JPWO2010150874A1 - Surgical inter-organ spacer - Google Patents

Abstract

Provided is a surgical tool made of a material that can be used in general surgery and endoscopic surgery, and has not only simple liquid absorption and liquid retention but also excellent liquid separation properties. The surgical instrument is an inter-organ spacer (10) including a liquid retention means (1) made of a porous soft material having a temporary liquid retention property and a shape retention property.

Description

  The present invention relates to a surgical inter-organ spacer and an insertion tool for inserting the spacer into a body.

  In general laparotomy and thoracotomy, for the purpose of removing blood and exudate, or for securing the physical space and sufficient field of view for the operation, and for the protection of organs As such, gauze, sponge, etc. are used as surgical retraction members. For example, Patent Document 1 discloses an extruding member for surgical operation (Patent Document 1) mainly composed of a cellulose-based sponge. In the background art column, gauze products, urethane sponge products, polyvinyl alcohol (PVA) sponges are disclosed. The product is listed.

  Further, in Patent Document 2, the outer side of a core member molded with a polyurethane home (for example, specific gravity 0.020) is an outer member of a flexible polyurethane home (for example, specific gravity 0.016) having a specific gravity smaller than that of the core member. A coated surgical filling is disclosed. Further, in Patent Document 2, since the polyurethane home of the material has flexibility, and has an appropriate elasticity and shape retention, when used for surgery, (1) a specific internal organ site is excluded or (2) Being safe with no risk of damaging organ tissue, (3) Good absorbability and retention of blood, (4) Preventing intestinal contents and blood from diffusing, during surgery It is disclosed that cleanliness and hygiene can be ensured.

  On the other hand, the endoscopic surgery is an operation performed in a chest or abdominal surgery while viewing an image projected by an endoscope (for example, a thoracoscope or a laparoscope) inserted in the chest cavity or abdominal cavity on a monitor. For example, in laparoscopic surgery, unlike conventional laparotomy, a plurality of thin tubes (trocars) of about 5 to 15 mm necessary for the operation are inserted and the abdominal cavity is inserted from these tubes without cutting the abdomen. Surgery is performed by inserting and removing thin forceps (a device that sandwiches and holds organs) that has been developed for mirrors and endoscopic surgery. In addition, in order to proceed with the operation while observing the inside of the abdominal cavity, carbon dioxide gas is inflated into the abdominal cavity (called pneumoperitoneum) or the abdominal wall is lifted.

Compared to open surgery, endoscopic surgery
・ Small surgical wounds, excellent cosmetics and less pain after surgery.
・ Enlarged viewing effect by laparoscope, delicate procedure and less bleeding.
It has made remarkable progress due to its low invasiveness. However, on the other hand, as a problem of endoscopic surgery,
・ Once bleeding, the field of view deteriorates, making it more difficult to stop bleeding than open surgery.
・ In general, carbon dioxide gas is injected into the abdominal cavity for pneumoperitoneum. However, when exudate or bleeding during the operation is aspirated, intraperitoneal gas (CO ₂ ) is also aspirated at the same time, making it difficult to maintain the visual field. Therefore, compared to laparotomy, suction is difficult.
-Since the monitor is two-dimensional, it is difficult to grasp the organ behind the field of view, and the organ may be damaged.
・ Organs cannot be palpated directly with fingers, and they are operated with hard forceps, making it difficult to handle the organs in a protective manner.
There are problems such as. These problems are common to all endoscopic abdominal surgery including gastroenterological surgery as well as gynecology and urology.

  These problems in the endoscopic surgery are not particularly problematic in the normal laparotomy, and are specific to the endoscopic surgery. For example, in normal laparotomy, even if bleeding occurs, it is possible to stop bleeding by directly pressing gauze or the like against the bleeding affected part, and it is easy to replace the gauze one after another. Further, in normal laparotomy, there is no need for pneumoperitoneum, and it is possible to directly observe an organ without using a monitor, and a sufficient visual field is secured. Furthermore, it is possible to handle the organ directly with fingers, and it is possible to protect and protect the organ in a friendly manner. As described above, the problems in the endoscopic surgery are not particularly problematic in the laparotomy having a long history, and thus there are no medical devices for solving these problems in a medical tool for laparotomy.

  Examples of the organ retraction and traction device in the endoscopic operation include a triangle retractor (Stema, Germany) and a retraction device (for example, Mizuho Medical Industry or Peace Medical Instrument). However, when these instruments are used, one trocar is occupied, and these are currently used only in very limited situations.

  Further, when absorbing blood or exudate, gauze containing an X-ray contrast yarn used in laparotomy is also used in endoscopic surgery. However, since it is difficult to take in and out frequently via the trocar, it is difficult to easily replace it with a new gauze as in open surgery, so blood that has been absorbed by the gauze once has been inserted separately from the trocar. In general, it is used to absorb the blood and reuse it for absorption of blood and the like. However, since gauze is inferior in thickness and strength, there is a possibility that an organ is damaged at the tip of the suction tube when sucked by the suction tube. In addition, the gauze adheres to the organ when dry, and there is a risk of organ damage when the gauze is peeled off, and it is difficult to fold it properly within the abdominal cavity. The disadvantage is that it is difficult to wrap or press the wrapping.

JP 2009-89900 A Japanese Utility Model Publication No. 53-137174

Under such circumstances, the present inventor has provided a completely new surgical tool in order to solve the problems peculiar to endoscopic surgery, which has not been a problem in laparotomy with a long history. We have eagerly searched for the purpose, completed a completely new surgical tool for mirror viewing, and have already filed a patent application (International Application No. PCT / JP2008 / 073859).
The function required for the surgical instrument according to the patent application is not limited to the following, but the first function is a temporary liquid storage function for sucking and removing blood and leachate during a surgical operation under the microscope. is there. The second function is a function for securing a physical space for surgery and a sufficient visual field. The third function is an organ protection function.

  In the development of the surgical instrument for endoscopic surgery, the present inventor not only has a liquid-absorbing property and a liquid-retaining property, but also has a liquid separating property capable of discharging blood or the like once absorbed from the surgical tool by suction or the like. It has been found that by selecting a material having (liquid removal property), an extremely excellent surgical tool can be obtained. In addition, in the course of further improving the surgical tool, the surgical tool made of such a material having a liquid-separating property is suitable for a non-invasive surgical operation that is difficult to perform complicated replacement. Even in the case of endoscopic surgery, the surgery can be continued without replacing (or suppressing the frequency of replacement) the surgical tools once placed to protect the organs and secure the surgical space. It has been found useful in various procedures including general surgery.

  Accordingly, an object of the present invention is a surgical instrument that can be used in general surgical operation and endoscopic surgery, and is made of a material having not only simple liquid absorption and liquid retention but also excellent liquid separation properties. Is to provide. In the present specification, the term “temporary liquid storage property” is used to indicate that all of the liquid absorbing property, the liquid retaining property, and the liquid separating property are provided.

The above-mentioned problem can be solved by the inter-organ spacer for surgery according to the present invention, which includes a liquid retaining means made of a porous soft material having temporary liquid storage properties and shape retention properties. As the porous soft material, a flexible polyurethane foam is preferable.
The inter-organ spacer for surgery according to the present invention can be used for non-microscopic surgery or can be used for endoscopic surgery.

The present invention also relates to a tool for inserting the inter-organ spacer into the body, which includes a cylindrical storage portion that can store the inter-organ spacer for endoscopic surgery.
According to a preferred aspect of the insertion tool of the present invention, the inter-organ spacer that can be inserted from one end side of the cylindrical storage portion and is stored in the cylindrical storage portion is connected to the other side of the cylindrical storage portion. Extruding means can be further included that can be extruded from the end of the.
According to another preferable aspect of the insertion tool of the present invention, it is possible to further include a retracting means capable of retracting the inter-organ spacer into the cylindrical storage portion.
According to still another preferable aspect of the insertion tool of the present invention, it can further include a funnel portion that can be provided at one end of the cylindrical storage portion.
Furthermore, the present invention relates to an endoscopic surgical kit including the inter-organ spacer for endoscopic surgery and the insertion tool.

  In the present specification, non-scopic operation means general surgical operation excluding the below-described microscopic operation, and includes, for example, laparotomy, thoracotomy, body surface surgery, and orthopedic surgery. Can do. Examples of the laparotomy include gastrointestinal surgery for the gastrointestinal tract such as the stomach and large intestine and the real organs such as the liver, biliary tract, pancreas, and spleen, as well as urological surgery for the kidney, adrenal gland, bladder, and prostate. A gynecological operation that deals with the uterus and ovaries can be mentioned. Examples of the thoracotomy include cardiovascular surgery, respiratory surgery that deals with lungs and trachea, esophageal surgery, and the like. Examples of the surface surgery include breast surgery, thyroid surgery, and hernia surgery.

  In the present specification, the endoscopic operation means an operation performed in a chest or abdominal operation while viewing an image projected by an endoscope (for example, a thoracoscope or a laparoscope) inserted in the chest cavity or abdominal cavity on a monitor. To do. For example, in laparoscopic surgery, unlike conventional laparotomy, several thin tubes (trocars) of about 5 to 15 mm necessary for the operation are inserted and the abdominal cavity is inserted from these tubes without cutting the abdomen significantly. Surgery is performed by inserting and removing thin forceps (a device that sandwiches and holds organs) that has been developed for mirrors and endoscopic surgery. In stomach and intestine surgery, a small incision of about 5 cm is often placed at the time of organ excision, removal, and anastomosis (joining), which is called laparoscopic-assisted surgery. Included in lower surgery.

According to the inter-organ spacer of the present invention, it is possible to solve various problems peculiar to various types of surgery including non-scopic surgery and microscopic surgery at one time, for example,
(1) Avoidance of visual field damage due to bleeding (2) Buffer of force to hold down organs and tissues (3) Avoidance of organ damage due to transmission of heat and vibration waves and avoidance of secondary damage when using automatic suturing device (4) Anticipation It is possible to obtain an advantageous effect such as compression hemostasis (5) exudate (mainly blood) suction against bleeding.

  In various operations, the effect (1) can prevent blood and the like from diffusing to the surroundings. However, especially in the case of endoscopic surgery, even a small amount of bleeding obstructs the visual field and makes it difficult to perform the operation. At that time, by inserting the inter-organ spacer of the present invention, it is immediately absorbed into the liquid retention means, and it is possible to prevent blood or leachate such as bile and intestinal fluid from diffusing to the surroundings.

  The inter-organ spacer of the present invention can buffer the force of pressing down an organ or tissue during organ excretion in various operations. However, with regard to the effect (2), particularly in the case of endoscopic surgery, Since the tissue cannot be pressed (excluded) in a loving manner with the hands and fingers, it is removed using tools such as forceps by remote control. At that time, the force is often concentrated on one point, which may cause damage to organs and tissues. Therefore, by placing the inter-organ spacer of the present invention between the forceps and the organ or tissue, it is possible to disperse the concentrated force and reduce the risk of damage.

Regarding the effect (3), in the case of endoscopic surgery, an organ or tissue is peeled and separated mainly using an electric knife or an ultrasonic coagulation / cutting device. However, unnecessary heat and vibration waves are not required for an important organ / tissue. There is a danger of causing unexpected damage. Therefore, the inter-organ spacer of the present invention is interposed between the organ / tissue to be exfoliated and the electrosurgical knife or ultrasonic coagulation / cutting device, or the inter-organ spacer of the present invention is placed in front of an important organ. Therefore, it is possible to avoid transmission of unnecessary heat and vibration waves and to prevent secondary damage.
Further, in the case of endoscopic surgery, an automatic suturing device is often used when organs or tissues are separated. At that time, there is a possibility that adjacent organs / tissues may be involved and damaged, but by interposing the inter-organ spacer of the present invention in between, secondary damage can be avoided.

  Regarding the effect (4), the basis of hemostasis is compression hemostasis. In various types of surgery, by inserting the inter-organ spacer of the present invention, it is possible to immediately stop bleeding against unexpected bleeding.

  Regarding the effect (5), in the surgical operation under the microscope, the accumulated exudate is usually sucked using a suction tube. However, the surrounding tissue may be drawn into the suction tube together, and the exudate may not be successfully sucked. For this reason, when there is a lot of bleeding, it can lead to a sudden loss of visual field, giving up the operation under the microscope. Regardless of whether the operation is endoscopic or non-scopic, using the inter-organ spacer of the present invention, the absorbed exudate is immediately sucked through the liquid retention means, and the exudate is efficiently removed. Can do.

It is a perspective view which shows typically the one aspect | mode of the inter-organ spacer of this invention. It is a schematic plan view of the inter-organ spacer shown in FIG. It is a typical bottom view of the inter-organ spacer shown in FIG. It is a typical side view of the inter-organ spacer shown in FIG. It is a perspective view which shows typically another one aspect | mode of the inter-organ spacer of this invention. It is a perspective view which shows typically the one aspect | mode of the insertion tool of this invention. It is a perspective view which shows typically another one aspect | mode of the insertion tool of this invention. It is a perspective view which shows typically another one aspect | mode of the insertion tool of this invention. It is a perspective view which shows typically the state which accommodated the funnel main body in the insertion tool shown in FIG. It is a perspective view which shows typically another one aspect | mode of the inter-organ spacer of this invention. It is a perspective view which shows typically another one aspect | mode of the inter-organ spacer of this invention. It is a perspective view which shows typically another one aspect | mode of the inter-organ spacer of this invention.

  The inter-surgical organ spacer of the present invention includes at least liquid retaining means made of a porous soft material having temporary liquid storage properties and shape retention properties, and can be provided on the surface of the liquid retaining means, for example, if desired. A strap (preferably a grip string including an X-ray contrast medium) or an X-ray contrast medium can further be included inside the liquid retaining means. The liquid retaining means, which is the main part of the inter-organ spacer of the present invention, has a temporary liquid storage function, and also has functions of securing a space and protecting the organ.

  The porous soft material used for forming the liquid retaining means in the present invention is not particularly limited as long as it is a material having at least a temporary liquid storage property and a shape retaining property, and further has flexibility. Is preferred.

In this specification, temporary liquid storage means (1) liquid absorption that can absorb blood or exudate during surgery, and (2) even if an external action is applied to the liquid retaining means during surgery (for example, (Moving during operation, contact with organs), liquid retaining ability to sufficiently retain absorbed blood, and (3) liquid retaining means by suction or the like for absorbing blood or the like absorbed in the liquid retaining means This means that it has a liquid separating property (liquid discharging property) that can be discharged from the water.
The inter-organ spacer of the present invention can be allowed to perform a draining operation with a suction tube or the like after the blood or the like is once sucked into the liquid retaining means and then held for a while, or By disposing a liquid retaining means at the tip and sucking in that state, blood or the like can also be sucked and removed through the liquid retaining means.

  The liquid absorptivity can be evaluated by, for example, a liquid absorption capacity for its own weight or a liquid absorption rate when a predetermined amount of solution is absorbed. The liquid absorbability of the porous soft material used in the present invention is preferably 100% to 5000% (1 to 50 times its own weight) of its own weight when the liquid absorption capacity for its own weight is used as an index. When it is 100% or more of its own weight, the effect of absorbing the liquid over the volume appears, and when the sponge is put into the body, the liquid such as body fluid interferes with the surgical space, or the body fluid etc. There is an advantage that the liquid does not overflow outside the body. On the other hand, if it exceeds 5000% of its own weight, the physical strength of the sponge may be weakened. The lower limit of liquid absorbency is more preferably 150% of its own weight, still more preferably 200%, and particularly preferably 300%. Moreover, an upper limit becomes like this. More preferably, it is 3000%, More preferably, it is 2000%, Most preferably, it is 1000%.

The liquid absorbency is a value measured by the procedure described below. That is,
(1) Measure the weight (Wd) of a subject (eg, sponge) before being immersed in artificial blood,
(2) Immerse in artificial blood for 3 minutes (soak the entire sponge in water and absorb water from the entire surface of the sponge as much as possible), then place it on a wire mesh for 30 seconds to let it drop naturally. Then, the weight (Ww) of the subject after water absorption is measured.
(3) The following formula:
(Ww−Wd) ÷ Wd × 100 (%)
Thus, the liquid absorption (%) is calculated by dividing the increased weight by the weight before liquid absorption.

Alternatively, when the liquid absorption rate when a predetermined amount of solution is absorbed is used as an index, the liquid absorbability of the porous soft material used in the present invention is preferably 40% to 100%. The lower limit of liquid absorbency is more preferably 60%, still more preferably 80%, still more preferably 85%, and particularly preferably 90%.
This liquid absorbency is a value measured by the procedure described below. That is, artificial blood is sufficiently sucked into a sample (cuboid shape, 50 mm × 50 mm × 20 mm) and sufficiently squeezed. A lid of a disposable petri dish with a diameter of 9 cm is placed on a table with the inside up, and 20 mL of artificial blood is put therein. Insert a sample that has been sufficiently squeezed, and press the sample 5 times on the bottom of the petri dish. When the sample is pushed, the sample is pushed to the point where it does not contract, and the pushing interval is about once per second. A sample is taken out and the amount of artificial blood remaining in the petri dish lid (V, unit mL) is measured. Following formula:
(20 mL-V) / 20 mL × 100 (%)
To calculate the liquid absorbency (%).

The liquid retention property of the porous soft material used in the present invention is preferably 90 to 100%, more preferably 92 to 100%, more preferably 94 to 100%, and still more preferably 97 to 100%. It is.
The liquid retention is a value measured by the following procedure. That is,
(1) Measure the weight (Wd) of the subject before liquid absorption,
(2) The artificial blood is sufficiently sucked into the subject, and the weight (Ww) is measured in the sucked state. (3) The sucked subject is placed on a plate, and the plate is placed at 45 °. After standing for 3 minutes in a tilted state, the weight (W ₃ ) is measured.
(4) The following formula:
(W ₃ −Wd) ÷ (Ww−Wd) × 100 (%)
The value obtained in step 1 is defined as liquid retention (%).

  The liquid releasing property of the porous soft material used in the present invention is preferably 10 to 100%, more preferably 15 to 100%, still more preferably 20 to 100%, still more preferably 40 to 100%. More preferably, it is 60 to 100%, and more preferably 65 to 100%. In the present invention, a porous soft material having a liquid separating property of 80 to 100% or 85 to 100% can also be used.

The liquid separating property is a value measured by the following procedure. That is,
(1) Measure the weight (Wd) of the subject before liquid absorption,
(2) The artificial blood is sufficiently sucked into the subject, and the weight (Ww) is measured in the sucked state. (3) The sucked subject is placed on a plate, and a suction fistula is attached. The weight (Ws) is measured after being pressed against the center of the subject and sucked for 1 minute by a suction ability of −600 to −650 mmHg (−80 to −85 kPa).
(4) The following formula:
(Ww−Ws) ÷ (Ww−Wd) × 100 (%)
The value obtained in step 4 is defined as liquid separation (%).

  In the present specification, low liquid separation means that the liquid separation measured by the measurement method is less than 40%, and high liquid separation means that it is 40% or more.

In this specification, the shape retention property substantially retains the shape even when various external pressures expected during the operation are applied after inserting the inter-organ spacer of the present invention into the body. It means the nature that can be done. Examples of the external pressure include a pressure applied during a draining operation using a suction tube, a pressure applied when moving an inter-organ spacer, a pressure applied when securing a surgical space, and a pressure applied when protecting an organ. Can do.
The shape retention can be evaluated by, for example, compression residual strain.

  The compressive residual strain of the porous soft material used in the present invention is preferably 10% or less, more preferably 5% or less. The lower the compression residual strain, the better. Therefore, the lower limit is 0%. If it exceeds 10% (preferably 5%), the surface area of the sponge may be reduced, the water absorption may be lowered, and the flexibility may be lowered.

In this specification, the compression residual strain means a value measured based on JIS K 6400: 1997. The outline is that the thickness of the central part of the test piece (50 mm × 50 mm × 20 mm) is measured to 0.1 mm using a caliper without deforming the foam (t ₀ ). Subsequently, the thickness of the test piece is compressed to 50% using two compression plates. Place in a constant temperature bath at a temperature of 70 ± 1 ° C. in a compressed state within at least 15 minutes and heat for 22 hours. The test apparatus is taken out of the thermostatic bath, and the test piece is taken out from the compression plate within 1 minute and placed on a material having low thermal conductivity such as wood. The specimen is allowed to stand for 30 minutes at a temperature of 23 ± 2 ° C. and a relative humidity of 50 ± 5% (in a tank adjusted for 16 hours or more) for recovery, and then the thickness of the same part is measured to 0.1 mm (t ₁ ) .
Following formula:
(T _o −t ₁ ) ÷ t _o × 100 (%)
[ _Where t _o is the thickness before compression and t ₁ is the thickness after compression]
The value obtained in is defined as compression residual strain (%).

  In this specification, the term “flexibility” means a surface property that does not damage an organ when it comes into contact with the organ. The said softness | flexibility can be evaluated by the hardness or impact resilience which measures based on JISK6400 or according to it, for example.

  The hardness of the porous soft material used in the present invention is preferably 10 to 200N. The lower limit of the hardness is more preferably 15N, still more preferably 20N, and particularly preferably 25N. The upper limit of the hardness is more preferably 150N, still more preferably 100N.

  In this specification, hardness means the value measured by the method of Example 5 mentioned later implemented according to JISK6400: 1997. That is, when an object (two 80 × 80 × 20 mm stacked) is placed on the table of the testing machine and a pressure plate (diameter 33.7 mm) is placed on the upper surface of the sample piece, the load is 0.2N. The thickness is read to 0.1 mm, and this is the initial thickness. Next, after pressing the pressure plate 10 mm at a speed of 100 ± 20 mm per minute, the load is immediately removed, the pressure plate is pushed again to 30 mm at a speed of 100 ± 20 mm, and the load when 20 seconds have passed after the rest is read. .

The impact resilience of the porous soft material used in the present invention is preferably 10 to 100. The lower limit is more preferably 20, and still more preferably 30.
In this specification, the impact resilience means a value measured by the method described in Example 6 described later, which is performed according to JIS K 6400: 1997. That is, a steel ball of 5/8 parallel balls specified in JISB1501 is installed at a distance of 476 mm from the subject (two 80 × 80 × 20 mm), freely dropped, and the top of the steel ball jumped up Measure the top surface. The numerical value is expressed by setting the position of 16 mm from the sample piece to 0 and the position of 476 mm to 100.

  The porous soft material used in the present invention may be deformable, resistant to sterilization, non-adhesiveness, durability, moderate swelling, as desired, in addition to the temporary storage, shape retention and flexibility described above. It is preferable to have indirect liquid absorption. The inter-organ spacer of the present invention is a surgical tool intended to be used in the body only during surgery, and is premised to be removed from the body when the surgical purpose is completed. The flexible soft material need not be biodegradable. Rather, it is preferably non-biodegradable from the viewpoint of strength or cost.

  Deformability in this specification means a property that can change the shape of the trocar into a shape that allows it to pass through, particularly when inserted into the body via the trocar in an endoscopic operation. If it has a shape and size that can pass through the trocar without changing the shape, the deformability is not necessarily required. The deformability and the shape retention described above seem to contradict each other at first glance. However, as described above, the shape retention in this specification refers to the load of various external pressures expected during surgery. In the present specification, the deformability in the present specification means that the shape can be substantially retained when it is applied, and as described above, the deformability in this specification means that a very high load (ie, The shape is changed by applying a load that is much higher than the external pressure expected during the operation. Therefore, deformability and shape retention are not contradictory properties.

  Further, by having resistance to sterilization treatment (for example, heat resistance, chemical resistance, UV resistance), a product can be provided in a sterilized state. Furthermore, by having non-sticking property, sticking to an organ can be prevented.

In addition, by having sufficient durability, even if a part thereof is grasped with forceps or the like, it will not be broken, or it will be prevented from being dissolved or disintegrated in the body and remaining in the body. Therefore, it can be safely used in surgery (especially surgery under the microscope).
The durability can be evaluated by, for example, tensile strength. The tensile strength of the porous soft material used in the present invention is preferably 5N or more, more preferably 8N or more, more preferably 10N or more, more preferably 20N or more, and further preferably 23N or more. is there. Moreover, the upper limit becomes like this. Preferably it is 200N, More preferably, it is 150N, More preferably, it is 100N, Most preferably, it is 50N.

  In this specification, the tensile strength means a value measured according to JIS K 6400-5: 2004. The outline is that a No. 2 type test piece with a thickness of 1 cm is prepared, pulled at 500 mm per minute, and the maximum load until the test piece is broken is measured.

The degree of swelling of the porous soft material used in the present invention is preferably 50% to 150%, more preferably 90% to 110%, and still more preferably 95% to 105%.
In this specification, the degree of swelling means a value measured by the method described in Example 8 described later. That is, 50 mL of artificial blood is put into a 100 mL beaker. Gently drop a sample (approx. 20 mm x 20 mm x 10 mm) whose vertical, horizontal, and height dimensions are measured in advance into a beaker containing artificial blood, leave it for 3 minutes, then gently remove it with tweezers and place it on a wire mesh for 30 seconds. After placing and dropping the artificial blood, the dimensions of the sample are measured again.
Following formula:
(Vw / Vd) x 100 (%)
[Wherein, Vw is the sample volume after liquid absorption, and Vd is the sample volume before liquid absorption]
The value obtained in is taken as the degree of swelling (%).

In this specification, indirect liquid absorbency means the performance evaluated by the method described in Example 9 described later. That is, a sample (cuboid shape, 80 mm × 80 mm × 20 mm) is left still in a 12 cm × 23 cm × 5 cm container containing 50 mL of artificial blood, and the upper surface of the sample is repeatedly pushed into the sample to sufficiently introduce artificial blood. Absorb liquid. After confirming that the artificial blood that was not sucked into the sample remained sufficiently around the sample, the tip of the suction fistula was applied to the center of the sample, and −600 to −650 mmHg (−80 to −85 kPa) Aspirate the artificial blood while pushing in under reduced pressure. It is confirmed whether or not the total amount of artificial blood in and around the sample is removed when aspirated over a sufficient amount of time. The suction time is 1 minute, and if artificial blood around the sample is removed within 1 minute, it is determined that the blood has indirect suction, and even after 1 minute of suction, the artificial blood around the sample is removed. If it remains, it is determined that there is no indirect suction.
If the porous soft material is indirectly liquid-absorbing, it is necessary to directly aspirate blood or bile, exudate such as intestinal fluid, or physiological saline used for washing organs, etc. Since the exudate can be removed indirectly via the liquid retaining means, the risk of damaging the tissue or the like can be avoided.

  Since the porous soft material used in the present invention has these various properties, various problems peculiar to the various operations described above can be solved. Among these various properties, simply being excellent in liquid absorbency and liquid retention is not sufficient as an inter-organ spacer for surgery, and in particular, liquid separation properties, indirect liquid absorption properties, and strength (for example, Properties such as tensile strength are important.

  Examples of the porous soft material used in the present invention include various sponges [soft foam (foam)] that can be used for medical purposes. As more specific materials, for example, polyurethane (low liquid-releasing polyurethane or high liquid-releasing polyurethane), polyvinyl alcohol, cellulose, polyethylene, etc. can be used as long as it has various properties described so far. Particularly preferred.

  When the various properties described so far (particularly, liquid separating property, strength, indirect liquid absorbing property, etc.) are combined, highly porous liquid releasing polyurethane is preferable as the porous soft material used in the present invention. For example, the highly liquid-releasing polyurethane (for example, Sample B, Sample C, Sample D, Sample E, Sample b) used in Examples described later can be mentioned. Among these highly liquid-releasing polyurethanes, Sample B and Sample E are preferable in view of the tensile strength. Alternatively, sample B, sample C, and sample D are preferable in view of indirect liquid absorption. Therefore, when all these are judged comprehensively, the sample B is most preferable.

  Various performances of the highly liquid-releasing polyurethane that can be used in the present invention are shown in Table 1 together with various performances of general polyurethanes that can be used in the present invention. In Table 1, column I is a preferred range common to sample B, sample C, sample D, sample E, and sample b, and column II is an update common to sample B, sample C, sample D, and sample E. The column III is a further preferred range common to Sample B and Sample E. The column IV relates to a general polyurethane.

  Moreover, as shown also in the below-mentioned Example, when the polyurethane b and the low liquid-release polyurethane A are compared, the low liquid-release polyurethane is excellent in terms of liquid absorbency, tensile strength, and the like. In addition, comparing polyvinyl alcohol used for organ pressure relief pads with low liquid release polyurethane, low liquid release polyurethane is superior in terms of flexibility (for example, hardness, rebound resilience) and compression residual strain. ing. When cellulose (for example, Ope sponge X; white cross) used for organ pressure relief pads is compared with low-release polyurethane, low-release polyurethane is superior in terms of mechanical strength. Further, in terms of liquid releasing properties, highly liquid releasing polyurethane is superior.

FIG. 1 schematically shows one embodiment of the inter-organ spacer of the present invention. Moreover, the top view, bottom view, and side view of the inter-organ spacer shown in FIG. 1 are shown in FIGS.
The inter-organ spacer 10 shown in FIG. 1 includes a sponge body 1 that functions as a liquid retaining means and a grasping string 2. The sponge body 1 has a quadrangular prism shape in which the upper surface 1a and the lower surface 1b are square, and is provided with a pair of through holes 3a and 3b penetrating from the upper surface 1a to the lower surface 1b. The string 2 includes an X-ray contrast thread, and has a ring-closing structure that connects a space near the upper surface 1a of the sponge body 1, one through hole 3a, a space near the lower surface 1b, and the other through hole 3b in this order. Become.

  The string 2 can be fixed to the sponge body 1 in the through holes 3a and 3b, or can be left unfixed. When the string 2 is fixed to the sponge body 1, the length of the approximate arc portion 2a protruding from the upper surface 1a and the length of the approximate linear portion 2b protruding from the lower surface 1b are unchanged during use. On the other hand, when the string 2 is not fixed to the sponge body 1, the respective lengths can be changed before and / or during use. Further, the length of the string can be adjusted so that only the portion protruding from one surface (upper surface 1a) (schematic arc portion 2a) functions as a gripping portion (see FIG. 4), or Portions protruding from both surfaces (upper surface 1a and lower surface 1b) can also function as gripping portions.

  The sponge body 1 can function as a spacer for securing a space necessary for the operation by evacuating it without damaging the organ during the operation. In surgery, it can function as a protective material for protecting an organ and a blood or exudate absorbing material.

  The size of the liquid retaining means (for example, the sponge body) in the inter-organ spacer of the present invention can be appropriately selected depending on each operation, and is not particularly limited. For example, in non-scopic surgery, it can be determined according to the space of the surgical field and the size of the organ. For example, the thickness can generally be selected in the range of 0.5 to 20 cm. Moreover, in the case of a rectangular parallelepiped shape, it can generally select in the range of 5 cm x 5 cm x 0.5 cm-40 cm x 40 cm x 20 cm.

  In the case of endoscopic surgery, there is no particular limitation as long as it can be inserted from the incised portion of the body surface by being compressed, rolled, folded, or inserted as it is. A typical incision in endoscopic surgery is a maximum of 40 mm, usually 5-12 mm, and a minimum of 2 mm. Moreover, the diameter of a general trocar is 2-30 mm normally, Preferably it is 5-12 mm. The size of the liquid retaining means can be appropriately determined according to the size of the incision or the trocar diameter. For example, the thickness can generally be selected in the range of 0.5 to 10 cm. Moreover, in the case of a rectangular parallelepiped shape, it can generally select in the range of 5 cm x 5 cm x 0.5 cm-10 cm x 10 cm x 10 cm. When the inter-organ spacer of the present invention is taken out from the body, it can be taken out through an incision or a trocar after being compressed, as it is, or after being cut into a plurality of small pieces with an electric knife or the like.

  The material of the grasping string that can be provided as desired in the inter-organ spacer of the present invention is not particularly limited as long as the sponge body can be freely moved by grasping with a forceps during the operation. Fiber, soft plastic, hard plastic, metal and the like can be used. When a hard material capable of maintaining the grip shape is used, the grip string can be easily gripped and the sponge body can be moved smoothly. When a soft material that does not maintain the grip shape is used, the risk of organ damage can be reduced.

The length of the grasping string in the inter-organ spacer of the present invention is not particularly limited as long as it can be grasped with forceps to move the liquid retaining means, but from the surface of the liquid retaining means (FIG. 4). Length L), preferably 1 mm to 100 mm, more preferably 1 mm to 50 mm.
When using a grasping string to indicate that it remains in the body, it is 100 mm to 1500 mm, more preferably 250 mm to 750 mm from the surface of the liquid retaining means (length L in FIG. 4). .

In the present invention, as long as the gripping string is provided on the surface of the liquid retaining means so that the liquid retaining means can be moved via the gripping string, the connecting method of the gripping string and the liquid retaining means is It is not particularly limited. For example, one or a plurality of through holes are provided in the liquid retaining means, the string is passed through the through hole, and then the connection is made by forming a closed ring, the liquid retaining means is divided into two, and the connection is made by sandwiching the string between them And a method of directly connecting a string to one or a plurality of surfaces of the liquid retaining means by an adhesive means (for example, an adhesive tape, an adhesive, or heat fusion). In view of the fact that it is not necessary to use an adhesive or the like, a method of connecting by forming a through hole in the sponge body, passing a string through the through hole, and then forming a closed ring is preferable.
The string can be used as a gripping string in a state where the string is passed through a single layer or a double layer. By passing more than double, for example, it is possible to increase the contrast intensity displayed during X-ray imaging, or to increase the stability of the inter-organ spacer (the contact area between the grasping cord and the liquid retaining means is increased). By increasing, it is possible to reduce the risk that the liquid retaining means is torn). In addition, when letting it pass more than double, it is preferable to make especially double from the surface of the said effect and cost.

As the X-ray contrast agent that can be included in the grasping string in the inter-organ spacer of the present invention, for example, barium sulfate or barium sulfate mixed with polyamide, polypropylene, or synthetic rubber is used. it can. Examples of the method of encapsulating the X-ray contrast medium in the gripping string include a method of forming a gripping string with an X-ray contrast thread and a method of enclosing the X-ray contrast thread in the gripping string.
In addition, in order to provide the inter-organ spacer of the present invention with the function of the X-ray contrast agent, in addition to using the grasping string, a method of forming a sponge after mixing the X-ray contrast agent into the sponge material, A method of injecting a contrast medium into the sponge, a method of inserting a string, a rod or a sheet containing an X-ray contrast medium into the sponge, a method of attaching a tag containing the X-ray contrast medium, or an X-ray contrast on a stapler The method is not particularly limited, for example, a method of adding an agent by attaching or coating it, a method of sewing an X-ray contrast thread created by the same method as that for the gripping string into a sponge, and the like.

The shape of the liquid retention means (for example, the sponge body) in the inter-organ spacer of the present invention is not particularly limited as long as it is a shape that can be used for organ exclusion in surgery.
A prismatic shape whose upper and lower surfaces are polygonal [eg, triangle, square, rectangle, parallelogram (preferably rhombus), trapezoid, regular hexagon],
Pyramidal shape, truncated truncated pyramid shape, or double pyramid (bottom of two pyramids) whose base is a polygon [eg, triangle, square, rectangle, parallelogram (preferably rhombus), trapezoid, regular hexagon] Three-dimensional shape made by contacting each other,
A cylindrical shape whose upper and lower surfaces are a circle, an ellipse, or an ellipse (a shape in which two semicircles are connected by a straight line; see FIG. 12);
Conical shape with truncated, oval or elliptical bottom, truncated truncated cone, or bicone (a solid made by bringing two cones into contact with each other),
A partial cylindrical shape whose upper and lower surfaces are partial circles, partial ellipses, or partial ellipses [e.g., semicircle, semi-ellipse, fan shape, arc shape (shape surrounded by arc and string)],
Partial cone shape, partial truncated truncated cone shape, or partial shape whose bottom surface is a partial circle, partial ellipse, or partial ellipse [eg, semicircle, semi-ellipse, fan shape, arc shape (shape surrounded by arc and string)] Bicone shape,
Sphere or its partial shape [hemisphere, sphere crown (each of solids generated by cutting the sphere in one plane), sphere (solid generated between the two planes when the sphere is cut in two parallel planes] )], Ellipsoidal sphere (or egg shape) or its partial shape,
Regular octahedron (consisting of 8 regular triangles), regular dodecahedron (consisting of 12 regular pentagons), or regular icosahedron (consisting of 20 regular triangles)
Etc. It should be noted that a thin sheet shape, string shape, band shape, or the like cannot form a necessary space between organs, and is not preferable as the shape of the inter-organ spacer of the present invention.
The partial shape of the ellipsoidal sphere shown in FIG. 5 (for example, one when the ellipsoidal sphere is equally divided into two planes) or the hemisphere is stable when the plane side (1c in FIG. 5) is down. In addition, the surface (1d in FIG. 5) in contact with the organ is a curved surface, which is preferable.

  When the inter-organ spacer of the present invention is inserted into the body, it is compressed, wound or folded from an incision point on the body surface (preferably via a trocar in the case of endoscopic surgery). It can be inserted in the state, in a changed state, or as it is. More specifically, for example, in a compressed state in a soft resin bag by a vacuum pack, or by removing from the bag and inserting it into the body, or inserting into the body using the insertion tool of the present invention And a method of changing the form at the time of insertion.

  The insertion tool of the present invention is not particularly limited as long as it includes at least a cylindrical storage part capable of storing the inter-organ spacer of the present invention therein, in addition to the cylindrical storage part, for example, Introducer type insertion tool provided with an extruding means for pushing out the inter-organ spacer in the state of being housed in the tubular housing portion, and a first extractor type comprising a retracting means for retracting the inter-organ spacer into the tubular housing portion An insertion tool, the 2nd extractor type insertion tool etc. which provide a funnel part in one edge part of a cylindrical storage part can be mentioned.

  The shape of the cylindrical storage portion is not particularly limited as long as the inter-organ spacer of the present invention can be compressed, rolled, folded, or stored as it is, for example, And a cylindrical shape whose cross section is a circle or an ellipse, and a cylindrical shape whose cross section is a polygon. The magnitude | size of a cylindrical storage part is not specifically limited as long as the whole and a part can be inserted in a trocar. For example, when the cylindrical storage portion has a cylindrical shape, it can be inserted into the trocar by making the outer diameter of the cylindrical storage portion smaller than the inner diameter of the trocar.

  As an introducer type insertion tool provided with a cylindrical storage part and an extrusion means, the insertion tool shown in FIG. 6 can be mentioned, for example. An introducer-type insertion tool 20 shown in FIG. 6 pushes out an interorgan spacer in a state of being accommodated in a cylindrical storage portion 21 that can store an interorgan spacer (not shown) inside, and in the cylindrical storage portion. And extrusion means 22 capable of producing The pushing means includes a pressing pad 22a that is in direct contact with the inter-organ spacer, a pressing rod 22b that is connected to the pressing pad, and an operation handle 22c that is connected to the other end of the pressing rod. In the present invention, the inter-organ spacer can be provided in a state of being inserted into the introducer-type insertion device in advance, or the inter-organ spacer and the introducer-type insertion device are provided in a separated state, and during the operation. The interorgan spacer can also be set in the insertion tool.

  As a 1st extractor type insertion tool provided with a cylindrical storage part and a drawing-in means, the insertion tool shown in FIG. 7 can be mentioned, for example. The extractor-type insertion tool 30 shown in FIG. 7 includes a cylindrical storage portion 31 that can store an inter-organ spacer (not shown) inside, and a retractor that can retract the inter-organ spacer into the cylindrical storage portion. Means 32. The retracting means 32 includes a gripping portion 32a that can grip the inter-organ spacer, a knob portion 32c for operating the gripping portion, and a connecting portion 32b that connects the gripping portion and the knob portion. When the knob portion 32c is pulled out (that is, moved in the direction indicated by arrow A in FIG. 7), the connecting portion 32b is also moved in the arrow A direction, the tip of the grasping portion 32a is closed, and the inter-organ spacer can be grasped. When the knob portion 32 c is further pulled out, the inter-organ spacer held by the holding portion 32 a can be drawn into the cylindrical storage portion 31. The inter-organ spacer stored in the cylindrical storage part 31 can be pushed out of the cylindrical storage part 31 by removing the retracting means 32 from the insertion tool 30 and using an appropriate pushing means (not shown) instead. it can.

  As a 2nd extractor type insertion tool provided with a cylindrical storage part and a funnel part, the insertion tool shown in FIG.8 and FIG.9 can be mentioned, for example. The extractor-type insertion tool 40 shown in FIGS. 8 and 9 includes a cylindrical storage portion 41 that can store an inter-organ spacer (not shown) inside, and a funnel portion 42 provided at one end portion 41a thereof. . The funnel body 42a of the funnel portion 42 shown in FIG. 8 can be stored in the cylindrical storage portion 41 as shown in FIG. 9 by operating the slidable knob portion 42b. When the inter-organ spacer is stored in the cylindrical storage portion, as shown in FIG. 8, it can be stored in the cylindrical storage portion from the end 41a side by opening the funnel body 42a. On the other hand, when pushing out the inter-organ spacer from the cylindrical storage portion, as shown in FIG. 9, in a state where the funnel body 42a is stored in the cylindrical storage portion 41, from either one of the end portions 41a or 41b, By inserting an appropriate pushing means into the cylindrical storage part 41, the inter-organ spacer can be pushed out of the cylindrical storage part from the opposite end.

  The extractor-type insertion tool (including the first and second extractor-type insertion tools) of the present invention can be used not only when inserting an inter-organ spacer into the body, but also after the operation. Also in the case of taking out, the inter-organ spacer can be housed in the cylindrical housing portion by the same operation, so that it can be used for both insertion into the body and removal from the body.

For example, in the case of the extractor-type insertion tool shown in FIG. 7, the end 31a on the side where the gripping portion 32a is provided is inserted into the body from an incision site on the body surface (for example, via a trocar), and retracting means By operating 32, the inter-organ spacer can be collected from the body into the cylindrical storage portion 31.
Alternatively, in the case of the extractor-type insertion tool shown in FIGS. 8 and 9, the end 41a side is inserted into the body from the incision site on the body surface, and the funnel body 42a is opened, so that the inter-organ spacer can be removed from the body. It can be collected in the shape storage part 41. In this case, by inserting the retracting means 32 shown in FIG. 7 from the end 41 b side of the cylindrical storage part 41, the inter-organ spacer can be more easily collected in the cylindrical storage part 41.

  The endoscopic surgical kit of the present invention is not particularly limited as long as it includes the inter-organ spacer of the present invention and the insertion tool of the present invention. The endoscopic surgical kit of the present invention can be provided in a state where the inter-organ spacer is set in the insertion tool from the beginning, or the inter-organ spacer and the insertion tool are provided separately, and surgery is performed. In this case, the inter-organ spacer can be set in the insertion tool. It is preferable to provide the inter-organ spacer in a state where it is set in the insertion tool in that sterilization is possible.

  EXAMPLES Hereinafter, the present invention will be specifically described by way of examples, but these do not limit the scope of the present invention.

Example 1: Evaluation of liquid absorbency
In this example and each of the following examples, as the porous soft material, low-release polyurethane (Tough Pongi; Hogi Medical), high-release polyurethane for laparotomy, polyvinyl alcohol (Retractor Pad; Peace Medical Instrument) (Hereinafter referred to as sample set A).
In addition, as another sample set, the low liquid-releasing polyurethane (Tuffponge; Hogi Medical; hereinafter referred to as Sample A), and four different types of high liquid-releasing polyurethane (hereinafter referred to as Samples B to E). 6 types (hereinafter referred to as sample set B) of polyethylene (hereinafter sometimes referred to as sample F). Table 2 shows the main performance of each porous soft material used in sample sets A and B. The elongation in Table 2 was measured according to JIS K 6400-5: 2004.

(1) Evaluation of liquid absorbency in sample set A The weight (Wd, unit g) of a sample (cuboid shape, 20 mm × 20 mm × 10 mm) before being immersed in artificial blood was measured. Subsequently, the sample is gently dropped into a 100 mL beaker containing 50 mL of artificial blood [Synthetic blood reagent mix, Johnson, Moen & co.], Left for 3 minutes, then gently removed with tweezers and placed on a wire mesh for 30 seconds. Then, artificial blood was dripped. The sample was placed in another beaker and its weight (Ww, unit g) was measured.
The liquid absorption is expressed by the following formula:
(Ww−Wd) ÷ Wd × 100 (%)
Calculated by

  The results are shown in Table 3. Three samples were prepared for each material, and the average value of liquid absorbency (%) in each sample was calculated. It shows that it is excellent in liquid absorptivity, so that a numerical value is high.

(2) Evaluation of liquid absorbency in sample set B The sample (cuboid shape, 50 mm × 50 mm × 20 mm) was sufficiently squeezed after sufficiently absorbing artificial blood. A lid of a disposable petri dish having a diameter of 9 cm was placed on a table in an inverted state, and 20 mL of artificial blood was placed therein. A sufficiently squeezed sample was put, and the sample was pressed 5 times on the bottom of the petri dish body. When the sample was pressed, the sample was pressed to the point where it did not contract, and the pressing interval was about once per second. A sample was taken out, and the amount of artificial blood remaining in the petri dish lid (V, unit mL) was measured.
The liquid absorption is expressed by the following formula:
(20 mL-V) / 20 mL × 100 (%)
Calculated by

  The results are shown in Table 4. Three samples were prepared for each material, and the average value of liquid absorbency (%) in each sample was calculated. It shows that it is excellent in liquid absorptivity, so that a numerical value is high.

<< Example 2: Evaluation of liquid retention >>
The weight (Wd, unit g) of the sample (rectangular shape, 20 mm × 20 mm × 80 mm) before the artificial blood was absorbed was measured. After artificial blood [Synthetic blood reagent mix, Johnson, Moen & co.] Was sufficiently absorbed, its weight (Ww, unit g) was measured. Subsequently, the sample was placed on a vinyl chloride plate and allowed to stand for 3 minutes with the plate tilted at 45 °, and then the weight of the sample (W ₃ , unit g) was measured.
The liquid retention is expressed by the following formula:
(W ₃ −Wd) ÷ (Ww−Wd) × 100 (%)
Calculated by

  The results for sample set A are shown in Table 5, and the results for sample set B are shown in Table 6, respectively. Three samples were prepared for each material, and the average value of liquid retention (%) in each sample was calculated. It shows that it is excellent in liquid retention property, so that a numerical value is high.

<< Example 3: Evaluation of liquid separating properties >>
The weight (Wd, unit g) of the sample (rectangular shape, 20 mm × 50 mm × 50 mm) before the artificial blood was absorbed was measured. Artificial blood [Synthetic blood reagent mix, Johnson, Moen & co.] Was sufficiently absorbed, then placed on a plastic plate, and its weight (Ww, unit g) was measured. The tip of the Yanker suction was applied to the center of the sample, and artificial blood was aspirated for 1 minute while being pressed under reduced pressure at −600 to −650 mmHg (−80 to −85 kPa). The sample weight (Ws, unit g) after the suction was measured while being placed on a plastic plate.
The liquid releasing property is expressed by the following formula:
(Ww−Ws) ÷ (Ww−Wd) × 100 (%)
Calculated by

  The results for sample set A are shown in Table 7, and the results for sample set B are shown in Table 8, respectively. Three samples were prepared for each material, and the average value of the liquid separating property (%) in each sample was calculated. It shows that it is excellent in liquid separation property, so that a numerical value is high.

Example 4: Evaluation of compressive residual strain
The thickness of the central part of the test piece (50 mm × 50 mm × 20 mm) was measured to 0.1 mm with a caliper without deforming the foam (t ₀ ). Subsequently, the thickness of the test piece was compressed to 50% using two compression plates. It was put into a thermostat having a temperature of 70 ± 1 ° C. in a compressed state within at least 15 minutes and heated for 22 hours. The test apparatus was taken out of the thermostat, and the test piece was taken out of the compression plate within 1 minute and placed on the vinyl chloride plate. After the specimen was allowed to recover for 30 minutes at a temperature of 23 ± 2 ° C. and a relative humidity of 50 ± 5% (in a tank adjusted for 16 hours or more), the thickness of the same part was measured to 0.1 mm (t ₁ ). .
The compression residual strain (%) is expressed by the following formula:
(T _o −t ₁ ) ÷ t _o × 100 (%)
Calculated with

  The results for sample set A are shown in Table 9, and the results for sample set B are shown in Table 10, respectively. Three samples were prepared for each material, and the average value of compression residual strain (%) in each sample was calculated. In polyvinyl alcohol, moisture was removed by drying at 70 ° C., and the flexibility was lost. The lower the numerical value of compression residual strain, the better the shape retention.

<< Example 5: Evaluation of hardness (flexibility) >>
A specimen obtained by stacking two 80 × 80 × 20 mm sample pieces was used. The subject (thickness 40 mm) was placed on a table of a testing machine, and a pressure plate (diameter 33.7 mm) was placed on the upper surface of the sample piece to make the load 0.2 N. Next, after pressing the pressure plate 10 mm at a speed of 100 ± 20 mm per minute, the load was immediately removed, and the pressure plate was again pushed 30 mm at a speed of 100 ± 20 mm, and the load when 20 seconds passed after it was stationary (N) I read.
The results for sample set A are shown in Table 11, and the results for sample set B are shown in Table 12, respectively. Three samples were prepared for each material, and the average value of hardness (N) in each sample was calculated.

Example 6: Evaluation of impact resilience
A specimen obtained by stacking two 80 × 80 × 20 mm sample pieces was used. A 5/8 chromium steel ball defined in JISB1501 was placed at a distance of 476 mm from the subject, and it was allowed to fall freely and the top surface of the steel ball jumped up was measured. A numerical value was obtained by setting the position of 16 mm from the sample piece as 0 and the position of 476 mm as 100.
The results for sample set A are shown in Table 13, and the results for sample set B are shown in Table 14, respectively. Three samples were prepared for each material, and the average value of rebound resilience in each sample was calculated.

<< Example 7: Evaluation of tensile strength >>
According to JIS K 6400-5: 2004, a No. 2 type test piece having a thickness of 1 cm was produced. The sample was pulled at 500 mm per minute, and the maximum load until the test piece was broken was measured.
The results for sample set A are shown in Table 15, and the results for sample set B are shown in Table 16, respectively. Three (sample set A) or five (sample set B) samples were prepared for each material, and the average value of tensile strength (N) in each sample was calculated.

<< Example 8: Evaluation of swelling degree >>
In a 100 mL beaker, 50 mL of artificial blood (Synthetic blood reagent mix, Johnson, Moen & co.) Was placed. Gently drop a sample (approx. 20 mm x 20 mm x 10 mm) whose vertical, horizontal, and height dimensions are measured in advance into a beaker containing artificial blood, leave it for 3 minutes, then gently remove it with tweezers and place it on a wire mesh for 30 seconds. After placing and dropping the artificial blood, the dimensions of the sample were measured again.
The degree of swelling is the following formula:
(Vw / Vd) x 100 (%)
[Wherein, Vw is the sample volume after liquid absorption, and Vd is the sample volume before liquid absorption]
Calculated by
The results for sample set B are shown in Table 17. Three samples were prepared for each material, and the average value of the degree of swelling (%) in each sample was calculated.

<< Example 9: Evaluation of indirect liquid absorption >>
Place the sample (cuboid shape, 80 mm x 80 mm x 20 mm) in a 12 cm x 23 cm x 5 cm container containing 50 mL of artificial blood, and repeatedly push the upper surface of the sample to sufficiently absorb artificial blood into the sample. I let you. After confirming that the artificial blood that was not sucked into the sample remained sufficiently around the sample, the tip of the suction fistula was applied to the center of the sample, and −600 to −650 mmHg (−80 to −85 kPa) The artificial blood was aspirated while pushing in under reduced pressure. It was confirmed whether or not the total amount of artificial blood in and around the sample was removed when aspirated over a sufficient amount of time.
The results are shown in Table 18. The time is 1 minute, and the symbol [-] shown in the table means that the artificial blood around the sample remained without being removed even after aspiration for 1 minute.

Example 10 Production of Interorgan Spacer
The inter-organ spacer of the present invention having the shape shown in FIGS. 10 to 12 was prepared using the low liquid release polyurethane used in the evaluation of Examples 1 to 9. The size of each inter-organ spacer is shown below.
(A) Disc shape (FIG. 10): Diameter 50 mm, thickness 20 mm
(B) Triangular prism shape (FIG. 11): Regular triangle height 60 mm, arc diameter of each apex of triangle 20 mm, thickness 20 mm
(C) Oval cylindrical shape (FIG. 12):
(C-1) An ellipse (a shape in which two semicircles are connected by two straight lines) is 70 mm in length, an ellipse is 40 mm in width, an ellipse is 40 mm in diameter and 20 mm in thickness.
(C-2) Ellipse length 65mm, ellipse width 35mm, semicircle part diameter 35mm, thickness 20mm

Moreover, the inter-organ spacer of this invention was produced by cutting out the low liquid releasing polyurethane and the high liquid releasing polyurethane used for evaluation of Examples 1-9 into the following shapes and sizes.
(A) rectangular parallelepiped shape: length x width x thickness (1) 50 mm x 50 mm x 5 mm, (2) 50 mm x 50 mm x 10 mm,
(3) 50 mm × 50 mm × 20 mm, (4) 50 mm × 50 mm × 30 mm,
(5) 50 mm × 50 mm × 50 mm,
(6) 80 mm × 80 mm × 5 mm, (7) 80 mm × 80 mm × 10 mm,
(8) 80 mm × 80 mm × 20 mm, (9) 80 mm × 80 mm × 30 mm,
(10) 80 mm × 80 mm × 50 mm,
(11) 100 mm × 100 mm × 5 mm, (12) 100 mm × 100 mm × 10 mm,
(13) 100 mm × 100 mm × 20 mm, (14) 100 mm × 100 mm × 30 mm,
(15) 100mm x 100mm x 50mm
(B) Cube shape: 1 side length (1) 20 mm, (2) 30 mm, (3) 40 mm, (4) 50 mm,
(5) 80mm, (6) 100mm
(C) Disc shape: diameter x thickness (1) diameter 50 mm x thickness 5 mm, (2) diameter 50 mm x thickness 10 mm,
(3) diameter 50 mm × thickness 20 mm, (4) diameter 50 mm × thickness 30 mm,
(5) Diameter 50 mm x thickness 50 mm,
(6) diameter 80 mm × thickness 5 mm, (7) diameter 80 mm × thickness 10 mm,
(8) Diameter 80 mm x thickness 20 mm, (9) Diameter 80 mm x thickness 30 mm,
(10) Diameter 80 mm x thickness 100 mm,
(11) diameter 100 mm × thickness 5 mm, (12) diameter 100 mm × thickness 10 mm,
(13) Diameter 100 mm x thickness 20 mm, (14) Diameter 100 mm x thickness 30 mm,
(15) Diameter 100mm x thickness 50mm

Among the inter-organ spacers, (A) rectangular parallelepiped (1), (2), (6), (7), (B) cubic (1), (C) disk The shapes (1), (2), (6), and (7) can be inserted into the cylindrical storage portion by being pushed from one end of the cylindrical storage portion having an inner diameter of 11 mm while being deformed by hand. did it. As for highly liquid-releasing polyurethane, (A) rectangular parallelepiped (1), (2), (3), (C) disk-shaped (1), (2), (3) are deformed by hand. In this state, it was confirmed that the tube was inserted into the cylindrical storage portion by pushing from one end of the cylindrical storage portion having an inner diameter of 11 mm.
Also, (A) rectangular parallelepiped (3), (4), (11), (12), (B) cubic (2), (C) disk-shaped (3), (4), (11 ) And (12) could be inserted into a cylindrical storage portion having an inner diameter of 15 mm in the same manner.

The inter-organ spacer of the present invention can be applied to various uses (non-scopic surgery or microscopic surgery).
As mentioned above, although this invention was demonstrated along the specific aspect, the deformation | transformation and improvement obvious to those skilled in the art are included in the scope of the present invention.

DESCRIPTION OF SYMBOLS 10 ... Organ spacer; 1 ... Sponge body; 2 ... Grasping string; 3 ... Through-hole; 20 ... Introducer type insertion tool; 21 ... Cylindrical storage part;・ ・ ・ Extruding means; 30 ・ ・ ・ Extractor type insertion tool; 31 ・ ・ ・ Cylinder storage part; 32 ・ ・ ・ Retraction means; 40 ・ ・ ・ Extractor type insertion tool; 41 ・ ・ ・ Cylinder storage part 42 ... funnel part.

Claims (6)

  An inter-organ spacer for surgery characterized by including a liquid retention means made of a porous soft material having temporary liquid storage properties and shape retention properties.   The interorgan spacer according to claim 1, wherein the porous soft material is a flexible polyurethane foam.   The inter-organ spacer according to claim 1 or 2, which is for non-scopic surgery.   The inter-organ spacer according to claim 1 or 2, which is for endoscopic surgery.   An insertion tool for inserting the inter-organ spacer into the body, comprising a cylindrical storage portion capable of storing the inter-organ spacer for surgical operation according to claim 4.   A kit for endoscopic surgery, comprising the inter-organ spacer for endoscopic surgery according to claim 4 and the insertion tool according to claim 5.

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