阅读说明：本技术 肠道内器具固定装置 (Intestinal tract appliance fixing device ) 是由 金载晃 郑敏好 金智显 于 2017-05-24 设计创作，主要内容包括：本发明的肠道内器具固定装置用于在管形态的器官切除手术后,为保护吻合部位,从肠道的外部将设置于肠道内的器具包围并固定,其特征在于,具有本体,上述本体呈具有规定厚度和宽度的带形态,上述本体由在人体内不发生异物反应的材质构成,上述材质为生物降解性物质——吸水性物质或非吸水性物质,沿着本体的长度方向具有低的延伸率,以柔韧的形态处理本体的宽度方向的两个边缘,来当与肠道的外表面相接触时,防止肠道的外表面受伤。根据如上所述的本发明,在管形态的器官切除手术后,为保护吻合部位,从肠道的外部将设置于肠道内的器具包围并固定的带形态的固定装置具有低于10％的长度延伸率,带的两个边缘呈柔韧的形态,从器官外部固定器具,并以适当的压力固定,来维持器官的器官壁形态并不影响器官。(The present invention provides an intestinal tract appliance fixing device for surrounding and fixing an appliance installed in an intestinal tract from the outside of the intestinal tract to protect an anastomotic site after a tubular organ resection, the device comprising a body having a band shape with a predetermined thickness and width, the body being made of a material which does not cause foreign body reaction in a human body, the material being a water-absorbent or non-water-absorbent material which is a biodegradable material, having a low elongation rate along the longitudinal direction of the body, and having both edges in the width direction of the body treated in a flexible shape to prevent the outer surface of the intestinal tract from being injured when the device comes into contact with the outer surface of the intestinal tract. According to the present invention as described above, in order to protect the anastomotic site after the organ resection operation in a tube shape, the band-shaped fixing device which surrounds and fixes the instrument placed in the intestine from the outside of the intestine has a length elongation of less than 10%, both edges of the band have a flexible shape, and the instrument is fixed from the outside of the organ and fixed with a proper pressure to maintain the organ wall shape of the organ without affecting the organ.)

1. An intestinal tract instrument fixing device for surrounding and fixing an instrument provided in an intestinal tract from the outside of the intestinal tract to protect an anastomotic site after a tubular organ resection operation, characterized by comprising a body having a band shape with a predetermined thickness and width, the body being made of a material which does not cause a foreign body reaction in a human body, the material being a degradable material or a non-water-absorbing material and having a low elongation rate in the longitudinal direction of the body.

2. The intestinal tract instrument fixing device according to claim 1, wherein the biodegradable material comprises at least one of pteroylglutamic acid, polylactic acid-glycolic acid copolymer, and palladium oxide.

3. The enteral device holder according to claim 1, wherein the body has an elongation of less than 10% along the length of the body.

4. The intestinal tract instrument fixing device according to claim 1, wherein the main body is formed in a mesh form by weaving using a raw yarn, the raw yarn is formed of a material that does not cause foreign body reaction in a human body, and the material is a degradable material or a non-water-absorbing material.

5. The intestinal device-fixing apparatus according to claim 4, wherein the lattice-form weave is formed of warp yarns and weft yarns, and the size of USP (USP) is 1-7, and the USP is the thickness of the filament.

6. The intestinal tract instrument fixing device according to claim 1, wherein both edges of the body of the fixing device in the width direction are treated in a flexible form to prevent the outer surface of the intestinal tract from being injured when contacting the outer surface of the intestinal tract.

7. The enteral instrument fixing device according to claim 6, wherein both edges in the width direction of the body are formed by circular arc-shaped concave-convex portions.

8. The intestinal tract instrument fixing device according to claim 6, wherein both edges in the width direction of the body are formed in a woven form having a density lower than that of a central portion of the body.

9. The enteral instrument holder according to claim 6, wherein the predetermined regions of the two edges in the width direction of the body are formed of a different fabric having higher flexibility than the fabric in the center of the body.

10. The enteral instrument holder according to claim 6, wherein a buffer substance for moderating sharpness or rigidity of the edge portion is applied to both edge portions in the width direction of the body.

11. The enteral instrument fixture according to claim 1, wherein the predetermined portion of the main body contains an X-ray contrast medium, and the position of the fixture is accurately confirmed by an X-ray device when the fixture is applied to the intestinal tract of a human body and sutured.

12. The enteral instrument holder according to claim 11, wherein said X-ray contrast agent is formed of a solid substance identifiable by X-rays.

13. The enteral instrument fixture according to claim 1, wherein a mark that can be distinguished by a scale or a color is formed at a predetermined position of the main body, so that a length of the fixture can be accurately calculated when a doctor performs an operation using the fixture.

14. The enteral instrument holder according to claim 1, wherein an adhesive is applied to at least one side end of the body as a joining means of both ends of the body.

15. The enteral instrument fixing device according to claim 1, wherein at least one protrusion is formed at one end of the body as a coupling means at both ends of the body, and at least one insertion hole for coupling with the protrusion is formed at the other end of the body.

16. The device for fixing an enteral instrument according to claim 1, wherein when a length of a fixing device for surrounding and fixing the instrument from outside the intestinal tract is assumed to be "L", the "L" is calculated by the following equation:

(D+2T)×π≤L<(D+2T+2H)×π，

wherein D is the diameter of the device at the location where the fixation device is installed, T is the intestinal wall thickness of the intestine, and H is the height of the protrusion of the device.

17. The device for fixing an enteral instrument according to claim 1, wherein when the width of the fixing device for surrounding and fixing the instrument from the outside of the intestinal tract is "WB", the "WB" is calculated by the following equation:

WB<W-2T，

wherein W is the distance between the protrusions of the device and T is the intestinal wall thickness of the intestine.

Technical Field

The present invention relates to an intestinal tract appliance fixing device, and more particularly, to an intestinal tract appliance fixing device including: after the intestinal resection, a tubular device is fixedly arranged in the intestinal tract in a manner of maintaining the shape of the intestinal wall and not influencing the intestinal tract in order to protect the anastomotic site.

Background

Generally, when a tubular organ (esophagus, rectum, large intestine, etc.) inside a human body is excised and then anastomosed, if there is a risk of exposure of the anastomotic site, the best protection method so far is to manufacture an abdominal artificial anus. Exposure of the anastomotic site has a risk of inducing sepsis and increasing recurrence of cancer, and therefore, in clinical practice, an operation for producing a temporary abdominal artificial anus is often performed. The abdominal artificial anus needs at least 3 months or more until it is substantially restored, and cannot be restored for a lifetime for various reasons within a range of about 30 to 60%. The most common reason is that the operation is required again when the artificial anus is restored, and the restoration operation is avoided because the operation itself is highly risky in the case of elderly or patients with cardiopulmonary disease.

As a solution to the above problem, another mode of the stool-discharging device has been proposed. That is, a tube made of a thin elastic waterproof material is sewn to the intestinal wall at a position of about 5 to 10cm above the anastomotic site of the intestinal tract with a string, thereby discharging feces without directly contacting the anastomotic site of the intestinal tract.

However, the aforementioned feces excretion device has the following problems, and therefore, it is not widely used. That is, it is difficult to sew the silicon or rubber to the inner wall of the intestine, which takes a long time, and particularly, the thin tube sewed to the inner wall of the intestine is always kept in a completely sewed state, but the sewed state cannot be maintained, and safety in use cannot be secured. Further, the thin tube used in the stool-discharging device is naturally dropped for about 5 to 10 days, and thus, although the tube is easily removed, it is difficult to continuously divert the stools for a desired time.

On the other hand, korean laid-open patent publication No. 10-2002-0028506 (patent document 1), which was filed by the present applicant earlier, discloses a medical intestinal tract management device for shunting stool of an intestinal tract operation patient, in which a fixing band is engaged with a locking portion provided between fixing balloons outside the intestinal tract in a state where the intestinal tract management device is inserted into the intestinal tract, and the intestinal tract management device is fixed in the intestinal tract.

However, in the case of patent document 1 described above, although the fixing band is fastened to the locking portion provided between the fixing balloons to fix the intestinal tract manager in the intestinal tract, a problem arises in that the intestinal tract is necrotized by applying a pressure to the intestine more than necessary depending on the degree of elasticity of the fixing band, or in the case where the ends of the fixing band at both side edge portions in the width direction are sharp, the outer wall skin of the intestinal tract is partially injured to induce intestinal erosion. The intestine is fragile to a pressure machine, and therefore, at present, there is not disclosed and used a device for fixing an instrument or the like outside the intestine of an instrument located in the intestine for a long time.

Disclosure of Invention

Technical problem

The present invention has been made to solve the above-described problems of the prior art, and an object of the present invention is to provide an enteral instrument fixing device including: after the internal-tube-shaped organ resection operation, in order to protect the anastomotic site, an instrument to be fixed in the intestinal tract adjacent to the anastomotic site from the outside of the organ maintains the shape of the intestinal wall of the organ without adversely affecting the intestinal tract.

Means for solving the problems

In order to achieve the above object, the present invention provides an intestinal device-fixing apparatus for surrounding and fixing a device provided in an intestinal tract from the outside of the intestinal tract after a tubular organ resection operation in order to protect an anastomotic site, the apparatus including a body formed in a band shape having a predetermined thickness and width, the body being made of a material which does not cause foreign body reaction in a human body, the material being a biodegradable (water-absorbing) material or a non-water-absorbing material and having a low elongation rate along a longitudinal direction of the body, and both edges of the body in the width direction being treated in a flexible shape so as to prevent an outer surface of the intestinal tract from being injured when the body comes into contact with the outer surface of the intestinal tract.

Wherein the body may have an elongation of less than 10% along a length direction of the body.

The body may be formed in a mesh form by weaving using raw fibers made of a material that does not react with foreign matter in the human body, and the material may be a biodegradable (water-absorbing) material or a non-water-absorbing material.

Further, both edges in the width direction of the body may be formed by circular arc-shaped concave and convex portions.

Further, both edges in the width direction of the main body may be configured in a form woven so that the density of the woven form is relatively lower than that of the central portion of the main body.

In addition, of the two edges in the width direction of the main body, the predetermined regions at the two edge portions are formed of another fabric having a flexibility (softness) relatively higher than that of the fabric at the center portion of the main body.

Further, a buffer substance for relaxing the sharpness (sharpness) or rigidity (stiffness) of the edge portion may be coated on both edge portions in the width direction of the body.

Further, the predetermined portion of the body may include an X-ray contrast medium, and the position of the fixing device may be accurately confirmed by an X-ray (X-ray) device when the fixing device is applied to the intestinal tract of the human body and sutured.

In this case, barium sulfate, iodine oil, organic iodine compounds, poly-crosslinked phthalocyanine compounds, and the like can be used as the X-ray contrast agent.

The X-ray contrast agent is formed of a solid substance that can be identified by X-rays.

Further, a mark that can be distinguished by a scale or a color may be formed at a predetermined portion of the body, so that a length of the fixing device can be accurately calculated when a surgeon performs a surgery using the fixing device.

And, an adhesive agent as a coupling means of both end portions of the body may be coated on at least one side end portion of the body.

In addition, as the coupling means of both end portions of the body, at least one protrusion may be formed at one end of the body, and at least one insertion hole for coupling with the protrusion may be formed at the other end of the body.

ADVANTAGEOUS EFFECTS OF INVENTION

According to the present invention as described above, in order to protect the anastomotic site after the organ resection operation in a tube shape, the fixing device in a band shape surrounding and fixing the instrument disposed in the intestine from the outside of the intestine has a length elongation of less than 10%, both edges of the band are formed in a flexible shape, the instrument is fixed from the outside of the organ and fixed with a proper pressure, so that the shape of the intestinal wall of the organ can be maintained without affecting the intestine.

This has the advantage of preventing, in advance, the problem of the conventional fixing band in which the intestinal tract is necrotized by applying a pressure to the intestinal tract more than necessary, or the intestinal tract is eroded by the sharpness of the opposite side edges of the fixing band.

Drawings

Fig. 1a is an external perspective view showing the structure of an enteral instrument fixing device according to an embodiment of the present invention.

Fig. 1b is a view showing an example in which both edges in the width direction of the intestinal tract appliance fixing device of the embodiment of the present invention are formed by circular arc-shaped concave-convex portions.

Fig. 2 is a sectional view illustrating a state in which the enteral instrument fixture shown in fig. 1a is applied to the intestine so as to surround the outside of the intestine.

Fig. 3 is a view of the fixing device after performing a finishing operation after surrounding the outside of the intestine with the intestinal tract appliance-fixing device of the present invention.

Fig. 4 is a view of an enteral device fixing device according to another embodiment of the present invention.

Detailed Description

The terms or words used in the present specification and claims should not be construed as being limited to conventional meanings or dictionary meanings, but interpreted as meanings and concepts conforming to the technical idea of the present invention on the basis of the principle that the inventor can appropriately define the concept of the term in order to describe his invention in the best way.

Throughout the specification, when a portion is referred to as "comprising" a structural element, unless specifically stated to the contrary, it is intended to include other structural elements as well, but not to exclude other structural elements.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Fig. 1a to 2 show an intestinal tract instrument fixing device according to an embodiment of the present invention, fig. 1a is an external perspective view showing an entire structure, fig. 1b is a view showing an example in which both edges in a width direction are formed of circular arc-shaped concave and convex portions, and fig. 2 is a cross-sectional view showing a state in which the device is applied to an intestinal tract to surround the outside of the intestinal tract.

Referring to fig. 1a to 2, an intestinal device fixture 100 (hereinafter, referred to as "fixture") according to the present invention is a fixture that surrounds and fixes a device 200 provided in an intestinal tract 250 from the outside of the intestinal tract 250 to protect an anastomotic site after an organ (e.g., rectum or large intestine) in a tubular state is excised, and has a body having a predetermined thickness and width as shown in the drawing. The body is made of a material which does not cause foreign body reaction in the human body, is a biodegradable (water-absorbing) material or a non-water-absorbing material, has a low elongation rate along the longitudinal direction of the body, and is treated in a flexible form at both edges E1 and E2 in the width direction of the body to prevent the outer surface of the intestinal tract 250 from being injured when contacting the outer surface of the intestinal tract 250. Among them, as the biodegradable substance, pteroylglutamic Acid (PGA), Polylactic Acid (PLA), Polylactic-co-Glycolic Acid (PLGA), palladium oxide (PDO), and the like can be used. Among them, in addition to the above-mentioned 3 kinds of substances, all water-absorbing substances (materials) which are harmless to the human body and do not cause tissue reaction in the human body can be used.

The main body as described above may be made of a material which is not decomposed and is permanently maintained (i.e., a non-water-absorbing material) according to circumstances. For example, in the case where the fixation device 100 is used for the purpose of permanently fixing an appliance or a machine within the intestine.

In this case, the body may be configured to have an elongation of less than 10% along a longitudinal direction of the body. The body is formed in a mesh (mesh) form by weaving using raw fibers made of a material that does not cause foreign body reaction in the human body, and the material is a biodegradable (water-absorbing) material or a non-water-absorbing material. The mesh-like fabric is formed of warp yarns and weft yarns, and the size of USP (precursor yarn thickness) is 1-7. Also, the USP (strand thickness) used in the warp and weft may be the same or different. However, depending on the case, a plate-shaped or cylindrical form may also be used instead of the woven form as described above.

As shown in fig. 1b, both edges E1 and E2 in the width direction of the main body may be terminated in a flexible form, and may be formed of, for example, an arc-shaped uneven portion 100E.

Hereinafter, the case where the elongation in the longitudinal direction of the main body is less than 10% will be described, but it is preferable to minimize the elongation in the longitudinal direction and the elongation in the width direction of the main body. This is because, if the fixing device 100 is made of a material having a high elongation percentage, it is difficult to accurately fix the tool 200 because the tool 200 has high fluidity when surrounding the tool 200.

Further, one loop of the main body, which is finished in a flexible form at both edges E1 and E2 in the width direction thereof, can be configured in a form woven so that the density of the woven form is relatively lower than that of the central portion of the main body (i.e., the woven form is looser than the central portion).

In addition, a loop of finishing treatment is performed in a flexible form at both edges E1 and E2 in the width direction of the main body, and the predetermined regions at both edge portions may be formed of another fabric having a flexibility (softness) relatively higher than that of the fabric at the central portion of the main body.

Also, similarly, a ring of the finishing process is performed in a flexible form at both edges E1, E2 in the width direction of the body, and a buffer substance for moderating the sharpness (sharpness) or rigidity (stiffness) of the edge portion may be applied at both edges in the width direction of the body. Among them, the buffer substance as described above is formed of a substance that is biodegradable in the human body, and it is preferable to select a biodegradable substance whose decomposition rate is relatively slower than that of the biodegradable substance constituting the main body of the fixing device 100.

Further, the predetermined portion of the main body may include an X-ray contrast medium 100b, so that when the fixing device 100 is applied to the intestinal tract of the human body to suture, the position of the fixing device 100 can be accurately confirmed by an X-ray (X-ray) device. In this case, as the X-ray contrast agent as described above, barium sulfate, iodine oil, organic iodine compound, poly-crosslinked phthalocyanine compound, or the like can be used.

Further, as the X-ray contrast agent, a solid substance (e.g., iron, nonferrous alloy, etc.) that can be identified by X-rays can be used. As described above, a substance capable of contrast can be used in addition to the contrast agent.

Further, marks that can be distinguished by the scale 100a or colors may be formed at predetermined positions of the body, so that the length of the fixing device 100 can be accurately calculated when a surgeon performs a surgery using the fixing device 100. The scale 100a may also function as the contrast medium 100b described above. That is, when the scale 100a is formed on the main body, the scale 100a is formed using an X-ray contrast material.

When the in-intestine device fixture 100 of the present invention configured as described above is applied to the intestine 250 of the human body, the in-intestine device fixture 100 is made of a biodegradable material, gradually decomposes in the human body, and maintains the physical properties of the fixture 100 for a predetermined period of time (for example, about 3 to 5 weeks). The time for maintaining the above-described physical properties may vary depending on the biodegradable material of the anchor 100 and the method of manufacturing, size, and method of attaching the anchor 100. Also, the fixing device 100 may be manufactured in different sizes according to the shape of the tool 200, and tied between the protrusions 200t to fix the position of the tool 200.

The properties of the anchor 100 are maintained during the restoration of the anastomotic portion (not shown) of the intestinal tract 250, and after the restoration of the anastomotic portion, the properties of the anchor 100 are lost, and the tool 200 is removed by an additional device connected to the outside of the human body. In the series of processes described above, the fixing device 100 fixes the tool 200 by applying pressure to the intestinal wall and maintaining the state of the applied pressure for a predetermined time, and in this case, necrosis of the intestinal wall tissue needs to be prevented. For this, as described above, the fixing device 100 is made of a material that is biodegradable in the human body.

Also, the length of the fixture 100 surrounding the outside of the intestine 250 is set according to the diameter of the instrument 200 inside the organ and the thickness of the intestinal wall of the organ. For example, it is reported that the thickness of the normal intestinal wall of the large intestine is about 1 to 2.6mm, but in a morbid state such as ileus, the thickness of the intestinal wall becomes thicker. Furthermore, depending on the shape of the tool 200, a plurality of fixtures 100 may be provided in one tool 200.

Hereinafter, a method of setting the length of the fixing device 100 will be additionally described.

The installation position of the fixing device 100 is different according to the shape of the appliance 200, and thus, the length thereof is adjusted. That is, when the diameter of the instrument 200 at the portion of the instrument 200 in the intestinal tract 250 to which the fixation device 100 is attached is "D", the intestinal wall thickness of the intestinal tract 250 is "T", the length of the fixation device 100 is "L", and the height of the protrusion 200T of the instrument 200 is "H", the length L of the fixation device 100 can be calculated by the following equation.

(D+2T)×π≤L<(D+2T+2H)×π

The width of the fixing device 100 is adjusted according to the position of the protrusion 200t of the tool 200. When the distance between the projections 200T of the instrument 200 is "W", the intestinal wall thickness of the intestinal tract 250 is "T", and the width of the anchor 100 is "WB", the width WB of the anchor 100 can be calculated by the following equation.

WB<W-2T

The specifications described above, which are provided for the purpose of protecting the safety of the intestinal wall, may vary depending on the shape and value of the instrument 200, and the thickness of the intestinal tract 250. I.e., to minimize the pressure of the blood vessels distributed through the intestinal wall, to prevent slippage and erosion of the intestinal wall during installation of the instrument 200.

On the other hand, fig. 3 is a view showing the anchor in a state where the anchor surrounds the outside of the intestinal tract and performs the operation of ending the intestinal tract with the anchor of the present invention.

Referring to fig. 3, in order to fix the tool 200 in the intestine using the fixing device 100, as described above, the fixing device 100 may be sutured by a suture thread 310 as shown in the drawing in such a manner that the outer surface of the intestine 250 between the protrusions 200 of the tool 200 surrounds the fixing device 100 and is coupled according to the illustrated specification. Also, suturing can be performed using staple fibers that are often used in surgical operations.

However, the suture method using the suture thread 310 as described above has disadvantages in that the suture state is incomplete, a large amount of work time is consumed, and the work is complicated. Therefore, in the present invention, as a solution for compensating for such a disadvantage, a fixing device according to another embodiment of fig. 4 is provided.

Fig. 4 is a view showing an enteral appliance-fixing device according to another embodiment of the present invention.

Referring to fig. 4, as shown in fig. 4 (a), an adhesive 400a, which is a coupling unit of both end portions of the body, may be applied to at least one side end portion of the body of the fixing device 400. This is because, when the doctor performs the ending work of the end portion of the fixing device 400 after the operation using the fixing device 400, the both end portions can be simply bonded by the adhesive 400a, and therefore, the ending work can be eased.

As shown in fig. 4 (B), at least one protrusion 400t may be formed at one end of the body of the fixing device 400 as a coupling means of both end portions of the body, and at least one insertion hole 400h may be formed at the other end of the body for coupling with the protrusion 400 t. This is because, when the doctor performs the ending work of the end portion of the fixing device 400 after the operation using the fixing device 400, the doctor can simply insert the protrusion 400t into the insertion hole 400h to connect, and therefore, the ending work can be eased. Wherein, if the body has the above-mentioned characteristics, a form other than the woven mesh may be used.

On the other hand, there is also a case where the instrument is permanently installed inside the organ, in which case the tape has the specifications and characteristics as described above, but may be made of a non-water-absorbent material (i.e., the intra-intestinal instrument fixing device of the present invention) instead of the water-absorbent material.

As described above, in the case where the fixing device 400 is coated with the adhesive 400a to perform the ending work by the adhesive 400a or the ending work is performed by the coupling method of the protrusion 400t and the insertion hole 400h, the doctor can perform the ending work more easily and in a shorter time than the ending method by the suture thread 310.

As described above, in the fixing device of the enteral tool according to the present invention, in order to protect the anastomotic site after the tubular organ resection operation, the fixing device in the form of a band which surrounds and fixes the tool provided in the intestinal tract outside the intestinal tract has a length elongation of less than 10%, both edges of the band are in a flexible form, and the tool is fixed from the outside of the organ with an appropriate pressure, thereby maintaining the form of the intestinal wall of the organ without affecting the organ.

Therefore, the conventional fixing band has an effect of preventing, for example, a problem that the intestinal tract is necrotized by applying a pressure to the intestinal tract more than necessary, or a problem that the intestinal tract is eroded by the sharpness of both side edge portions of the fixing band.

It is obvious to those skilled in the art that the present invention has been described in detail with reference to the preferred embodiments, and that the present invention is not limited thereto, and various changes and applications can be made without departing from the technical spirit of the present invention. Therefore, the scope of the invention is indicated by the appended claims, and all technical equivalents that fall within the scope of the claims are intended to be embraced therein.