JP2015066116A - Bone treatment system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a bone treatment system capable of shortening a treatment period by easily and quickly placing a hardened bone filling material in a treatment object bone.SOLUTION: An indwelling device 12 of a bone treatment system 10 includes: a shaft 18 having a first lumen 30 and a second lumen 32; a space forming balloon 20 provided at a distal end of the shaft 18; and an indwelling balloon 22 provided at the distal end of the shaft 18. The space forming balloon 20 can be inflated with introduction of an inflation fluid 34. The indwelling balloon 22 can be inflated with the introduction of the bone filling material C.

Description

  The present invention relates to a bone treatment system for placing a bone filler material inside a bone.

  When osteoporosis occurs due to a decrease in bone density or the like, for example, the wrist may be fractured (distal radius fracture) by placing a hand when it falls. Currently, for the treatment of distal radius fractures, plate fixation (mainly a locking plate) is placed across the fractured main bone fragment and peripheral bone fragment, and the plate and each bone are reduced and fixed with screws. It has been adopted. However, since the plate is installed outside the bone, the surrounding tissue (flexor tendon, extensor tendon, etc.) may be damaged by the screw or the end of the plate. In addition, in order to avoid complications such as tendon rupture, there are not a few cases in which a plate nail is necessary. In that case, it is necessary to perform an operation by incising the skin twice when the plate is installed and at the time of nail extraction.

  For this reason, in the treatment of fractures, treatment with less invasiveness and less complications has been demanded. For example, as disclosed in Patent Document 1, a bone filling material is placed inside a bone, A method for promoting bonding has been proposed. The device disclosed in Patent Document 1 includes a balloon made of a bioabsorbable material at the tip of the device. In treatment, a balloon filled with a bone filling material is placed inside the bone. When the balloon is absorbed by the living body after indwelling, the bone filling material hardened in the balloon is exposed, and the fracture site is supported from the inside of the bone in place of the plate and screw in the previous plate fixation, and the bone joint is promoted.

JP-T-2006-505339

  By the way, in the treatment disclosed in Patent Document 1, the balloon of bioabsorbable material is placed in a state of being filled with the bone filling material, and it is long until the balloon is absorbed by the living body and the bone filling material is exposed in the bone. It takes time. For this reason, it takes a lot of time for the bone filling material to exert its effect, and the treatment period is significantly increased.

  On the other hand, when the bone filling material is directly filled into the bone without using the bioabsorbable material balloon, it is difficult to join the bones with sufficient joint strength. Calcium phosphate bone filling materials have a high affinity for water, so when exposed from the balloon in a fluid state (liquid or paste) before hardening, it dissolves and diffuses relatively easily in the bone. Because it ends up.

  In view of the above circumstances, the present invention provides a bone treatment system capable of shortening a treatment period by easily and quickly placing a hardened bone filling material in a bone to be treated. Objective.

  To achieve the above object, the present invention provides a bone treatment system for placing a bone filling material in a bone to be treated, the first lumen through which an expansion fluid can flow, and the bone filling material A shaft having a second lumen through which the fluid can be circulated, and provided at a distal end portion of the shaft, and is expandable as the expansion fluid is introduced through the first lumen. A space-forming balloon that forms an indwelling space in the bone, and a distal end portion of the shaft, and the bone filling material is introduced through the second lumen in the indwelling space. And an indwelling balloon that is expansible and exposes the bone filling material into the bone by being broken after the bone filling material is introduced.

  Since the bone treatment system according to the present invention has a structure in which a space forming balloon and an indwelling balloon are provided on a shaft, the space formation and the bone filling material injection can be performed with one device. That is, since it is not necessary to use separate devices for the space formation and the bone filling material injection, the procedure for placing the bone filling material can be performed quickly and smoothly. In addition, after the bone filling material is introduced, when the bone filling material is hardened, the indwelling balloon can be broken to expose the bone filling material in the bone in a relatively short time, thereby shortening the treatment period. be able to. In addition, bone filling materials that are prone to collapse or poor hardening when in contact with body fluids during injection can be placed in the bone in a more reliably cured state, suppressing the effects of body fluids. The improvement and treatment effect can be enhanced.

  In the above bone treatment system, the indwelling balloon may be made of a stretchable material. According to this configuration, the indwelling balloon is deflated by its own elastic restoring force when ruptured, and the bone filling material is quickly exposed in the bone. Therefore, the indwelling balloon after rupture can be collected easily and quickly.

  In the above bone treatment system, the indwelling balloon is disposed in a contracted state inside the space forming balloon, and is expanded on the distal side from the space forming balloon with the introduction of the bone filling material. Also good. According to this configuration, the space forming balloon can be expanded and contracted in the bone without affecting the indwelling balloon, thereby forming the indwelling space in the bone. In addition, since the indwelling balloon expands on the tip side of the space forming balloon with the introduction of the bone filling material, the indwelling balloon can be expanded without any trouble in the indwelling space after the space forming balloon contracts and retracts. Can do.

  In the above bone treatment system, a mandrel that can be inserted into the second lumen and the indwelling balloon and that has a distal end close to or in contact with the inner surface of the inflated indwelling balloon may be provided. According to this configuration, after the bone filling material is introduced into the indwelling balloon through the second lumen, the mandrel is inserted into the second lumen and the indwelling balloon while the bone filling material is uncured. When the mandrel is removed while the bone filling material is cured, a cavity having a shape corresponding to the mandrel is formed in the bone filling material. Therefore, a part of the indwelling balloon can be easily broken by applying some physical or chemical action to the inflated indwelling balloon using the formed cavity.

  In the bone treatment system, at least a portion of the mandrel that is inserted into the second lumen and the indwelling balloon may be configured in a straight line. By using such a mandrel, a linear cavity can be formed coaxially with the shaft in the bone filling material introduced into the indwelling balloon. Therefore, the distal end portion of the inflated indwelling balloon can be broken using the hollow portion, whereby the indwelling balloon can be easily recovered from within the bone.

  In the above bone treatment system, it can be inserted into a cavity formed in the bone filling material as the mandrel is removed from the shaft, and a part of the inflated indwelling balloon is broken. You may provide the effect | action member which exerts a physical effect on. According to this structure, the front-end | tip part of an action member can be reached to the inner surface of an indwelling balloon via a cavity part, and a part of this indwelling balloon can be broken easily.

  In the above bone treatment system, the action member may be a puncture member that punctures the indwelling balloon. According to this configuration, since a part of the indwelling inflated balloon is broken by puncturing, the bone filling material can be exposed in the bone easily and quickly.

  According to the bone treatment system of the present invention, the treatment period can be shortened by easily and quickly placing the hardened bone filling material in the bone to be treated.

It is the schematic which shows the whole structure of the bone treatment system which concerns on one Embodiment of this invention. FIG. 3 is a partially omitted longitudinal sectional view of the indwelling device in the bone treatment system shown in FIG. 1. FIG. 3A is a longitudinal cross-sectional view of the indwelling device with the space-forming balloon expanded, and FIG. 3B is a longitudinal cross-sectional view of the indwelling device with the indwelling balloon expanded. 4A is a schematic diagram illustrating a distal radius fracture to which the bone treatment system of FIG. 1 is applied, and FIG. 4B is a first explanatory diagram illustrating a flow of treatment of the distal radius fracture of FIG. 4A. 4C is a second explanatory diagram for explaining the flow of treatment following FIG. 4B, and FIG. 4D is a third explanatory diagram for explaining the flow of treatment following FIG. 4C. FIG. 5A is a first explanatory view showing a bone filling material placement operation using the bone treatment system, and FIG. 5B is a second explanatory view showing a bone filling material placement operation following FIG. 5A. 6A is a third explanatory view showing the bone filling material placement operation following FIG. 5B, and FIG. 6B is a fourth explanatory view showing the bone filling material placement operation following FIG. 6A. 7A is a fifth explanatory view showing the bone filling material placement operation following FIG. 6B, and FIG. 7B is a sixth explanatory view showing the bone filling material placement operation following FIG. 7A. FIG. 8A is a seventh explanatory view showing the bone filling material placement operation following FIG. 7B, and FIG. 8B is an eighth explanatory view showing the bone filling material placement operation following FIG. 8A. 9A is a ninth explanatory view showing the bone filling material placement operation following FIG. 8B, and FIG. 9B is a 10th explanatory view showing the bone filling material placement operation following FIG. 9A. FIG. 10A is a partially omitted longitudinal sectional view showing an indwelling device in the case where the indwelling balloon is ruptured by another means, and FIG. 10B is a case in which the indwelling balloon is ruptured by the mandrel and the puncture member according to the modification. It is a partially abbreviated longitudinal sectional view showing an indwelling device. FIG. 11A is a partially omitted longitudinal sectional view showing a distal end portion of an indwelling device provided with an indwelling balloon according to a first modification, and FIG. 11B is an indwelling device provided with an indwelling balloon according to a second modification. FIG. It is a partially-omission longitudinal cross-sectional view which shows the indwelling device provided with the balloon for indwelling concerning a 3rd modification.

  Preferred embodiments of the bone treatment system according to the present invention will be described below in detail with reference to the accompanying drawings.

  A bone treatment system 10 according to the present invention includes a plurality of devices shown in FIG. 1 and is a system that performs minimally invasive treatment with a bone filling material C (see FIG. 3B and the like) on a fractured part of a patient. That is, the surgeon uses a plurality of devices of the bone treatment system 10 at a predetermined timing to perform a procedure of placing the bone filling material C inside the bone. The indwelling bone filling material C treats the bone over time.

  Here, the “bone filling material” in the present specification has a fluidity (for example, liquid or paste) that can be filled into a bone treatment site at the initial stage, and is cured (for example, solidified) over time. Or semi-solid). The “bone filling material” includes the treatment of bone (in addition to joining, improvement of bone such as joining promotion, enhancement, etc.) by bonding, resorption, replacement or organization to the indwelling bone. ).

  The material of the bone filling material C is not particularly limited. For example, polymethacrylic resin (PMMA) such as polymethyl methacrylate, α-type tricalcium phosphate (TCP), β-type TCP, and hydroxyapatite. Calcium phosphate (CPC) such as can be suitably applied. In particular, CPC can be solidified in a relatively short time from the paste state, gradually joined (resorbed) from the solidified state to the bone, and finally replaced with autologous bone to join the bone. Therefore, it is preferable. The concept of the bone filling material C includes so-called “bone cement”. Bone cement refers to the above PMMA in a narrow sense, but includes PMMA and CPC in a broad sense.

  Examples of the treatment target using the bone treatment system 10 include a wrist fracture (distal radius fracture). Of course, the bone treatment system 10 is not limited to the treatment of the distal radius fracture, but can be applied to treat other fracture sites or to strengthen osteoporotic bones. Further, the treatment site is not limited to the inside of the bone, and various positions where the bone filling material C can be placed can be targeted. Furthermore, it goes without saying that it can be applied to the treatment of bones of other animals besides humans.

  In the following description, when the direction of each device of the bone treatment system 10 is indicated, the left side in FIG. 1 is referred to as the “distal end” side, and the right side in FIG.

  The bone treatment system 10 injects (fills) an uncured bone filling material C into a bone to be treated (for example, inside a rib to be described later) and hardens the bone filling material C. It is a treatment kit for performing a bone filling material placement operation to be placed inside. As shown in FIG. 1, the bone treatment system 10 includes an indwelling device 12, a mandrel 14, and a puncture member 16. Hereinafter, each component will be specifically described.

  The bone treatment system 10 can apply some devices (not shown) in addition to the above devices. For example, an opening / closing tool for incising or perforating living tissue around the fracture site, a drill for perforating the denseness of the rib, a cannula for constructing a guide path such as a drill or an indwelling device 12, It may include a fixture or the like to maintain. Since these devices can be applied to known devices, detailed description thereof is omitted.

  The indwelling device 12 forms an indwelling space 80 (see FIG. 6A) for placing the bone filling material C in the bone to be treated, and fills the indwelling space 80 with the bone filling material C. It is a device for detention. The indwelling device 12 is provided at the shaft 18, the space forming balloon 20 provided at the distal end portion of the shaft 18, the indwelling balloon 22 provided at the distal end portion of the shaft 18, and the proximal end portion of the shaft 18. And a hub 24 (gripping portion).

  The shaft 18 is an elongated linear tubular member having a length that can reach the bone to be treated from outside the body. As shown in FIG. 2, the shaft 18 includes an inner tube 26, an outer tube 28 disposed substantially concentrically outside the inner tube 26, a first lumen 30 through which the expansion fluid 34 can flow, a bone And a second lumen 32 through which the filling material C can be distributed. A second lumen 32 is constituted by a hollow portion of the inner tube 26 extending in the axial direction and penetrating therethrough. A first lumen 30 is constituted by a gap extending in the axial direction between the inner tube 26 and the outer tube 28. The distal end of the inner tube 26 protrudes in the distal direction from the distal end of the outer tube 28. The proximal end of the inner tube 26 protrudes in the proximal direction from the proximal end of the outer tube 28. For example, the inner diameter of the inner tube 26 (the diameter of the second lumen 32) is preferably 2 to 5 mm, and more preferably 2.5 to 4.5 mm.

  The shaft 18 is preferably made of a material having an appropriate rigidity in order to easily approach the bone to be treated. Examples of the constituent material of the shaft 18 include metal materials such as stainless steel, aluminum alloy, and copper alloy, polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, and polyimide. , Resin materials such as fluororesin, PEEK, and polyethylene terephthalate. The constituent materials of the inner tube 26 and the outer tube 28 may be different. The inner tube 26 and the outer tube 28 may each have flexibility.

  The space forming balloon 20 is expandable as the expansion fluid 34 (see FIG. 3A) is introduced through the first lumen 30 to form an indwelling space 80 in the bone to be treated. The balloon. The space forming balloon 20 is disposed so as to surround a predetermined range on the distal end side of the inner tube 26. Specifically, the space forming balloon 20 includes a distal end side non-deformable portion 35 fixed to the distal end outer peripheral portion of the inner tube 26, a proximal end side undeformed portion 36 fixed to the distal end portion of the outer tube 28, It has a deformable portion 37 that can be deformed (expanded and contracted) and constitutes between the distal end side non-deformed portion 35 and the proximal end side non-deformed portion 36.

  The space forming balloon 20 has a strength that is not broken by the spongy material in the bone (for example, ribs) even in the expanded state, and is made of a stretchable or non-stretchable material. The constituent material of the space forming balloon 20 is not particularly limited, and examples thereof include a resin material such as polyurethane nylon. Examples of non-stretchable materials include fibrous porous membranes such as woven fabrics, knitted fabrics, nonwoven fabrics, and paper materials, non-fibrous porous membranes, and dense membranes such as polymer sheets.

  The internal space of the space forming balloon 20 configured as described above (the space formed by the space forming balloon 20 and the inner tube 26) communicates with the first lumen 30. Through the first lumen 30, the inflow (introduction) of the expansion fluid 34 into the space forming balloon 20 and the discharge of the expansion fluid 34 from the space forming balloon 20 are possible. The space forming balloon 20 expands as the expansion fluid 34 is introduced into the space forming balloon 20. In a fully expanded state, the space forming balloon 20 has, for example, a substantially spherical shape as shown in FIG. 3A.

  In addition, the shape of the balloon 20 for space formation in an expanded state is not limited to a substantially spherical shape, and may be an oval shape or the like in a side view, as long as the shape is rounded as a whole. Further, the cross-sectional shape of the space forming balloon 20 in the expanded state is not limited to a circle (including a substantially circle), and may be an oval shape.

  The expansion fluid 34 supplied to the space forming balloon 20 is not particularly limited, and examples thereof include a radiation (X-ray) contrast agent and physiological saline. In particular, the X-ray contrast agent can image how much the space forming balloon 20 is expanded in the bone under X-ray imaging, and sets the amount of filling of the subsequent bone filling material C. It is also effective from the viewpoint.

  A part or the whole of the space forming balloon 20 may have X-ray contrast properties. For example, the material forming the space forming balloon 20 may include an X-ray opaque material, or a layer made of the X-ray opaque material may be formed on the outer surface of the space forming balloon 20. Examples of the radiopaque material include gold, platinum, and tungsten (tungsten alloy).

  In FIG. 2, the indwelling balloon 22 can be expanded in the indwelling space 80 as the bone filler material C is introduced through the second lumen 32, and after the bone filler material C is introduced. The balloon for exposing the bone filling material C (hardened bone filling material C) to the bone by being broken. The indwelling balloon 22 is disposed inside the space forming balloon 20 in a contracted state, and expands on the front side of the space forming balloon 20 as the bone filling material C is introduced.

  Specifically, the indwelling balloon 22 in the contracted state is disposed inside the inner tube 26. In FIG. 2, the indwelling balloon 22 in a contracted state has a hollow shape with the distal end closed and the proximal end opened, and extends in the axial direction of the inner tube 26. The proximal end portion of the indwelling balloon 22 is fixed (joined) to the inner peripheral portion of the inner tube 26 by appropriate joining means such as adhesion or fusion. Of the indwelling balloon 22, a portion of the distal end side with respect to the proximal end portion is not fixed to the inner peripheral portion of the inner tube 26 and can be displaced in the axial direction with respect to the inner tube 26.

  In this embodiment, the indwelling balloon 22 is configured to be more flexible than the space forming balloon 20, and greatly expands (elastically deforms) and becomes thin when expanded. Therefore, when the indwelling balloon 22 is expanded in the rib 70, the indwelling balloon 22 has a three-dimensional shape that is appropriately deformed according to the shape of the indwelling space 80. The constituent material of the indwelling balloon 22 is not particularly limited, but is preferably formed of a material having a certain degree of flexibility. Examples of such a material include polyethylene, polypropylene, polybutene, and ethylene-propylene copolymer. Polyolefins such as coalescence, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these, thermoplastic resins such as soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin, Silicone rubber and latex rubber can be used.

  The indwelling balloon 22 may partially or entirely have X-ray contrast properties. For example, the material constituting the indwelling balloon 22 may include a radiopaque material, or a layer made of the radiopaque material may be formed on the outer surface of the indwelling balloon 22. Examples of the radiopaque material include gold, platinum, and tungsten (tungsten alloy).

  The hollow portion of the indwelling balloon 22 communicates with the second lumen 32 formed in the inner tube 26. The bone filling material C can flow into the indwelling balloon 22 through the second lumen 32. As the bone filling material C is introduced into the indwelling balloon 22, the indwelling balloon 22 expands. Specifically, as the bone filling material C is introduced, the indwelling balloon 22 having elasticity stretches elastically and protrudes from the inner tube 26 as shown in FIG. 3B. It swells at the tip side, for example, exhibits a spherical shape in an expanded state. In an actual bone filling material placement operation, the placement balloon 22 is expanded in a shape corresponding to the shape of the placement space 80 formed in the preceding step.

  Next, the hub 24 provided at the proximal end portion of the shaft 18 will be described with reference to FIG. The hub 24 is formed with a diameter larger than that of the shaft 18 so that an operator can easily hold and operate it during the procedure. In the present embodiment, the hub 24 includes a linear body portion 38 that is coaxially connected to the shaft 18, and two branch portions 40 and 42 (hereinafter referred to as “first branch portion 40”) branched from the body portion 38. , Referred to as “second branch portion 42”).

  In the hub 24, a communication path 44 that communicates the mouth portion 40 a of the first branch portion 40 and the first lumen 30 of the inner tube 26 is provided. The communication path 44 is provided from the first branch portion 40 of the hub 24 to the body portion 38. An expansion / contraction operation device 46 can be connected to the mouth portion 40 a of the first branch portion 40. The expansion / contraction operation device 46 supplies the expansion fluid 34 into the space forming balloon 20 via the hub 24 (the communication passage 44 thereof) and the shaft 18 (the first lumen 30 thereof), or within the space forming balloon 20. A device for discharging the expansion fluid 34 from the device.

  The expansion / contraction operation device 46 may be configured by a syringe, for example. When the expansion / contraction operation device 46 is a syringe, the surgeon causes the expansion fluid 34 to flow out of the syringe by an operation of pushing out the pusher (not shown), and the hand is released from the pusher (or pulled). The operation of sucking the working fluid 34 is performed.

  The expansion / contraction operation device 46 may be configured to indicate the filling amount of the bone filling material C corresponding to the supply amount of the space forming balloon 20 (or to indicate the supply amount of the expansion fluid 34 itself). . That is, since the volume of the indwelling space 80 formed by the space forming balloon 20 is substantially the same as the supply amount of the expansion fluid 34, the index for filling the bone filling material C later can do. For example, the expansion / contraction operation device 46 is configured so that the filling amount of the bone filling material C is written on the scale of the pusher of the syringe, and the advancement position of the pusher is automatically marked when the expansion fluid 34 is supplied most. Thereby, based on the filling amount of the bone filling material C shown, it becomes possible to accurately fill the bone filling material C later.

  Further, inside the hub 24, a main passage 48 that is formed coaxially with the inner pipe 26 and communicates with the second lumen 32, a second branch portion 42, and a second passage through the main passage 48. An introduction passage 50 communicating with the lumen 32 is provided. A supply device 52 can be connected to the mouth portion 42 a of the second branch portion 42. The supply device 52 is a device for supplying the bone filling material C into the indwelling balloon 22 via the hub 24 (the introduction passage 50 and the main passage 48) and the shaft 18 (the second lumen 32 thereof). is there.

  The supply device 52 may be configured by a syringe, for example. When the pusher of the supply device 52 is pushed out by the operator, the bone filling material C is discharged from the distal end opening of the syringe. The discharged bone filling material C is introduced and filled into the indwelling balloon 22 through the introduction passage 50 in the hub 24, the main passage 48, and the second lumen 32 in the shaft 18. As a result, the indwelling balloon 22 is in an expanded state as shown in FIG. 3B. The filled bone filling material C is in a state of being hardened to such an extent that it can be placed in the bone after a predetermined time (for example, about 5 to 15 minutes) has passed.

  In FIG. 2, a male screw portion 38 a is formed on the outer peripheral surface of the base end of the body portion 38. A guide member 54 having a female screw portion 54 a that is screwed into the male screw portion 38 a is fixed to the proximal end portion of the body portion 38. The guide member 54 has an insertion hole 54b that coincides with the axis of the main passage 48, and a tapered guide hole 54c whose inner diameter increases from the insertion hole 54b toward the proximal direction. A valve body 56 having an openable / closable through hole 57 is provided between the body portion 38 of the hub 24 and the guide member 54. The valve body 56 has a function of preventing leakage of the bone filling material C while allowing and guiding the insertion of the mandrel 14 and the puncture member 16.

  Next, the mandrel 14 shown in FIG. 1 will be described. The mandrel 14 can be inserted into the second lumen 32 and the indwelling balloon 22, and the distal end portion 15 can contact the inner surface of the inflated indwelling balloon 22. The mandrel 14 is a straight line that reaches (or substantially reaches) the inner surface of the distal end portion 22 a of the indwelling balloon 22 after the bone filling material C is introduced into the indwelling balloon 22. Used to form a hollow 84 (see FIG. 8A).

  The mandrel 14 in the illustrated example is a bar member formed in an elongated and linear shape. The outer diameter of the mandrel 14 is smaller than the inner diameter of the inner tube 26 (the diameter of the second lumen 32), the main passage 48 of the hub 24, and the insertion hole 54b of the guide member 54. The mandrel 14 is longer than the indwelling device 12.

  The mandrel 14 is preferably made of a material having X-ray contrast so that it is easy to recognize the relative position of the mandrel 14 with respect to the indwelling balloon 22. Further, the distal end portion 15 of the mandrel 14 is preferably formed with a rounded corner so that it does not break even if it contacts the inflated indwelling balloon 22. In order to facilitate the advance operation of the mandrel 14, it is preferable that an operation unit 60 having a diameter larger than that of the mandrel 14 is attached to the base end portion of the mandrel 14.

  Note that a lubricant 59 that facilitates relative movement with respect to the hardened bone filling material C may be applied to the outer peripheral surface of the mandrel 14. Examples of the lubricant 59 include silicon oil.

  The puncture member 16 is used to puncture the indwelling balloon 22 filled with the bone filling material C from the inside. Therefore, the puncture member 16 can be inserted into the cavity 84 (see FIG. 8B) formed in the bone filling material C and has a physical action so as to break a part of the indwelling indwelling balloon 22. Functions as an acting member.

  Specifically, like the mandrel 14, the puncture member 16 is formed in an elongated linear shape and has a sharp needle tip 17 at the tip. The outer diameter of the puncture member 16 is substantially the same as or slightly smaller than the outer diameter of the mandrel 14. The needle tip 17 of the puncture member 16 moves in the distal direction of the indwelling device 12 and can contact the expanded indwelling balloon 22 to easily break the indwelling balloon 22. In order to improve the slidability of the puncture member 16 with respect to the bone filling material C (to reduce the sliding resistance against the bone filling material C), a lubricant 61 is applied to the outer peripheral surface of the puncture member 16. Also good. Examples of such a lubricant 61 include silicon oil.

  Although the constituent material of the mandrel 14 and the puncture member 16 is not specifically limited, For example, it is good to be comprised with metal materials, such as stainless steel. Moreover, it is preferable that the puncture member 16 also has an X-ray contrast property. Thereby, at the time of the advance operation of the puncture member 16, it can be recognized that the needle tip 17 has reached the indwelling balloon 22 and has broken the indwelling balloon 22.

  The bone treatment system 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.

  First, in order to facilitate understanding of the bone treatment system 10, a distal radius fracture is taken as an example of bone treatment, and an outline of the treatment of the distal radius fracture by placement of the bone filling material C will be described. To do. As shown in FIG. 4A, the human body has a radius 70 positioned closer to the thumb and an ulna 72 positioned closer to the little finger as the bones of the upper limb distal to the elbow. The rib 70 includes a body part 70a, and a distal end part 70b and a proximal end part (not shown) that are thicker than the body part 70a on both ends of the body part 70a. Osteoporosis of the rib 70 is a loss of bone density due to the loss of bone tissue of the cancellous 76 inside the dense material 74 on the outer peripheral surface side of the bone.

  A fracture at the distal end of the radius occurs when the dense material 74 at the connecting portion between the body portion 70a and the distal end portion 70b is broken (divided or cracked) by receiving an impact or the like. As a concrete fracture state, a closed fracture (including collet fracture) or an open fracture in which the distal end portion 70b divided with respect to the trunk portion 70a is displaced, or an insertion in which the trunk portion 70a is recessed into the distal end portion 70b. Examples include fractures.

  In the treatment of the distal radius fracture, as shown in FIG. 4B, a reduction operation is performed to restore the position of the distal end 70b that has been displaced with respect to the body 70a. Thereby, the trunk | drum 70a and the distal end part 70b are arrange | positioned in a mutually normal position (henceforth a state after reduction).

  In this post-reduction state, the position of the body part 70a and the distal end part 70b is maintained, and the bone treatment system 10 is used to place the bone filling material C as shown in FIG. To implement.

  After placement of the bone filling material C, the wrist is fixed with a cast or the like, and the fixed state is continued for a predetermined period. During this period, the bone filling material C is absorbed in an easy and reliable manner in contact with the bone around the placement site in the rib 70 as shown in FIG. 4D. The absorbed bone filling material C is gradually replaced with autologous bone, strengthens the inside of the rib 70, and joins the trunk portion 70a and the distal end portion 70b. In the treatment of indwelling the bone filling material C, the influence on the surrounding tissue of the fracture site is reduced, and treatment can be performed more safely than the conventional treatment method in which the fracture site is fixed using a metal plate or a screw. it can.

  Next, the bone filling material placement operation performed using the bone treatment system 10 will be specifically described. As shown in FIG. 4B, the bone filling material placement operation is performed after the operator reduces the fractured portion of the rib 70 and sets the body portion 70a and the distal end portion 70b to a normal positional relationship. In addition, during implementation of the bone filling material placement operation, the state of the fracture site of the rib 70 is confirmed in real time with an X-ray image.

  In the bone filling material indwelling method, as shown in FIG. 5A, a hole 78 into which the indwelling device 12 can be inserted with a drill or the like is first formed in the dense material 74 of the rib 70 while maintaining the reduced state, and then indwelled. The device 12 is inserted into the hole 78. At this time, the space forming balloon 20 is in a deflated state, and the distal end portion of the indwelling device 12 is easily inserted into the rib 70.

  The inside of the rib 70 allows the insertion of the indwelling device 12 relatively easily because the sponge 76 is fragile due to osteoporosis. The indwelling device 12 is more easily inserted into the rib 70 when, for example, the indwelling device 12 is advanced along a place where a crack is formed by a fracture. In addition, the insertion direction of the indwelling device 12 with respect to the rib 70 is not specifically limited, You may set suitably according to a fracture condition.

  As shown in FIG. 5B, the distal end portion of the indwelling device 12 is inserted to the depth of the rib 70 (the dense material 74 on the side opposite to the hole 78). Next, as shown in FIG. 6A, the space forming balloon 20 is expanded. Specifically, an expansion / contraction operation device 46 is connected to the first branch portion 40 provided in the hub 24 (see FIG. 2), and the expansion / contraction operation device 46 is operated to expand the expansion fluid via the first lumen 30. 34 is introduced into the space forming balloon 20, and the space forming balloon 20 is expanded in the bone.

  Since the space forming balloon 20 has sufficient strength, it expands while crushing the bristle sponge 76. Thereby, an indwelling space 80 corresponding to the expansion amount (volume) of the space forming balloon 20 is formed inside the rib 70. When the indwelling space 80 is formed, the space forming balloon 20 is deflated.

  After the deflation of the space forming balloon 20, the indwelling device 12 is retracted with respect to the rib 70 within a range where the indwelling device 12 is not completely pulled out from the rib 70 as shown in FIG. 6B. At this time, the position of the indwelling device 12 is set with respect to the rib 70 so that the most distal portion of the indwelling device 12 is positioned at the outermost part of the indwelling space 80 (the most advanced portion just faces the indwelling space 80). To do. As a result, the tip of the indwelling balloon 22 faces the indwelling space 80 as shown in FIG. 6B.

  Therefore, next, as shown in FIG. 7A, the indwelling balloon 22 is expanded in the rib 70. Specifically, the supply device 52 is connected to the second branch portion 42 provided in the hub 24 (see FIG. 2), and the supply device 52 is operated to be uncured via the hub 24 and the second lumen 32. The bone filling material C in a state (liquid state) is introduced into the indwelling balloon 22, and the space forming balloon 20 is expanded in the indwelling space 80. Since the hub 24 is provided with the valve body 56 (see FIG. 2), the bone filling material C does not leak from the proximal end side of the hub 24.

  In the following description, when the bone filling material C is described separately before being hardened (uncured state) and after being hardened (cured state), reference numerals are given for the bone filling material C in an uncured state. C1 is used, and the reference symbol C2 is used for the filling material C for bone in a cured state (a cured state at least enough not to be disintegrated by a body fluid or a state cured beyond that).

  When supplying the bone filling material C into the space forming balloon 20 through the second lumen 32, an air vent tube 82 (see FIG. 6B) thinner than the diameter of the second lumen 32 is provided in the inner tube 26. The air in the second lumen 32 and the inflated indwelling balloon 22 may be discharged to the outside of the indwelling device 12 by using the air vent tube 82. At this time, the air mixed in the bone filling material C is arranged by placing the distal end of the air bleeding tube 82 as close as possible to the distal end of the indwelling balloon 22 as long as the distal end opening of the air bleeding tube 82 is not closed. The amount of can be reduced.

  The indwelling balloon 22 is expanded in accordance with the shape of the indwelling space 80 at the tip of the shaft 18 by being filled with the bone filling material C1. The expansion amount of the indwelling balloon 22 is preferably set to be approximately equal to the volume of the indwelling space 80 or slightly smaller. This prevents the indwelling balloon 22 from being strongly compressed between the hardened bone filling material C2 and the inner surface of the rib 70. Therefore, the indwelling balloon 22 can be collected smoothly.

  After the indwelling balloon 22 is expanded, the mandrel 14 is inserted into the indwelling device 12 before the bone filling material C is cured, as shown in FIG. 7B. In this case, specifically, the mandrel 14 is inserted from a guide member 54 (see FIGS. 1 and 2) provided at the proximal end of the hub 24. Then, the mandrel 14 is advanced with respect to the indwelling device 12, and the distal end portion 15 of the mandrel 14 is inserted into the indwelling balloon 22 through the hub 24 (main passage 48) and the shaft 18 (second lumen 32). . Since the bone filling material C is in an uncured state, the mandrel 14 can easily advance in the bone filling material C.

  Then, as shown in FIG. 7B, when the mandrel 14 is advanced to a position where the tip 15 of the mandrel 14 contacts the inner surface of the indwelling balloon 22 (the inner surface of the distal end portion 22a), the mandrel 14 is stopped. The mandrel 14 is not unnecessarily pushed out against the indwelling balloon 22 by confirming the position of the tip 15 under X-ray contrast, so that the indwelling balloon C before the bone filling material C is cured. 22 can be prevented from bursting.

  The timing of inserting the mandrel 14 into the indwelling device 12 is not particularly limited. For example, the mandrel 14 may be inserted in advance before filling with the bone filling material C, and during the filling of the bone filling material C, It may be inserted. Thereby, when the mandrel 14 is inserted after filling the bone filling material C, it is possible to suppress an increase in the fluid pressure of the bone filling material C.

  After the mandrel 14 is inserted, the bone filling material C is cured by waiting for a predetermined time (for example, about 5 to 15 minutes). If the bone filling material C is, for example, CPC, the bone filling material C is cured to such an extent that it is not easily disintegrated by body fluids in about 10 minutes.

  After a predetermined time has elapsed, an operation is performed to pull out the mandrel 14 from the cured bone filling material C2. The mandrel 14 formed in a straight line can be smoothly pulled out along the axial direction of the indwelling device 12 without inconvenience such as being caught by the bone filling material C2.

  When the mandrel 14 is pulled out, as shown in FIG. 8A, a cavity 84 is formed inside the hardened bone filling material C2. The cavity 84 extends linearly from the inner surface of the distal end portion 22 a of the indwelling balloon 22 and reaches the valve body 56 provided at the proximal end of the hub 24. In FIG. 7B, the mandrel 14 has been advanced to a position where the distal end portion 15 abuts against the inner surface of the indwelling balloon 22. However, the bone filling material C is thin enough to remain on the inner surface of the indwelling balloon 22. If so, the distal end portion 15 may not contact the inner surface of the indwelling balloon 22, and the mandrel 14 may be stopped at a position where the distal end portion 15 is close to the inner surface. In the case of the membranous bone filling material C, the puncture member 16 to be used later can penetrate even in the cured state, and the indwelling balloon 22 can be punctured.

  After the mandrel 14 has been pulled out, as shown in FIG. 8B, the puncture member 16 is inserted into the indwelling device 12 using the cavity 84 formed in the bone filling material C, and the indwelling balloon 22 is inserted. Perform an operation to puncture from the inside. Specifically, the puncture member 16 is inserted from a guide member 54 (see FIGS. 1 and 2) provided at the proximal end of the hub 24. The cavity 84 is linearly formed to the inner surface of the indwelling balloon 22 (or a position close to the inner surface). For this reason, the surgeon smoothly advances the puncture member 16 along the cavity portion 84, brings the needle tip 17 into contact with the substantially middle position of the indwelling balloon 22 facing the cavity portion 84, and moves the indwelling balloon 22 Can be punctured from the inside.

  When the indwelling balloon 22 is punctured by the puncture member 16, the indwelling balloon 22 is ruptured. In this case, specifically, as shown in FIG. 8B, the indwelling balloon 22 starts to tear from the back side (puncture site) of the indwelling space 80. FIG. 8B shows a state immediately after the start of the rupture of the indwelling balloon 22. The needle tip 17 pierces the most extended portion of the indwelling indwelling balloon 22, and is urged to burst actively. As a result, the hardened bone filling material C2 is exposed in the indwelling space 80.

  The inflatable indwelling balloon 22 is cracked from the distal end side (distal side) of the indwelling device 12 so that the broken membrane portion (rupture piece 22b) is fixed to the shaft 18 as shown in FIG. 9A. It acts to move to the end side. That is, the rupture piece 22b moves between the outer peripheral surface of the bone filling material C2 and the inner peripheral surface of the bone forming the indwelling space 80, and approaches the shaft 18 side, and the bone filling material C2 Is actively exposed.

  After the bone filling material C2 is exposed, the puncture member 16 is withdrawn from the cavity 84, and the indwelling device 12 is withdrawn from the rib 70 as shown in FIG. 9B. As a result, the bone filling material C <b> 2 in a hardened state is placed in the placement space 80 of the rib 70. In addition, when the indwelling balloon 22 has X-ray contrast properties, it can be easily confirmed whether the indwelling balloon 22 after rupture has been reliably removed from the rib 70 or not.

  The bone filling material C2 in a hardened state is absorbed by the bone around the rib 70, and then gradually replaced with autologous bone. As a result, the rib 70 is joined to the body part 70a and the distal end part 70b.

  As described above, since the bone treatment system 10 according to the present embodiment is configured to include the space forming balloon 20 and the indwelling balloon 22 on the shaft 18, the formation of the indwelling space 80 and the bone filling material are provided. C can be injected by one device (indwelling device 12). That is, since it is not necessary to use separate devices for the space formation and the bone filling material injection, the procedure for placing the bone filling material C can be performed quickly and smoothly. Further, after the bone filling material C is introduced into the indwelling balloon 22, when the bone filling material C is cured, the indwelling balloon 22 is broken to expose the bone filling material C in the bone in a relatively short time. Therefore, the treatment period can be shortened. In addition, the bone filling material C, which tends to collapse or fail to harden when it comes into contact with body fluids during injection, can be placed in the bone in a more reliably cured state while suppressing the influence of body fluids. Strength improvement and treatment effect can be enhanced.

  In particular, in the case of the present embodiment, the indwelling balloon 22 is made of a material having elasticity, so that the indwelling balloon 22 contracts at the time of rupture, and the bone filling material C is quickly exposed in the bone. Therefore, the indwelling balloon 22 after rupture can be collected easily and quickly.

  In the case of the present embodiment, the indwelling balloon 22 is disposed in a contracted state inside the space forming balloon 20, and is expanded on the distal side of the space forming balloon 20 with the introduction of the bone filling material C. To do. According to this configuration, the indwelling space 80 can be formed in the bone by expanding and contracting the space forming balloon 20 in the bone without affecting the indwelling balloon 22. Further, since the indwelling balloon 22 is expanded on the distal end side with respect to the space forming balloon 20 as the bone filling material C is introduced, the indwelling balloon 22 contracts and retracts in the indwelling space 80. It can be expanded without hindrance.

  Furthermore, since the bone treatment system 10 of the present embodiment includes the mandrel 14 that can be inserted into the indwelling device 12, a cavity that reaches the inner surface of the indwelling balloon 22 in the bone filling material C injected into the indwelling device 12. A portion 84 can be formed. Therefore, a part of the indwelling balloon 22 can be easily broken using the formed hollow portion 84.

  In this case, in this embodiment, at least a portion of the mandrel 14 that is inserted into the second lumen 32 and the indwelling balloon 22 is configured in a straight line. By using such a mandrel 14, a linear cavity 84 can be formed coaxially with the shaft 18 in the bone filling material C introduced into the indwelling balloon 22. Therefore, the distal end portion 22a of the expanded indwelling balloon 22 can be broken using the hollow portion 84, and the indwelling balloon 22 can be easily recovered from the bone.

  In the case of the bone treatment system 10 according to the present embodiment, the puncture member 16 that punctures the indwelling balloon 22 is provided as an action member that exerts a physical action so as to break a part of the inflated indwelling balloon 22. With this configuration, the distal end portion of the puncture member 16 that is an action member can reach the inner surface of the indwelling balloon 22 via the cavity portion 84, and a part of the indwelling balloon 22 can be easily broken. In particular, since the tip of the puncture member 16 is the needle tip 17, the bone filling material C can be easily and quickly exposed to the bone by easily penetrating and rupturing the wall of the indwelling balloon 22. Can do.

  Next, some modified examples will be described below in relation to the bone treatment system 10 described above.

  Instead of puncturing the indwelling balloon 22 with the puncture member 16 and rupturing it, as shown in FIG. 10A, after forming the cavity 84 in the bone filling material C, the solution 86 is poured into the cavity 84. The indwelling balloon 22 may be ruptured. That is, a part of the indwelling balloon 22 (the part exposed by the presence of the cavity 84 in the indwelling balloon 22) may be dissolved by the dissolving solution 86, and the indwelling balloon 22 may be ruptured. FIG. 10A shows a state in which the solution 86 has reached the vicinity of the inner surface of the indwelling balloon 22.

  The dissolution solution 86 depends on the constituent material of the indwelling balloon 22, but for example, if the indwelling balloon 22 is a styrene-based elastomer, soybean oil, Lipiodol (registered trademark), or the like may be used.

  Thus, the configuration for breaking and rupturing a part of the indwelling balloon 22 is not particularly limited, and various configurations can be adopted. For example, as an action member that replaces the puncture member 16 described above, a device having a heating portion at the tip may be inserted into the cavity portion 84, and a portion of the indwelling balloon 22 may be cut and ruptured by the heating portion. Alternatively, as another action member, a device having a scissor mechanism at the tip may be inserted into the cavity 84, and a part of the indwelling balloon 22 may be cut and ruptured by the scissor mechanism.

  Instead of the mandrel 14 and the puncture member 16 described above, a part of the indwelling balloon 22 may be broken using the mandrel 14a and the puncture member 16a according to the modification shown in FIG. . The mandrel 14a is configured as a tubular body having a through passage 90 along the axial direction. The puncture member 16a can be inserted through the through passage 90 of the mandrel 14a. For this reason, after the bone filling material C is cured, the puncture member 16a is advanced and the part of the indwelling balloon 22 (distal end part 22a) is punctured immediately without removing the mandrel 14a from the indwelling device 12. Can do.

  The mandrel 14a can obtain various effects. For example, if the mandrel 14a is inserted before filling the bone filling material C, the mandrel 14a is inserted through the through passage 90 when filling the bone filling material C. The air in the second lumen 32 can be discharged.

  Like the indwelling balloon 92 according to the first modification shown in FIG. 11A, the wall thickness in the expanded state may vary depending on the region. In FIG. 11A, the distal end portion 92a (the portion farthest from the shaft 18) of the indwelling balloon 92 in the expanded state is formed thin, and the portion 92b adjacent to the shaft 18 is formed thick. Thus, by changing the thickness of the indwelling balloon 92 in the expanded state, the indwelling balloon 92 can be ruptured and the indwelling balloon 22 can be recovered more easily.

  In other words, the puncture member 16 pierces the thin portion (distal end portion 92a) of the indwelling balloon 92, and the rupture of the indwelling balloon 92 is promoted. In addition, since the cracked indwelling balloon 92 is pulled in with a high elastic force at the thick portion 92b (base end portion), the rupture piece can be easily moved to the base end side.

  As in the indwelling balloon 94 according to the second modification shown in FIG. 11B, lubricant coating layers 96 and 98 may be provided on the outer peripheral surface and the inner peripheral surface. The lubricant coating layer 96 on the outer peripheral surface side slides the indwelling balloon 94 against the bone, and the lubricant coating layer 98 on the inner peripheral surface side is placed on the bone filling material C2 in a cured state. The balloon 94 is slid. When the indwelling balloon 94 is broken, the lubricant coating layers 96 and 98 facilitate the movement of the indwelling balloon 94 to the proximal end side, and the indwelling balloon 94 can be collected more reliably. The lubricant may be applied only to either the outer peripheral surface or the inner peripheral surface of the indwelling balloon 94.

  Instead of the indwelling balloons 22, 92, and 94 made of the stretchable material described above, as shown in FIG. 12, the indwelling balloon 100 according to the third modification made of a non-stretchable material is used. It may be adopted. In this indwelling balloon 100, the portion 102 on the opening end side is connected and fixed to the inner tube 26 of the shaft 18, and is accommodated in the inner tube 26 (second lumen 32) in a contracted state.

  When the bone filler material C flows in the second lumen 32 toward the distal end of the inner tube 26, reaches the contracted indwelling balloon 100, and further flows in the distal direction, the indwelling balloon 100 moves in the distal direction. It is pushed and then the front and back are reversed. Then, at the stage where the bone filling material C is sufficiently introduced (filled) into the indwelling balloon 100, the indwelling balloon 100 is in an expanded state as indicated by a virtual line in FIG. The indwelling balloon 100 can be expanded to a size that fills the indwelling space 80 or is slightly smaller than the indwelling space 80.

  In the case of the indwelling device 12 employing the indwelling balloon 100, the distal end portion 100a of the indwelling balloon 100 filled with the bone filling material C in the bone is broken by the puncture member 16 or the like, and then the indwelling device 12 is used. Is retracted, the indwelling balloon 100 is torn starting from the torn location. As a result, the hardened bone filling material C can be exposed in the bone, and the indwelling balloon 100 can be recovered from the bone.

  In the above-described embodiment, the indwelling balloon 22 is ruptured in the bone after the bone filling material C is in a cured state, that is, after the bone filling material C is cured to such an extent that the bone filling material C does not collapse. The indwelling balloon 22 may be ruptured in the bone before the material C is cured to such an extent that it does not collapse with the body fluid. Also by this method, a high therapeutic effect can be obtained as compared with the case where the bone filling material C is introduced into the bone without using a balloon.

  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. Yes.

DESCRIPTION OF SYMBOLS 10 ... Bone treatment system 12 ... Indwelling device 14, 14a ... Mandrel 16, 16a ... Puncture member 18 ... Shaft 20 ... Space formation balloon 22, 92, 94, 100 ... Indwelling balloon

Claims (7)

A bone treatment system for placing a bone filling material in a bone to be treated,
A shaft having a first lumen through which an expansion fluid can flow and a second lumen through which bone filling material can flow;
A balloon for forming a space, which is provided at a distal end portion of the shaft and is expandable as the expansion fluid is introduced through the first lumen, and forms an indwelling space in the bone to be treated. When,
It is provided at the tip of the shaft and is expandable in the indwelling space as the bone filling material is introduced through the second lumen, and after the introduction of the bone filling material, An indwelling balloon that exposes the bone filler material in the bone by tearing,
A bone treatment system characterized by that. The bone treatment system according to claim 1, wherein
The indwelling balloon is made of a stretchable material,
A bone treatment system characterized by that. The bone treatment system according to claim 1 or 2,
The indwelling balloon is disposed in a contracted state inside the space forming balloon, and expands on the distal side of the space forming balloon with the introduction of the bone filling material.
A bone treatment system characterized by that. The bone treatment system according to any one of claims 1 to 3,
A mandrel capable of being inserted into the second lumen and the indwelling balloon and having a distal end portion approaching or contacting the inner surface of the inflated indwelling balloon;
A bone treatment system characterized by that. The bone treatment system according to claim 4, wherein
Of the mandrel, at least the second lumen and the portion inserted into the indwelling balloon are configured in a straight line,
A bone treatment system characterized by that. The bone treatment system according to claim 4 or 5,
An action that can be inserted into a cavity formed in the bone filling material with the removal of the mandrel from the shaft and exerts a physical action so as to break a part of the indwelling balloon in an expanded state. Comprising members,
A bone treatment system characterized by that. The bone treatment system according to claim 6, wherein
The action member is a puncture member that punctures the indwelling balloon.
A bone treatment system characterized by that.

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