JP2013043066A - Surgical exclusion body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a surgical exclusion body that can be easily taken out of the body without damaging tissue in the body.SOLUTION: The exclusion body inserted into the body in surgery includes: an exclusion body 6 formed by compressing and drying a water-absorbing expansible material; an X-ray contrast thread 6b arranged at one longitudinal end of the exclusion body; and a locking thread 6c for sewing the X-ray contrast thread to the exclusion body. At least one of the X-ray contrast thread and the locking thread is heat-weldable, and the X-ray contrast thread and the locking thread are bonded to the exclusion body by heat welding.

Description

  The present invention relates to a surgical retraction body for isolating and protecting surrounding tissues and organs from a surgical target during surgery.

  Conventionally, as an abdominal surgery, an abdominal surgery is performed with a large incision in the abdomen, and a medical device is inserted into the abdominal cavity through a small hole of about 5 to 12 mm opened in the abdomen, and the operation is performed while viewing the monitor screen. Laparoscopic surgery is known.

  In the above surgical operation, for example, excision or removal of a tumor part of an organ is performed. However, in the case where a tissue or organ in the vicinity of an organ to be operated becomes an obstacle to the operation, these are secured in order to secure a surgical field. It is necessary to isolate tissues and organs.

  As an isolation method, a method of sandwiching an excretion body between an organ to be operated and an adjacent organ is performed, and it is known to use a cellulosic sponge as the excision body.

  Exclusion bodies made of this type of cellulosic sponge expand and absorb flexibility by absorbing liquids such as physiological saline, body fluids and blood, so there is no risk of damaging organs. Because it has a strong repulsive force and does not move easily, it can be inserted between the organs, and the organs in the vicinity can be isolated from the target organ without the need for support from the operator or assistant. (For example, refer to Patent Document 1).

JP 2009-89900 A

  The above-mentioned exfoliated body that has been inflated and used for surgery must be taken out of the body before the operation is completed to prevent any residual accidents. There is also an important factor in performance.

  However, a conventional extrudate made of a cellulose-based sponge is generally shaped in a rectangular shape and absorbs water to expand the whole, so that there is a problem that the sponge is caught and damaged when taken out from the trocar. Therefore, so far, the extrudate has been removed from the organ excision part which is incised by 2 cm or more.

  Although a method of attaching a loop-like thread to the end of the exclusion body and grasping the thread with a forceps and pulling it out has been studied, in that case, the knot of the attached thread damages tissues and organs in the body. There is a risk that the thread will not endure the pulling by the forceps and will break.

  The present invention has been made in consideration of the above-described problems in the conventional exclusion body, and provides a surgical exclusion body that can be reliably removed from the body without damaging tissues and organs in the body. is there.

The present invention relates to an extrudate inserted into the body during surgery,
An extrudate body formed by compressing and drying the water-swellable material; and
An X-ray contrast yarn disposed at one end in the longitudinal direction of the exclusion body,
A locking thread for sewing the X-ray contrast thread to the exclusion body;
At least one of the X-ray contrast thread and the locking thread has a heat-welding property, and the X-ray contrast thread and the locking thread are bonded to the exclusion body by heat welding. (Hereinafter, it may be abbreviated as an exclusion body).

  In the present invention, the exclusion body means a surgical auxiliary material configured to protect or exclude a tissue or organ in the vicinity of an organ to be operated.

  In the present invention, it is preferable that the X-ray contrast thread is sewn to the exclusion body with the X-ray contrast thread as a lower thread and the locking thread as an upper thread, and expansion due to water absorption is suppressed at the sewn portion. Therefore, it can be smoothly inserted into or removed from the body through the trocar.

  In the present invention, the water-swellable material is preferably composed of cellulose sponge.

  The surgical retraction body of the present invention has the advantage that it can be relieved without damaging tissues and organs in the body and can be easily taken out after use.

(a) is a perspective view which shows the shape before use of the exclusion body main body which concerns on this invention, (b) is a perspective view of an expanded state. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a first prototype exclusion body manufactured as a prototype in the process of completing an exclusion body according to the present invention, (a) is a perspective view showing a shape before use, and (b) is a perspective view in an expanded state. It is a 2nd trial production exclusion body, (a) is a perspective view which shows the shape before use, (b) is a perspective view of an expansion state. It is a 3rd prototype extruding body main body, (a) is a perspective view which shows the shape before use, (b) is a perspective view of an expanded state. FIG. 4 is a fourth prototype displacement body, (a) is a perspective view showing a shape before use, (b) is a perspective view in an expanded state, and (c) is a sectional view after sewing. (a) is a perspective view which shows the shape before use of the exclusion body which concerns on this invention, (b) is a perspective view of an expanded state. It is the graph which compared the friction coefficient of the exclusion body of this invention, and the exclusion body which consists of another material. It is the graph which compared the liquid absorption speed of the exclusion body of this invention, and the exclusion body which consists of another material.

  Hereinafter, the present invention will be described in detail based on the embodiments shown in the drawings.

  In completing the exclusion body of the present invention, first, an exclusion body main body having various shapes is prototypically searched for a shape that can be easily and reliably inserted or removed through the trocar, and the shape is determined. In addition, we sought a structure that would not damage the tissues and organs in the body at the time of removal.

1. Shape of Exclusion Body Main Body In FIG. 1, the exclusion body main body 1 completed after various trial manufactures is made of a molded product in which cellulose sponge is formed into an arc shape. For example, the length L in the longitudinal direction is 20 to 100 mm. The width W is 4 to 12 mm, the maximum width Wmax in the direction orthogonal to the longitudinal direction is 15 mm, the thickness t is 1 to 8 mm, and the arc R is 10 to 40 mm.

  The said exclusion body 1 is made into the final molded product in a state where the cellulose sponge cut in an arc shape is compressed to about 1/10 in the thickness direction and then dried. Therefore, the restoring force remains inside, and expands when it absorbs water, so that it is substantially restored to the size before compression.

  When the above-described exclusion body 1 is used in laparoscopic surgery, it must pass through a trocar (not shown), and therefore the insertion resistance is preferably as small as possible. For this reason, as shown in FIG. 1 (a), the exclusion body main body 1 of the present invention has a generally elongated rod-like appearance as shown in FIG. An arc shape is formed, and both longitudinal ends 1a and 1b are formed in a semicircular shape. By adopting such a shape, it is possible to obtain a point contact with a low insertion resistance with respect to the trocar, thereby allowing the retraction body 1 to be smoothly inserted into the body.

  In addition, the above-exemplified exclusion body 1 is an example of a size for laparoscopic surgery, and is not limited to the above-mentioned size when directly inserted into the body, such as a laparoscopic operation, but a larger size is also available. Can be used.

  On the other hand, FIG.1 (b) shows the exclusion body main body 1 of the state which absorbed the liquid and expanded.

  In the figure, the thickness t of the exclusion body 1 expands to t ′, and the range S exhibits an exclusion function that can isolate an organ in the vicinity thereof from the organ to be operated.

  However, since the one end 1a of the exclusion body 1 is constrained by a locking thread described later, the thickness t before use is maintained. Thereby, the one end 1a functions as a grip portion H that can be easily grasped with forceps.

2. Structure that does not damage the tissues and organs in the body Figures 2 to 5 show the prototype extrudates that have been prototyped to the point where they do not damage the tissues or organs in the body even if one end 1a of the body 1 is restrained. The main body is shown.

2.1 First Trial Exclusion Body Main Body The first trial evacuation body 2 shown in FIG. 2 (a) has a through hole 2b in the thickness direction at one end 2a, and an X through the through hole 2b. A line contrast yarn (or a twisted yarn of an X-ray contrast yarn and another yarn) 2c is passed, a knot 2d is made, and the X-ray contrast yarn (hereinafter abbreviated as contrast yarn) 2c is fixed to one end 2a. It is.

  FIG. 2 (b) shows the appearance after expansion, and the thickness t is expanded to t ', but since one end 2a is constrained by the contrast thread 2c, the play of the contrast thread 2c is shown. There is some swelling.

  The knot 2d in this configuration is fixed to the one end 2a to be expanded and cannot move, and the knot 2d becomes a protrusion protruding from the one end 2a of the exclusion body 2 and, of course, the hardness remains. There is a risk of damaging tissues and organs in the body.

  Further, in the case of performing exclusion body protection in a narrow space at the time of surgery, the contrast thread 2c itself may interfere with the surgical operation.

  In addition, if the knot is grasped with forceps when taking out from the body cavity, the body of the exclusion body may be caught by the trocar, and the contrast thread 2c may be damaged or cut.

2.2 Second Trial Exclusion Body Main Body The second trial evacuation body 3 shown in FIG. 3 (a) has a locking thread 3b that restrains expansion over the entire width direction of one end 3a in the longitudinal direction. The contrast medium 3c in which an X-ray non-transparent material (for example, barium sulfate) is kneaded is welded in a belt-like manner on one plane (rear side surface in the figure) of the sequestering body 3.

  FIG. 3 (b) shows the expanded second prototype exclusion body 3 which has expanded to a thickness t ', but one end 3a is constrained by the locking thread 3b. Therefore, it has not expanded.

  Therefore, although a grasping portion that can be easily grasped by the forceps can be formed, there is a possibility that the end portion of the welded contrast thread may damage tissues or organs in the body. There is also a problem that the end 3b 'of the locking thread 3b is likely to fray from the one end 3a.

2.3 Third Trial Exclusion Body Main Body The third exclusion body main body 4 shown in FIG. 4 (a) is sewn on the entire width of one end portion 4a with a locking thread 3b for restraining expansion. A contrast medium 3c is welded in a band shape so as to cover the locking thread 3b.

  FIG. 4 (b) shows the expanded third prototype explosive body 4 in which the thickness t is expanded to t ', but one end 4a is constrained by the locking thread 3b. Therefore, it has not expanded.

  Therefore, a grasping portion that can be easily grasped by the forceps can be formed, and fraying of the locking thread 3b that has a problem in the second prototype extruding body does not occur. However, the end 3b ′ welded with the locking thread 3b still protrudes and remains hard, and there is a risk of damaging tissues and organs in the body.

2.4 Fourth Prototype Exclusion Body Main Body A fourth trial extrudate body 5 shown in FIG. 5 (a) has one end 5a sewn with a contrast thread 5b. A locking thread 5c that restrains the expansion of the portion 5a is sewn (see FIG. 5C).

  Specifically, the locking thread 5c is passed through a sewing needle (not shown) as an upper thread, and the sewing needle is pierced from the upper surface of the exclusion body 5 to form a loop on the lower surface side of the trial displacement body 5, and the loop The contrast thread 5 b is used as a lower thread, and the sewing needle is pulled out from the exclusion body 5. By repeating this operation, a plurality of contrast threads 5b were sewn to the exclusion body 5 with the locking threads 5c.

  FIG. 5 (b) shows the expanded fourth prototype extruding body 5 in which the thickness t is expanded to t ', but one end 5a is constrained by the locking thread 5c. Therefore, it has not expanded.

  In this configuration, as shown in FIGS. 3 and 4, the end of the locking thread 5c did not protrude from the one end 5a, but the contrast thread 5b and the locking thread 5c overlap each other (FIG. 5 (c )) Protruded from the surface of the trial extrudate body 5, and there is a risk of damaging tissues and organs in the body.

  In addition, there is a problem that a portion where the contrast thread 5b and the locking thread 5c overlap is easily frayed.

2.5 Exclusion Body of the Present Invention The exclusion body shown in FIG. 6 is one of the embodiments of the present invention that was finally completed by producing various prototype exclusion body and evaluating the performance.

  In FIG. 5A, the exclusion body 6 is provided with a contrast thread 6b at one end 6a, and a locking thread 6c for restraining the expansion of the one end 6a is sewn from above the contrast thread 6b. It is attached. Up to this point, the method is the same as the method for sewing the contrast thread 5b shown in FIG.

  In the exclusion body of the present invention, an olefin resin yarn that can be thermally welded to the cellulose sponge, such as polyester yarn, polyamide, polypropylene, or polystyrene yarn, can be used as the locking yarn 6c. On the other hand, as the contrast yarn 6b, a yarn in which an X-ray contrast agent such as barium sulfate is combined with polyester, polypropylene, polystyrene or the like can be used. The contrast thread 6b is sewn to the surface of the exclusion body 6 by the locking thread 6c.

  The locking thread 6c is not limited to the olefin resin thread and may be a silk thread. However, in this case, it is necessary that the contrast yarn side has heat-welding properties as described above.

  FIG. 6B shows the expelled body 6 inflated. The thickness t is inflated to t ′, but the one end 6a is restrained by the locking thread 6c, so that it does not expand. .

  In this configuration, as shown in FIGS. 3 and 4, the end of the locking thread does not protrude from the one end 6a, and the contrast thread 6b is sewn to the exclusion body 6 by the locking thread 6c. Since the contrast thread 6b and the locking thread 6c are both welded to the surface of the exclusion body 6, the exclusion body 6, the contrast thread 6b, and the locking thread 6c can be integrated completely. Therefore, the contrast thread 6b and the locking thread 6c do not protrude at all from the surface of the exclusion body 6 and are in a flat state in which softness is maintained.

  Thereby, according to the exclusion body of the present invention, the one end portion 6a can be easily grasped with forceps without being damaged to any tissue or organ in the body, and can be easily taken out through the trocar as it is. Become.

  FIG. 7 is a graph comparing the friction coefficient between the exclusion body of the present invention and an exclusion body made of another material. Note that the coefficient of friction is measured according to JIS K 7312-1996 “Physical Test Method for Thermosetting Polyurethane Elastomers”. The friction coefficient test was applied.

Procedure of test method
(1) An exclusion body as a specimen cut into a size of 30 mm × 50 mm × 0.8 mm is fixed to a metal weight (30 mm × 50 mm × 8 mm thickness) with a thread.
(2) Fix the porcine organs (spleen, pancreas, liver, stomach, lungs) horizontally on the fixed table.
(3) Place the above-mentioned exclusion body fixed on the weight on the organ of the pig, fix one of the strings to the hook of the weight, and attach the other string to the tensile testing machine through the low friction pulley of the fixed base.
(4) Pull a distance of 50 mm at a speed of 10 mm / min and measure the frictional force of the retraction body. The number of samples was 5.

  The organs were always kept wet with purified water so as not to dry.

  In the graph of FIG. 7, P1 indicates the friction coefficient between the porcine organ and the extrudate of the present invention, P2 indicates the friction coefficient with the extrudate made of polyurethane, P3 also indicates the friction coefficient with gauze, and P4 Also shows the coefficient of friction with the cellulose nonwoven fabric.

  In each friction coefficient graph, a to e indicate organ types, a is the spleen, b is the pancreas, c is the liver, d is the stomach, and e is the lung.

  The friction coefficient of cellulose sponge shows the highest value among the spleen, pancreas and liver. Between the stomach and lung, the coefficient of friction is not as high as that of gauze or cellulose nonwoven fabric, but a sufficiently high value is obtained compared to polyurethane.

  From the graph, it can be seen that the extrudate of the present invention made of cellulose sponge has a stable coefficient of friction for any organ.

  FIG. 8 is a graph comparing the liquid absorption speed between the exclusion body of the present invention and an exclusion body made of another material. The liquid absorption speed was measured by applying a dropping method according to JIS L 1907 “Test method for water absorption of textile products”. The number of specimens is 5.

  The procedure of the test method is as follows.

  First, the burette is fixed so that the distance between the specimen and the burette is 1 cm. Next, one drop of physiological saline was dropped from the burette, and the time until the droplet was absorbed by the specimen and only the wet state remained was measured.

  Since the liquid absorption speed is high, a series of work was filmed and analyzed to analyze the liquid absorption speed. However, when one or more specimens were not absorbed even after 60 seconds or longer, “60 seconds or longer” was added to the test report.

  As can be seen from the graph of FIG. 8, the cellulose nonwoven fabric has the fastest liquid absorption speed, followed by gauze and cellulose sponge in this order, but the difference in liquid absorption speed between gauze and cellulose sponge is substantially 0.1 seconds. There is no difference.

  In addition, there was a specimen in which polyurethane did not absorb liquid even after 60 seconds or more, and it was confirmed that the liquid absorption speed was inferior to cellulose sponge.

DESCRIPTION OF SYMBOLS 1 Exclusion body 1a, 1b Longitudinal end 2 Prototype exclusion body 2a One end 2b Through hole 2c Contrast thread 2d Knot 3 Second trial exclusion body 3a One end 3b Locking thread 3c Contrast agent 4 Third 4a one end part 5a one end part 5b contrast thread 5c locking thread 6 exclusion body 6a one end part 6b contrast thread (X-ray contrast thread)
6c Locking thread

Claims (4)

In the exclusion body inserted into the body during surgery,
An extrudate body formed by compressing and drying the water-swellable material; and
An X-ray contrast yarn disposed at one end in the longitudinal direction of the exclusion body,
A locking thread for sewing the X-ray contrast thread to the exclusion body;
At least one of the X-ray contrast yarn and the locking yarn has a heat welding property, and the X-ray contrast yarn and the locking yarn are bonded to the exclusion body by heat welding. Surgical retraction body.   The surgical exclusion body according to claim 1, wherein the X-ray contrast thread is sewn to the exclusion body main body with the X-ray contrast thread as a lower thread and the locking thread as an upper thread.   The surgical exclusion body according to claim 1 or 2, wherein the exclusion body is formed in an arc shape, and both end portions in the longitudinal direction are formed in a semicircular shape.   The surgical retraction body according to claim 1, wherein the water-swellable material is cellulose sponge.