JP2015027576A - Cuff member and cuff member unit - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a cuff member and a cuff member unit capable of making a puncture angle small.SOLUTION: In cuff members 1 and 1A comprising sponge-like synthetic resin, and provided with a puncturing tube insertion hole 2 into which a living body puncturing tube is inserted, the puncturing tube insertion hole 2 is pierced from a rear face 1R or a lateral face 1S of the cuff member overlapped on a living body surface to a front face 1F of the cuff member. The front face 1F is provided with a low place 1b and a high place 1a having a different height from the rear face 1R, and a step surface 1c between the low place and the high place. The puncturing tube insertion hole 2 extends from the step surface 1c to the rear face 1R or the lateral face 1S in a direction inclined or parallel to the rear face 1R. The high place 1a comprises a curve surface protrudingly curved.

Description

  The present invention relates to a cuff member that is disposed on the outer surface of a living body and into which a living body insertion tube is inserted, and more particularly, the cuff member configured to be drawn obliquely or almost parallel to the body surface of the living body. About. The present invention also relates to a cuff member unit in which a pad is provided on the cuff member.

  As a cuff member having a hole through which a living body insertion tube (hereinafter simply referred to as an insertion tube) is inserted, a cuff member made of a sponge-like synthetic resin and having a pad disposed on the front surface side (outer surface side) is used. JP-A-2007-98116 and JP-A-2008-295480. FIG. 3 of Japanese Patent Application Laid-Open No. 2007-98116 describes a cuff member having a flange portion and a cylindrical portion obliquely intersecting the flange portion.

  FIG. 6 shows the cuff member shown in FIG. 3 of JP-A-2007-98116. The cuff member 12 includes a flange portion 13 and a cylindrical portion 14 erected from one surface of the flange portion 13. In the center of the flange portion 13, a circular opening having a diameter of about 5 to 100 mm is provided coaxially with the cylindrical portion 14. Between the inner peripheral edge and the outer peripheral edge of the flange portion 13, a protruding line 13 t is provided so as to go around. The pad 15 is overlapped with the inner region of the ridge 13t so as to be fitted and bonded with an adhesive. An opening is also provided in the center of the pad 15.

  A tube (piercing tube) 16 is inserted through the tubular portion 14. The pad 15 and the tube 16 are bonded with an adhesive 17. The flange portion 3 is superimposed on the outer surface of the living body, and the tube 16 is inserted into the living tissue.

JP2007-98116 JP 2008-295480 A

  There are central parenteral nutrition, peritoneal dialysis, auxiliary artificial heart, etc. as the therapy for indwelling a living body insertion tube for a long period of time, and the technology has been steadily progressing. Although it has not been a major problem with the indwelling of flexible small-bore catheters such as peritoneal dialysis, it has been introduced into the ultra-small implantable artificial heart using a centrifugal pump or an axial flow pump that has been put into practical use in recent years. Tubes have changed to hard cables (drive lines), and new challenges have emerged. Although a conventional flexible biopsy tube can be flexed to some extent from the part that goes out of the living body, a hard driveline (though a thick artificial blood vessel needs to be strong even for a conventional artificial heart). As a result, it became hard, so there was a similar problem) that it was difficult to bend. For this reason, the living body insertion tube is not perpendicular to the living body surface, but obliquely, in particular, so that the insertion angle (intersection angle between the inserting tube and the living body surface) is as small as possible, more preferably substantially parallel to the living body surface. It is becoming preferable that it is indwelled.

  An object of this invention is to provide the cuff member and cuff member unit which can make a piercing angle small.

  The cuff member of the present invention (Claim 1) is made of a sponge-like synthetic resin, and is provided with a insertion tube insertion hole through which a biological insertion tube is inserted. The cuff member that overlaps with the surface penetrates from the rear surface or side surface to the front surface of the cuff member, and the front surface of the cuff member has a height difference between the lower surface and the height and a step surface between the low and high regions. The insertion tube insertion hole extends from the step surface to the rear surface or side surface in an oblique or parallel direction to the rear surface, and the height is a curved surface that is convexly curved. It is characterized by comprising.

  The cuff member according to claim 2 is characterized in that, in claim 1, the front insertion tube insertion hole is open across the rear surface and the side surface on the rear surface side of the cuff member. It is.

  A cuff member according to a third aspect is characterized in that, in the first or second aspect, an intersection angle between a hole axial center line of the insertion tube insertion hole and a rear surface of the cuff member is 45 ° or less. .

The cuff member according to claim 4 is the cuff member according to any one of claims 1 to 3, wherein the sponge-like synthetic resin has an average pore diameter of 100 to 650 μm and an apparent density of 0.01 to 0.1 g / in dry state. It has a porous three-dimensional network structure of cm ³ .

  In the cuff member unit of the present invention (Claim 5), a synthetic resin pad is superimposed on the front surface of the cuff member according to any one of Claims 1 to 4, and an opening for inserting the insertion tube is provided in the pad. It is what has been.

  In the cuff member of the present invention, the insertion tube insertion hole extends from the front surface of the cuff member to the rear surface or side surface of the cuff member that overlaps the surface of the living body.

  When a pad is attached to the front surface of the cuff member, a cuff member unit having the insertion tube inserted through the insertion tube insertion hole is attached to the surface of the living body, and the insertion tube is embedded in the living body, When the insertion angle is lowered, the portion of the cuff member that is pressed by the insertion tube is deformed flexibly, so that the insertion angle can be reduced while suppressing stimulation caused by pressure on the living body. The epidermis of the portion where the insertion tube is inserted rises due to the volume of the insertion tube in the living body, but in the present invention, the height of the pad that overlaps the height of the cuff member is also curved convexly. The living body epidermis and the pad of the left part become a continuous surface, and the skin can be maintained in a natural state.

It is a block diagram of the cuff member concerning an embodiment. It is a top view of a pad. It is sectional drawing of a cuff member unit. It is sectional drawing which shows the usage example of a cuff member unit. It is sectional drawing of the cuff member unit which concerns on another embodiment. It is sectional drawing of the conventional cuff member unit. It is a chart which shows the IR spectrum of the sample obtained by the Example and the comparative example. It is a chart which shows the light absorbency of the sample obtained by the Example and the comparative example. It is a chart which shows the GPC spectrum of the sample obtained by the Example and the comparative example.

  The first embodiment will be described below with reference to FIGS. 1A is a front view of a cuff member, FIG. 1B is a side view, FIG. 1C is a plan view, and FIG. 1D is a cross-sectional view taken along line DD in FIG. FIG. 2 is a plan view of the pad, and FIG. 3 is a longitudinal sectional view of the cuff member unit. FIG. 4 is a cross-sectional view showing a state in which the cuff member unit is mounted on the living body surface.

  This cuff member 1 is made of a porous synthetic resin having a substantially circular or substantially elliptical shape in plan view, and the lower surface side of FIGS. (B) and (c) is the rear surface 1R, and is superimposed on the surface of the living body. Further, the upper surface side of FIGS. (B) and (d) is the front surface 1F.

  The front surface 1F is provided with a high place 1a having a relatively high height, a low place 1b having a relatively low height, and a step surface 1c between the two. The high portion 1a is a convexly curved surface, and the low portion 1b is a concavely curved surface. The heights “high” and “low” represent a state in which the low portion 1b side of the rear surface 1R of the cuff member 1 is superimposed on a horizontal plane.

  A penetration tube insertion hole 2 is provided to penetrate from the rear surface 1R to the step surface 1c. The low part 1b has a substantially arc-shaped cross section in a direction perpendicular to the axial center line of the insertion tube insertion hole 2.

  The pad 3 that is in close contact with and overlaps the cuff member 1 is made of a thin sheet-like synthetic resin that follows the front surface 1F of the cuff member 1, as shown in FIGS. The pad 3 includes a height 3a that is convexly curved with the same radius of curvature as the height 1a, a height 3b that is in close contact with the height 1b, and a step that is in close contact with the step surface 1c. It has the surface 3c and the opening 4 provided in this level | step difference surface 3c. The opening 4 has the same diameter as the insertion tube insertion hole 2 and is provided so as to be coaxial with the insertion tube insertion hole 2.

  The pad 3 is superimposed on the front surface 1F of the cuff member 1 and bonded to form the cuff member unit 5. Adhesive may be used to bond the pad 3 and the front surface 1F, but when the pad 3 and the cuff member 1 are made of polyurethane resin, a solvent such as DMF, NMP, or THF, or these It can also be carried out with a 5 to 20% by weight polyurethane solution of the above solvent. The pad 3 is the same size as the cuff member 1 or is slightly smaller than the cuff member 1. When the pad 3 is stacked on the front surface 1F of the cuff member 1, the entire periphery of the cuff member 1 is A predetermined length (preferably 0 to 50 mm, particularly 1 to 10 mm) extends outward from the entire periphery of the pad 3.

This pad 3 is preferably made of polyvinyl chloride resin, polyurethane resin, polyamide resin, polylactic acid resin, polyolefin resin, polyester resin, fluorine resin, urea resin, phenol resin, epoxy resin, polyimide resin, silicon resin, acrylic resin, It consists of a polymer material such as one or more selected from the group consisting of methacrylic resin, chitin, chitosan, keratin, hyaluronic acid, fibroin and derivatives thereof. This material preferably has a softness of about 50 to 150 (JIS Shore A hardness). The thickness of the pad 3 is preferably about 0.1 to 10 mm, particularly about 0.5 to 2.0 mm. By making the pad 3 soft and thin and imparting flexibility, the interface between the cutaneous incision cross section and the cuff member outer periphery, which is considered to be impossible to achieve complete medical (pathology, histology) adhesion. Therefore, stable adhesion can be expected because the swinging stress of the insertion tube is not transmitted.
In addition, when the pad 3 is transparent, it is possible to visually recognize the state of the structured cuff member 1 (usually the color of the subcutaneous tissue), which is a useful function for diagnostic purposes by medical personnel, It may be lacking in aesthetics for the patient. In that case, it is possible to improve the aesthetics by preventing pigmentation and coloring by mixing pigments, and imitating the color of the patient's skin. In this case, it is possible to make the pad inconspicuous by performing flocking.

  A tube 6 such as an insertion tube or a drive line (a cable bundled with a motor harness, a sensor lead wire, a motor speed control harness, etc.) is inserted into the opening 4 and the insertion tube insertion hole 2 of the cuff member unit 5. The

  The tube 6 is adhered to the pad 4 in a watertight manner by high-frequency fusion, thermal fusion, laser fusion, ultrasonic fusion, adhesive, or the like.

  The procedure for inserting the tube 6 into the living body using the cuff member unit 5 will be described with reference to FIG. First, the skin is incised to expose the living tissue, and the subcutaneous tissue and the skin are peeled off with a punch or the like to create a pocket enough for the cuff member 1 to enter. Next, the tube 6 is inserted from the pocket so that the skin and the subcutaneous tissue are interspersed, and the tube 6 is inserted into the living tissue at an arbitrary site. The cuff member 1 for guiding the tube 6 is installed so as to be embedded in the pocket and overlapped with the outer surface of the living tissue. The distance at which the tube 6 is twisted, that is, the distance from the pocket to the site where the living tissue is inserted, is left to the operator's judgment. By increasing this distance, bacteria existing in the vicinity of the pocket Intrusion into the living body from the insertion site can be prevented, and since the adhesion area between the tube 6 and the subcutaneous tissue is increased, the tube can be prevented from being pulled out.

  The biological tissue incision around the tube 6 is sutured as necessary. The edge of the skin around the exposed surface of the biological tissue is superimposed on the peripheral edge of the cuff member 1. The peripheral edge of the cuff member 1 and the skin are stitched, or the peripheral edge of the pad 3 and the skin are stitched. When the pad 3 is sutured to the skin, if several holes are drilled in the vicinity of the outer edge of the pad 3, it is not necessary to penetrate the pad 3 with a suture needle, and the stitching can be performed easily. Furthermore, a wound dressing material and an adhesive tape (not shown) having air permeability and water shielding properties are attached so as to straddle the outer edge of the pad 3 and the surrounding skin. It is also possible to prevent intrusion.

  When the tube 6 is inserted using the cuff member unit 5, the lower portion 1 b of the cuff member 1 on the right side of the tube 6 in FIG. 3 is compressed from above by the tube 6. The left height portion 1a is compressed by the tube 6 from below. Between the insertion site and the cuff member 1, the skin rises due to the volume of the tube 6.

In this cuff member unit 5, the distance L ₁ of the high-order part 3 a from the opening edge of the pad 3 to the edge on the distal side in the living body insertion direction, and the length of the insertion tube insertion hole 4 (of the hole 4 relationship with the inner most of the front side or third view of the ceiling-side length of the circumferential surface) _{L 2} is, for example, _{L 2} 100 to 500 percent of _{L 1,} it is preferred in particular 100 to 300%. When the relationship between L ₁ and L ₂ is within the range, present only substantially flexible cuff member 1 between the tube 6 and the pad higher portion 3a when defeating tube 6 to a living body surface However, there is substantially no living tissue between the pad and the tube 6. Since the flexible cuff member 1 is easily compressed, the stimulation caused by the pressure applied to the surface of the living body becomes small.

  As described in the problem to be solved by the invention, it is preferable to place the tube 6 in a state that is almost parallel to the surface of the living body when it goes out of the living body, but it is impossible to bend the tube suddenly. Deformation (loss of function to send liquid due to kinks) and damage to cables and materials inserted inside the drive line are major problems. In order to gradually change the angle, in a state where no external force is applied to the cuff member 1, the rear surface of the cuff member 1 (in this embodiment, a line segment connecting the front end 1f and the rear end 1e in the tube extending direction) The crossing angle of the insertion tube insertion hole 2 with the axial direction is preferably 45 ° or less, for example, 0 to 45 °, particularly preferably about 0 to 30 °. Thus, by inclining the insertion tube insertion hole 2 deeply, the tube 6 can be attached to a living body so that the insertion angle becomes small, for example, the insertion angle is 30 ° or less.

  Generally, on the upstream side of the insertion site, the insertion tube is generally fixed using a dressing material or tape so that a certain length from the insertion site contacts or is close to the skin. . The reason for this is to reduce the direct movement of the catheter's swivel load, removal direction load, and push-in direction load to the insertion site (preventing infection at the exit and puncture of the insertion site), and when wearing clothes To avoid getting in the way and to make the fact that the tube is stuck inconspicuous. According to the cuff member unit 5, the insertion angle of the tube 6 can be made extremely small, so that it is easy to fix the insertion tube in contact with or close to the skin as described above.

  As described above, the skin between the insertion site and the cuff member rises by about 6 to 30 mm depending on the volume of the insertion tube, but the surface (skin) of this skin is a surface that is smoothly continuous with the pad 3. In this way, after the cuff member is placed, the skin surface and the pad surface raised by the volume of the insertion tube are continuous, so there is no skin pulling or deformation and the skin is maintained in a natural state. it can. In addition, the skin does not deform excessively (small wrinkles, two-stage belly-like wrinkles, twists, etc.), so it is excellent in aesthetics and does not impose an excessive load on the skin, so the cuff member and living tissue adhere well. Transition to

  The thickness of the cuff member 1 is preferably about 10 to 100%, particularly about 10 to 50% of the diameter of the insertion tube insertion hole 2 at the intersection 1g between the step surface 1c and the low portion 1b. The thickness of the cuff member 1 at the portion 1h where the ceiling surface of the insertion tube insertion hole 2 and the rear surface of the cuff member 1 intersect is preferably about 10 to 100%, particularly about 10 to 50% of the diameter of the insertion tube insertion hole 2. It is.

  In the above embodiment, the rear surface 1R of the cuff member 1 is a curved surface that is convexly curved as shown in the figure. However, like the cuff member 1A of the cuff member unit 5A in FIG. ) May be flat. In this case, it is preferable that the insertion tube insertion hole 2 is opened on the side surface 1S of the cuff member 1A. Although not shown, the insertion tube insertion hole 2 may be opened across the rear surface 1R and the side surface 1S on the rear surface side of the cuff member.

[Porous material constituting the cuff member 1, 1A]
As the porous material constituting the cuff members 1 and 1A, a porous synthetic resin having continuous pores is suitable.

The porous material constituting the cuff member 1 or 1A is preferably made of a thermoplastic resin or a thermosetting resin, and has an average pore diameter of about 50 to 1,000 μm, particularly about 100 to 650 μm, in a dry state. It has a porous three-dimensional network structure with an apparent density of 0.01 to 0.5 g / cm ^3, particularly 0.01 to 0.1 g / cm ³ .

  The average pore diameter and the apparent density are measured as follows.

[Measurement of average pore size]
Using a photograph of the plane (cut surface) of the sample cut with a double-blade razor taken with an electron microscope (SM200, manufactured by Topcon), each hole on the same plane is surrounded by a three-dimensional network structure. The image is processed (using an Nileco LUZEX AP as the image processing apparatus, and an image capturing CCD camera using Sony Corporation's LE N50), and the area of each figure is measured. This is defined as a perfect circle area, and the diameter of the corresponding circle is determined as the hole diameter. However, the fine holes drilled in the skeleton portion of the porous body due to the effect of phase separation during the formation of the porous body are ignored, and only the communication holes on the same plane are measured.

[Measurement of apparent density]
A value obtained by cutting a porous structure into a rectangular parallelepiped of about 10 mm × 10 mm × 3 mm with a double-blade razor and obtaining a volume from the dimensions obtained by measurement with a projector (Nikon, V-12), and dividing the weight by the volume. The apparent density is obtained from

  Examples of the thermoplastic resin or thermosetting resin constituting such a porous three-dimensional network structure include polyurethane resin, polyamide resin, polylactic acid resin, polyolefin resin, polyester resin, fluorine resin, urea resin, phenol resin, epoxy resin. Resins, polyimide resins, acrylic resins and methacrylic resins and derivatives thereof are exemplified. These may be used alone or in combination of two or more. Of these, polyurethane resins are particularly preferred, and segmented polyurethane resins are particularly preferred.

The segmented polyurethane resin is synthesized from three components of a polyol, a diisocyanate and a chain extender, and has an elastomeric property due to a block polymer structure having a so-called hard segment portion and soft segment portion in the molecule. Therefore, the elastic properties obtained when this segmented polyurethane resin is used are that the subcutaneous tissue and cuff member when the patient, catheter or cannula move, or when the skin around the puncture site moves during disinfection work, etc. The effect of attenuating the stress generated at the interface with can be expected.
The segmented polyurethane resins described above are polyether-based, polyester-based, polyether-polyester-based, polycarbonate-based (also referred to as “polycarbonate-based”), depending on the soft segment structure and the structure of the soft segment / hard segment joint. In the present invention, it is preferable to use a polycarbonate-based polyurethane resin. The reason for this is that polyurethane resin is generally a material that is susceptible to hydrolysis, and when implanted in a living body, it is naturally hydrolyzed by the action of body fluid (water) and body temperature, decomposed by the action of enzymes, and released from immune cells. While it is known that the skin cuff member of the present invention is easily decomposed and weakened by the action of active oxygen or the like, the skin cuff member of the present invention is stably present in the living body for a long time (in the case of permanent use, the life of the patient). It is preferable to use a polycarbonate-based polyurethane resin for the purpose of the function). This polycarbonate-based polyurethane resin is a resin that has the property of protecting nearby urethane bonds from decomposition by the strong crystal cohesive strength of the polycarbonate segment, and is extremely superior in hydrolysis resistance compared to other polyurethane resins. is there.

  Below, an example of the manufacturing method of the porous three-dimensional network structure which consists of a thermoplastic polyurethane resin which comprises a cuff member is demonstrated.

  In order to produce a porous three-dimensional network structure made of a thermoplastic polyurethane resin, first, a polyurethane resin, a water-soluble polymer compound described later as a pore-forming agent, and an organic solvent that is a good solvent for the polyurethane resin are used. Mix to produce polymer dope. Specifically, after a polyurethane resin is mixed with an organic solvent to form a uniform solution, a water-soluble polymer compound is mixed and dispersed in this solution. Examples of the organic solvent include N, N-dimethylformamide, N-methyl-2-pyrrolidinone, and tetrahydrofuran, but are not limited thereto as long as the thermoplastic polyurethane resin can be dissolved. It is also possible to melt the polyurethane resin by the action of heat without reducing the amount of the organic solvent or using it, and to mix the pore forming agent therewith.

  Examples of the water-soluble polymer compound as the pore-forming agent include polyethylene glycol, polypropylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, alginic acid, carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, and ethyl cellulose, but are homogeneously dispersed with the thermoplastic resin. If it forms a polymer dope, this does not apply. Depending on the type of thermoplastic resin, it is also possible to use not only water-soluble polymer compounds but also lipophilic compounds such as phthalates and paraffins and inorganic salts such as lithium chloride and calcium carbonate. It is also possible to promote the generation of secondary particles during solidification, that is, the formation of a skeleton of the porous body, using a crystal nucleating agent for a polymer.

  Next, a polymer dope produced from a thermoplastic polyurethane resin, an organic solvent and a water-soluble polymer compound is immersed in a coagulation bath containing a poor solvent for the thermoplastic polyurethane resin, and the organic solvent and the coagulation bath are immersed in the coagulation bath. The water-soluble polymer compound is extracted and removed. In this way, a porous three-dimensional network material made of polyurethane resin can be obtained by removing part or all of the organic solvent and the water-soluble polymer compound. Examples of the poor solvent used here include water, lower alcohols, and low-carbon ketones. After the polyurethane resin is solidified, the porous three-dimensional network material is washed with water or the like to remove the organic solvent and pore-forming agent remaining in the porous three-dimensional network material.

In the porous three-dimensional network material, it is preferable that fine pores are also formed in the skeletal base material itself constituting the network structure. In particular, the porous three-dimensional network material has an average pore diameter of 100 to 650 μm and forms a continuous three-dimensional network structure with an apparent density in a dry state of 0.10 g / cm ³ or less. In addition, the skeleton base material itself constituting the network structure is a porous body having a porosity of 70% or more, and the surface layer of the skeleton base material is a dense layer interspersed with fine pores. Is preferred. This micropore makes the surface of the skeletal base material not a smooth surface but a complex uneven surface, so it is also effective in retaining collagen, cell growth factors, etc., and as a result increases cell engraftment Is possible. However, the fine pores of the skeleton substrate itself are not included in the concept of calculating the average pore diameter of the porous three-dimensional network structure referred to in the present invention.

  As described above, the skeleton base material itself that forms the network structure of the porous three-dimensional network material is porous with a high porosity, and the surface layer of the skeleton base material is a dense layer interspersed with fine pores. In addition, the following effects are exhibited by the fact that the pores inside the skeleton base material communicate with the outside through the fine pores in the surface layer. That is, since the skeleton base material of the porous three-dimensional network material is porous, the skeleton base material is infiltrated with an extracellular matrix such as collagen, albumin, oxygen, waste products, water, electrolyte, etc. These diffusions and exchanges are performed between the base material and the living tissue. Thereby, oxygen and nutrients can be replenished to the whole porous three-dimensional network material through this skeleton base material. Note that infiltration of cells into the skeletal base material is blocked by the dense layer on the surface of the skeletal base material, so that no cell component is present inside the skeletal base material. As a result, the inside of the skeleton base material is prevented from being clogged, and a capillary-like function for supplying oxygen and nutrients to the entire porous three-dimensional network material through the skeleton base material is maintained. As a result, functions useful as a bio-implanting material such as good tissue infiltration, engraftment, maturation and angiogenesis are expressed.

In order to obtain the porosity of the skeleton base material of the porous three-dimensional network material made of polyurethane, first, the average pore diameter is measured as described above. That is, the cut surface of the porous three-dimensional network material is photographed, and in the photograph, the resin portion is white and the void (air portion) is black, and the area of the white portion and the area of the black portion are calculated by image processing. . A calculated apparent density is obtained from the total area of the visual field of measurement obtained by the image processing, the total area of the gap portion, and the specific gravity of the polyurethane resin according to JIS K7311. This apparent density is generally about 10 times or more larger than the actually measured value. This error is caused by assuming that the skeleton portion of the porous three-dimensional network material is a solid structure made of polyurethane resin. Therefore, the skeleton group of the porous three-dimensional network material is calculated by substituting the calculated apparent density A and the actually measured apparent density B into the calculation formula (AB) / A × 100 (%). It becomes possible to obtain the porosity of the material itself. When the calculated apparent density is 0.91 g / cm ³ and the actually measured apparent density is 0.077 g / cm ³ , the skeleton substrate of the porous three-dimensional network material has a porosity of 91.5%. Calculated to be porous.

  In this porous 3D network material made of polyurethane, there are micropores on the surface of the skeletal base material, but this is not the size that cells can infiltrate, but it only forms irregularities that help cell engraftment It is the thing to do. That is, as described above, the surface of the skeletal base becomes a complex uneven surface due to the micropores, so that the cell engraftment is high. However, although these micropores are not sized to allow cells to infiltrate, nutrients, oxygen, water, etc. are sized to infiltrate. Oxygen, water, etc. are diffused and exchanged. That is, oxygen and nutrients can be replenished to the entire porous three-dimensional network material through this skeleton substrate.

  Each of the above embodiments shows an example of the present invention, and the present invention is not limited to the above configuration.

EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention is not limited to the following examples unless it exceeds the gist.
[Example 1]
<Production of film>
The polycarbonate-based polyurethane resin produced according to the above-described method was embedded in the goat subcutaneously. Six months after the implantation, the tissue adhered to the resin was peeled off and the resin was extracted. After cutting out the extracted resin to a size of about 10 mm square, many slits are formed with a double-edged razor and washed with physiological saline for 72 hours to remove water-derived water-soluble components such as blood and plasma proteins. did. Subsequently, this resin was treated with a Soxhelt extraction apparatus for 72 hours using 2-propanol as an extraction solvent, thereby removing lipids and foreign matters adhering to the resin. The 2-propanol that penetrated into the pores of the resin by this treatment was replaced with methanol. Furthermore, this resin was treated with a Soxhelt extraction apparatus for 72 hours using a methanol fresh solution as an extraction solvent, thereby removing the electrolyte component adhering to the resin. The resin was dried and then immersed in THF. Magnesium sulfate was added to the THF solution and the mixture was stirred for 48 hours to dissolve the polycarbonate-based polyurethane resin component. The THF solution and the fiber were removed by filtering the THF solution, the filtrate was concentrated with an evaporator, and this concentrated solution was dropped into diethyl ether to reprecipitate the polycarbonate-based polyurethane resin. This reprecipitation with diethyl ether was purified by repeating a plurality of times, and it was again dissolved in THF, cast on a glass plate, and dried to obtain a transparent film made of polycarbonate polyurethane.

[Example 2]
A transparent film made of polycarbonate-based polyurethane was obtained in the same manner as in Example 1 except that the period of subcutaneous implantation of the goat was 27 months.

[Comparative Example 1]
As a comparative example, a resin made at the same time as the polycarbonate-based polyurethane resin used in Example 1 and stored at room temperature without being buried under the skin of goats was made by polyurethane by performing the same operation as above. A film was obtained.

  The purity of the films of Examples 1 and 2 and Comparative Example 1 was confirmed by analysis by infrared spectroscopy. The obtained IR spectrum is shown in FIG. All the films showed the same peak in the entire wave number region. Moreover, since no irregular peak was confirmed, it is presumed that cytoplasm, blood, protein, lipid and the like infiltrated into each resin were removed.

<Film analysis>
(1) Measurement of absorbance When a polyurethane resin is decomposed in vivo, a primary amine derived from a urethane bond is generated. In this analysis, the degree of decomposition of the polyurethane resins of Examples 1 and 2 and Comparative Example 1 was evaluated by measuring the absorption of the amine. That is, the absorption of N-H scissor (1615 cm ^-1), normalized by the absorption of the C-C stretch benzene nucleus present in the MDI and polycarbonate segment of the urethane resin ^{(1530cm -1) (N-H} / C- C ratio) and evaluated. The results are shown in FIG. As is clear from FIG. 2, no significant change was observed in the films of Examples 1 and 2 and Comparative Example 1.

  In the polyether polyurethane resin widely used in lead wires for cardiac pacemakers, the NH / CC ratio is about 6 months after transplantation in vivo, and the NH / CC ratio before transplantation is It has been reported that it is about four times as large as the above. This is considered to be because primary amines are produced by hydrolysis of urethane bonds, decomposition by enzymes and active oxygen.

  Since the resins of Examples 1 and 2 are porous resins as compared with the resin having no holes used for the above-mentioned lead for cardiac pacemaker, the surface area is large and easily affected by body fluids. It was a case where it was embedded in the living body for a month, and there was almost no change in the NH / CC ratio.

  Polyether polyurethane resins used for lead wires for cardiac pacemakers are originally developed and utilized as industrial elastomer resins, not biodegradable resins. From the measurement of the absorbance, it was found that the polycarbonate polyurethane resin is more stable in the living body than the polyether polyurethane resin. That is, the cuff member using the polycarbonate-based polyurethane resin is different from the cuff member made of polyurethane resin for the purpose of biodegradation function.

(2) Measurement by GPC The films prepared in Examples 1 and 2 and Comparative Example 1 were dissolved in a 30 mM lithium bromide DMF solution, and the number average molecular weight in terms of polyethylene glycol was determined by GPC (gel permeation chromatography). It was measured. The results are shown in FIG. In Experimental Examples 1 and 2, tailing was slightly strong on the low molecular weight side and the degree of dispersion increased, but the average molecular weight did not change significantly.

1,1A Cuff member 1a High place 1b Low place 1c Stepped surface 1F Front face 1R Rear face 1S Side face 2 Insertion tube insertion hole 3 Pad 4 Opening 5 Cuff member unit 6 Insertion tube (tube)

The cuff member of the present invention (Claim 1) is made of a sponge-like synthetic resin, and is provided with a insertion tube insertion hole through which a biological insertion tube is inserted. It penetrates from the side surface of the cuff member which overlaps with the surface to front surface of the cuff member, the front surface, the step surface between the different heights lower locations and altitude and low plant and heights from the rear surface provided, the puncturing pipe insertion hole, a stepped surface to the side surface extends in a rear surface and oblique交方direction, that the high plant consisting of a curved surface which is curved convexly It is a feature.

The cuff member of claim 2 is characterized in that, in claim 1, the rear surface is a flat surface .

In the cuff member of the present invention, thorn pipe insertion hole disposed through until the cuff member side surface overlying the surface of a living body from the front cuff member.

It is a block diagram of the cuff member concerning a reference example . It is a top view of a pad. It is sectional drawing of a cuff member unit. It is sectional drawing which shows the usage example of a cuff member unit. It is a cross-sectional view of a cuff member unit according to the embodiment of the implementation. It is sectional drawing of the conventional cuff member unit. It is a chart which shows the IR spectrum of the sample obtained by the Example and the comparative example. It is a chart which shows the light absorbency of the sample obtained by the Example and the comparative example. It is a chart which shows the GPC spectrum of the sample obtained by the Example and the comparative example.

A reference example will be described below with reference to FIGS. 1A is a front view of a cuff member, FIG. 1B is a side view, FIG. 1C is a plan view, and FIG. 1D is a cross-sectional view taken along line DD in FIG. FIG. 2 is a plan view of the pad, and FIG. 3 is a longitudinal sectional view of the cuff member unit. FIG. 4 is a cross-sectional view showing a state in which the cuff member unit is mounted on the living body surface.

In the reference example , the rear surface 1R of the cuff member 1 is a curved surface that is convexly curved as shown in the figure. However, like the cuff member 1A of the cuff member unit 5A in FIG. 5, the rear surface (bottom surface) of the cuff member 1A. May be flat. In this case, it is preferable that the insertion tube insertion hole 2 is opened on the side surface 1S of the cuff member 1A .

Claims (5)

Made of sponge-like synthetic resin,
In the cuff member provided with the insertion tube insertion hole through which the biological insertion tube is inserted,
The insertion tube insertion hole penetrates from the rear surface or side surface of the cuff member that overlaps the biological surface to the front surface of the cuff member,
On the front surface, there are provided a low surface and a high region with different heights from the rear surface and a step surface between the low region and the high region,
The insertion tube insertion hole extends from the step surface to the rear surface or side surface in an oblique direction or a parallel direction with the rear surface,
The cuff member is characterized in that the height is a curved surface that is convexly curved.   2. The cuff member according to claim 1, wherein the front insertion tube insertion hole is opened across the rear surface and the side surface on the rear surface side of the cuff member.   The cuff member according to claim 1 or 2, wherein an intersection angle between a hole axial center line of the insertion tube insertion hole and a rear surface of the cuff member is 45 ° or less. The porous three-dimensional resin according to any one of claims 1 to 3, wherein the sponge-like synthetic resin has an average pore diameter of 100 to 650 µm and an apparent density in a dry state of 0.01 to 0.1 g / cm ^3. A cuff member having a net-like structure.   A cuff member unit in which a synthetic resin pad is superimposed on the front surface of the cuff member according to any one of claims 1 to 4, and an opening for inserting a insertion tube is provided in the pad.

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