Medical elastic sheet and medical instrument using same
By designing a medical elastic tablet with a plate-shaped base and continuous edge, the problem of the medical elastic tablet in the prior art expanding the damage when the sharp medical device is contacted, and effective damage suppression and physical protection are achieved.
Patent Information
- Application Number
- CN202411369242.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-10-05
- Filing Date
- 2024-09-29
- Publication Date
- 2025-04-08
AI Technical Summary
Existing medical elastic tablets are prone to damage when in contact with the front end of the sharp medical device and expand the range of damage, resulting in difficult cutting and cutting, and may cause the elastic tablet to break and separate into the body cavity.
An elastic sheet for medical use is designed, which has a plate-shaped base and a ridge. The edges are continuously formed in the base surface and surround a plurality of unit areas. The entire circumference of the unit area is surrounded by the edges, and the edges are continuously connected to each other. When the elastic sheet contacts the sharp front end of the medical device, the edges can suppress the expansion of damage.
Effectively maintain protection to the body, even when the sharp front end of the medical device is in contact, the damage to the elastic sheet can inhibit the expansion of the damage and reduce the risk of fracture and separation into the body cavity.
Smart Images
Figure CN119770093A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a medical elastic sheet and a medical device using the medical elastic sheet. Background Art
[0002] In endoscopic surgery, medical devices such as retractors, dilators, and compressors are used to maintain incisions, maintain dilated natural openings, and repress organs (see, for example, Patent Documents 1, 2, and 3).
[0003] The wound edge protection device described in Patent Document 1 comprises: two coaxially opposed rings, and a tubular member (elastic sheet) made of silicone rubber fixed to the two rings in an expanded state near both ends. The compression and exclusion device described in Patent Document 2 comprises: a ring-shaped frame, and a planar sheet (elastic sheet) made of silicone rubber fixed to the frame at the circumferential end.
[0004] The tissue retractor described in Patent Document 3 comprises: an outer ring, an inner ring, and a flexible sheath (elastic sheet) made of a wear-resistant and / or puncture-resistant material fixed to the outer ring and the inner ring in a state of expansion near both ends. The flexible sheath is formed of a plurality of layers including a polymer film layer (e.g., a polyurethane layer) and a fabric layer (e.g., a polyester woven fabric, a metal fiber or a metal component of a strand), and the elasticity in the longitudinal direction and the circumferential direction can be changed by the weaving method of the fibers and twisted yarns of the fabric layer.
[0005] Patent Document 1: Japanese Utility Model Registration No. 3062106
[0006] Patent Document 2: Japanese Patent No. 5221447
[0007] Patent Document 3: Japanese Patent No. 6247003
[0008] Medical instruments include surgical instruments with sharp front ends such as scissors, trocars, scalpels, and suture needles, and syringes. The tubular component of the wound edge protection device described in Patent Document 1 is formed of thin silicone rubber, so there is a possibility that the tubular component may be damaged by contact with the sharp front end of the surgical instrument. When in use, the flexible sheath is in a stretched state, so the damaged part is torn and expanded due to the tension, and there is a concern that it is difficult to maintain the incision, and a part of the tubular component breaks and separates and falls into the body cavity, causing it to remain in the body. The compression and exclusion device described in Patent Document 2 also has the same concerns as Patent Document 1.
[0009] According to the tissue retractor described in Patent Document 3, the flexible sheath has poor flexibility and elongation due to the material of the fabric layer combined with the polymer film layer, and it is difficult to make a protective wound at the incision site tissue compared to a flexible sheath composed only of a polymer film layer. Summary of the invention
[0010] An object of the present invention is to provide a medical elastic sheet which maintains protection for the body and can suppress the extension of the damage even if the elastic sheet is damaged by contact with a sharp tip of a medical instrument or the like, and a medical instrument using the medical elastic sheet.
[0011] In order to solve the above-mentioned problems, the present invention provides a medical elastic sheet, which comprises: a plate-shaped base; and an edge portion formed on at least one surface of the base portion.
[0012] In the base, a plurality of unit regions are continuously formed in a plane via the ridges, and the entire circumference of each unit region is surrounded by the ridges.
[0013] The ridges are continuously connected to each other.
[0014] In order to solve the above problems, the present invention provides a medical device comprising: an annular outer ring and an inner ring disposed coaxially and facing each other; and the medical elastic sheet having both ends fixed to the outer ring and the inner ring.
[0015] In order to solve the above-mentioned problems, the present invention provides a medical device including: an annular ring; and the medical elastic sheet, wherein a peripheral end portion is fixed to the ring.
[0016] According to the present invention, the protective property for the body can be maintained, and even if the elastic sheet is damaged due to contact with a sharp tip of a medical instrument or the like, the damage can be suppressed from spreading. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Figure 1 It is a perspective view showing an example of a schematic structure of a retractor according to the first embodiment of the present invention.
[0018] Figure 2 yes Figure 1 A longitudinal cross-sectional view of the retractor is shown.
[0019] Figure 3 The elastic sheet before the ends are fixed to the outer ring and the inner ring, wherein (a) is a front view, (b) is an enlarged view of the A portion shown in (a), and (c) is a sectional view taken along the line BB shown in (a).
[0020] Figure 4 (a) to (e) are diagrams for explaining the function of the elastic sheet to suppress damage expansion.
[0021] Figure 5 (a) is Figure 1 A top view of the retractor is shown, Figure 5 (b) is Figure 5 CC section view shown in (a).
[0022] Figure 6 yes Figure 1 A front view of the retractor is shown.
[0023] Figure 7 (a) is Figure 6 The D-D line cross-sectional view shown in the figure is Figure 7 (b) is Figure 7 EE line sectional view shown in (a).
[0024] Figure 8 It is a cross-sectional view showing an example of a usage state of the retractor according to the first embodiment.
[0025] Fig. 9A It is a diagram showing a modification 1 of the unit region.
[0026] Fig. 9B A modification example 2 of the unit region is shown, wherein (a) is a front view and (b) is a cross-sectional view taken along line FF of (a).
[0027] Fig.10 It is a perspective view showing an example of a schematic structure of a retractor according to a second embodiment of the present invention.
[0028] Fig.11 yes Fig.10 A longitudinal cross-sectional view of the retractor is shown.
[0029] Fig.12 yes Fig.10 A top view of the retractor is shown.
[0030] Fig.13 yes Fig.10 A front view of the retractor is shown.
[0031] Fig.14 It is a perspective view showing an example of a schematic structure of a retractor according to a third embodiment of the present invention.
[0032] Fig.15 (a) is Fig.14 A longitudinal section view of the retractor shown, Fig.15 (b) is a longitudinal sectional view showing an example of a usage state.
[0033] Fig.16It is a plan view showing an example of a schematic structure of a squeezer according to a fourth embodiment of the present invention.
[0034] Fig.17 yes Fig.16 A front view of the squeezer is shown.
[0035] Fig.18 yes Fig.16 The G-G line cross-sectional view is shown.
[0036] Fig.19A (a) to (e) are diagrams showing experimental examples of damage to the elastic sheet of the embodiment.
[0037] Fig.19B (f) to (h) are diagrams showing experimental examples of damage to the elastic sheet of the embodiment.
[0038] Fig. 20 (a) to (e) are diagrams showing experimental examples of damage to the elastic sheet of the comparative example.
[0039] Description of Reference Numerals
[0040] 1…retractor; 2, 2A, 2B…outer ring; 3…inner ring; 4A, 4B, 4C…elastic sheet; 4a…tube; 4b…outer flat plate; 4c…inner flat plate; 5a-5e…lesion; 10…displacer; 12…ring; 14…elastic sheet; 21…core material; 22…covering tube; 31…core material; 32…covering tube; 41…base; 41a…unit area; 42…edge; 43…end; 43a…joining part; 44…adhesive; 100…body wall; 101. ..incision; 102...body cavity; 110...surgical target site; 121...core material; 122...first covering tube; 123...second covering tube; 141...base; 141a...unit area; 142...edge; 143...peripheral end; 143a...joining part; 144...adhesive; 145...opening; d...diameter of a circle inscribed in the unit area; H...axial size of the unit area; h...height of the edge; t...thickness of the base; W...width of the edge. DETAILED DESCRIPTION
[0041] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, in each figure, components having substantially the same function are denoted by the same reference numerals, and repeated descriptions are omitted.
[0042] For medical instruments such as retractors, dilators, and compression devices, if the elastic sheet used in the retractors is partially damaged by the sharp front end of the medical instruments during treatment, there is a risk that the medical instruments will be damaged or partially broken and separated and remain in the body if they are used as they are, so the development direction of medical instruments is to improve the strength. However, the inventors of the present invention have changed the existing concept of developing medical instruments with a strength that does not break even if the medical instruments are damaged, and have considered developing medical instruments that do not expand even if they are partially broken, and have completed the present invention.
[0043] [First embodiment]
[0044] Figure 1 It is a perspective view showing an example of a schematic structure of a retractor according to the first embodiment of the present invention. Figure 2 yes Figure 1 A longitudinal cross-sectional view of the retractor is shown.
[0045] The retractor 1 according to the first embodiment includes: an annular outer ring 2 and an inner ring 3 disposed coaxially and facing each other; and both end portions 43 (see Figure 3 The retractor 1 is a cylindrical elastic piece 4A fixed to the outer ring 2 and the inner ring 3. Figure 8 As shown, the retractor 1 is attached to an incision 101 formed in a body wall 100 such as the abdominal wall of a living body (human, animal, etc.). The retractor 1 is an example of a medical instrument. The elastic sheet 4A is an example of a medical elastic sheet.
[0046] The outer ring 2 and the inner ring 3 are as described below. Figure 8 As shown in the figure, the outer ring 2 and the inner ring 3 are respectively arranged on the outer side and the inner side of the body wall 100 through the incision 101. The inner ring 3 has flexibility so that it can be inserted into the body cavity 102 from the incision 101 in a state of being flattened into an ellipse, and has the ability to recover to the original state (circular state) in the body cavity 102. The outer ring 2 has flexibility and recovery similarly to the inner ring 3. The outer ring 2 and the inner ring 3 have, for example, a circular diameter (hereinafter referred to as the outer diameter) larger than the length of the incision 101.
[0047] The elastic sheet 4A is formed of a material having the shape of the incision 101 to maintain the softness of the incision 101 in a protective manner, and having elasticity that can expand and fix the vicinity of the end 43 to the outer ring 2 and the inner ring 3. In addition, the elastic sheet 4A has a function of suppressing the expansion of the injury (damage expansion suppression function) when the sharp tip of a medical instrument or the like contacts and partially damages the elastic sheet 4A. The details of the damage expansion suppression function will be described later.
[0048] The elastic sheet 4A expands near the end 43 and covers the outer ring 2 and the inner ring 3 all around, and the end 43 of the elastic sheet 4A is overlapped to form a joint 43a, which is fixed to the outer ring 2 and the inner ring 3 by bonding or welding, thereby forming a cylinder 4a with an inner diameter of about 60 mm, an outer flat plate 4b and an inner flat plate 4c with an outer diameter of about 100 mm. Therefore, the outer flat plate 4b and the inner flat plate 4c are in a state of being given tension.
[0049] (Structure of elastic sheet)
[0050] Figure 3 The elastic piece 4A is shown before the end portion 43 is fixed to the outer ring 2 and the inner ring 3, wherein (a) is a front view, (b) is an enlarged view of the A portion shown in (a), and (c) is a BB line sectional view shown in (a).
[0051] The elastic sheet 4A includes a plate-shaped base 41 and an edge 42 formed on at least one surface of the base 41 (in this embodiment, the outer surface of the cylindrical elastic sheet 4A). Before the two end portions 43 are fixed to the outer ring 2 and the inner ring 3, as shown in FIG. Figure 3 As shown in (a) of FIG. 1 , the elastic piece 4A is formed in a cylindrical shape.
[0052] When both end portions 43 of the cylindrical elastic piece 4A are to be fixed to the outer ring 2 and the inner ring 3 , the vicinity of the end portions 43 of the elastic piece 4A is expanded so that the end portions 43 become joining portions 43 a fixed to the outer ring 2 and the inner ring 3 .
[0053] In addition, in the present embodiment, the ridge 42 is formed only on the outer surface of the cylindrical elastic sheet 4A, but it may be formed only on the inner surface, or may be formed on both the outer surface and the inner surface. In addition, in the present embodiment, the elastic sheet 4A is always exposed as a whole, so it is preferred that the unit area to be described later surrounded by the ridge 42 is formed to the end 43, but in the case where the elastic sheet is not always exposed as a whole (for example, the third embodiment), the unit area may not be formed at the end 43 or the vicinity including the end 43.
[0054] The elastic sheet 4A is formed integrally from a resin material (e.g., silicone rubber, synthetic rubber, natural rubber, polyurethane, polyethylene, etc.) having flexibility, elasticity, etc. From the viewpoint of elasticity, the tensile elongation of the material constituting the elastic sheet 4A is preferably, for example, 200% or more, and more preferably, 400% or more. In addition, from the viewpoint of flexibility, the Shore A hardness (JIS K6253) of the material constituting the elastic sheet 4A is preferably, for example, about A20 to A70.
[0055] like Figure 3As shown in (a), for the base 41, the plurality of unit regions 41a each surrounded by the ridge 42 on the entire circumference (enclosed and surrounded) are arranged in the plane, for example, in two different directions (for example, in Figure 3 In (a), the ridges 42 surrounding the unit region 41a are continuously connected to each other, for example, forming a mesh shape.
[0056] The shape of the unit region 41a is a hexagon in the case shown in the figure, but is not limited to this, and may also be a triangle, a quadrilateral, or a circle (see Fig. 9A ) etc. In addition, when emphasis is placed on elongation, the unit area 41a may be increased, and when emphasis is placed on resistance to rupture, the unit area 41a may be reduced. In addition, the shape or area of the unit area 41a may be a shape or area having different softness and elasticity in the axial and circumferential directions. For example, the outer flat plate portion 4b and the inner flat plate portion 4c are expanded to be larger than the barrel portion 4a, so the area of the unit area 41a of the outer flat plate portion 4b and the inner flat plate portion 4c may be larger than the area of the unit area 41a of the barrel portion 4a. In addition, the side of the outer flat plate portion 4b and the inner flat plate portion 4c close to the end portion 43 is expanded to be larger than the side close to the barrel portion 4a, so the area of the unit area 41a on the side close to the end portion 43 may be larger than the area of the unit area 41a on the side close to the barrel portion 4a.
[0057] The arrangement direction of the unit area 41a is not limited to the inclined direction, and may be other directions such as the axial direction and the circumferential direction. In addition, the arrangement direction of the unit area 41a may also be a direction corresponding to the shape of the unit area 41a. For example, in the case where the unit area 41a is a quadrilateral, by setting the arrangement direction of the unit area 41a to the axial direction and the circumferential direction, the area of the ridge 42 can be reduced. In the case of comparing with polygons with the same diameter of the circumscribed circle, as in the present embodiment, by setting the shape of the unit area 41a to a hexagon, the area of the unit area 41a can be made larger than other shapes (triangle, quadrilateral, etc.), and the area of the ridge 42 can be reduced. As a result, the flexibility and elasticity are excellent, and it is not easy to generate thickness when the elastic sheet is rolled up (refer to the third embodiment described later).
[0058] In this embodiment, Figure 3The axial size H of the unit area 41a shown in (b) and the diameter d of the circle inscribed in the unit area 41a are set to H=3mm and d=3mm, for example, but the following values can be adopted. That is, the axial size H of the unit area 41a (the diameter d of the inscribed circle) is preferably larger in order to maintain the flexibility of the elastic sheet 4A, for example, it is set to 1.5mm or more, and it can also be set to 2.5mm or more. In addition, the axial size H of the unit area 41a (the diameter d of the inscribed circle) is preferably smaller in order to suppress the expansion of the damage when a part of the elastic sheet 4A is damaged due to contact with the sharp tip of a medical device, etc., for example, it is set to 20mm or less, and it can also be set to 10mm or less or 7mm or less.
[0059] In this embodiment, Figure 3 The thickness t of the base 41 shown in (c) is set to t=0.4 mm, for example, but the following values can be adopted. That is, the thickness t of the base 41 is preferably small in order to maintain the softness of the elastic sheet 4A, for example, it is set to 2 mm or less, and it can also be set to 1 mm or less. In addition, the thickness t of the base 41 is preferably large in order to suppress the expansion of the above-mentioned damage, for example, it is set to 0.2 mm or more, and it can also be set to 0.3 mm or more.
[0060] In this embodiment, Figure 3 The width W of the ridge portion 42 shown in (b) is, for example, set to W=1 mm, but the following values can be adopted. That is, the width W of the ridge portion 42 is preferably small in order to maintain the flexibility of the elastic sheet 4A, for example, set to 5 mm or less, and can also be further set to 2 mm or less. In addition, the width W of the ridge portion 42 is preferably large in order to suppress the expansion of the above-mentioned damage, for example, set to 0.5 mm or more or 0.7 mm or more, and can also be further set to 1.5 mm or more.
[0061] In this embodiment, Figure 3 The height h of the ridge 42 shown in (c) is, for example, set to h=0.4 mm, but the following values can be adopted. That is, the height h of the ridge 42 is preferably small in order to maintain the flexibility of the elastic sheet 4A, for example, set to 2 mm or less, and can also be further set to 1 mm or less. In addition, the height h of the ridge 42 is preferably large in order to suppress the expansion of the above-mentioned damage, for example, set to 0.2 mm or more, and can also be further set to 0.3 mm or more. In addition, the height h of the ridge 42 can also be constant.
[0062] (Elastic sheet’s function of suppressing damage expansion)
[0063] Figure 4Figures (a) to (e) are used to illustrate the function of the elastic sheet 4A to suppress the expansion of the injury. When the retractor 1 is attached to the incision 101 formed in the body wall 100, tension is applied to the entire elastic sheet 4A. When the sharp tip of a medical instrument or the like contacts the base 41 of the elastic sheet 4A in this state, a tension is generated. Figure 4 In the case of the damaged portion 5a shown in (a), the damage may be Figure 4 The damaged part 5b shown in (b) expands further to Figure 4 The damaged portion 5c shown in (c) expands, but the crack is stopped by the ridge 42, which can suppress the expansion of the damage. Figure 4 As shown in (d), even if cracks are formed at the edge 42, Figure 4 As shown in (e), the damage portion 5e of the adjacent unit region 41a can be suppressed from expanding. That is, even when tension is applied to the elastic sheet 4A, the ridge portion 42 can prevent the damage from expanding widely and becoming unable to maintain the incision 101.
[0064] (Structure of outer and inner rings)
[0065] Figure 5 (a) is Figure 1 The top view of the retractor 1 is shown, Figure 5 (b) is Figure 5 CC section view shown in (a). Figure 6 yes Figure 1 A front view of the retractor 1 is shown. Figure 7 (a) is Figure 6 The D-D line cross-sectional view shown in the figure is Figure 7 (b) is Figure 7 EE line sectional view shown in (a).
[0066] like Figure 5 As shown in (b), the outer ring 2 includes a ring-shaped core material 21 and a covering tube 22 covering the surface of the core material 21. Figure 7 As shown in FIG. 2 ( b ), the inner ring 3 includes an annular core material 31 and a covering tube 32 covering the surface of the core material 31 .
[0067] The core materials 21 and 31 are made of a material having high flexibility and resilience, for example, a superelastic alloy such as a Ni-Ti metal. By using a superelastic alloy as the material of the core material 31, as described later, Figure 8 As shown, the inner ring 3 can be inserted into the body cavity 102 from the incision 101 in a state where the inner ring 3 is flattened into an elliptical shape, and can have the flexibility to restore to the original state (ring state) in the body cavity 102.
[0068] If the end 43 of the elastic sheet 4A is directly fixed to the core material 21, 31, when the core material 21, 31 is deformed, the elastic sheet 4A may not be able to absorb the deformation and the elastic sheet 4A may be damaged from the end 43 of the elastic sheet 4A. In order to suppress such damage to the elastic sheet 4A, in this embodiment, the core materials 21, 31 are covered with covering tubes 22, 32, and the end 43 of the elastic sheet 4A is fixed to the covering tubes 22, 32. The covering tubes 22, 32 are formed of resins such as silicone rubber, polyamide, and polyurethane. In addition, Figure 5 (b) shows a state where the end portion 43 of the elastic sheet 4A is bonded to the outer ring 2 via the adhesive 44 filled in the cell region 41 a.
[0069] The outer diameter of the outer ring 2 and the inner ring 3 is preferably larger than the length of the incision 101. As shown in Table 1, the outer diameter of the inner ring 3 is particularly preferably a value corresponding to the length of the incision 101 (for example, a value about 20 to 40 mm larger than the length of the incision 101). In addition, as shown in Table 1, the inner diameter of the cylindrical portion 4a of the elastic sheet 4A is preferably a value corresponding to the length of the incision 101 (for example, a value about 10 to 40 mm smaller than the length of the incision 101). In the present embodiment, the thickness of the outer ring 2 and the inner ring 3 is set to, for example, 5 mm in diameter, but may be 3 to 6 mm. In addition, the thickness of the outer ring 2 and the inner ring 3 may be different. For example, by making the thickness of the inner ring 3 thinner than the outer ring 2, it is easy to flatten the inner ring 3 into an elliptical shape when it is installed on the incision 101, and by making the thickness of the inner ring 3 thicker than the outer ring 2, it is not easy to fall off from the incision 101.
[0070]
Table 1
[0071]
[0072] The interval between the outer ring 2 and the inner ring 3 is preferably selected to be less than the thickness of the body wall 100. Thus, the elastic sheet 4A is easily extended and closely adheres to the body wall 100. In addition, in the present embodiment, the outer diameter of the outer ring 2 is set to be equal to that of the inner ring 3, but it may be set to a different value (for example, a value larger than the outer diameter of the inner ring 3).
[0073] (Manufacturing method)
[0074] Next, an example of a method for manufacturing the retractor 1 is described. First, the outer ring 2, the inner ring 3, and the cylindrical elastic sheet 4A are prepared. The cylindrical elastic sheet 4A is manufactured, for example, by injection molding liquid silicone rubber. In addition, the cylindrical elastic sheet 4A can also be manufactured by compression molding high-viscosity silicone rubber. The surface of the elastic sheet 4A becomes a smooth surface by injection molding. The outer ring 2 and the inner ring 3 are manufactured, for example, by covering the core materials 21 and 31 with covering tubes 22 and 32 composed of silicone rubber. Next, the vicinity of the end 43 of the cylindrical elastic sheet 4A is expanded and covered with the outer ring 2 and the inner ring 3 throughout the entire circumference, and the end 43 is bonded to the outer ring 2 and the inner ring 3 by bonding. The retractor 1 is manufactured in the above manner. In addition, for the elastic sheet 4A, a cylindrical elastic sheet material that can take multiple lengths can be prepared and cut from the elastic sheet material as needed.
[0075] (Example of using a retractor)
[0076] Figure 8 1 is a cross-sectional view showing an example of a state in which the retractor 1 according to the present embodiment is used. In addition, in this figure, the unit area 41a is omitted. After an incision 101 is formed on the body wall 100 of a living body such as a human or an animal, the inner ring 3 of the retractor 1 is inserted into the body cavity 102 from the incision 101 in a state of being flattened into an elliptical shape, and the retractor 1 is attached to the incision 101. The inner diameter of the barrel 4a of the retractor 1 is the same as the length of the incision 101 or is about 10 to 40 mm smaller, so that the barrel 4a is in close contact with the incision 101. Thereafter, an in vivo insertion instrument (surgical instrument, endoscope, etc.) is inserted into the body cavity 102 through the barrel 4a, and surgery, observation, etc. are performed on the surgical target site 110.
[0077] [Modification 1]
[0078] Fig. 9A FIG. 4 is a diagram showing a first modification of the unit region 41a. In the present embodiment, the unit region 41a is formed into a hexagonal shape, but various modifications are possible. For example, Fig. 9A As shown in (a), the shape of the unit region 41a is set to a quadrilateral. Fig. 9A As shown in (b) and (c), the shape of the unit region 41a is set to a triangle or a circle. In addition, the arrangement direction of the unit region 41a is not limited to two different directions, and can also be as follows Fig. 9A (d) shows a random configuration. Fig. 9AAs shown in (e), the size of the unit area 41a can also be various sizes, or the unit areas 41a can be randomly arranged and of different sizes. In addition, the shape of the unit area 41a is not limited to the above, and is arbitrary. For example, in addition to a hexagon, it can also be a pentagon or octagon with more than a quadrilateral, a polygon, a stripe, etc., or an ellipse, a trapezoid, etc. In addition, the shape of the unit area 41a can also be applied to other embodiments described later.
[0079] [Modification 2]
[0080] Fig. 9B Deformation example 2 of the unit region 41a is shown, wherein (a) is a main view and (b) is a cross-sectional view of line F-F of (a). In the present embodiment, the unit region 41a is provided on only one surface of the base 41, but as shown in the figure, it may also be provided on two surfaces of the base 41. In this case, as shown in the figure, in order to improve the function of suppressing damage expansion, the unit region 41a provided on one surface and the unit region 41a provided on the other surface are preferably provided so as to be staggered by a predetermined distance (e.g., half the pitch) from each other. In addition, Deformation example 2 can also be applied to other embodiments described later.
[0081] (Effects of this embodiment)
[0082] According to this embodiment, the following effects are achieved.
[0083] (a) elastic sheet 4A is formed by material with flexibility and elasticity, so can maintain the protectiveness to health. In addition, elastic sheet 4A has the function of suppressing damage and expanding, so even if elastic sheet 4A is damaged due to the contact of the sharp front end of medical apparatus etc., the expansion of this damage can be suppressed.
[0084] (b) The elastic sheet 4A is formed of a single resin material, so that the material cost can be kept low compared to elastic sheets using a plurality of materials. In addition, the number of manufacturing steps is reduced, so that an inexpensive elastic sheet can be provided.
[0085] (c) Since the ridge 42 is provided on the outer side of the base 41 of the tube 4a, the ridge 42 is pressed against the body wall, and thus the deviation relative to the incision 101 can be suppressed.
[0086] In addition, the outer ring 2 and the inner ring 3 may be elliptical rings, and the elastic sheet 4A may be formed into an elliptical cylinder. Thus, by installing the outer ring 2 and the inner ring 3 on the incision 101 in a manner that the direction perpendicular to the linear smaller incision 101 is the long axis of the ellipse, a larger operating space can be obtained. In addition, when installed along the intercostal space, a reasonable incision can be made in the intercostal space, which can significantly reduce intercostal pain after surgery.
[0087] [Second Embodiment]
[0088] Fig.10 It is a perspective view showing an example of a schematic structure of a retractor according to a second embodiment of the present invention. Fig.11 yes Fig.10 A longitudinal cross-sectional view of the retractor is shown. Fig.12 yes Fig.10 A top view of the retractor is shown. Fig.13 yes Fig.10 A front view of the retractor is shown.
[0089] In the first embodiment, the ridge 42 is formed on the outer surface of the cylindrical elastic sheet 4A, but in the present embodiment, the ridge 42 is formed on the inner surface of the cylindrical elastic sheet 4B. In the first embodiment, the outer diameter of the inner ring 3 is equal to the outer diameter of the outer ring 2, but in the present embodiment, the outer diameter of the inner ring 3 is smaller than the outer diameter of the outer ring 2, and the thickness of the inner ring 3 is smaller than the thickness of the outer ring 2, and the other parts are configured in the same manner as the first embodiment. The following description will focus on the points different from the first embodiment. The retractor 1 according to the second embodiment is manufactured in the same manner as the first embodiment, so the description of the manufacturing method is omitted.
[0090] like Figure 10 to Figure 13 As shown in FIG. 1 , the retractor 1 according to the second embodiment includes: an annular outer ring 2 and an inner ring 3 disposed coaxially opposite to each other; and a cylindrical elastic sheet 4B having both ends 43 fixed to the outer ring 2 and the inner ring 3. The ends 43 of the elastic sheet 4B are fixed to the outer ring 2 and the inner ring 3 by bonding or welding to form a joint 43a. The elastic sheet 4B is an example of an elastic sheet for medical use.
[0091] The elastic sheet 4B has a function of suppressing the expansion of damage similarly to the first embodiment, and includes a plate-shaped base 41 and an edge 42 formed on at least one surface of the base 41 (in this embodiment, the inner surface of the cylindrical elastic sheet 4B). The elastic sheet 4B is formed into a cylindrical shape before the end 43 is fixed to the outer ring 2 and the inner ring 3. The present retractor 1 is used, for example, for surgeries where tissues are easily damaged, such as breast lymph node resection, and therefore a thinner elastic sheet 4B than that of other embodiments may be used (for example, the thickness of the base 41 is about 0.3 mm, and the height of the edge 42 is about 0.3 mm) so as not to impose a burden on the tissue.
[0092] The outer ring 2 has a circular ring-shaped core material 21 and a covering tube 22 covering the surface of the core material 21, similarly to the first embodiment. The inner ring 3 has a circular ring-shaped core material 31 and a covering tube 32 covering the surface of the core material 31, similarly to the outer ring 2. However, the thickness of the inner ring 3 is formed to be thinner than that of the outer ring 2, and the outer diameter of the inner ring 3 is formed to be smaller than the outer diameter of the outer ring 2. In addition, the outer ring 2 and the inner ring 3 may be elliptical rings, and the elastic sheet 4B may be formed as an elliptical cylinder.
[0093] According to the second embodiment, the same effects as those of the first embodiment are achieved, and the following effects are also achieved. That is, the ridge 42 is provided on the inner surface of the base 41 of the tube 4a, so the contact area on the inner surface of the tube 4a is reduced, the friction force on the surgical instrument can be reduced, and the damage to the elastic sheet 4B can be expected to be suppressed. In addition, the thickness of the inner ring 3 is formed to be thinner than the thickness of the outer ring 2, and the outer diameter of the inner ring 3 is formed to be smaller than the outer diameter of the outer ring 2, so it is easy to insert the inner ring 3 from the incision 101 into the body cavity 102 in a state of being flattened into an elliptical shape.
[0094] [Third Embodiment]
[0095] Fig.14 It is a perspective view showing an example of a schematic structure of a retractor according to a third embodiment of the present invention. Fig.15 (a) is Fig.14 A longitudinal section view of the retractor shown, Fig.15 (b) is a longitudinal sectional view showing an example of a usage state.
[0096] The first embodiment has a tube 4a, an outer flat plate 4b, and an inner flat plate 4c, but the third embodiment has a tube 4a so that the upper part of the elastic sheet 4C can be rolled up without providing the outer flat plate 4b and the inner flat plate 4c, and is otherwise configured in the same manner as the first embodiment. The following description will focus on the differences from the first embodiment.
[0097] The retractor 1 according to the third embodiment includes a pair of annular outer rings 2A, 2B and an inner ring 3 disposed opposite to each other on the same axis, and a tubular elastic sheet 4C having both ends 43 fixed to the outer rings 2A, 2B and the inner ring 3, and has a cylindrical barrel portion 4a. The ends 43 of the elastic sheet 4C are fixed to the outer rings 2A, 2B and the inner ring 3 by bonding or welding to form a joint portion 43a. The elastic sheet 4C is an example of an elastic sheet for medical use.
[0098] The elastic sheet 4C has the function of suppressing the expansion of damage similarly to the first embodiment, and includes a plate-shaped base 41, an edge 42 formed on at least one surface of the base 41 (in this embodiment, the outer surface of the cylindrical elastic sheet 4C), and an end 43 of the elastic sheet 4C is fixed to the outer rings 2A, 2B and the inner ring 3. The retractor 1 of this embodiment does not have the outer flat plate portion 4b and the inner flat plate portion 4c as in the first embodiment, so it does not need to have elasticity for expanding and fixing the vicinity of the end 43 of the elastic sheet 4C to the ring. The elastic sheet 4C is formed into a cylindrical shape before the end 43 is fixed to the outer rings 2A, 2B and the inner ring 3.
[0099] The axial length of the elastic sheet 4C is adapted to the thickness of the body wall 100 by being rolled up multiple times, so the value corresponding to the outer diameter of the outer rings 2A, 2B is preferably about 100 mm when the outer diameter of the outer rings 2A, 2B is 70 mm, and is preferably about 150 mm when the outer diameter is 100 mm.
[0100] The pair of outer rings 2A and 2B are formed of an elastic material (such as silicone rubber, polyurethane, etc.), and the core material 21 as in the first embodiment is not provided. In addition, the outer rings 2A and 2B can also be composed of a core material made of a superelastic alloy or the like and a covering tube covering the core material as in the first embodiment.
[0101] The pair of outer rings 2A and 2B are formed integrally with each other, or joined by bonding or welding along the axial direction of the retractor 1. Thus, the repulsive force during rolling can be maintained, and unwinding can be prevented. In addition, the outer rings 2A and 2B may also be a shape in which two rings are integrated (for example, a flat oval shape that is long in the axial direction of the retractor 1).
[0102] The inner ring 3 is formed of an elastic material (such as silicone rubber, polyurethane, etc.), and is not provided with a core material 31 as in the first embodiment. In addition, the inner ring 3 may also include an annular core material 31 and a covering tube 32 covering the surface of the core material 31, as in the first embodiment. The outer diameter of the inner ring 3 may be equal to or different from that of the pair of outer rings 2A and 2B.
[0103] According to the third embodiment, the same effects as those of the first embodiment are achieved, and the following effects are also achieved. Fig.15As shown in (b), by rolling up the upper part of the elastic sheet 4C (a pair of outer circles 2A, 2B) in the direction indicated by the arrow in the figure according to the installation site of the biological body, the distance L between the outer circle 2B and the inner circle 3 can be adjusted. In addition, since the axial length of the cylinder 4a can be adjusted by changing the number of rolling according to the thickness of the body wall 100, fewer types of product specifications are required. In addition, there is no need to forcibly stretch the elastic sheet 4C when installing it on the incision 101, so cracks are not easy to expand. In addition, the direction in which the pair of outer circles 2A, 2B are rotated when rolling can also be the same as Fig.15 The direction is opposite to the direction shown in (b).
[0104] In addition, the outer rings 2A, 2B and the inner ring 3 may be elliptical rings, and the elastic sheet 4C may be formed into an elliptical cylinder. In addition, the area near the end 43 of the elastic sheet 4C may not form the unit area 41a but only be composed of the base 41. In this case, it becomes easy to roll up, and it is not easy to generate thickness when rolling up.
[0105] [Fourth Embodiment]
[0106] Fig.16 It is a plan view showing an example of a schematic structure of a squeezer according to a fourth embodiment of the present invention. Fig.17 yes Fig.16 A front view of the squeezer is shown. Fig.18 yes Fig.16 The G-G line cross-sectional view is shown.
[0107] The expelling device 10 involved in the fourth embodiment has, for example, a roughly elliptical shape similar to a rugby ball with a major axis of 120 mm and a minor axis of 80 mm, and has a roughly elliptical ring-shaped (including an elliptical ring-shaped) ring 12, and an elastic sheet 14 with a peripheral end portion 143 fixed to the ring 12, and is used, for example, when protectively expelling organs such as lungs (temporarily pushing out organs, tumors, and other objects that become obstacles to surgical operations and surgical areas). The expelling device 10 is an example of a medical device. The elastic sheet 14 is an example of a medical elastic sheet.
[0108] like Fig.18 As shown, the ring 12 includes a core material 121 having a substantially elliptical ring shape (including an elliptical ring shape), a first covering tube 122 covering the surface of the core material 121, and a second covering tube 123 covering the first covering tube 122. The second covering tube 123 may not be provided.
[0109] The core material 121 is formed of a material having high flexibility and resilience, for example, a superelastic alloy such as Ni—Ti metal, similarly to the first embodiment.
[0110] The first covering tube 122 and the second covering tube 123 are formed of resin such as silicone rubber, polyamide, or polyurethane, similarly to the first embodiment.
[0111] The elastic sheet 14 is formed of a material having flexibility and stretchability similarly to the first embodiment. In addition, the peripheral end portion 143 of the elastic sheet 14 is fixed to the ring 12 by bonding or welding.
[0112] The elastic sheet 14 has the same function as the first embodiment in suppressing the expansion of damage. Fig.16 and Fig.18 As shown, it has: a plate-like base 141 formed into a planar shape that is roughly elliptical (including an elliptical ring); an edge 142 formed on at least one surface of the base 141 (the upper surface in this embodiment); a peripheral end 143 for fixing the plate-like base 41 to the ring 12; and a plurality of openings 145 for inserting wires and tools. The peripheral end 143 of the elastic sheet 14 is fixed to the ring 12 by bonding or welding to form a joint 143a. In addition, Fig.18 , the figure shows a state in which the peripheral end portion 143 of the elastic sheet 14 is bonded to the ring 12 via the adhesive 144 filled in the cell region 141 a.
[0113] like Fig.16 As shown, for the base 141, similarly to the first embodiment, the unit area 141a surrounded by the ridge 142 is formed in two different directions (for example, in Fig.16 The shape of the unit area 141a is a hexagon as in the first embodiment, but may be other shapes. In addition, the ridge portion 142 may be formed only on the lower surface of the base 141, or may be formed on the upper and lower surfaces of the base 141.
[0114] (Manufacturing method)
[0115] Next, an example of a method for manufacturing the excluder 10 is described. First, a ring 12 and a planar elastic sheet 14 are prepared. The planar elastic sheet 14 is manufactured, for example, by injection molding liquid silicone rubber. In addition, the planar elastic sheet 14 can also be manufactured by compression molding high-viscosity silicone rubber. The surface of the elastic sheet 14 becomes a smooth surface by injection molding. The ring 12 is manufactured, for example, by covering the core material 121 with a first covering tube 122 and a second covering tube 123 made of silicone rubber. Next, the peripheral end portion 143 of the planar elastic sheet 14 is joined to the ring 12 by bonding or welding. The excluder 10 is manufactured in the above manner. In addition, for the elastic sheet 14, a planar elastic sheet material of multiple sizes can be prepared and cut from the elastic sheet material as needed.
[0116] According to the fourth embodiment, the excluder 10 is set to a substantially elliptical shape, so it is easy to reduce the diameter when inserted into the body cavity 102. In addition, the elastic sheet 14 has a function of suppressing the expansion of damage, so even if the elastic sheet 14 is damaged due to contact with the sharp tip of a medical instrument, the expansion of the damage can be suppressed.
[0117] In addition, the shape of the elastic sheet 14 is arbitrary, and may be a shape corresponding to the annular shape of the ring 12. For example, the ring 12 may be annular, and the elastic sheet 14 may be formed in a planar shape such as a circle, a quadrilateral, or a polygon. In addition, for the elastic sheet 14, a planar elastic sheet material of multiple sizes may be prepared and cut from the elastic sheet material as needed.
[0118] [Example]
[0119] Next, refer to Fig.19A , Fig.19B , Fig. 20 , experimental examples of damage to the elastic sheets of the embodiments and comparative examples are described. Fig.19A , Fig.19B (a) to (h) are diagrams showing experimental examples of damage to the elastic sheet 4A of the embodiment. Fig. 20 (a) to (e) are diagrams showing experimental examples of damage to the elastic sheet of the comparative example.
[0120] (Experimental product of the embodiment)
[0121] The experimental products of the embodiment correspond to the first embodiment, and the following experimental products are used. Regarding the size of the retractor 1, the inner diameter of the barrel 4a is set to 35 mm, and the outer diameter is set to 100 mm. Regarding the physical properties of the material of the elastic sheet 4A, silicone rubber with a tensile elongation of 285% and a hardness of A30 is used. Regarding the size of the cross-sectional shape of the elastic sheet 4A, the width W of the ridge 42 is set to 1 mm, the thickness t of the base 41 is set to 0.4 mm, and the height h of the ridge 42 is set to 0.4 mm. Regarding the shape and size of the unit area 41a, the shape of the unit area 41a is hexagonal, the axial size H of the unit area 41a is set to 3 mm, and the diameter d of the circle inscribed in the unit area 41a is set to 3 mm.
[0122] (Comparative Example Experimental Product)
[0123] The following experimental products were used as the experimental products of the comparative example. Regarding the size of the retractor, the inner diameter of the barrel was set to 35 mm and the outer diameter was set to 100 mm. Regarding the physical properties of the material of the elastic sheet, silicone rubber with a tensile elongation of 285% and a hardness of A30 was used. Regarding the size of the cross-sectional shape of the elastic sheet, the thickness without the edge was set to 1 mm.
[0124] (Experimental results of the embodiment)
[0125] As a pre-treatment, Fig.19A As shown in (a), Figure 3 The upper side of the tubular elastic piece 4A shown in (a) is cut so that the axial length (height) becomes 35 mm. Fig.19A As shown in (b), the vicinity of the end portion 43 of the elastic sheet 4A is expanded and fixed to the inner ring 3 having an outer diameter of 100 mm.
[0126] Next, if Fig.19A As shown in (c), the inner flat plate portion 4c is cut with a length of 5 mm to simulate the damage caused by the sharp tip of the surgical instrument (the same below) to form a damaged portion. Fig.19A As shown in (d), a 5 mm long incision is formed on both sides of the damaged part (the parts indicated by reference numerals 2 and 3 in the partial enlarged view). Fig.19A As shown in (e), a 5 mm long incision is formed in the center of the damaged part (the part indicated by reference numeral 4 in the partial enlarged view). Fig.19B As shown in (f) and (g), a 5 mm long incision is formed in the center of the damaged part (the part indicated by reference numeral 4 in the partial enlarged view). At this stage, the damaged part has not expanded significantly, but if a 5 mm long incision is formed again in the center of the damaged part (the part indicated by reference numeral 4 in the partial enlarged view), as shown in Fig.19B As shown in (h), the cracks expanded from the damaged portion to the central opening. That is, the elastic sheet 4A was damaged by a total of seven cuts.
[0127] (Experimental results of comparative example)
[0128] As a pre-treatment, Fig. 20 As shown in (a), Figure 3 The upper side of the tubular elastic piece shown in (a) is cut so that the axial length (height) becomes 35 mm. Fig. 20 As shown in (b), the vicinity of the end of the elastic sheet is expanded and fixed to the inner ring 3 having an outer diameter of 100 mm.
[0129] Next, if Fig. 20 As shown in (c), a 5 mm long cut is formed on the inner flat plate to form a damaged portion. Fig. 20 As shown in (d), a 5 mm long incision is formed on both sides of the damaged part (the parts indicated by reference numerals 2 and 3 in the partial enlarged view). At this stage, the damaged part has not expanded significantly, but if a 5 mm long incision is formed in the center of the damaged part (the part indicated by reference numeral 4 in the partial enlarged view), as shown in Fig. 20 As shown in (e), the cracks expanded from the damaged part to the central opening. That is, the elastic sheet was damaged by a total of four cuts.
[0130] (Summary of experimental results)
[0131] Although the overall thickness of the elastic sheet 4A of the embodiment is 0.8 mm (0.4 mm at the base and 0.4 mm at the edge), which is thinner than the thickness of the elastic sheet of the comparative example of 1 mm, the embodiment was damaged after 7 cuts, while the comparative example was damaged after 4 cuts. It can be considered that the reason why the number of cuts until the elastic sheet of the embodiment was damaged was greater than that of the comparative example is that the elastic sheet 4A of the embodiment has the function of suppressing the expansion of damage.
[0132] The following inventions can be grasped from this description.
[0133] [1] A medical elastic sheet comprising:
[0134] plate-like base; and
[0135] An edge portion formed on at least one surface of the base portion,
[0136] In the base, a plurality of unit regions are continuously formed in the plane via the ridges, and the entire circumference of each unit region is surrounded by the ridges.
[0137] The edges are continuously connected to each other.
[0138] [2] The above-mentioned unit area can also be triangular, polygonal, circular or elliptical.
[0139] [3] The above-mentioned unit area may also be a hexagon.
[0140] [4] The base and the ribs may be formed from the same resin material.
[0141] [5] In any one of the medical elastic sheets described in [1] to [4],
[0142] The base is formed into a cylindrical shape.
[0143] The ridge portion is formed on at least one of the outer surface and the inner surface of the cylindrical base portion.
[0144] [6] In any one of the medical elastic sheets described in [1] to [4],
[0145] The base is formed in a flat shape.
[0146] [7] A medical device comprising:
[0147] The annular outer ring and inner ring are coaxially disposed opposite to each other; and
[0148] The medical elastic sheet described in the above-mentioned [5] has both ends fixed to the outer ring and the inner ring.
[0149] [8] A medical device comprising:
[0150] annular loops; and
[0151] The medical elastic sheet described in the above-mentioned [6] has a peripheral end portion fixed to the above-mentioned ring.
[0152] According to the medical elastic sheet and the medical instrument configured as described above, the following effects are achieved.
[0153] According to the invention described in [1] above, protection for the body can be maintained, and even if the elastic sheet is damaged by contact with the sharp tip of a surgical instrument such as a medical instrument, the damage can be suppressed from spreading.
[0154] According to the invention described in the above [2], the shape of the unit region is a simple shape, so it is easy to surround the unit region with the edge portion.
[0155] According to the invention described in the above [3], when the diameter of the circumscribed circle is the same, the area is larger than other shapes of the unit region, and the flexibility and stretchability are excellent.
[0156] According to the invention described in the above [4], compared with a medical elastic sheet using a plurality of materials, the material cost can be kept low and the number of manufacturing steps can be reduced, so that an inexpensive medical elastic sheet can be provided.
[0157] According to the inventions described in [5] and [7] above, by attaching rings to both ends of the tubular medical elastic sheet, the sheet can be used as a retractor for a medical instrument.
[0158] According to the inventions described in [6] and [8] above, by attaching a ring to the peripheral end portion of the planar medical elastic sheet, the sheet can be used as a repellent for medical instruments.
[0159] The embodiments of the present invention are described above, but the embodiments of the present invention are not limited to the above embodiments, and various modifications and implementations are possible. For example, in the above embodiments, retractors and compression devices are described, but the present invention can also be applied to other medical devices such as dilators for maintaining the expanded state of natural openings.
[0160] In addition, a part of the components of the above-mentioned embodiment may be omitted or changed. In addition, in the method of using the above-mentioned embodiment, steps may be added, deleted, changed, replaced, etc.
Claims
1. A medical elastic sheet, characterized in that: have: plate-like base; and an edge portion formed on at least one surface of the base portion, In the base, a plurality of unit regions are continuously formed in a plane via the ridges, and the entire circumference of each unit region is surrounded by the ridges. The edge portions are continuously connected to each other.
2. The medical elastic sheet according to claim 1, characterized in that: The unit area is in the shape of a triangle, a polygon, a circle or an ellipse.
3. The medical elastic sheet according to claim 2, characterized in that: The unit area is hexagonal.
4. The medical elastic sheet according to claim 1, wherein: The base portion and the ridge portion are formed of the same resin material.
5. The medical elastic sheet according to any one of claims 1 to 4, characterized in that: The base is formed into a cylindrical shape, The ridge portion is formed on at least one of an outer surface and an inner surface of the cylindrical base portion.
6. The medical elastic sheet according to any one of claims 1 to 4, characterized in that: The base is formed in a flat shape.
7. A medical device, characterized in that: have: The annular outer ring and inner ring are coaxially disposed opposite to each other; and The medical elastic sheet according to claim 5, wherein both end portions are fixed to the outer ring and the inner ring.
8. A medical device, characterized in that: have: annular loops; and The medical elastic sheet according to claim 6, wherein the peripheral end portion is fixed to the ring.
Citation Information
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