JP2017051331A - Textured long-sized device for medical treatment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent resistance of a wire from increasing due to loss of a lubricant from the surface.SOLUTION: A long-sized device for medical treatment comprises: an insertion object made of solid or hollow elastic body, the insertion object extending along an axis and having a surface making a cylindrical surface around the axis; one or more recesses or grooves recessed radially inward from the surface; and a lubricant applied to the surface and the recesses or grooves.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a medical long instrument including forms such as a wire, a needle, a tube, and a catheter, and more particularly, a medical long instrument capable of maintaining a good lubricity by holding a lubricant by a surface texture. About.

  In order to insert it deep into the human body and use it for medical purposes, an elongated elongated device such as a wire may be used. Such a long instrument needs to have an appropriate rigidity and bends flexibly depending on the application, and is made of a metal such as stainless steel. The tip of the long tool may be sharply pointed and take the form of a needle, and may take the form of a hollow tube, cannula or the like instead of being solid.

  For example, if a longer catheter in the form of a needle is covered with a shorter catheter, the patient's body is punctured with the catheter, and only the needle is removed, the catheter can be introduced into the blood vessel or body cavity. Such an instrument is called an indwelling catheter or the like. Alternatively, the wire or catheter itself is a long device, and the long device may be inserted deep into the patient's body through a hollow device that has been punctured in advance.

  Medical personnel operate a long instrument based on a subtle feel and guide its tip to the target location, so it is necessary for the long instrument to slide very smoothly and without resistance against the human body or catheter. . In addition, the smooth sliding of the long instrument contributes to reducing the patient's pain.

  Patent Documents 1 and 2 disclose related techniques related to a needle assembly used for introducing a catheter.

JP2015-47493 JP2012-223644

  In order to promote the sliding of the long device, the surface of the long device is usually processed extremely smoothly, and a lubricant such as silicone oil may be applied to the surface. However, since silicone oil has high affinity for the human body, the human body in contact with it may be wiped off. Due to such a situation or other situation, the silicone oil may be lost from the surface of the long device, and sufficient lubricity may not be obtained. The present inventors have intensively studied to solve such problems.

  An elongated medical device extends along an axis and has an insertion body made of a solid or hollow elastic body having a cylindrical surface around the axis, and is recessed radially inward from the surface. And one or more depressions or grooves, and a lubricant applied to the surface and the depressions or grooves.

  Preferably, the groove is at least one of a curved line and a polygonal line excluding a spiral around the axis. More preferably, the groove is one or more of a closed loop, an independent curve, and an independent polygonal line on the surface. More preferably, the long medical instrument includes both the recess and the groove, and the recess is connected to and communicates with the groove.

  There is provided a medical long instrument that can provide continuous lubricity.

FIG. 1 is a perspective view of an indwelling needle including a long medical instrument according to an embodiment of the present invention. FIG. 2 is a partial plan view of an insert illustrating details of a depression or groove in the surface and various variants thereof. FIG. 3 is a cross-sectional view of a long medical instrument, a human tissue, and the like, illustrating a state in which a human tissue or the like is in contact with the surface of the insert. FIG. 4 is a partial cross-sectional view of an insert illustrating various variations in cross-sectional shape. FIG. 5 is a partial plan view of the surface showing the relationship between groove orientation and lubricant behavior. FIG. 6 is a partial plan view of the surface illustrating the irregular shape of the groove. FIG. 7 is an enlarged schematic view of a surface illustrating a groove including a lubricating oil reservoir. FIG. 8 is an enlarged schematic view of the surface illustrating another variant of the depression. FIG. 9 is an enlarged schematic view of the surface illustrating an example in which the gap between the lands functions as a groove. FIG. 10 is a partial plan view of the insert for explaining a part of the manufacturing process.

  Several exemplary embodiments of the present invention are described below with reference to the accompanying drawings.

  The present invention relates to a medical long instrument that is inserted into a blood vessel or body cavity of a human body and used for medical practice. The elongated device may be a hollow tube or catheter, or may be a solid wire. The tip may be in the form of a needle.

  Although the textured medical long instrument may be used alone, it is often used by being incorporated in another assembly 1 as shown in FIG. According to such an example, the needle assembly 1 generally comprises a handle 3 and a needle 7 extending forward from the handle 3. The tip of the needle 7 is ground obliquely to form a needle tip, which can be used for puncture. The insertion body 9 can be used to introduce the insertion body 9 into the blood vessel by placing the insertion body 9 on the needle 7 and puncturing the body of the patient together with the needle 7. The insert 9 is a catheter in this example. After the needle 7 is removed, the catheter is connected to an external circuit and used for infusion and angiography. In this example, the needle 7 is retracted by the spring mechanism activated by the button 5, but such a configuration is not essential.

  The insert 9 may be another instrument such as a sheath or a dilator instead of the catheter. The needle 7 can be in the form of an elongated wire or can be in the form of a non-needle. In these examples, only catheters, sheaths, dilators, etc. are used for medical practice, but of course there may be embodiments where needles or wires are used for medical practice.

  In the following, an example in which a texture is applied to the insert 9 will be described. However, instead of or in addition to this, a texture may be applied to a needle or a wire. In that case, the elements used in combination with the texture, such as lubricants, of course also apply to the needles or wires.

  Referring to FIG. 2, the insert 9 is made of an appropriate elastic body, and an example thereof is an appropriate polymer material such as a resin or a metal. Examples of such resins include polypropylene (PP), polyurethane (PU), fluororesins (PTFE, PFA, FEP), polyamide (PA), and polyethylene (PE). An example of the metal is stainless steel.

  The entire insert 9 extends along the axis, and its surface 9S forms a generally cylindrical surface around the axis. Further, the surface 9S is partially smooth but is generally textured. For example, the insert 9 includes one or more grooves 11 that are recessed radially inward from the surface 9S. The groove 11 may reach the front end at the front and may reach the rear end at the rear. The same applies to the case where a texture is applied to a needle or a wire.

  A lubricant 21 is applied to the surface 9S and the inside of the groove 11 as shown in FIG. The lubricant 21 is usually a silicone oil approved for medical use, but olive oil, glycerin, physiological saline, or the like can also be used as the lubricant. The lubricant 21 is usually applied prior to distribution, or may be distributed without lubricant and applied immediately before use. Furthermore, the patient's bodily fluid or blood may unintentionally or intentionally wet the surface 9S of the insert 9, and may have a lubricating effect with or in place of the lubricant 21.

  Referring to FIG. 3 (a), when a soft object such as human tissue 13 comes into contact with an insert 9 'without a groove, the insert 9' can be used as long as the surface of the insert 9 'is sufficiently smooth. It can slide as shown by the arrow M with respect to the human body tissue 13. However, if the lubricant is lost from the surface, the smoothness of sliding is correspondingly impaired. Further, since the human body tissue 13 has a specific body pressure and is extremely flexible, the human body tissue 13 tries to come into close contact with the surface 9S of the insert 9 'with a constant body pressure. This also impairs the smoothness of sliding.

  Referring to FIG. 3B, when the insertion body 9 has a groove, the human tissue 13 enters the groove due to the body pressure. If no lubricant is applied to the insert 9, in particular its groove, the intruded human tissue 13 is caught in the groove, thereby causing resistance to movement. Therefore, the insert 9 can no longer be expected to slide smoothly. . This can hinder the precise operation of the insert 9 by medical personnel, and can further increase patient pain.

  Referring to FIG. 3 (c), when the lubricant 21 is combined, the groove can rather act to reduce the resistance. That is, the lubricant 21 wets not only the surface of the insert 9 but also the groove. Although the human tissue 13 can penetrate into the groove due to the body pressure, a dynamic pressure is generated in the lubricant 21 with the movement M of the insert 9, and the dynamic pressure causes the lubricant 21 to flow between the groove and the human tissue 13. An intruding stream 21F is generated. Such dynamic pressure creates buoyancy in the human tissue 13 and tries to pull it away from the groove, thus reducing friction. Furthermore, since the flow 21F supplies new lubricant to the surface of the insert 9, the lubricant 21 is prevented from being lost between the human tissue 13 and the insert 9. The groove can store a larger amount of the lubricant 21 than the surface, and continuously supplies the lubricant 21 to the surface of the insert 9. That is, since the film of the lubricant 21 is maintained throughout the human tissue 13 and the insert 9, the resistance can be reduced rather than when there is no groove.

  The effects as described above are the same even when the target to which the insertion body 9 contacts is not the human tissue 13 but a flexible catheter, sheath, or dilator. Since these need to be deformed following the blood vessel, they are made of a very flexible material, and enter the groove when body pressure is applied. Without a lubricant, an invading catheter will create resistance, but if lubricant is present, the flow of lubricant will create buoyancy and rather reduce resistance.

  Examples of such flexible materials include acrylic resins (PMMA, etc.), epoxy resins, elastomers, aliphatic polyamides, silicone resins, celluloses, polyamide resins, halogenated polyolefins, finoxy resins, phenol resins, fluororesins, modified polyolefins. , Aramids, polyacrylonitrile, polyamide polyimide, polyimide, polyurethane, polyether, polyester, polyesteramide imide, polyester polyimide, polyethylene, polyethylene terephthalate, polyethylene glycol, polyvinyl chloride, polyolefin, polycarbonate, polystyrene, polysulfone, polybutadiene, polypropylene Can be illustrated.

  The effect as described above naturally depends on the dimensions of the groove. When viewed in a cross section parallel to the axial direction as shown in FIGS. 4 (a) to 4 (e), if the width W of the groove reaches a level of several tens of millimeters, the groove will no longer function as a groove and It ’s just the top step. Therefore, the width W is preferably 1 mm or less, and more preferably 200 μm or less. Further, when the width W is less than 1 μm, the function of holding the lubricant 21 becomes poor, and therefore, the width W is preferably 1 μm or more.

  If the depth of the groove is extremely shallow, there is no substantial change from smoothness, and a clear effect cannot be expected. If the depth is less than 1 μm, the effect cannot be expected, and the depth is preferably 1 μm or more, more preferably 10 μm or more. On the other hand, if the depth is too deep, the invasion of the human tissue 13 or the catheter in contact with the insert 9 becomes remarkable and the resistance is rather increased. Therefore, the depth is preferably 1 mm or less, more preferably 200 μm or less.

  Further, in the example in which the grooves 11 are orthogonal to the axial direction of the insertion body 9 as shown in FIG. 2C, if the pitch P between the grooves in the axial direction is extremely large, the overall smoothness is substantially changed. There is no place. Probably, the effect cannot be expected when the pitch P is about several tens to several mm, and the pitch P is preferably 1 mm or less, more preferably 200 μm or less. Further, the pitch P may be very small, or adjacent grooves may be in contact with each other as shown in FIG.

  There may be various variations in the cross-sectional shape of the groove. For example, as illustrated in FIG. 4A, the groove 11 may be rectangular in cross section. Moreover, as illustrated in FIG. 4B, a triangle or another polygon may be used. Furthermore, as illustrated in FIG. 4C, the shape may be circular, elliptical, or indefinite.

  The boundary between the groove and the surface does not have to be sharp as shown in each figure, and may be appropriately rounded. Furthermore, as shown in FIG. 4D, a gentle inclination from the surface 9S toward the groove 11 may be formed.

  In any case described above, adjacent grooves 11 may be in contact with each other as shown in FIG.

  From the viewpoint of ease of manufacture, the shape of the groove edge as shown in FIG. 4B or the shape of the groove edge as shown in FIG. A round shape like this is more advantageous. On the other hand, in order to generate a strong dynamic pressure by the lubricant 21, it is advantageous to have a shape in which the edge of the groove is raised as shown in FIG.

  Further, the surface shape of the groove may have various shapes. For example, the spiral shape that rotates around the axis illustrated in FIG. 2A is advantageous in that the groove 11 can be easily formed. Alternatively, the groove 11 can be easily formed in a pair of spiral shapes or turtle shell patterns that rotate in opposite directions illustrated in FIG.

  As understood with reference to FIGS. 2 (a) and 2 (b) in combination with FIG. 5 (a), if the groove 11 is parallel to the axial direction or oblique to the axial direction, the movement M of the insert 9 is The resulting lubricant flow 21F is exclusively along the groove 11 and the effect of getting over the edge of the groove 11 is reduced. In order to solve such a problem, for example, as shown in FIGS. 2 (c) and 5 (b), it is preferable that the grooves 11 are not parallel to the axial direction, but have a certain angle, and the orthogonality is preferable. The plurality of grooves 11 are independent from each other, and each groove 11 may be a closed loop around the periphery of the insert 9 or may be open.

  Moreover, the groove | channel 11 does not need to be linear, and may be a waveform as illustrated to Fig.6 (a). Since the lubricant flow 21F gathers at the portion corresponding to the bottom of the wave and gets over the edge of the groove 11, this point can be the lubricant supply point 11P. Further, as illustrated in FIG. 6B, the groove 11 may be a broken line. Similarly, the angle opposite to the direction of the movement M can be the lubricant supply point 11P.

  In addition to the groove or instead of the groove, the insert 9 may be provided with a recess having another shape. For example, FIGS. 7A and 7B are examples in which the insertion body 9 includes a circular recess 11 </ b> R communicating with the groove 11 </ b> L. The recess 11R is not limited to a circle, but may be an ellipse, a polygon, another geometric figure, or an indefinite shape. The recess 11R can store a larger amount of the lubricant, and the end opposite to the direction of the movement M can be mainly a supply point of the lubricant.

  When the groove 11L and the recess 11R communicating with the groove 11L are combined as in the example of FIG. 7A, the groove 11L may be spiral as shown in FIG. Since the recess 11R can act as a supply point of the lubricant, the above-described problem does not occur. Of course, grooves and depressions perpendicular to the axial direction as shown in FIGS. 2 (c) and 5 (b) may be combined, or as shown in FIG. 7 (b), they may be combined with corrugations or broken lines. In this case, the recess 11R may be located at the bottom of the wave of the groove 11 or the corner of the broken line.

  The depression may be independent of the groove or may be without a groove. 2 (e) and 8 (a) are examples in which the insert 9 has a plurality of depressions 11 without grooves. Similarly to the above, the end opposite to the direction of the movement M can be mainly the supply point of the lubricant. Further, as shown in FIG. 8B, the recess 11 may be a closed loop on the surface 9S or may be an open loop.

  As illustrated in FIG. 9, the surface 9 </ b> S may have a structure like a separated cylinder, and the groove 11 may be a depression between them. Instead of a cylinder, a polygonal column, another solid, or an irregular column may be used.

  Although the example which has a groove | channel or a hollow in the outer surface of an insert was mentioned in the above-mentioned description, the insert may be hollow and may be equipped with a groove | channel or a hollow in the inner surface. Lubricity can be maintained as well when inserting a catheter, dilator, or wire through the inside of the insert.

  The groove 11 can be formed by various methods, and examples thereof include laser processing, water jet processing, etching, transfer, and machining. For example, in the case of laser processing, as shown in FIG. 10, rotation R and translational motion F are given to the insert 9 while irradiating the insert 9 with a laser beam L. A groove is formed at the irradiation point S, and the irradiation point S advances in a spiral manner on the surface of the insert 9, so that a spiral groove 11 can be formed.

  Although the present invention has been described with reference to preferred embodiments, the present invention is not limited to the above-described embodiments. Based on the above disclosure, a person having ordinary skill in the art can implement the present invention by modifying or modifying the embodiment.

  There is provided a medical long instrument that can provide continuous lubricity.

1 Needle assembly 3 Handle 5 Button 7 Needle 9, 9 'Insert 9S Surface 11 Groove, dent 11L Groove 11P Supply point 11R Depression 13 Human tissue 21 Lubricant 21F Flow F Translation L Laser beam M Movement P Pitch R Rotation S Irradiation point W width

Claims (4)

An insert made of a solid or hollow elastic body having a surface extending along an axis and forming a cylindrical surface around the axis;
One or more indentations or grooves recessed radially inward from the surface;
A lubricant applied to the surface and the recess or groove;
Medical long instrument equipped with.   The medical long instrument according to claim 1, wherein the groove is at least one of a curved line and a polygonal line excluding a spiral around the axis.   The medical long instrument according to claim 2, wherein the groove is at least one of a closed loop, an independent curve, and an independent polygonal line on the surface.   The medical long instrument according to any one of claims 1 to 3, comprising both the recess and the groove, and the recess is connected to and communicated with the groove.

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