JP2012070931A - Handle holder and bone cement injection needle set - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a handle holder capable of being easily attached to/detached from the outer needle base of a puncture needle without requiring large power, and a bone cement injection needle set comprising a combination of such the handle holder and a bone cement injection puncture needle.SOLUTION: The bone cement injection needle set 10 includes a bone cement injection puncture needle 11 having the outer needle base 16, and a handle holder 60 capable of being attached to/detached from the outer needle base 16. The handle holder 60 includes a holder body 62 formed into a long bar shape, and a connection part 64 which is provided to one end part of the holder body 62 and can be fitted to a side port 42 provided to the side part of the outer needle base 16.

Description

  The present invention relates to a handle holder connected to an outer needle base of a bone cement injection puncture needle, and a bone cement injection needle set comprising a combination of such a handle holder and a bone cement injection puncture needle.

  Percutaneous vertebroplasty is a treatment that reinforces the vertebral body by injecting bone cement into the vertebral body injury site in order to eliminate 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. A bone biopsy needle is generally used as a puncture needle for injecting bone cement (see, for example, Patent Document 1 below). Patent Document 2 below discloses a puncture needle for injecting bone cement.

  As a conventional example of a bone cement injection puncture needle, a puncture needle 100 having a configuration shown in FIG. 10 is known. The puncture needle 100 includes a long tubular outer needle 102, an outer needle base 104 fixed to the proximal end portion of the outer needle 102, an inner needle 106 inserted through the hollow portion of the outer needle 102, And an inner needle base 108 fixed to the proximal end portion. The inner needle base 108 is configured to be detachable from the outer needle base 104.

  In percutaneous vertebroplasty, in order to puncture the target bone with the puncture needle 100 configured as described above, after determining the puncture position and puncture target under fluoroscopy, the inner needle 106 is attached. The puncture needle 100 in a state is hit with a hammer to puncture to the puncture target in the bone. In this puncturing operation, in order to prevent X-ray exposure, a long rod-shaped handle holder 112 having a C-shaped connecting portion 110 at the tip may be used. The operator connects the connecting portion 110 of the handle holder 112 to the small diameter portion 114 provided in the lower portion of the outer needle base 104, and holds the puncture needle 100 in a desired position by holding the handle holder 112. The user's hand can be retracted outside the X-ray irradiation area.

JP 2003-24663 A International Publication No. 2010/044462

  By the way, when using the conventional handle holder 112, when the outer needle base 104 is attached to or detached from the small diameter portion 114, the connecting portion 110 is elastically deformed in the direction of opening the C-shape, so the user puts a certain amount of force. In this state, the handle holder 112 and the puncture needle 100 must be handled. Since a sharp cutting edge 116 is formed at the tip of the puncture needle 100, a situation in which the handle holder 112 and the puncture needle 100 must be handled with a large force applied may cause anxiety and fear to the user. There is a possibility to give.

  The present invention has been made in view of the above circumstances, a handle holder that can be easily attached to and detached from the outer needle base of the puncture needle without requiring a large force, and such a handle holder. An object of the present invention is to provide a bone cement injection needle set comprising a combination with a puncture needle for bone cement injection.

  In order to achieve the above object, the present invention has an outer needle having a bone cement passage penetrating in the axial direction, an outer needle base fixed to a proximal end portion of the outer needle, and a needle tip at a distal end. And an outer needle base of a bone cement injection puncture needle comprising: an inner needle slidably inserted into a hollow portion of the outer needle; and an inner needle base fixed to a proximal end portion of the inner needle. A detachable handle holder, which can be fitted to a holder body formed in a long bar shape, and a fitting part provided on one end of the holder body and provided on the side of the outer needle base And a connecting portion.

  According to said structure, since a handle holder and an outer needle base can be connected by fitting, a handle holder can be attached or detached without requiring big force. For this reason, the user can smoothly attach and detach the handle holder without feeling anxiety or fear. In addition, even when the puncture needle is struck with a hammer to puncture the bone with the puncture needle, the handle holder and the outer needle base are firmly connected, so the handle holder is difficult to come off from the outer needle base, so the procedure is smooth. Is possible.

  In the above handle holder, the holder main body may have a hollow portion penetrating in the axial direction.

  According to said structure, the connection object of a handle holder has the slow pressure channel | path provided in the outer needle in order to prevent the pressure rise in the bone at the time of bone cement injection, and the side port provided in the outer needle base In the case of a puncture needle, the handle holder functions as a flow path for letting gas or liquid in the bone out of the body by communicating the hollow portion with the slow pressure passage of the puncture needle. For this reason, even when connected to a puncture needle with a gradual pressure function, it is possible to fulfill the function of supporting the puncture needle without impairing the gradual pressure function of the puncture needle.

  In the above handle holder, the holder body may be configured to be extendable.

  According to the above configuration, the handle holder can be made compact in a state where it is not connected to the puncture needle, and the length can be adjusted as needed after being extended during use, so that it is easy to use.

  Said handle holder WHEREIN: The said holder main body may have a liquid storage part which can store a liquid.

  According to said structure, the liquid which flowed out from the inside of a bone can be stored in a holder main body, taking out the gas from the inside of a living body at the time of bone cement injection | pouring. For this reason, it is possible to prevent or suppress the liquid from the bone from flowing out of the handle holder.

  In the handle holder described above, the holder main body may be provided with an absorber that absorbs liquid in the hollow portion.

  According to the above configuration, at the time of bone cement injection, the liquid flowing out from the bone can be absorbed by the absorbent body provided in the handle body while the gas from the bone is taken out of the living body. For this reason, it is possible to prevent or suppress the liquid from inside the bone from flowing out of the handle.

  In the above handle holder, the holder main body may be provided with a gas permeable membrane that allows gas to pass but not liquid.

  According to said structure, gas can be discharged | emitted outside, without leaking the liquid from the inside of bone.

  Said handle holder WHEREIN: The said holder main body is good to have transparency of the grade which can visually recognize an inside.

  According to the above configuration, when the liquid flowing out from the bone flows into the handle holder, the internal liquid can be visually recognized from the outside of the handle holder. Can contribute to the progress of

  The present invention also provides a bone cement injection needle set comprising a bone cement injection puncture needle for injecting bone cement into the bone, and a handle holder detachable from the bone cement injection puncture needle. The bone cement injection puncture needle includes an outer needle having a bone cement passage penetrating in the axial direction, an outer needle base fixed to a proximal end portion of the outer needle, and provided with a fitting portion on a side portion, An inner needle that has a needle tip at the tip and is slidably inserted into a hollow portion of the outer needle; and an inner needle base that is fixed to a proximal end portion of the inner needle, and the handle holder Has a holder main body formed in a long bar shape, and a connecting portion provided at one end of the holder main body and capable of fitting into the fitting portion of the outer needle base. .

  According to the above configuration, since the handle holder can be attached and detached without requiring a large force, the user can smoothly attach and remove the handle holder without feeling anxiety or fear. In addition, since the handle holder is unlikely to be detached from the outer needle base, the procedure can be performed smoothly.

  In the bone cement injection needle set, the fitting portion is provided at one end in the longitudinal direction of the outer needle base, and the handle holder is connected to the outer needle base, It is better to point in the longitudinal direction.

  According to the above configuration, when percutaneous vertebroplasty, a plurality of bone cement injection puncture needles are punctured into a patient's body in a direction in which the outer needle bases are parallel to each other, the puncture needles are connected. The handle holder does not interfere with the other puncture needles, and the procedure can be performed smoothly.

  In the bone cement injection needle set, the fitting portions are provided at both ends in the longitudinal direction of the outer needle base, and the handle holder is connected to the outer needle base, and the outer needle base is connected. May be oriented in the longitudinal direction.

  According to the above configuration, since the connection position of the handle holder with respect to the outer needle base can be selected, for example, during the puncturing operation of the puncture needle, if necessary, the connection position of the handle holder is set to the position of the outer needle base. It is possible to change from one end in the longitudinal direction to the other end. When there are a plurality of handle holders, the puncture needle can be more stably held by connecting the handle holders to both ends in the longitudinal direction of the outer needle base.

  In the above bone cement injection needle set, the fitting portion may have a screw portion for screwing the connecting portion.

  According to said structure, since the connection of a handle holder and an outer needle base is hold | maintained more suitably, and a handle holder becomes difficult to remove | deviate from an outer needle base, it is possible to perform a procedure more smoothly.

  In the bone cement injection needle set, the outer needle includes a first side hole located in the outer peripheral portion near the distal end portion, a second side hole located in the outer peripheral portion near the proximal end portion, and the bone cement. A slow pressure passage that is independent of the passage and communicates the first side hole and the second side hole, and the second side of the outer needle base includes A side port communicating with the hole and having the screw portion is provided, and the holder body preferably has a hollow portion penetrating in the axial direction.

  According to the above configuration, with the handle holder connected to the outer needle base of the puncture needle, the hollow portion provided in the handle holder communicates with the gradual pressure passage of the puncture needle, so that the handle holder becomes a gas in the bone or Since it functions as a flow path for letting liquid out of the body, the slow pressure function of the puncture needle is not hindered.

  According to the present invention, the handle holder can be easily attached to and detached from the outer needle base of the puncture needle without requiring a large force.

It is a whole perspective view of the bone cement injection needle set 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. FIG. 2 is a partially omitted cross-sectional view of the handle holder shown in FIG. 1. It is a partially omitted sectional view of the bone cement injection needle set in a state where the handle holder is connected to the outer needle base of the bone cement injection puncture needle. 6A is a partially omitted cross-sectional view of a bone cement injection puncture needle according to a first modification, and FIG. 6B is a partially omitted cross-sectional view of a bone cement injection puncture needle according to a second modification. FIG. 7A is a partially omitted cross-sectional view of a bone cement injection puncture needle according to a third modification, and FIG. 7B is a partially omitted cross-sectional view of a bone cement injection puncture needle according to a fourth modification. FIG. 8A is a partially omitted sectional view of the handle holder according to the first modified example, FIG. 8B is a partially omitted sectional view of the handle holder according to the second modified example, and FIG. 8C is a third modified example. FIG. 6 is a partially omitted cross-sectional view of the handle holder according to FIG. FIG. 9A is a partially omitted sectional view of a handle holder according to a fourth modification, and FIG. 9B is a partially omitted sectional view of a handle holder according to a fifth modification. It is a whole perspective view of the puncture needle for bone cement injection concerning a conventional example.

  Hereinafter, preferred embodiments of a bone cement injection puncture needle 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).

  FIG. 1 is an overall perspective view of a bone cement injection needle set 10 (hereinafter also referred to as “injection needle set 10”) according to an embodiment of the present invention. As shown in FIG. 1, the injection needle set 10 is detachable from the puncture needle 11 and a puncture needle 11 (hereinafter also referred to as “puncture needle 11”) for injecting bone cement into the bone. Handle holder 60. In this injection needle set 10, when the puncture needle 11 is punctured into a target bone, the handle holder 60 and the puncture needle 11 are combined, that is, the handle holder 60 is connected to the outer needle base 16 of the puncture needle 11. Use in state.

  First, the configuration of the puncture needle 11 will be described. FIG. 2 is a partially omitted cross-sectional view of the puncture needle 11 shown in FIG. FIG. 3 is a partially omitted cross-sectional view of the outer needle 12 with the inner needle 14 removed.

  The puncture needle 11 includes a hollow outer needle 12, an outer needle base 16 fixed to the proximal end of the outer needle 12, an inner needle 14 slidably inserted into the hollow portion of the outer needle 12, And an inner needle base 20 fixed to the proximal end portion of the needle 14. In FIG.1 and FIG.2, the state which inserted the inner needle 14 in the hollow part of the outer needle 12 is shown.

  In the following description, the axial direction of the inner needle 14 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. Among the Z directions, in particular, a direction toward the distal end side of the puncture needle 11 is defined as Z1, and a direction toward the proximal end side of the puncture needle 11 is defined as Z2.

  The outer needle 12 is a member having a hollow structure with both ends open, and a sharp cutting edge 13 is formed at the tip of the outer needle 12. The illustrated outer needle 12 has an inner tube 22 through which the inner needle 14 is inserted, and an outer tube 24 surrounding the inner tube 22, thereby forming a double tube structure.

  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 (hollow portion) 26 inside. The bone cement passage 26 functions as a hole through which the inner needle 14 is inserted when the inner needle 14 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 1.5 to 2.7 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 provided at the distal end portion of the inner tube portion 28. The tip portion 30 has a larger diameter than the inner tube portion 28. The base end portion 22 a of the inner tube 22 is expanded in diameter and supported by the inner peripheral surface of the base end portion 24 a of the outer tube 24.

  Both ends of the outer tube 24 are open, and the inner tube 22 is inserted into the hollow portion. The length of the outer tube 24 is about 100 to 200 mm, and is set shorter than the inner tube 22 by the length of the tip portion 30. The outer tube 24 is a hollow cylindrical tube. The inner diameter d2 of the outer tube 24 is set to be larger than the outer diameter d1 of the narrow portion of the inner tube 22, and a slow pressure passage 32 extending in the axial direction is formed between the outer tube 24 and the inner tube 22. Is done. The inner diameter of the outer tube 24 is, for example, about 1.9 to 3.2 mm.

  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, whereby the distal end side of the slow pressure passage 32 is closed. Since the base end portion 22a of the inner tube 22 is supported by the inner peripheral portion of the base end portion 24a of the outer tube 24, the base end portion 22a of the inner tube 22 and the base end portion 24a of the outer tube 24 are in close contact with each other. Thus, the rear end side of the slow pressure passage 32 is closed.

  In the vicinity of the distal end portion of the outer tube 24, a first side hole 34 is provided. The first side hole 34 is a hole penetrating the inside and outside of the outer tube 24, and a plurality of first side holes 34 are preferably provided in the circumferential direction and the axial direction. The number of the first side holes 34 is preferably 4 to 36, and more preferably 10 to 26.

  The distance L1 from the most distal position of the outer needle 12 to the first side hole 34 (specifically, the most proximal side portion of the corresponding first side hole 34) located on the most proximal side is: In a state where the outer needle 12 is punctured into the bone, the first side hole 34 on the most proximal side is not positioned outside the bone, that is, all the first side holes 34 are set within the bone. . Specifically, the distance L1 is set within 20 mm, and preferably set within 15 mm.

  The sizes of the first side holes 34 are not necessarily the same, and the sizes may be different. For example, when the cleaning device is connected to the side port 42 to clean the inside of the bone, the amount of the cleaning liquid sprayed from the base side of the first side hole 34 that is proximal from the side port 42 does not become larger than the tip side. Thus, it is possible to increase the hole diameter as the side hole is closer to the tip. The shape of the first side hole 34 does not need to be circular, and may be, for example, an ellipse or a polygon, or a mixture of different shapes.

  The size of the first side hole 34 is preferably set so that the gas or liquid in the bone (for example, exudate or blood) can smoothly flow into the outer needle 12. When the 1st side hole 34 is circular, it is preferable that the diameter is set to 0.3-0.7 mm. When the 1st side hole 34 is shapes other than circular, the dimension of the narrowest part is good to set to 0.3-0.7 mm.

  If the first side hole 34 is too small, the liquid from the bone tends to clog the first side hole 34, but by setting the lower limit of the size of the first side hole 34 as described above, It becomes difficult for the liquid from the bone to clog the first side hole 34. If the first side hole 34 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 34 as described above, Increase in penetration resistance can be suppressed.

  In the vicinity of the base end portion of the outer tube 24, a second side hole 36 is provided. The second side hole 36 is a hole penetrating the inside and outside of the outer tube 24. The shape of the second side hole 36 is not necessarily circular, and may be, for example, an ellipse or a polygon.

  The size of the second side hole 36 is preferably set so that a gas or a liquid (for example, a leachate or blood) in the bone can smoothly flow out from the slow pressure passage 32. When the 1st side hole 34 is circular, it is preferable that the diameter is set to about 0.3-0.7 mm. When the 1st side hole 34 is shapes other than circular, the dimension of the narrowest part is good to set to about 0.3-0.7 mm.

  The distance L2 from the most distal position of the outer needle 12 to the second side hole 36 (specifically, the most distal side (Z1 direction side portion) of the second side hole 36) The second side hole 36 is set so as to be surely positioned outside the body when puncture is performed. Specifically, the distance L2 is 80 mm or more, preferably 120 mm or more.

  Although only one second side hole 36 is provided in the configuration example shown in FIG. 3, a plurality of second side holes 36 may be provided as in a modified example described later. The first side hole 34 and the second side hole 36 communicate with each other via a slow pressure passage 32 formed between the inner tube 22 and the outer tube 24. The slow pressure passage 32 is a passage independent of the bone cement passage 26.

  In the illustrated puncture needle 11, a side port forming member 18 is embedded in the outer needle base 16. The side port forming member 18 is formed so as to cover the periphery of the second side hole 36 and to communicate the outer side of the outer needle base 16 with the second side hole 36. Specifically, the side port forming member 18 includes a coupling portion 38 into which the outer needle 12 is inserted, and a hollow port main body portion 40 extending outward (X2 direction) from the side portion of the coupling portion 38. Have.

  The coupling portion 38 has a hollow cylindrical shape, and its inner diameter is set to be substantially the same as the outer diameter of the outer tube 24. The inner peripheral surface of the coupling portion 38 and the outer peripheral surface of the outer needle 12 (outer tube 24) are bonded with an adhesive. The second side hole 36 faces the proximal end side opening 40 a of the port main body 40. The inner diameter of the base end side opening 40a of the port main body 40 is preferably set larger than the second side hole 36, and is set to about 1.5 to 5.0 mm, for example.

  The distal end portion of the side port forming member 18 protrudes from the outer needle base 16 and is configured as a side port 42 to which other devices or structures can be attached and detached. Is formed with a male threaded portion 42a. The hollow portion of the port main body portion 40 can be formed with a constant inner diameter along the axial direction, but as shown in FIG. 3, it may be formed in a tapered shape that expands toward the distal end side. By forming such a taper shape, when a distal end tube portion 70 (see FIG. 4) described later of the handle holder 60 is inserted into the side port 42, the outer peripheral portion of the distal end tube portion 70 and the inner periphery of the side port 42. The part is in close contact with each other, and it is easy to keep the space liquid-tight.

  The constituent material of the side port forming member 18 is not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene. -Styrene copolymers, polyesters such as polyethylene terephthalate, 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 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 11 to grip. The outer needle base 16 is formed by insert molding so as to cover the proximal end portion of the outer needle 12 and the side port forming member 18. Although it does not specifically limit as a constituent material of the outer needle base 16, For example, it can select from what was illustrated as a constituent material of the side port 42, for example. The constituent materials of the outer needle base 16 and the side port 42 need not be the same, and may be different.

  The outer needle base 16 is formed so as to protrude (extend) on both sides in the direction (X direction) perpendicular to the axis of the outer needle 12, and the side port 42 described above is in the longitudinal direction of the outer needle base 16. Open at one end. A passage 44 communicating with the bone cement passage 26 of the outer needle 12 is formed inside the outer needle base 16. A main port 46 to which the inner needle base 20 is connected is provided at the end of the outer needle base 16 in the Z2 direction, and the hollow portion of the main port 46 constitutes a part of the passage 44. On the outer peripheral portion of the main port 46, a male screw portion 44a for removably engaging a lockable bone cement injection tool (for example, a syringe) is formed.

  In addition, as will be described later, the main port 46 also functions as an insertion port for connecting a syringe for supplying bone cement to the puncture needle 11 to the puncture needle 11.

  As shown in FIG. 2, the inner needle 14 is a rod-shaped member that is inserted into the bone cement passage 26 of the outer needle 12 and has a sharp cutting edge 15 at the tip. The constituent material of the inner needle 14 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 14 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 14 is a hollow portion (lumen) of the outer needle 12. It should be set to such an extent that it can be smoothly inserted into a certain bone cement passage 26 and there is almost no gap between the outer periphery of the inner needle 14 and the inner periphery of the outer needle 12 (inner periphery of the inner tube 22).

  The length of the inner needle 14 is set so that the tip of the inner needle 14 slightly protrudes from the tip of the outer needle 12 in a state where the inner needle base 20 is 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 cutting edge surface of the cutting edge 15 of the inner needle 14 is flush with the cutting edge surface of the cutting edge 13 of the outer needle 12, and the cutting edge 13 of the outer needle 12 and the inner needle 14. , 15 together constitute the needle tip 47 of the puncture needle 11.

  The inner needle base 20 is a member coupled to the proximal end portion of the inner needle 14. The outer diameter of the inner needle base 20 is set to be larger than the outer diameter of the inner needle 14, and specifically, it is easy for a user (medical worker 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 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.

  As shown in FIGS. 1 and 2, the puncture needle 11 has a lock mechanism 48. The locking mechanism 48 is provided on the outer needle base 16 and a plurality of protrusions 50 a and 50 b that protrude from the outer periphery of the inner needle base 20, and when the inner needle base 20 is connected to the outer needle base 16, A plurality of engaging grooves 52a and 52b engaging with 50b are provided. 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 end of the engagement groove 52a on the X2 direction side is located at the approximate center in the thickness direction of the outer needle base 16, and the other end is opened on one side (Y1 side) of the outer needle base 16. One end of the engagement groove 52b on the X1 direction side is located at the approximate center in the thickness direction of the outer needle base 16, and the other end is opened on the other side (Y2 side) 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 of the blade edge 15 of the inner needle 14 and the blade surface of the blade edge 13 of the outer needle 12 are flush with each other, and this state is maintained.

  Since the puncture needle 11 is configured as described above, when the puncture needle 11 is punctured into a target bone and bone cement is injected into the bone through the hollow portion of the outer needle 12, the gas or liquid in the bone (For example, exudate or blood) can enter the slow pressure passage 32 from the first side hole 34 and out of the body from the second side hole 36. Can be prevented, and the bone cement can be prevented from leaking out of the bone.

  Next, the configuration of the handle holder 60 will be described with reference to FIG. As shown in FIG. 4, the handle holder 60 is a tubular body, and includes a holder main body 62 formed in a long bar shape and a connection portion 64 that can be attached to and detached from the outer needle base 16.

  The holder main body 62 has a linear hollow cylindrical shape having a hollow portion 66 penetrating in the axial direction. In the illustrated example, the inner diameter of the hollow portion 66 is substantially constant along the axial direction. The outer diameter of the holder main body 62 is set to about 6 to 11 mm, preferably about 7 to 10 mm so that the user can easily grip it. The inner diameter of the holder main body 62 is set to about 3 to 10 mm, preferably about 5 to 8 mm so that gas or liquid from the bone easily flows.

  The length of the holder main body 62 can be retracted from the X-ray irradiation region by grasping the handle holder 60 connected to the puncture needle 11 by the user when puncturing the target bone with the puncture needle 11 under fluoroscopy. Thus, it is set to about 200 to 400 mm, preferably about 250 to 350 mm.

  The connection portion 64 is provided at one end portion (right end portion in FIG. 4) of the holder main body 62 and can be fitted to one end (fitting portion) of the side port 42 provided at the side portion of the outer needle base 16. It is configured. The connecting portion 64 in the illustrated example has a tip tube portion 70 having a passage 68 communicating with the hollow portion 66 of the holder main body 62, and a cylindrical lock portion 72 surrounding the tip tube portion 70.

  The distal end pipe part 70 can be inserted into the side port 42, and the distal end pipe part 70 and the side port 42 are configured to fit with no gap in a state where the distal end pipe part 70 is inserted into the side port 42. . The tip tube portion 70 and the side port 42 may be configured to be taper-fitted. In this case, the distal end pipe portion 70 has a male luer taper, and the side port 42 has a female luer taper.

  The distal end of the distal tube portion 70 slightly protrudes in the axial direction from the lock portion 72. An annular fitting groove 74 into which the side port 42 can be inserted is formed between the lock portion 72 and the distal end tube portion 70. A female screw portion 72 a that can be screwed into a male screw portion (screw portion) 42 a formed on the outer peripheral portion of the side port 42 is provided on the inner peripheral portion of the lock portion 72.

  The holder main body 62 and the connection portion 64 may be integrally formed by injection molding or the like, or may be joined by an appropriate joining means such as adhesion or welding of separately manufactured parts. The holder body 62 is not limited to a cylindrical shape, and may be formed as a non-circular (elliptical, polygonal, etc.) cylindrical body.

  The constituent material of the handle holder 60 is preferably a resin material having stable rigidity even when the puncture needle 11 is hit with a hammer or the like, and is selected from, for example, those exemplified as the constituent material of the side port forming member 18. be able to.

  In order to inject bone cement into the bone using the injection needle set 10 configured as described above, first, a handle holder 60 is connected to the outer needle base 16 of the puncture needle 11 as shown in FIG. In this case, since the handle holder 60 and the outer needle base 16 can be connected by screw fitting, the handle holder 60 can be attached to and detached from the outer needle base 16 without requiring a large force. For this reason, the user can smoothly attach and detach the handle holder 60 without feeling anxiety or fear.

  Next, after determining a puncture position and a puncture target under image guidance (under X-ray fluoroscopy or CT fluoroscopy), the puncture needle 11 connected with the handle holder 60 is hit with a hammer, and a bone (for example, vertebra) 76 is obtained. Puncture to the puncture target inside. At this time, the operator can retreat his / her hand from the X-ray irradiation area by grasping the holder main body 62 of the handle holder 60 instead of the outer needle base 16. Further, since the handle holder 60 and the outer needle base 16 are firmly connected by screw fitting, the handle holder 60 is not easily detached from the outer needle base 16 even when the puncture needle 11 is hit with a hammer, so that the procedure is smoothly performed. Can be done.

  Before puncturing the patient with the puncture needle 11, a cleaning liquid supply tube is connected to the main port 46, and the cleaning liquid is supplied to the bone cement passage 26 of the inner needle 14 via the passage 44. May be washed. Similarly, a cleaning liquid supply tube is connected to the side port 42, and the cleaning liquid is supplied through the hollow portion 66 and the second side hole 36 of the port main body portion 40 to the slow pressure passage between the outer tube 24 and the inner tube portion 28. The gradual pressure passage 32 may be washed by supplying the pressure to the throat 32.

  After puncturing the puncture needle 11 to the puncture target, the inner needle 14 is removed from the outer needle 12. At this time, the first side hole 34 is located in the bone 76, and the second side hole 36 is located outside the body.

  Next, a syringe containing bone cement is attached to the main port 46 of the outer needle base 16, and the bone cement in the syringe is injected into the bone 76 through the passage 44 and the bone cement passage 26. At this time, the gas or liquid (for example, exudate or blood) in the bone 76 is used for the first side hole 34, the slow pressure passage 32, the second side hole 36, the side port 42, and the hollow portion 66 of the handle holder 60. It is possible to get out of the body through. This prevents an increase in the internal pressure in the bone 76 due to the injection of the bone cement, so that the bone cement can be prevented from leaking out of the bone 76.

  Thus, since the handle holder 60 also has a function as a flow path for letting the gas or liquid in the bone 76 out of the body, even when the handle holder 60 is connected to the puncture needle 11 with a gradual pressure function, It is possible to fulfill the function of supporting the puncture needle 11 without impairing the pressure function.

  If the handle holder 60 is made of a material having transparency that allows the internal state to be visually recognized (for example, polycarbonate), when the liquid flowing out from the bone 76 flows into the handle holder 60, the handle holder 60. Since the liquid inside can be visually recognized from the outside, the outflow of the liquid from the bone 76 can be confirmed at an early stage. If a suction device is connected to the proximal end portion of the handle holder 60 to assist the discharge of gas or liquid in the slow pressure passage 32, an increase in internal pressure in the bone 76 can be prevented more effectively.

  After injecting the required amount of bone cement in the syringe, the syringe is removed. The inner needle 14 is then inserted into the passage of the outer needle base 16 and the bone cement passage 26 of the outer needle 12 to push the bone cement remaining in the passage and bone cement passage 26 into the bone 76.

  In percutaneous vertebroplasty, when a plurality of puncture needles 11 are used, the plurality of puncture needles 11 may be punctured into the patient's body in a direction in which the outer needle bases 16 are parallel to each other. When the side port 42 is provided at the longitudinal end of the outer needle base 16 like the puncture needle 11 according to the present embodiment, the side port 42 does not get in the way between the adjacent puncture needles 11 and the procedure is performed smoothly. It becomes possible.

  In the present embodiment, the handle holder 60 is oriented in the longitudinal direction of the outer needle base 16 while being connected to the outer needle base 16, so that the plurality of puncture needles 11 are parallel to each other. When puncturing the patient's body in the direction, the handle holder 60 connected to the puncture needle 11 does not get in the way in relation to the other puncture needles 11, and the procedure can be performed smoothly.

  In the injection needle set 10 described above, a bone cement injection puncture needle 11A (hereinafter referred to as “puncture needle 11A”) according to a second modification shown in FIG. In this puncture needle 11A, the handle holder 60 can be connected to the longitudinal end of the outer needle base 16 opposite to the side where the side port 42 is provided, with respect to the puncture needle 11 shown in FIG. A fitting portion 80 is provided. The fitting portion 80 is formed in a cylindrical shape having a hole portion 82 into which the distal end tube portion (connecting portion) 70 of the handle holder 60 can be inserted, and a lock portion 72 of the handle holder 60 can be screwed onto the outer peripheral portion thereof. A male screw portion (screw portion) 84 is provided.

  According to such a configuration, since the connection position of the handle holder 60 with respect to the outer needle base 16 can be selected, for example, during the puncturing operation of the puncture needle 11A, the connection position of the handle holder 60 can be selected as necessary. Can be changed from one end in the longitudinal direction of the outer needle base 16 to the other end. When there are a plurality of handle holders 60, the puncture needle 11A can be held more stably by connecting the handle holders 60 to both ends in the longitudinal direction of the outer needle base 16.

  In the injection needle set 10 described above, a bone cement injection puncture needle 11B (hereinafter referred to as “puncture needle 11B”) according to a second modification shown in FIG. 6B may be employed instead of the puncture needle 11. In this puncture needle 11B, the side port forming member 18a has side ports 42 and 43 at both ends in the longitudinal direction of the outer needle base 16, and the outer needle 12 has a second port communicating with the side ports 42 and 43, respectively. Side holes 36 and 37 are provided. The side ports 42 and 43 have the same configuration as the side port 42 shown in FIG. 2 and the like, and the handle holder 60 can be connected thereto.

  According to such a configuration, the same effect as that of the puncture needle 11A shown in FIG. 6A can be obtained, and the gas or liquid from the bone 76 can be more smoothly brought out of the body through the two side ports 42 and 43. By taking out, the pressure rise in the bone 76 can be prevented more effectively.

  In the injection needle set 10 described above, a bone cement injection puncture needle 11C (hereinafter referred to as “puncture needle 11C”) according to a third modification shown in FIG. The puncture needle 11C is provided with a side port 42 on one side surface (a surface on the Y1 direction side) of the outer needle base 16. That is, in the puncture needle 11 </ b> C, the side port 42 protrudes in a direction perpendicular to the axial direction of the outer needle 12 and perpendicular to the longitudinal direction of the outer needle base 16.

  Even when the puncture needle 11C configured as described above is used, the puncture needle 11C is connected to the outer needle base 16 of the puncture needle 11C when puncturing the puncture needle 11C under fluoroscopy, as in the case of using the puncture needle 11. By gripping the holder main body 62 of the handle holder 60, the user can retreat his / her hand from the X-ray irradiation area.

  In the injection needle set 10 described above, a bone cement injection puncture needle 11D (hereinafter referred to as “puncture needle 11D”) according to a fourth modification shown in FIG. 7B may be employed instead of the puncture needle 11. In this puncture needle 11D, the outer needle 12a is configured as a single tube, and a fitting portion 86 to which the handle holder 60 can be connected is provided at one end portion of the outer needle base 16 in the longitudinal direction. The fitting portion 86 is formed in a cylindrical shape having a hole portion 88 into which the distal end tube portion 70 of the handle holder 60 can be inserted, and a male screw portion to which a lock portion 72 of the handle holder 60 can be screwed. (Screw part) 90 is provided. The fitting portion 86 may be provided on one side surface of the outer needle base 16 similarly to the side port 42 shown in FIG. 7A.

  Even when the puncture needle 11D configured as described above is used, as in the case of using the puncture needle 11, the holder body 62 of the handle holder 60 is grasped when the puncture needle 11D is punctured under fluoroscopy. Thus, the user can retreat his / her hand from the X-ray irradiation area.

  Unlike the puncture needle 11 shown in FIG. 2 and the like, the puncture needle 11D does not have a gradual pressure function. Therefore, when the puncture needle 11D is used, the handle holder 60 described above is not a hollow structure but a solid structure. May be configured.

  In the injection needle set 10 described above, instead of the handle holder 60, a handle holder 60A according to a first modification shown in FIG. 8A may be employed. The handle holder 60 </ b> A includes a holder main body 92 that is formed in a long bar shape and is configured to be stretchable and a connection portion 64 provided at one end of the holder main body 92.

  The holder main body 92 is configured as a telescopic mechanism 94 in which a plurality of cylindrical members having different sizes are connected so as to be relatively movable in the axial direction. The holder main body 92 in the illustrated example has a cylindrical first cylindrical body 96 and a second cylindrical body 98 in order from the distal end side to the proximal end side of the handle holder 60A.

  An annular inner convex portion 96a projecting inward in the radial direction provided at the base end portion of the first cylindrical body 96, and an annular outer portion projecting out in the radial direction provided at the distal end portion of the second cylindrical body 98 The convex portion 98a constitutes a stopper for preventing the first cylinder 96 and the second cylinder 98 from coming off. The first cylinder 96 and the second cylinder 98 are not limited to being cylindrical, and may be formed as non-circular (elliptical, polygonal, etc.) cylinders. The number of cylinders constituting the holder main body 92 (telescopic mechanism 94) is not limited to two, and may be three or more.

  The structure of the connection portion 64 of the handle holder 60A is the same as that of the connection portion 64 of the handle holder 60 shown in FIG. In the percutaneous vertebroplasty, when the puncture needle 11D having no gradual pressure function shown in FIG. 7B is used, the second cylinder 98 of the handle holder 60A is not a hollow structure but a solid structure. May be configured.

  According to the handle holder 60A configured as described above, the same operational effects as those of the handle holder 60 shown in FIG. 4 can be obtained, and further, the handle holder 60A can be made compact when the handle holder 60A is not connected to the puncture needle 11. In addition, it is easy to use because it can be stretched during use and the length can be adjusted as necessary.

  The telescopic mechanism 94 of the handle holder 60A shown in FIG. 8A is configured such that the outer diameter of the tubular member on the proximal end side becomes smaller (the outer diameter of the second cylinder 98 is the outer diameter of the first cylinder 96). Is smaller than the cylindrical member on the proximal end side, like the holder main body 92a (telescopic mechanism 94a) of the handle holder 60B according to the second modification shown in FIG. 8B. Also good.

  That is, in the handle holder 60B, the outer diameter of the second cylinder 122 is larger than the outer diameter of the first cylinder 120. In the telescopic mechanism 94a, an annular outer convex portion 120a that protrudes outward in the radial direction provided at the proximal end portion of the first cylindrical body 120, and a radially inward portion provided at the distal end portion of the second cylindrical body 122. A protruding stopper for preventing the first cylindrical body 120 and the second cylindrical body 122 from coming off is constituted by the projecting inner convex portion 122a. The first cylinder 120 and the second cylinder 22 are not limited to being cylindrical, and may be formed as non-circular (elliptical, polygonal, etc.) cylinders. The number of cylinders constituting the telescopic mechanism 94a is not limited to two, and may be three or more.

  The same effect as the handle holder 80A can be obtained by the handle holder 60B configured as described above.

  In the injection needle set 10 described above, instead of the handle holder 60, a handle holder 60C according to a third modification shown in FIG. 8C may be employed. The handle holder 60 </ b> C includes a holder main body 126 that is formed in a long bar shape and has a reduced diameter of the opening 100 on the base end side, and a connection portion 64 provided at one end (tip end) of the holder main body 126. Have. The opening 128 on the proximal end side of the holder body 126 is smaller than the inner diameter of the hollow portion 66. Thereby, the hollow part 66 is comprised as the liquid storage part 130 which can store a liquid. The structure of the connection portion 64 of the handle holder 60C is the same as that of the connection portion 64 of the handle holder 60 shown in FIG.

  According to the handle holder 60C configured as described above, the same effect as that of the handle holder 60 shown in FIG. 4 can be obtained. Further, when bone cement is injected, the gas from the bone 76 is taken out of the living body. Meanwhile, the liquid flowing out from the bone 76 can be stored in the liquid storage part 130 in the holder main body 126. For this reason, it is possible to prevent or suppress the liquid from the bone 76 from flowing out of the handle holder 60B.

  In the injection needle set 10 described above, instead of the handle holder 60, a handle holder 60D according to a fourth modification shown in FIG. 9A may be employed. The handle holder 60D includes a holder main body 62 formed in a long bar shape, an absorber 132 provided in the holder main body 62, and a connection portion 64 provided at one end (tip portion) of the holder main body 62. And have.

  The configurations of the holder main body 62 and the connection portion 64 of the handle holder 60D are the same as the holder main body 62 and the connection portion 64 of the handle holder 60 shown in FIG. The absorber 132 is a sponge-like or cotton-like member having a function of absorbing liquid, and is disposed in the hollow portion 66 on the proximal end side of the holder main body 62 in the illustrated example.

  According to the handle holder 60D configured as described above, the same effect as that of the handle holder 60 shown in FIG. 4 can be obtained. Further, when bone cement is injected, the gas from the bone 76 is discharged outside the living body. Meanwhile, the liquid flowing out from the bone 76 can be absorbed by the absorbent body 132 provided in the handle main body 62. For this reason, it is possible to prevent or suppress the liquid from the bone 76 from flowing out of the handle holder 60D.

  In the injection needle set 10 described above, instead of the handle holder 60, a handle holder 60E according to a fifth modification shown in FIG. 9B may be employed. The handle holder 60E includes a holder main body 62 formed in a long rod shape, a gas permeable film 134 provided on the holder main body 62, and a connection portion 64 provided on one end (tip portion) of the holder main body 62. And have.

  The configurations of the holder main body 62 and the connection portion 64 of the handle holder 60E are the same as the holder main body 62 and the connection portion 64 of the handle holder 60 shown in FIG. The gas permeable membrane 134 is a member made of, for example, expanded porous PTFE that has a function (property) that does not allow liquid to pass but allows gas to pass. In the illustrated configuration example, the gas permeable membrane 134 is held in a hole portion of a holding portion 136 provided (fixed) at the proximal end portion of the holder main body 62. The holder main body 62 and the holding part 136 may be constituted by separate members, or may be formed integrally.

  According to the handle holder 60E configured as described above, the same effect as that of the handle holder 60 shown in FIG. 4 can be obtained, and further, the gas permeable membrane 134 does not pass liquid when bone cement is injected. The liquid from the bone 76 can be prevented from flowing out of the handle holder 60E.

  In the puncture needles 11, 11A to 11C, the outer needle base 16 and the side port forming member 18 are configured as separate members, but the outer needle base 16 and the side port forming member 18 are integrated as one member. May be adopted. That is, the side port forming member 18 is omitted, and instead, when the outer needle base 16 is insert-molded, a portion corresponding to the side port forming member 18 may be integrally formed as a part of the outer needle base 16. .

  In the puncture needles 11 and 11A to 11D, the outer needle base 16 is not limited to being formed by insert molding, but the outer needle base 16 manufactured in advance by injection molding or the like is used for the outer needle 12 by using appropriate joining means or fixing means. , 12a may be fixed.

  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.

DESCRIPTION OF SYMBOLS 10 ... Bone cement injection needle set 11, 11A, 11B, 11C, 11D ... Puncture needles 12 and 12a for bone cement injection ... Outer needle 14 ... Inner needle 16 ... Outer needle base 20 ... Inner needle base 26 ... Bone cement passage 42, 43 ... Side ports 42a, 43a, 84 ... Male threaded portions 60, 60A, 60B, 60C, 60D, 60E ... Handle holders 62, 92, 91a, 120 ... Holder body 64, 86 ... Connection portion 80 ... Fitting portion

Claims (12)

An outer needle having a bone cement passage extending axially therethrough;
An outer needle base fixed to a proximal end portion of the outer needle;
An inner needle that has a needle tip at the tip and is slidably inserted into the hollow portion of the outer needle;
An inner needle base fixed to a proximal end portion of the inner needle;
A handle holder detachable from the outer needle base of the bone cement injection puncture needle comprising:
A holder body formed in a long bar shape;
Provided at one end of the holder body, and provided with a connecting portion that can be fitted into a fitting portion provided on a side portion of the outer needle base,
A handle holder characterized by that. The handle holder according to claim 1,
The holder body has a hollow portion penetrating in the axial direction.
A handle holder characterized by that. The handle holder according to claim 1 or 2,
The holder body is configured to be extendable and retractable.
A handle holder characterized by that. The handle holder according to claim 2,
The holder body has a liquid storage part capable of storing liquid,
A handle holder characterized by that. The handle holder according to claim 2,
The holder body is provided with an absorber that absorbs liquid in the hollow portion,
A handle holder characterized by that. The handle holder according to claim 2,
The holder body is provided with a gas permeable membrane that allows gas to pass but not liquid.
A handle holder characterized by that. The handle holder according to any one of claims 1 to 6,
The holder body has transparency so that the inside can be visually confirmed.
A handle holder characterized by that. A bone cement injection needle set comprising a bone cement injection puncture needle for injecting bone cement into the bone, and a handle holder detachable from the bone cement injection puncture needle,
The bone cement injection puncture needle is:
An outer needle having a bone cement passage extending axially therethrough;
An outer needle base fixed to a proximal end portion of the outer needle and provided with a fitting portion on a side portion;
An inner needle that has a needle tip at the tip and is slidably inserted into the hollow portion of the outer needle;
An inner needle base fixed to a proximal end portion of the inner needle,
The handle holder is
A holder body formed in a long bar shape;
Provided at one end of the holder main body, and having a connecting portion that can be fitted into the fitting portion of the outer needle base,
Bone cement injection needle set characterized by that. The bone cement injection needle set according to claim 8,
The fitting portion is provided at one end in the longitudinal direction of the outer needle base,
The handle holder is oriented in the longitudinal direction of the outer needle base while being connected to the outer needle base.
Bone cement injection needle set characterized by that. The bone cement injection needle set according to claim 8,
The fitting portions are provided at both ends in the longitudinal direction of the outer needle base,
The handle holder is oriented in the longitudinal direction of the outer needle base while being connected to the outer needle base.
Bone cement injection needle set characterized by that. In the bone cement injection needle set according to any one of claims 7 to 10,
The fitting portion has a screw portion for screwing the connection portion,
Bone cement injection needle set characterized by that. In the bone cement injection needle set according to any one of claims 7 to 11,
The outer needle is a passage independent of the first side hole located in the outer peripheral portion near the distal end portion, the second side hole located in the outer peripheral portion near the proximal end portion, and the bone cement passage. A gradual pressure passage communicating the first side hole and the second side hole,
The side portion of the outer needle base is provided with a side port that communicates with the second side hole and has the fitting portion.
The holder body has a hollow portion penetrating in the axial direction.
Bone cement injection needle set characterized by that.

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