGS. 8-15. FIG. 8 is a view showing the design of the overtube. The overtube tapers conically at its distal end 6a, in order to avoid injuries during insertion. A complete slit 6c extends over the entire length of the overtube. The overtube may be funnel-shaped at its proximal end 6b to facilitate insertion of medical instruments. FIG. 9 is a cross-sectional view showing a conical distal end 6a and a funnel-shaped proximal end 6b.
[0094] FIG. 10 shows how a flexible endoscope 3 is inserted or retracted via slit 6c at the distal end of the overtube. FIG. 11 shows how a flexible endoscope 3 is inserted into or retracted from the overtube via slit 6c. FIG. 12 shows how a flexible endoscope 3 is fully inserted inside the overtube.
[0095] FIG. 13 shows how a drainage line 4 is inserted along with an endoscope 3 in the overtube. FIG. 14 shows a cross-sectional view of an overtube, with an inserted endoscope 3 and a drainage line 4. FIG. 15 shows how a pair of semiflexible endoscopy forceps 4 is inserted as an instrument together with an endoscope.
[0096] Another embodiment according to the invention is shown in FIGS. 16-21. FIG. 16 shows a view of a kinked drainage tube 20, with a sponge 10 at the distal end of drainage tube 20. FIG. 17 shows the cross-sectional view of FIG. 16.
[0097] FIG. 18 shows a cross-sectional view of a sponge 10 having a central cavity or recess 17. FIG. 19 shows a three-dimensional view of FIG. 18. FIG. 20 shows a cross-sectional view of a sponge with a central recess 17, into which a drainage tube 20 has been inserted.
[0098] FIG. 21 shows a cross-section of a suction sleeve 22, at the distal end of which a sponge 10 is attached. An additional suction drainage tube 20, which is removable and via which suction can be performed, is inserted into the suction sleeve. Suction sleeve 22 and the suction drainage tube are flushly fitted 23 to each other.
[0099] Another embodiment according to the invention is shown in FIGS. 22-26. FIG. 22 shows a view of the sponge drainage with guide wire 3 disposed in a probe 4 which is guided through sponge 10 and has lateral perforation openings at its distal end and which is disposed in the sponge disposed. The drainage line 20 disposed in sponge 20 is provided at its distal end with perforation openings over the length of the sponge.
[0100] FIG. 23 shows a cross-sectional view of the arrangement in FIG. 22. FIG. 24 shows a cross-sectional view of the arrangement in FIG. 22 in which the probe 4 guided through sponge 10 is designed to be displaceable and has been withdrawn into sponge 10.
[0101] FIG. 25 shows a cross-sectional view of a sponge drainage unit with conically tapering ends 18 to sponge 10, which has been attached to a drainage line 20 having lateral perforation openings over the length of sponge 10. Guide wire 3 is disposed in drainage tube 20. FIG. 26 shows a cross-sectional view of a sponge drainage having two conical sponges 10, 30, a guide wire 3 and a drainage tube 20.
[0102] Another embodiment according to the invention is shown in FIGS. 27-32. FIG. 27 is a view showing the arrangement of the complete drainage system (tubular sponge 10 and drainage tube 20) on the distal end of a flexible endoscope 3 guided through an overtube 6. A feeding tube 4 has already been advanced through the working channel of the endoscope.
[0103] FIG. 28 shows how release of sponge 10 is handled. The overtube 6 is guided in a distal direction on endoscope 3. The sponge slips over the distal end of the endoscope. FIG. 29 shows how sponge 10 is finally released. At this moment, a negative pressure can be applied via drainage tube 20. Due to the negative pressure being applied to an intestinal lumen or in a cavity, the sponge adheres to tissue and the feeding tube 4 is simultaneously fixed inside the sponge.
[0104] FIG. 30 shows a cross-sectional view of a sponge 10 placed in an intestine 100, with drainage tube 20. There are perforation openings 21 at the distal end of drainage tube 20, inside sponge 10. FIG. 31 shows a sponge 10 which is placed in an intestine 100 and which has collapsed under a vacuum. This also causes the intestinal lumen 110 to collapse onto sponge 10 and results in artificial closure of intestinal lumen 110. Perforation openings 21 are provided at the distal end of drainage tube 20.
[0105] FIG. 32 shows a cross-sectional view of the entire drainage system (tubular sponge 10, drainage tube 20 with perforation openings 21 at its distal end) mounted on the distal end of an endoscope 3. Endoscope 3 lies inside an overtube 6. There is a feeding tube 4 in the working channel of endoscope 3.
[0106] Another embodiment in accordance with the invention is shown in FIGS. 33-37. FIG. 33 shows a view of a sponge 10 into which a plurality of drainage tubes 20 perforated at their distal end have been inserted. Drainage tubes 20 are connected to each other via a connector member 40. The sponge is perforated between the drainage tubes (perforation line 19). FIG. 34 shows a cross-sectional view of FIG. 33.
[0107] FIG. 35 shows the separation of a subunit 10a from sponge 10. FIG. 36 shows the complete separation of a subunit 10a from sponge 10.
[0108] FIG. 37 shows a schematic view of vacuum sponge drainage units 2 of different sizes arranged in the abdominal cavity 200.
[0109] In the Figures, the inventive channel in the fluid collecting member is marked with the reference sign 11.
[0110] The features described with reference to FIGS. 8-15 apply analogously to the slit fluid collecting member.
[0111] Although FIGS. 16-21 illustrate only a recess 17, a channel 11 according to the invention may be provided in the advantageous manner described in the foregoing. The fluid collecting member is advantageously embodied in cap-like form, and the fluid communication member does not extend along the entire length of the fluid collecting member.
[0112] FIGS. 33-37 illustrate a plurality of fluid communication members. A channel 11 according to the invention may additionally be provided. Each of subunits 10a is preferably embodied as described with reference to FIGS. 16-21. In another embodiment, subunits 10a are a vacuum sponge unit according to the invention.
[0113] The vacuum sponge system illustrated in FIG. 38 comprises a fluid collection member, such as a sponge 110 having an open-pore structure which may be realized by an open-pore polyurethane foam, a drainage tube 120 and a delivery member comprising an enteral feeding device 140. The drainage tube 120 and enteral feeding device 140 are accommodated within a channel of the sponge 110 extending in an axial direction of the sponge from a proximal end 112 to a distal end 114 of the sponge 110.
[0114] In a distal end portion 160 of drainage tube 120 a plurality of perforations 122 are formed which penetrate the tube 120 and terminate in an inner lumen of the tube 120. By applying a reduced pressure to the inner lumen of drainage tube 120, reduced pressure is generated in the vicinity of outer surface 116 of sponge 110 via perforations 122. When positioning sponge 110 over an esophageal defect and applying a reduced pressure to drainage tube 120, the esophageal lumen closes and collapses onto the outer surface 116 of sponge 110. Further, the surface of the channel, which accommodates drainage tube 120 and the enteral feeding device 140, collapses on the outer surface of the drainage tube 120 and the enteral feeding device 140 accommodated within the channel. In this manner, reduced pressure may be applied to the esophageal defect in order to promote healing thereof, while simultaneously making it possible to perform enteral feeding via enteral feeding device 140. As noted, the enteral feeding device 140 may extend through the sponge 110 in an axial direction thereof from the proximal end 112 to the distal end 114. Drainage tube 120 may be attached to sponge material 110 by surgical sewing material. The enteral feeding device 140 may comprise a plurality of perforations 142 at a distal portion thereof arranged distally from distal end 114 of the sponge 110. The perforations 142 of the enteral feeding device 140 are different from the perforations of the drainage tube. They are disposed outside of the sponge in a region arranged distally from the sponge. The perforations 142 allow to supply feeding solution into the stomach or the small intestine when the device 140 is applied to the human body.
[0115] The embodiment shown in FIG. 39 mainly differs from the embodiment shown in FIG. 33 in that enteral feeding device 140 is arranged radially outside of the sponge 110. When applying a reduced pressure to the outer surface 116 of the sponge 110, this outer surface adapts in shape to the shape of the enteral feeding device 140 to thereby result in a sealing transition between the outer surface 116 of the sponge 110 to the inner surface of the intestinal lumen into which the sponge 110 is inserted, e.g. the esophagus.
[0116] The embodiment shown in FIG. 40 differs from the embodiment shown in FIG. 34 in that the enteral feeding device 140 is covered by covering member 144. The covering member 144 may have may guide the transmission of the reduced pressure applied to the outer surface 116 of sponge 110 to a region 145 of the enteral feeding device 140 opposite to the outer surface 116 of the sponge 110. The covering member 144 may be formed by open-pore foam and/or a multi-layer film having perforation openings terminating in a drainage lumen arranged between the layers of the multi-layer film. In the embodiment shown in FIG. 40, covering member 144 extends over the entire length of the sponge 110 and also extends beyond the distal end 114 and the proximal end 112 of the sponge 110. Further, in the embodiment shown in FIG. 40, cover member 144 runs around the entire circumference of enteral feeding device 140. However, the illustrated example is not limiting this disclosure. In some embodiments, covering member 144 may extend only over a portion of the entire length of the sponge 110 and may run around the enteral feeding device 140 only about a portion of the circumference thereof. The enteral feeding device 140 may be accommodated within covering member 144 such that it is displaceable within covering member 144 in an axial direction thereof.
[0117] In the embodiment shown in FIG. 41, drainage tube 120 is accommodated within the sponge 110 similar to the embodiment shown in FIG. 38. The embodiment shown in FIG. 41 differs from the embodiment shown in FIG. 33 in that an additional, separate tube 150 is provided. In embodiments, the delivery member comprising the enteral feeding device 140 may include the tube 150. The tube 150 may extend from proximal end 112 of the sponge 110 to the distal end 114 thereof. In the embodiment shown in FIG. 41, the separate tube 150 is accommodated in a separate channel of the sponge 110, spaced apart from the drainage tube 120 in a radial direction of the sponge 110. In other words, the separate channel and the separate tube accommodated in the separate channel are spaced apart from the drainage tube in a radial direction, which means that the sponge material is disposed between the drainage tube and the separate tube.
[0118] The embodiment shown in FIG. 41 is intended for the treatment of defects in the small intestine or the large intestine where intestinal gases or stool may exit via the separate tube 150.
[0119] In the vacuum sponge system shown in FIG. 42 enteral feeding device 140 extends through drainage tube 120. In this embodiment the enteral feeding device 140 and the drainage tube 120 are combined in a multi-lumen tube 180. One lumen 182 is responsible for drainage and generating reduced pressure in the vicinity of the outer surface 116 of sponge 110. The other lumen 184 is used for enteral feeding. The drainage lumen 182 terminates within the sponge body and is perforated within the sponge body. The enteral feeding lumen 184 extends beyond the sponge body in a distal direction.
[0120] FIG. 43 illustrates an example method for the treatment of esophageal defects in accordance with some embodiments. The method may be performed using the embodiments described above in reference to FIGS. 38 to 40. In step 1 of the method illustrated in FIG. 43 sponge 110 is inserted into an intestinal lumen over an esophageal defect. In step 2 an enteral feeding device is advanced distally of the sponge into the stomach or small intestine. Following the placement of the enteral feeding device the sponge is placed under reduced pressure such that the esophageal lumen closes (step 3). Finally, in step 4, enteral nutrition is performed via the enteral feeding device.
[0121] FIG. 44 illustrates an example method for a defect in the small intestine or the large intestine in accordance with some embodiments. The method may be performed using the embodiments described above in reference to FIG. 41. In step 1 of the method illustrated in FIG. 44, a sponge is inserted into an intestinal lumen orally or anally over a defect. In step 2 the sponge disposed in the intestinal lumen is set under reduced pressure such that the intestinal lumen in the vicinity of the defect collapses. In step 3, gases and/or stool may exit via an additional tube of the vacuum sponge system.
