Gastric calibration tube

Abstract

The invention proposes that in a gastric calibration tube (1) having an elongate flexible hollow body (2) which has an outer wall (4) and a first and a second tube end (7, 14), wherein the elongate flexible hollow body (2) has at least one opening (22, 18) in the region of the second tube end (14), the ratio of the wall thickness of the elongate flexible hollow body to the outer diameter of the elongate flexible hollow body is between 0.1 and 0.25.

Description

[0001] Gastric calibration tube

[0002] The invention relates to a gastric calibration tube according to the preamble of claim 1.

[0003] Gastric calibration tubes are known from the state of the art and can be used in surgical procedures, particularly in gastric interventions and bariatric procedures such as gastric resections, laparoscopic banded sleeve gastrectomy (LBSG), conventional sleeve gastrectomy (LCSG), fundoplication, gastric banding, and, for example, gastric bypasses. The gastric calibration tube is used for the visible and tactile demarcation of parts of the stomach, the introduction of air or fluid (methylene blue), as well as for decompression, emptying, and removal of fluids.

[0004] The gastric calibration tube comprises an elongated, flexible hollow body with an outer wall and a first and a second tube end. The second tube end can be inserted through the mouth and esophagus into the stomach. The first tube end remains outside the body. Medical devices such as syringes, cannulas, or devices that introduce or remove air or fluids into the calibration tube can be connected to the first tube end. Removal can be achieved, for example, by creating a negative pressure in the calibration tube.

[0005] The object of the present invention is to provide a gastric calibration tube which is further improved.

[0006] The features of claim 1 serve to solve this problem.

[0007] The invention advantageously provides that the ratio between the wall thickness of the elongated flexible hollow body relative to the outer diameter of the elongated flexible hollow body is between 0.1 and 0.25.

[0008] The present invention has the advantage that the gastric calibration tube does not kink when the wall thickness is appropriate relative to the outer diameter of the hollow body.

[0009] If a tube kink occurs, the flow of liquids or gases is disrupted or completely blocked. The kink can also damage the calibration tube. It can also prevent the second end of the tube from reaching its anatomical target, such as the junction between the stomach and duodenum.

[0010] Given the geometric conditions of the present gastric calibration tube according to the invention, kinking no longer occurs or is hardly observed.

[0011] The elongated, flexible hollow body can be made of a material containing silicone, preferably silicone rubber. The material, in particular the silicone rubber, can preferably have a Shore A hardness between 60 and 100. Due to the features according to the invention, the gastric calibration tube is very difficult to cut through and / or to staple over with a surgical stapler.

[0012] The Shore hardness test is a simple and effective method for materials testing and a straightforward procedure for measuring the hardness of elastomers and deformable base materials. Shore hardness refers to the resistance of a sample to penetration by a conical body of specific dimensions under a defined compressive force. Depending on the design of the measuring body, a distinction is made between Shore A and Shore D. The information provided here refers to Shore A hardness.

[0013] A detailed description of how the hardness test is to be carried out is described in DIN ISO 7619 / 1.

[0014] The silicone rubber in particular has a Shore A hardness between 70 and 90.

[0015] The flexible hollow body is elongated and has a longitudinal axis. The hollow body is therefore longer in a direction parallel to the longitudinal axis than it is wide in a direction perpendicular to the longitudinal axis.

[0016] In the present invention, the term "in the region of the second hose end" is used, whereby the term is to be understood that this region comprises at least half of the calibration hose, which also comprises the second hose end. Preferably, "in the region of" is to be understood that only 1 / 3, in particular 1 A, particularly preferably 1 / 5 of the calibration hose, which includes the respective hose end.

[0017] The same applies when using the term "in the area of ​​the first hose end." The elongated, flexible hollow body can have at least such a kink resistance that, for a hose section with a maximum length of 20 cm, the two hose section ends can be brought together without the hose section kinking.

[0018] The elongated flexible hollow body can furthermore have at least such a kink resistance that, in the case of a hose section with a maximum length of 15 cm, the two hose section ends can be brought together and the hose section does not kink.

[0019] Buckling resistance means the resistance or resistance of the hollow body to buckling.

[0020] The ratio between the wall thickness of the elongated flexible hollow body relative to the outer diameter of the elongated flexible hollow body can be between 0.16 and 0.2.

[0021] Outlet openings can be provided in the area of ​​the second hose end.

[0022] A closing element can be provided at the second end of the hose to close off the hollow body.

[0023] The end element can be blunt. This allows the gastric calibration tube to be easily inserted through the esophagus into the stomach without damaging any tissue.

[0024] The terminating element may comprise a material comprising radiopaque material, preferably barium sulfate.

[0025] This allows the closure element to be located using X-ray equipment, for example. This can ensure that the calibration tubes are not lost during surgery. The closure element can have at least one exit opening.

[0026] In the present invention, the term "flexible hollow body" is used. Flexible in this context means that the hollow body can be bent. Preferably, it should be able to be bent by at least 90°.

[0027] The material from which the end element is made may be softer than the material from which the elongated flexible hollow body is made.

[0028] A material is softer if it deforms more quickly. For example, it deforms more quickly under pressure or other stresses.

[0029] The material of the end element may be silicone, preferably silicone rubber.

[0030] At least one color stripe can be arranged along the longitudinal direction of the elongated flexible hollow body.

[0031] The color strip may differ in material and / or color from the elongated flexible hollow body.

[0032] The color strip can be arranged countersunk in the elongated flexible hollow body so that the surface of the color strip is flush with the outer surface of the elongated flexible hollow body.

[0033] The color stripe can have a thickness that does not exceed the wall thickness of the elongated, flexible hollow body. Thus, the color stripe cannot penetrate the wall thickness of the hollow body.

[0034] The elongated, flexible hollow body can have first outlet openings on a first side of the hollow body in the region of the second hose end, and second outlet openings on a second side of the hollow body opposite the first side. The first and second outlet openings can be arranged offset from one another.

[0035] In the following, an embodiment of the present invention is explained in more detail with reference to the drawings.

[0036] They show schematically:

[0037] Fig. 1a shows a gastric calibration tube according to the present invention,

[0038] Fig. 1b a locking slide for closing the calibration hose

[0039] Fig. 2 a section of the gastric calibration tube with outlet opening,

[0040] Fig. 3 the section from Fig. 2 in a different side view and with color stripes,

[0041] Fig. 4 a cross-section of the gastric calibration tube,

[0042] Fig. 5 a longitudinal cross-section of a section of the gastric calibration tube,

[0043] Fig. 6 shows another view of a section of the gastric calibration tube.

[0044] Fig. 1a shows a gastric calibration tube 1. The gastric calibration tube 1 has an elongated, flexible hollow body 2. The elongated, flexible hollow body 2 has a longitudinal axis 60. Furthermore, the hollow body 2 has an outer wall 4. The hollow body 2 has a first tube end 7 and a second tube end 14. The second tube end 14 can be inserted into the stomach via the mouth and esophagus during surgery. The first tube end 7 remains outside the body.

[0045] The gastric calibration tube 1 can be used in surgical procedures, especially in gastric interventions and bariatric procedures such as gastric resections, laparoscopic banded sleeve gastrectomy (LBSG), conventional sleeve gastrectomy (LCSG), fundoplication, gastric banding, and, for example, gastric bypasses. The gastric calibration tube 1 can be used for the visible and palpable demarcation of parts of the stomach, as well as for decompression, emptying, and removal of gastric acid.

[0046] The calibration hose 1 has a terminal element 16 at the second hose end 14. The terminal element 16 is blunt so that no injuries can occur when inserting the second hose end 14 into the human body. The hollow body 2 has at least one channel 6. The channel 6 extends in the longitudinal direction of the hollow body 2.

[0047] The gastric calibration tube 1 has at least one outlet opening 22 in the region of the second tube end 14. In the present case, several outlet openings 22 are provided in the hollow body 2. Furthermore, the closure element 16 can also have at least one outlet opening 18 that opens into the channel 6.

[0048] At the first hose end 7, medical aids can be coupled to the channel 6, such as syringes, cannulas or devices that introduce or discharge air or liquids into the channel 6 of the calibration hose 1. For discharge, a negative pressure can be generated in the channel 6 of the calibration hose 1. If a negative pressure is generated in the channel 6, a negative pressure is also present at the outlet openings 22 and 18. In this way, suction can be carried out by means of the first channel 6. In Fig. 1a, a connecting device 64 is provided which is connected to the first hose end, the calibration hose 1 being plugged into the connecting device 64. By means of the connecting device 64, a simple and secure coupling of different medical devices with a wide variety of connection geometries can be ensured.

[0049] At the end of the connecting device facing away from the calibration hose 1, the connecting device for coupling different medical aids has at least one second tapered depression and at least one tapered recess surrounding the second depression in a ring shape, so that the different medical aids can be inserted optionally into the second tapered depression or into the tapered recess for coupling.

[0050] However, the calibration hose according to the invention can also be connected to a medical device without or with another connecting device.

[0051] Fig. 1a also shows a closure slide 80. This is shown in more detail in Fig. 1b. It has a passage opening 82 with a first region 84 through which the calibration hose 1 can be guided without being clamped. The passage opening 82 has a second tapered region 87. When the calibration hose 1 is pressed in the direction of the second tapered region, the calibration hose 1 is compressed and the channel 6 of the calibration hose is closed.

[0052] Fig. 2 shows the calibration hose in more detail, with the first hose end 7 and the second hose end 14 being shown in more detail for the sake of clarity, and the central region of the hollow body 2 being left out. Furthermore, the connecting device 64 and the closure slide 80 are not shown in Fig. 2. The outlet openings 22 at the second hose end 14 are shown in Fig. 2. The closing element 16 can also be seen. The closing element 16 also has an outlet opening 18. The outer diameter of the closing element 16 can, as shown, have the same width as the diameter D of the elongated hollow body 2. Both the closing element 16 and the elongated flexible hollow body 2 can be made of silicone, preferably silicone rubber. The material of the elongated flexible hollow body 2 preferably has a Shore A hardness between 60 and 100.The Shore A hardness of the end element 16 is preferably lower than the Shore A hardness of the flexible hollow body. The end element 16 is thus preferably softer than the hollow body 2.

[0053] Fig. 3 shows the gastric calibration tube 1 from Fig. 2, but in a different side view. In this side view, it can be seen that at least one colored stripe 30 can be arranged in the longitudinal direction of the elongated, flexible hollow body 2. Furthermore, it can be seen that, in the region of the second tube end 14, first outlet openings 22 can be arranged on a first side of the hollow body 2, and second outlet openings 23 can be arranged on a second side of the hollow body 2 opposite the first side. The first and second outlet openings 22, 23 are preferably arranged offset from one another.

[0054] Fig. 4 shows a cross-section through the elongated, flexible hollow body 2 from Fig. 3. Fig. 4 shows the outer diameter D of the elongated, flexible hollow body and the inner diameter d. Furthermore, the wall thickness w is shown.

[0055] According to the present invention, the ratio between the wall thickness w of the elongate, flexible hollow body 2 and the outer diameter D of the elongate, flexible hollow body is between 0.1 and 0.25, in particular between 0.16 and 0.20. Furthermore, it can also be seen in Fig. 4 that a colored stripe 30 can be provided. This is an optional feature. The colored stripe can, as shown, be recessed into the elongate, flexible hollow body 2, so that the surface of the colored stripe is flush with the outer surface of the elongate, flexible hollow body 2. The colored stripe has a width b and a thickness t. The thickness t of the colored stripe is preferably smaller than the wall thickness w of the hollow body 2, so that the wall of the hollow body 2 is not pierced or broken through.

[0056] Fig. 5 shows a longitudinal section through the hollow body 2. It can be seen again that the first outlet openings 22 and the second outlet opening 23 are offset from one another. Furthermore, it can be seen that the outlet openings 22 and 23 have a diameter E. The diameter E is preferably between 2 and 6 mm. The distance S between the outlet openings 22 and 23 is preferably between 10 and 30 mm.

[0057] The end element 16 is formed from a material 20 which preferably comprises barium sulfate and is thus detectable by X-ray methods.

Claims

Claims 1. Gastric calibration hoses (1) with an elongated flexible hollow body (2) which has an outer wall (4) and a first and a second hose end (7, 14), wherein the elongated flexible hollow body (2) has at least one opening (22, 18) in the region of the second hose end (14), characterized in that the ratio between the wall thickness of the elongated flexible hollow body based on the outer diameter of the elongated flexible hollow body is between 0.1 and 0.

25.

2. Gastric calibration hoses (1) according to claim 1, characterized in that the elongate flexible hollow body consists of a material comprising silicone, preferably silicone rubber, wherein the silicone rubber preferably has a Shore A hardness between 60 and 100.

3. Gastric calibration tubes (1) according to claim 1 or 2, characterized in that the elongated flexible hollow body has at least such a kink resistance that, with a tube section of a maximum length of 20 cm, the two tube section ends can be brought together and the tube section does not kink.

4. Gastric calibration tubes (1) according to claim 3, characterized in that the elongated flexible hollow body has at least such a kink resistance that, with a tube section of a maximum length of 15 cm, the two tube section ends can be brought together and the tube section does not kink.

5. Gastric calibration tubes (1) according to one of claims 1 to 4, characterized in that the ratio between the wall thickness of the elongated flexible hollow body relative to the outer diameter of the elongated flexible hollow body is between 0.16 and 0.

20.

6. Gastric calibration hoses (1) according to one of claims 1 to 5, characterized in that outlet openings are provided in the region of the second hose end.

7. Gastric calibration hoses (1) according to one of claims 1 to 6, characterized in that a closing element (16) is provided at the second hose end (14), which closes off the hollow body (2).

8. Gastric calibration hoses (1) according to claim 7, characterized in that the end element (16) is blunt.

9. Gastric calibration hoses (1) according to claim 7 or 8, characterized in that the closing element (16) has at least one outlet opening.

10. Gastric calibration tubes (1) according to one of claims 7 to 9, characterized in that the closing element (16) comprises a material comprising radiopaque material, preferably barium sulfate.

11. Gastric calibration tubes (1) according to one of claims 7 to 10, characterized in that the material from which the closing element (16) is made is softer than the material from which the elongated flexible hollow body (2) is made.

12. Gastric calibration hoses (1) according to one of claims 1 to 11, characterized in that the material of the closing element is silicone, preferably silicone rubber.

13. Gastric calibration tubes (1) according to one of claims 1 to 12, characterized in that at least one color stripe is arranged in the longitudinal direction of the elongate flexible hollow body (2) along the elongate flexible hollow body.

14. Gastric calibration tubes (1) according to one of claims 1 to 13, characterized in that the color strip is arranged countersunk in the elongated flexible hollow body, so that the surface of the color strip is flush with the outer surface of the elongated flexible hollow body.

15. Gastric calibration hoses (1) according to one of claims 1 to 11, characterized in that the elongated flexible hollow body in the region of the second hose end has first outlet openings on a first side of the hollow body and second outlet openings on a second side of the hollow body opposite the first side.

16. Gastric calibration tubes (1) according to claim 15, characterized in that the first and second outlet openings are arranged offset from one another.

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