JP2020127682A - Medical lancing device and manufacturing method thereof - Google Patents

Abstract

To provide a medical lancing device and manufacturing method thereof, which may rapidly protrude a needle to the outside of a first hollow member for accommodating the needle.SOLUTION: There is provided a medical lancing device 1 comprising a first hollow member 10, a second hollow member 20 arranged in an inner cavity 11 of the first hollow member 10, and a needle 30 which is fixed in the inner cavity 21 of the second hollow member 20 and communicates with the inner cavity 21. A plane 41 which is perpendicular to a distal/proximal direction of the first hollow member 10 and which has the maximum cross-sectional area of the second hollow member 20 within a section 40 from a distal end of the second hollow member 20 to a position apart from the distal end at 15 cm to the proximal side satisfies (1) and (2): (1) the center point Cin of an inscribed circle 25 of the second hollow member 20 is positioned at an eccentric position from the center point Cout of a circumscribed circle 26; (2) a vector A whose starting point is the center point Cin and whose end point is point P where a perpendicular line L drawn from a tip 30a of the needle 30 to the plane 41 intersects the plane 41 is the same direction with a vector B whose starting point is the center point Cin and whose end point is the center point Cout.SELECTED DRAWING: Figure 2

Description

The present invention relates to a medical lancing device for injecting a liquid into a tissue site of a body lumen and a method for manufacturing the same.

Under the endoscope, physiological saline or hyaluronic acid solution is injected into the submucosal layer under the polyp formed on the stomach wall, intestinal wall, etc. with an injection needle to elevate the polyp, then capture the polyp with a snare wire, etc. However, the polyp may be excised using a high-frequency treatment tool such as an electric knife. For injecting physiological saline or the like, a puncture device is used which is delivered from a forceps port of an endoscope through a forceps channel to a treatment target site in a body lumen of a patient. The puncture device includes a needle, an inner tube (second hollow member) that holds the needle, and an outer tube (first hollow member) that houses the needle and the inner tube until they are delivered to a treatment target site. The inner diameter of the distal end portion of the outer tube is narrowed due to the restriction of the movement of the needle and the inner tube toward the distal side of the outer tube. However, since the tip of the needle is generally displaced from the center of the long axis of the needle, the needle of the puncture device that has passed through the bent forceps channel of the endoscope placed in the body cavity is opened at the distal end of the outer tube. When protruding from the outer tube, the needle may come into contact with the part where the inner diameter of the outer tube is narrow and stick, and the needle may not come out of the outer tube. Therefore, a method for smoothly protruding the needle from the outer tube has been studied.

Patent Document 1 discloses an endoscope injection tool in which the vicinity of the injection needle of the inner tubular tube is bent and formed at an angle at which the tip of the injection needle is directed toward the approximate center of the opening. Thus, the bending angle of the inner tubular tube can be set to an angle at which the tip of the injection needle always faces the approximate center of the opening. Patent Document 2 discloses an injection device in which the tip of the injection needle is curved so that the acute angle portion of the tip of the injection needle is located at the axis of the injection needle. In Patent Document 3, a sharply-shaped blade portion is formed at the tip portion of the needle tube, and the blade portion is provided with a first blade surface and a pair of second blade surfaces forming the tip of the blade portion. Needles are disclosed. By providing the second blade surface, a backcut portion having a role of preventing the blade portion from sticking into the sheath is formed at the tip of the blade portion and on the tip-side rear surface of the first blade surface.

Japanese Utility Model Publication No. 3-64653 Japanese Utility Model Publication No. 63-3801 JP, 2005-313828, A

However, since the injection device described in Patent Document 1 has a tendency to form the inner tube by heat processing, the shape of the inner tube may change unnecessarily. In the injection device described in Patent Document 2, since the injection needle is curved, when the injection is performed, the curved portion may enter into the tissue and push and spread the tissue to damage it. Further, by bending the injection needle having a narrow lumen, turbulent flow occurs in the flow of the physiological saline solution passing through the inside of the needle, and the flow performance deteriorates. In the puncture needle described in Patent Document 3, the position of the needle tip can be displaced only by the thickness of the needle. Therefore, an object of the present invention is to provide a medical puncture device capable of quickly projecting a needle tube out of the first hollow member for accommodating the needle tube and a method for manufacturing the same.

An embodiment of the medical puncture device of the present invention which has been able to solve the above-mentioned problems is a first hollow member extending in the perspective direction and a first hollow member which is arranged in the inner cavity of the first hollow member. Medical device having a second hollow member movable in a perspective direction with respect to the hollow member, and a needle tube fixed in the lumen of the second hollow member at a distal portion thereof and communicating with the lumen. The puncture device, which is a plane perpendicular to the perspective direction of the first hollow member, and the cross-sectional area of the second hollow member in the section from the distal end of the second hollow member to the proximal side 15 cm from the distal end. In the surface where the maximum is (the surface including the distal end of the second hollow member when the cross-sectional area of the second hollow member is uniform in the perspective direction), the following (1) and (2) are satisfied. To do.
(1) The center point Cin of the inscribed circle of the second hollow member is eccentric from the center point Cout of the circumscribed circle of the second hollow member.
(2) The direction of the vector A whose starting point is the center point Cin and the ending point is the point P where the perpendicular line drawn from the tip of the needle tube to the above surface intersects with the above surface, and the starting point is the center point Cin and the ending point is the center point Cout. The direction of vector B is the same.

According to the above requirements (1) and (2), the center of the long axis of the needle tube arranged in the inner cavity of the second hollow member can be displaced from the center point Cout of the circumscribed circle of the second hollow member. Further, the tip of the needle tube is arranged closer to the center point Cout of the circumscribed circle of the second hollow member. Therefore, when the needle tube is projected from the opening on the distal side of the first hollow member, it becomes difficult for the tip of the needle tube to come into contact with the distal end portion of the first hollow member, so that the needle tube can be quickly moved to the outside of the first hollow member. Can be projected.

The second hollow member preferably includes an inner tube and a spacer that is fixed inside the inner tube and outside the needle tube.

It is preferable that the spacer has an inner cavity that encloses the needle tube, and that the circumscribed circle of the spacer and the inscribed circle inscribed in the inner cavity of the spacer are eccentric to each other on the above surface.

The second hollow member preferably includes an inner tube and a spacer fixed to the outside of the inner tube.

The needle tube has a beveled opening edge at the distal end, the opening edge has a most distal portion and a most proximal portion, and the spacer is on the most distal portion side of the needle tube. Is preferred.

The thickness of the spacer in the direction parallel to the vector B is preferably uniform in the perspective direction.

The long axis direction of the needle tube is preferably inclined with respect to the perspective direction of the first hollow member.

The long axis direction of the needle tube is preferably parallel to the perspective direction of the first hollow member.

The needle tube preferably intersects the above surface.

It is preferable that the second hollow member has an uneven thickness shape whose thickness varies depending on the location.

The present invention also includes a method for manufacturing a medical lancing device. One embodiment of the method for manufacturing a medical puncture device of the present invention has a step of heating the medical puncture device, and applies an external force to the needle tube in the direction from the point P to the center point Cout during heating. It has a feature in adding.

Another embodiment of the method for manufacturing a medical puncture device of the present invention has a step of heating the medical puncture device, and the point P after heating is greater than the distance between the point P before heating and the center point Cout. Is characterized by a short distance between the center point Cout and the center point Cout.

The spacer has an inner cavity that encloses the needle tube, and in the above surface, the circumscribing circle of the spacer and the inscribed circle inscribed in the inner cavity of the spacer are eccentric to each other. It is preferable to have the step of inserting the proximal end of the needle tube from the distal end side of the lumen.

The spacer has an inner cavity that encloses the needle tube, and in the above surface, the circumscribing circle of the spacer and the inscribed circle inscribed in the inner cavity of the spacer are eccentric to each other. It is preferable to have a step of fixing the outer side surface and the inner side surface of the inner tube by heat welding or an adhesive.

The method for manufacturing a medical lancing device as described above, wherein the second hollow member includes an inner tube and a spacer that is fixed to the inner side of the inner tube and to the outer side of the needle tube. It is preferable to have a step of fixing to the inner wall of the inner tube by heat welding or an adhesive.

In the method for manufacturing a medical puncture device, a step of inserting a needle tube into the inner cavity of a first tube having a non-circular cross section perpendicular to the long axis, and a second tube having heat shrinkability It is preferable to include a step of covering the tube and a step of heating the second tube.

In the method for manufacturing a medical puncture device, a step of covering a first tube in a state in which a needle tube is inserted into an inner cavity with a second tube having a non-circular cross section perpendicular to the long axis and having heat shrinkability And, it is preferable to include a step of heating the second tube.

In the medical puncture device manufacturing method, it is preferable that the second tube covers both the first tube and the needle tube.

In the method for manufacturing a medical puncture device, a step of covering a third tube in a state where the needle tube is inserted into a lumen with a fourth tube having heat shrinkability, a step of heating the fourth tube, and a third tube It is preferable to include a step of removing the fourth tube from.

According to the above requirements (1) and (2), the center of the long axis of the needle tube arranged in the inner cavity of the second hollow member can be displaced from the center point Cout of the circumscribed circle of the second hollow member. Further, the tip of the needle tube is arranged closer to the center point Cout of the circumscribed circle of the second hollow member. Therefore, in the medical puncture device configured as described above, when the needle tube is projected from the opening on the distal side of the first hollow member, the tip of the needle tube is unlikely to contact the distal end portion of the first hollow member. Therefore, the needle tube can be quickly projected to the outside of the first hollow member.
Further, according to the method for manufacturing a medical puncture device according to the present invention, it is possible to manufacture a medical puncture device capable of quickly protruding the needle tube to the outside of the first hollow member.

1 is a plan view (partially sectional view) of a medical lancing device according to an embodiment of the present invention. FIG. 2 is an enlarged perspective view of a distal end portion of the medical lancing device shown in FIG. 1. FIG. 3 shows a cross-sectional view of the medical lancing device shown in FIG. 2 taken along the perspective direction. 4 is a cross-sectional view taken along line IV-IV of FIG. 3, showing a schematic view of the first surface of the medical lancing device. The modification of the perspective view of the medical puncture device shown in FIG. 2 is represented. FIG. 6 is a cross-sectional view of the medical lancing device shown in FIG. 5 taken along the perspective direction. FIG. 7 is a cross-sectional view taken along the line VII-VII of FIG. 6, showing a schematic view of the first surface of the medical puncture device. 9 shows a modification of the cross-sectional view shown in FIG. 7. 10 shows another modification of the cross-sectional view shown in FIG. 7. FIG. 6 shows a perspective view of a medical lancing device according to another embodiment of the present invention. FIG. 11 is a cross-sectional view of the medical lancing device shown in FIG. 10 taken along the perspective direction. FIG. 11 is a cross-sectional view taken along line XII-XII in FIG. 11, showing a schematic view of the first surface of the medical puncture device. 11 shows a modification of the perspective view of the medical lancing device shown in FIG. 10. FIG. 14 is a cross-sectional view taken along the perspective of the medical lancing device shown in FIG. 13. 14 is a cross-sectional view taken along line XV-XV in FIG. 14, showing a schematic view of the first surface of the medical puncture device. 15 shows a modification of the cross-sectional view of the medical lancing device shown in FIG. 14 taken along the perspective direction. 15 shows a modification of the cross-sectional view of the medical lancing device shown in FIG. 14 taken along the perspective direction. 15 shows a modification of the cross-sectional view of the medical lancing device shown in FIG. 14 taken along the perspective direction. FIG. 3A is a schematic diagram illustrating step 1A of the method for manufacturing a medical puncture device according to the embodiment of the present invention. The schematic diagram explaining process 1B-1 of the manufacturing method of the medical puncture device which concerns on one embodiment of this invention is represented. Fig. 6 is a schematic diagram illustrating step 1B-2 of the method for manufacturing the medical puncture device according to the embodiment of the present invention. Fig. 6 is a schematic diagram illustrating step 1B-2 of the method for manufacturing the medical puncture device according to the embodiment of the present invention. FIG. 3 is a cross-sectional view perpendicular to the long axes of the first tube and the second tube in the method for manufacturing the medical lancing device according to the embodiment of the present invention. FIG. 6 is a cross-sectional view perpendicular to the long axes of the first tube and the second tube of the method for manufacturing the medical lancing device according to another embodiment of the present invention. FIG. 10 is a cross-sectional view perpendicular to the long axis of the third tube, the fourth tube, and the needle tube of the method for manufacturing the medical lancing device according to still another embodiment of the present invention. FIG. 10 is a cross-sectional view perpendicular to the long axis of the third tube, the fourth tube, and the needle tube of the method for manufacturing the medical lancing device according to still another embodiment of the present invention. FIG. 10 is a cross-sectional view perpendicular to the long axis of the third tube, the fourth tube, and the needle tube of the method for manufacturing the medical lancing device according to still another embodiment of the present invention.

Hereinafter, the present invention will be described more specifically on the basis of the following embodiments, but the present invention is not limited by the following embodiments, and may be appropriately modified within a range compatible with the gist of the above-mentioned and the following. In addition, it is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. Note that, in each drawing, for convenience, hatching, member reference numbers, and the like may be omitted, but in such a case, the specification and other drawings are referred to. In addition, the dimensions of various members in the drawings are different from the actual dimensions because priority is given to contributing to the understanding of the features of the present invention.

1. Medical lancing device The basic configuration of the medical lancing device will be described with reference to Figs. 1 is a plan view (partially sectional view) of a medical lancing device according to an embodiment of the present invention, and FIG. 2 is an enlarged perspective view of a distal end portion of the medical lancing device shown in FIG. FIG. 3 shows a cross-sectional view of the medical lancing device shown in FIG. 2 taken along the perspective direction, and FIG. 4 shows a cross-sectional view taken along the line IV-IV of FIG. 3, showing the medical lancing device. The schematic diagram of the 1st surface (details are mentioned later) is shown.

In the present invention, the medical puncture device is a device used for injecting a liquid into a tissue site in a body cavity in endoscopic surgery, and is inserted into the body cavity via a forceps port of the endoscope, for example. It is a thing. The liquid to be injected may be a liquid containing a drug or cells in addition to a physiological saline solution or a hyaluronic acid solution. The medical puncture device 1 has a first hollow member 10, a second hollow member 20, and a needle tube 30.

In the medical puncture device 1, the proximal side refers to the hand side of the user, that is, the operator with respect to the extending direction of the first hollow member 10, and the distal side is opposite to the proximal side, that is, the treatment. Refers to the target side. Further, the direction from the proximal side to the distal side of the first hollow member 10 or the direction from the distal side to the proximal side is referred to as the perspective direction. The left side of FIG. 1 represents the distal side, and the right side of FIG. 1 represents the proximal side. The inward direction of the medical lancing device 1 refers to the direction toward the center of the major axis of the first hollow member 10 in the radial direction of the first hollow member 10, and the outward direction is the radiation in the opposite direction to the inward direction. Point in the direction.

The first hollow member 10 is a member formed in a hollow shape for accommodating the second hollow member 20 and the needle tube 30 so as not to damage the non-treatment target tissue portion of the body lumen or the forceps channel of the endoscope. is there. The first hollow member 10 extends in the perspective direction.

As shown in FIG. 3, the inner cavity 11 of the first hollow member 10 extends in the perspective direction and communicates with the outside through an opening 12 provided on the distal side of the first hollow member 10. ing. When puncturing the target tissue with the needle tube 30, the needle tube 30 is projected from the opening 12.

The inner diameter of the first hollow member 10 may be uniform in the perspective direction, but the first hollow member 10 may have a section in which the inner diameter decreases toward the distal end 10a. For example, as shown in FIGS. 1 to 3, it is preferable that the first hollow member 10 has a tapered portion 13 formed at its distal end portion, the taper portion 13 tapering toward the distal end 10a. By providing the tapered portion 13, it is possible to prevent the second hollow member 20 and the needle tube 30 from moving to the distal side from the opening 12 of the first hollow member 10. The minimum inner diameter of the tapered portion 13 is preferably smaller than the outer diameter of the distal end 20a of the second hollow member 20 and larger than the outer diameter of the needle tube 30.

The second hollow member 20 is arranged in the inner cavity 11 of the first hollow member 10 and is movable in the perspective direction with respect to the first hollow member 10. The inner cavity 21 of the second hollow member 20 functions as a flow path for flowing a liquid such as physiological saline or a drug. The lumen 21 of the second hollow member 20 communicates with the lumen 31 of the needle tube 30 at the distal end of the second hollow member 20.

Each of the first hollow member 10 and the second hollow member 20 preferably has a tubular shape as a whole, and can be, for example, a tubular shape, an elliptic tubular shape, or a polygonal tubular shape. The 1st hollow member 10 and the 2nd hollow member 20 may be constituted by one member, and may be constituted by a plurality of members. 1 to 4 show an example in which the first hollow member 10 and the second hollow member 20 are composed of one member. The thicknesses of the first hollow member 10 and the second hollow member 20 may be uniform, or may be different depending on the location. The first hollow member 10 and the second hollow member 20 may have the same thickness or different thicknesses.

The second hollow member 20 preferably has a section whose cross-sectional shape perpendicular to the perspective direction is a shape having no rotational symmetry, and from the distal end of the second hollow member 20 to the distal end thereof. It is more preferable that the shape does not have rotational symmetry in any part of the section up to the proximal side of 15 cm, and it is further preferable that the shape is not a perfect circle or a regular polygon. As a result, the center point Cin of the inscribed circle 25 of the second hollow member 20 is easily arranged at a position eccentric from the center point Cout of the circumscribed circle 26 of the second hollow member 20. 2 and 4, the cross section perpendicular to the perspective direction of the second hollow member 20 has an isosceles triangular shape.

At any part of the section from the distal end of the second hollow member 20 to the proximal side of 15 cm from the distal end, the cross section perpendicular to the perspective direction of the second hollow member 20 has an elliptical shape, a polygonal shape, or these. It is preferable that the shape is a combination thereof. As a result, the center point Cin of the inscribed circle 25 of the second hollow member 20 is easily arranged at a position eccentric from the center point Cout of the circumscribed circle 26 of the second hollow member 20.

If there is a gap between the second hollow member 20 and the needle tube 30 at the distal end of the second hollow member 20, it is preferable that the distal end of the second hollow member 20 be sealed. As a result, the gap between the second hollow member 20 and the needle tube 30 is filled, so that the liquid can be prevented from leaking from the second hollow member 20. For example, as shown in FIGS. 2 to 3, it is preferable that the medical puncture device 1 be provided with a tip member 27 that seals the distal end portion of the second hollow member 20.

The first hollow member 10 and the second hollow member 20 are preferably made of resin. As the resin forming the first hollow member 10 and the second hollow member 20, polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, natural rubber, etc. Is mentioned. These may be used alone or in combination of two or more. Among them, polyamide resin, polyester resin, polyurethane resin, polyolefin resin, and fluorine resin are preferably used. The resins forming the first hollow member 10 and the second hollow member 20 may be different or the same.

The needle tube 30 is fixed in the inner cavity 21 of the second hollow member 20 at the distal portion, and communicates with the inner cavity 21. The needle tube 30 is fixed to the second hollow member 20 so that the tip of the needle is located on the distal side. The needle tube 30 is formed in a tubular shape such as a circular tube so that a liquid such as physiological saline can flow therein. By puncturing the target site (for example, the submucosal layer) of the tissue with the needle tube 30, a liquid such as physiological saline can be injected. The tissue infused with liquid rises. The raised tissue can be captured and squeezed with a treatment tool such as a snare wire to excise the tissue, or the tissue can be excised using a high frequency treatment instrument such as an electric knife. The distal portion of the second hollow member 20 to which the needle tube 30 is fixed is farther from the center of the second hollow member 20 in the perspective direction, and includes the distal end 20a of the second hollow member 20. Is preferred.

The distal end portion of the needle tube 30 is not particularly limited as long as it is formed so as to easily puncture tissue, but as shown in FIG. 3, the needle tube 30 has an inclined opening edge 32 at the distal end. Is preferred.

The tip 30a (distal end) of the needle tube 30 is arranged more distally than the distal end 20a of the second hollow member 20 so that the tip 30a of the needle tube 30 can be punctured into tissue.

In order to improve the flow of the liquid in the lumen 31 of the needle tube 30, it is preferable that the shape of the cross section of the needle tube 30 perpendicular to the long axis direction is circular or elliptical.

As shown in FIG. 3, the long axis direction of the needle tube 30 is preferably parallel to the perspective direction of the first hollow member 10. Since the needle tube 30 easily moves along the perspective direction of the first hollow member 10, when the needle tube 30 is projected from the opening 12 on the distal side of the first hollow member 10, the tip 30a of the needle tube 30 has the first hollow member 30a. It becomes difficult to contact the distal end portion of 10.

As the material for forming the needle tube 30, in addition to the resin materials mentioned as the preferable materials for the first hollow member 10 and the second hollow member 20, metallic materials such as stainless steel and Ni—Ti alloy can be used.

As shown in FIGS. 2 to 4, the medical puncture device 1 is a surface perpendicular to the perspective direction of the first hollow member 10, and is from the distal end 20a of the second hollow member 20 to the distal end 20a. A surface 41 that maximizes the cross-sectional area of the second hollow member 20 in the section 40 up to the proximal side of 15 cm (if the cross-sectional area of the second hollow member 20 is uniform in the perspective direction, the distal end of the second hollow member 20). The surface including 20a) (hereinafter sometimes referred to as “first surface”) satisfies the following (1) and (2).
(1) The center point Cin of the inscribed circle 25 of the second hollow member 20 is eccentric from the center point Cout of the circumscribed circle 26 of the second hollow member 20.
(2) The direction of the vector A whose starting point is the central point Cin and the ending point is the point P where the perpendicular L drawn from the tip 30a of the needle tube 30 to the surface 41 and the surface 41 intersect, and the central point Cin as the starting point and the central point Cout Is the same as the direction of the vector B whose end point is.

In the present invention, the inscribed circle 25 of the second hollow member 20 is a circle having the largest radius that is in contact with at least a part of the inner wall forming the inner cavity 21 of the second hollow member 20 on the first surface 41. is there. Further, in the requirement of (2), the fact that the vector A and the vector B are in the same direction means that there is a difference of 30 degrees or less between the direction of the vector A and the direction of the vector B. 2 to 3, the cross-sectional area of the second hollow member 20 is uniform in the perspective direction. When there is a section where the cross-sectional area of the second hollow member 20 is maximum as described above, the surface including the most distal end of the section is defined as the first surface 41. Similarly, the first surface 41 can be uniquely defined in the following aspects. Therefore, in FIGS. 2 to 3, the surface including the distal end 20a of the second hollow member 20 is shown as the first surface 41.

According to the above requirements (1) and (2), the center of the long axis of the needle tube 30 arranged in the inner cavity 21 of the second hollow member 20 can be displaced from the center point Cout of the circumscribed circle 26 of the second hollow member 20. .. Further, the tip end 30a of the needle tube 30 is arranged near the center point Cout of the circumscribed circle 26 of the second hollow member 20. Therefore, when the needle tube 30 is projected from the opening 12 on the distal side of the first hollow member 10, the tip 30a of the needle tube 30 is less likely to contact the distal end portion of the first hollow member 10, so that the needle tube 30 is 1 The hollow member 10 can be quickly projected to the outside.

In the present invention, the difference between the directions of the vector A and the vector B within 30 degrees is allowed. However, as shown in FIG. 2 and FIG. It is preferable that the point P is located at. As a result, the angle formed by the vector A and the vector B becomes 0 degrees, so that when the needle tube 30 is projected from the opening 12 on the distal side of the first hollow member 10, the tip 30a of the needle tube 30 has the tip 30a. It becomes difficult to contact the distal end of the.

The distance between the center point Cout of the circumscribed circle 26 of the second hollow member 20 and the point P is preferably shorter than the distance between the center point Cin of the inscribed circle 25 of the second hollow member 20 and the point P. By setting the position of the tip 30a of the needle tube 30 in this manner, the tip 30a of the needle tube 30 can be brought close to the center point Cout of the circumscribed circle 26 of the second hollow member 20. When the distal end 30a of the needle tube 30 approaches the center point Cout of the circumscribing circle 26 of the second hollow member 20, the distal end of the needle tube 30 is protruded from the opening 12 on the distal side of the first hollow member 10. It becomes difficult for 30a to contact the distal end portion of the first hollow member 10.

As shown in FIGS. 2 and 3, the needle tube 30 preferably intersects with the surface 41 (first surface 41). As a result, the center of the long axis of the needle tube 30 deviates from the center Cout of the circumscribing circle 26 of the second hollow member 20 in at least a portion of the needle tube 30 in the long axis direction. It becomes easy to approach the center Cout of the circumscribed circle 26 of 20.

Another example in which the second hollow member 20 is composed of one member will be described with reference to FIGS. 5 to 7. 5 shows a modification of the perspective view of the medical lancing apparatus 1 shown in FIG. 2, FIG. 6 shows a cross-sectional view of the medical lancing apparatus 1 shown in FIG. 5 along the perspective direction, and FIG. 6 is a cross-sectional view taken along the line VII-VII of FIG. 6, showing a schematic view of the first surface 41 of the medical puncture device 1. In order to facilitate understanding of the invention, the first hollow member 10 is omitted in FIG.

The second hollow member 20 may have an uneven thickness shape whose thickness varies depending on the location. For example, in the section 40 from the distal end 20a of the second hollow member 20 to the proximal side of the distal end 20a by 15 cm, the second hollow member 20 has an uneven thickness shape whose thickness varies depending on the location. Good. Specifically, the thickness of the portion of the first surface 41 surrounding the inner cavity 21 of the second hollow member 20 is preferably different depending on the position in the circumferential direction. By changing the thickness of the second hollow member 20 in this way, the tip 30a of the needle tube 30 can be brought closer to the center Cout of the circumscribed circle 26 of the second hollow member 20.

The inner cavity 21 of the second hollow member 20 is preferably arranged radially outside the center Cout of the circumscribing circle 26 of the second hollow member 20. By arranging the inner cavity 21 of the second hollow member 20 in this manner, the second hollow member 20 can have an uneven thickness shape.

The thickness of the thickest portion of the second hollow member 20 on the first surface 41 is preferably larger than the outer diameter of the needle tube 30. By setting the wall thickness of the second hollow member 20 in this way, the second hollow member 20 can also be made to have an uneven thickness shape.

An example in which the second hollow member 20 has an uneven thickness shape will be described with reference to FIGS. 7 to 9. 8 to 9 show modifications of the schematic view of the first surface 41 of the second hollow member 20 having the uneven thickness shape. As shown in FIG. 7, the outer shape of the second hollow member 20 on the first surface 41 may be a perfect circle, and the inner shape of the second hollow member 20 may be an elliptical shape. Further, as shown in FIG. 8, both the outer shape and the inner shape of the second hollow member 20 on the first surface 41 may be a perfect circular shape. In that case, it is preferable that the inner cavity 21 of the second hollow member 20 is arranged radially outward of the center Cout of the circumscribing circle 26 of the second hollow member 20. Further, as shown in FIG. 9, the outer shape of the second hollow member 20 on the first surface 41 may be a perfect circle, and the inner shape of the second hollow member 20 may be a triangular shape. By making the outer shape and the inner shape different in this way, it becomes easier to form the second hollow member 20 having an uneven thickness shape.

Next, an example in which the second hollow member 20 is composed of two or more members will be described. 10 shows a modification of the perspective view of the medical lancing apparatus 1 according to another embodiment, FIG. 11 shows a cross-sectional view of the medical lancing apparatus 1 shown in FIG. 10 along the perspective direction, and FIG. 11 is a cross-sectional view taken along line XII-XII in FIG. 11, showing a schematic view of the first surface 41 of the medical puncture device 1. The second hollow member 20 may have an inner tube 22 and a spacer 23. In FIG. 11, the cross-sectional area of the second hollow member 20 is the largest in the section from the distal end 22a of the inner tube 22 to the proximal end 23b of the spacer 23, so in FIG. 12 the distal end 22a of the inner tube 22 is shown. The surface including is shown as the first surface 41.

The inner tube 22 is a tubular member arranged in the inner cavity 11 of the first hollow member 10. A needle tube 30 is arranged inside the inner tube 22. The inner tube 22 preferably extends along the perspective direction of the first hollow member 10. The inner tube 22 preferably moves in the perspective direction with respect to the first hollow member 10.

The shape of the cross section of the inner tube 22 perpendicular to the perspective direction is preferably circular or elliptical. Thereby, the second hollow member 20 can be easily moved in the perspective direction with respect to the first hollow member 10, and the manufacturing process of the inner tube 22 can be prevented from being complicated.

The spacer 23 is provided to adjust the position of the tip 30a of the needle tube 30. The spacer 23 can be formed into, for example, a solid rod shape, a cylinder shape, an elliptic cylinder shape, a rectangular cylinder shape, or the like, a lump shape, or a flat plate shape. A plurality of spacers 23 having the same or different thickness may be laminated. Alternatively, the plurality of spacers 23 may be arranged side by side in the long axis direction.

A plurality of spacers 23 may be provided. For example, the plurality of spacers 23 may be arranged so as to be separated from each other in the perspective direction or the circumferential direction. By thus providing the spacers 23 in a divided manner, it becomes easy to secure the flexibility at the distal portion of the second hollow member 20. The interval between the spacers 23 is not particularly limited, but when a plurality of spacers 23 are provided in the perspective direction, for example, the distance can be equal to or greater than the length of the spacers 23 in the perspective direction.

The length of the spacer 23 in the perspective direction is preferably longer than the thickness of the spacer 23 in the direction parallel to the vector B. As a result, the inner tube 22 or the needle tube 30 can be supported in a wide range by the spacer 23.

The distal end 23a of the spacer 23 may be arranged more distally than the proximal end of the section 40 from the distal end 20a of the second hollow member 20 to 15 cm proximal to the distal end 20a. preferable. By disposing the spacer 23 in the section 40, it becomes easy to form the surface 41 having the maximum cross-sectional area of the second hollow member 20.

The proximal end 23b of the spacer 23 may be located closer to the proximal side than the proximal end of the section 40 from the distal end 20a of the second hollow member 20 to the proximal side 15 cm from the distal end 20a. .. As a result, the inner tube 22 or the needle tube 30 can be supported in a wide range by the spacer 23.

The material forming the inner tube 22 and the spacer 23 is not particularly limited as long as it has biocompatibility, but may be formed of the same resin as the resin forming the first hollow member 10 and the second hollow member 20, for example.

The spacer 23 may be an adhesive layer formed of a polyurethane-based, epoxy-based, cyano-based, or silicone-based adhesive. As a result, the inner tube 22 and the needle tube 30 can be reliably fixed, and the needle tube 30 can be prevented from falling off the inner tube 22.

In order to improve the bondability between the spacer 23 and the inner tube 22, the spacer 23 and the inner tube 22 may be made of the same material.

As shown in FIGS. 10 to 12, the second hollow member 20 may include an inner tube 22 and a spacer 23 that is fixed inside the inner tube 22 and outside the needle tube 30. preferable. By providing the spacers 23 in this manner, it becomes easy to obtain a configuration that satisfies the above conditions (1) and (2).

The distal end 23a of the spacer 23 is arranged more proximally than the tip 30a of the needle tube 30 so that the needle tube 30 can be punctured into the target tissue.

The spacer 23 has an inner cavity 24 that encloses the needle tube 30, and in the surface 41 (first surface 41), the circumscribed circle of the spacer 23 and the inscribed circle inscribed in the inner cavity 24 of the spacer 23 are eccentric to each other. Is preferred. By arranging the needle tube 30 in the inner cavity 24 of the spacer 23 in this way, it becomes easy to obtain a configuration that satisfies the above conditions (1) and (2).

When the spacer 23 has the inner cavity 24 that encloses the needle tube 30, the spacer 23 has a structure in which it is arranged over the entire circumference of the needle tube 30. In this case, the spacer 23 is preferably formed in a cylindrical shape such as a cylinder, an elliptic cylinder, or a rectangular cylinder.

As shown in FIG. 12, it is preferable that the inner cavity 24 of the spacer 23 is arranged radially outward of the center Cout of the circumscribing circle 26 of the second hollow member 20. This facilitates disposing the center point Cin of the inscribed circle 25 of the second hollow member 20 at a position eccentric from the center point Cout of the circumscribed circle 26 of the second hollow member 20.

As shown in FIG. 11, the distal end 23a of the spacer 23 may be disposed more distally than the distal end 22a of the inner tube 22 in the perspective direction. As a result, the outer diameter of the distal portion of the second hollow member 20 can be reduced toward the distal side, so that the needle tube 30 can be prevented from being damaged due to the concentration of stress due to the sudden change of the outer diameter. it can. Although not shown, the position of the distal end 23a of the spacer 23 and the position of the distal end 22a of the inner tube 22 may match. Since the spacer 23 is not present on the distal side of the distal end 22a of the inner tube 22, it becomes easy to confirm the position of the needle tube 30 under the endoscope.

The position of the proximal end 23b of the spacer 23 preferably coincides with the position of the proximal end 30b of the needle tube 30, or is located closer to the proximal side than the proximal end 30b of the needle tube 30. A dead space is formed outside the needle tube 30 inside the inner tube 22, and it is possible to prevent the liquid from staying.

When the spacer 23 has the inner cavity 24, the inner surface of the spacer 23 (the inner wall forming the inner cavity 24) is fixed to the outer surface of the needle tube 30, and the outer surface of the spacer 23 is the inner tube 22. It is preferably fixed to the side surface. By fixing the spacer 23 in this way, even if the second hollow member 20 is moved, the spacer 23 and the needle tube 30 are unlikely to fall off from the distal side.

13 to 15 show an example in which the spacer 23 is provided outside the inner tube 22. 13 shows a modification of the perspective view of the medical lancing apparatus 1 shown in FIG. 10, FIG. 14 shows a cross-sectional view of the medical lancing apparatus 1 shown in FIG. 13 along the perspective direction, and FIG. 14 is a cross-sectional view taken along the line XV-XV in FIG. 14, showing a modification of the schematic view of the first surface 41 of the medical puncture device 1. In FIG. 14, the cross-sectional area of the second hollow member 20 is the largest in the section from the distal end 23a to the proximal end 23b of the spacer 23. Therefore, in FIGS. 14 to 15, the surface including the distal end 23a of the spacer 23 is shown as the first surface 41.

As shown in FIGS. 13 to 15, the second hollow member 20 preferably includes an inner tube 22 and a spacer 23 fixed to the outside of the inner tube 22. By attaching the spacer 23 to the outside of the inner tube 22, it becomes easy to perform the step of eccentricizing the center point Cin of the inscribed circle 25 of the second hollow member 20 from the center point Cout of the circumscribed circle 26.

As shown in FIG. 13, the inner tube 22 is arranged over the entire circumference of the needle tube 30, and the spacer 23 is arranged outside the inner tube 22 and in a part of the inner tube 22 in the circumferential direction. Is preferred. In manufacturing the medical puncture device 1, the step of inserting the needle tube 30 into the spacer 23 can be omitted.

The needle tube 30 has a beveled opening edge 32 at the distal end, the opening edge 32 has a most distal portion 32a and a most proximal portion 32b, and the spacer 23 is at least the side surface of the needle tube 30. It preferably exists on the side of the distal portion 32a. As a result, the tip 30a of the needle tube 30 comes to be disposed closer to the center point Cout of the circumscribed circle 26 of the second hollow member 20. Further, the spacer 23 may be present on the most distal portion 32a side of the side surface of the needle tube 30 and may not be present on the most proximal portion 32b side. Here, the presence of the spacer 23 on the side of the most distal portion 32a of the side surface of the needle tube 30 allows the interior angle to be within ±30 degrees including the most distal portion 32a, and the spacer 23 The presence on the side of the most proximal portion 32b of the side surface of the needle tube 30 allows the interior angle including the most proximal portion 32b to exist within a range of ±30 degrees.

When the spacer 23 is fixed to the outside of the inner tube 22, the shape of the cross section of the spacer 23 perpendicular to the perspective direction is preferably circular or elliptical. The outer side surface of the spacer 23 faces the inner side surface of the first hollow member 10. However, by forming the cross section of the spacer 23 in this way, the slidability of the spacer 23 with respect to the first hollow member 10 becomes good.

The outer surface of the spacer 23 is preferably fixed to the outer surface of the inner tube 22. By fixing the spacer 23 as described above, even when the second hollow member 20 is moved, the spacer 23 and the needle tube 30 are less likely to drop from the distal side.

When the spacer 23 is fixed to the outside of the inner tube 22, it is preferable that the outer surface of the spacer 23 be coated with a lubricant. Thereby, the slidability of the second hollow member 20 with respect to the first hollow member 10 can be improved.

The outer surface of the inner tube 22 and the outer surface of the spacer 23 may be directly bonded to each other, or the outer surface of the inner tube 22 and the outer surface of the spacer 23 may be indirectly bonded via an adhesive layer. ..

The spacer 23 is preferably disposed distally of the center of the inner tube 22 in the perspective direction, and a section from the distal end 20a of the second hollow member 20 to the proximal side of the distal end 20a by 15 cm. More preferably, it is arranged at 40. This makes it possible to support the second hollow member 20 in the vicinity where the needle tube 30 is arranged, while ensuring a large inner cavity of the inner tube 22.

The spacer 23 may be disposed over the entire inner tube 22 in the perspective direction. The spacer 23 facilitates disposing the entire needle tube 30 in the perspective direction near the center point Cout of the circumscribed circle 26 of the second hollow member 20.

As shown in FIGS. 13 to 14, it is preferable that the distal end 23 a of the spacer 23 is arranged closer to the proximal side than the proximal end 30 b of the needle tube 30 in the perspective direction. By shifting the positions of the needle tube 30 and the spacer 23 in the perspective direction in this way, it is possible to suppress local increase in rigidity in the portion where the needle tube 30 is provided.

FIG. 16 shows a modification of the cross-sectional view of the medical puncture device 1 shown in FIG. As shown in FIG. 16, the distal end 23a of the spacer 23 is aligned with or proximal to the distal end 22a of the inner tube 22, and the proximal end 30b of the needle tube 30. It may be arranged on the distal side. This makes it easier for the spacer 23 to support the portion of the inner tube 22 where the needle tube 30 is provided, so that the tip 30a of the needle tube 30 is arranged closer to the center point Cout of the circumscribed circle 26 of the second hollow member 20. It will be easier. In FIG. 16, the position of the first surface 41 in the perspective direction is shown as 41a.

As shown in FIGS. 13 to 15, it is preferable that the thickness of the spacer 23 in the direction parallel to the vector B is uniform in the perspective direction. This facilitates making the major axis direction of the needle tube 30 parallel to the perspective direction of the first hollow member 10. 13 to 15, the direction parallel to the vector B is the direction from the top to the bottom of the paper.

When the thickness of the spacer 23 in the direction parallel to the vector B is uniform in the perspective direction, it is preferable that the spacer 23 is arranged over the entire perspective direction of the inner tube 22. As a result, the second hollow member 20 is likely to be eccentric over the entire perspective direction.

17 to 18 show modified examples of sectional views taken along the perspective direction of the medical lancing apparatus 1 shown in FIG. 14. As shown in FIGS. 17 to 18, it is preferable that the major axis direction of the needle tube 30 is inclined with respect to the perspective direction of the first hollow member 10. The tip position of the needle tube 30 can be adjusted by inclining the long axis direction of the needle tube 30, and the tip 30a of the needle tube 30 can be easily brought closer to the center point Cout of the second hollow member 20 on the first surface 41. 17 to 18, the position of the first surface 41 in the perspective direction is shown as 41a.

It is preferable that the entire longitudinal direction of the needle tube 30 is inclined with respect to the perspective direction of the first hollow member 10. Inclination of the entire needle tube 30 instead of bending the needle tube 30 in this manner makes it difficult to apply a load to the needle tube 30, and thus damage to the needle tube 30 can be prevented.

It is preferable that the spacer 23 has a section thickened in the distal direction. By providing such a section, the needle tube 30 can be tilted. In particular, when the needle tube 30 has an inclined opening edge 32 at the distal end (tip 30a), and the opening edge 32 has the most distal portion 32a and the most proximal portion 32b, the needle tube 30 has The thickness of the spacer 23 in the direction parallel to the vector B of the portion of the side surface existing on the most distal portion 32a side of the opening edge 32 (vertical direction on the paper surface in FIGS. 17 and 18) is set to the proximal side. It is preferably smaller toward the bottom. The needle tube 30 can be tilted also by forming the spacer 23 in this manner. The thickness of the spacer 23 in the direction parallel to the vector B (the vertical direction on the paper surface in FIGS. 17 and 18) of the portion of the side surface of the needle tube 30 that is present on the most proximal portion 32b side of the opening edge 32 is: It may increase toward the proximal side.

The thicker section of the spacer 23 toward the distal direction may be provided over the entire distance of the spacer 23 in the perspective direction, or may be provided at a part of the spacer 23 in the perspective direction. It may be provided in the section 40 from the distal end 20a of the above to 15 cm proximal side from this distal end 20a. The distal end of the thicker section of the spacer 23 in the distal direction may be aligned with the distal end 23a of the spacer 23, and the distal end of the spacer 23 is located closer to the distal end 23a. It may have been done. In addition, the proximal end of the thicker section of the spacer 23 in the distal direction may be aligned with the proximal end of the spacer 23, and the proximal end of the spacer 23 is arranged on the distal side of the proximal end. It may have been done.

The distance in the perspective direction of the spacer 23 that is thicker in the distal direction is preferably longer than the length of the portion of the needle tube 30 disposed in the second hollow member 20 in the perspective direction. .. By setting the length of the section in this way, when the needle tube 30 is projected from the opening 12 on the distal side of the first hollow member 10, the tip position of the needle tube 30 can be made appropriate.

The major axis direction of the needle tube 30 is preferably inclined 3 degrees or more, more preferably 5 degrees or more, and further preferably 10 degrees or more with respect to the perspective direction of the first hollow member 10. .. By setting the inclination in this way, it becomes easy to avoid contact between the tip 30a of the needle tube 30 and the distal end of the first hollow member 10. The upper limit of the angle of inclination of the needle tube 30 in the long axis direction with respect to the perspective direction of the first hollow member 10 is not particularly limited, but may be 30 degrees or less, for example. The inclination of the needle tube 30 with respect to the perspective direction of the first hollow member 10 can be appropriately selected according to the angle required for the device and the sizes of the needle tube 30 and the hollow member.

As shown in FIG. 17, in the perspective direction, the major axis direction of the inner tube 22 may be parallel to the perspective direction of the first hollow member 10.

As shown in FIG. 18, the inner tube 22 may have a section in which the major axis direction is inclined with respect to the perspective direction of the first hollow member 10. For example, the section may be formed in the inner tube 22 by bending the distal portion of the inner tube 22.

The configuration on the hand side for moving the medical puncture device 1 will be described. As shown in FIG. 1, the first handle 51 is connected to the proximal side of the first hollow member 10. The first handle 51 is provided outside the second handle 52, and the second handle 52 is configured to be movable in the long axis direction with respect to the first handle 51. The second handle 52 is connected to the proximal side of the second hollow member 20. The first handle 51 and the second handle 52 are portions that an operator holds in order to move the second hollow member 20 and the needle tube 30 in the perspective direction. The second handle 52 is configured to be movable along the perspective direction. By moving the second handle 52 in the perspective direction, the needle tube 30 is exposed from the distal end portion of the first hollow member 10 or is housed in the first hollow member 10. A container containing a liquid is connected to the proximal side of the second handle 52. The first handle 51 and the first hollow member 10, and the second handle 52 and the second hollow member 20 can be connected by a method such as thermocompression bonding or adhesion with an adhesive. It is only necessary that the first handle 51 and the second handle 52 be movable relative to each other, and the second handle 52 may be movable in the long axis direction with respect to the first handle 51. The second handle 52 may be configured to be movable in the long axis direction.

2. Method for Manufacturing Medical Puncturing Device Next, a method for manufacturing the medical puncturing device 1 described above will be described.

An embodiment of a method for manufacturing the medical puncture device 1 will be described with reference to FIGS. 19 to 21. This method has a step of heating the medical puncture device 1, and applies an external force to the needle tube 30 in the direction D from the point P toward the center point Cout during the heating. Further, the medical puncture device 1 has a step of heating, and heating is performed so that the distance between the point P and the center point Cout after heating is shorter than the distance between the point P and the center point Cout before heating. The method will also be described.

The first hollow member 10 and the second hollow member 20 having the needle tube 30 inserted into the inner cavity 21 are prepared (step 1A). At this time, the needle tube 30 may not be fixed in the inner cavity 21 of the second hollow member 20. In step 1A, the center of the major axis of the second hollow member 20 and the center of the major axis of the needle tube 30 may be aligned.

As shown in FIG. 19, in step 1A, the second hollow member 20 includes an inner tube 22 and a spacer 23 arranged inside the inner tube 22 and outside the needle tube 30, Spacer 23 preferably has a lumen 24 that interiorly extends needle tube 30. In that case, the spacer 23 is more preferably made of resin. In the subsequent step 1B, when the medical puncture device 1 is heated and an external force is applied to the needle tube 30, the spacer 23 melts and the needle tube 30 easily moves, and then the medical puncture device 1 cools to form the spacer. The needle tube 30 can be fixed by 23. Further, the inner tube 22 preferably has heat shrinkability. In step 1B, when the medical puncture device 1 is heated, the inner tube 22 contracts, so that the gap between the inner tube 22 and the spacer 23 can be reduced. Here, the description has been given using the second hollow member 20 as shown in FIG. 19, but the second hollow member 20 is not limited to this mode, and all the modes described in “1. Medical lancing device” are applied. It is possible.

The medical lancing device 1 is heated (step 1B). Specifically, as shown in FIG. 19, it is preferable to heat the second hollow member 20, more preferably to heat the distal end portion of the second hollow member 20, and to heat the distal portion of the spacer 23. Is more preferable. By heating the medical puncture device 1, the resin around the needle tube 30 can be softened. The section 40 from the distal end 20a of the second hollow member 20 to the proximal side of the distal end 20a by 15 cm is preferably made of a thermoplastic resin. In the heating step, a heat-shrinkable tube made of a material different from the material may be arranged outside the second hollow member 20 and heated outside the second hollow member 20. The heat shrink tube should be removed after heating. As shown in FIG. 20, in step 1B, an external force in the direction D from the point P toward the center point Cout is applied to the needle tube 30 during heating (step 1B-1). As a result, the needle tube 30 arranged in the second hollow member 20 is eccentric from the center point Cout of the circumscribed circle 26 of the second hollow member 20. As the needle tube 30 moves, the inner cavity 21 of the second hollow member 20 in which the needle tube 30 is inserted also moves, so that the center point Cin of the inscribed circle 25 of the second hollow member 20 is the circumscribed circle of the second hollow member 20. It can be decentered from the center point Cout of 26. External force may be applied not only during heating but also before and after heating.

In the step of applying an external force, an external force is applied from the point P to the center point Cout side of the circumscribing circle 26 of the second hollow member 20 on the first surface 41, so the arrangement of members around the needle tube before heating should be set arbitrarily. You can Above all, the point P on the first surface 41 is more radially inward than the center point Cin of the inscribed circle 25 of the second hollow member 20 and more than the center point Cout of the circumscribed circle 26 of the second hollow member 20. It is preferable to heat in a state of being arranged radially outward. This makes it possible to manufacture the medical puncture device 1 that allows the needle tube 30 to quickly project to the outside of the first hollow member 10.

The second hollow member 20 is inserted into the inner cavity 11 of the first hollow member 10 (step 1C).

Another embodiment of Step 1B will be described with reference to FIGS. 21 to 22. 21 is a cross-sectional view showing the first surface 41 of the medical lancing device 1 in the state before the step 1B, and FIG. 22 shows the first surface 41 of the medical lancing device 1 in the state after the step 1B. It is sectional drawing shown. There is a step (step 1B) of heating the medical puncture device 1, and the point P and the center point Cout after the heating are more than the distance La (illustrated in FIG. 21) between the point P and the center point Cout before the heating. The heating is performed so that the distance Lb (shown in FIG. 22) of is short (step 1B-2). As shown in FIG. 21, before the step 1B, the center point Cout of the circumscribed circle 26 of the second hollow member 20 and the center point Cin of the inscribed circle 25 overlap. On the other hand, as shown in FIG. 22, after step 1B, the center point Cin of the inscribed circle 25 of the second hollow member 20 is displaced from the center point Cout of the circumscribed circle 26, and the point P (the tip of the needle tube 30) The position corresponding to 30a) is arranged near the center point Cout of the circumscribed circle 26 of the second hollow member 20. As described above, by heating as in step 1B-2 instead of step 1B-1, it is possible to manufacture the medical puncture device 1 capable of quickly projecting the needle tube 30 out of the first hollow member 10. it can. In step 1B-2, the medical puncture device having the above structure can be manufactured by heating with a spacer having a shape as shown in FIGS. 10 to 12 before heating.

Although not shown, the medical puncture device 1 having the second hollow member 20 formed of one member can also be manufactured by the following method. In step 1A, the second hollow member 20 is positioned such that the center of the long axis of the core material forming the inner cavity 21 of the second hollow member 20 is eccentric from the center point Cout of the circumscribed circle 26 of the second hollow member 20. You may manufacture by carrying out extrusion molding in the fixed state (process 1A-2). In that case, in step 1B, it is preferable to arrange the needle tube 30 in the inner cavity 21 of the second hollow member 20 and heat the second hollow member 20 without applying an external force to the needle tube 30 (step 1B-3). In step 1A-2, since the inscribed circle 25 of the second hollow member 20 can be eccentric, it is not necessary to heat while eccentric as in step 1B-1 or step 1B-2. After step 1B-3, step 1C is performed. The medical lancing device 1 can also be manufactured by such a method.

Next, an embodiment of a method for manufacturing the medical puncture device 1 having the spacer 23 will be described. The second hollow member 20 includes an inner tube 22 and a spacer 23 that is fixed to the inner side of the inner tube 22 and to the outer side of the needle tube 30, and the spacer 23 is an inner cavity inside the needle tube 30. 24, and the manufacturing method of the medical puncture device 1 in which the circumscribed circle of the spacer 23 and the inscribed circle inscribed in the inner cavity 24 of the spacer 23 are eccentric to each other on the surface 41 (first surface 41). Includes the step of inserting the proximal end of the needle tube 30 from the distal end side of the inner cavity 24 of the spacer 23.

First, the spacer 23 having the needle tube 30 and the lumen 24 enclosing the needle tube 30 is prepared (step 2A). Note that, on the first surface 41, the circumscribed circle of the spacer 23 and the inscribed circle inscribed in the inner cavity 24 of the spacer 23 are eccentric to each other. In order to be able to enclose the needle tube 30, the diameter of the inner cavity 24 of the spacer 23 is larger than the outer diameter of the needle tube 30. In step 2A, a core material is inserted into an inner cavity of a cylindrical body having a circular cross section perpendicular to the perspective direction, and the core material is directed from the outer side in the radial direction toward the center of the long axis of the cylindrical body. The spacer 23 in which the circumscribed circle and the inscribed circle inscribed in the lumen 24 are eccentric to each other may be manufactured by heating the distal end portion of the tubular body while applying an external force in the direction.

The proximal end 30b of the needle tube 30 is inserted from the distal end side of the inner cavity 24 of the spacer 23 (step 2B). Since the circumscribed circle of the spacer 23 and the inscribed circle inscribed in the inner cavity 24 of the spacer 23 are eccentric to each other on the first surface 41, the center point of the circumscribed circle of the spacer 23 is the circumscribed circle of the second hollow member 20. It is located near the center point Cout of 26. Therefore, by inserting the needle tube 30 into the spacer 23, the needle tube 30 can be decentered from the circumscribed circle 26 of the second hollow member 20 on the first surface 41.

Another embodiment of the method for manufacturing the medical puncture device 1 having the spacer 23 will be described. Specifically, the second hollow member 20 includes an inner tube 22 and a spacer 23 that is fixed to the inner side of the inner tube 22 and the outer side of the needle tube 30, and the spacer 23 includes the needle tube 30 inside. The medical puncture having an inner lumen 24 that faces the inner surface of the spacer 23 and the circumscribed circle of the spacer 23 and the inscribed circle of the spacer 23 that are inscribed in the inner lumen 24 of the spacer 23 are eccentric to each other on the surface 41 (first surface 41). The method of manufacturing the device 1 includes a step of fixing the outer surface of the spacer 23 and the inner surface of the inner tube 22 by heat welding or an adhesive.

Similarly to step 2A, a needle tube 30 and a spacer 23 having an inner cavity 24 that encloses the needle tube 30 are prepared (step 3A).

Similarly to step 2B, it is preferable to insert the tip 30a of the needle tube 30 from the proximal end side of the inner cavity 24 of the spacer 23 (step 3B).

The outer surface of the spacer 23 and the inner surface of the inner tube 22 are fixed by heat welding or an adhesive (step 3C). Here, the outer surface of the spacer 23 refers to the outer peripheral surface of the spacer 23, and the inner surface of the inner tube 22 refers to the inner peripheral surface of the inner tube 22. Since the manufacturing method according to the present invention has the step 3C, it is easy to form the second hollow member 20 satisfying the requirements (1) and (2).

In step 3C, the outer surface of the spacer 23, the inner surface of the inner tube 22, and the outer surface of the needle tube 30 may be fixed together by heat welding or an adhesive.

After step 3C, the inner surface of the spacer 23 and the outer surface of the needle tube 30 may be fixed by heat welding or an adhesive (step 3D).

Before the step 3C, the inner surface of the spacer 23 and the outer surface of the needle tube 30 may be fixed by heat welding or an adhesive (step 3E).

In steps 3C to 3E, it is preferable that at least one of the inner tube 22 and the spacer 23 is made of resin in order to fix the members to each other by heat welding. Further, from the viewpoint of firmly fixing the needle tube 30 and the spacer 23, the needle tube 30 may be made of resin.

As the adhesive used in steps 3C to 3E, polyurethane-based, epoxy-based, cyano-based, and silicone-based adhesives are preferable.

Still another embodiment of the method for manufacturing the medical puncture device 1 having the spacer 23 will be described. Specifically, the second hollow member 20 includes the inner tube 22, and the spacer 23 fixed to the inner side of the inner tube 22 and the outer side of the needle tube 30. The method includes a step of fixing the spacer 23 to the outer wall of the inner tube 22 or the inner wall of the inner tube 22 by heat welding or an adhesive.

Similar to the step 2A, the needle tube 30 and the spacer 23 having the inner cavity 24 containing the needle tube 30 are prepared (step 4A).

Similarly to step 2B, it is preferable to insert the tip 30a of the needle tube 30 from the proximal end side of the inner cavity 24 of the spacer 23 (step 4B).

The spacer 23 is arranged inside the inner tube 22 (step 4C).

After step 4C, the spacer 23 is fixed to the inner wall of the inner tube 22 by heat welding or an adhesive (step 4D). Since the manufacturing method according to the present invention has the step 4D, it is easy to form the second hollow member 20 satisfying the requirements (1) and (2).

Instead of the step 4C, the spacer 23 may be arranged outside the inner tube 22 (step 4E).

After step 4E, the spacer 23 is fixed to the outer wall of the inner tube 22 by heat welding or an adhesive (step 4F). Since the manufacturing method according to the present invention has the step 4F, it is easy to form the second hollow member 20 satisfying the requirements (1) and (2).

As the adhesive used in step 4D and step 4F, the adhesive mentioned in step 3C to step 3E can be used.

A method for manufacturing the medical puncture device 1 including a method for manufacturing at least the distal end portion of the second hollow member 20 using the first tube 61 and the second tube 62 will be described.

The method for manufacturing the medical puncture device 1 includes a step of inserting the needle tube 30 into the inner cavity of the first tube 61 whose cross-section perpendicular to the long axis is a non-circular shape, and heat-shrinking the first tube 61. The method includes a step of covering the second tube 62 that the user has and a step of heating the second tube 62.

Each step will be described below. First, the first tube 61 and the second tube 62 are prepared (step 5A). At least the distal end of the second hollow member 20 can be made by the first tube 61 and the second tube 62.

The first tube 61 has an inner cavity into which the needle tube 30 can be inserted. The lumen of the first tube 61 preferably extends from the distal end to the proximal end of the first tube 61. The cross section of the first tube 61 perpendicular to the major axis thereof has a non-round shape. Here, "the shape of the cross section perpendicular to the long axis is a non-round shape" means that at least one of the inner shape (outer diameter of the lumen) and the outer shape is taken in the cross section perpendicular to the long axis of the first tube 61. Means a non-round shape. In the cross section perpendicular to the major axis of the first tube 61, the inner shape and the outer shape of the first tube 61 are preferably concentric figures having different sizes. FIG. 23 shows a cross-sectional view of the first tube 61 and the second tube 62 perpendicular to the long axis. In FIG. 23, the inner shape and the outer shape of the cross section of the first tube 61 perpendicular to the long axis are both triangular.

The second tube 62 has heat shrinkability. The second tube 62 has a lumen, which preferably extends from the distal end to the proximal end of the second tube 62. The shape of the cross section of the second tube 62 perpendicular to the long axis may be a perfect circle, an ellipse, a polygon, or a combination thereof, but a perfect circle or an ellipse is preferable. Accordingly, the slidability of the second hollow member 20 in the first hollow member 10 in the perspective direction becomes good. The shape of the cross section of the second tube 62 perpendicular to the long axis may be the same as or different from the shape of the cross section of the first tube 61 perpendicular to the long axis. In FIG. 23, the cross section perpendicular to the long axis of the second tube 62 has a perfect circular shape.

The 1st tube 61 and the 2nd tube 62 can be comprised from the resin mentioned as a preferable material of the 1st hollow member 10 or the 2nd hollow member 20 demonstrated in "1. medical puncture device."

The needle tube 30 is inserted into the inner cavity of the first tube 61 whose cross-sectional shape perpendicular to the long axis is non-circular (step 5B). In step 5B, the tip 30a of the needle tube 30 can be inserted from the proximal end of the lumen of the first tube 61.

After the step 5B, the first tube 61 may be heated (step 5C). In that case, it is preferable that the first tube 61 also has heat shrinkability. The heating causes the first tube 61 to contract, and the inner surface of the first tube 61 easily adheres to the outer surface of the needle tube 30, so that the needle tube 30 can be firmly fixed to the first tube 61.

The first tube 61 is covered with the second tube 62 having heat shrinkability (step 5D).

In step 5D, the distal end of the first tube 61 may be covered so as to match the distal end of the second tube 62. Further, in step 5D, the distal end of the first tube 61 may be arranged on the distal side of the distal end of the second tube 62.

The second tube 62 is heated (step 5E). The second tube 62 contracts due to heating, and the second tube 62 is deformed so as to follow the shape of the first tube 61. Since the shape of the cross section of the first tube 61 perpendicular to the major axis is a non-round shape, the center point Cin of the inscribed circle 25 of the second hollow member 20 is separated from the center Cout of the circumscribed circle 26 of the second hollow member 20. Can be eccentric.

In Step 5E, the second tube 62 is preferably heated over the entire circumferential direction. Since the second tube 62 easily adheres to the first tube 61 in the entire circumferential direction, it becomes difficult to form a gap between the first tube 61 and the second tube 62.

In step 5E, the first tube 61 may be heated together with the second tube 62. In that case, it is preferable that the first tube 61 also has heat shrinkability. The heating causes the first tube 61 to contract, and the inner surface of the first tube 61 comes into close contact with the outer surface of the needle tube 30, so that the needle tube 30 can be firmly fixed to the first tube 61 and the second tube 62.

In step 5C or step 5E, a commercially available heating device can be used for heating each tube.

As a result of step 5E, the second tube 62 preferably covers both the first tube 61 and the needle tube 30. Thereby, since the needle tube 30 is firmly fixed to the first tube 61 and the second tube 62, even if the second hollow member 20 is moved in the perspective direction, the needle tube 30 does not fall off from the second hollow member 20. Can be prevented.

In step 5D, when the distal end of the first tube 61 is arranged more distally than the distal end of the second tube 62, after the step 5E, the first tube 61 is heated from the distal end face side. Is preferably performed (step 5F). This preferably seals the gap between the first tube 61 and the second tube 62 at the distal end of the first tube 61.

Another method for manufacturing the medical puncture device 1 using the first tube 61 and the second tube 62 will be described. In the method for manufacturing the medical puncture device 1, the second tube 62 having a non-circular cross section perpendicular to the major axis and having heat shrinkability is added to the first tube 61 in a state where the needle tube 30 is inserted into the inner cavity. And a step of heating the second tube 62.

Each step will be described below. First, the first tube 61 and the second tube 62 are prepared (step 6A). At least the distal end of the second hollow member 20 can be made by the first tube 61 and the second tube 62.

The first tube 61 has an inner cavity into which the needle tube 30 can be inserted. The lumen of the first tube 61 preferably extends from the distal end to the proximal end of the first tube 61. The shape of the cross section of the first tube 61 perpendicular to the major axis may be a perfect circle, an ellipse, a polygon, or a combination thereof, but a perfect circle or an ellipse is preferable. Accordingly, the slidability of the second hollow member 20 in the first hollow member 10 in the perspective direction becomes good. The shape of the cross section of the first tube 61 perpendicular to the long axis may be the same as or different from the shape of the cross section of the second tube 62 perpendicular to the long axis. FIG. 24 shows a cross-sectional view of the first tube 61 and the second tube 62 perpendicular to the long axis. In FIG. 24, the cross section perpendicular to the long axis of the first tube 61 has a perfect circular shape.

The second tube 62 has heat shrinkability. The second tube 62 has a lumen, which preferably extends from the distal end to the proximal end of the second tube 62. The second tube 62 has a non-round shape in a cross section perpendicular to its long axis. Here, "the shape of the cross section perpendicular to the long axis is a non-round shape" means that at least one of the inner shape (outer diameter of the lumen) and the outer shape is taken in the cross section perpendicular to the long axis of the second tube 62. Means a non-round shape. In the cross section perpendicular to the long axis of the second tube 62, the inner shape and the outer shape of the second tube 62 are preferably concentric figures having different sizes. In FIG. 24, the inner shape and the outer shape of the cross section of the second tube 62 perpendicular to the long axis are both triangular.

The 1st tube 61 and the 2nd tube 62 can be comprised from the resin mentioned as a preferable material of the 1st hollow member 10 or the 2nd hollow member 20 demonstrated in "1. medical puncture device."

It is preferable to insert the needle tube 30 into the inner cavity of the first tube 61 (step 6B). In step 6B, it is more preferable to insert the tip 30a of the needle tube 30 from the proximal end of the lumen of the first tube 61. As a result, the tip 30a of the needle tube 30 is arranged on the distal side. The puncture portion of the needle tube 30 is arranged more distally than the distal end of the first tube 61. The inner diameter of the first tube 61 is larger than the outer diameter of the needle tube 30.

After the step 6B, the first tube 61 may be heated (step 6C). Step 6C can be carried out in the same manner as in step 5C.

The first tube 61 in the state where the needle tube 30 is inserted into the inner cavity is covered with the second tube 62 having a non-circular cross section perpendicular to the long axis and having heat shrinkability (step 6D). Step 6D can be performed in the same manner as in step 5D.

The second tube 62 is heated (step 6E). Although the second tube 62 contracts by heating and comes into close contact with the first tube 61, the shape of the cross section perpendicular to the long axis of the second tube 62 remains a non-round shape even after heating. Therefore, by performing the step 6E, the center point Cin of the inscribed circle 25 of the second hollow member 20 can be decentered from the center Cout of the circumscribed circle 26 of the second hollow member 20. Note that step 6E can be performed by the same method as step 5E.

As a result of step 6E, the second tube 62 preferably covers both the first tube 61 and the needle tube 30. Thereby, since the needle tube 30 is firmly fixed to the first tube 61 and the second tube 62, even if the second hollow member 20 is moved in the perspective direction, the needle tube 30 does not fall off from the second hollow member 20. Can be prevented.

In step 6D, when the distal end of the first tube 61 is arranged more distally than the distal end of the second tube 62, after the step 6E, the first tube 61 is heated from the distal end face side. Is preferably performed (step 6F). Step 6F can be performed in the same manner as step 5F.

Still another method for manufacturing the medical puncture device 1 using the third tube 63 and the fourth tube 64 will be described. The method for manufacturing the medical puncture device 1 includes a step of covering the third tube 63 in a state where the needle tube 30 is inserted into the inner cavity with a fourth tube 64 having heat shrinkability, and a step of heating the fourth tube 64, And a step of removing the fourth tube 64 from the third tube 63. By controlling the outer shape of the third tube 63 during heating by the fourth tube 64 that can be removed after heating, the positional relationship between the third tube 63 and the needle tube 30 is controlled, and the third tube 63 at the predetermined position is controlled. The center point C3in of the inscribed circle 65 is arranged at a position eccentric from the center point C3out of the circumscribed circle 66 of the third tube 63, or the center point C3in of the inscribed circle 65 of the third tube 63 is the starting point and the tip of the needle tube 30 To make the direction of the vector whose end point is the point Q where the perpendicular line drawn from the above to the predetermined surface intersects the predetermined surface and the direction of the vector whose starting point is the central point C3in and whose ending point is the central point C3out. You can

Each step will be described below. First, the third tube 63 and the fourth tube 64 are prepared (step 7A). The third tube 63 has an inner cavity into which the needle tube 30 can be inserted. The lumen of the third tube 63 preferably extends from the distal end to the proximal end of the third tube 63. The third tube 63 allows at least the distal end of the second hollow member 20 to be made. The fourth tube 64 has an inner cavity, and the third tube 63 is arranged in this inner cavity. The fourth tube 64 contracts when heated, but the heating temperature is set to be equal to or lower than the melting point of the resin forming the fourth tube 64. The melting point of the resin forming the fourth tube 64 is higher than the melting point of the resin forming the third tube 63. The outer shape of the third tube 63 during heating can be controlled by the shape of the surface of the fourth tube 64 that is perpendicular to the long axis after contraction.

In addition, the tip of the needle tube 30 is controlled by controlling the positions of the third tube 63 and the needle tube 30 in the plane perpendicular to the long axis in the fourth tube 64, which are arranged in the inner cavity of the fourth tube 64 during heating. The position of the third tube 63 can be controlled. To control in this way, for example, there is a method of fixing the third tube 63 and the needle tube 30 to each other.

In order to prevent the third tube 63 and the fourth tube 64 from being joined to each other during heating, it is preferable that the third tube 63 and the fourth tube 64 are made of different materials.

The cross-sectional shape of the third tube 63 and the fourth tube 64 perpendicular to the long axis may be a perfect circular shape, an elliptical shape, a polygonal shape, a non-perfect circular shape, or a combination thereof. The cross-sectional shape of the third tube 63 perpendicular to the long axis may be the same as or different from the cross-sectional shape of the fourth tube 64 perpendicular to the long axis.

The third tube 63 in the state where the needle tube 30 is inserted into the inner cavity is covered with the fourth tube 64 having heat shrinkability (step 7B).

The fourth tube 64 is heated (step 7C). By this step, the third tube 63 arranged in the inner cavity of the fourth tube 64 is also heated. After heating, the fourth tube 64 can have a non-round shape (preferably a shape having no rotational symmetry) in the shape (inner shape) of the lumen in a cross section perpendicular to the long axis of the fourth tube 64. .. Since the third tube 63 is deformed to the shape of the fourth tube 64 after heating by heating, the outer shape of the cross section of the third tube 63 perpendicular to the major axis of the fourth tube 64 after step 7C is The shape may be a non-round shape (preferably a shape having no rotational symmetry) substantially matching the shape of the cavity.

The fourth tube 64 is cooled (step 7D). As a result, the third tube 63 can be solidified, and thus the shape attached in step 7C can be stably retained.

The fourth tube 64 is removed from the third tube 63 (step 7E). This makes it possible to manufacture at least the distal end portion of the second hollow member 20 having a non-circular outer shape in a cross section perpendicular to the long axis from the third tube 63. In step 7E, the fourth tube 64 may be torn and removed.

A change in cross-sectional shape before and after heating due to a difference in cross-sectional shape between the third tube 63 and the fourth tube 64 will be described with reference to FIGS. 25 to 27. 25 to 27 show cross-sectional views of the third tube 63, the fourth tube 64, and the needle tube 30 which are perpendicular to the long axis, (a) of each figure represents a state before heating, and (b) of each figure shows The state after heating is shown.

As shown in FIG. 25A, in the step 7A, a tube in which the fourth tube 64 has a non-round shape in the cross section perpendicular to the long axis direction after being heated can be used. As a result, as shown in FIG. 25B, in step 7C, the shape of the cross section of the third tube 63 perpendicular to the major axis can be a non-round shape.

As shown in FIG. 26A, in the step 7A, it is possible to use a tube whose cross section perpendicular to the major axis direction of the third tube 63 is a non-round shape. In that case, the cross-sectional shape of the fourth tube 64 perpendicular to the long axis is not particularly limited, and may have, for example, a triangular outer shape and a perfectly circular inner lumen. By using the third tube 63 and the fourth tube 64 having a predetermined shape, or by applying an external force to the needle tube 30, the third tube 63, and the fourth tube 64 in the heating step (step 7C), FIG. The shape may be as shown in FIG. In addition, in order to obtain the shape as shown in FIG. 26B, it is possible to control the position of the third tube 63, which is arranged in the inner cavity of the fourth tube 64, in a plane perpendicular to the long axis. For example, by inserting a core material into the inner cavity of the needle tube 30, fixing the core material and the fourth tube 64, and then heating the core material, the center point C3in of the inscribed circle 65 of the third tube 63 at a predetermined position. Is placed at a position eccentric from the center point C3out of the circumscribed circle 66 of the third tube 63, or is lowered from the tip of the needle tube 30 to a predetermined surface starting from the center point C3in of the inscribed circle 65 of the third tube 63. It is possible to make the direction of the vector whose end point is the point Q where the perpendicular line intersects the predetermined surface and the direction of the vector whose center point C3in is the start point and whose center point C3out is the end point.

As shown in FIG. 27A, in step 7A, the third tube 64 may have a non-round diameter in the cross section perpendicular to the major axis direction. Also in that case, the cross-sectional shape of the fourth tube perpendicular to the long axis is not particularly limited, but, for example, the outer shape may be a perfect circular shape and the lumen may be a triangular shape. As a result, in step 7C, the shape shown in FIG. 27B can be obtained.

1: Medical lancing device 10: First hollow member 10a: Distal end 11 of the first hollow member 11: Lumen 12 of the first hollow member 12: Opening 13: Tapered portion 20: Second hollow member 20a: Second hollow member Distal end 21: second hollow member lumen 22: inner tube 22a: inner tube distal end 23: spacer 23a: spacer distal end 23b: spacer proximal end 24: spacer lumen 25: Inner circle 26 of the second hollow member: Outer circle 27 of the second hollow member 27: Tip member 30: Needle tube 30a: Needle tube tip 31: Inner cavity 32: Opening edge 32a: Outmost edge portion 32b of opening edge: Opening edge Most proximal part 40: section 41 from the distal end of the second hollow member to the proximal side 15 cm from the distal end 41: surface (first surface)
41a: Position of the first surface in the perspective direction 51: First handle 52: Second handle 61: First tube 62: Second tubes A and B: Vector Cin: Center point Cout of the inscribed circle of the second hollow member: Center point D of the circumscribed circle of the second hollow member: Direction from the point P to the center point Cout L: Vertical line drawn from the tip of the needle tube to the surface La: Distance Lb between the point P and the center point Cout before heating Lb: Heating Distance P between the point P and the center point Cout afterward: a point where a perpendicular line drawn from the tip of the needle tube to the surface and the surface (first surface) start from the center point of the inscribed circle of the second hollow member

Claims (19)

A first hollow member extending in the perspective direction;
A second hollow member disposed in the inner cavity of the first hollow member and movable in a perspective direction with respect to the first hollow member;
A needle tube fixed in the lumen of the second hollow member at the distal portion thereof and communicating with the lumen;
A medical lancing device having:
The cross-sectional area of the second hollow member is the largest in the section perpendicular to the perspective direction of the first hollow member and extending from the distal end of the second hollow member to the proximal side of 15 cm from the distal end. (A surface including the distal end of the second hollow member when the cross-sectional area of the second hollow member is uniform in the perspective direction), the following (1) and (2) are satisfied. Medical lancing device.
(1) The center point Cin of the inscribed circle of the second hollow member is eccentric from the center point Cout of the circumscribed circle of the second hollow member.
(2) A direction of a vector A whose starting point is the center point Cin and whose end point is a point P where a perpendicular line drawn from the distal end of the needle tube to the surface intersects the surface, and the center point which is the starting point Cin The direction of the vector B whose end point is Cout is the same. The medical puncture device according to claim 1, wherein the second hollow member includes an inner tube and a spacer that is fixed inside the inner tube and outside the needle tube. The medical device according to claim 2, wherein the spacer has an inner cavity that encloses the needle tube, and the circumscribed circle of the spacer and the inscribed circle inscribed in the inner cavity of the spacer are eccentric to each other on the surface. Lancing device. The medical puncture device according to claim 1, wherein the second hollow member includes an inner tube and a spacer fixed to the outside of the inner tube. The needle tube has a beveled opening edge at a distal end, the opening edge has a most distal portion and a most proximal portion, and the spacer is the most distal portion of the side surface of the needle tube. The medical lancing device according to claim 4, which is present on the side. The medical puncture device according to any one of claims 2 to 5, wherein a thickness of the spacer in a direction parallel to the vector B is uniform in the perspective direction. The medical puncture device according to any one of claims 1 to 6, wherein a major axis direction of the needle tube is inclined with respect to a perspective direction of the first hollow member. The medical puncture device according to any one of claims 1 to 6, wherein a long axis direction of the needle tube is parallel to a perspective direction of the first hollow member. The medical puncture device according to any one of claims 1 to 6, wherein the needle tube intersects with the surface. The medical puncture device according to any one of claims 1 to 9, wherein the second hollow member has an uneven thickness shape whose thickness varies depending on a location. It is a manufacturing method of the medical puncture device as described in any one of Claims 1-10, Comprising: The step of softening the resin around the needle tube by heating the medical puncture device, and the needle tube, A method for manufacturing a medical puncture device, comprising the step of applying an external force in a direction from the point P toward the center point Cout. It is a manufacturing method of the medical puncture device as described in any one of Claims 1-10, Comprising: It has a process of heating this medical puncture device, The said point P and the said center point before the said heating. A method for manufacturing a medical lancing device, wherein the distance between the point P and the center point Cout after the heating is shorter than the distance from Cout. The method for manufacturing a medical puncture device according to claim 3, comprising the step of inserting the proximal end of the needle tube from the distal end side of the inner cavity of the spacer. Method. The method for manufacturing a medical puncture device according to claim 3, further comprising a step of fixing the outer surface of the spacer and the inner surface of the inner tube by heat welding or an adhesive. Production method. It is a manufacturing method of the medical puncture device as described in any one of Claims 2-10, Comprising: It has the process of fixing the said spacer to the outer wall of the said inner tube or the inner wall of the said inner tube by heat welding or an adhesive agent. A method for manufacturing a medical lancing device. It is a manufacturing method of the medical puncture device as described in any one of Claims 1-10, Comprising: The said needle tube is inserted in the internal cavity of the 1st tube whose shape of the cross section perpendicular|vertical to a major axis is a non-round shape. And a step of covering the first tube with a heat-shrinkable second tube, and a step of heating the second tube. It is a manufacturing method of the medical puncture device as described in any one of Claims 1-10, Comprising: The shape of the cross section perpendicular|vertical to a major axis is non-true in the 1st tube in the state which inserted the said needle tube in an inner cavity. A method of manufacturing a medical puncture device, comprising: a step of covering a second tube having a circular shape and having heat shrinkability; and a step of heating the second tube. The method for manufacturing a medical puncture device according to claim 16 or 17, wherein the second tube covers both the first tube and the needle tube. It is a manufacturing method of the medical puncture device as described in any one of Claims 1-10, Comprising: The process which covers the 4th tube which has heat shrinkability to the 3rd tube in the state which inserted the said needle tube in an internal cavity. And a step of heating the fourth tube, and a step of removing the fourth tube from the third tube, a method for manufacturing a medical puncture device.

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