WO2014049790A1

WO2014049790A1 - Puncture needle for injecting bone cement and method for producing same

Info

Publication number: WO2014049790A1
Application number: PCT/JP2012/074967
Authority: WO
Inventors: 早川浩一
Original assignee: テルモ株式会社
Priority date: 2012-09-27
Filing date: 2012-09-27
Publication date: 2014-04-03

Abstract

This puncture needle (10) for injecting bone cement is provided with: a needle body (12) having a hollow structure; a port-forming member (14) that is affixed to the base end of the needle body (12), has at least one port (36, 38), and has a hollow structure; and a handle (16) that covers the base end of the needle body (12) and the port-forming member (14). Of the handle (16) and the port-forming member (14), only the lumen of the port-forming member (14) interconnects with the lumen of the needle body (12).

Description

Puncture needle for bone cement injection and method for manufacturing the same

The present invention relates to a bone cement injection puncture needle for injecting bone cement into bone and a method for manufacturing the same.

Percutaneous vertebroplasty is a treatment that reinforces the vertebral body by injecting bone cement into the vertebral body in order to remove pain caused by vertebral body compression fractures. Percutaneous vertebroplasty is a relatively new treatment performed for the first time in France in 1987, but in recent years it has been performed in many facilities in Japan.

In percutaneous vertebroplasty, a hollow puncture needle is punctured from the pedicle located on the left and right sides of the vertebral body, and bone cement is injected into the vertebral body through an injection passage in the puncture needle. The pedicle approach is fundamental. Medical devices for performing such percutaneous vertebroplasty include bone biopsy needles and puncture needles for bone cement injection.

Generally, a puncture needle for bone cement injection includes an outer needle having a hollow structure, an outer needle base (handle) fixed to the proximal end of the outer needle, an inner needle that can be inserted into a hollow portion of the outer needle, An inner needle base fixed to the proximal end. Literatures showing conventional examples of puncture needles for injecting bone cement include, for example, International Publication No. 2008/063944 Pamphlet and International Publication No. 2012/043247 Pamphlet.

In the bone cement injection puncture needle (canula system) disclosed in the pamphlet of International Publication No. 2008/063944, a main port (port 74) and a side port (port 78) are provided on the outer needle base (canula handle 62). It is configured so that a syringe can be connected to the side port and bone cement can be supplied from the side port to the outer needle (canula body 64). Hereinafter, this is referred to as Prior Art 1.

In the puncture needle for bone cement injection disclosed in International Publication No. 2012/043247 pamphlet, the outer needle has a double tube structure including an inner tube and an outer tube, and a bone cement passage is formed in the inner tube. A slow pressure passage is formed between the tube and the outer tube, and a main port communicating with the bone cement passage is integrally formed in the outer needle base. A side port forming member having a side port communicating with the slow pressure passage is fixed to the proximal end of the outer needle. With this configuration, when bone cement is injected into the bone, the air in the bone is discharged to the outside through the slow pressure passage to prevent the pressure in the bone from rising. Hereinafter, this is referred to as Prior Art 2.

In the bone cement injection puncture needle according to Prior Art 1, the main port and the side port are integrally formed with the outer needle base. In the puncture needle for bone cement injection according to Prior Art 2, the side port is provided on a side port forming member which is a separate member from the outer needle base, but the main port is formed integrally with the outer needle base. .

In the prior arts 1 and 2, the resin portion that contacts the bone cement is preferably composed of a medical resin. However, in the prior art 1, since the main port and the side port are integrally formed with the outer needle base, not only the main port and the side port but also the outer needle base portion must be made of expensive medical resin. The manufacturing cost increases. In the prior art 2, since the main port is integrally formed with the outer needle base, not only the main port but also the portion of the outer needle base must be made of expensive medical resin, and the manufacturing cost is reduced. Bulky.

The present invention has been made in view of such problems, and an object thereof is to provide a bone cement injection puncture needle and a method for manufacturing the same, which can reduce the manufacturing cost.

In order to achieve the above object, the present invention provides a bone cement injection puncture needle for injecting bone cement into bone, and is fixed to a hollow needle body and a proximal end portion of the needle body. A hollow port-forming member having at least one port, and a handle that covers the proximal end portion of the needle body and the port-forming member, and of the port-forming member of the handle and the port-forming member. Only the lumen communicates with the lumen of the needle body.

According to the above configuration, the port is not formed integrally with the handle, and the port is provided only in the port forming member configured separately from the handle. For this reason, an expensive medical resin can be used only for the port forming member that comes into contact with the drug during use, and an inexpensive general-purpose resin can be used for the handle constituting the majority of the proximal end side of the puncture needle. As a result, the manufacturing cost can be reduced.

In the bone cement injection puncture needle, the port forming member may be provided with a plurality of the ports.

According to the above configuration, it is possible to effectively reduce the manufacturing cost of a bone cement injection puncture needle having a plurality of ports.

The bone cement injection puncture needle includes an inner needle that can be inserted through the needle body, wherein the plurality of ports are disposed on an extension in a proximal direction of the needle body and into which the inner needle can be inserted. A first port and at least one second port extending in a direction intersecting the axis of the first port, wherein the lumen of the first port and the lumen of the second port are the needle body You may communicate with the lumen of.

According to the above configuration, it is possible to effectively reduce the manufacturing cost of a bone cement injection puncture needle that is used in combination with a needle body as an outer needle and an inner needle when puncturing a patient.

In the puncture needle for bone cement injection, the needle body penetrates in the axial direction and communicates with a lumen of the first port, and a side located on an outer peripheral portion in the vicinity of the distal end portion of the needle body And a gradual pressure passage that is independent of the bone cement passage and opens in the proximal direction on the proximal end side of the needle body and communicates the side hole with the lumen of the second port. You may have.

According to the above configuration, it is possible to effectively reduce the manufacturing cost of a puncture needle for bone cement injection that can prevent an increase in internal pressure in the bone due to the injection of bone cement.

In the puncture needle for bone cement injection, the needle body forms an inner tube that forms the bone cement passage on an inner side thereof, and concentrically surrounds the inner tube and forms the gradual pressure passage between the inner tube and the inner tube. The proximal end of the inner tube protrudes in the proximal direction from the proximal end of the outer tube, and the proximal end of the inner tube and the proximal end of the outer tube are respectively You may fix to the different position of a port formation member.

According to the above configuration, the proximal end of the inner tube and the proximal end of the outer tube are respectively fixed at different positions of the port forming member, thereby realizing centering of the proximal end side of the inner tube and the outer tube. In addition, it is not necessary to provide a shape portion (for example, a diameter-expanded shape or a diameter-reduced shape) for realizing the centering on the proximal end side in the inner tube or the outer tube, and it is possible to simplify the double tube structure and The processing cost for the shape part can be reduced.

In the bone cement injection puncture needle, the proximal-side opening of the slow pressure passage may be an annular opening that opens toward the proximal direction.

According to the above configuration, the opening area of the outlet of the gradual pressure passage can be increased compared with the configuration in which the side hole for the outlet of the gradual pressure passage is provided on the proximal end side of the outer tube. Therefore, the slow pressure performance can be effectively improved.

In the bone cement injection puncture needle, the port forming member may have positioning means for defining an insertion length of the inner tube by contacting the proximal end of the inner tube.

According to the above configuration, since the axial alignment between the port forming member and the needle body can be accurately and easily performed, the alignment of the mold during the insert molding is facilitated, and the molding yield is improved. be able to.

The present invention relates to a method for manufacturing a bone cement injection puncture needle for injecting bone cement into a bone, wherein the port forming member having at least one port has a tubular member whose lumen is the port forming member. An adhering step of adhering to the proximal end portion of the tubular member so as to communicate with the lumen, and a handle forming step of forming a handle that covers the port forming member together with the proximal end portion of the tubular member by insert molding,
Of the handle and the port forming member, only the lumen of the port forming member communicates with the lumen of the tubular member.

According to the above-described method for manufacturing a bone cement injection puncture needle, an expensive medical resin is used only for the port forming member, and the handle constituting the majority of the proximal end side of the bone cement injection puncture needle is inexpensive. By using a general-purpose resin, the manufacturing cost can be reduced.

In the above method for manufacturing a bone cement injection puncture needle, the tubular member includes an inner tube that forms a bone cement passage that penetrates in the axial direction on the inside, and an outer tube that surrounds the inner tube, The proximal end of the tube protrudes in the proximal direction from the proximal end of the outer tube, and is a passage that is independent of the bone cement passage between the inner tube and the outer tube, and is the base of the needle body. A slow pressure passage that opens in the proximal direction is formed on the end side, and in the fixing step, the proximal end of the inner tube and the proximal end of the outer tube are respectively fixed at different positions of the port forming member. Thus, the inner tube and the outer tube may be held concentrically.

According to the above manufacturing method, the proximal end of the inner tube and the proximal end of the outer tube are respectively fixed at different positions of the port forming member, thereby realizing centering of the inner tube and the outer tube. For this reason, it is not necessary to provide a shape portion for realizing the centering on the proximal end side in the inner tube or the outer tube, and the centering of the inner tube and the outer tube can be performed accurately, reliably and easily.

In the above-described method for manufacturing a puncture needle for bone cement injection, in the fixing step, the tubular member is inserted into the port forming member, and positioning means provided on an inner peripheral portion of the port forming member is used as a positioning means of the inner tube. You may position the said port formation member with respect to the said needle body by making it contact | abut with a base end.

According to the above manufacturing method, since the axial alignment between the port forming member and the needle body can be performed accurately and easily, the alignment of the mold at the time of insert molding is facilitated, and the molding yield is improved. Can be planned.

It is a perspective view of the puncture needle for bone cement injection concerning one embodiment of the present invention. FIG. 2 is a partially omitted cross-sectional view of the bone cement injection puncture needle shown in FIG. 1. FIG. 2 is a partially omitted cross-sectional view showing a state where the inner needle is removed from the outer needle in the bone cement injection puncture needle shown in FIG. 1. 4A is a longitudinal sectional view of the inner tube material, FIG. 4B is a longitudinal sectional view of an inner tube member formed by cutting the inner tube material, and FIG. 4C is a longitudinal section of the outer tube material. FIG. 4D is a longitudinal sectional view of the outer tube formed by drilling the outer tube material, and FIG. 4E is a double member that is an original member of the outer needle of the bone cement injection puncture needle. It is a longitudinal cross-sectional view which shows a pipe member. FIG. 5A is a longitudinal sectional view of a state in which the port forming member is fixed to the proximal end portion of the double tube member, and FIG. 5B is an outer needle base that covers the proximal end portion of the double tube member and the port forming member. FIG. 5C is a vertical cross-sectional view of a state where a rod-like member to which an inner needle base is attached is inserted into a hollow portion of a double tube member, and FIG. It is a longitudinal cross-sectional view of the puncture needle for bone cement injection | pouring which was given. It is a longitudinal cross-sectional view of the puncture needle for bone cement injection which concerns on the modification of this invention.

Hereinafter, preferred embodiments of the bone cement injection puncture needle according to the present invention will be described with reference to the accompanying drawings.

In this specification, “bone cement” includes not only bone cement (plastic preparation, etc.) but also bone paste (calcium phosphate preparation, etc.).

FIG. 1 is a perspective view of a bone cement injection puncture needle 10 (hereinafter also referred to as “puncture needle 10”) according to an embodiment of the present invention. FIG. 2 is a partially omitted cross-sectional view of the puncture needle 10 shown in FIG. FIG. 3 is a partially omitted cross-sectional view of the outer needle 12 with the inner needle 18 removed.

As shown in FIG. 1, a bone cement injection puncture needle 10 includes a hollow outer needle 12 (needle body), a port forming member 14 fixed to a proximal end portion of the outer needle 12, and a base of the outer needle 12. An outer needle base 16 (handle) that covers the end portion and the port forming member 14, an inner needle 18 that is slidably inserted into the hollow portion of the outer needle 12, and an inner needle fixed to the proximal end portion of the inner needle 18 Group 20. FIG. 1 shows a state where the inner needle 18 is inserted into the hollow portion of the outer needle 12.

In the following description, the axial direction of the inner needle 18 and the outer needle 12 is the Z direction, the direction perpendicular to the Z direction and the extending direction of the outer needle base 16 is the X direction, and is perpendicular to the Z direction and the X direction. This direction is the Y direction. 2 and 3, the X direction is a direction perpendicular to the Z direction and parallel to the paper surface, and the Y direction is a direction perpendicular to the paper surface. Among the X directions, in particular, the right direction in FIGS. 2 and 3 is X1, and the left direction is X2. Among the Z directions, in particular, a direction toward the distal end side of the puncture needle 10 is defined as Z1, and a direction toward the proximal end side of the puncture needle 10 is defined as Z2.

The outer needle 12 is a member having a hollow structure that is open at both ends, and has an inner tube 22 through which the inner needle 18 is inserted, and an outer tube 24 that concentrically surrounds the inner tube 22, and the inner tube 22 and the outer tube. 24 constitutes a double tube structure. A sharp cutting edge 13 is formed at the tip of the outer needle 12.

The constituent material of the inner tube 22 and the outer tube 24 is not particularly limited as long as it has an appropriate strength that does not break or deform during puncture and extraction from the bone. , Aluminum alloys, copper alloys and the like.

As shown in FIG. 3, the inner tube 22 is open at both ends and has a bone cement passage 26 (lumen) inside. The bone cement passage 26 functions as a hole for inserting the inner needle 18 when the inner needle 18 and the outer needle 12 are combined, and functions as a flow path through which the bone cement flows when the bone cement is injected. The length of the inner tube 22 is about 100 to 200 mm. In the configuration example shown in FIG. 3, the inner tube 22 is a hollow cylindrical tube, and the inner diameter thereof is about 1.8 to 2.4 mm.

The inner tube 22 includes an inner tube portion 28 that forms an inner tube wall of a double tube structure, and a tip portion 30 that is provided at the tip of the inner tube portion 28 and has a larger diameter than the inner tube portion 28. Yes. The proximal end of the inner tube portion 28 protrudes in the proximal direction from the proximal end of the outer tube 24 and is inserted into an inner tube fixing portion 42 provided in the base portion 34 of the port forming member 14. It is fixed. At the end of the inner tube portion 28 on the cutting edge 13 side, an annular step having substantially the same diameter as the inner diameter of the outer tube 24, that is, a diameter larger than the outer diameter of the inner tube portion 28 and smaller than the outer diameter of the tip portion 30. A part 31 is provided. The annular step portion 31 functions as a positioning means for positioning the distal ends of the inner tube 22 and the outer tube 24 concentrically in the manufacturing process of the puncture needle 10.

Both ends of the outer tube 24 are open, and the inner tube 22 is inserted into the hollow portion. The outer tube 24 is shorter than the inner tube portion 28 of the inner tube 22, and its length is about 100 to 200 mm. The outer tube 24 is a hollow cylindrical tube. The inner diameter of the outer tube 24 is set larger than the outer diameter of the inner tube portion 28, and is, for example, about 1.9 to 3.2 mm. Between the outer tube 24 and the inner tube portion 28, an annular slow pressure passage 32 (a lumen) extending in the axial direction is formed. The slow pressure passage 32 is a passage independent of the bone cement passage 26.

The distal end portion of the outer tube 24 is fixed to the tip portion 30 of the inner tube 22 by means such as welding (for example, laser welding), whereby the distal end side of the slow pressure passage 32 is closed. From the proximal end portion of the outer tube 24, the inner tube 22 (specifically, the inner tube portion 28) protrudes in the proximal direction. The base end portion of the outer tube 24 is inserted into the base portion 34 of the port forming member 14 and fixed by means such as an adhesive. The proximal end of the slow pressure passage 32 formed between the inner tube 22 and the outer tube 24 is configured as an annular opening opened in the proximal direction between the proximal end portion of the outer tube 24 and the inner tube 22. Yes.

The distance L1 (see FIG. 3) from the most distal position of the outer needle 12 to the proximal end portion of the outer tube 24 (the proximal end of the slow pressure passage 32) is determined when the puncture needle 10 is punctured into the bone. The proximal end is set so as to be surely located outside the body. Specifically, the distance L1 is 80 mm or more, preferably 100 mm or more.

A side hole 33 is provided near the tip of the outer tube 24. The side holes 33 are holes that penetrate the inside and outside of the outer tube 24, and a plurality of side holes 33 are preferably provided in the circumferential direction and the axial direction. The sizes of the side holes 33 are not necessarily the same, and the sizes may be different. The shape of the side hole 33 does not need to be circular, and may be, for example, an ellipse or a polygon, or different shapes may be mixed.

The distance L2 from the most distal position of the outer needle 12 to the side hole 33 located at the most proximal side (specifically, the part at the most proximal side of the corresponding side hole 33) is the distance L2 between the outer needle 12 and the bone. In the punctured state, the most proximal side hole 33 is not positioned outside the bone, that is, all the side holes 33 are set in the bone.

The port forming member 14 is fixed to the proximal end portion of the outer needle 12 while being embedded in the outer needle base 16, and the lumen of the port forming member 14 is formed between the bone cement passage 26 and the slow pressure passage 32. Communicate. Specifically, the port forming member 14 includes a hollow cylindrical base 34 fixed to the base end of the outer needle base 16, a base end direction (Z2 direction) extending from the base 34, and a lumen 36 a thereof. A main port 36 (first port) communicating with the bone cement passage 26 and a base 34 extending in a direction intersecting the axis of the main port 36 (orthogonal direction in the illustrated example), and its lumen 38a is gradually reduced A side port 38 (second port) communicating with the passage 32 is provided. The proximal end of the inner tube 22 and the proximal end of the outer tube 24 are respectively fixed at different positions of the port forming member 14 with respect to the axial direction of the outer needle 12. Of the outer needle base 16 and the port forming member 14, only the lumen of the port forming member 14 communicates with the lumen of the outer needle 12 (the bone cement passage 26 and the slow pressure passage 32).

The base portion 34 has a communication portion 40 that opens to the distal end side (Z1 side), and an inner tube fixing portion 42 that is connected to the proximal end side (Z2 side) of the communication portion 40 and has an inner diameter smaller than that of the communication portion 40. . The inner diameter of the communication portion 40 is substantially the same as the outer diameter of the outer tube 24, and the distal end side inner peripheral surface of the communication portion 40 and the outer peripheral surface of the base end of the outer tube 24 are appropriately fixed means (adhesive or the like). It is fixed by. The opening on the base end side (Z2 side) of the slow pressure passage 32 faces the internal space of the communication portion 40.

The inner diameter of the inner tube fixing portion 42 is substantially the same as the outer diameter of the inner tube portion 28, and the inner peripheral surface of the inner tube fixing portion 42 and the outer peripheral surface of the inner tube portion 28 are appropriately fixed (adhesive or the like). ). On the main port 36 side of the inner tube fixing portion 42, an annular reduced diameter step portion 44 (positioning means) is provided that defines the insertion length of the inner tube 22 by abutting with the proximal end of the inner tube 22. The base portion 34 is provided with a hole 45 that communicates the inner peripheral surface of the inner tube fixing portion 42 and the outer peripheral surface of the base portion 34.

The main port 36 is disposed on an extension in the proximal direction of the outer needle 12 and protrudes from the bottom of a recess 54 (see FIG. 3) provided on the upper portion of the outer needle base 16. The main port 36 functions as an insertion port for connecting a bone cement injection tool (for example, a syringe) for supplying bone cement to the puncture needle 10. Therefore, a male screw portion 37 for detachably engaging the bone cement injection tool is formed on the outer peripheral portion of the main port 36.

The front end portion (the end portion on the X2 side) of the side port 38 protrudes from the outer needle base 16, and other devices or structures are configured to be detachable. A male screw portion 39 to which another device or structure can be screwed is formed on the outer peripheral portion of the distal end of the side port 38. The inner diameter of the inner cavity 38a of the side port 38 may be constant along the axial direction, or may expand toward the distal end side.

In the port forming member 14, the inner peripheral surface of the main port 36 comes into contact with the bone cement when the puncture needle 10 is used. Therefore, the constituent material of the port forming member 14 is preferably a medical resin that does not easily react with bone cement. For example, polyamide (for example, nylon 6, nylon 6.6, nylon 6.10, nylon 12, PTFE, PFA). , ETFE, PP, PE, PET) and the like.

The outer needle base 16 is a member coupled to the proximal end portion of the outer needle 12 and has a function as a grip for the user of the puncture needle 10 to grip. And it is formed so that the port formation member 14 may be covered. The outer needle base 16 is formed so as to project (extend) on both sides in a direction (X direction) perpendicular to the axis of the outer needle 12. The side port 38 described above opens at one end of the outer needle base 16 in the longitudinal direction (X direction).

The constituent material of the outer needle base 16 is preferably a resin having appropriate rigidity and suitable for insert molding. Unlike the port forming member 14, the outer needle base 16 does not need to be made of an expensive medical resin because the outer needle base 16 does not have a portion in contact with the bone cement. Therefore, a general-purpose resin such as polypropylene, polycarbonate, acrylic resin, ABS resin (acrylonitrile-butadiene-styrene copolymer) can be used as the constituent material of the outer needle base 16. By employing an inexpensive general-purpose resin as the constituent material of the outer needle base 16, the manufacturing cost of the entire puncture needle 10 can be reduced.

2, the inner needle 18 is a rod-like member that is inserted into the bone cement passage 26 of the outer needle 12 and has a sharp cutting edge 19 at the tip. The constituent material of the inner needle 18 is not particularly limited as long as it has an appropriate strength that is not damaged or deformed when inserted into a bone. For example, stainless steel, aluminum alloy, copper-based alloy, etc. Is mentioned.

The outer diameter of the inner needle 18 is preferably set to be substantially the same as the inner diameter of the outer needle 12 (the inner diameter of the inner tube 22). Specifically, the inner needle 18 is a bone cement that is the lumen of the outer needle 12. It should be set to such an extent that it can be smoothly inserted into the passage 26, and there is almost no gap between the outer peripheral surface of the inner needle 18 and the inner peripheral surface of the outer needle 12 (inner peripheral surface of the inner tube 22).

The length of the inner needle 18 is set so that the tip of the inner needle 18 slightly protrudes from the tip of the outer needle 12 with the inner needle base 20 connected to the outer needle base 16. In a state where the inner needle base 20 is connected to the outer needle base 16, the blade surface 19 a of the cutting edge 19 of the inner needle 18 is flush with the blade surface 13 a of the cutting edge 13 of the outer needle 12, and the outer needle 12 and the inner needle 18 are aligned. The cutting edges 13 and 19 are integrated to form the needle tip 46 of the puncture needle 10.

The inner needle base 20 is a member coupled to the proximal end portion of the inner needle 18. The outer diameter of the inner needle base 20 is set to be larger than the outer diameter of the inner needle 18, and specifically, a user (medical staff such as a doctor) can easily pinch and pull or rotate with a finger. It is set to such a size. The constituent material of the inner needle base 20 is not particularly limited, but a constituent material similar to the constituent material of the outer needle base 16, for example, a hard resin such as polycarbonate can be used.

1 and 2, the puncture needle 10 further has a lock mechanism 48. The lock mechanism 48 is provided on the outer needle base 16 and a plurality of

protrusions

50 a and 50 b protruding from the outer peripheral surface of the inner needle base 20, and can be engaged with the

protrusions

50 a and 50 b provided on the inner needle base 20. A plurality of engaging

grooves

52a, 52b. The

protrusions

50a and 50b are disposed on the outer periphery of the inner needle base 20 at symmetrical positions (opposite positions). The engaging

grooves

52 a and 52 b extend in the thickness direction (Y direction) of the outer needle base 16 on the side wall forming the concave portion 54 of the outer needle base 16. One engagement groove is provided at a position close to one side (Y1 side) of the outer needle base 16, and the other engagement groove is provided at a position close to the other side (Y2 side) of the outer needle base 16. And open on the opposite sides with respect to the thickness direction (Y direction) of the outer needle base 16.

Since the lock mechanism 48 is configured as described above, when the inner needle base 20 is engaged with the outer needle base 16 in order to connect the inner needle base 20 to the outer needle base 16, By relative rotation with the outer needle base 16, the

protrusions

50a and 50b engage with the engaging

grooves

52a and 52b, respectively. At this time, the blade surface 19a of the cutting edge 19 of the inner needle 18 and the blade surface 13a of the cutting edge 13 of the outer needle 12 are flush with each other and this state is maintained.

In order to inject bone cement into the bone using the puncture needle 10 configured as described above, first, after determining a puncture position and a puncture target under image guidance (under X-ray fluoroscopy or CT fluoroscopy), The puncture needle 10 with the inner needle 18 attached is struck with a hammer or punctured to the puncture target in the bone while applying torque manually. In this case, the target bone is, for example, a vertebra.

Prior to puncturing the patient with the puncture needle 10, a cleaning liquid supply tube is connected to the main port 36, and the cleaning liquid is supplied to the bone cement passage 26 of the inner needle 18 through the lumen 36 a of the main port 36. The bone cement passage 26 may be cleaned. Similarly, a cleaning liquid supply tube may be connected to the side port 38, and the cleaning liquid may be supplied to the slow pressure passage 32 via the inner cavity 38 a of the side port 38 to clean the slow pressure passage 32.

After puncturing the puncture needle 10 to the puncture target, the inner needle 18 is removed from the outer needle 12. At this time, the side hole 33 provided on the distal end side of the outer needle 12 is located in the bone, and the proximal end of the outer tube 24 (the proximal end opening of the slow pressure passage 32) is located outside the body.

Subsequently, a syringe containing bone cement is attached to the main port 36 of the outer needle base 16, or the syringe is connected to the main port 36 of the outer needle base 16 via an extension tube, so that the bone in the syringe Cement is injected into the bone through the main port 36 and the bone cement passage 26. At this time, gas or liquid (for example, exudate or blood) in the bone enters the slow pressure passage 32 from the side hole 33, and the slow pressure passage 32, the lumen of the base portion 34 (communication portion 40), and the side port 38. It is possible to get out of the body through the lumen 38a. Thereby, since the raise of the internal pressure in the bone by injection | pouring of bone cement is prevented, it can prevent that bone cement leaks out of bone. If a suction device is connected to the side port 38 to assist the discharge of the gas or liquid in the slow pressure passage 32, an increase in internal pressure in the bone can be more effectively prevented.

After injecting the required amount of bone cement in the syringe, remove the syringe. Next, the inner needle 18 is inserted into the main port 36 and the bone cement passage 26 of the outer needle 12, and the bone cement remaining in the main port 36 and the bone cement passage 26 is pushed out into the bone.

In percutaneous vertebroplasty, when a plurality of bone cement injection puncture needles 10 are used, a plurality of bone cement injection puncture needles 10 are placed on the patient's body so that the outer needle bases 16 are parallel to each other. May puncture. When the side port 38 is provided at the longitudinal end of the outer needle base 16 as in the puncture needle 10 according to the present embodiment, the side port 38 does not get in the way between adjacent puncture needles 10 and the procedure is performed smoothly. It becomes possible.

Next, a method for manufacturing the puncture needle 10 configured as described above will be described. As shown in FIG. 4A, a tubular inner tube material 56 having a predetermined length, outer diameter, and inner diameter is prepared. The inner tube material 56 is a material of the inner tube 22 constituting the outer needle 12. The inner tube material 56 is cut to produce an inner tube member 22a having a tip enlarged diameter portion 30a, an inner tube portion 28, and an annular step portion 31, as shown in FIG. 4B. In this embodiment, the cutting edge 13 (see FIG. 2) is not formed at this time. In the subsequent process, the inner tube 22 is formed by performing processing for forming the cutting edge 13 on the inner tube member 22a.

Meanwhile, as shown in FIG. 4C, a tubular outer tube material 58 having a predetermined length, outer diameter and inner diameter is prepared. The outer tube material 58 is a material of the outer tube 24 of the outer needle 12 and is shorter than the inner tube material 56. Drilling is performed on one end side of the outer tube material 58 to form a side hole 33 as shown in FIG. 4D. Moreover, the process which attaches the uneven | corrugated shape 60 to the outer peripheral surface of the other end side of the outer tube | pipe raw material 58 so that joining strength with the outer needle base 16 shape | molded by a post process may be given. Such a concavo-convex shape 60 can be, for example, a large number of protrusions, ribs or grooves extending along the axial direction or spirally, or depressions. By providing such a concavo-convex shape 60, relative rotation between the outer needle base 16 formed by insert molding in a subsequent process and the outer needle 12 is prevented.

After producing the inner tube member 22a and the outer tube 24, the inner tube member 22a is inserted into the outer tube 24, and the distal end surface of the outer tube 24 and the proximal end surface of the distal end enlarged portion 30a of the inner tube member 22a are, for example, By joining by laser welding, a double tube member 62 (tubular member) is manufactured as shown in FIG. 4E. In this case, since the annular step portion 31 is provided in the inner tube member 22a, the outer tube 24 and the inner tube member 22a are fitted by fitting the inner peripheral portion of the distal end of the outer tube 24 with the annular step portion 31. Centering on the tip side can be performed accurately and easily.

After the outer tube 24 and the inner tube member 22a are welded, polishing may be performed to smooth the welded portion. After performing such polishing, in order to wash the slow pressure passage 32 of the double-pipe member 62, when the cleaning liquid is passed through the slow pressure passage 32, the opening on the proximal end side of the slow pressure passage 32 is in the proximal direction. Since the annular opening is open toward the surface, the cleaning liquid is easily discharged. Therefore, the cleaning operation can be performed easily and quickly. On the other hand, unlike the present embodiment, the proximal end of the gradual pressure passage 32 is closed by the inner tube member 22 a and the outer tube 24, and a side hole 33 for the outlet of the gradual pressure passage 32 is provided on the proximal end side of the outer tube 24. In the case of the configuration described above, the cleaning liquid is difficult to be discharged from the slow pressure passage 32 during the cleaning step after polishing, and the cleaning operation becomes complicated.

4E is a member in a state before the cutting edge 13 of the outer needle 12 is formed. The inner pipe member 22a may be formed by joining the tip enlarged diameter part 30a and the inner pipe part 28 which are separately manufactured by welding or the like.

Next, an adhering step for adhering the port forming member 14 to the proximal end portion of the double tube member 62 is performed. Specifically, as shown in FIG. 5A, the base end portion of the double tube member 62 is inserted into the base portion 34 of the port forming member 14 formed in a predetermined shape by injection molding or the like. In this case, the base end of the outer tube 24 is inserted into the communication portion 40 of the base portion 34, and the base end of the inner tube member 22 a is inserted into the inner tube fixing portion 42 of the base portion 34. In this case, the proximal end of the inner tube member 22a abuts on the reduced diameter step portion 44, whereby the axial alignment between the port forming member 14 and the double tube member 62 can be accurately and easily performed.

After the base end portion of the double tube member 62 is inserted into the base portion 34 of the port forming member 14, an adhesive is applied between the base portion 34 and the double tube member 62, and the applied adhesive is cured, so that the port The forming member 14 and the double tube member 62 are joined together. In the case of the present embodiment, the base 34 is provided with a hole 45 that communicates the inner peripheral surface of the inner tube fixing portion 42 and the outer peripheral surface of the base 34, so that the double pipe member 62 is connected to the port forming member 14. In the state of being inserted into the inner pipe member 22a, the adhesive is injected from the outside of the base portion 34 through the hole 45, whereby the base end outer peripheral surface of the inner pipe member 22a constituting the double pipe member 62 and the inner pipe fixing portion 42 are An adhesive can be easily applied between the inner peripheral surface and the inner peripheral surface. The port forming member 14 is preferably transparent so that it can be visually recognized that the adhesive permeates the entire circumference of the double tube member 62.

By the fixing process described above, the main port 36 of the port forming member 14 communicates with the lumen (bone cement passage 26) of the inner tube member 22a, and the side port 38 of the port forming member 14 is connected to the inner tube member 22a and the outer tube 24. The double pipe member 62 and the port forming member 14 are fixed to each other in a state of communicating with the slow pressure passage 32 formed therebetween. Further, the inner tube member 22a and the outer tube 24 are centered on the proximal end sides of the inner tube member 22a and the outer tube 24, and the state is maintained.

As the adhesive used in the fixing step, it is preferable to use a heat-resistant adhesive so that the adhesiveness of the adhesive does not disappear due to heat at the time of insert molding to be performed later. The heat-resistant temperature of the heat-resistant adhesive in this case needs to be equal to or higher than the temperature of the molten resin (for example, 200 ° C.) injected during insert molding. Examples of the heat resistant adhesive include an epoxy adhesive, an ultraviolet curable adhesive, and a ceramic adhesive.

An ultraviolet curable adhesive is applied between the port forming member 14 and the double tube member 62, and the ultraviolet curable adhesive is cured by irradiating the applied ultraviolet curable adhesive with ultraviolet rays. Good. In this case, by configuring the port forming member 14 with a transparent member (for example, polycarbonate having excellent transparency), it is possible to irradiate the ultraviolet curable adhesive with ultraviolet rays transmitted through the port forming member 14. By using the ultraviolet curable adhesive, the port forming member 14 and the double tube member 62 can be fixed in a short time.

Next, as shown in FIG. 5B, an outer needle base forming step (handle forming step) in which an outer needle base 16 having a predetermined shape that covers the port forming member 14 together with the base end portion of the double tube member 62 is formed by insert molding. Do. After the outer needle base 16 is formed by insert molding, next, as shown in FIG. 5C, a rod-like member 64 with the inner needle base 20 fixed to the base end portion is inserted into the hollow portion of the double tube member 62, The needle base 20 is connected to the outer needle base 16. The inner needle base 20 is formed by, for example, insert molding at the base end portion of the rod-shaped member 64. Alternatively, the inner needle base 20 formed in advance by injection molding or the like may be fixed to the end of the rod-shaped member 64 by adhesion, fusion, or the like.

Next, as shown in FIG. 5D, in a state where the outer needle base 16 and the inner needle base 20 are connected (the rod-shaped member 64 is inserted through the double-tube member 62), the rod-shaped member 64 and the double tube The blade surface machining is performed simultaneously on the member 62 to form the blade edges 13 and 19. Thus, the blade surfaces 13a and 19a that are flush with each other when the outer needle base 16 and the inner needle base 20 are connected to each other by simultaneously performing the blade surface processing on the rod-shaped member 64 and the double tube member 62. It can be formed easily. Before insert molding the inner needle base 20 and the outer needle base 16, the blade surfaces 13a and 19a are processed by cutting the blade surfaces at the tips of the rod member 64 and the double tube member 62 (or the inner tube member 22a), respectively. May be formed.

According to the puncture needle 10 and the manufacturing method thereof according to the above-described embodiment, the main port 36 and the side port 38 are not integrally formed on the outer needle base 16 and are configured separately from the outer needle base 16. Only the port forming member 14 is provided with a main port 36 and a side port 38. For this reason, expensive medical resin can be used only for the port forming member 14, and inexpensive general-purpose resin can be used for the outer needle base 16 that constitutes most of the proximal end side of the puncture needle 10. The manufacturing cost can be reduced as a whole.

In particular, in the case of this embodiment, the outer needle 12 is provided with a slow pressure passage 32 in addition to the bone cement passage 26, and the lumen 36a of the main port 36 communicates with the bone cement passage 26. The inner cavity 38 a of the side port 38 is configured to communicate with the slow pressure passage 32. Therefore, the manufacturing cost of the puncture needle 10 that can prevent an increase in internal pressure in the bone due to the injection of bone cement can be effectively reduced.

In the case of the present embodiment, the outer needle 12 has an inner tube 22 and an outer tube 24 concentrically surrounding the inner tube 22, and the proximal end of the inner tube 22 is more than the proximal end of the outer tube 24. Projecting in the proximal direction, the proximal end of the inner tube 22 and the proximal end of the outer tube 24 are fixed at different positions of the port forming member 14. According to this configuration, the proximal end of the inner tube 22 and the proximal end of the outer tube 24 are fixed at different positions on the port forming member 14, respectively, thereby centering the proximal ends of the inner tube 22 and the outer tube 24. Therefore, it is not necessary to provide the inner tube 22 or the outer tube 24 with a shape portion (for example, a diameter-enlarged shape or a diameter-reduced shape) for realizing the centering on the proximal end side, and the double tube structure can be simplified. This can reduce the processing cost.

Furthermore, in the case of the present embodiment, the opening on the base end side of the slow pressure passage 32 is an annular opening opened toward the base end direction, and therefore, an outlet side hole 33 is provided on the base end side of the outer tube 24. Compared to the configuration, the opening area of the outlet of the slow pressure passage 32 can be widened. Therefore, the slow pressure performance can be effectively improved.

In the case of the present embodiment, the port forming member 14 has a diameter-reduced step portion 44 that functions as a positioning means that regulates the insertion length of the inner tube 22 by contacting the proximal end of the inner tube 22. According to this configuration, the axial alignment between the port forming member 14 and the outer needle 12 can be accurately and easily performed, so that the mold can be easily aligned during the insert molding, and the molding yield can be improved. Can be planned.

In the puncture needle 10 according to the above-described embodiment, the outer needle 12 having a double tube structure is employed. However, the present invention is not limited to this, and the puncture needle 10a for bone cement injection (hereinafter referred to as “puncture needle”) shown in FIG. The outer needle 12a (needle body) having a single-layer structure having only the bone cement passage 26 penetrating in the axial direction may be employed.

In this puncture needle 10a, the port forming member 14a includes a hollow cylindrical base 66 fixed to the base end of the outer needle 12a, a main port 36 extending from the base 66 toward the base end of the outer needle 12a, A side port 38 extending from the base 66 in a direction orthogonal to the axis of the main port 36. In order to minimize the leakage of bone cement from the side port 38, a reduced diameter portion 38 b that protrudes inwardly is provided on the base end side (base portion 66 side) of the side port 38. The opening should be as small as possible, for example, about the size of a needle hole.
The base 66, the main port 36, and the side port 38 are integrally formed by injection molding or the like.

The inner peripheral surface of the distal end of the base portion 66 and the outer peripheral surface of the proximal end of the outer needle 12a are fixed by appropriate fixing means such as an adhesive. The lumen 36 a of the main port 36 and the lumen 38 a of the side port 38 communicate with the bone cement passage 26 via the lumen 66 a of the base 66. In addition, in the puncture needle 10a, the same code | symbol is attached | subjected to the component same as the puncture needle 10 mentioned above.

Also in the puncture needle 10a according to the modified example, the main port 36 is not part of the outer needle base 16, and the main port 36 and the side port 38 are integrated to form the port forming member 14a. An expensive medical resin can be used only for the member 14a, and an inexpensive general-purpose resin can be used for the outer needle base 16 that constitutes most of the proximal end side of the puncture needle 10a, thereby reducing the manufacturing cost. it can. In addition, as for the puncture needle 10a, the same operational effects can be obtained for the same components as the puncture needle 10 described above.

In the puncture needle 10a configured as described above, the port forming member 14a communicates with the lumen of the outer needle 12a (or the tubular body that is the material of the outer needle 12a) with the lumen of the port forming member 14a. Fixing the outer needle 12a (or the tubular body) to the outer needle 12a (or the tubular body) and an outer needle base for forming the outer needle base 16 covering the port forming member 14a together with the proximal end portion of the outer needle 12a (or the tubular body) by insert molding It can manufacture with the manufacturing method including a formation process.

In the puncture needles 10 and 10a, the number of side ports 38 is not limited to one, and a plurality of side ports 38 may be provided. For example, a pair of side ports 38 may be provided in the directions orthogonal to the axis of the main port 36 in directions opposite to each other from the

base portions

34 and 66. Further, the extending direction of the side port 38 from the

bases

34 and 66 is not limited to the direction orthogonal to the axis of the main port 36, and may be a direction inclined with respect to the axis of the main port 36. The side port 38 may be provided on the side surface (surface on the Y direction side) of the outer needle base 16. In the puncture needles 10 and 10a, a plurality of ports (main port 36 and side port 38) are provided, but only one port (only the main port 36) may be provided.

In the above description, the present invention has been described with reference to preferred embodiments and modifications. However, the present invention is not limited to the above-described embodiments and modifications, and various modifications can be made without departing from the spirit of the present invention. Needless to say, modification is possible.

Claims

A bone cement injection puncture needle (10, 10a) for injecting bone cement into the bone,
A hollow needle body (12, 12a);
A hollow port-forming member (14, 14a) fixed to the proximal end of the needle body (12, 12a) and having at least one port (36, 38);
A handle (16) covering the proximal end of the needle body (12, 12a) and the port forming member (14, 14a),
Of the handle (16) and the port forming member (14, 14a), only the lumen of the port forming member (14, 14a) communicates with the lumen of the needle body (12, 12a).
A puncture needle (10, 10a) for injecting bone cement.
The bone cement injection puncture needle (10, 10a) according to claim 1,
The port forming member (14, 14a) is provided with a plurality of the ports (36, 38).
A puncture needle (10, 10a) for injecting bone cement.
In the bone cement injection puncture needle (10, 10a) according to claim 2,
An inner needle (18) that can be inserted through the needle body (12, 12a);
The plurality of ports (36, 38) are disposed on an extension in the proximal direction of the needle body (12, 12a) and the first port (36) into which the inner needle (18) can be inserted; At least one second port (38) extending in a direction intersecting the axis of the first port (36);
The lumen (36a) of the first port (36) and the lumen (38a) of the second port (38) communicate with the lumen of the needle body (12, 12a);
A puncture needle (10, 10a) for injecting bone cement.
The puncture needle (10) for bone cement injection according to claim 3,
The needle body (12) includes a bone cement passage (26) penetrating in the axial direction and communicating with the lumen (36a) of the first port (36), and an outer periphery in the vicinity of the distal end portion of the needle body (12). The side hole (33) located in the portion and the bone cement passage (26) are independent from each other and open in the proximal direction on the proximal end side of the needle body (12) and the side hole (33). And a slow pressure passage (32) communicating with the lumen (38a) of the second port (38),
A puncture needle (10) for injecting bone cement.
The puncture needle (10) for bone cement injection according to claim 4,
The needle body (12) is formed between the inner tube (22) that forms the bone cement passage (26) on the inner side and the inner tube (22) concentrically and between the inner tube (22). An outer tube (24) forming a slow pressure passage (32),
The proximal end of the inner tube (22) protrudes in the proximal direction from the proximal end of the outer tube (24),
The proximal end of the inner tube (22) and the proximal end of the outer tube (24) are fixed at different positions of the port forming member (14), respectively.
A puncture needle (10) for injecting bone cement.
The bone cement injection puncture needle (10) according to claim 5,
The opening on the base end side of the slow pressure passage (32) is an annular opening opened toward the base end direction.
A puncture needle (10) for injecting bone cement.
The bone cement injection puncture needle (10) according to claim 5,
The port forming member (14) has positioning means (44) for defining an insertion length of the inner tube (22) by abutting with a proximal end of the inner tube (22).
A puncture needle (10) for injecting bone cement.
A method for producing a bone cement injection puncture needle (10, 10a) for injecting bone cement into bone,
A port forming member (14, 14a) having at least one port (36, 38) is connected to the tubular member (14, 14a) such that the lumen of the port forming member (14, 14a) communicates with the lumen of the tubular member (62). An adhering step for adhering to the base end of the member (62);
A handle forming step of forming a handle (16) covering the port forming member (14, 14a) together with a base end portion of the tubular member (62) by insert molding,
Of the handle (16) and the port forming member (14, 14a), only the lumen of the port forming member (14, 14a) communicates with the lumen of the tubular member (62).
A method for producing a puncture needle (10, 10a) for injecting bone cement.
In the manufacturing method of the puncture needle (10) for bone cement injection of Claim 8,
The tubular member (62) has an inner tube (22) that forms a bone cement passage (26) penetrating in the axial direction on the inside, and an outer tube (24) surrounding the inner tube (22),
The proximal end of the inner tube (22) protrudes in the proximal direction from the proximal end of the outer tube (24),
Between the inner tube (22) and the outer tube (24), the passage is independent of the bone cement passage (26) and gradually opens in the proximal direction on the proximal end side of the needle body (12). A pressure passage (32) is formed;
In the fixing step, the proximal end of the inner tube (22) and the proximal end of the outer tube (24) are respectively fixed at different positions of the port forming member (14), thereby the inner tube (22). And the outer tube (24) are concentrically held,
A method for producing a puncture needle (10) for injecting bone cement, wherein:
In the manufacturing method of the puncture needle (10) for bone cement injection according to claim 9,
In the fixing step, the tubular member (62) is inserted into the port forming member (14), and positioning means (44) provided on the inner periphery of the port forming member (14) is replaced with the inner tube (22). ), The port forming member (14) is positioned with respect to the needle body (12).
A method for producing a puncture needle (10) for injecting bone cement, wherein: