Patent Description:
In general, in the case in which a possibility of leakage from an anastomosis region is suspicious at the time of anastomosis after resection of a tubular internal organ (the alimentary canal, the rectum, the large intestine, or the like) in the human body, the best protection method to date is to form an abdominal stoma. Leakage from the anastomosis region is very dangerous, for example, causes sepsis and increases the recurrence of cancers, temporary abdominal stoma is frequently performed in a clinical manner. It generally takes at least <NUM> months for an abdominal stoma to be reduced, and about <NUM> to <NUM>% of abdominal stomas are not reduced in their lifetime for various reasons. The most frequent reason is that it is necessary to perform surgery again even at the time of restoring a stoma. For the elderly and infirm or people who suffer from both heart and pulmonary diseases, therefore, a restoration operation is avoided, since the surgery is dangerous.

As an alternative to such a problem, another type of feces discharge apparatus has been suggested. That is, the feces discharge apparatus is configured such that a tube made of a thin flexible waterproof material is sutured with the inner wall of an intestine at a position corresponding to about <NUM> to <NUM> above an anastomosis region of an intestinal canal, whereby feces are discharged outside without direct contact with the anastomosis region of the intestinal canal.

However, the above feces discharge apparatus has the following problems and thus has not been widely used. That is, suture of silicone or rubber with the inner wall of the intestine is not easy, and it takes a long time to perform surgery. In particular, the state in which the thin tube is completely sutured with the inner wall of the intestine must be constantly maintained, but actually the sutured state is not maintained, whereby safety in use is not guaranteed. In addition, the thin tube used in the feces discharge apparatus is naturally separated in about <NUM> to <NUM> days, whereby it is easy to remove the tube. However, it is difficult to continuously bypass feces for a desired period of time.

Meanwhile, <CIT> entitled MEDICAL INTESTINAL CANAL CONTROL DEVICE FOR BYPASS OF FECES OF INTESTINAL CANAL OPERATION PATIENT (Patent Document <NUM>), which has been filed in the name of the same applicant as the applicant of the present application, discloses technology for fitting a fixing band onto a catching portion formed between fixing balloons outside an intestinal canal in the state in which an intestinal canal control device is inserted into the intestinal canal in order to fix the intestinal canal control device in the intestinal canal.

In the case of Patent Document <NUM> above, the effect of fixing the intestinal canal control device in the intestinal canal is achieved as the fixing band is fitted onto the catching portion formed between the fixing balloons. However, more than necessary pressure is applied to the intestine depending on the extent of elasticity of the fixing band, whereby the intestine may become necrotic. Also, in the case in which width-directional opposite edges of the fixing band are finished in a sharp state, the edges of the fixing band may damage the surface of the outer wall of the intestine, whereby the intestine may be eroded. Since the intestinal canal is particularly weak to pressure, an apparatus for fixing an instrument located in the intestinal canal for a long period of time, such as an instrument outside the intestinal canal, has neither been introduced nor used.

Document <CIT> discloses a biodegradable mesh band for fixing artificial intestinal tract.

Document <CIT> discloses a suture-less wound closure device for lumen within human body.

The present invention has been made in view of the above problems, and it is an object of the present invention to provide an apparatus for fixing an instrument in an intestinal canal that is capable of fixing the instrument installed in the portion of the intestinal canal adjacent to an anastomosis region outside an internal organ in order to protect the anastomosis region after resection of a tubular intestinal canal in the human body while maintaining the shape of an intestinal wall of the internal organ without adversely affecting the intestinal canal.

In accordance with the present invention, the above and other objects can be accomplished by the provision of an apparatus for fixing an instrument in an intestinal canal as defined in appended claim <NUM>.

Here, the body may be configured to have an elongation of less than <NUM>% in the longitudinal direction of the body.

In addition, the body may be configured in a structure in which yarn made of a biodegradable (absorbent) substance or a non-absorbent substance that has no foreign body reaction in the human body is woven in a mesh form.

In addition, the width-directional opposite edges of the body may be configured in a form in which the width-directional opposite edges are woven at lower density than a central portion of the body.

In addition, predetermined portions of the width-directional opposite edges of the body may be made of fabric having higher softness than fabric of the central portion of the body.

In addition, a shock-absorbing substance may be applied to the width-directional opposite edges of the body in order to alleviate sharpness or stiffness of the edges.

In addition, a predetermined portion of the body may include an X-ray contrast medium enabling accurate confirmation of the position of the apparatus using X-ray equipment in the case in which suture is performed in the state in which the apparatus is applied to the intestinal canal of the human body.

At this time, barium sulfate, iodized oil, an organic iodine compound, a poly cross linked phthalocyanine compound, or the like may be used as such an X-ray contrast medium.

In addition, a solid substance that is distinguishable by an X-ray may be used as the X-ray contrast medium.

In addition, a scale enabling an operator to accurately calculate the length of the apparatus when performing an operation using the apparatus or a mark distinguishable by color may be formed at a predetermined portion of the body.

In addition, an adhesive, which serves as a means for coupling opposite ends of the body, may be applied to at least one end of the body.

In addition, at least one protrusion may be formed on one end of the body and at least one insertion hole, into which the protrusion is coupled, may be formed in the other end of the body as a means for coupling the opposite ends of the body.

According to the present invention, as described above, the apparatus for fixing the instrument in the intestinal canal according to the present invention, i.e. the band-shaped fixing apparatus for fixing the instrument installed in the intestinal canal in order to protect the anastomosis region after resection of the tubular internal organ in the state of wrapping the instrument outside the intestinal canal, has an elongation of less than <NUM>%, and the opposite edges of the band are flexible, whereby the instrument is fixed outside the internal organ with appropriate pressure. As a result, it is possible to maintain the shape of the intestinal wall of the internal organ without affecting the internal organ.

Consequently, the present invention has the effect of preventing a problem in which more than necessary pressure is applied to the intestine, whereby the intestine becomes necrotic, as in a conventional fixing band, or a problem in which the intestine is eroded by opposite edges of the fixing band, which are sharp.

It should be noted that terms or words used in this specification and the claims are not to be interpreted as having ordinary and dictionary-based meanings but as having meanings and concepts coinciding with the technical idea of the present invention based on the principle that the inventors may properly define the concepts of the terms in order to explain the invention in the best way.

In the case in which a part "includes" a component, throughout this specification, this means that the part may not exclude another component but may further include another component unless otherwise mentioned.

<FIG> show an apparatus for fixing an instrument in an intestinal canal, wherein <FIG> is an external appearance perspective view showing the overall construction of the apparatus, <FIG> is a view showing an example in which round concave and convex portions are formed at width-directional opposite edges of the apparatus according to the invention, and <FIG> is a sectional view showing the state in which the apparatus is applied to an intestinal canal in the state of wrapping the instrument outside the intestinal canal.

Referring to <FIG>, the apparatus <NUM> for fixing the instrument in the intestinal canal (hereinafter referred to as a "fixing apparatus") is a fixing apparatus for fixing an instrument <NUM> installed in an intestinal canal <NUM> in the state of wrapping the instrument outside the intestinal canal <NUM> in order to protect an anastomosis region after resection of a tubular internal organ (e.g. the rectum or the large intestine), and includes a band-shaped body having a predetermined thickness and width, as shown. Here, in particular, such a body is a made of a biodegradable (absorbent) substance or a non-absorbent substance that has no foreign body reaction in the human body, and has low elongation in a longitudinal direction of the body. Width-directional opposite edges E1 and E2 of the body are finished in a flexible form so as not to damage the outer surface of the intestinal canal <NUM> when coming into contact with the outer surface of the intestinal canal <NUM>. Here, pteroylglutamic acid (PGA), poly lactic acid (PLA), polylactic-co-glycolic acid (PLGA), palladium oxide (PDO), or the like may be used as the biodegradable substance. Here, of course, any of absorbent substances (materials) that are harmless to the human body and have no tissue reaction in the human body may be used in addition to the three substances specified above.

In addition, such a body may be made of a substance that is permanently maintained without being decomposed (i.e. a non-absorbent substance) depending on circumstances. For example, this corresponds to the case in which the fixing apparatus <NUM> is used in order to permanently fix an instrument or an appliance in the intestinal canal.

At this time, the body may be configured so as to have an elongation of less than <NUM>% in the longitudinal direction of the body. In addition, the body may be configured in a structure in which yarn made of a biodegradable (absorbent) substance or a non-absorbent substance that has no foreign body reaction in the human body is woven in a mesh form. Here, weaving in the mesh form may be performed using warp and weft, each of which may have a size of USP <NUM> to USP <NUM> (yarn thickness). In addition, USP (yarn thickness) of warp may be equal to or different from that of weft. Depending on circumstances, however, a sheet-shaped or cylindrical form may also be possible instead of such a woven form.

In addition, as shown in <FIG>, which illustrates the present invention, round concave and convex portions 100e may be formed at the width-directional opposite edges E1 and E2 of the body as an example in which the width-directional opposite edges are finished in a flexible form.

Here, when adding further description in relation to that the elongation of the body in the longitudinal direction thereof is less than <NUM>%, it is preferable to minimize the elongation of the body in the longitudinal direction thereof as well as the longitudinal direction thereof. The reason for this is that, in the case in which the fixing apparatus <NUM> is manufactured using a material exhibiting high elongation, it is difficult for the fixing apparatus to properly fix the instrument <NUM> when wrapping the instrument <NUM> since mobility of the fixing apparatus is high.

In addition, the width-directional opposite edges E1 and E2 of the body may be configured in a form in which the width-directional opposite edges are woven at lower density than the central portion of the body (i.e. looser than the central portion) as an example in which the width-directional opposite edges are finished in a flexible form.

In addition, predetermined portions of the width-directional opposite edges E1 and E2 of the body may be made of fabric having higher softness than the fabric of the central portion of the body as an example in which the width-directional opposite edges are finished in a flexible form.

In addition, similarly, a shock-absorbing substance may be applied to the width-directional opposite edges E1 and E2 of the body in order to alleviate sharpness or stiffness of the edges as an example in which the width-directional opposite edges of the body are finished in a flexible form. Here, such a shock-absorbing substance is made of a substance that is biodegradable in the human body, and a biodegradable substance that has a slower decomposition speed than the biodegradable substance constituting the body of the fixing apparatus <NUM> is preferably selected.

In addition, a predetermined portion of the body may include an X-ray contrast medium 100b enabling accurate confirmation of the position of the fixing apparatus <NUM> using X-ray equipment in the case in which suture is performed in the state in which the fixing apparatus <NUM> is applied to the intestinal canal of the human body. At this time, barium sulfate, iodized oil, an organic iodine compound, a poly cross linked phthalocyanine compound, or the like may be used as such an X-ray contrast medium.

In addition, a solid substance that is distinguishable by an X-ray (e.g. iron, a non-ferrous alloy, or the like) may be used as the X-ray contrast medium. Here, a substance capable of functioning as a contrast medium may also be used instead of a dedicated contrast medium.

In addition, a scale 100a enabling an operator to accurately calculate the length of the fixing apparatus <NUM> when performing an operation using the fixing apparatus <NUM> or a mark distinguishable by color may be formed at a predetermined portion of the body. Here, such a scale 100a may also function as the X-ray contrast medium 100b described above. That is, the scale 100a is formed on the body, and the scale 100a is formed using the X-ray contrast medium.

In the case in which the apparatus <NUM> for fixing the instrument in the intestinal canal having the above construction is applied to the intestinal canal <NUM> of the human body, the apparatus is slowly decomposed in the human body, since the apparatus is made of a biodegradable substance. The physical properties of the apparatus <NUM> are maintained for a predetermined period of time (e.g. about <NUM> to <NUM> weeks). The period during which the physical properties of the apparatus are maintained may vary depending on the biodegradable substance, the method of manufacturing the fixing apparatus <NUM>, the size of the fixing apparatus, and the method of mounting the fixing apparatus. In addition, the fixing apparatus <NUM> may be manufactured so as to have various sizes depending on the shape of the instrument <NUM>. Basically, the fixing apparatus is bent between protrusions 200t in order to fix the position of the instrument <NUM>.

While the anastomosis region (not shown) of the intestinal canal <NUM> is recovered, the physical properties of the apparatus <NUM> are maintained. After the anastomosis region is recovered, the physical properties of the apparatus <NUM> are extinguished, and the instrument <NUM> is removed by a separate apparatus connected to the outside of the human body. In such a series of processes, the fixing apparatus <NUM> must apply pressure to the intestinal wall and maintain such a state in order to fix the instrument <NUM>. At this time, it is necessary to prevent tissues of the intestinal wall from becoming necrotic. To this end, the fixing apparatus is made of a substance (a material) that is biodegradable in the human body, as described above.

In addition, the length of the fixing apparatus <NUM> that wraps the instrument <NUM> outside the intestinal canal <NUM> is set in consideration of the diameter of the instrument in the internal organ and the thickness of the intestinal wall of the internal organ. For example, it is reported that the thickness of a normal intestinal wall of the large intestine is about <NUM> to <NUM>; however, the thickness of the intestinal wall may be increased in a sick state, such as intestinal obstruction or the like. In addition, a plurality of fixing apparatuses <NUM> may be installed at a single instrument <NUM> depending on the shape of the instrument <NUM>.

Hereinafter, setting the length of the fixing apparatus <NUM> will be further described.

The mounting position of the fixing apparatus <NUM> varies depending on the shape of the instrument <NUM>, and therefore the length of the fixing apparatus is also adjusted. That is, on the assumption that the diameter of the portion of the instrument <NUM> in the intestinal canal <NUM> at which the fixing apparatus <NUM> is mounted is "D," the thickness of the intestinal wall of the intestinal canal <NUM> is "T," the length of the fixing apparatus <NUM> is "L," and the height of each of the protrusions 200t of the instrument <NUM> is "H," the length L of the fixing apparatus <NUM> may be calculated from the following mathematical expression.

In addition, the width of the fixing apparatus <NUM> is adjusted depending on the position of the protrusions 200t of the instrument <NUM>. On the assumption that the distance between the protrusions 200t of the instrument <NUM> is "W," the thickness of the intestinal wall of the intestinal canal <NUM> is "T," and the width of the fixing apparatus <NUM> is "WB," the width WB of the fixing apparatus <NUM> may be calculated from the following mathematical expression.

The above standard is variable depending on the shape and dimensions of the instrument <NUM> and the thickness of the intestinal canal <NUM>, and this standard is necessary for safety of the intestinal wall. That is, it is necessary to minimize pressure applied to blood vessels distributed in the intestinal wall in order to prevent necrosis and erosion of the intestinal wall during mounting of the instrument <NUM>.

Meanwhile, <FIG> is a view showing the apparatus for fixing the instrument in the intestinal canal according to the present invention in the state in which finishing work is performed after the instrument is wrapped using the apparatus outside the intestinal canal.

Referring to <FIG>, suture using a suture fiber <NUM> is possible in order to fix the instrument in the intestinal canal using the fixing apparatus <NUM>, as shown, as a manner in which the fixing apparatus <NUM> wraps the outer surface of the intestinal canal <NUM> between the protrusions 200t of the instrument <NUM> and is coupled thereto so as to be suitable for a displayed standard, as described above. In addition, suture using a staple, which is mainly used in a surgical operation, is also possible.

In such suture using the suture fiber <NUM>, however, the sutured state is incomplete, much time is required, and work is troublesome. As a solution to the above problems, therefore, the present disclosure provides a fixing apparatus according to another embodiment shown in <FIG> and <FIG>.

<FIG> and <FIG> are views showing an apparatus for fixing an instrument in an intestinal canal according to another embodiment.

Referring to <FIG> and <FIG>, an adhesive 400a, which serves as a means for coupling opposite ends of the body, may be applied to at least one end of the body of the fixing apparatus <NUM>, like (A). In this case, it is possible for an operator to simply adhere the opposite ends of the fixing apparatus <NUM> via the adhesive 400a when performing finishing work on the ends of the fixing apparatus <NUM> after performing an operation using the fixing apparatus, whereby the finishing work is easily performed.

In addition, at least one protrusion 400t may be formed on one end of the body of the fixing apparatus <NUM> and at least one insertion hole <NUM>, into which the protrusion 400t is coupled, may be formed in the other end of the body as a means for coupling the opposite ends of the body, like (B). Even in this case, it is possible for the operator to simply insert and fasten the protrusion 400t into the insertion hole <NUM> when performing finishing work on the ends of the fixing apparatus <NUM> after performing an operation using the fixing apparatus, whereby the finishing work is easily performed. Here, the body may be configured in a form other than a woven mesh form, as long as the body has the above characteristics.

Meanwhile, there may also be the case in which the instrument is permanently disposed in the internal organ. In this case, a band (i.e. the apparatus for fixing the instrument in the intestinal canal according to the present invention) may be made of a material that has the standard and characteristics described above and is non-absorbent, rather than absorbent.

When applying the adhesive 400a to the fixing apparatus <NUM> in order to perform finishing work based on the adhesive 400a or when performing finishing work in a manner of coupling using the protrusion 400t and the insertion hole <NUM>, as described above, it is possible for the operator to finish work more easily and more rapidly than in the manner of finishing using the suture fiber <NUM>.

As described above, the apparatus for fixing the instrument in the intestinal canal according to the present invention, i.e. the band-shaped fixing apparatus for fixing the instrument installed in the intestinal canal in order to protect the anastomosis region after resection of the tubular internal organ in the state of wrapping the instrument outside the intestinal canal, has an elongation of less than <NUM>%, and the opposite edges of the band are flexible, whereby the instrument is fixed outside the internal organ with appropriate pressure. As a result, it is possible to maintain the shape of the intestinal wall of the internal organ without affecting the internal organ.

Claim 1:
An apparatus (<NUM>) for fixing an instrument (<NUM>) installed in an intestinal canal (<NUM>) in a state of wrapping the instrument outside the intestinal canal in order to protect an anastomosis region after resection of a tubular internal organ, the apparatus comprising:
a band-shaped body having a predetermined thickness and width, wherein
the body is made of a biodegradable substance or a non-absorbent substance that has no foreign body reaction in a human body, and has low elongation in a longitudinal direction of the body,
characterised in that
width-directional opposite edges of the body of the apparatus are finished in a flexible form so as not to damage an outer surface of the intestinal canal when coming into contact with the outer surface of the intestinal canal, round concave and convex portions (100e) being formed at the width-directional opposite edges of the body.