JP7182490B2 - Medical puncture device and manufacturing method thereof - Google Patents

Description

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

Using an injection needle, physiological saline or hyaluronic acid solution is injected into the submucosa under the polyp formed on the stomach wall, intestinal wall, etc. under an endoscope to raise the polyp. Then, the polyp may be excised using a high-frequency treatment tool such as an electric knife. A puncture device is used to inject physiological saline or the like, which is delivered from the forceps port of the endoscope through the forceps channel to the site to be treated in the body lumen of the patient. The puncture device is composed of a needle, an inner tube (second hollow member) that holds the needle, and an outer tube (first hollow member) that accommodates the needle and the inner tube until they are delivered to the treatment target site. The inner diameter of the distal end of the outer tube is narrowed to restrict movement of the needle and inner tube distally 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 pushed through the opening on the distal side 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 pierce, and the needle may not come out of the outer tube. Therefore, methods for smoothly protruding the needle from the outer tube have been studied.

Patent Literature 1 discloses an endoscopic injection tool in which the vicinity of the injection needle of the inner tubular tube is bent at an angle such that the tip of the injection needle faces substantially the center of the opening. As a result, the bending angle of the inner tube can be set such that the tip of the injection needle always faces substantially the center of the opening. Patent Literature 2 discloses an injection device in which the tip of the injection needle is curved so that the sharp-angled portion of the tip of the injection needle is positioned on the axis of the injection needle. In Patent Document 3, a sharp-shaped blade is formed at the tip of a needle tube, and the blade has a first blade and a pair of second blades that constitute the tip of the blade. A needle is disclosed. By providing the second blade surface, a back cut portion is formed at the tip of the blade and on the rear surface of the first blade surface on the tip side, which serves to prevent the blade from sticking into the sheath.

Japanese Utility Model Laid-Open No. 3-64653 Japanese Utility Model Laid-Open No. 63-3801 JP-A-2005-312828

However, since the injection device described in Patent Document 1 deforms the inner cylindrical tube by thermal processing, there is a possibility that the shape of the inner cylindrical tube may change unnecessarily. In the injection device described in Patent Document 2, since the injection needle is curved, there is a risk that the curved portion may enter the tissue when an injection is performed, spreading the tissue and damaging it. Also, bending an injection needle with a narrow lumen creates turbulence in the flow of saline through the needle, reducing flow performance. With the puncture needle described in Patent Document 3, the position of the tip of the needle can be shifted only by the thickness of the needle. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a medical lancing device capable of quickly projecting a needle tube out of a first hollow member for accommodating the needle tube, and a method of manufacturing the same.

One embodiment of the medical puncture device of the present invention, which has been able to solve the above problems, is a first hollow member extending in the near-far direction; A medical device comprising: a second hollow member movable in a distal and proximal direction relative to the hollow member; and a needle tube fixed within the lumen at a distal portion of the second hollow member and communicating with the lumen In the puncture device, the cross-sectional area of the second hollow member in the section perpendicular to the distal-to-near direction of the first hollow member, from the distal end of the second hollow member to 15 cm proximal to the distal end is the maximum (the plane 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. do.
(1) The center point Cin of the inscribed circle of the second hollow member is offset from the center point Cout of the circumscribed circle of the second hollow member.
(2) The direction of the vector A starting at the center point Cin and ending at the point P where the perpendicular drawn from the tip of the needle tube to the above-mentioned surface intersects with the above-mentioned surface, and the direction of the vector A starting at the center point Cin and ending at the center point Cout. is the same as the direction of the vector B that

According to the requirements (1) and (2) above, the center of the long axis of the needle tube placed in the lumen of the second hollow member can be shifted from the center point Cout of the circumscribed circle of the second hollow member. Also, 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 protrudes from the opening on the distal side of the first hollow member, the tip of the needle tube is less likely to come into contact with the distal end of the first hollow member. can be protruded.

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

The spacer has a lumen that encloses the needle tube, and on the surface, the circumscribed circle of the spacer and the inscribed circle that inscribes the lumen of the spacer are preferably eccentric to each other.

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 slanted opening edge at the distal end, the opening edge has a most distal part and a most proximal part, and the spacer is present on the most distal side of the sides of the needle tube. is preferred.

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

It is preferable that the longitudinal direction of the needle tube is inclined with respect to the distance direction of the first hollow member.

It is preferable that the longitudinal direction of the needle tube is parallel to the far-near direction of the first hollow member.

Preferably, the needle tube intersects the plane.

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

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

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

The spacer has a lumen that encloses the needle tube, and the circumscribed circle of the spacer and the inscribed circle that inscribes the lumen of the spacer are eccentric on the above surface. 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 a lumen that encloses the needle tube, and the circumscribed circle of the spacer and the inscribed circle that inscribes the lumen of the spacer are eccentric on the above surface. It is preferable to have a step of fixing the outer surface and the inner surface of the inner tube by heat welding or adhesive.

The second hollow member includes an inner tube and a spacer fixed inside the inner tube and outside the needle tube. It is preferable to have the step of fixing to the inner wall of the inner tube by heat welding or adhesive.

The method of manufacturing the medical puncture device includes the steps of: inserting a needle tube into a lumen of a first tube having a non-perfect circular cross section perpendicular to the long axis; It is preferable to include the steps of covering the tube and heating the second tube.

The method for manufacturing the medical puncture device includes the step of covering the first tube with the needle tube inserted into the lumen with the heat-shrinkable second tube having a non-perfect circular cross section perpendicular to the long axis. and heating the second tube.

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

The method for manufacturing the medical puncture device includes the steps of covering the third tube with the needle tube inserted into the lumen with a fourth heat-shrinkable tube, heating the fourth tube, and heating the third tube. Preferably, the step of removing the fourth tube from the is included.

According to the requirements (1) and (2) above, the center of the long axis of the needle tube placed in the lumen of the second hollow member can be shifted from the center point Cout of the circumscribed circle of the second hollow member. Also, 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 protrudes from the distal opening of the first hollow member, the tip of the needle tube is less likely to come into contact with the distal end of the first hollow member. Therefore, the needle tube can be quickly projected out 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 that can quickly project the needle tube out of the first hollow member.

1 is a plan view (partial cross-sectional view) of a medical puncture device according to an embodiment of the present invention; FIG. FIG. 2 shows an enlarged perspective view of the distal end of the medical puncture device shown in FIG. 1; FIG. 3 shows a cross-sectional view of the medical puncture device shown in FIG. 2 along the perspective direction; 4 represents a cross-sectional view along line IV-IV of FIG. 3 and shows a schematic view of the first surface of the medical puncture device. FIG. FIG. 3 shows a modification of the perspective view of the medical puncture device shown in FIG. 2 ; FIG. 6 shows a cross-sectional view of the medical puncture device shown in FIG. 5 along the perspective direction; FIG. 7 represents a cross-sectional view along line VII-VII of FIG. 6 and shows a schematic diagram of the first surface of the medical puncture device. FIG. 8 represents a modification of the cross-sectional view shown in FIG. 7 ; 8 shows another modification of the cross-sectional view shown in FIG. 7 ; FIG. FIG. 4 shows a perspective view of a medical puncture device according to another embodiment of the present invention; FIG. 11 shows a cross-sectional view of the medical puncture device shown in FIG. 10 along the perspective direction; FIG. 11 represents a cross-sectional view taken along line XII-XII in FIG. 11 and shows a schematic diagram of the first surface of the medical puncture device. 11 shows a modification of the perspective view of the medical puncture device shown in FIG. 10. FIG. FIG. 14 shows a cross-sectional view of the medical puncture device shown in FIG. 13 along the perspective direction; FIG. 14 represents a cross-sectional view taken along line XV-XV of FIG. 14 and shows a schematic diagram of the first surface of the medical puncture device. FIG. 15 shows a modification of the cross-sectional view of the medical puncture device shown in FIG. 14 along the perspective direction. FIG. 15 shows a modification of the cross-sectional view of the medical puncture device shown in FIG. 14 along the perspective direction. FIG. 15 shows a modification of the cross-sectional view of the medical puncture device shown in FIG. 14 along the perspective direction. FIG. 4 is a schematic diagram for explaining step 1A of the manufacturing method of the medical puncture device according to the embodiment of the present invention; FIG. 4 is a schematic diagram for explaining step 1B-1 of the method for manufacturing the medical puncture device according to one embodiment of the present invention; FIG. 4 is a schematic diagram for explaining step 1B-2 of the manufacturing method of the medical puncture device according to the embodiment of the present invention; FIG. 4 is a schematic diagram for explaining step 1B-2 of the manufacturing method of the medical puncture device according to the embodiment of the present invention; FIG. 4B 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 puncture device according to the embodiment of the present invention; FIG. 10B is a cross-sectional view perpendicular to the major axes of the first tube and the second tube in the method of manufacturing a medical puncture device according to another embodiment of the present invention; FIG. 13B is a cross-sectional view perpendicular to the long axis of the third tube, the fourth tube, and the needle tube in the manufacturing method of the medical puncture device according to still another embodiment of the present invention; FIG. 13B is a cross-sectional view perpendicular to the long axis of the third tube, the fourth tube, and the needle tube in the manufacturing method of the medical puncture device according to still another embodiment of the present invention; FIG. 13B is a cross-sectional view perpendicular to the long axis of the third tube, the fourth tube, and the needle tube in the manufacturing method of the medical puncture device according to still another embodiment of the present invention;

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope of the above and later descriptions. It is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

1. Medical Puncture Apparatus A basic configuration of a medical puncture apparatus will be described with reference to FIGS. 1 to 4. FIG. FIG. 1 is a plan view (partial cross-sectional view) of a medical puncture device according to an embodiment of the present invention, and FIG. 2 is an enlarged perspective view of the distal end portion of the medical puncture device shown in FIG. 3 represents a cross-sectional view along the perspective direction of the medical puncture device shown in FIG. 2, FIG. 4 represents a cross-sectional view along the IV-IV line in FIG. 1 shows a schematic diagram of a first surface (details of which will be described later); FIG.

In the present invention, a medical puncture device is a device used for injecting liquid into a tissue site within a body cavity in endoscopic surgery, and is inserted into the body cavity, for example, through a forceps port of an endoscope. It is. The liquid to be injected may be physiological saline, hyaluronic acid solution, or liquid containing drugs or cells. 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 refers to the direction opposite to the proximal side, that is, the treatment direction. Point to the target side. Also, 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 far-near direction. The left side of FIG. 1 represents the distal side, and the right side of FIG. 1 represents the proximal side. In addition, the term "inward" of the medical puncture device 1 refers to the direction toward the longitudinal center of the first hollow member 10 in the radial direction of the first hollow member 10, and the term "outward" refers to the radial direction opposite to the inner direction. pointing in the direction.

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

As shown in FIG. 3, the lumen 11 of the first hollow member 10 extends in the near-and-far 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 near-to-far direction, but the first hollow member 10 may have a section of decreasing inner diameter towards the distal end 10a. For example, as shown in FIGS. 1-3, first hollow member 10 preferably has a tapered portion 13 at its distal end that tapers toward distal end 10a. By providing the tapered portion 13 , movement of the second hollow member 20 and the needle tube 30 to the distal side from the opening 12 of the first hollow member 10 can be restricted. The minimum inner diameter of the tapered portion 13 is preferably smaller than the outer diameter of the distal end 20 a 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 lumen 11 of the first hollow member 10 and is movable in the distance direction with respect to the first hollow member 10 . A lumen 21 of the second hollow member 20 functions as a channel for flowing liquids such as physiological saline and drugs. 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 have, for example, a cylindrical shape, an oval tubular shape, or a polygonal tubular shape. The first hollow member 10 and the second hollow member 20 may be composed of one member, or may be composed of a plurality of members. FIGS. 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 differ 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 in which the cross-sectional shape perpendicular to the perspective direction has no rotational symmetry. It is more preferable to have a shape that does not have rotational symmetry at any part of the section up to the 15 cm proximal side, for example, it is more preferable that it is neither a perfect circle nor a regular polygon. This makes it easier for the center point Cin of the inscribed circle 25 of the second hollow member 20 to be located 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 of the second hollow member 20 perpendicular to the perspective direction has an isosceles triangle shape.

In any part of the section from the distal end of the second hollow member 20 to 15 cm proximal to the distal end, the cross section perpendicular to the near-far direction of the second hollow member 20 has an elliptical shape, a polygonal shape, or any of these shapes. It is preferable that the shape is a combination of This makes it easier for the center point Cin of the inscribed circle 25 of the second hollow member 20 to be located 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, the distal end of the second hollow member 20 is preferably sealed. Since this fills the gap between the second hollow member 20 and the needle tube 30 , it is possible to prevent the liquid from leaking from the second hollow member 20 . For example, as shown in FIGS. 2 and 3, the medical puncture device 1 is preferably provided with a tip member 27 that seals the distal end of the second hollow member 20 .

The first hollow member 10 and the second hollow member 20 are preferably made of resin. Examples of resins constituting the first hollow member 10 and the second hollow member 20 include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, fluorine-based resins, vinyl chloride-based resins, silicone-based resins, natural rubber, and the like. is mentioned. These may use only 1 type and may use 2 or more types together. Among them, polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, and fluorine-based resins are preferably used. The resins forming the first hollow member 10 and the second hollow member 20 may be different or the same.

A needle tube 30 is fixed within the lumen 21 at the distal portion of the second hollow member 20 and communicates with the lumen 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 tube shape such as a circular tube shape so that a liquid such as physiological saline can flow inside. A liquid such as physiological saline can be injected by puncturing a target site (for example, submucosa) of tissue with the needle tube 30 . The fluid-infused tissue bulges. The raised tissue can be captured and strangled by 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 located on the distal side of the center of the second hollow member 20 in the far-near direction, and includes the distal end 20a of the second hollow member 20. is preferably

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. is preferred.

A tip 30a (distal end) of the needle tube 30 is arranged on the distal side of the distal end 20a of the second hollow member 20 so that the tip 30a of the needle tube 30 can puncture tissue.

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

As shown in FIG. 3 , the longitudinal direction of the needle tube 30 is preferably parallel to the perspective direction of the first hollow member 10 . Since the needle tube 30 is easier to move along the first hollow member 10 in the far-near direction, when the needle tube 30 is protruded from the opening 12 on the distal side of the first hollow member 10, the tip 30a of the needle tube 30 is aligned with the first hollow member. The distal end of 10 is less accessible.

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

As shown in FIGS. 2 to 4, the medical puncture device 1 extends from the distal end 20a of the second hollow member 20 to the distal end 20a of the first hollow member 10 perpendicular to the near-far direction. A plane 41 where the cross-sectional area of the second hollow member 20 is the largest in the section 40 to the proximal side of 15 cm (when the cross-sectional area of the second hollow member 20 is uniform in the near-far 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 offset from the center point Cout of the circumscribed circle 26 of the second hollow member 20 .
(2) The direction of vector A starting from center point Cin and ending at point P where surface 41 intersects perpendicular line L drawn from tip 30a of needle tube 30, and center point Cout starting from center point Cin. 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 the circle with the largest radius that is in contact with at least a portion of the inner wall forming the lumen 21 of the second hollow member 20 on the first surface 41. be. Further, in the requirement (2), the term "vector A and vector B are in the same direction" means that the direction of vector A and the direction of vector B are allowed to differ within 30 degrees. 2 and 3, the cross-sectional area of the second hollow member 20 is uniform in the perspective direction. In this way, when there is a section where the cross-sectional area of the second hollow member 20 is the largest, the first surface 41 is the plane including the most distal portion of the section. Similarly, the first surface 41 can be univocally defined for the following aspects as well. Therefore, the plane including the distal end 20a of the second hollow member 20 is shown as the first plane 41 in FIGS.

According to the requirements (1) and (2) above, the center of the long axis of the needle tube 30 arranged in the lumen 21 of the second hollow member 20 can be shifted from the center point Cout of the circumscribed circle 26 of the second hollow member 20. . Also, the tip 30 a of the needle tube 30 is arranged closer to the center point Cout of the circumscribed circle 26 of the second hollow member 20 . Therefore, when the needle tube 30 protrudes 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 come into contact with the distal end portion of the first hollow member 10. 1 can be protruded out of the hollow member 10 quickly.

In the present invention, the difference between the direction of vector A and the direction of vector B is allowed to be within 30 degrees. It is preferable that the point P is located at . As a result, the angle formed by vector A and vector B becomes 0 degree. less contact with the distal end of the

The distance connecting 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 connecting 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 30 a of the needle tube 30 in this way, the tip 30 a of the needle tube 30 can be brought closer to the center point Cout of the circumscribed circle 26 of the second hollow member 20 . When the tip 30a of the needle tube 30 approaches the center point Cout of the circumscribed circle 26 of the second hollow member 20 and projects the needle tube 30 from the opening 12 on the distal side of the first hollow member 10, the tip of the needle tube 30 30 a becomes less likely to contact the distal end of the first hollow member 10 .

As shown in FIGS. 2 and 3, needle tube 30 preferably intersects 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 circumscribed circle 26 of the second hollow member 20 in at least a part of the long axis direction of the needle tube 30, so that the position of the tip 30a of the needle tube 30 is shifted to the position of the second hollow member. It becomes easier 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. FIG. 5 shows a modification of the perspective view of the medical puncture device 1 shown in FIG. 2, FIG. 6 shows a cross-sectional view of the medical puncture device 1 shown in FIG. 7 represents a cross-sectional view along the VII-VII line in FIG. 6 and shows a schematic diagram of the first surface 41 of the medical puncture device 1. FIG. In order to facilitate understanding of the invention, the first hollow member 10 is omitted in FIG. 5 .

The second hollow member 20 may have an uneven thickness shape with different thicknesses 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 15 cm from the distal end 20a, the second hollow member 20 has an uneven thickness shape with different thicknesses depending on the location. good too. Specifically, the thickness of the portion of the first surface 41 surrounding the lumen 21 of the second hollow member 20 preferably varies depending on the position in the circumferential direction. By changing the thickness of the second hollow member 20 in this manner, the tip 30 a 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 lumen 21 of the second hollow member 20 is preferably arranged radially outside the center Cout of the circumscribed 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 be formed into a shape with uneven thickness.

It is preferable that the thickness of the thickest portion of the second hollow member 20 on the first surface 41 is larger than the outer diameter of the needle tube 30 . By setting the thickness of the second hollow member 20 in this manner, the second hollow member 20 can be made to have an uneven thickness.

An example in which the second hollow member 20 has uneven thickness will be described with reference to FIGS. 7 to 9. FIG. 8 and 9 show modifications of the schematic diagram of the first surface 41 of the second hollow member 20 having uneven thickness. As shown in FIG. 7, the outer shape of the second hollow member 20 may be a perfect circle on the first surface 41, and the inner shape of the second hollow member 20 may be an elliptical shape. Moreover, 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 perfectly circular. In that case, the lumen 21 of the second hollow member 20 is preferably arranged radially outward of the center Cout of the circumscribed circle 26 of the second hollow member 20 . Furthermore, 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 triangular. 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.

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 a perspective view of a medical puncture device 1 according to another embodiment, FIG. 11 shows a cross-sectional view of the medical puncture device 1 shown in FIG. FIG. 11 is a cross-sectional view taken along line XII-XII of FIG. 11 and shows a schematic diagram of the first surface 41 of the medical puncture device 1. FIG. The second hollow member 20 may have an inner tube 22 and spacers 23 . 11, the cross-sectional area of the second hollow member 20 is greatest 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. is shown as a first surface 41 .

The inner tube 22 is a tubular member arranged in the lumen 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 distance direction of the first hollow member 10 . The inner tube 22 preferably moves toward and away from the first hollow member 10 .

The cross-sectional shape of the inner tube 22 perpendicular to the perspective direction is preferably circular or elliptical. This makes it easier to move the second hollow member 20 in the far-near direction with respect to the first hollow member 10 , and it is possible to suppress complication of the manufacturing process of the inner tube 22 .

A spacer 23 is provided to adjust the position of the tip 30 a of the needle tube 30 . The spacer 23 can be formed, for example, in the shape of a solid rod, a cylinder such as a cylinder, an elliptical cylinder, or a rectangular cylinder, a mass, or a flat plate. A plurality of spacers 23 having the same thickness or different thicknesses may be laminated. Alternatively, a plurality of spacers 23 may be arranged side by side in the longitudinal 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 dividing the spacer 23 in this way, it becomes easier to ensure the flexibility of the distal portion of the second hollow member 20 . The distance between the spacers 23 is not particularly limited, but when a plurality of spacers 23 are provided in the distance direction, the distance can be equal to or greater than the length of the spacers 23 in the distance 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. Thereby, the spacer 23 can support the inner tube 22 or the needle tube 30 in a wide range.

The distal end 23a of the spacer 23 is arranged distally of 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 arranging the spacer 23 in the section 40, it becomes easier to form the surface 41 that maximizes the cross-sectional area of the second hollow member 20. As shown in FIG.

The proximal end 23b of the spacer 23 may be located proximal to 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. . Thereby, the spacer 23 can support the inner tube 22 or the needle tube 30 in a wide range.

Materials for the inner tube 22 and the spacer 23 are not particularly limited as long as they are biocompatible.

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 securely fixed, and the dropout of the needle tube 30 from the inner tube 22 can be prevented.

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

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

The distal end 23a of the spacer 23 is arranged proximal to 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 a lumen 24 containing the needle tube 30, and on the surface 41 (first surface 41), the circumscribed circle of the spacer 23 and the inscribed circle inscribed in the lumen 24 of the spacer 23 are eccentric to each other. preferably. By arranging the needle tube 30 in the lumen 24 of the spacer 23 in this way, it becomes easier to achieve a configuration that satisfies the above conditions (1) and (2).

When the spacer 23 has the lumen 24 enclosing the needle tube 30 , the structure is such that the spacer 23 is arranged over the entire circumferential direction of the needle tube 30 . In this case, the spacer 23 is preferably formed in a tubular shape such as a cylinder, an elliptical 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 circumscribed circle 26 of the second hollow member 20 . This makes it easier for the center point Cin of the inscribed circle 25 of the second hollow member 20 to be located 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 positioned distally relative to the distal end 22a of the inner tube 22 in the near-to-far direction. As a result, since the outer diameter of the distal portion of the second hollow member 20 can be reduced toward the distal side, it is possible to prevent damage to the needle tube 30 due to concentration of stress caused by a sudden change in the outer diameter. 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 coincide. Since the spacer 23 does not exist on the distal side of the distal end 22a of the inner tube 22, it becomes easier to confirm the position of the needle tube 30 under an endoscope.

It is preferable that the position of the proximal end 23b of the spacer 23 matches the position of the proximal end 30b of the needle tube 30 or is arranged closer to the proximal side than the proximal end 30b of the needle tube 30 . It is possible to prevent a dead space from being formed inside the inner tube 22 and outside the needle tube 30 and causing the liquid to stagnate.

When the spacer 23 has a lumen 24 , the inner surface of the spacer 23 (the inner wall forming the lumen 24 ) is fixed to the outer surface of the needle tube 30 and the outer surface of the spacer 23 is inside the inner tube 22 . It is preferably fixed to the side. Fixing the spacer 23 in this way also makes it difficult for the spacer 23 and the needle tube 30 to fall off from the distal side even when the second hollow member 20 is moved.

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

As shown in FIGS. 13-15, the second hollow member 20 preferably includes an inner tube 22 and a spacer 23 fixed to the outside of the inner tube 22 . Attaching the spacer 23 to the outside of the inner tube 22 facilitates the process of eccentrically shifting 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 circumferential direction of the needle tube 30, and the spacer 23 is arranged outside the inner tube 22 and 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 its distal end, the opening edge 32 having a distalmost portion 32a and a most proximal portion 32b, and the spacer 23 extending at least the most of the side surfaces of the needle tube 30. It is preferably present on the distal portion 32a side. As a result, the distal end 30 a of the needle tube 30 is arranged 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 side of the needle tube 30 on the side of the most distal portion 32a and may not be present on the side of the most proximal portion 32b. Here, the fact that the spacer 23 exists on the side of the most distal portion 32a of the side surfaces of the needle tube 30 allows that the inner angle including the most distal portion 32a exists within a range of ±30 degrees, and the spacer 23 is Existence on the most proximal portion 32b side among the side surfaces of the needle tube 30 allows the interior angle to exist within a range of ±30 degrees including the most proximal portion 32b.

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 surface of the spacer 23 faces the inner surface of the first hollow member 10, and 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 is improved.

Preferably, the outer surface of spacer 23 is fixed to the outer surface of inner tube 22 . 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 less likely to fall off from the distal side.

When the spacer 23 is fixed to the outside of the inner tube 22, the outer surface of the spacer 23 is preferably lubricated. Thereby, the slidability of the second hollow member 20 with respect to the first hollow member 10 can be enhanced.

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 distal and proximal direction, and extends from the distal end 20a of the second hollow member 20 to 15 cm proximal to the distal end 20a. 40 is more preferred. Thereby, the second hollow member 20 can be supported in the vicinity where the needle tube 30 is arranged while securing a wide lumen of the inner tube 22 .

The spacers 23 may be arranged over the entire length of the inner tube 22 . The spacer 23 facilitates arranging the entire needle tube 30 in the distance direction toward the center point Cout of the circumscribed circle 26 of the second hollow member 20 .

As shown in FIGS. 13 and 14, the distal end 23a of the spacer 23 is preferably located closer to the proximal side than the proximal end 30b of the needle tube 30 in the near-far direction. By shifting the positions of the needle tube 30 and the spacer 23 in the far-near direction in this way, it is possible to suppress local increase in rigidity at 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 coincides with or is proximal to the distal end 22a of the inner tube 22, and the proximal end 30b of the needle tube 30 It may be located distal to the . 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. easier. In addition, 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, the spacer 23 preferably has a uniform thickness in the direction parallel to the vector B in the perspective direction. This makes it easier to make the longitudinal direction of the needle tube 30 parallel to the perspective direction of the first hollow member 10 . 13 to 15, the direction parallel to vector B is the direction from top to bottom of the paper.

If the thickness of the spacer 23 in the direction parallel to vector B is uniform in the perspective direction, it is preferable that the spacer 23 is arranged in the entire distance direction of the inner tube 22 . This makes it easier for the second hollow member 20 to be eccentric over the entire distance direction.

17 and 18 show modifications of cross-sectional views of the medical puncture device 1 shown in FIG. 14 along the direction of near and far. As shown in FIGS. 17 and 18, the longitudinal direction of the needle tube 30 is preferably inclined with respect to the distance direction of the first hollow member 10 . By tilting the longitudinal direction of the needle tube 30 , the tip position of the needle tube 30 can be adjusted, and the tip 30 a 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 and 18, the position of the first surface 41 in the perspective direction is represented as 41a.

It is preferable that the entire longitudinal direction of the needle tube 30 is inclined with respect to the far-near direction of the first hollow member 10 . By tilting the entire needle tube 30 instead of bending the needle tube 30 in this manner, a load is less likely to be applied to the needle tube 30, and damage to the needle tube 30 can be prevented.

Spacer 23 preferably has a section that is thickened in the distal direction. By providing such a section, the needle tube 30 can be tilted. Specifically, when the needle tube 30 has an inclined opening edge 32 at its distal end (tip 30a), and the opening edge 32 has a most distal portion 32a and a most proximal portion 32b, the needle tube 30 The thickness of the spacer 23 in the direction parallel to the vector B (in FIGS. 17 and 18, the vertical direction of the paper surface) of the portion existing on the most distal portion 32a side of the opening edge 32 among the side surfaces is increased to the proximal side. It is preferable that it becomes smaller toward the direction. The needle tube 30 can also be tilted by forming the spacer 23 in this way. In addition, the thickness of the spacer 23 in the direction parallel to the vector B 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 (vertical direction in FIGS. 17 and 18) is It may increase proximally.

The section of the spacer 23 formed thicker toward the distal direction may be provided over the entire length of the spacer 23 in the distance direction, or may be provided in a portion of the distance direction. from the distal end 20a to 15 cm proximal to the distal end 20a. The distal end of the distally thickened section of spacer 23 may coincide with distal end 23a of spacer 23 and is located proximally relative to distal end 23a of spacer 23. may have been In addition, the proximal end of the section of the spacer 23 that is thickened toward the distal direction may coincide with the proximal end of the spacer 23, and is arranged on the distal side of the proximal end of the spacer 23. may have been

It is preferable that the length in the distance direction of the section of the spacer 23 formed thicker toward the distal direction is longer than the length in the distance direction of the portion of the needle tube 30 that is disposed inside the second hollow member 20. . By setting the length of the section in this manner, the tip position of the needle tube 30 can be made appropriate when the needle tube 30 is protruded from the opening 12 on the distal side of the first hollow member 10 .

The long axis direction of the needle tube 30 is preferably inclined by 3 degrees or more, more preferably by 5 degrees or more, and further preferably by 10 degrees or more with respect to the far-near direction of the first hollow member 10. . By setting the inclination in this way, contact between the tip 30a of the needle tube 30 and the distal end of the first hollow member 10 can be easily avoided. Although the upper limit of the inclination angle of the long axis direction of the needle tube 30 with respect to the perspective direction of the first hollow member 10 is not particularly limited, it can be, for example, 30 degrees or less. The inclination of the needle tube 30 with respect to the distance direction of the first hollow member 10 can be appropriately selected according to the angle required for the device and the size of the needle tube 30 and the hollow member.

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

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

A configuration on the hand side for moving the medical puncture device 1 will be described. As shown in FIG. 1 , a 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 with respect to the first handle 51 in the longitudinal direction. A 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 parts grasped by the operator in order to move the second hollow member 20 and the needle tube 30 in the distance direction. The second handle 52 is configured to be movable along the distance direction. By moving the second handle 52 in the far-near direction, the needle tube 30 is exposed from the distal end of the first hollow member 10 or retracted inside the first hollow member 10 . A container containing 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 bonding with an adhesive. The first handle 51 and the second handle 52 may be relatively movable, and the second handle 52 may be movable in the longitudinal direction with respect to the first handle 51. It may be configured to be movable in the longitudinal direction with respect to the second handle 52 .

2. Method for Manufacturing Medical Puncture Device Next, a method for manufacturing the medical lancing 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. FIG. This method has a step of heating the medical puncture device 1, and applies an external force in the direction D from the point P toward the center point Cout to the needle tube 30 during the heating. It also has a step of heating the medical lancing device 1, and heats 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. A method is also described.

A first hollow member 10 and a second hollow member 20 having a needle tube 30 inserted into a lumen 21 are prepared (step 1A). At this time, the needle tube 30 may not be fixed inside the lumen 21 of the second hollow member 20 . In step 1A, the longitudinal center of the second hollow member 20 and the longitudinal center of the needle tube 30 may coincide.

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 for receiving needle tube 30 therein. In that case, it is more preferable that the spacer 23 is 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 becomes easier to move. A needle tube 30 can be fixed by 23 . Moreover, the inner tube 22 preferably has heat shrinkability. In step 1B, the gap between the inner tube 22 and the spacer 23 can be reduced by shrinking the inner tube 22 when the medical lancing device 1 is heated. Here, the second hollow member 20 as shown in FIG. 19 has been described, but the second hollow member 20 is not limited to this aspect, and all aspects described in "1. Medical puncture device" can be applied. It is possible.

The medical lancing device 1 is heated (step 1B). Specifically, it is preferable to heat the second hollow member 20, more preferably to heat the distal end of the second hollow member 20, and to heat the distal portion of the spacer 23, as shown in FIG. is more preferred. By heating the medical puncture device 1, the resin around the needle tube 30 can be softened. A section 40 from the distal end 20a of the second hollow member 20 to 15 cm proximal to the distal end 20a is preferably made of thermoplastic resin. In the heating step, a heat-shrinkable tube made of a material different from that of the second hollow member 20 may be placed outside the second hollow member 20 and heated. Remove the heat shrink tube after heating. As shown in FIG. 20, in step 1B, an external force is applied to needle tube 30 in direction D from point P toward center point Cout during heating (step 1B-1). As a result, the needle tube 30 arranged inside 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 lumen 21 of the second hollow member 20 into which the needle tube 30 is inserted also moves. 26 can be decentered from the center point Cout. An external force may be applied not only during heating but also before and after heating.

In the step of applying the external force, since the external force is applied from the point P on the first surface 41 toward the center point Cout of the circumscribed circle 26 of the second hollow member 20, the arrangement of the members around the needle tube before heating can be set arbitrarily. can be done. Among them, the point P on the first surface 41 is positioned radially inward of the center point Cin of the inscribed circle 25 of the second hollow member 20 and from the center point Cout of the circumscribed circle 26 of the second hollow member 20. Heating is preferably performed in a state of being arranged radially outward. As a result, it is possible to manufacture the medical puncture device 1 that can quickly project the needle tube 30 out of the first hollow member 10 .

A second hollow member 20 is inserted into the lumen 11 of the first hollow member 10 (step 1C).

Another embodiment of step 1B will be described with reference to FIGS. 21 is a cross-sectional view showing the first surface 41 of the medical puncture device 1 in the state before step 1B, and FIG. 22 shows the first surface 41 of the medical puncture device 1 in the state after step 1B. It is a sectional view showing. It has a step (step 1B) of heating the medical lancing device 1, and the distance between the point P and the center point Cout after heating is greater than the distance La (shown in FIG. 21) between the point P and the center point Cout before heating. 22) is shortened (step 1B-2). As shown in FIG. 21, before 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 shifted from the center point Cout of the circumscribed circle 26, and the point P (the tip of the needle tube 30 30 a ) is arranged near the center point Cout of the circumscribed circle 26 of the second hollow member 20 . Thus, by performing heating in step 1B-2 instead of step 1B-1, it is possible to manufacture the medical puncture device 1 that can quickly project the needle tube 30 out of the first hollow member 10. can. In step 1B-2, the medical lancing device having the structure described above can be manufactured by heating using 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 composed of one member can also be manufactured by the following method. In step 1A, the second hollow member 20 is arranged such that the center of the long axis of the core material forming the lumen 21 of the second hollow member 20 is offset from the center point Cout of the circumscribed circle 26 of the second hollow member 20. It may be manufactured by extrusion molding in a fixed state (step 1A-2). In this case, in step 1B, it is preferable to place the needle tube 30 in the lumen 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, the inscribed circle 25 of the second hollow member 20 can be eccentric, so the eccentric heating as in step 1B-1 or step 1B-2 is unnecessary. After step 1B-3, step 1C is performed. The medical puncture device 1 can also be manufactured by such a method.

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

First, a needle tube 30 and a spacer 23 having a lumen 24 containing the needle tube 30 are prepared (step 2A). In the first surface 41, the circumscribed circle of the spacer 23 and the inscribed circle of the spacer 23 inscribed in the lumen 24 are eccentric to each other. In order to enclose the needle tube 30, a spacer 23 having a diameter of the lumen 24 larger than the outer diameter of the needle tube 30 is prepared. In step 2A, the core material is inserted into the inner cavity of the cylindrical body having a circular cross section perpendicular to the perspective direction, and the core material is directed toward the longitudinal center of the cylindrical body from the outside in the radial direction with respect to the core material. By heating the distal end of the tubular body while applying a directional external force, a spacer 23 may be produced in which the circumscribed circle and the inscribed circle inscribed in the lumen 24 are eccentric to each other.

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

Another embodiment of the method of 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 fixed inside the inner tube 22 and outside the needle tube 30, the spacer 23 inserting the needle tube 30 inside. The above-mentioned medical puncture device has a lumen 24 directed toward each other, and in the surface 41 (first surface 41), the circumscribed circle of the spacer 23 and the inscribed circle inscribed in the lumen 24 of the spacer 23 are eccentric to each other. The manufacturing method of 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 adhesive.

As in step 2A, a needle tube 30 and a spacer 23 having a lumen 24 containing the needle tube 30 are prepared (step 3A).

As in step 2B, it is preferable to insert the tip 30a of the needle tube 30 from the proximal end side of the lumen 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 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 includes step 3C, it is easy to form the second hollow member 20 that satisfies the requirements (1) and (2).

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

In steps 3C to 3E, at least one of the inner tube 22 and the spacer 23 is preferably made of resin so as to fix the members together by thermal welding. Moreover, 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 of 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 fixed inside the inner tube 22 and outside the needle tube 30. The method includes 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 adhesive.

As in step 2A, needle tube 30 and spacer 23 having lumen 24 containing needle tube 30 are prepared (step 4A).

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

A spacer 23 is placed 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 adhesive (step 4D). Since the manufacturing method according to the present invention includes step 4D, it is easy to form the second hollow member 20 that satisfies the requirements (1) and (2).

Instead of step 4C, the spacer 23 may be placed 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 adhesive (step 4F). Since the manufacturing method according to the present invention includes step 4F, it is easy to form the second hollow member 20 that satisfies the requirements (1) and (2).

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

A method of manufacturing the medical puncture device 1 including a method of 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 manufacturing method of the medical puncture device 1 includes the steps of inserting the needle tube 30 into the lumen of the first tube 61 having a non-perfect circular cross section perpendicular to the long axis, and applying heat shrinkability to the first tube 61 . 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 a lumen into which the needle tube 30 can be inserted. The lumen of first tube 61 preferably extends from the distal end to the proximal end of first tube 61 . The first tube 61 has a non-perfect circular 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-perfect circular shape" means that in the cross section perpendicular to the long axis of the first tube 61, at least one of the inner shape (the outer shape of the lumen) and the outer shape is non-circular. In a cross section perpendicular to the long axis of the first tube 61, the inner shape and the outer shape of the first tube 61 are preferably concentric figures with different sizes. FIG. 23 shows a cross-sectional view perpendicular to the longitudinal axis of the first tube 61 and the second tube 62. FIG. In FIG. 23, both the inner shape and the outer shape in the cross section perpendicular to the long axis of the first tube 61 are triangular.

The second tube 62 has heat shrinkability. The second tube 62 has a lumen which preferably extends from the distal end of the second tube 62 to the proximal end. The second tube 62 may have a circular, elliptical, polygonal, or a combination of these cross-sectional shapes perpendicular to the long axis, preferably circular or elliptical. As a result, the slidability of the second hollow member 20 in the distance direction within the first hollow member 10 is improved. Also, the shape of the cross section perpendicular to the long axis of the second tube 62 may be the same as or different from the shape of the cross section perpendicular to the long axis of the first tube 61 . In FIG. 23, the cross section perpendicular to the long axis of the second tube 62 has a perfect circular shape.

The first tube 61 and the second tube 62 can be made of the resin mentioned as a preferable material for the first hollow member 10 or the second hollow member 20 described in "1. Medical puncture device".

The needle tube 30 is inserted into the lumen of the first tube 61 having a non-perfect circular cross section perpendicular to the long axis (Step 5B). At step 5B, the distal end 30a of the needle tube 30 can be inserted through the proximal end of the lumen of the first tube 61 .

After 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 shrink, making it easier for the inner surface of the first tube 61 to adhere 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 a heat-shrinkable second tube 62 (step 5D).

At step 5D, the distal end of the first tube 61 may be fitted over the distal end of the second tube 62 . Also, in step 5D, the distal end of the first tube 61 may be positioned further distally than the distal end of the second tube 62 .

The second tube 62 is heated (step 5E). The heating causes the second tube 62 to shrink, and the second tube 62 deforms along the shape of the first tube 61 . Since the shape of the cross section perpendicular to the long axis of the first tube 61 is non-perfect circular, the center point Cin of the inscribed circle 25 of the second hollow member 20 is shifted 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 along its entire circumference. Since the second tube 62 is likely to come into close contact with the first tube 61 in the entire circumferential direction, a gap is less likely to be formed between the first tube 61 and the second tube 62 .

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

A commercially available heating device can be used to heat each tube in step 5C or step 5E.

Second tube 62 preferably covers both first tube 61 and needle tube 30 as a result of step 5E. As a result, the needle tube 30 is firmly fixed to the first tube 61 and the second tube 62, so that even if the second hollow member 20 is moved in the far-near direction, the needle tube 30 does not come off from the second hollow member 20. can be prevented.

In step 5D, when the distal end of the first tube 61 is arranged on the distal side of the distal end of the second tube 62, after step 5E, the first tube 61 is heated from the distal end surface side. preferably (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 of manufacturing the medical puncture device 1 using the first tube 61 and the second tube 62 will be described. In the method of manufacturing the medical puncture device 1, a heat-shrinkable second tube 62 having a non-perfect circular cross section perpendicular to the long axis is attached to the first tube 61 with the needle tube 30 inserted into the lumen. 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 a lumen into which the needle tube 30 can be inserted. The lumen of first tube 61 preferably extends from the distal end to the proximal end of first tube 61 . The shape of the cross section perpendicular to the long axis of the first tube 61 may be circular, elliptical, polygonal, or a combination thereof, but is preferably circular or elliptical. As a result, the slidability of the second hollow member 20 in the distance direction within the first hollow member 10 is improved. Also, the shape of the cross section perpendicular to the long axis of the first tube 61 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 perpendicular to the longitudinal axis of the first tube 61 and the second tube 62. FIG. 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 of the second tube 62 to the proximal end. The second tube 62 has a non-perfect circular shape in a cross section perpendicular to its longitudinal axis. Here, "the shape of the cross section perpendicular to the long axis is a non-perfect circular shape" means that at least one of the inner shape (the outer shape of the lumen) and the outer shape in the cross section perpendicular to the long axis of the second tube 62 is non-circular. In a cross section perpendicular to the long axis of the second tube 62, the inner shape and outer shape of the second tube 62 are preferably concentric figures with different sizes. In FIG. 24, both the inner shape and the outer shape in the cross section perpendicular to the long axis of the second tube 62 are triangular.

The first tube 61 and the second tube 62 can be made of the resin mentioned as a preferable material for the first hollow member 10 or the second hollow member 20 described in "1. Medical puncture device".

Preferably, the needle tube 30 is inserted into the lumen of the first tube 61 (step 6B). More preferably, the tip 30a of the needle tube 30 is inserted from the proximal end of the lumen of the first tube 61 in step 6B. 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 on the distal side of 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 step 6B, the first tube 61 may be heated (step 6C). Step 6C can be performed in the same manner as Step 5C.

The first tube 61 with the needle tube 30 inserted into the lumen is covered with a heat-shrinkable second tube 62 having a non-perfect circular cross section perpendicular to the long axis (Step 6D). Step 6D can be performed in a manner similar to step 5D.

The second tube 62 is heated (step 6E). Although the second tube 62 shrinks due to heating and adheres closely to the first tube 61, the shape of the cross section perpendicular to the long axis of the second tube 62 maintains a non-perfect circular shape even after heating. Therefore, the center point Cin of the inscribed circle 25 of the second hollow member 20 can be offset from the center Cout of the circumscribed circle 26 of the second hollow member 20 by performing step 6E. In addition, the process 6E can be implemented by the method similar to the process 5E.

Second tube 62 preferably covers both first tube 61 and needle tube 30 as a result of step 6E. As a result, the needle tube 30 is firmly fixed to the first tube 61 and the second tube 62, so that even if the second hollow member 20 is moved in the far-near direction, the needle tube 30 does not come off from the second hollow member 20. can be prevented.

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

Still another manufacturing method of the medical puncture device 1 using the third tube 63 and the fourth tube 64 will be described. The manufacturing method of the medical puncture device 1 includes the steps of covering the third tube 63 with the needle tube 30 inserted into the lumen with the fourth tube 64 having heat shrinkability, heating the fourth tube 64, and removing the fourth tube 64 from the third tube 63 . By controlling the external 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 a predetermined position. 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 match the direction of the vector whose end point is the point Q where the perpendicular line drawn down from the above to the predetermined surface intersects the predetermined surface with the direction of the vector whose starting point is the center point C3in and whose ending point is the center point C3out. can be done.

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 a lumen into which the needle tube 30 can be inserted. The lumen of third tube 63 preferably extends from the distal end of third tube 63 to the proximal end. At least the distal end of the second hollow member 20 can be made by the third tube 63 . The fourth tube 64 has a lumen in which the third tube 63 is arranged. The fourth tube 64 shrinks when heated, but the heating temperature should be 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 perpendicular to the longitudinal axis of the fourth tube 64 after contraction.

Also, during heating, by controlling the positions of the third tube 63 and the needle tube 30 arranged in the lumen of the fourth tube 64 in a plane perpendicular to the long axis of the fourth tube 64, the tip of the needle tube 30 and the position of the third tube 63 can be controlled. For such control, 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, the third tube 63 and the fourth tube 64 are preferably made of different materials.

The cross-sectional shape perpendicular to the long axis of the third tube 63 and the fourth tube 64 may be circular, elliptical, polygonal, non-circular, or a combination thereof. The cross-sectional shape perpendicular to the long axis of the third tube 63 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 with the needle tube 30 inserted into the lumen is covered with the fourth heat-shrinkable tube 64 (Step 7B).

The fourth tube 64 is heated (step 7C). Through this process, the third tube 63 arranged in the lumen of the fourth tube 64 is also heated. After heating, the fourth tube 64 can have a shape (inner shape) of the lumen in a cross section perpendicular to the long axis of the fourth tube 64 that is non-perfectly circular (preferably a shape that does not have rotational symmetry). . By heating, the third tube 63 is deformed into the shape of the fourth tube 64 after heating. It can have a non-perfect circular shape (preferably a shape without rotational symmetry) that approximately matches the shape of the cavity.

Cool the fourth tube 64 (Step 7D). As a result, the third tube 63 can be solidified, so that the shape formed in step 7C can be stably maintained.

Remove the fourth tube 64 from the third tube 63 (step 7E). As a result, at least the distal end portion of the second hollow member 20 having a non-perfect circular outer shape in a cross section perpendicular to the long axis can be manufactured from the third tube 63 . At step 7E, the fourth tube 64 may be removed by tearing.

The change in cross-sectional shape before and after heating due to the 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. FIG. 25 to 27 show cross-sectional views perpendicular to the long axis of the third tube 63, the fourth tube 64, and the needle tube 30. (a) of each figure shows the state before heating, and (b) of each figure shows the state before heating. It shows the state after heating.

As shown in FIG. 25(a), in step 7A, the fourth tube 64 can be a tube whose inner lumen has a non-perfect circular shape in a cross section perpendicular to the longitudinal direction after being heated. Thereby, as shown in FIG. 25(b), in step 7C, the shape of the cross section perpendicular to the long axis of the third tube 63 can be made into a non-perfect circular shape.

As shown in FIG. 26A, in step 7A, a third tube 63 whose cross section perpendicular to the longitudinal direction has a non-perfect circular shape can be used. In that case, the cross-sectional shape of the fourth tube 64 perpendicular to the long axis is not particularly limited, and for example, the outer shape may be triangular and the lumen may be circular. By using the third tube 63 and the fourth tube 64 having a predetermined shape and 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), etc. can be shaped as shown in 26(b), it is also possible to control the position of the third tube 63 arranged in the lumen of the fourth tube 64 in a plane perpendicular to the long axis. For example, by inserting a core material into the lumen of the needle tube 30, fixing the core material and the fourth tube 64, and then heating, the center point C3in of the inscribed circle 65 of the third tube 63 at a predetermined position is placed at an eccentric position 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 is lowered from the tip of the needle tube 30 to a predetermined plane. The direction of the vector whose end point is the point Q where the perpendicular intersects the predetermined surface can be made to coincide with the direction of the vector whose start point is the center point C3in and whose end point is the center point C3out.

As shown in FIG. 27(a), in step 7A, a third tube 64 whose inner lumen has a non-perfect circular shape in a cross section perpendicular to the longitudinal direction can be used. Also in this 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 circle and the lumen may be triangular. As a result, the shape shown in FIG. 27(b) can be obtained in step 7C.

1: Medical puncture device 10: First hollow member 10a: Distal end of first hollow member 11: Lumen of first hollow member 12: Opening 13: Tapered portion 20: Second hollow member 20a: Second hollow member 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: Inscribed circle 26 of the second hollow member: Circumscribed circle 27 of the second hollow member: Tip member 30: Needle tube 30a: Tip of needle tube 31: Lumen 32: Opening edge 32a: Most distal part of opening edge 32b: Opening edge Proximal portion 40 of: Section 41 from the distal end of the second hollow member to 15 cm proximal to the distal end: Surface (first surface)
41a: Position of the first plane in the perspective direction 51: First handle 52: Second handle 61: First tube 62: Second tubes A, 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 point P to center point Cout L: Perpendicular line drawn from the tip of the needle tube to the surface La: Distance between point P and center point Cout before heating Lb: Heating The distance P between the point P and the center point Cout after: The point where the perpendicular drawn from the tip of the needle tube to the surface and the surface (first surface) intersect with the center point of the inscribed circle of the second hollow member as the starting point

Claims (19)

a first hollow member extending in a perspective direction;
a second hollow member disposed within the lumen of the first hollow member and movable in a distal or proximal direction relative to the first hollow member;
a needle tube fixed within and communicating with the lumen at the distal portion of the second hollow member;
A medical puncture device comprising
The cross-sectional area of the second hollow member is the maximum in a plane perpendicular to the distal and proximal directions of the first hollow member and extending from the distal end of the second hollow member to 15 cm proximal to the distal end. The following (1) and (2) are satisfied in a plane (a plane 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). Medical lancing device.
(1) The center point Cin of the inscribed circle of the second hollow member is offset from the center point Cout of the circumscribed circle of the second hollow member.
(2) The direction of a vector A starting from the center point Cin and ending at a point P where the plane intersects the perpendicular line drawn from the tip of the needle tube to the surface, and the center point starting from the center point Cin. The direction is the same as the direction of vector B with Cout as the end point. 2. The medical puncture device according to claim 1, wherein said second hollow member includes an inner tube and a spacer fixed inside said inner tube and outside said needle tube. 3. The medical treatment according to claim 2, wherein the spacer has a lumen containing the needle tube, and the circumscribed circle of the spacer and the inscribed circle inscribed in the lumen of the spacer are eccentric on the surface. lancing device for. 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 slanted opening edge at its distal end, the opening edge has a distalmost portion and a most proximal portion, and the spacer is disposed on the distalmost portion of the side surface of the needle tube. 5. The medical lancing device according to claim 4, wherein the medical lancing device is present on the side. The medical puncture device according to any one of claims 2 to 5, wherein the thickness of the spacer in the direction parallel to the vector B is uniform over the distance direction. The medical puncture device according to any one of claims 1 to 6, wherein the longitudinal direction of the needle tube is inclined with respect to the distance direction of the first hollow member. The medical puncture device according to any one of claims 1 to 6, wherein the longitudinal direction of the needle tube is parallel to the distance direction of the first hollow member. The medical puncture device according to any one of claims 1 to 6, wherein the needle tube intersects 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 with different thicknesses depending on locations. The method for manufacturing the medical puncture device according to any one of claims 1 to 10, wherein the medical puncture device is heated to soften the resin around the needle tube; A method for manufacturing a medical lancing device, including the step of applying an external force in a direction from said point P toward said center point Cout. The method for manufacturing the medical puncture device according to any one of claims 1 to 10, further comprising a step of heating the medical puncture device, wherein the point P and the center point before the heating A method of manufacturing a medical lancing device, wherein the distance between the point P and the central point Cout after the heating is shorter than the distance from the center point Cout. 4. The manufacturing method of the 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 lumen of the spacer. Method. 4. The method of manufacturing the medical puncture device according to claim 3, further comprising the step of fixing the outer surface of the spacer and the inner surface of the inner tube by heat welding or adhesive. Production method. The method for manufacturing the medical puncture device according to any one of claims 2 to 6 , comprising the step of fixing the spacer to the outer wall of the inner tube or the inner wall of the inner tube by heat welding or adhesive. A manufacturing method for a medical puncture device. The method for manufacturing a medical puncture device according to any one of claims 1 to 10, wherein the needle tube is inserted into the lumen of the first tube having a non-perfect circular cross section perpendicular to the long axis. a step of covering the first tube with a heat-shrinkable second tube; and a step of heating the second tube. The method for manufacturing a medical puncture device according to any one of claims 1 to 10, wherein the shape of the cross section perpendicular to the major axis of the first tube in a state in which the needle tube is inserted into the lumen is non-true. A method of manufacturing a medical lancing device, comprising the steps of: covering with a circular heat-shrinkable second tube; and heating the second tube. 18. The method of manufacturing a medical puncture device according to claim 16 or 17, wherein said second tube covers both said first tube and said needle tube. 11. The method for manufacturing the medical puncture device according to any one of claims 1 to 10, wherein the step of covering the third tube with the needle tube inserted into the lumen with a fourth heat-shrinkable tube. , heating the fourth tube, and removing the fourth tube from the third tube.

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