WO2014162382A1

WO2014162382A1 - Implant assembly

Info

Publication number: WO2014162382A1
Application number: PCT/JP2013/059820
Authority: WO
Inventors: 本間康之
Original assignee: テルモ株式会社
Priority date: 2013-04-01
Filing date: 2013-04-01
Publication date: 2014-10-09

Abstract

This implant assembly (10) is provided with a balloon (12), a tube (14) for supplying a filling material to the balloon (12), a connection mechanism (16) for connecting the balloon (12) and the tube (15) in a detachable and liquid-tight manner, and a release unit (18) for releasing the connection state in which the balloon (12) and the tube (14) are connected by the connection mechanism (16). The connection mechanism (16) includes a first connection unit (22) provided at the base end of the balloon (12), and a second connection unit (24) provided at the leading end of the tube (14). By displacing the release unit (18) along the direction in which the tube (14) extends, engagement between the first connection unit (22) and the second connection unit (24) is released, and the balloon (12) and the tube (14) can be separated.

Description

Implant assembly

The present invention relates to an implant assembly having an implant composed of a balloon at the tip.

Lumbar spinal canal stenosis is a disease in which the spinal canal is constricted due to retrograde degeneration of the intervertebral disc or ligament, and causes symptoms such as low back pain, leg pain, and intermittent claudication. The mainstream of treatment for lumbar spinal canal stenosis is an operation that removes a part of the spine where the spinal canal is narrowed (laminectomy) or an operation that fixes the spine (spine fusion). On the other hand, as a relatively minimally invasive technique compared to laminectomy or spinal fusion, a metal spacer has recently been placed between the spinous processes to release the spinal nerve and nerve root compression. It has been developed. However, this method requires the incision of the back muscles and ligaments in order to place the spacer, so that the degree of invasiveness to the patient is still high, and hospitalization is also prolonged.

In response to such a problem, another method has been proposed in which a spacer implant is inserted between spinous processes and placed in a less invasive manner. As another method, for example, in US Patent Application Publication No. 2009/0118833, a puncture device that can puncture a living body and an expandable balloon are used, and the balloon is folded through an outer cylinder of the puncture device. A method is disclosed in which, after being inserted percutaneously between the spinous processes percutaneously in a state and filled with a filler such as bone cement in the balloon, the balloon is expanded and placed between the spinous processes. Since the filler is cured after filling the balloon, the balloon can be kept in a semi-permanent state.

By the way, a catheter tube for injecting a filler into the balloon is connected to the balloon as a spacer implant. In order to place the expanded balloon in the body, the balloon is cured after the filler in the balloon is cured. And the catheter tube need to be detached.

Conventionally, screw fitting is used as a mechanism for separating the balloon and the catheter tube. In the case of screw fitting, since it is necessary to rotate the catheter tube in order to separate the balloon and the catheter tube, the catheter tube is required to have a certain degree of torque transmission. However, if a blade wire (reinforcing layer) is inserted in order to provide torque transmission, the flexibility of the catheter tube is lowered and the operability may be deteriorated. Also, in screw fitting, it is necessary to strengthen the fitting in order to maintain liquid-tightness so that the filler does not leak out, but if the fitting is too strong, the fitting force will reduce the torque transmission of the catheter tube. There is a possibility that the balloon and the catheter tube cannot be detached.

The present invention has been made in consideration of such a problem, and an implant capable of reliably detaching the balloon and the catheter tube while ensuring sufficient liquid-tightness at the connection portion between the balloon and the catheter tube. An object is to provide an assembly.

In order to achieve the above object, an implant assembly according to the present invention is configured to be expandable by being filled with a filler therein, and a balloon configured as an implant to be inserted and placed in a living body, A tube having a lumen communicating with the inside of the balloon and functioning as a flow path for the filler supplied to the balloon; a connection mechanism for detachably and liquid-tightly connecting the balloon and the tube; A release portion that is displaceable along an extending direction of the tube and that releases the connection state between the balloon and the tube by the connection mechanism, and the connection mechanism is provided at a proximal end of the balloon A hollow first connection portion, and a hollow second connection portion that is provided at the tip of the tube and removably engages with the first connection portion, By displacing the release portion along the extending direction of the tube, the engagement between the first connection portion and the second connection portion is released, and the balloon and the tube can be detached. Features.

According to the above configuration, the connection structure between the balloon and the tube is not a screw fitting as in the prior art, but the first connection portion and the second connection portion are merely displaced by moving the release portion along the extending direction of the tube. Since the engagement can be released, the balloon and the tube can be reliably detached while ensuring sufficient liquid tightness.

In the above-described implant assembly, the second connection portion is configured to be able to reduce the diameter, and has a tapered portion that is inclined with respect to the axial direction, and the release portion is displaced in the extending direction of the tube. In this case, the release portion may press the tapered portion inward, so that the second connection portion is reduced in diameter, and the engagement between the first connection portion and the second connection portion may be released.

According to said structure, the 2nd connection part shrinks | reduces with the displacement of a cancellation | release part by the effect | action of the inclination of a taper part, and engagement with a 1st connection part and a 2nd connection part is cancelled | released. Therefore, the engagement between the first connection portion and the second connection portion can be easily and quickly released with a small amount of operation with respect to the release portion, and the operability is excellent.

In the above-described implant assembly, the tapered portion has an inclination that decreases in diameter toward the distal end direction of the second connection portion, and the release portion is displaced when the release portion is displaced in the proximal direction of the tube. May press the taper portion inwardly.

According to the above configuration, since the engagement between the first connection portion and the second connection portion can be released by an operation of pulling the release portion in the proximal direction, rather than pushing the release portion in the distal direction and releasing it. Easy to release.

In the above-described implant assembly, an engagement portion configured by a hole or a groove is provided on a proximal end side of the first connection portion, and an engagement portion is provided on a distal end side of the second connection portion. A mating projection is provided, the second connection portion is fitted inside the first connection portion, and the engagement between the engagement portion and the projection portion is reduced as the diameter of the second connection portion is reduced. Should be released.

According to the above configuration, when the release portion is not operated, the engagement state between the engagement portion and the projection portion can be reliably maintained, and when the release portion is operated, the projection portion is separated from the engagement portion. The engagement can be easily released by releasing.

In the above-described implant assembly, the distal end portion of the second connection portion is elastically compressed in the axial direction by being held by the first connection portion in a state where the engagement portion and the projection portion are engaged. The first connection portion and the second connection portion may be in liquid-tight contact.

According to the above configuration, since the tip end portion of the second connection portion is in close contact with the first connection portion in an elastically compressed state, high liquid tightness can be effectively ensured.

In the above-described implant assembly, a plurality of the engaging portions are provided at intervals in the circumferential direction of the first connection portion, and a plurality of the protrusion portions are provided at intervals in the circumferential direction of the second connection portion. May be.

According to the above configuration, the engagement state between the engagement portion and the projection portion can be more reliably maintained without the release portion being operated.

It is a partially-omission side view of the implant assembly which concerns on one Embodiment of this invention. It is a side view of the connection mechanism of the implant assembly shown in FIG. 1, and its peripheral part. It is a longitudinal cross-sectional view of the connection mechanism of the implant assembly shown in FIG. 1 and its peripheral part, and is a view showing a state where the first connection part and the second connection part of the connection mechanism are engaged. It is a longitudinal cross-sectional view of the connection mechanism of the implant assembly shown in FIG. 1, and its peripheral part, Comprising: It is a figure which shows the state by which engagement with the 1st connection part and 2nd connection part of the connection mechanism was cancelled | released. FIG. 2 is an exploded perspective view of a connection mechanism and a release portion shown in the implant assembly shown in FIG. 1. It is a longitudinal cross-sectional view of the puncture tool used in order to insert the implant assembly shown in FIG. 1 in a biological body. FIG. 7A is a first diagram illustrating a method for inserting and placing an implant between spinous processes, and FIG. 7B is a second diagram illustrating a method for inserting and placing an implant between spinous processes. FIG. 8A is a third diagram illustrating a method of inserting and placing an implant between spinous processes, and FIG. 8B is a fourth diagram illustrating a method of inserting and placing an implant between spinous processes. It is a 5th figure explaining the method of inserting and indwelling an implant between spinous processes.

Hereinafter, preferred embodiments of the implant assembly according to the present invention will be described with reference to the accompanying drawings.

FIG. 1 is a partially omitted side view of an implant assembly 10 according to an embodiment of the present invention. The implant assembly 10 is provided between a balloon 12 provided at the distal end, a catheter tube 14 connected to the proximal end of the balloon 12 (hereinafter referred to as “tube 14”), and the balloon 12 and the tube 14. Provided with a connection mechanism 16 and a release portion 18 provided along the tube 14.

The balloon 12 functions as an implant (spacer implant) to be inserted and placed in the living body, and is configured to be expandable by being filled with a filler. The part in the living body into which the balloon 12 is inserted is, for example, between spinous processes, a shoulder joint, and an intervertebral disc. The balloon 12 is folded in the initial state and contracted as shown by the solid line in FIG. On the other hand, when the filler is injected into the balloon 12 through the tube 14, the balloon 12 is expanded as shown by the phantom line in FIG.

The shape of the balloon 12 when expanded can be, for example, a shape in which a pair of bulged portions 12b are connected via a constricted portion 12a as shown in FIG. When the shape of the balloon 12 at the time of expansion is such a dumbbell type, a wheel type (H type), or the like, a pair of bulging portions 12b disposed on both sides of the constricted portion 12a inserted through the interspinous ligaments are spinous processes This is preferable because B1 (see FIG. 8B) is sandwiched. The shape of the balloon 12 may be other shapes such as a cylindrical shape.

The material of the balloon 12 is not particularly limited as long as it is a material that can be expanded by being injected with a filler and can withstand the external pressure associated with the movement of the vertebral body and tissues such as spinous processes and interspinous ligaments surrounding the balloon 12. For example, vinyl chloride, polyurethane elastomer, nylon, PET and the like can be mentioned.

The tube 14 connected to the proximal end side of the balloon 12 via the connection mechanism 16 is for feeding (supplying) the filler to the balloon 12. Specifically, the tube 14 is a long and thin member, and communicates with the inside of the balloon 12 (the lumen 13) and functions as a flow path for the filler supplied to the balloon 12 (see FIG. 3). The lumen 15 communicates from the distal end to the proximal end of the tube 14.

The tube 14 has appropriate flexibility so that it can be inserted into a curved puncture device 50 described later. Examples of the constituent material of the tube 14 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, and the like. , Nylon, polyamide, polyester, polyester elastomer, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a polymer material or a mixture thereof.

The base end of the tube 14 is provided with a hub 20 having a hollow structure that holds the base end. The hub 20 is made of, for example, a hard resin, has a lumen communicating with the lumen 15 of the tube 14, and has a base end portion configured to be connectable to a filler supply source such as a syringe or a pump (not shown). Yes.

The connection mechanism 16 provided between the balloon 12 and the tube 14 is a detachable and liquid-tight connection between the balloon 12 and the tube 14. The release portion 18 can be displaced along the extending direction of the tube 14 and is for releasing the connection state between the balloon 12 and the tube 14 by the connection mechanism 16.

Here, FIG. 2 is a side view of the connection mechanism 16 and its peripheral part, and FIG. 3 is a longitudinal sectional view of the connection mechanism 16 and its peripheral part. As shown in FIG. 2 and FIG. 3, specifically, the connection mechanism 16 includes a hollow first connection portion 22 provided at the proximal end of the balloon 12 and a distal end of the tube 14. And a hollow second connection portion 24 detachably engaged with the portion 22. When the release part 18 is displaced along the extending direction of the tube 14 (in the present embodiment, the base end direction), the engagement between the first connection part 22 and the second connection part 24 is released, and the balloon 12 and the tube 14 can be detached.

The first connection part 22 has a fitting cylinder part 26 fitted to the inner peripheral part of the proximal end of the balloon 12 and an engagement cylinder part 28 provided on the proximal end side of the fitting cylinder part 26. A plurality of crests 26 a and troughs 26 b extending in an annular shape are alternately formed in the axial direction on the outer peripheral portion of the fitting cylinder portion 26, and the plurality of crest portions 26 a are formed on the inner periphery of the proximal end of the balloon 12. I am biting into the club. Further, in the present embodiment, as shown in FIG. 3, an adhesive 27 is provided in the valley portion 26 b, and the adhesive 27 causes the inner surface of the proximal end portion of the balloon 12 and the outer peripheral portion of the fitting cylinder portion 26 to Is glued.

The engagement tube portion 28 has a larger diameter than the engagement tube portion 26, and the distal end surface 28 a abuts on the base end surface 12 c of the balloon 12, thereby positioning the first connecting portion 22 in the axial direction with respect to the balloon 12. Has been made.

Here, FIG. 5 is an exploded perspective view of the connection mechanism 16 and the release unit 18. As shown in FIG. 5, a plurality of (four in the illustrated example, four at 90 ° intervals) holes 30 functioning as the engaging portions are provided in the engaging cylinder portion 28 at intervals in the circumferential direction. The hole 30 is formed so as to penetrate the wall constituting the engagement cylinder portion 28 inward and outward.

Note that only one hole 30 that functions as an engaging portion may be provided. Further, in place of the hole 30, one or a plurality of grooves functioning as the engaging portion may be provided in the inner peripheral portion of the fitting cylindrical portion 26.

The first connection portion 22 is 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 various biocompatible metal materials may be mentioned, 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 composite, 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) may be mentioned.

The second connecting portion 24 includes a protrusion 32 provided on the outer peripheral portion on the distal end side, and a tapered portion 34 provided on the base end side with respect to the protrusion 32 and inclined with respect to the axial direction. Composed. The protrusion 32 is a portion that engages with the hole 30 that functions as the engaging portion, and in the illustrated example, a plurality of (four) corresponding to the plurality of holes 30 provided in the first connecting portion 22. The protrusions 32 are provided at intervals in the circumferential direction.

As shown in FIG. 3, in the engaged state of the hole 30 and the protrusion 32, the protrusion 32 enters the hole 30, and the base end surface 32 a of the protrusion 32 abuts on the side surface 30 a on the base end side of the hole 30, In addition, the distal end surface 24 a of the second connection portion 24 is in contact with the proximal end surface 26 c of the fitting tube portion 26 of the first connection portion 22. A portion of the second connecting portion 24 from the distal end surface 24a to the proximal end surface 32a of the protruding portion 32 is in an elastically compressed state in the axial direction, and the second connecting portion 24 (specifically, the elastic force). The front end surface 24a is in liquid-tight contact with the first connection portion 22 (specifically, the base end surface 26c of the fitting tube portion 26).

As shown in FIG. 5, a plurality (four in the illustrated example) of protrusions 36 are provided on the outer peripheral part on the proximal end side of the second connection part 24 at intervals in the circumferential direction. A plurality of tapered portions 34 are provided on the distal end side of 36. The circumferential positions of the plurality of taper portions 34 correspond to the circumferential positions of the plurality of protrusions 32 provided on the tip side thereof.

In the present embodiment, each tapered portion 34 is inclined so as to be reduced in diameter toward the distal end side. In other words, each taper part 34 inclines so that it may approach the center of the 2nd connection part 24 as it goes to the front end side. In the present embodiment, a plurality of groove portions 38 are provided between the plurality of protrusions 36 at intervals in the circumferential direction.

Since the second connection portion 24 is made of an elastic material, it can be elastically reduced in diameter when subjected to a pressing force from the outside to the inside. Examples of the constituent material of the second connection portion 24 include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, and urethane rubber. , Various rubber materials such as silicone rubber, fluoro rubber, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, chlorinated polyethylene Various thermoplastic elastomers such as these are mentioned, and one or more of these are mixed and used.

The release portion 18 does not press the taper portion 34 inward at the initial position (first position) shown in FIG. 3, and presses the taper portion 34 inward at the release position (second position) shown in FIG. The diameter is reduced. Specifically, the release portion 18 includes a pressing portion 40 that can press the tapered portion 34 inward, and an extending portion 42 that extends from the pressing portion 40 along the tube 14 to the proximal end side of the tube 14. Have

In the present embodiment, the pressing portion 40 is formed in an annular shape extending in the circumferential direction, and is arranged outside the second connecting portion 24 so as to be slidable in the axial direction. A plurality of (four in the illustrated example) elongated holes 44 extending in the axial direction are formed at the distal end side of the extending portion 42 at intervals in the circumferential direction. In the plurality of long holes 44, the protrusions 36 provided on the second connection portion 24 are arranged. In other words, the wall portions 45 constituting the portions between the long holes 44 adjacent to each other in the circumferential direction are arranged in the plurality of groove portions 38 provided in the second connection portion 24. With this configuration, an increase in the outer diameter on the distal end side of the release portion 18 can be suppressed.

When the implant assembly 10 is inserted into the body using a puncture device 50 (see FIG. 6) having a curved outer cylinder 52 and an inner needle 56, which will be described later, at least a portion of the extension part 42 of the release part 18 is It is preferable to have appropriate flexibility so that the outer cylinder 52 can be deformed along the curved shape. In this case, the release portion 18 can be made of one or more materials exemplified as the constituent material of the tube 14 described above. Moreover, it is more preferable that the pressing part 40 is harder than the constituent material of the tube 14, and the material illustrated as a constituent material of the 1st connection part 22 may be used.

Note that the release portion 18 may be configured not to provide the elongated hole 44 in the release portion 18 but to completely cover the proximal end side of the second connection portion 24. Further, in the present embodiment, the extending portion 42 is substantially entirely configured in a tubular shape, but may not be configured in a tubular shape as long as it can be displaced along the extending direction of the tube 14.

When the release portion 18 configured as described above is in the initial position shown in FIG. 3, the pressing portion 40 that constitutes the distal end portion of the release portion 18 is located on the distal end side of the tapered portion 34, and the pressing portion 40 Since the taper portion 34 is not pressed inward, the engagement between the hole 30 and the projection portion 32, that is, the connection between the first connection portion 22 and the second connection portion 24 is maintained. On the other hand, as shown in FIG. 4, when the release portion 18 is displaced in the proximal direction with respect to the tube 14, the pressing portion 40 presses the tapered portion 34 inward along with the displacement of the release portion 18. The distal end side of the second connection portion 24 is reduced in diameter. And when the front end side of the 2nd connection part 24 carries out diameter reduction more than predetermined, engagement with the hole 30 (engagement part) and the projection part 32 will be cancelled | released.

As shown in FIG. 1, a release operation unit 46 is provided at the proximal end of the release unit 18. The release operation unit 46 has a larger diameter than the release unit 18. The release portion 18 can be displaced in the proximal direction with respect to the tube 14 by gripping and pulling the release operation portion 46 in the proximal direction.

The implant assembly 10 according to the present embodiment is basically configured as described above, and its operation and effects will be described below. Here, a technique for percutaneously inserting and placing the balloon 12 between adjacent spinous processes in the living body using the puncture device 50 shown in FIG. 6 will be described mainly with reference to FIGS. 7A to 9.

In FIG. 6, the puncture device 50 includes a hollow arc-shaped outer cylinder 52, a hub 54 fixed to the proximal end of the outer cylinder 52, an arc that can be inserted into the outer cylinder 52 and has the same curvature as the outer cylinder 52. It has an inner needle 56 formed in a shape, and a handle 58 fixed to the proximal end of the inner needle 56. FIG. 3 shows a state where the inner needle 56 is inserted into the hollow portion of the outer cylinder 52 as far as possible.

The outer cylinder 52 is a member having a hollow structure that is open at both ends and has a hollow portion into which the inner needle 56 can be inserted. The hub 54 fixed to the base end of the outer cylinder 52 has an outer diameter larger than that of the outer cylinder 52 and is provided in a flange shape.

The inner needle 56 is a rod-like member that is inserted into the hollow portion of the outer cylinder 52 and curved in an arc shape having a sharp needle tip 56a at the tip. When the inner needle 56 is inserted to the maximum with respect to the outer cylinder 52, the tip of the inner needle 56 protrudes from the tip of the outer cylinder 52 by a predetermined length. The inner needle 56 may be either a solid structure or a hollow structure. A handle 58 provided at the proximal end of the inner needle 56 functions as a grip for the user of the puncture device 50 to grasp.

A radiopaque marker may be provided on at least a part of the distal end side of the outer cylinder 52 or the inner needle 56 so as to be recognized under fluoroscopy.

The puncture device 50 used together with the implant assembly 10 is not limited to the puncture device 50 having the configuration shown in FIG. 6. For example, a straight type puncture device having a linear outer cylinder and an inner needle may be used. .

7A to 9, reference symbol B is a vertebra, and reference symbol B1 is a spinous process formed at the rear part of the vertebra B.

In the operation of placing the balloon 12 as a spacer implant in the living body, first, after confirming the lesioned part with an X-ray fluoroscope, MRI, ultrasonic diagnostic apparatus or the like, the patient P is placed in the prone position. Next, as shown in FIG. 7A, the puncture device 50 with the inner needle 56 inserted into the outer cylinder 52 is inserted into the patient P under fluoroscopy (introduction step). In this case, when the user (operator) of the puncture device 50 holds the handle 58 and applies a force to insert the puncture device 50, the puncture device 50 is inserted into the living body so as to draw an arc orbit. To go.

In the insertion step, more specifically, the interspinous ligament between adjacent spinous processes is penetrated in the direction intersecting the axial direction of the spine with the outer cylinder 52 and the inner needle 56 of the puncture device 50. In this case, the distal end portion of the puncture device 50 is inserted to a position beyond a distance between the spinous processes by a predetermined length. After the puncture device 50 has been inserted for a desired length, the inner needle 56 is then removed from the outer cylinder 52 while the position of the outer cylinder 52 is maintained, that is, while the outer cylinder 52 is inserted into the patient P (inner needle). Extraction step). Thereby, the outer cylinder 52 is detained in a state where it is stuck in the living body.

Next, as shown in FIG. 7B, the implant assembly 10 in which the balloon 12 is in a deflated state is inserted into the hollow portion of the outer cylinder 52 (insertion step). In this insertion step, specifically, as shown in FIG. 7B, the balloon 12 is located in the distal end portion of the outer cylinder 52, and the center in the axial direction of the balloon 12 is an interspinous ligament between adjacent spinous processes. The implant assembly 10 is inserted so as to be located at the center of the center. Thereby, the implant assembly 10 is inserted to a predetermined position in the outer cylinder 52. At this time, the proximal end portion of the implant assembly 10 (the hub 20, the proximal end portion of the release portion 18 and the release operation portion 46) is exposed outside the patient P without being inserted into the outer cylinder 52.

Next, as shown in FIG. 8A, only the outer cylinder 52 (and the hub 54) is retracted in the proximal direction so that the entire length of the balloon 12 is exposed inside the body (outer cylinder retracting step). Next, a filler supply source (not shown) is connected to the hub 20 (see FIG. 1), and the filler supply source is operated to inject the filler into the balloon 12 through the tube 14 as shown in FIG. 8B. Thus, the balloon 12 is expanded (expansion step).

The filler is either a fluid at the time of injection, and a material that hardens after injection (eg, bone cement, acrylic resin, two-component mixed cross-linked polymer, etc.) or a material that is a fluid at the time of injection and maintains the fluid after injection. Can also be applied. The expanded balloon 12 has a shape in which a pair of bulging portions 12b are connected via a constricted portion 12a. The constricted portion 12a penetrates the interspinous ligament between the spinous processes, and a pair of bulging portions on both sides thereof. An interspinous ligament is located between 12b. Thereby, the space | interval between spinous processes is expanded by the expanded constriction part 12a, and the balloon 12 will be in the state from which the escape from the interspinous ligament between spinous processes was prevented.

After the balloon 12 has been expanded, the engagement between the first connection part 22 and the second connection part 24 constituting the connection mechanism 16 is then released (engagement release step). Specifically, when the release operation unit 46 (see FIG. 1) provided at the proximal end of the release unit 18 is gripped and pulled in the proximal direction, the connection mechanism is operated by the pressing unit 40 as shown in FIG. The taper part 34 provided in the 16 2nd connection part 24 is pressed inward, and the 2nd connection part 24 diameter-reduces. Then, as the diameter of the second connecting portion 24 is reduced, all the protruding portions 32 are displaced inward, so that the protruding portions 32 are formed from the holes 30 constituting the engaging portions provided in the first connecting portion 22. Comes off. Thereby, the engagement between the first connection part 22 and the second connection part 24 is released. When the protrusion 32 is removed from the hole 30, the portion of the second connecting portion 24 from the distal end surface 24a to the base end surface 32a of the protrusion 32 is elastically restored and slightly extends in the axial direction.

Next, in a state where the engagement between the first connection portion 22 and the second connection portion 24 is released, the tube 14 is pulled away from the balloon 12 by pulling the tube 14 in the proximal direction (removal). Step).

In addition, the first connection portion 22 in a state where the engagement with the second connection portion 24 is released, the portion of the second connection portion 24 that fits into the first connection portion 22 (the tip of the first connection portion 22). By inserting and fitting a sealing connecting portion (not shown) having the same shape and material as the side portion) and having the proximal end sealed, the proximal end side of the first connecting portion 22 is fitted. The opening may be sealed (sealing step).

In addition, when the filler is a material that is a fluid at the time of injection and is cured after the injection, the balloon 12 and the tube 14 are preferably detached after the filler is cured. In this case, the cured filler is also cut and separated. When the release operation part 46 provided at the base end of the release part 18 is gripped and pulled in the base end direction in the engagement release step described above, the taper part 34 provided in the second connection part 24 is pressed by the pressing part 40. As the second connecting portion 24 is pressed inward and the diameter of the second connecting portion 24 is reduced, the hardened filler inside the second connecting portion 24 is also pressed together and the inner side of the first connecting portion 22 that is not pressed. There is a difference in pressing force with the cured filler. Subsequently, by pulling the tube 14 in the base end direction and moving backward in the above-described detachment step, the cured filler is cut at the portion where the difference in pressing force is generated. Thereby, the tube 14 and the hardened filler can be suitably detached from the balloon 12 without providing a filler cutting step. Further, when the filler is a material that maintains the fluid even after injection, a backflow prevention structure (check valve) may be provided at the inlet of the balloon 12.

When the balloon 12 and the tube 14 are separated, the tube 14, the second connection portion 24, and the release portion 18 are removed from the outer cylinder 52 and the outer cylinder 52 is completely removed from the patient P. As a result, the balloon 12 is placed between the spinous processes.

As described above, according to the implant assembly 10 according to the present embodiment, the connection structure between the balloon 12 and the tube 14 is not screw fitting as in the prior art, and the release portion 18 is extended in the direction in which the tube 14 extends. Since the engagement between the first connection portion 22 and the second connection portion 24 can be released simply by displacing the tube 12 between the balloon 12 and the tube 14 while ensuring sufficient liquid tightness. Detachment can be performed reliably.

In the case of the present embodiment, due to the action of the inclination of the tapered portion 34 provided in the second connection portion 24, the second connection portion 24 is reduced in diameter in accordance with the displacement of the release portion 18, and the first connection portion 22 and the second connection portion 24. Since the engagement with the connection portion 24 is released, the engagement between the first connection portion 22 and the second connection portion 24 can be easily and quickly released with a small amount of operation with respect to the release portion 18. It is easy to operate.

In particular, in the case of the present embodiment, the tapered portion 34 has an inclination that decreases in diameter toward the distal end direction of the second connection portion 24, and when the release portion 18 is displaced in the proximal direction of the tube 14, the release portion 18 is configured to press the tapered portion 34 inward. According to this configuration, since the engagement between the first connection portion 22 and the second connection portion 24 can be released by an operation of pulling the release portion 18 in the proximal direction, the release portion 18 is released by pushing in the distal direction. It is easier to perform the release operation.

Further, in the case of the present embodiment, an engagement portion constituted by a hole 30 or a groove is provided on the proximal end side of the first connection portion 22, and an engagement portion is provided on the distal end side of the second connection portion 24. A projecting portion 32 to be engaged is provided, the second connecting portion 24 is fitted inside the first connecting portion 22, and the engagement portion and the projecting portion 32 are connected to each other as the diameter of the second connecting portion 24 is reduced. The engagement is released. According to this configuration, when the release portion 18 is not operated, the engagement state between the engagement portion (hole 30 or groove) and the protrusion 32 can be reliably maintained, and when the release portion 18 is operated. The engagement can be easily released when the protrusion 32 is disengaged from the engagement portion.

Furthermore, in the case of this embodiment, the front-end | tip part of the 2nd connection part 24 is hold | maintained at the 1st connection part 22 in the state which the engaging part (hole 30 or groove | channel) and the projection part 32 engaged. An elastic compression state is established in the axial direction, and the first connection portion 22 and the second connection portion 24 are in close contact with each other in a liquid-tight manner. According to this structure, since the front-end | tip part of the 2nd connection part 24 closely_contact | adheres to the 1st connection part 22 in an elastic compression state, high liquid-tightness can be ensured effectively.

In the case of this embodiment, as shown in FIG. 5, a plurality of engaging portions (holes 30 or grooves) are provided at intervals in the circumferential direction of the first connecting portion 22, and the protruding portions 32 are the second connecting portions. A plurality of portions 24 are provided at intervals in the circumferential direction of the portion 24. According to this configuration, the engagement state between the engagement portion and the projection portion 32 can be more reliably maintained in a state where the release portion 18 is not operated.

In the present embodiment described above, the inclination of the taper portion 34 is an inclination that decreases in diameter toward the distal end direction of the second connection portion 24, but the inclination in the opposite direction, that is, the second connection. The inclination may be such that the diameter of the portion 24 decreases in the proximal direction. In this case, by pressing the release portion 18 in the distal direction, the pressing portion 40 presses and displaces the tapered portion 34 inward, and the engagement between the first connection portion 22 and the second connection portion 24 is released. It will be.

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.

Claims

A balloon (12) configured to be expandable by being filled with a filler, and configured as an implant to be inserted and placed in a living body;
A tube (14) having a lumen communicating with the interior of the balloon (12) and functioning as a flow path for the filler supplied to the balloon (12);
A connection mechanism (16) for detachably and liquid-tightly connecting the balloon (12) and the tube (14);
A release portion (18) that is displaceable along an extending direction of the tube (14) and for releasing a connection state between the balloon (12) and the tube (14) by the connection mechanism (16); With
The connection mechanism (16)
A hollow first connecting portion (22) provided at a proximal end of the balloon (12);
A hollow second connection portion (24) provided at the tip of the tube (14) and detachably engaged with the first connection portion (22);
By displacing the release portion (18) along the extending direction of the tube (14), the engagement between the first connection portion (22) and the second connection portion (24) is released, The balloon (12) and the tube (14) can be detached.
Implant assembly (10) characterized in that.
The implant assembly (10) according to claim 1,
The second connecting portion (24) is configured to be capable of reducing the diameter, and has a tapered portion (34) inclined with respect to the axial direction.
When the release portion (18) is displaced in the extending direction of the tube (14), the release portion (18) presses the taper portion (34) inward, whereby the second connection portion ( 24) is reduced in diameter, and the engagement between the first connection portion (22) and the second connection portion (24) is released.
Implant assembly (10) characterized in that.
Implant assembly (10) according to claim 2,
The taper portion (34) has an inclination that decreases in diameter toward the distal end direction of the second connection portion (24);
When the release portion (18) is displaced in the proximal direction of the tube (14), the release portion (18) presses the tapered portion (34) inward.
Implant assembly (10) characterized in that.
Implant assembly (10) according to claim 2 or 3,
On the base end side of the first connection portion (22), an engagement portion (30) configured by a hole or a groove is provided,
On the distal end side of the second connection portion (24), a protrusion (32) that engages with the engagement portion (30) is provided,
The second connection part (24) is fitted inside the first connection part (22),
As the diameter of the second connecting portion (24) is reduced, the engagement between the engaging portion (30) and the protruding portion (32) is released.
Implant assembly (10) characterized in that.
Implant assembly (10) according to claim 4,
With the engagement portion (30) and the protrusion (32) engaged, the tip of the second connection portion (24) is held by the first connection portion (22) so that the axis line The first connection portion (22) and the second connection portion (24) are in close contact with each other in a liquid-tight manner.
Implant assembly (10) characterized in that.
Implant assembly (10) according to claim 4,
A plurality of the engaging portions (30) are provided at intervals in the circumferential direction of the first connecting portion (22),
A plurality of the protrusions (32) are provided at intervals in the circumferential direction of the second connection portion (24).
Implant assembly (10) characterized in that.