JP2014200286A - Implant and implant assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an implant and an implant assembly including the implant in which an expanded state of a container can be easily and accurately grasped on the basis of pressure change of an inside of the container.SOLUTION: An implant 20 that can be detained inside an organism includes a flexible container 30 that can be expanded to be deformed by introducing filler m. The container 30 has a pressure indication unit 40 for indicating pressure inside the container 30 under an X-ray fluoroscopic image by change of an indication state depending on pressure change inside the container 30 associated with introduction of the filler m.

Description

  The present invention relates to an implant that can be placed in a living body.

  In the medical field, there are known various techniques related to an implant placed in a living body and a method for placing an implant in a living body. For example, Patent Document 1 describes an implant placed between spinous processes of a living body for the treatment of lumbar spinal canal stenosis.

  In this prior art, a filler is injected into an expandable and deformable flexible container such as a balloon, and the container is used as an implant for maintaining a space between spinous processes. In this method, after the container is folded and inserted percutaneously between the spinous processes, the container is filled with a relatively viscous filler in the state of a fluid such as bone cement. Expand and place between spinous processes. Since the filling material hardens after filling into the container, the container can hold the expanded state semipermanently.

US Patent Publication No. 2009/0118833

  By the way, when filling a container with a filler, a supply device such as a tubular tube connected to the container or an indeflator connected to the tube is used. The supply device is generally provided with instruments such as a meter for displaying the pressure (pressure at the injection hand) when the filler is pumped to the container. For this reason, when performing the operation | work which pumps, the expansion state of a container can be grasped | ascertained by confirming this displayed pressure value.

  However, when using the above-mentioned filler having a relatively high viscosity at the time of filling, the pressure displayed at the injection hand and the actual pressure for pumping the filler due to friction between the filler and the tube wall of the tube A difference will occur between In addition, even when a thin tube is used as the tube connected to the container, there is a difference between the pressure at the injection hand and the actual pressure at which the filler is pumped regardless of the viscosity of the filler. Will occur. That is, in the conventional container type implant, even if the pressure value at the injection hand can be confirmed, there is a problem that the expanded state of the container cannot be accurately grasped from the value.

  Accordingly, the present invention has been made to solve the above-described problem, and includes an implant that can easily and accurately grasp the expanded state of the container based on a pressure change in the container, and the implant. An object is to provide an implant assembly.

  (1) An implant of the present invention for achieving the above object is an implant that can be placed in a living body, and includes a flexible container that can be expanded and deformed by introduction of a filler. Under the fluoroscopic image, a pressure display unit that indicates a pressure in the container is displayed by changing a display state according to a pressure change in the container accompanying the introduction of the filler.

  (2) The pressure display unit connects the movable member having an X-ray contrast property different from the X-ray contrast property of the container, the movable member and the container, and changes the pressure in the container according to the change in pressure in the container. And an elastic member that holds the movable member in a movable manner in the container.

  (3) The pressure display unit has an X-ray contrast property different from the X-ray contrast property of the container, and is stretched in the container so that an outer shape is deformed according to a change in pressure in the container. The implant according to (1) or (2) above, comprising a plate-like elastic member.

  (4) The pressure display part has a seal part that is broken when the pressure in the container is increased, and partitions the internal pressure display area into which the filler is introduced when the seal part is broken and the container. The implant according to any one of (1) to (3) above, comprising a partition member.

  (5) The container has a proximal portion provided with an inflow port into which the filler is introduced, and a front portion in the inflow direction of the filler relative to the proximal portion with respect to the proximal portion. The pressure display section is configured to change a display state in at least a part of the distal section. (1) The implant according to any one of (4) to (4).

  (6) It has fluid discharging means that enables a predetermined fluid different from the filler to be discharged from the distal portion of the container via the pressure display portion and the distal portion. The implant according to (5) above.

  (7) An implant assembly according to the present invention for achieving the above object is configured such that the implant described in any one of (1) to (6) above and one side of the implant assembly can be connected to the implant. A long member having a lumen through which the filler can circulate, and a filler capable of being connected to the other side of the long member and capable of supplying the filler into the implant through the lumen A supply unit.

  According to the invention described in (1) above, under the X-ray fluoroscopic image, the pressure display unit that indicates the pressure in the container by changing the display state according to the change in the pressure in the flexible container. Since it is provided, it is possible to easily and accurately grasp the pressure in the container, and thus the expanded state of the container, by confirming the display content of the pressure display section.

  Further, according to the invention described in (2) above, since the change in the pressure in the container can be confirmed based on the amount of movement of the movable member provided in the pressure display unit, the expanded state of the container can be further facilitated. I can grasp it.

  Further, according to the invention described in (3) above, since the change in pressure in the container can be confirmed based on the outer shape of the plate-like elastic member provided in the pressure display unit, the expanded state of the container can be further improved. It can be grasped more easily.

  Further, according to the invention described in (4) above, it is possible to confirm a change in the pressure in the container based on the introduction of the filler into the internal pressure display area accompanying the fracture of the seal portion provided in the pressure display section. The expanded state of the container can be grasped more easily.

  In addition, according to the invention described in (5) above, it is possible to confirm a change in pressure in the distal portion apart from the proximal portion where the inflow of the filler into the container is started. It is possible to prevent the display content of the pressure display unit from changing due to the influence of the inflow pressure of the filler. Therefore, the expanded state of the container can be grasped more accurately from the display content of the pressure display unit.

  According to the invention described in (6) above, when a predetermined fluid different from the filler is mixed in the container, the fluid is discharged from the distal side portion of the container via the fluid discharging means. Therefore, the filling rate of the filler in the container can be increased, and the implant into which the filler is introduced can be stably placed in the living body for a long period of time.

  Further, according to the invention described in (7) above, it is possible to provide an implant assembly capable of easily and accurately grasping the expanded state of the container by the pressure display portion provided in the container.

It is sectional drawing which shows the whole structure of the implant assembly which concerns on embodiment of this invention with the implant before expansion deformation. It is sectional drawing which shows the whole structure of the implant assembly which concerns on embodiment of this invention with the implant after expansion deformation. It is the elements on larger scale for demonstrating the filling member for sending a filler to an inlet and an implant of an implant, Comprising: It is a figure which shows the state before connecting an inlet and a filling member. It is the elements on larger scale for demonstrating the filling member for sending a filler to an inlet and an implant of an implant, Comprising: It is a figure which shows the state with which the inlet and the filling member were connected. It is a figure for demonstrating the puncture tool used in order to introduce | transduce an implant into a biological body, Comprising: It is a figure which shows the inner needle and outer needle which comprise a puncture tool. It is a figure for demonstrating the puncture tool used in order to introduce | transduce an implant into a biological body, Comprising: It is a figure which shows the state which assembled | attached and integrated the inner needle and the outer needle. It is a figure for demonstrating the spinous process of the biological body to which an implant is applied, Comprising: It is a figure which simplifies and shows the waist | hip | lumbar part of a biological body. It is a figure for demonstrating the spine of a biological body to which an implant is applied, Comprising: It is a figure which expands and shows a spine. It is a figure for demonstrating the spinous process of the biological body to which an implant is applied, Comprising: It is the arrow directional view of the lumbar vertebrae seen from the arrow 5C direction of FIG. 5B. It is a figure for demonstrating the operation | work which indwells an implant to a biological body, Comprising: It is a figure which shows the state before making a puncture tool puncture a biological body. It is a figure for demonstrating the operation | work which indwells an implant to a biological body, Comprising: It is a figure which shows the state which punctured the biological body. It is a figure for demonstrating the operation | work which indwells an implant to a biological body, Comprising: It is a figure which shows the state which located the implant between spinous processes. It is a figure for demonstrating the operation | work which indwells an implant to a biological body, Comprising: It is a figure which shows the state which expanded the implant between spinous processes. It is a figure which shows the implant detained between spinous processes, Comprising: It is a top view which shows an implant with a spinous process. It is a figure which shows the implant detained between spinous processes, Comprising: It is a front view which shows an implant with a spinous process. It is a figure for demonstrating the effect | action of the implant in 1st Embodiment, Comprising: It is a figure which shows typically the implant before expanding by introduction of a filler. It is a figure for demonstrating the effect | action of the implant in 1st Embodiment, Comprising: It is a figure which shows the implant after expansion deformation typically. It is a figure for demonstrating the effect | action of the implant in a modification, Comprising: It is a figure which shows typically the implant before expanding by introduction of a filler. It is a figure for demonstrating the effect | action of the implant in a modification, Comprising: It is a figure which shows the implant after an expansion deformation | transformation typically. It is a figure for demonstrating the effect | action of the implant in the modification of 2nd Embodiment, Comprising: It is a figure which shows typically the implant before expanding by introduction of a filler. It is a figure for demonstrating the effect | action of the implant in the modification of 2nd Embodiment, Comprising: It is a figure which shows the implant after an expansion deformation | transformation typically. It is a figure for demonstrating the effect | action of the implant in the modification of 3rd Embodiment, Comprising: It is a figure which shows typically the implant before expanding by introduction of a filler. It is a figure for demonstrating the effect | action of the implant in the modification of 3rd Embodiment, Comprising: It is a figure which shows the implant after an expansion deformation | transformation typically.

(First embodiment)
Hereinafter, the present invention will be described based on embodiments with reference to the drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. The dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

  With reference to FIG. 1 and FIG. 2, the implant 20 which concerns on embodiment is outlined. The implant 20 is an implant that can be placed in a living body and includes a flexible container 30 that can be expanded and deformed by introducing the filler m. The container 30 has a pressure display unit 40 that indicates the pressure in the container 30 by changing the display state according to the pressure change in the container 30 accompanying the introduction of the filler m under the fluoroscopic image. .

  The implant assembly 10 is configured to be connectable to the implant 20, one side to the implant 20, and to be connectable to the other side of the long member 80 having a lumen through which the filler m can circulate, and the other side of the long member 80. And a filler supply unit 110 that can supply the filler m into the implant 20 through the lumen. The implant assembly 10 is configured by the implant 20, the long member 80, and the filler supply unit 110.

  In the embodiment, the implant 20 of the present invention is applied to a spacer for maintaining a space between spinous processes used for the treatment of lumbar spinal canal stenosis (lumbar spinal canal stenosis).

  A brief description of lumbar spinal canal stenosis will be given.

  Referring to FIGS. 5A to 5C, a lumbar vertebra 126 located on the back 121 of the living body 120 has an anterior half vertebral body 125 and a vertebral disc 127 for the latter half connected via a pedicle 128. On the lamina 127, processes such as a spinous process 123, a lateral process 131, an upper joint process 132, and a lower joint process 133 are formed. The lumbar vertebra 126 is normally lightly bent toward the front side of the living body 120. Adjacent lumbar vertebrae are connected via an intervertebral disc (intervertebral disc) 129, and a lumbar vertebra adjacent to the lumbar vertebra is a vertebra between the intervertebral disc 129, the upper joint process 132 and the lower joint process 133 The inter-joint 134 is not displaced. However, when a load is applied to the lumbar vertebra 126 repeatedly due to sports or the like and a fatigue fracture occurs, the lumbar vertebra 126 is separated at the pedicle 128 portion, vertebral joint 134 deformation, or intervertebral disc 129 degeneration. It becomes difficult to fix the lumbar vertebra 126 located on the upper side, and degenerative spondylolisthesis occurs, which causes a shift. Furthermore, when the lumbar vertebra 126 slides strongly, the spinal canal narrows, causing intermittent claudication, which is a symptom of lumbar spinal canal stenosis. The implant 20 according to the embodiment is used as a spacer for maintaining a space between the spinous processes 123, and can treat various diseases related to the lumbar vertebra 126 as described above with minimal invasiveness without performing a large surgical procedure. It makes it possible.

  The implant 20 is introduced into the living body 120 in a state before being expanded and deformed (see FIGS. 1 and 7A). Further, after being positioned at the indwelling position in the vicinity of the spinous process 123, it is expanded and deformed, and indwelled in an expanded and deformed state (see FIGS. 2 and 7B).

  The implant 20 after the expansion deformation is formed with a body part 21 extending in the longitudinal direction and a wide part 22 having a larger width than the body part 21. The body portion 21 is formed at the center portion of the implant 20, and wide portions 22 are formed at both ends of the implant 20 so as to sandwich the body portion 21 therebetween. The implant 20 after expansion deformation has a dumbbell (substantially H-shaped) outer shape. The interval between the adjacent spinous processes 123 is maintained in the trunk portion 21 of the implant 20. Further, the spinous processes 123 are sandwiched between the wide portions 22 located at both ends of the implant 20, thereby preventing the positional displacement of the implant 20 after placement. The shape of the implant 20 before and after expansion is appropriately changed as long as it can function as a spacer for supporting bones in the living body by the expanded and deformed implant and maintaining a space between the bones. Is possible.

  The expansion of the implant 20 can be performed by filling the filling portion 31 of the implant 20 with various fillers such as solid or fluid (gas, liquid, gel), and the material of the filler is not particularly limited. However, in order to maintain the expanded state for a long period of time, as a filler, a solid or a curing material that is cured after introduction with a fluid when introduced into the filling portion 31 (hereinafter also simply referred to as “curing material”). Is preferably used.

  The material of the container 30 of the implant 20 is not particularly limited as long as it is a material that can withstand the external pressure accompanying the movement of the tissue and the vertebral body 125 such as the spinous processes 123. For example, vinyl chloride, polyurethane elastomer, styrene Thermosetting elastomers such as ethylene-butylene-styrene copolymer (SEBS) and styrene-ethylene-propylene-styrene copolymer (SEPS), thermoplastic resins such as nylon and PET, or rubber and silicone elastomers It is preferable to use a resin, and it is particularly preferable to use a porous material such as a nonwoven fabric, a woven fabric, a knitted fabric, or ePTFE. Moreover, it is also possible to use these in combination as appropriate.

  Examples of the solid used as the filler include solids such as metals (super elastic wires, coils, etc.), granular polymers, and granular ceramics. After being introduced into the implant 20, the indwelled state of the implant 20 is maintained without being damaged by body movement, so that the implant 20 is expanded and deformed as a spacer between the spinous processes 123 over a long period of time. Can function.

  The hardener preferably has at least one of the following characteristics: (a) safe for the patient; (b) little or no damage to the tissue; (c) a temperature close to the patient's body temperature (about 35-35). (D) No shrinkage or expansion can occur and the cured shape can be maintained; (e) 1 to 60 minutes after injection, preferably 5 to 30 minutes, more preferably 10 minutes (F) As a solvent, water, buffer solution, physiological saline, contrast medium, or oils and fats such as olive oil and castor oil can be used.

  Specific examples of the curing material include: (g) two-component mixed crosslinked polymer; (h) hot melt adhesive; (i) urethane elastomer; (j) photocurable resin; (k) acrylic resin; ) Bone cement; (m) solutions that crystallize upon external stimulation.

  In the above (g), the two-component mixed crosslinked polymer is preferably a combination of an aromatic diepoxide resin or an aliphatic diepoxide resin and an amine compound.

  In the above (h), as the hot melt adhesive, a combination of a material that can be cured by reacting with water and water, EVA (ethylene vinyl acetate copolymer) system, PO (polyolefin) system, PA (polyamide) system SR (synthetic rubber) system, ACR (acrylic) system, PUR (polyurethane / moisture curing type) system, and the like.

  In the above (i), the urethane elastomer is preferably a polymer derived from a polyol and an aromatic polyisocyanate.

  In the above (j), examples of the photopolymerizable monomer include acrylic acid esters, methacrylic acid esters, and ethylenically unsaturated carboxylic acids. A polymerization accelerator, a crosslinking agent, a photopolymerization initiator, and the like may be used as necessary. it can.

In the above (k), examples of the acrylic resin include methyl (meth) acrylate, (meth)
Ethyl acrylate, butyl (meth) acrylate, n-hexyl (meth) acrylate, cyclohexyl (meth) acrylate, 2-ethylhexyl (meth) acrylate, n-octyl (meth) acrylate, (meth) Known methods for monomers such as nonyl acrylate, decyl (meth) acrylate, (meth) acrylic acid, glycidyl (meth) acrylate, vinyl acetate, styrene, α-methylstyrene, (meth) acrylamide, (meth) acrylonitrile And those polymerized in step (b).

  In the above (l), the bone cement is made of, for example, polymethyl methacrylate, methyl methacrylate-styrene copolymer, benzoyl peroxide, barium sulfate, etc., and methyl methacrylate, N, N-dimethyl-para-toluidine, hydroquinone, etc. It is produced by mixing the solvent. Or, organic cement from which organic cement sodium alginate and inorganic calcium phosphate are produced by mixing a solvent with dental cement that hardens by acid-base reaction of zinc oxide and phosphoric acid, sodium alginate, sodium phosphate, calcium chloride, etc. -Inorganic composite materials can also be used.

  In (m) above, examples of the solution crystallized by external stimulation include an aqueous solution in which sodium acetate, sodium chloride, and the like are dissolved. Examples of the external stimulus include physical impact, heat, light, electricity, and ultrasonic waves.

  When introduced as a filler, it functions as a spacer between the spinous processes 123 over a long period of time in a state where the implant 20 is expanded and deformed in the same manner as in the case of using a solid as the filler by using a hardening material that hardens after introduction with a fluid. Can be made.

  Referring to FIGS. 3A and 3B, the introduction port 50 provided in the implant 20 includes an inner tube member 51 having an open end 54 communicated with the filling portion 31 defined by the container 30, and an open end in the inner tube member 51. The seal part 52 which covers the opening end 53 located on the opposite side of 54 and the outer tube member 55 which can be attached to and detached from the inner tube member 51 are provided.

  The inner tube member 51 and the outer tube member 55 are made of a metal material or a resin material.

  Examples of the metal material include SUS, titanium, magnesium, chromium, cobalt, nickel, aluminum, gold, silver, copper, iron, iridium, tantalum, molybdenum, zirconium, chromium / titanium alloy, chromium / nickel alloy, chromium / cobalt. One or more different biocompatible metal materials are used such as alloys, cobalt / titanium alloys, nickel / titanium alloys such as nitinol, platinum, and platinum-tungsten alloys.

  Examples of the resin material include polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polycarbonate urethane (PCU), reinforced polyphenylene (SRP), carbon or glass fiber reinforced polymer, ABS, polycarbonate, polyethylene, ultra-high Biocompatible polymers such as molecular weight polyethylene (UHMWPE), nylon, polymer composites, acetal, polyester, polypropylene, polytetrafluoroethylene (PTFE, ePTFE), poly L lactic acid (PLLA), poly lactic acid (PLA), and poly One or more various biocompatible metal materials such as glycolic acid (PGA) are used.

  The end portion 32 of the container 30 is connected to each other while being sandwiched between a predetermined portion on the outer surface of the inner tube member 51 and a predetermined portion on the inner surface of the outer tube member 55. The container 30 is attached to the inner pipe member 51 by, for example, fitting, adhesive, heat fusion, or the like.

  The outer tube member 55 is provided with an opening 57 for introducing the distal end portion 81 of the long member 80. For the attachment of the inner tube member 51 and the outer tube member 55, for example, a connection form in which both the members 51 and 55 are mechanically connected is used. For example, the outer tube member 55 is provided with an engagement pin 56 that can be engaged with the inner tube member 51. The inner pipe member 51 and the outer pipe member 55 are connected by the engagement pin 56. Thereby, the container 30 may be connected by engagement of the inner tube member 51 and the outer tube member 55 without being attached by, for example, an adhesive or heat fusion.

  The seal portion 52 is made of an elastic material that can be elastically deformed. For example, examples of the elastic material include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, and fluorine rubber. And various thermoplastic elastomers such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluororubber, chlorinated polyethylene, etc. 1 type or 2 types or more of these are mixed and used. By using such an elastic material, the seal portion 52 can obtain appropriate elasticity, and thus the seal portion 52, the inner tube member 51, and the outer tube member 55 can be in liquid-tight contact.

  In the container 30 of the implant 20, one introduction port 50 is provided. The introduction port 50 is provided in the proximal portion 30b (the right side in FIGS. 1 and 2) of the container 30 in the introduction direction to the living body. The introduction port 50 can be used to fill the container 30 of the implant 20 with the filler. The distal portion 30a provided on the distal end side (left side in FIGS. 1 and 2) in the direction of introduction of the implant 20 into the living body in the container 30 will be described in detail later.

  A long member 80 for feeding the filler into the filling portion 31 is provided at the distal end portion 81 inserted into the filling portion 31 of the implant 20 through the introduction port 50, and the filler is provided in the filling portion 31. And a tubular member 83 including a lumen 85 communicating with the opening 84.

  1 to 3A and 3B, the distal end portion 81 of the long member 80 is formed in a needle shape so as to be able to penetrate the seal portion 52 of the introduction port 50. The distal end portion 81 can be made of, for example, a metal material or a resin material having a predetermined rigidity.

  The tubular member 83 is constituted by a tube having a lumen 85 formed therein. A tube can be comprised by the well-known resin tube etc. which are widely used in the medical field etc., for example.

  On the proximal end side of the tubular member 83, a connector 87 to which a filler supply unit 110 for feeding the filler is connected is provided (see FIG. 7A). The connector 87 also has a function as a valve for holding the inside of the lumen 85 of the tubular member 83 liquid-tight and air-tight.

  An inner lumen 86 communicating with the lumen 85 of the tubular member 83 is provided at the distal end portion 81 of the long member 80. The filler fed through the lumen 85 of the tubular member 83 is introduced into the filling portion 31 through the opening 84 provided at the distal end portion 81 of the long member 80. The shape and installation position of the opening 84 are not particularly limited as long as the filler can be introduced into the filling portion 31 from the opening 84 in a state where the implant 20 and the long member 80 are connected. For example, it is possible to provide a hole opened on the side surface of the tip 81 and use the hole as the opening.

  To connect the implant 20 and the long member 80, the distal end portion 81 of the long member 80 is pushed into the seal portion 52 of the introduction port 50, and the opening portion 84 provided in the distal end portion 81 of the long member 80 is filled with the filling portion 31. (See FIG. 3B). In this way, the connection operation of the implant 20 and the long member 80 and the preparation of the filling material filling operation into the filling portion 31 performed through the opening 84 are performed in the same process.

  After the connection, since the outer peripheral surface of the tubular member 83 is covered with the seal portion 52, the space between the tubular member 83 and the seal portion 52 can be maintained in a liquid-tight / air-tight state.

  Separation of the implant 20 and the long member 80 is performed by pulling the distal end portion 81 of the long member 80 from the filling portion 31. When the distal end portion 81 of the long member 80 is pulled out, the seal portion 52 is elastically deformed to close the introduction port 50. The seal part 52 has such a self-sealing function.

  4A and 4B show a puncture device 90 used for introducing the implant 20 into a living body. The puncture device 90 includes an inner needle 91 that is punctured into a living body and an outer needle 96 that is used by being assembled to the inner needle 91. The inner needle 91 has a main body portion 92 provided with a needle portion 93 at the tip. The outer needle 96 has a grip portion 97 and a cylindrical portion 98 into which the main body portion 92 of the inner needle 91 can be inserted and removed.

  The inner needle 91 and the outer needle 96 are fixed to each other in a state where the main body 92 of the inner needle 91 is inserted into the cylindrical portion 98 of the outer needle 96 (see FIG. 4B). Fixing is performed by screwing with a screw portion 99 (not shown) formed in the main body portion 92 of the inner needle 91 and the cylindrical portion 98 of the outer needle 96. When the implant 20 is introduced, the inner needle 91 and the outer needle 96 are assembled, and the needle portion 93 of the inner needle 91 is punctured into the living body 120 (see FIG. 6B). In this state, the inner needle 91 is separated from the outer needle 96, the main body portion 92 of the inner needle 91 is extracted from the cylindrical portion 98, and the inner needle 91 is extracted from the living body 120 as it is. The implant 20 is introduced into a predetermined part of the living body 120 using the cylindrical portion 98 of the outer needle 96.

  The outer shape of the inner needle 91 is not particularly limited as long as it can puncture a living body. For example, the outer shape of the inner needle 91 may include a linearly extended outer shape. However, in this case, the cylindrical portion 98 of the outer needle 96 into which the inner needle is inserted is configured to have a shape that matches the outer shape of the inner needle 91.

  Next, a configuration that characterizes the present invention will be described with reference to FIGS.

  The pressure display unit 40 connects the movable member 1 having an X-ray contrast property different from the X-ray contrast property of the container 30, the movable member 1 and the container 30, and the movable member 1 according to a change in pressure in the container 30. And the elastic member 2 that holds the inside of the container 30 so as to be movable.

  The container 30 has a proximal portion 30b provided with an inlet 50 into which the filler m is introduced, and a front portion in the inflow direction of the filler m with respect to the proximal portion 30b with respect to the proximal portion 30b. The pressure indicator 40 is configured such that the display state changes in at least a part of the distal portion 30a.

  As shown in FIG. 1 and the like, the pressure display unit 40 is disposed on the distal portion 30 a of the container 30 of the implant 20. The movable member 1 is movably held by the elastic member 2. The elastic member 2 is held by the fixed member 3 at the end opposite to the side held by the movable member 1. The fixing member 3 is fixed to the end of the distal portion 30 a of the container 30 of the implant 20.

  The movable member 1 and the fixed member 3 are plates made of a metal material or a resin material. The elastic member 2 is a spring made of a metal material.

  Examples of the metal material include SUS, titanium, magnesium, chromium, cobalt, nickel, aluminum, gold, silver, copper, iron, iridium, tantalum, molybdenum, zirconium, chromium / titanium alloy, chromium / nickel alloy, chromium / cobalt. One or more different biocompatible metal materials are used such as alloys, cobalt / titanium alloys, nickel / titanium alloys such as nitinol, platinum, and platinum-tungsten alloys.

  Examples of the resin material include polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polycarbonate urethane (PCU), reinforced polyphenylene (SRP), carbon or glass fiber reinforced polymer, ABS, polycarbonate, polyethylene, ultra-high Biocompatible polymers such as molecular weight polyethylene (UHMWPE), nylon, polymer composites, acetal, polyester, polypropylene, polytetrafluoroethylene (PTFE, ePTFE), poly L lactic acid (PLLA), poly lactic acid (PLA), and poly One or more various biocompatible metal materials such as glycolic acid (PGA) are used.

  The movable member 1 may be made of an elastic material, for example, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber. , Various rubber materials such as urethane rubber, silicone rubber, fluoro rubber, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, chlorine And various thermoplastic elastomers such as a modified polyethylene, and one or more of these various biocompatible elastic materials are used. By using such an elastic material, the movable member 1 can obtain an appropriate elasticity, so that the movable member 1 and the distal portion 30a of the container 30 can come into liquid-tight contact. Furthermore, the movable member 1 may be configured by appropriately combining the above metal material, resin material, and elastic material.

  The thickness of the movable member 1 is about 0.1 to 5.0 mm.

  The movable member 1 is movable in response to a change in pressure in the container 30 of the implant 20. The pressure display unit 40 is provided with a scale 4 that can be visually recognized by making the pressure value in the container 30 of the implant 20 correspond to the movable position of the movable member 1.

  The scale 4 is actually provided on the outer surface of the distal portion 30a of the container 30 of the implant 20 so as to be visible. In FIG. 1, a scale 4 is indicated on the cross-sectional view by a two-dot broken line. The scale 4 has an X-ray contrast property different from that of the container 30. As the scale 4, an appropriate amount of the filler m is filled into the container 30 of the implant 20 from the scale 4a having an internal pressure value of 0 atm indicating that the container 30 of the implant 20 is not filled with the filler m and no internal pressure is applied. The scale is provided every 1 atm up to the scale 4 b of the internal pressure value 5 atm indicating that the pressure is applied. As a range indicated by the scale 4, 0 to 5 atm is taken as an example so that one scale represents 1 atm. By increasing the number of scales and / or increasing the resistance (for example, the spring constant) of the elastic member 2, The range can be changed as appropriate from 0 to 20 atm. In other words, the scale 4b that is the upper limit of the range indicated by the scale 4 is preferably 1 to 20 atm, and more preferably 2 to 10 atm.

  As shown in FIG. 9A, the movable member 1 is in a state where filling of the filler m from the filler supply unit 110 to the implant 20 is not started (the value of the pressure gauge 111 of the filler supply unit 110 is 0 atm). It is stationary at the position of the scale 4a indicating 0 atm. In addition, the movable member 1 starts filling the implant 20 from the filler supply unit 110 into the implant 20, but when the filler m does not reach the container 30 of the implant 20, Since the pressure does not fluctuate, the pressure is stationary at the position of the scale 4a indicating 0 atm.

  On the other hand, as shown in FIG. 9B, the movable member 1 is in a state where the implant 20 is filled with an appropriate amount of the filler material m (substantially H-shaped final expanded shape placed in the living body 120). The pressure value in the container 30 of the implant 20 becomes 5 atm, and when the filler m in the container 30 is pushed leftward in the drawing, the implant 20 moves to the position of the scale 4b indicating 5 atm.

  Under the X-ray fluoroscopic image, when the movable member 1 moves to the position of the scale 4b indicating 5 atm, the operator of the filler supply unit 110 stops the pumping of the filler m from the filler supply unit 110. Thus, by providing the pressure display unit 40 in the implant 20, the expanded state of the container 30 of the implant 20 is accurately determined under a fluoroscopic image. The operator introduces the filler while confirming the internal pressure value displayed on the scale 4 under the X-ray fluoroscopic image, and determines that the introduction of the filler m is stopped when the predetermined pressure is reached. The predetermined pressure is appropriately determined from the range of 2 to 10 atm.

  Further, as shown in FIGS. 9A and 9B, the implant 20 allows a predetermined fluid different from the filler m to be discharged from the distal portion 30a of the container 30 via the pressure indicator 40 and the distal portion 30a. It has a fluid discharge means 5 that makes it possible.

  Here, in the movable member 1, as shown in FIGS. 9A and 9B, for example, when a fluid such as air a is mixed in the implant 20, the air a is filled when an appropriate amount of the filler m is filled in the container 30. A plurality of holes 1a are formed to push the container toward the distal portion 30a of the container 30.

  Then, by providing the fluid discharge means 5 in the implant 20, the air a pushed out toward the distal portion 30 a of the container 30 through the plurality of holes 1 a of the movable member 1 is discharged to the outside of the implant 20. The Thus, by having the fluid discharge means 5, the container 30 is uniformly filled with the filler m.

  With reference to FIG. 9B, the expanded shape of the implant 20 is maintained over a long period of time by the filler m filled in the filling portion 31.

  Next, the placement procedure of the implant 20 according to the embodiment and the operation of the implant 20 will be described.

  Referring to FIG. 6A, a puncture device 90 in which an inner needle 91 and an outer needle 96 are assembled is prepared.

  Referring to FIG. 6B, puncture device 90 is introduced into living body 120. At this time, the distal end portion of the inner needle 91 and the distal end portion of the outer needle 96 are positioned between the piercing projections. Next, the inner needle 91 is separated from the outer needle 96 and pulled out.

  With reference to FIG. 7A, the implant 20 before expansion deformation is introduced into the living body 120 through the cylindrical portion 98 of the inner needle 91. The implant 20 is led out from the tip of the outer needle 96 and positioned between the spinous processes 123. The implant 20 can be introduced by a practitioner using a hand or by using a pushing member such as a rod or a tube.

  With reference to FIG. 7B, the implant 20 is expanded and deformed by introducing the filler m into the filling portion 31 of the implant 20.

  When a hardening material or a fluid is used as the filler m, a filler supply unit 110 for pumping the filler m can be used. A known indeflator or the like can be used for the filler supply unit 110. When the filler supply unit 110 is used, the filler supply unit 110 is connected via the connector 87 provided in the long member 80. When a solid is used for the filler m, the introduction can be performed by pouring or pushing the filler m into the cylindrical portion 98 of the outer needle 96 without using the filler supply unit 110. .

  In addition, before performing the operation | work which fills with the filler m, the contrast agent is filled in the filling part 31. FIG. By performing such an operation, the implant 20 is preliminarily expanded, so that the expansion operation using the filler m can be performed smoothly. Moreover, the introduction position of the implant 20 and the final expanded shape can be confirmed by performing X-ray fluoroscopy with the contrast agent filled. The contrast agent is sucked by an indeflator or the like and discharged from the filling portion 31 before the filler m is introduced.

  1 and 2, when the implant 20 is expanded in the living body 120, when the filler m is fed into the tubular member 83, expansion deformation of the implant 20 starts.

  7B and 8A, the elongate member 80 is separated from the implant 20. Thereafter, the outer needle 96 of the puncture member is removed from the living body 120. The implant 20 is placed between the spinous processes 123 and is used as a spacer for maintaining a space between the spinous processes 123.

As described above, the method for indwelling the implant according to the present embodiment in vivo is as follows.
(I) an implant insertion step of inserting an implant provided with a flexible container that can be expanded and deformed into a predetermined position in the living body; and (ii) for expanding the container into the flexible container. A filler introduction step for introducing a filler, and (iii) a pressure confirmation step for confirming a pressure change in the container by confirming a display state of a pressure display portion provided in the implant under a fluoroscopic image. And (iv) a stop step of stopping the introduction of the filler in response to the fact that the pressure change in the container has reached a predetermined pressure in the confirmation step.

  In the above method, the predetermined position in the living body is between adjacent spinous processes, and the flexible container is a balloon.

  As described above, according to the present embodiment, the pressure display indicating the pressure in the container 30 by changing the display state according to the change in the pressure in the flexible container 30 under the X-ray fluoroscopic image. Since the portion 40 is provided, the pressure in the container 30 and thus the expanded state of the container 30 can be easily and accurately grasped by confirming the display content of the pressure display portion 40.

  Further, as described above, according to the present embodiment, since the change in the pressure in the container 30 can be confirmed based on the amount of movement of the movable member 1 provided in the pressure display unit 40, the expanded state of the container 30 can be changed. It can be grasped more easily.

  In addition, as described above, according to the present embodiment, it is possible to confirm a change in pressure in the distal portion 30a away from the proximal portion 30b where the inflow of the filler m into the container 30 is started. Therefore, it is possible to effectively prevent the container 30 from being damaged under the influence of the inflow pressure of the filler m. In the present embodiment, it has been described that the pumping of the filler m is stopped when the scale 4 indicates 5 atm. However, the present invention is not limited to this, and the surgeon introduces the filler m when the predetermined pressure is reached. The decision to stop should be made. The predetermined pressure is appropriately determined from the range of 2 to 10 atm.

  Further, as described above, according to the present embodiment, when a predetermined fluid different from the filler m is mixed in the container 30, the fluid discharge means 5 is passed from the distal portion 30 a of the container 30. Since the fluid can be discharged, the filling rate of the filler m in the container 30 can be increased, and the implant 20 into which the filler m has been introduced can be stably placed in the living body 120 for a long period of time. .

  Further, as described above, according to the present embodiment, the filler m can be supplied into the container 30 via the long member 80 and the filler supply unit 110, and the pressure indication provided in the container 30 is displayed. The implant assembly 10 in which the expanded state of the container 30 can be easily and accurately grasped by the portion 40 can be provided.

(Modification)
Next, a modification of the first embodiment will be described with reference to FIGS. 10A and 10B. In addition, the same code | symbol is attached | subjected and demonstrated to the member same as 1st Embodiment mentioned above, and the overlapping description is abbreviate | omitted.

  In this modification, the pressure display unit 240 disposed in the distal portion 230a of the container 230 of the implant 220 includes the movable member 1 having an X-ray contrast property different from the X-ray contrast property of the container 230; A gas g enclosed in a distal portion 230a partitioned by the movable member 1 that holds the movable member 1 movably in the container 230 in accordance with a change in the internal pressure of the container 230. The implant 220 is different from the implant 20 of the first embodiment in that the configuration of the pressure display unit 240 is different.

  The gas g enclosed in the distal portion 230 a partitioned by the movable member 1 is, for example, air, and is compressed or expanded by the movable member 1 in accordance with a change in the internal pressure of the container 230.

  As shown in FIG. 10A, the movable member 1 is stationary at the position of the scale 4a indicating 0 atm when the implant 220 is not filled with the filler m. In addition, the movable member 1 starts filling of the implant 220 with the filler m, but when the filler m does not reach the container 230 of the implant 220, the pressure in the container 230 does not fluctuate. It is stationary at the position of the scale 4a indicating 0 atm.

  On the other hand, as shown in FIG. 10B, when the movable member 1 is in a state where the implant 220 is filled with an appropriate amount of the filler m, the pressure value in the container 230 of the implant 220 becomes 5 atm, and the filling in the container 230 is performed. When the material m is pushed leftward in the drawing, it moves to the position of the scale 4 indicating 5 atm.

  Here, as shown in FIG. 10B, the air a pushed out toward the distal portion 230 a of the container 230 along with the filling of the filler m is discharged from the fluid discharging means 5 of the implant 220.

  As described above, according to the present modification, in the implant 220, the pressure display unit 240 includes the movable member 1 and the gas g enclosed in the distal portion 230a partitioned by the movable member 1. The filler m can be pumped to the container 230 while confirming the change in the pressure in the container 230 based on the movement of the movable member 1 displayed on the pressure display unit 240. Thus, according to the present modification, the pressure display unit can be configured with a simple configuration as compared to the configuration of the first embodiment.

(Second Embodiment)
Next, a second embodiment will be described with reference to FIGS. 11A and 11B. In addition, the same code | symbol is attached | subjected and demonstrated to the member same as 1st Embodiment mentioned above, and the overlapping description is abbreviate | omitted.

  In the present embodiment, the pressure display unit 340 has an X-ray contrast property different from the X-ray contrast property of the container 330, and the outer shape of the container 330 is deformed according to a change in the internal pressure of the container 330. It has a plate-like elastic member 6 stretched inside. The implant 320 is different from the implant 20 of the first embodiment in that the configuration of the pressure display unit 340 is different.

  The plate-like elastic member 6 is a leaf spring formed of a resin material such as a rubber film or plastic, and its outer shape is deformed (projected) in accordance with a change in the internal pressure of the container 330.

  The thickness of the plate-like elastic member 6 is about 0.1 to 5.0 mm.

  As shown in FIG. 11A, the plate-like elastic member 6 is stationary at the position of the scale 4a indicating 0 atm when the implant 320 is not yet filled with the filler m. In the plate-like elastic member 6, when the filling material m is started to fill the implant 320, but the filling material m does not reach the container 330 of the implant 320, the pressure in the container 330 fluctuates. Therefore, it is stationary at the position of the scale 4a indicating 0 atm.

  On the other hand, as shown in FIG. 11B, the central portion 6b of the plate-like elastic member 6 has a pressure value of 5 atm in the container 330 of the implant 320 when the implant 320 is filled with an appropriate amount of the filler m. When it is pushed leftward in the drawing by the filler m in the container 330, it protrudes to the position of the scale 4b indicating 5 atm.

  Here, as shown in FIGS. 11A and 11B, for example, when fluid such as air is mixed in the implant 320, the plate-like elastic member 6 is filled with an appropriate amount of the filler m in the container 330. A plurality of holes 6a for pushing air toward the distal portion 330a of the container 330 are formed.

  The implant 320 has the fluid discharge means 5 so that the air pushed toward the distal portion 330 a of the container 330 through the plurality of holes 6 a of the plate-like elastic member 6 is discharged to the outside of the implant 320. Is done. Thus, by having the fluid discharge means 5, the container 330 is uniformly filled with the filler m.

  As described above, according to the present embodiment, since the change in pressure in the container 330 can be confirmed based on the outer shape of the plate-like elastic member 6 included in the pressure display unit 340, the expanded state of the container 330 is Can be grasped more easily.

  As described above, according to the present embodiment, the pressure display unit can be provided with a simple configuration that includes only the plate-like elastic member 6 as compared with the configurations of the first embodiment and the modified example of the first embodiment. It can be configured.

(Third embodiment)
Next, a third embodiment will be described with reference to FIGS. 12A and 12B. In addition, the same code | symbol is attached | subjected and demonstrated to the member same as 1st Embodiment mentioned above, and the overlapping description is abbreviate | omitted.

  In the present embodiment, the pressure display unit 440 includes the seal portion 8 that breaks when the pressure in the container 430 increases, and the internal pressure display region 9 into which the filler m flows when the seal portion 8 breaks. A partition member 7 that partitions the container 430 is provided. The implant 420 is different from the implant 20 of the first embodiment in that the configuration of the pressure display unit 440 is different.

  The partition member 7 is securely attached to the distal portion 430a of the container 430 of the implant 420. And the seal part 8 is arrange | positioned in the center part of the division member 7 in the state which penetrated the division member 7. FIG. The partition member 7 and the seal portion 8 are closely arranged.

  The internal pressure display region 9 is a region in the container 430 of the distal portion 430a of the container 430 of the implant 420, and is separated from other regions in the container 430 by the partition member 7 and the seal portion 8. is there.

  The partition member 7 and the seal portion 8 are made of a metal material or a resin material.

  Examples of the metal material include SUS, titanium, magnesium, chromium, cobalt, nickel, aluminum, gold, silver, copper, iron, iridium, tantalum, molybdenum, zirconium, chromium / titanium alloy, chromium / nickel alloy, chromium / cobalt. One or more different biocompatible metal materials are used such as alloys, cobalt / titanium alloys, nickel / titanium alloys such as nitinol, platinum, and platinum-tungsten alloys.

  Examples of the resin material include polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polycarbonate urethane (PCU), reinforced polyphenylene (SRP), carbon or glass fiber reinforced polymer, ABS, polycarbonate, polyethylene, ultra-high Biocompatible polymers such as molecular weight polyethylene (UHMWPE), nylon, polymer composites, acetal, polyester, polypropylene, polytetrafluoroethylene (PTFE, ePTFE), poly L lactic acid (PLLA), poly lactic acid (PLA), and poly One or more various biocompatible metal materials such as glycolic acid (PGA) are used.

  The thickness of the partition member 7 and the seal part 8 is about 0.1 to 5.0 mm.

  As shown in FIG. 12A, the seal portion 8 is disposed at a center portion of the partition member 7 and is stationary when the implant 420 is not yet filled with the filler m. In addition, the seal portion 8 starts filling the implant 420 with the filler m, but when the filler m does not reach the container 430 of the implant 420, the pressure in the container 430 does not fluctuate. It is disposed at the center of the partition member 7 and is stationary. At this time, since the internal pressure display region 9 in the distal portion 430a of the container 430 of the implant 420 is isolated from the other regions of the container 430 by the partition member 7 and the seal portion 8, the internal pressure display region 9 includes Filler m is not flowing.

  On the other hand, as shown in FIG. 12B, when the seal part 8 is in a state where an appropriate amount of the filler m is filled in the implant 420, the pressure value in the container 430 of the implant 420 becomes 5 atm, and the filling in the container 430 is performed. By being pushed by the material m in the left direction in the drawing, it is detached from the partition member 7 and pushed out to the internal pressure display region 9 in the distal portion 430a of the container 430 of the implant 420. Thereby, the filler m filled in the container 430 of the implant 420 flows into the internal pressure display region 9 in the distal portion 430a. Although the pressure of 5 atm is taken as an example of the pressure at which the seal portion 8 is released from the partition member 7, the value can be changed as appropriate by changing the pressure resistance of the seal portion 8. Furthermore, the value is preferably in the range of 1 to 20 atm, more preferably in the range of 2 to 10 atm.

  In addition, although this embodiment demonstrates as a structure by which the seal | sticker part 8 is penetrated by the center part of the division member 7, not only this but the cut | interruption is originally formed in the center part of the division member 7, and the pressure in the container 430 is demonstrated. When the height increases, the cut may be broken to form an opening. Thereby, the filler m filled in the container 430 is injected into the internal pressure display region 9 through the opening.

  Under the fluoroscopic image, when the seal portion 8 is detached from the partition member 7 and pushed into the internal pressure display area 9 in the distal portion 430a of the container 430 of the implant 420, the filler m flows out into the internal pressure display area 9. The user of the filler supply unit 110 stops the pumping of the filler m from the filler supply unit 110. Thus, by providing the pressure display part 440 in the implant 420, the implant m is pushed out of the seal part 8 penetrated by the partition member 7 and flows into the internal pressure display area 9 under the X-ray fluoroscopic image. The expanded state of the 420 containers 430 is accurately determined.

  As described above, according to the present embodiment, the change in the pressure in the container 430 is confirmed based on the introduction of the filler m into the internal pressure display region 9 due to the fracture of the seal portion 8 included in the pressure display unit 440. Therefore, the expanded state of the container 430 can be grasped more easily.

  Each embodiment mentioned above can be changed suitably.

  In the description of the embodiment, the method of introducing the implant 20 into the living body 120 by the puncture device 90 including the inner needle 91 and the outer needle 96 has been described, but the method of introducing the implant 20 is not limited to this. As long as introduction into a predetermined site in a living body can be performed, it can be appropriately changed. For example, it is possible to employ a method of performing puncturing and implant introduction in one step using a puncture needle or the like provided with a body part into which the implant can be inserted and held.

  The implant 20 can exhibit an effect that can reduce the load on the living body at the time of placement only by the implant 20. Therefore, as described in the embodiment, it is possible to use only the implant 20 for the procedure without using it as the implant assembly 10 combined with the long member 80.

  Moreover, the application site | part of the implant 20 is not limited only between the spinous processes 123 in the biological body 120, It can apply widely as a spacer which has a space | interval maintenance function with respect to each organ of the biological body.

DESCRIPTION OF SYMBOLS 1 Movable member 2 Elastic member 3 Fixed member 4 Scale 5 Fluid discharge | emission means 6 Plate-shaped elastic member 7 Partition member 8 Seal part 9 Internal pressure display area 10 Implant assembly,
20, 220, 320, 420 implants,
21 torso,
22 Wide part,
30, 230, 330, 430 containers,
30a, 230a, 330a, 430a distal portion,
30b proximal portion,
31 filling section,
40, 240, 340, 440 pressure display,
50 inlet,
80 long member,
81 tip,
83 tubular member,
84 opening,
85 lumens,
90 Puncture tool,
120 living body,
123 Spinous processes,
Air a,
Filler m,
Gas g.

Claims (7)

An implant that can be placed in a living body, including a flexible container that can be expanded and deformed by introduction of a filler,
The container includes a pressure display unit that indicates a pressure in the container by changing a display state according to a pressure change in the container accompanying introduction of the filler under an X-ray fluoroscopic image. Implant.   The pressure display unit connects the movable member having an X-ray contrast property different from the X-ray contrast property of the container, the movable member and the container, and displays the movable member according to a change in pressure in the container. The implant according to claim 1, further comprising an elastic member that is movably held in the container.   The pressure display unit has an X-ray contrast property different from the X-ray contrast property of the container, and a plate stretched in the container so that an outer shape is deformed in accordance with a change in pressure in the container The implant according to claim 1, wherein the implant has an elastic member.   The pressure display part has a seal part that breaks when the pressure in the container increases, and a partition member that partitions the container from the internal pressure display area into which the filler flows in along with the breakage of the seal part. The implant according to any one of claims 1 to 3, characterized by comprising: The container includes a proximal portion provided with an inflow port through which the filler is introduced, and a pair of the proximal portion on the front side in the inflow direction of the filler with respect to the proximal portion. A distal portion disposed,
The implant according to any one of claims 1 to 4, wherein the pressure display unit is configured to change a display state in at least a part of the distal portion.   A fluid discharging means for enabling a predetermined fluid different from the filler to be discharged from the distal portion of the container through the pressure display portion and the distal portion. Item 6. The implant according to Item 5. An implant according to any one of claims 1 to 6;
A long member having a lumen through which the filler can circulate while being configured to be connectable to one side of the implant,
An implant assembly comprising: a filler supply portion configured to be connectable to the other side of the elongate member and capable of supplying the filler into the implant through the lumen.

Images