Stomach calibration tube

Abstract

The invention proposes a gastric calibration tube (1) having an elongate flexible hollow body (2) with an outer wall (4) and a first and a second tube end (7, 14), the elongate flexible hollow body (2) having 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 being between 0.1 and 0.25.

Description

Technical Field

[0001] The present invention relates to the gastric calibration tube as described in the preamble of claim 1. Background Technology

[0002] Gastric calibration tubes are known in the prior art and can be used in surgical procedures, particularly for gastric and bariatric surgeries such as gastrectomy, laparoscopic banded sleeve gastrectomy (LBSG), conventional sleeve gastrectomy (LCSG), fundoplication, gastric banding, and, for example, gastric bypass surgery. Gastric calibration tubes are used to visually and intuitively delineate portions of the stomach, to inject air or liquid (methylene blue), and to decompress, empty, and remove fluid.

[0003] The gastric calibration tube has an elongated, flexible, hollow body with an outer wall and a first tube end and a second tube end. The second tube end can be inserted into the stomach through the mouth and esophagus. The first tube end remains outside the body. Medical aids, such as syringes, cannulas, or devices for injecting or expelling air or liquid into the gastric calibration tube, can be connected to the first tube end. For example, discharge can be achieved by creating negative pressure within the calibration tube. Summary of the Invention

[0004] The purpose of this invention is to provide a further improved gastric calibration tube.

[0005] This objective is achieved by the features defined in claim 1.

[0006] The present invention advantageously provides a scheme in which the ratio of the wall thickness of the slender flexible hollow body to the outer diameter of the slender flexible hollow body is between 0.1 and 0.25.

[0007] An advantage of this invention is that the gastric calibration tube will not kink if the wall thickness of the hollow body is appropriate relative to the outer diameter.

[0008] If the tube becomes kinked, it means that the flow of liquid or gas within the tube will be disrupted or completely blocked. Kinking can also damage the gastric calibration tube. Furthermore, kinking may result in the second tube end being unable to be guided to anatomical targets, such as the transition zone between the stomach and duodenum.

[0009] The geometric proportions of the gastric calibration tube according to the invention make kinking no longer occur or almost never occur.

[0010] The slender, flexible hollow body can be made of a material containing silicone, preferably silicone rubber. The material, particularly silicone rubber, preferably has a Shore A hardness between 60 and 100.

[0011] Due to the features of this invention, the gastric calibration tube is difficult to cut with a surgical stapler and / or difficult to suture (stapleover).

[0012] The Shore hardness test is a simple and effective material testing method, and a straightforward procedure for measuring the hardness of elastomers and deformable substrates. Shore hardness is the resistance of a sample to penetration through a cone of specific dimensions under a specified compressive force. Depending on the design of the measuring body, it can be classified as Shore A or Shore D. In this case, the specification refers to Shore A.

[0013] DIN ISO 7619 / 1 provides detailed instructions on how to perform hardness testing.

[0014] Specifically, the silicone rubber has a Shore A hardness between 70 and 90.

[0015] The flexible hollow body is elongated and has a longitudinal axis. Therefore, the length of the hollow body in the direction parallel to the longitudinal axis is greater than its width in the direction perpendicular to the longitudinal axis.

[0016] In this invention, the term "in the region of the second tube end" is used, and this term should be understood to mean that this region includes at least half of the gastric calibration tube containing the second tube end. Preferably, "within the range" should be understood to mean that only 1 / 3, particularly 1 / 4, and especially preferably 1 / 5 of the gastric calibration tube includes the corresponding tube end.

[0017] The same applies to the use of the term "in the area of ​​the first tube end".

[0018] The slender, flexible hollow body has at least the following resistance to kinking: for a pipe segment with a maximum length of 20 cm, the two ends of the pipe segment can be joined together and the pipe segment will not kink.

[0019] The slender, flexible hollow body can also have at least the following resistance to kinking: for a pipe segment with a maximum length of 15 cm, the two ends of the pipe segment can be joined together and the pipe segment will not kink.

[0020] Knot resistance refers to the resistance or resistance of a hollow body to kinking.

[0021] The ratio of the wall thickness to the outer diameter of the slender flexible hollow body is between 0.16 and 0.2.

[0022] Output openings can be provided in the area at the second end of the tube.

[0023] A terminating element can be installed at the second tube end to close the hollow body.

[0024] The terminating element can be blunt. In this way, the gastric calibration tube can be easily inserted into the stomach through the esophagus without damaging the tissue.

[0025] The terminating element may comprise a material having a radiopaque material, preferably barium sulfate.

[0026] In this way, the termination element can be located, for example, using an X-ray device. This ensures that the calibration tube is not lost inside the body during surgery.

[0027] The termination element may have at least one outlet opening.

[0028] The term "flexible hollow body" is used in this invention. In this context, "flexible" means that the hollow body can be bent. Preferably, it should be able to bend at least 90°.

[0029] The material constituting the terminating element can be softer than the material constituting the slender, flexible hollow body.

[0030] If a material deforms faster, it is softer. For example, it deforms faster under pressure or other loads.

[0031] The material constituting the terminating element may include silicone resin, preferably silicone rubber.

[0032] In the longitudinal direction of the slender flexible hollow body, at least one color strip can be arranged along the slender flexible hollow body.

[0033] The ribbon may differ from the slender, flexible hollow body in material and / or color.

[0034] The ribbon can be recessed into the slender, flexible hollow body, so that the surface of the ribbon is flush with the outer surface of the slender, flexible hollow body.

[0035] The ribbon can have a thickness not exceeding the wall thickness of the slender, flexible hollow body. Therefore, the ribbon will not penetrate the wall thickness of the hollow body.

[0036] The slender, flexible hollow body may have a first outlet opening on the first side of the hollow body in the region of the second tube end, and a second outlet opening on the second side of the hollow body opposite to the first side.

[0037] The first outlet opening and the second outlet opening can be arranged staggered from each other. Attached Figure Description

[0038] Embodiments of the present invention will now be described in more detail with reference to the accompanying drawings.

[0039] The attached diagram schematically shows:

[0040] Figure 1a A gastric calibration tube according to the invention is shown;

[0041] Figure 1b The locking slider for closing the gastric calibration tube is shown;

[0042] Figure 2 A cross-section of a gastric calibration tube with an outlet opening is shown;

[0043] Figure 3 Show Figure 2 Different side views and cross-sections with color bands;

[0044] Figure 4 A cross-section of the gastric calibration tube is shown;

[0045] Figure 5 The longitudinal cross-section of one section of the gastric calibration tube is shown.

[0046] Figure 6 Another view showing a cross-section of the gastric calibration tube. Detailed Implementation

[0047] Figure 1a A gastric calibration tube 1 is shown. This 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 end 7 and a second end 14. The second end 14 can be inserted into the stomach through the mouth and esophagus. The first end 7 remains outside the body.

[0048] The gastric alignment tube 1 can be used in surgical procedures, particularly for gastric and bariatric surgeries such as gastrectomy, laparoscopic banded sleeve gastrectomy (LBSG), conventional sleeve gastrectomy (LCSG), fundoplication, gastric banding, and procedures such as gastric bypass. The gastric alignment tube 1 is used to visually and intuitively delineate portions of the stomach, and for decompression, emptying, and removal of gastric acid.

[0049] The gastric calibration tube 1 has a termination element 16 at the second end 14. The termination element 16 is blunt so as not to cause damage when the second end 14 is inserted into the human body. The hollow body 2 has at least one channel 6. The channel 6 extends longitudinally along the hollow body 2.

[0050] The gastric calibration tube 1 has at least one outlet opening 22 in the region of the second tube end 14. In this embodiment, multiple outlet openings 22 are provided in the hollow body 2. In addition, the termination element 16 may also have at least one outlet opening 18 leading to the channel 6.

[0051] Medical assistive devices, such as syringes, cannulas, or devices for injecting or expelling air or liquid into or out of the channel 6 of the gastric calibration tube 1, can be connected to the channel 6 at the first end 7. For the purpose of expulsion, negative pressure can be generated in the channel 6 of the gastric calibration tube 1. If negative pressure is generated in the channel 6, negative pressure will also exist at the outlet openings 22 and 18. In this way, aspiration can be performed using the first channel 6.

[0052] exist Figure 1a The device includes a connecting device 64, which connects to the first tube end, and the calibration tube 1 is inserted into the connecting device 64. The connecting device 64 can be used to ensure simple and safe coupling of different medical devices with various connection geometries.

[0053] At the end of the connecting device away from the gastric calibration tube 1, the connecting device for connecting different medical auxiliary devices has at least one second tapered indentation and at least one tapered recess surrounding the second tapered indentation, so that different medical auxiliary devices can be inserted into the second tapered indentation or the tapered recess for connection.

[0054] However, the gastric calibration tube according to the invention can also be connected to a medical assistive device without a connecting device or using a different connecting device.

[0055] Figure 1a Locking slider 80 is also shown. Figure 1b The locking slider 80 is shown in more detail below. The locking slider 80 has a passage opening 82 with a first region 84 through which the gastric calibration tube 1 can pass without being clamped. The passage opening 82 has a second tapered region 87. When the gastric calibration tube 1 is pressed along the direction of the second tapered region, the gastric calibration tube 1 is compressed and the passage 6 of the gastric calibration tube is closed.

[0056] Figure 2 The gastric calibration tube is shown in more detail; for clarity, the first tube end 7 and the second tube end 14 are shown in more detail, while the middle portion of the hollow body 2 is omitted. Furthermore, in Figure 2 The connecting device 64 and the locking slider 80 are not shown.

[0057] Figure 2The outlet opening 22 at the second tube end 14 is shown. The termination element 16 is also visible. The termination element 16 also has an outlet opening 18. As shown, the outer diameter of the termination element 16 can be the same as the diameter D of the elongated hollow body 2. Both the termination element 16 and the elongated flexible hollow body 2 can be made of silicone resin, preferably silicone rubber. The material of the elongated flexible hollow body 2 preferably has a Shore hardness A between 60 and 100. The Shore hardness A of the termination element 16 is preferably lower than that of the flexible hollow body. Therefore, the termination element 16 is preferably softer than the hollow body 2.

[0058] Figure 3 It shows Figure 2 The gastric calibration tube 1 is shown in a different side view. In this side view, at least one color band 30 can be seen along the longitudinal direction of the elongated flexible hollow body 2. Furthermore, a first outlet opening 22 can be provided on the first side of the hollow body 2 in the region of the second tube end 14, and a second outlet opening 23 can be provided on the second side of the hollow body 2 opposite to the first side. The first outlet opening 22 and the second outlet opening 23 are preferably staggered from each other.

[0059] Figure 4 It shows Figure 3 The cross-section of the slender, flexible hollow body 2. Figure 4 The outer diameter D and inner diameter d of the slender, flexible hollow body are shown. The wall thickness w is also shown.

[0060] According to the present invention, the ratio of the wall thickness w of the elongated flexible hollow body 2 to the outer diameter D of the elongated flexible hollow body is between 0.1 and 0.25, particularly between 0.16 and 0.20.

[0061] Figure 4 It is also shown that a ribbon 30 can be provided. This is an optional feature. As shown, the ribbon can be recessed into the elongated flexible hollow body 2, such that the surface of the ribbon is flush with the outer surface of the elongated flexible hollow body 2. The ribbon has a width b and a thickness t. The thickness t of the ribbon is preferably less than the wall thickness w of the hollow body 2, so that the wall of the hollow body 2 will not be pierced or broken through.

[0062] Figure 5 A longitudinal section of the hollow body 2 is shown. There, the first outlet opening 22 and the second outlet opening 23 can again be seen to be staggered from each other. It can also be seen that outlet openings 22 and 23 have a diameter E. The diameter E is preferably between 2 and 6 mm. The distance S between outlet openings 22 and 23 is preferably between 10 and 30 mm.

[0063] The termination element 16 is formed of a material 20 preferably containing barium sulfate, and can therefore be identified by X-ray methods.

Claims

1. A gastric calibration tube (1), comprising: The slender, flexible hollow body (2) has an outer wall (4) and a first tube end and a second tube end (7, 14). The slender flexible hollow body (2) has at least one opening (22, 18) in the region of the second tube end (14). Its features are, The ratio of the wall thickness to the outer diameter of the slender flexible hollow body is between 0.1 and 0.

25.

2. The gastric calibration tube (1) according to claim 1, characterized in that, The elongated flexible hollow body is composed of a material containing silicone resin, preferably silicone rubber, which preferably has a Shore A hardness between 60 and 100.

3. The gastric calibration tube (1) according to claim 1 or 2, characterized in that, The slender, flexible hollow body has at least the following resistance to kinking: for a pipe segment with a maximum length of 20 cm, the two ends of the pipe segment can be joined together without the pipe segment kinking.

4. The gastric calibration tube (1) according to claim 3, characterized in that, The slender, flexible hollow body has at least the following resistance to kinking: for a pipe segment with a maximum length of 15 cm, the two ends of the pipe segment can be joined together without kinking.

5. The gastric calibration tube (1) according to any one of claims 1 to 4, characterized in that, The ratio of the wall thickness to the outer diameter of the slender, flexible hollow body is between 0.16 and 0.

20.

6. The gastric calibration tube (1) according to any one of claims 1 to 5, characterized in that, An outlet opening is provided in the region of the second pipe end.

7. The gastric calibration tube (1) according to any one of claims 1 to 6, characterized in that, A termination element (16) is provided at the second tube end (14), and the termination element (16) terminates the hollow body (2).

8. The gastric calibration tube (1) according to claim 7, characterized in that, The terminating element (16) is blunt.

9. The gastric calibration tube (1) according to claim 7 or 8, characterized in that, The termination element (16) includes at least one outlet opening.

10. The gastric calibration tube (1) according to any one of claims 7 to 9, characterized in that, The termination element (16) has a material comprising a non-transmissive material, preferably barium sulfate.

11. The gastric calibration tube (1) according to any one of claims 7 to 10, characterized in that, The material constituting the termination element (16) is softer than the material constituting the elongated flexible hollow body (2).

12. The gastric calibration tube (1) according to any one of claims 1 to 11, characterized in that, The material constituting the terminating element includes silicone resin, preferably silicone rubber.

13. The gastric calibration tube (1) according to any one of claims 1 to 12, characterized in that, At least one color band is provided along the longitudinal direction of the slender flexible hollow body (2).

14. The gastric calibration tube (1) according to any one of claims 1 to 13, characterized in that, The colored strip is recessed into the slender flexible hollow body, so that the surface of the colored strip is flush with the outer surface of the slender flexible hollow body.

15. The gastric calibration tube (1) according to any one of claims 1 to 11, characterized in that, The slender, flexible hollow body has a first outlet opening on the first side of the hollow body in the region of the second tube end, and a second outlet opening on the second side of the hollow body opposite to the first side.

16. The gastric calibration tube (1) according to claim 15, characterized in that, The first and second outlet openings are arranged staggered from each other.

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