WO2011111652A1

WO2011111652A1 - Bone cement injection puncture needle

Info

Publication number: WO2011111652A1
Application number: PCT/JP2011/055220
Authority: WO
Inventors: 滝澤謙治; 早川浩一; 猿橋誠; 宇野拓也
Original assignee: 学校法人聖マリアンナ医科大学; テルモ株式会社
Priority date: 2010-03-09
Filing date: 2011-03-07
Publication date: 2011-09-15
Also published as: JP2011182994A

Abstract

In an outer needle base (14) of a bone cement injection puncture needle (10) are provided an injection port (30) for supplying bone cement to an outer needle (12), and a suction port (34) for suctioning by use of a suction device. Near the base end of the outer needle (12) is provided a side hole (22), and further, in the suction port (34) is provided a multi-way stopcock (70) as a device for maintaining reduced pressure. The bone cement injection puncture needle (10) punctures a target bone, and after an inner needle (16) is removed from the outer needle (12), the suction device is connected to the suction port (34) and gas and liquid inside the bone is suctioned, creating a negative pressure in the bone. By this means, when the bone cement is injected into the bone, said bone cement can be prevented from leaking to outside of the bone. Further, by means of putting the multi-way stopcock (70) in a closed state after suctioning, the negative pressure in the bone can be maintained.

Description

Puncture needle for bone cement injection

The present invention relates to a puncture needle for injecting bone cement into a bone.

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. As a puncture needle for injecting bone cement, a bone biopsy needle is generally used (see, for example, JP-A-2003-24339). The pedicle approach includes a two-needle method of puncturing from both the left and right sides and a one-needle method of puncturing from only one side. The one-needle method is considered to be a more preferable puncture method because it has the advantages of reducing costs, reducing complications, reducing the amount of exposure, and shortening the procedure execution time compared to the two-needle method.

However, the conventional puncture needle has a problem that bone cement may leak out of the bone when the bone cement is injected by the single needle method.

That is, when bone cement is injected by a single needle method using a conventional puncture needle, the internal pressure in the bone increases with the injection of the bone cement, so that the bone cement is outside the bone (for example, in the spinal canal or in the vein). There was a possibility of leakage. Therefore, the emphasis is on avoiding the problem of increased internal pressure rather than the advantage of the one-needle method which is preferable for both patients and surgeons, and the procedure is performed by the two-needle method which can reduce the internal pressure in the bone using one needle. It was recommended to do.

The present invention has been made in view of the above circumstances, and provides a puncture needle for injecting bone cement that can inject bone cement into bone without increasing the internal pressure in the bone even with a single needle method. Objective.

The puncture needle for bone cement injection according to the present invention includes a hollow outer needle having a bone cement passage, an outer needle base fixed to a proximal end portion of the outer needle, a needle tip at a distal end, and the outer needle. An inner needle that is slidably inserted into a hollow portion of the needle, and an outer needle base that communicates with the bone cement passage through a proximal end opening of the outer needle, and bone cement is applied to the outer needle. An injection port for supplying, and a suction port provided in the outer needle base for sucking gas or liquid in the bone using a suction device, wherein the outer needle is a puncture target In the state where the bone is punctured, the inside of the bone and the suction port communicate with each other, and the suction port can open and close an internal flow path and can be connected to the suction device. A device is provided.

According to the configuration of the present invention described above, the suction port is provided in the outer needle base, and when the outer needle is punctured into the bone to be punctured, the inside of the bone and the internal flow path of the suction port communicate with each other. Since the outer needle is configured, when the puncture needle is punctured into the target bone (for example, vertebra), the gas or liquid in the bone can be sucked through the suction port using the suction device. As a result, since negative pressure is generated in the bone, leakage of the bone cement to the outside of the bone can be prevented even if bone cement is injected into the bone. Moreover, since bone cement can be inject | poured, maintaining the negative pressure in a bone, the adhesiveness of the bone cement in a bone can be made favorable. Furthermore, according to the present invention, the negative pressure in the bone after suction is maintained without maintaining the connected state of the suction device by closing the flow path of the suction port with the negative pressure maintaining device after suction with the suction device. Can be maintained. Therefore, since the suction device can be removed after the suction, the suction device does not get in the way in the subsequent operation, and the operation can be performed smoothly.

In the vicinity of the proximal end portion of the outer needle, a side hole is provided, and the suction port may communicate with the bone cement passage through the side hole.

According to the above configuration, the side hole is provided in the vicinity of the proximal end portion of the outer needle, and the suction port communicates with the bone cement passage through the side hole, so that the outer needle is punctured into the bone to be punctured. In this state, the bone and the flow channel in the injection port communicate with each other. Therefore, it is possible to realize a structure in which the bone and the suction port are communicated with each other with a simple configuration.

The channel cross-sectional area of the side hole may be set smaller than the channel cross-sectional area of the bone cement passage.

According to the above configuration, when the bone cement flows through the bone cement passage, the outflow amount of the bone cement flowing out to the suction port side through the side hole is suppressed. For this reason, it becomes possible to inject the bone cement into the bone with an accurate injection amount.

In the suction port, it is preferable to provide a cement passage blocking means that allows passage of gas or liquid sucked from inside the bone while blocking passage of bone cement.

According to the above configuration, the outflow amount of the bone cement flowing out to the suction port side can be suppressed by providing the cement passage blocking means. For this reason, it becomes possible to inject the bone cement into the bone with an accurate injection amount.

The outer needle has an inner tube that has the bone cement passage and the inner needle is inserted therethrough, and an outer tube that surrounds the inner tube, and the outer tube is positioned near a distal end portion. A side hole and a second side hole located in the vicinity of the base end, and the first side hole and the second side hole are formed between the inner tube and the outer tube. It is good to communicate through the decompression passage.

According to the above configuration, the decompression passage is formed between the inner tube and the outer tube constituting the double pipe, and the first side hole and the second side hole communicate with each other via the decompression passage. In a state where the outer needle is punctured into the bone to be punctured, the bone and the flow path in the injection port communicate with each other. Therefore, it is possible to realize a structure in which the bone and the suction port are communicated with each other with a simple configuration. That is, according to this configuration, when the outer needle is punctured into the bone and the first side hole is located in the bone and sucked by the suction device through the suction port, the gas or liquid in the bone is the first It enters into the decompression passage from the side hole and flows into the suction port from the second side hole. Thereby, by making negative pressure in the bone, it is possible to prevent the bone cement from leaking out of the bone when the bone cement is injected into the bone.

A plurality of the first side holes may be provided in the circumferential direction and the axial direction of the outer tube.

According to the above configuration, even if some of the first side holes are clogged with the liquid from the bone, the liquid can flow into the outer needle from the other first side holes. Can be more reliably prevented.

It is a whole block diagram of the puncture needle for bone cement injection which concerns on 1st Embodiment. FIG. 2 is a partially omitted sectional view taken along line II-II in FIG. 1. In the puncture needle for bone cement injection concerning a 1st embodiment, it is a partially omitted sectional view in the state where an inner needle was extracted from an outer needle. 4A is a view showing a state where a bone cement injection puncture needle has been punctured into a bone, FIG. 4B is a view showing a state where a syringe filled with bone cement is connected to an outer needle base, and FIG. It is a figure which shows a mode that the gas and liquid in a bone are attracted | sucked using the syringe for suction. FIG. 5A is a view showing a state in which the suction port channel is closed by turning the lever of the multiway cock, FIG. 5B is a view showing a state in which bone cement is injected into the bone, and FIG. It is a figure which shows a mode that the inner needle is penetrated to a needle | hook and the bone cement in a bone cement channel | path is extruded. FIG. 6 is a partially omitted cross-sectional view of a bone cement injection puncture needle according to a second embodiment. It is a partially abbreviated sectional view showing the connector in the state where the valve body is deformed and its peripheral part. FIG. 8A is a view showing a state where a syringe filled with bone cement is connected to an outer needle base of a puncture needle for injecting bone cement, and FIG. 8B is a drawing of sucking gas and liquid in the bone using a syringe for suction. It is a figure which shows a mode that it does. FIG. 9A is a view showing a state in which the flow path of the suction port is closed by the valve body of the connector, and FIG. 9B is a view showing a state in which bone cement is injected into the bone. FIG. 10A is a partially omitted cross-sectional view showing the outer needle base and the outer needle fixed to the outer needle base according to the first modification, and FIG. 10B is the outer needle base and the outer needle according to the second modification. It is a partially omitted sectional view showing an outer needle fixed to a needle base. It is a side view which shows the outer needle base and its peripheral member which concern on a 3rd modification. It is a partially omitted sectional view of a bone cement injection puncture needle according to a third embodiment. In the puncture needle for bone cement injection concerning a 3rd embodiment, it is a partially omitted sectional view in the state where the inner needle was extracted from the outer needle. It is a partially abbreviated enlarged view showing a distal end portion and its peripheral portion of an outer needle of a bone cement injection puncture needle according to a third embodiment. FIG. 15A is a view showing a state where a syringe filled with bone cement is connected to an outer needle base of a puncture needle for injecting bone cement, and FIG. 15B is a drawing of sucking gas and liquid in the bone using a syringe for suction. It is a figure which shows a mode that it does. FIG. 16A is a view showing a state in which the suction port channel is closed by turning the lever of the multiway cock, and FIG. 16B is a view showing a state in which bone cement is injected into the bone. It is a partially omitted sectional view of a bone cement injection puncture needle according to a fourth embodiment. FIG. 18A is a view showing a state where a syringe filled with bone cement is connected to an outer needle base of a puncture needle for injecting bone cement, and FIG. 18B is a drawing of sucking gas and liquid in the bone using a syringe for suction. It is a figure which shows a mode that it does. FIG. 19A is a view showing a state where the flow path of the suction port is closed by the valve body of the connector, and FIG. 19B is a view showing a state in which bone cement is injected into the bone. It is a side view which shows the outer needle base and its peripheral member which concern on a modification.

Hereinafter, preferred embodiments of the puncture needle for injecting bone cement according to the present invention will be described with reference to the accompanying drawings. In the present specification, “bone cement” includes not only bone cement (plastic preparation and the like) but also bone paste (calcium phosphate preparation and the like).

[First Embodiment]
FIG. 1 is an overall configuration diagram of a bone cement injection puncture needle 10 (hereinafter referred to as “puncture needle 10”) according to a first embodiment of the present invention. As shown in FIG. 1, the puncture needle 10 is slidably inserted into an outer needle 12 having a hollow structure, an outer needle base 14 fixed to the proximal end portion of the outer needle 12, and a hollow portion of the outer needle 12. The inner needle 16, the inner needle base 18 fixed to the proximal end portion of the inner needle 16, and a multi-way cock (depressurization maintaining device) 70 provided on the outer needle base 14. FIG. 1 shows a state in which the inner needle 16 is inserted into the hollow portion of the outer needle 12.

In the following description, the axial direction of the inner needle 16 and the outer needle 12 is the Z direction, the direction perpendicular to the Z direction is the X direction, and the direction perpendicular to the Z direction and the X direction is the Y direction. In FIG. 1, 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 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.

FIG. 2 is a partially omitted sectional view taken along line II-II in FIG. FIG. 3 is a partially omitted cross-sectional view of the puncture needle 10 with the inner needle 16 removed from the outer needle 12. As shown in FIGS. 2 and 3, the outer needle 12 is a hollow structure member that is open at both ends and has a bone cement passage 20 inside. The distal end of the outer needle 12 is configured as a sharp cutting edge, and is integrated with the needle tip 37 of the inner needle 16 when the inner needle 16 is inserted into the outer needle 12 (the state shown in FIGS. 1 and 2). Thus, the needle tip of the puncture needle 10 is configured.

The constituent material of the outer needle 12 is not particularly limited as long as it has an appropriate strength so as not to be damaged or deformed during puncture and extraction from the bone. For example, stainless steel, aluminum alloy, Examples include copper-based alloys.

As shown in FIG. 3, the bone cement passage 20 functions as a hole for inserting the inner needle 16 when the inner needle 16 and the outer needle 12 are combined, and the bone cement is inserted when the bone cement is injected. Functions as a flow channel. The length of the outer needle 12 is about 100 to 200 mm. The inner diameter d1 of the outer needle 12 is about 1.5 to 2.8 mm, and the outer diameter D of the outer needle 12 is about 1.9 to 3.5 mm.

A side hole 22 is provided in the vicinity of the proximal end portion of the outer needle 12. The side hole 22 is a hole that penetrates the inside and outside of the outer needle 12. The distance L1 from the most distal position of the outer needle 12 to the side hole 22 (specifically, the most distal side (Z1 direction side portion) of the side hole 22) is the side when the puncture needle 10 is punctured into the bone. It sets so that the hole 22 may be reliably located outside the body. Specifically, the distance L1 is 80 mm or more, preferably 120 mm or more.

The outer needle base 14 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. The constituent material of the outer needle base 14 is not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene- Examples thereof include styrene copolymers, polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) and the like.

The outer needle base 14 is formed so as to cover the proximal end portion of the outer needle 12 and to be fixed to the proximal end portion of the outer needle 12. The outer needle 12 may be fixed to the outer needle base 14 by press-fitting, bonding, welding, or insert molding of the outer needle 12 to the outer needle base 14. Further, in order to prevent the outer needle 12 from coming off from the outer needle base 14, the base end portion of the outer needle base 14 may be formed in a flare shape whose diameter increases toward the base end opening. The outer needle 12 can be fixed to the outer needle base 14 by molding.

An upper end portion (end portion in the Z2 direction) of the outer needle base 14 communicates with the bone cement passage 20 through the proximal end opening of the outer needle 12 and is used to supply (transfer) bone cement to the outer needle 12. A port 30 is provided. A male screw portion 32 is formed on the outer peripheral portion of the injection port 30, and is screwed to both the inner needle base 18 and the syringe 40 (see FIG. 4B) as an injection device by the male screw portion 32. Can be connected. The outer needle base 14 is formed with a first passage 24 that extends from the mouth of the injection port 30 to a position facing the end opening of the outer needle 12.

A suction port 34 that communicates with the bone cement passage 20 via the side hole 22 is provided on one side surface (surface in the Y direction) of the outer needle base 14. A male screw portion 36 is formed on the outer peripheral portion of the suction port 34, and the male screw portion 36 can be screwed and connected to a distal end portion of a syringe 50 (see FIG. 4C) as a suction device. . The outer needle base 14 is formed with a second passage 26 extending from the mouth of the suction port 34 to a position facing the side hole 22.

The size of the side hole 22 is such that the gas or liquid in the bone (for example, exudate or blood) can smoothly flow into the outer needle 12, and the bone cement flows into the side hole 22 when the bone cement flows through the bone cement passage 20. It is good to set so that the quantity which passes can be suppressed. For this reason, the channel cross-sectional area of the side hole 22 is preferably set smaller than the channel cross-sectional area of the bone cement passage 20. That is, when the side hole 22 is circular, the diameter d2 of the side hole 22 is preferably set smaller than the inner diameter d1 of the outer needle 12 (diameter of the bone cement passage 20). It is preferable to be about 1/5 to 1/20 (for example, 0.3 mm or less).

The inner needle 16 is a rod-shaped member that is inserted into the bone cement passage 20 of the outer needle 12 and has a sharp needle tip 37 at the tip. The constituent material of the inner needle 16 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 16 is preferably set to be substantially the same as the inner diameter of the outer needle 12. Specifically, the inner needle 16 is smoothly inserted into the bone cement passage 20 that is a hollow portion (lumen) of the outer needle 12. The inner needle 16 and the outer circumference of the outer needle 12 (the inner circumference of the inner tube) are preferably set so that there is almost no gap between them.

The length of the inner needle 16 is set so that the tip of the inner needle 16 slightly protrudes from the tip of the outer needle 12 with the inner needle base 18 connected to the outer needle base 14. In a state where the inner needle base 18 is connected to the outer needle base 14, the protruding length of the inner needle 16 from the tip of the outer needle 12, that is, the distance L2 between the tip of the inner needle 16 and the tip of the outer needle 12 is preferably 2 to 10 mm is preferable. The needle tip 37 may be completely exposed from the tip of the outer needle 12 with the inner needle base 18 connected to the outer needle base 14.

The inner needle base 18 is a member coupled to the proximal end portion of the inner needle 16. The outer diameter of the inner needle base 18 is set to be larger than the outer diameter of the inner needle 16, and specifically, it is easy for a user (medical staff such as a doctor) to pinch and pull or rotate with a finger. It is set to such a size. The constituent material of the inner needle base 18 is not particularly limited, but a constituent material similar to the constituent material of the outer needle base 14, for example, a hard resin such as polycarbonate can be used.

The inner needle base 18 is formed with a female screw portion 19 that can be screwed into the male screw portion 32 of the injection port 30. When the inner needle base 18 is connected to the outer needle base 14 by screwing the male screw portion 32 and the female screw portion 19, the state where the inner needle 16 is inserted into the bone cement passage 20 of the outer needle 12 is maintained. .

The multiway cock 70 functions as a negative pressure maintaining device that can open and close the internal flow path and can be connected to a syringe 50 (see FIG. 4C) as a suction device. Hereinafter, a two-way cock having two ports will be described as a configuration example of the multi-way cock 70, but the multi-way cock 70 may be configured to have three or more ports.

The multi-way stopcock 70 includes a body portion 75 having a hollow first port 73 and a second port 88 projecting from a bottomed cylindrical housing 72, a central shaft 78 and a lever that are rotatably inserted into the housing 72. And a cock 74 having 76.

The first port 73 is configured to be fitted into the suction port 34. A fixing member 80 is rotatably provided on the main body 75 so as to surround the outer periphery of the first port 73. An internal thread portion 82 is formed on the inner peripheral portion of the fixing member 80, and the first port 73 can be inserted into the suction port 34 and fixed by rotating the fixing member 80. A male screw portion 90 is formed on the outer peripheral portion of the second port 88 so that a syringe 50 (see FIG. 4C) as a suction device can be screwed and connected.

The cock 74 is a component for opening and closing the flow path in the main body 75, and by rotating the lever 76, the center shaft 78 coupled to the lever 76 rotates. The middle shaft 78 is provided with a communication passage 78a. By rotating the middle shaft 78 in the housing 72, the first port 73 and the second port 88 are communicated with each other through the communication passage 78a. It is configured to be able to switch between a closed state where the port 73 and the second port 88 are blocked.

The puncture needle 10 according to the first embodiment is basically configured as described above, and the operation and effect will be described next.

FIGS. 4A to 4C and FIGS. 5A to 5C are diagrams illustrating a method of injecting bone cement into bone using the puncture needle 10. FIG. In order to inject bone cement into the bone using the puncture needle 10, first, after determining the puncture position and puncture target under image guidance (under X-ray fluoroscopy or CT fluoroscopy), the state where the inner needle 16 is attached The puncture needle 10 is hit with a hammer to puncture the puncture target in the bone 38 (see FIG. 4A). At this time, the side hole 22 is located outside the body. The target bone 38 is, for example, a vertebra. When the puncture needle 10 is punctured into the bone 38, the multiway cock 70 may be removed as shown in FIG. 4A. In this way, the multiway cock 70 does not get in the way and the puncturing operation can be performed smoothly.

Before puncturing the patient with the puncture needle 10, a tube for supplying a cleaning solution is connected to the injection port 30 or the suction port 34, and a cleaning solution such as physiological saline is supplied through the first passage 24 or the second passage 26. The bone cement passage 20 may be supplied and the bone cement passage 20 may be cleaned and filled.

After the puncture needle 10 has been punctured into the bone 38, the inner needle 16 is removed from the outer needle 12, and then a syringe (aspiration device) 40 filled with bone cement 48 is connected to the injection port 30 and a multiway cock 70 Is connected to the suction port 34 (see FIG. 4B). At this time, the cock 74 of the multiway cock 70 is rotated to the closed position. Either the timing of connecting the syringe 40 to the injection port or the timing of connecting the multiway cock 70 to the suction port 34 may be first.

The syringe 40 includes an outer cylinder 42 configured to be connectable by screwing the distal end portion thereof to the injection port 30, and a pusher 44 having a gasket 46 that slides in the outer cylinder 42 at the distal end. A bone cement 48 is filled in the cylinder 42.

Next, after the suction syringe 50 is connected to the second port 88 of the multiway cock 70, the cock 74 of the multiway cock 70 is rotated to bring the multiway cock 70 into an open state (see FIG. 4C). Thereby, the second passage 26 in the suction port 34 and the inside of the syringe 50 communicate with each other through the multiway cock 70. The syringe 50 may be connected to the multiway cock 70 via a relay tube (not shown).

The syringe 50 has an outer cylinder 52 configured to be connectable by screwing the tip portion with the suction port 34, and a pusher 54 provided with a gasket 56 that slides in the outer cylinder 52 at the tip. The syringe 50 preferably has a lock function that can restrain the pusher 54 at a desired position. .

As shown in FIG. 4C, when the multiway cock 70 is in the open state, the pusher 54 of the syringe 50 is moved in the pulling direction. Then, the gas or liquid in the bone 38 flows into the syringe 50 through the bone cement passage 20, the side hole 22, the second passage 26, and the multiway cock 70. Thereby, the inside of the bone 38 is in a negative pressure state. In addition, since the viscosity of the bone cement 48 is very large, even if the negative pressure is applied to the inside of the bone 38 by the syringe 50, the bone cement 48 is not sucked to the bone cement passage 20 side.

When the inside of the bone 38 is in a negative pressure state, the cock 74 is rotated to close the multiway cock 70, and the syringe 50 is removed from the multiway cock 70 (see FIG. 5A). In this case, since the multiway cock 70 is closed, the negative pressure in the bone 38 is maintained even if the syringe 50 is removed from the multiway cock 70. Thereby, in subsequent operation, the syringe 50 does not get in the way and the operation can be performed smoothly.

Next, the bone cement 48 in the syringe 40 is injected into the bone 38 through the first passage 24 and the bone cement passage 20 (see FIG. 5B). At this time, since the inside of the bone 38 is under negative pressure due to suction, even if the bone cement 48 is injected into the bone 38, the bone 38 expands or the bone cement 48 leaks out of the bone 38. Can be prevented. Further, since the bone cement 48 can be injected while maintaining the negative pressure in the bone 38, the adhesion of the bone cement 48 in the bone 38 can be improved.

As described above, the flow passage cross-sectional area of the side hole 22 is set smaller than the flow passage cross-sectional area of the bone cement passage 20, and therefore when the bone cement 48 is flowed through the bone cement passage 20, the side hole 22. The amount of outflow of the bone cement 48 that flows out to the suction port 34 side is suppressed. That is, the bone cement 48 having a high viscosity has a high fluid resistance to flow through the side hole 22 having a small channel cross-sectional area, and therefore flows preferentially through the bone cement passage 20 having a small channel resistance. For this reason, when the bone cement 48 flows into the bone cement passage 20, the outflow amount of the bone cement 48 that flows out to the suction port 34 side through the side hole 22 can be suppressed. As a result, the bone cement 48 enters the bone 38. The cement 48 can be injected with an accurate injection amount.

In the process of injecting the bone cement 48 into the bone 38, if the bone cement 48 passes through the outer needle 12, the multiway cock 70 may be removed. Even if the multiway cock 70 is removed, the bone cement passage 20 is already filled with the bone cement 48, so that outside air does not flow into the bone cement passage 20 from the suction port 34 and the side hole 22, and the negative pressure in the bone 38 is Maintained. Thereby, in the subsequent operation, the multiway cock is not in the way, and the operation can be performed smoothly.

When a predetermined amount of bone cement 48 has been injected into the bone 38, the syringe 40 is removed. Next, the inner needle 16 is inserted into the first passage 24 and the bone cement passage 20 of the outer needle 12, and the bone cement 48 remaining in the first passage 24 and the bone cement passage 20 is pushed into the bone 38 (FIG. 5C). reference).

As described above, according to the puncture needle 10 according to the first embodiment, when the outer needle base 14 is provided with the suction port 34 and the outer needle 12 is punctured into the bone 38 to be punctured, the bone Since the outer needle 12 is configured so that the inside of the valve 38 communicates with the internal flow path of the injection port 30, when the puncture needle 10 is punctured into the bone 38, the bone is obtained via the suction port 34 using the syringe 50. The gas or liquid in 38 can be aspirated. Thereby, since the inside of the bone 38 becomes a negative pressure, even if the bone cement 48 is subsequently injected into the bone 38, the bone 38 can be prevented from expanding or leaking out of the bone. . Further, since the bone cement 48 can be injected while maintaining the negative pressure in the bone 38, the adhesion of the bone cement 48 in the bone 38 can be improved.

Furthermore, according to the puncture needle 10, the suction port 34 is closed by the multiway cock 70 after being sucked by the syringe 50, so that the negative pressure in the bone 38 after sucking can be reduced without maintaining the connected state of the syringe 50. Can be maintained. Therefore, since the syringe 50 can be removed after the suction, the syringe 50 does not get in the way in the subsequent operation, and the operation can be performed smoothly.

In the first embodiment described above, the multi-way cock 70 has been described as being configured to be detachable from the outer needle base 14, but the multi-way cock 70 and the outer needle base 14 may be configured to be inseparable from each other. .

[Second Embodiment]
FIG. 6 is a partially omitted cross-sectional view of a bone cement injection puncture needle 10a (hereinafter referred to as “puncture needle 10a”) according to the second embodiment. In the puncture needle 10a according to the second embodiment, elements having the same or similar functions and effects as those of the puncture needle 10 according to the first embodiment are denoted by the same reference numerals, and detailed description is given. Omitted.

The puncture needle 10a according to the second embodiment is obtained by replacing the multiway cock 70 of the puncture needle 10 according to the first embodiment with a connector 100. That is, as shown in FIG. 6, the puncture needle 10a has a check valve as another configuration of a negative pressure maintaining device that can open and close an internal flow path and that can be connected to a suction syringe 50 (see FIG. 8B). A connector 100 having a function is provided.

As shown in FIG. 6, the connector 100 according to one configuration example includes a valve body 104 having an overall outer diameter of a substantially columnar shape, and a connector housing 102 that houses (installs) the valve body 104.

The valve body 104 is made of an elastic material (flexible material) that can be elastically deformed, and has a head portion 120 and a body portion 118 provided on the base end side (Y2 direction side) of the head portion 120. is doing. The head 120 is formed with a lumen 121 through which a fluid can pass and a slit 122 that reaches the lumen 121 from a flat top surface 123. The trunk portion 118 is formed of a cylindrical body having a bellows shape. Such a body portion 118 functions as a deforming portion (biasing means) that urges the valve body 104 from the proximal end side toward the distal end side.

The connector housing 102 includes a housing main body 102a and a lid portion 102b. When the lid portion 102b is fitted into the housing main body 102a, the valve body 104 is accommodated in the internal space thereof. At one end of the housing body 102a (the Y2 direction side end in FIG. 6), an inner cylindrical portion 112 that can be fitted into the suction port 34, and an outer cylindrical portion 114 that surrounds the inner cylindrical portion 112 with an annular gap therebetween. And are provided. A female screw portion 116 that can be screwed into the male screw portion 36 on the outer peripheral portion of the suction port 34 is formed on the inner peripheral portion of the outer cylindrical portion 114.

The connector housing 102 has a first lumen portion 106 into which a distal end portion 58 (see FIG. 7) of the suction syringe 50 can be inserted, and a first inner portion adjacent to the Y2 direction side of the first lumen portion 106. A second lumen 108 having a larger diameter than the cavity 106, and adjacent to the Y2 direction side of the second lumen 108, and a proximal end of the valve body 104 (on the opposite side to the head 120). A third lumen portion 110 for accommodating the end portion).

The first lumen 106 can be inserted into the head 120 of the valve body 104 and has an inner diameter that is substantially the same as the outer diameter of the head 120. As shown in FIG. 6, when the head 120 of the valve body 104 is positioned in the first lumen 106, the slit 122 formed in the head 120 is closed. The second lumen 108 has an inner diameter that is larger than the outer diameter of the head 120 in a natural state (a state that is not compressed and deformed).

The lid 102b is connected to the tip of the housing body 102a. A male screw part 125 that can be screwed onto the tip of the syringe 50 is formed on the outer periphery of the lid part 102b.

7, when connecting the syringe 50 to the connector 100, the distal end portion 58 of the syringe 50 is inserted into the first lumen portion 106, and the head portion 120 of the valve body 104 is pressed. Then, the valve body 104 compresses and deforms in the axial direction, so that the head 120 enters the second lumen 108. The head 120 has been restricted by the inner peripheral surface of the first lumen 106 until then, but the restriction is released by moving to the second lumen 108, and as a result, the compression in the axial direction results. The diameter can be increased. This opens the slit 122 as shown in FIG. As a result, the inside of the syringe 50 and the second passage 26 in the suction port 34 are in communication with each other.

On the other hand, when the syringe 50 is removed from the connector 100, the valve body 104 is restored to the shape shown in FIG. 6 by its own elasticity. That is, the slit 122 is closed when the head 120 moves into the first lumen 106. As a result, the flow path in the connector 100 is blocked, and the inflow of outside air to the outer needle base 14 side is prevented.

8A, 8B, 9A, and 9B are views for explaining a method of injecting bone cement into bone using the puncture needle 10a according to the second embodiment. In order to inject bone cement into the bone using the puncture needle 10a, first, the puncture needle 10a is punctured into the bone 38 which is a puncture target by the same method as in FIG. 4A. When the puncture needle 10a is punctured into the bone 38, the connector 100 is preferably removed, so that the connector 100 does not get in the way and the puncture operation can be performed smoothly.

After puncturing the puncture needle 10a into the bone 38, the inner needle 16 is removed from the outer needle 12, and then a syringe (aspiration device) 40 filled with bone cement 48 is connected to the injection port 30 and the connector 100 is connected. Connect to the suction port 34 (see FIG. 8A). Either the timing for connecting the syringe 40 to the injection port 30 or the timing for connecting the connector 100 to the suction port 34 may be first.

Next, the suction syringe 50 is connected to the connector 100 (see FIG. 8B). Then, as described above, the slit 122 of the valve body 104 is opened, and as a result, the inside of the syringe 50 and the second passage 26 in the suction port 34 are in communication with each other. After the suction syringe 50 is connected to the connector 100 in this way, the pusher 54 of the syringe 50 is moved in the pulling direction, and the gas in the bone 38 is removed via the bone cement passage 20, the second passage 26 and the connector 100. Aspirate liquid. As a result, negative pressure is generated in the bone 38.

When the inside of the bone 38 is in a negative pressure state, the syringe 50 is removed from the connector 100 (see FIG. 9A). Then, as described above, the slit 122 of the valve body 104 is closed. As a result, the flow path in the connector 100 is closed, and the inflow of outside air to the outer needle base 14 side is prevented. Therefore, even if the syringe 50 is removed from the multiway cock 70, the negative pressure in the bone 38 is maintained.

In the process of injecting the bone cement 48 into the bone 38, when the bone cement 48 passes through the outer needle 12, the connector 100 may be removed. Even when the connector 100 is removed, since the bone cement passage 20 is already filled with the bone cement 48, the outside air does not flow into the bone cement passage 20 from the suction port 34 and the side hole 22, and the negative pressure in the bone 38 is maintained. Is done. Thereby, in the subsequent operation, the connector 100 does not get in the way, and the operation can be performed smoothly.

Next, the bone cement 48 in the syringe 40 is injected into the bone through the first passage 24 and the bone cement passage 20 (see FIG. 9B). When a predetermined amount of bone cement 48 is injected into the bone 38, the inner needle 16 is inserted into the outer needle 12 in the same manner as in FIG. 5C, and the bone remaining in the first passage 24 and the bone cement passage 20 is retained. Cement 48 is pushed into bone 38.

As described above, according to the puncture needle 10a according to the second embodiment, similarly to the puncture needle 10 according to the first embodiment, the suction port 34 and the bone cement are used by using the syringe 50 that is a suction device. Since the gas or liquid in the bone 38 can be sucked through the passage 20 and negative pressure can be generated in the bone 38, even if the bone cement 48 is subsequently injected into the bone 38, the bone 38 is expanded. The bone cement 48 can be prevented from leaking out of the bone 38. Further, since the bone cement 48 can be injected while maintaining the negative pressure in the bone 38, the adhesion of the bone cement 48 in the bone 38 can be improved.

Further, according to the puncture needle 10a, the suction port 34 is closed by the connector 100 after being sucked by the suction syringe 50, so that the shadow in the bone 38 after suction is maintained without maintaining the connected state of the syringe 50. Pressure can be maintained. Therefore, since the syringe 50 can be removed after the suction, the syringe 50 does not get in the way in the subsequent operation, and the operation can be performed smoothly.

In the second embodiment, the same components and the same effects as those provided by the respective components in the first embodiment are the same as or similar to those in the first embodiment. Of course.

In the second embodiment described above, the connector 100 has been described as being configured to be detachable from the outer needle base 14, but the connector 100 and the outer needle base 14 may be configured to be inseparable.

In the first and second embodiments described above, instead of the outer needle base 14, the outer needle base 14a according to the first modification shown in FIG. 10A and the outer needle base 14b according to the second modification shown in FIG. 10B. May be adopted.

As shown in FIG. 10A, in the suction port 34 of the outer needle base 14a according to the first modification, the passage of gas or liquid sucked from inside the bone is allowed while the passage of bone cement is blocked. As a means, a porous body 60 is provided. The porous body 60 can pass gas or liquid in the bone, but cannot substantially pass bone cement, and is fixed in the suction port 34.

Thus, since the outer needle base 14a is provided with the porous body 60 in the suction port 34, when the bone cement is allowed to flow into the bone cement passage 20, the bone cement having a high viscosity Can hardly pass. For this reason, the outflow amount of the bone cement flowing out to the suction port 34 side through the side hole 22 can be suppressed, and as a result, the bone cement can be injected into the bone with an accurate injection amount.

As shown in FIG. 10B, in the suction port 34 of the outer needle base 14b according to the second modified example, the passage of gas or liquid sucked from inside the bone is allowed while the passage of cement is prevented from passing through the bone cement. As a means, a mesh 62 is provided. The mesh 62 allows gas or liquid in the bone to pass therethrough but cannot pass bone cement substantially, and is fixed in the suction port 34.

As described above, since the mesh 62 is provided in the suction port 34 in the outer needle base 14b, when the bone cement is allowed to flow through the bone cement passage 20, the bone cement having a high viscosity almost passes through the mesh 62. I can't. For this reason, the outflow amount of the bone cement flowing out to the suction port 34 side through the side hole 22 can be suppressed, and as a result, the bone cement can be injected into the bone with an accurate injection amount.

In the first and second embodiments described above, the case where the suction port 34 is provided on the side surfaces (surfaces facing the Y direction) of the

outer needle bases

14, 14a, 14b has been described, but the outer needle base 14c shown in FIG. As described above, the suction port 35 may be provided at one end in the left-right direction (end in the X direction). The suction port 35 has the same function as the suction port 34, and can connect the multi-way cock 70 and the connector 100.

In percutaneous vertebroplasty, when using multiple bone cement injection puncture needles, puncture the patient's body with multiple bone cement injection puncture needles so that the outer needle bases are parallel to each other. There is. When the suction port 35 is provided at the end in the longitudinal direction as in the outer needle base 14c shown in FIG. 11, the suction port 35 does not get in the way between adjacent puncture needles, and the procedure can be performed smoothly. .

The outer needle base 14c may have an integral configuration that cannot be separated from the multi-way cock 70 and the connector 100. In this case, a structure having functions equivalent to those of the multi-way cock 70 and the connector 100 is provided inside the outer needle base 14c. May be provided.

[Third Embodiment]
FIG. 12 is a partially omitted cross-sectional view of a bone cement injection puncture needle 10b (hereinafter referred to as “puncture needle 10b”) according to the third embodiment. FIG. 13 shows an inner needle 16 and an inner needle base 18. It is a partially omitted sectional view showing a removed state. Note that, in the puncture needle 10b according to the third embodiment, elements having the same or similar functions and effects as those of the puncture needle 10 according to the first embodiment are denoted by the same reference numerals, and detailed description is given. Omitted.

In the puncture needle 10b according to the third embodiment, the outer needle 12 and the outer needle base 14 of the puncture needle 10 according to the first embodiment are replaced with an outer needle 130 and an outer needle base 132 that are different from these. The other components are the same as those of the puncture needle 10 according to the first embodiment.

As shown in FIGS. 12 and 13, the outer needle 130 is a member having a hollow structure opened at both ends, and has an inner tube 134 through which the inner needle 16 is inserted, and an outer tube 136 surrounding the inner tube 134. Thus, a double tube structure is formed. As the constituent material of the inner tube 134 and the outer tube 136, the same constituent material as that of the outer needle can be used.

As shown in FIG. 13, the inner tube 134 is open at both ends and has a bone cement passage 131 inside. The bone cement passage 131 functions as a hole for inserting the inner needle 16 when the inner needle 16 and the outer needle 130 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 134 is about 100 to 200 mm. In the configuration example shown in FIG. 13, the inner tube 134 is a hollow cylindrical tube, and the inner diameter thereof is about 1.8 to 2.4 mm.

A first flare-shaped portion 138 is formed at the proximal end portion of the inner tube 134. In the configuration example shown in FIGS. 12 and 13, the first flare-shaped portion 138 extends conically in the proximal direction (Z2 direction). The angle of the first flare shape portion 138 with respect to the axis of the outer needle 130 is set to about 15 to 60 °, for example.

The outer tube 136 is open at both ends, and the inner tube 134 is inserted into the hollow portion. The length of the outer tube 136 is about 100 to 200 mm, and is set slightly longer than the inner tube 134. The outer tube 136 is a hollow cylindrical tube. An inner diameter d4 of the outer tube 136 is set larger than an outer diameter d3 of the inner tube 134, and a decompression passage 142 extending in the axial direction is formed between the outer tube 136 and the inner tube 134. The inner diameter of the outer tube 136 is, for example, about 2.1 to 2.3 mm.

A first side hole 144 is provided in the vicinity of the distal end portion of the outer tube 136. The first side hole 144 is a hole that penetrates the inside and outside of the outer tube 136, and a plurality of the first side holes 144 are preferably provided in the circumferential direction and the axial direction. The number of the first side holes 144 is preferably 4 to 36, and more preferably 10 to 26. A preferable arrangement and dimensions of the first side hole 144 will be described later.

Near the proximal end of the outer tube 136, a second side hole 146 is provided. The second side hole 146 is a hole that penetrates the inside and outside of the outer tube 136. The distance L3 from the most distal position of the outer needle 130 to the second side hole 146 (specifically, the most distal end side (Z1 direction side portion) of the second side hole) When puncturing, the second side hole 146 is set so as to be surely located outside the body. Specifically, the distance L3 is 80 mm or more, preferably 120 mm or more.

The number of the second side holes 146 may be one, but a plurality of the second side holes 146 may be provided in the circumferential direction or the axial direction. In the configuration example shown in FIG. 12, two second side holes 146 are provided in the circumferential direction. The first side hole 144 and the second side hole 146 communicate with each other via a decompression passage 142 formed between the inner tube 134 and the outer tube 136.

A tapered portion 148 that is tapered is provided at the distal end of the outer tube 136. The angle of the tapered portion 148 with respect to the axis of the outer needle 130 is set to about 1 to 30 °, for example. The distal end portion of the inner tube 134 is supported by the inner peripheral portion of the tapered portion 148, whereby the distal end side of the decompression passage 142 is closed.

A second flare-shaped portion 140 is formed at the rear end portion of the outer tube 136. In the configuration example shown in FIGS. 11 and 12, the second flare-shaped portion 140 extends conically toward the proximal direction (Z2 direction). The angle of the second flare shape portion 140 with respect to the axis of the outer needle 130 is set to be substantially the same as the angle of the first flare shape portion 138 with respect to the axis of the outer needle 130. The first flare-shaped portion 138 is supported by the second flare-shaped portion 140, and the first flare-shaped portion 138 and the second flare-shaped portion 140 are in close contact with each other. Closed.

The outer needle base 132 is a member coupled to the proximal end portion of the outer needle 130, and has a function as a grip for the user of the puncture needle 10b to grip. Examples of the constituent material of the outer needle base 132 include the same materials as those exemplified as the constituent material of the outer needle base 14.

In the configuration example shown in FIG. 12, the outer needle base 132 is formed so as to cover the proximal end portion of the outer needle 130 and be fixed to the proximal end portion of the outer needle 130 by insert molding. The outer needle base 132 is provided with a taper support portion 141 that comes into contact with the outer surface of the second flare shape portion 140. Accordingly, the second flare shape portion 140 is supported by the taper support portion 141.

An injection for supplying (transferring) bone cement to the outer needle 130 at the upper end portion (end portion in the Z2 direction) of the outer needle base 14 communicates with the bone cement passage 131 through the proximal end opening of the outer needle 12. A port 150 is provided. A male screw portion 152 is formed on the outer peripheral portion of the injection port 150, and the male screw portion 152 is screwed to both the inner needle base 18 and the syringe 40 (see FIG. 15B) as an injection device. Can be connected. The outer needle base 132 is formed with a first passage 154 extending from the mouth of the injection port 150 to a position facing the end opening of the outer needle 130.

A suction port 158 communicating with the bone cement passage 131 through the side hole 22 is provided on one side surface (surface in the X direction) of the outer needle base 132. A male screw portion 160 is formed on the outer peripheral portion of the suction port 158, and the male screw portion 160 can be screwed into and connected to the distal end portion of the syringe 50 as a suction device. The outer needle base 132 has a second passage 147 communicating with the second side hole 146 so as to surround the outer needle 130, and a third passage 156 extending from the second passage 147 to the mouth of the suction port 158. And are formed.

In a state where the inner needle base 18 is connected to the outer needle base 132, the protruding length of the inner needle 16 from the distal end of the outer needle 130, that is, the distance L4 between the distal end of the inner needle 16 and the distal end of the outer needle 130 is as described above. It is good to set like L2.

FIG. 14 is a partially omitted enlarged view showing the first side hole 144 provided in the outer needle 130 and its periphery. The distance L5 from the most distal position of the outer needle 130 to the first side hole 144 located on the most proximal side (specifically, the most proximal side portion of the corresponding first side hole 144) is: With the outer needle 130 pierced into the bone, the first side hole 144 on the most proximal side is not positioned outside the bone, that is, all the first side holes 144 are set within the bone. . Specifically, the distance L5 is 20 mm or less, preferably 15 mm or less.

When a large number of the first side holes 144 are provided, as shown in FIG. 14, it is preferable that the first side holes 144 are provided in a zigzag shape in a circumferential direction. That is, assuming that the plurality of first side holes 144 arranged in the axial direction of the outer needle 130 are considered as one row (side hole row), the positions of the first side holes 144 in the adjacent side hole rows are in the axial direction. Each first side hole 144 is preferably arranged so as to be displaced. If comprised in this way, the 1st side hole 144 will be suitably arrange | positioned in the outer needle 130, and the intensity | strength fall of the outer needle 130 of the area | region in which the some 1st side hole 144 is arrange | positioned will be suppressed suitably. be able to.

The sizes of the first side holes 144 are not necessarily the same, and the sizes may be different. For example, when a cleaning device is connected to the suction port 158 to clean the inside of the bone, the amount of cleaning liquid sprayed from the base side of the first side hole 144 that is proximal from the suction port 158 is not greater than that of the distal end side. Thus, it is possible to increase the hole diameter as the side hole is closer to the tip. Further, the shape of the first side hole 144 does not have to be circular as shown in FIG. 14, and may be, for example, an ellipse or a polygon, or a mixture of different shapes.

The size of the first side hole 144 is preferably set so that a gas or liquid in the bone (for example, a leachate or blood) can smoothly flow into the outer needle 130. When the first side hole 144 is circular, the diameter is preferably set to 0.3 to 0.7 mm. When the first side hole 144 has a shape other than a circle, the size of the narrowest portion is preferably set to 0.3 to 0.7 mm.

If the first side hole 144 is too small, the liquid from the bone tends to clog the first side hole 144, but by setting the lower limit of the size of the first side hole 144 as described above, The liquid from the bone is less likely to clog the first side hole 144. If the first side hole 144 is too large, the piercing resistance increases, which causes a decrease in the smoothness of the procedure, but by setting the upper limit of the size of the first side hole 144 as described above, Increase in penetration resistance can be suppressed.

FIG. 15A, FIG. 15B, FIG. 16A and FIG. 16B are diagrams for explaining a method of injecting bone cement into bone using the puncture needle 10b according to the third embodiment. In order to inject bone cement into the bone using the puncture needle 10b, first, the puncture needle 10b is punctured into the bone 38 which is a puncture target by the same method as in FIG. 4A. At this time, puncture is performed so that all the first side holes 144 are located in the bone 38. When the puncture needle 10b is punctured into the bone 38, the multiway stopcock 70 is preferably removed, so that the multiway stopcock 70 does not get in the way and the puncture operation can be performed smoothly.

After the puncture needle 10b has been punctured into the bone 38, the inner needle 16 is removed from the outer needle 12, and then a syringe (aspiration device) 40 filled with bone cement 48 is connected to the injection port 150 and the multiway cock 70 Is connected to the suction port 158 (see FIG. 15A). At this time, the cock 74 of the multiway cock 70 is rotated to the closed position. Either the timing for connecting the syringe 40 to the injection port 150 or the timing for connecting the multiway cock 70 to the suction port 158 may be the first.

Next, after connecting the suction syringe 50 to the second port 88 of the multiway cock 70, the cock 74 of the multiway cock 70 is rotated to open the multiway cock 70 (see FIG. 15B). Thereby, the inside of the bone 38 and the inside of the syringe 50 communicate with each other through the first side hole 144, the decompression passage 142, the second side hole 146, the second passage 147, the third passage 156, and the multiway cock 70. .

Also, as shown in FIG. 15B, when the multiway cock 70 is opened, the pusher 54 of the syringe 50 is moved in the pulling direction. Then, the gas or liquid in the bone 38 is transferred to the syringe 50 via the first side hole 144, the decompression passage 142, the second side hole 146, the second passage 147, the third passage 156, and the multiway cock 70. Sucked. Thereby, the inside of the bone 38 becomes a negative pressure.

When the inside of the bone 38 is in a negative pressure state, the cock 74 is rotated to close the multiway cock 70, and the syringe 50 is removed from the multiway cock 70 (see FIG. 16A). In this case, since the multiway cock 70 is closed, the negative pressure in the bone 38 is maintained even if the syringe 50 is removed from the multiway cock 70.

Next, the bone cement 48 in the syringe 50 is injected into the bone 38 through the first passage 24 and the bone cement passage 20 (see FIG. 16B). When a predetermined amount of bone cement 48 is injected into the bone 38, the inner needle 16 is inserted into the outer needle in the same manner as in FIG. 5C, and the bone cement remaining in the first passage 154 and the bone cement passage 131 is retained. 48 is pushed into the bone 38.

As described above, according to the puncture needle 10b according to the third embodiment, using the syringe 50, which is a suction device, the gas or liquid in the bone 38 is sucked and the inside of the bone 38 is made negative pressure. Can do. Therefore, even if the bone cement 48 is subsequently injected into the bone 38, leakage of the bone cement 48 to the outside of the bone 38 and the like can be prevented as in the puncture needle 10 according to the first embodiment. Further, since the syringe 50 can be removed after the suction, the syringe 50 does not get in the way in the subsequent operation, and the operation can be performed smoothly.

Moreover, in the puncture needle 10b according to the third embodiment, the bone cement passage 131 and the decompression passage 142 are formed independently of each other, so that the bone cement 48 does not flow out to the suction port 158 side, and the bone Bone cement 48 can be injected into 38 with an accurate injection amount.

Note that in the third embodiment, the same components and the same effects as those provided by the respective common components in the first embodiment are obtained for the components that are common to the first embodiment. Of course.

In the above-described third embodiment, the multi-way cock 70 has been described as being detachable from the outer needle base 132. However, the multi-way cock 70 and the outer needle base 132 may be configured to be inseparable from each other. .

[Fourth Embodiment]
FIG. 17 is a partially omitted cross-sectional view of a bone cement injection puncture needle 10c (hereinafter referred to as “puncture needle 10c”) according to a fourth embodiment. Note that, in the puncture needle 10c according to the fourth embodiment, elements having the same or similar functions and effects as those of the puncture needle 10 according to the first embodiment are denoted by the same reference numerals, and detailed description is given. Omitted.

The puncture needle 10c according to the fourth embodiment includes an outer needle 12 and an outer needle base 14 of the puncture needle 10a according to the second embodiment, and an outer needle 130 and an outer needle of the puncture needle 10b according to the third embodiment. The group 132 is replaced.

FIG. 18A, FIG. 18B, FIG. 19A and FIG. 19B are views for explaining a method of injecting bone cement into bone using the puncture needle 10c according to the fourth embodiment. In order to inject bone cement into the bone using the puncture needle 10c, first, the puncture needle 10c is punctured into the bone 38 which is a puncture target by the same method as in FIG. 4A. When the puncture needle 10c is punctured into the bone 38, the connector 100 may be removed, so that the connector 100 does not get in the way and the puncture operation can be performed smoothly. In addition, it is preferable that the connector 100 is attached or provided in advance to the puncture needle 10c because the operation is simplified during the operation.

After puncturing the puncture needle 10c into the bone 38, the inner needle 16 is removed from the outer needle 12, and then a syringe (aspiration device) 40 filled with bone cement 48 is connected to the injection port 150 and the connector 100 is connected. Connect to the suction port 158 (see FIG. 18A). Either the timing for connecting the syringe 40 to the injection port 30 or the timing for connecting the connector 100 to the suction port 34 may be first.

Next, the suction syringe 50 is connected to the connector 100 (see FIG. 18B). Then, as described above, the slit 122 of the valve body 104 opens. Thereby, the inside of the bone 38 and the inside of the syringe 50 communicate with each other through the first side hole 144, the decompression passage 142, the second side hole 146, the second passage 147, the third passage 156, and the connector 100.

When the syringe 50 for suction is connected to the connector 100, the pusher 54 of the syringe 50 is moved in the drawing direction. Then, the gas or liquid in the bone is sucked into the syringe 50 via the first side hole 144, the decompression passage 142, the second side hole 146, the second passage 147, the third passage 156, and the connector 100. The Thereby, the inside of the bone 38 becomes a negative pressure.

When the inside of the bone 38 is in a negative pressure state, the syringe 50 is removed from the connector 100 (see FIG. 19A). Then, the slit 122 of the valve body 104 is closed. As a result, the flow path in the connector 100 is closed, and the inflow of outside air to the outer needle base 132 side is prevented. Therefore, even if the syringe 50 is removed from the connector 100, the negative pressure in the bone 38 is maintained.

Next, the bone cement 48 in the syringe 40 is injected into the bone through the first passage 154 and the bone cement passage 131 (see FIG. 19B). When a predetermined amount of bone cement 48 has been injected into the bone 38, the inner needle 16 is inserted into the outer needle 130 in the same manner as in FIG. 5C, and the bone remaining in the first passage 154 and the bone cement passage 131 remains. Cement 48 is pushed into bone 38.

As described above, according to the puncture needle 10c according to the fourth embodiment, the gas or liquid in the bone 38 is sucked using the syringe 50, which is a suction device, and the inside of the bone 38 is set to a negative pressure. it can. Therefore, even if the bone cement 48 is subsequently injected into the bone 38, leakage of the bone cement 48 to the outside of the bone 38 and the like can be prevented as in the puncture needle 10 according to the first embodiment. Further, since the syringe 50 can be removed after the suction, the suction device does not get in the way in the subsequent operation, and the operation can be performed smoothly.

Moreover, in the puncture needle 10c according to the fourth embodiment, the bone cement passage 131 and the decompression passage 142 are formed independently of each other, so that the bone cement 48 does not flow out to the suction port 158 side, and the bone Bone cement 48 can be injected into 38 with an accurate injection amount.

Note that in the fourth embodiment, the same components as those in the first embodiment have the same or similar operations and effects as those provided by the common components in the first embodiment. Of course.

In the above-described fourth embodiment, the connector 100 has been described as being detachable from the outer needle base 132. However, the connector 100 and the outer needle base 132 may be configured to be inseparable.

In the puncture needles 10b and 10c according to the third and fourth embodiments described above, the outer needle base 14c shown in FIG. 11 may be employed instead of the outer needle base 132. When the outer needle base 14c is employed in the puncture needles 10b and 10c, the outer needle base 14c may have an integral configuration that cannot be separated from the multi-way cock 70 and the connector 100. In this case, the multi-way cock 70 and the connector A structure having a function equivalent to 100 may be provided inside the outer needle base 14c.

In the third and fourth embodiments, the outer needle base 132a according to the modification shown in FIG. 20 may be employed instead of the outer needle base 132. In the outer needle base 132 of the puncture needles 10b and 10c according to the third and fourth embodiments, the injection port 150 and the portion surrounding the outer needle 130 are integrally formed by insert molding. The outer needle base 132 a includes a main body member 170 surrounding the outer needle 130 and a stopper member 172 that is engaged with and fixed to the main body member 170.

Examples of the constituent material of the main body member 170 and the stopper member 172 include the same materials as those exemplified as the constituent material of the outer needle base 14 in the first embodiment. The constituent material of the main body member 170 and the constituent material of the stopper member 172 may be different. The main body member 170 includes a second passage 171, a third passage 174, and a suction port 176 having functions and configurations similar to those of the second passage 147, the third passage 156, and the suction port 158 of the outer needle base 132.

The stopper member 172 is for fixing the first flare shape portion 138 and the second flare shape portion 140 of the outer needle 130 between the main body member 170 and is fixed to the female screw portion 178 provided on the main body member 170. A first male screw portion 180 to be screwed is formed. The stopper member 172 also functions as an injection port for supplying bone cement to the outer needle 130, and a first passage 175 is formed therein. In the stopper member 172, a second male screw portion 182 that is screwed into a female screw portion 19 provided on the inner needle base 18 is formed on the outer periphery of the end opposite to the first male screw portion 180.

The outer needle base 132a includes a detent pin 184 that passes through the first flare shape portion 138 and the second flare shape portion 140 and is inserted into the main body member 170. The rotation preventing pin 184 prevents relative rotation between the first flare shape portion 138 and the second flare shape portion 140 and the main body member 170. The configuration of other parts of the outer needle base 132a is the same as that of the outer needle base 132.

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

Claims

A hollow outer needle (12, 130) having a bone cement passage (20, 131);
An outer needle base (14, 14a, 14b, 14c, 132, 132a) fixed to a proximal end portion of the outer needle (12, 130);
An inner needle (16) provided with a needle tip at the tip and slidably inserted into a hollow portion of the outer needle (12, 130);
Provided on the outer needle base (14, 14a, 14b, 14c, 132, 132a) so as to communicate with the bone cement passageway (20, 131) through the proximal opening of the outer needle (12, 130); An injection port (30, 150, 172) for supplying bone cement to the outer needle (12, 130);
Aspiration ports (34, 35, 158, 176) provided on the outer needle base (14, 14a, 14b, 14c, 132, 132a) for aspirating gas or liquid in the bone using the aspiration device (50). )When,
With
The outer needle (12, 130) communicates with the inside of the bone and the suction port (34, 35, 158, 176) in a state where the outer needle (12, 130) is pierced into a bone to be punctured. Configured as
The suction port (34, 35, 158, 176) is provided with a negative pressure maintaining device (70, 100) capable of opening and closing an internal flow path and connectable to the suction device (50).
A puncture needle (10, 10a, 10b, 10c) for injecting bone cement.
The bone cement injection puncture needle (10, 10a) according to claim 1,
In the vicinity of the base end portion of the outer needle (12), a side hole (22) is provided,
The suction ports (34, 35) communicate with the bone cement passageway (20) via the side holes (22);
A puncture needle (10, 10a) for injecting bone cement.
In the bone cement injection puncture needle (10, 10a) according to claim 2,
The channel cross-sectional area of the side hole (22) is set smaller than the channel cross-sectional area of the bone cement passage (20),
A puncture needle (10, 10a) for injecting bone cement.
In the bone cement injection puncture needle (10, 10a) according to claim 2,
In the suction ports (34, 35), cement passage blocking means (60, 62) for allowing passage of gas or liquid sucked from inside the bone while blocking passage of bone cement is provided.
A puncture needle (10, 10a) for injecting bone cement.
In the puncture needle (10b, 10c) for bone cement injection according to claim 1,
The outer needle (130) has the bone cement passage (131), an inner tube (134) through which the inner needle (16) is inserted, and an outer tube (136) surrounding the inner tube (134). Have
The outer pipe (136) has a first side hole (144) located near the distal end portion and a second side hole (146) located near the proximal end portion, and the first side hole (144) and the second side hole (146) communicate with each other via a decompression passage (142) formed between the inner pipe (134) and the outer pipe (136).
A bone cement injection puncture needle (10b, 10c) characterized by the above.
The puncture needle (10b, 10c) for bone cement injection according to claim 5,
A plurality of the first side holes (144) are provided in the circumferential direction and the axial direction of the outer pipe (136).
A bone cement injection puncture needle (10b, 10c) characterized by the above.