Probe system for endoluminal negative pressure therapy

Description

[0001] Negative pressure therapy, also known as vacuum therapy, is a treatment method in which negative pressure is applied to a chronic or acute wound or inflamed area and usually maintained continuously or periodically over a longer period. This can contribute to improved wound healing, for example, by effectively suctioning wound secretions. An overview of applications of negative pressure therapy and negative pressure therapy devices can be found, for example, in DE 10 2016 114 819 A1.

[0002] Negative pressure therapy is increasingly being used endoluminally, i.e., inside a body cavity, for example, in the lumen of the gastrointestinal tract. Such applications are also described in detail in the aforementioned German patent DE 10 2016 114 819 A1. In endoluminal negative pressure therapy, a probe body connected to a tube is inserted into the lumen and positioned at the site to be treated. To enable comprehensive drainage of wound secretions while simultaneously ensuring gentle treatment of the tissue forming the lumen wall, a fluid collection chamber, formed by a sponge, is integrated into the probe body according to current technology.

[0003] In medical practice, however, it has become apparent that such spongy probes carry a significant risk of adhesion to the tissue forming the lumen wall. This limits the time a given probe can remain in the lumen and necessitates multiple probe system changes for endoluminal negative pressure therapy during the healing process of an endoluminal wound, which can extend over several weeks.

[0004] A probe system from the prior art is disclosed in US 2013 / 0211385 A1. Other known probe systems are described, for example, in US 2019 / 0307933 A1, US 2020 / 0330652 A1, US 2014 / 0052111 A1 and US 2021 / 0260260 A1.

[0005] The object of the invention is therefore to provide an improved probe system for endoluminal negative pressure therapy that can remain in the lumen long-term. This object is achieved by a probe system for endoluminal negative pressure therapy with the features of claim 1. Advantageous embodiments of the invention are the subject of the dependent claims.

[0006] The probe system according to the invention for endoluminal negative pressure therapy comprises a probe tube and a probe body connected to the probe tube. The probe body has a base body with an inner lumen and with at least one opening extending from the inner lumen and through the outer wall of the base body to an outer surface of the base body.

[0007] In many cases, it is advantageous for the base body to be cylindrical. The lumen can, for example, be formed by an opening or bore running coaxially to the cylinder axis of the cylindrical base body; the opening(s) that guide the inner lumen and the outer surface of the base body can then preferably penetrate the outer wall, formed by the cylinder shell, perpendicular to the cylinder axis. It is preferred if several openings are present, pointing in different directions, so that when a vacuum is generated, suction is created in multiple directions.

[0008] A key aspect of the invention is that the probe body has several rod-shaped and / or at least one lamellar structure on the outside of the base body, particularly on its outer surface. In some embodiments of the invention, these structures may also have a channel with an outlet opening, the channel communicating with the inner lumen of the base body.

[0009] The term "rod-shaped" applies in particular to structures whose length, measured from their starting point on the base body to their end opposite the base body, is several times, preferably more than five times, the greatest extent of their cross-section perpendicular to this longitudinal direction. The cross-section can change along the longitudinal direction of the structure. Particularly preferred are embodiments with a circular cross-section, so that rod-shaped structures can have the geometry of a cylinder, a truncated cone, or a cone, the height of which is several times, preferably more than five times, its greatest diameter.

[0010] The term "lamellar" applies in particular to discs and ribbon-shaped structures if their height, measured from their starting point on the base body to their end opposite the base body, is several times, in particular more than five times, their thickness (which is defined in particular by the distance between their largest surfaces).

[0011] These rod-shaped and / or lamellar structures ensure that the respective wall of the body opening or body cavity into which they are inserted is spaced away from the base body and cannot be sucked into openings of the base body of the probe body by negative pressure.

[0012] At the same time, even when several such structures are present, they are individual structures that are spaced apart from each other, so that, unlike the sponge-like structures of the prior art, the risk of adhesions between the probe body and tissue is drastically reduced.

[0013] The efficiency of removing wound secretions is surprisingly high, even though no absorption of the wound secretions occurs through a sponge, which is presumably due to the fact that the sponge presents a relatively high suction resistance, thus making the suction more efficient.

[0014] The probe body of the probe system according to the invention offers particular advantages when it is used not only for negative pressure wound therapy but also for introducing irrigation fluids or medications to clean the wound or to clear blockages. The combination of irrigation and suction ensures sufficient drainage of wound secretions. This combination is not present in sponge systems, which are therefore prone to clogging.

[0015] With the probe body of the probe system according to the invention, the liquid can be allowed to exit directly from the openings of the base body.

[0016] Furthermore, previous experience suggests that the structures on the probe body according to the invention cause stimulation of the tissue that promotes the healing process.

[0017] It is particularly preferred if the base body and the probe tube are manufactured in one piece or bonded together by a single material. This ensures a particularly reliable integrity of the probe system, even during insertion into or removal from the lumen. For the same reason, a one-piece design or bonded connection between the base body and the structures is also preferred.

[0018] According to the invention, the structures extend perpendicularly away from the base body and / or are perpendicular to the outside of the base body, i.e., to its outer wall, through which the openings lead when the probe body is not inserted into a body cavity.

[0019] Since the structures are arranged in a ring-like or spiral shape on the outer wall of the base body according to the invention, they ensure a simultaneous spacing of the base body from the wall of the body opening into which the probe body is inserted, in all directions perpendicular to the direction of travel or extension of the base body. This reduces the probability of openings becoming clogged and increases the probability of unclogged openings.

[0020] It is particularly advantageous if the structures are flexible and / or elastic. There are two main reasons for this: First, in this case, they can deform when negative pressure is applied and, if necessary, even lie against the base body, which improves suction efficiency while still ensuring that the body cavity does not collapse completely onto the surface of the base body, because the body cavity is still held at a distance from the base body by the structures that are then in contact with it. Second, current experience suggests that this method achieves a particularly efficient and gentle stimulation of the tissue, which promotes wound healing.

[0021] By varying the length, i.e., the distance between its starting point on the base body and the end opposite the base body, the probe body can be adapted in terms of its geometry and thus, for example, made particularly easy to insert into the body cavity.

[0022] According to the invention, the probe tube is a two-lumen tube. In this configuration, a flushing function can be implemented particularly easily in addition to the negative pressure therapy function. In this flushing function, a flushing fluid, e.g., a saline solution, is supplied through one lumen and aspirated through the other. A medically important advantage of the two-lumen system is that secretions already aspirated and located in the suction lumen are not returned to the body orifice, e.g., the intestine, during the flushing process. Furthermore, this results in a shorter flushing time with the two-lumen system.

[0023] In the case of the use of a probe hose with only one lumen, which is also possible in principle but not part of the claimed invention, it must be ensured during switching between the rinsing operation and the vacuum operation that the liquid or vacuum source not in use is completely sealed against the probe hose in order to guarantee the proper execution of the action currently being carried out, whereas with a two-lumen probe hose such a seal does not have to be renewed with each switchover, but only once when the probe hose is connected to the respective sources.

[0024] According to the invention, the two lumens of the double-lumen tube have different cross-sectional areas, and the rinsing fluid is supplied via the lumen with the smaller cross-sectional area. A particularly preferred embodiment is one in which the cross-sectional area of ​​the lumen used for suction is as large as possible. The cross-section referred to is a section perpendicular to the direction of travel of the probe tube.

[0025] Such a double-lumen probe tube is particularly easy to manufacture if, according to the invention, the cross-section of both lumens of the double-lumen tube is circular.

[0026] If both the irrigation and negative pressure therapy functions are to be implemented, it can be advantageous to provide two lumens in the probe's main body, which particularly enables the simultaneous use of both functions. If both irrigation and suction are to occur across the entire circumference of the main body, these can be designed, for example, as two concentric coils or a double helix; alternatively, they can simply run parallel to each other. Accordingly, in this case, the openings in the main body will then have either only an irrigation function or only a suction function, whereas otherwise their function changes depending on the currently active operating mode.

[0027] For precise positioning of the probe head, it is advantageous to have a marking on the outside of the probe tube so that the position of the probe system in a lumen into which it is inserted can be read.

[0028] An alternative or additional measure that enables the precise positioning of the probe body within the lumen involves attaching a radiopaque strip to the probe tube and / or impregnating the material of the probe tube and / or probe body with a radiopaque contrast agent. This makes it possible to accurately determine the position of the probe body within the lumen using an X-ray image.

[0029] By sealing the inner lumen of the base body with a plug on the side opposite the connection point to the probe tube, an opening is prevented from forming at the distal end of the base body. This opening could allow particles from the body cavity wall, into which the probe body is inserted, or larger particles present therein, to be drawn into the inner lumen and / or clog it. While this could theoretically also be achieved by sealing the lumen distally with a wall, this would lead to the aforementioned problems when adjusting the length of the base body. Therefore, the plug also facilitates length adjustment of the probe body.

[0030] If a loop is arranged on the distal side of the base body opposite the connection point to the probe tube, the probe can be easily inserted using endoscopic tools.

[0031] It is particularly advantageous if the probe body and tube are made of silicone. This material exhibits excellent biocompatibility and high chemical resistance to various media. At the same time, it is soft, flexible, and tear-resistant.

[0032] The invention is explained in more detail below with reference to figures showing exemplary embodiments. These figures show: Fig. 1a: A top view of a first embodiment of a probe system; Fig. 1b: A cross-section through the probe system made of Figure 1a Fig. 2a: a top view of a probe body, second embodiment of a probe system; Fig. 2b: an enlarged view of the plug of the probe body made of Fig. 2aFig. 3a: a probe body of a third embodiment of a probe system; Fig. 3b: a probe body of a fourth embodiment of a probe system; Fig. 3c: a probe body of a fifth embodiment of a probe system; Fig. 3d: a probe body of a sixth embodiment of a probe system; Fig. 3e: a probe body of a seventh embodiment of a probe system; Fig. 3f: a probe body of an eighth embodiment of a probe system; Fig. 3g: a probe body of a ninth embodiment of a probe system; Fig. 4a: a cross-section through a first variant of a two-lumen probe tube; Fig. 4b: a cross-section through a variant of a two-lumen probe tube not according to the invention; and Fig. 4c: a cross-section through another variant of a two-lumen probe tube not according to the invention.

[0033] The same reference numerals are used for different representations of identical embodiments. However, to maintain clarity in the figures, not all reference numerals are always shown. In particular, structures or components that are present in large numbers in an embodiment—for example, the openings in the base body and rod- or lamellar-shaped structures—are only provided with an example of a reference numeral that is the same for all these structures or components of a given embodiment.

[0034] The Figures 1a and 1b Figure 1 shows two views of a first probe system 100. The probe system 100 has a probe tube 11 which is connected to the cylindrical base body 12 of a probe body 1. The lumen of the probe tube 11 communicates, as the Figure 1bThis is illustrated by the inner lumen 13 of the base body 12, which runs coaxially to the cylinder axis of the cylindrical base body 12 and defines its direction of extension. The inner lumen 13 is closed at its distal end, opposite the probe tube 11. A multitude of rod-shaped structures 14 are formed on the outer surface of the base body 12, extending perpendicularly, i.e., radially, from the outer surface of the base body 12, perpendicular to its cylinder axis. The rod-shaped structures 14 are grouped into several groups, with the starting points of the rod-shaped structures 14 of a given group lying on a ring on the surface of the base body 12, thus forming a ring-shaped arrangement. Openings 15 lead from the inner lumen 13 of the base body 12 to its outer surface.Accordingly, fluid can be aspirated from or introduced into the vicinity of the probe body 1 via the lumen of the probe tube 11, the inner lumen 13, and the openings 15. Furthermore, a loop 16 is arranged at the distal end of the base body 12 to facilitate the placement of the probe body 1.

[0035] The in the Figures 2a and b as well as the probe bodies 2, 3, 4, 5, 6, 7, 8, 9 shown in 3a to 3g can each be connected to a probe system 100 with a probe tube onto the in Figures 1a and 1b The probes are connected in the manner shown. Therefore, the probe tube belonging to the respective probe systems is not shown in these figures.

[0036] The one in Figure 2aThe probe body 2 shown, with a cylindrical base body 22 with an inner lumen 23 and rod-shaped structures 24 and openings 25, differs from the probe body 1 in its length and the number of rod-shaped rings 24 arranged on it. In fact, the probe body 2 can be obtained by shortening the probe body 1; the opening thereby created at the distal end of the probe body 2 is connected to the one shown in Figure 2b The enlarged image shows the plug 26 closed.

[0037] The in the Figures 3a to 3gThe probe bodies 3, 4, 5, 6, 7, 8, 9 shown, with cylindrical base bodies 32, 42, 52, 62, 72, 82, 92, with an inner lumen (not shown in the figures) and openings 35, 45, 55, 65, 75, 85, 95, differ in the shape and distribution of the rod-shaped and / or lamellar structures 34, 44, 54, 64, 74, 84 arranged on them. The preferred shape and distribution of the structures 34, 44, 54, 64, 74, 84 may depend in particular on the anatomical conditions of the body cavity and / or the wound to be treated.

[0038] In Figure 3a are rod-shaped structures 34, whose length increases continuously from proximal to distal and then decreases continuously, arranged spirally around the base body 32.

[0039] In the Figures 3b and 3eA lamellar structure 44 or 74 is arranged spirally around the base body 42 or 72, respectively, with the number of helixes differing and the height of the helixes increasing from proximal to distal in probe body 4, while decreasing from proximal to distal in probe body 7.

[0040] In the Figures 3c, 3d and 3g Several lamellar structures 54, 64, 94 in the form of disks of different diameters are concentrically formed on the cylindrical base body 52, 62, 92 with its cylindrical axis. In this process, Figure 3c the diameter of the lamellar structures 54 increases sharply from proximal to distal, in 3D figure the diameter of the lamellar structures 64 decreases sharply from proximal to distal and in Figure 3gThe diameter of the lamellar structures 94 varies slightly from proximal to distal. Furthermore, the spacing and number of lamellar structures 54, 64, and 94, respectively, vary.

[0041] The in Figure 3f The probe body 8 shown has a lamellar, disc-shaped structure 84 at its proximal end, as well as a plurality of rod-shaped structures 84, four of which form a group arranged in a cross shape at a given location on the base body 82. The length of the rod-shaped structures 84 in each group decreases continuously from proximal to distal.

[0042] The Figures 4a to 4c Three cross-sections of double-lumen probe tubes 110, 120, 130 are shown, which can be used to easily implement a flushing and vacuum operation of the probe system by providing a separate lumen for each operating mode, with only the in Figure 4aThe embodiment shown belongs to the claimed invention. Accordingly, the probe hoses 110, 120, 130 are each configured with two lumens, 111, 112; 121, 122 and 131, 132 respectively, wherein the lumens 112, 122, 132 intended for flushing operation each have a smaller cross-section. While the embodiment according to Figure 4a which is particularly easy to manufacture, is in the embodiment of the Figure 4c The cross-section of the lumen is maximized to 131, which offers advantages for extraction.

[0043] Specifically, in Figure 4a the cross-section of both lumens 111,112 of the two-lumen tube is circular, while in the part not belonging to the invention Figure 4bThe cross-section of one of the lumens 122 of the two-lumen tube is circular, and the cross-section of the other lumen 121 of the two-lumen tube is crescent-shaped, with the concave side of the crescent facing the circular lumen 122. In the embodiment not belonging to the claimed invention, the Figure 4c The two lumens 131,132 of the double-lumen tube are separated from each other in cross-section by a straight wall 133, which allows a particularly large volume to be created for extraction. Reference symbol list

[0044] 1, 2, 3, 4, 5, 6, 7, 8, 9 Probe body 11, 110, 120, 130 Probe tube 12, 22, 32, 42, 52, 62, 72, 82, 92 Base body 13, 23 Inner lumen 14, 24, 34, 44, 54, 64, 74, 84, 94 Structure 15, 25, 35, 45, 55, 65, 75, 85, 95 Opening 16 Loop 26 Plug 100 Probe system 111, 112, 121, 122, 131, 132 Lumen 133 Wall

Claims

1. A probe system (100) for endoluminal negative-pressure therapy, comprising a probe tube (11, 110, 120, 130) and a probe body (1, 2, 3, 4, 5, 6, 7, 8, 9) connected to the probe tube (11, 110, 120, 130), wherein the probe body comprises a base body (12, 22, 32, 42, 52, 62, 72, 82, 92) having an inner lumen (13, 23) and at least one opening (15, 25, 35, 45, 55, 65, 75, 85, 95), which leads from the inner lumen (13, 23) through an outer wall of the base body (12, 22, 32, 42, 52, 62, 72, 82, 92) to an outer side of the base body (12, 22, 32, 42, 52, 62, 72, 82, 92), wherein the probe body (1, 2, 3, 4, 5, 6, 7, 8, 9) on the outer side of the base body (12, 22, 32, 42, 52, 62, 72, 82, 92) comprises a plurality of rod-shaped structures (14, 24, 34, 84) and / or at least one lamella-shaped structure (44, 54, 64, 74, 94), wherein the structures (14, 24, 34, 44, 54, 64, 74, 84, 94) are arranged perpendicularly to the outer wall of the base body (12, 22, 32, 42, 52, 62, 72, 82), wherein the structures (14, 24, 34, 44, 54, 64, 74, 84, 94) are arranged in a ring-shaped or spiral-shaped manner on the outer wall of the base body (12, 22, 32, 42, 52, 62, 72, 82, 92), and wherein the probe tube (11, 110, 120, 130) is a dual-lumen tube, wherein the cross sections of the two lumens (111, 112, 121, 122, 131, 132) of the dual-lumen tube have different cross-sectional areas, and wherein the irrigation fluid is supplied via the lumen having the smaller cross-sectional area, and wherein the cross section of both lumens (111, 112) of the dual-lumen tube is circular, and wherein the inner lumen (13, 23) of the base body (12, 22, 32, 42, 52, 62, 72, 82, 92) is closed by a plug (26) on the side opposite the connection point to the probe tube (11, 110, 120, 130).

2. The probe system (100) according to claim 1, characterized in that the base body (12, 22, 32, 42, 52, 62, 72, 82, 92) and the probe tube (11, 110, 120, 130) are formed in one piece or are materially bonded to one another.

3. The probe system (100) according to one of claims 1 or 2, characterized in that the structures (14, 24, 34, 44, 54, 64, 74, 84, 94) are flexible and / or elastic.

4. The probe system (100) according to one of claims 1 to 3, characterized in that the length of the structures (14, 24, 34, 44, 54, 64, 74, 84, 94) varies.

5. The probe system (100) according to one of claims 1 to 4, characterized in that a marking is applied to the outer side of the probe tube (11, 110, 120, 130), such that the position of the probe system (100) within a lumen of a body cavity into which it is inserted can be read.

6. The probe system (100) according to one of claims 1 to 5, characterized in that an X-ray contrast strip is incorporated into the probe tube (11, 110, 120, 130) and / or that the material from which the probe tube (11, 110, 120, 130) and / or the probe body (1, 2, 3, 4, 5, 6, 7, 8, 9) is made is mixed with an X-ray contrast agent.

7. The probe system (100) according to one of claims 1 to 6, characterized in that a loop (15) is arranged on the side of the base body (12, 22, 32, 42, 52, 62, 72, 82, 92) opposite the connection point to the probe tube (11, 110, 120, 130).

8. The probe system (100) according to one of claims 1 to 7, characterized in that the probe body (1, 2, 3, 4, 5, 6, 7, 8, 9) and the probe tube (11, 110, 120, 130) are made of silicone.