JP2006326044A - Implant material introduction device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an implant material introduction device by which bone defect site of any shape can be filled securely and the strength of the reproduced bone tissue is improved by an easy operation. <P>SOLUTION: The implant material introduction device 1 comprising a space forming member 2 surrounding an bone defect site B for forming an implant space in the bone defect site B, and a fixing means 3 for fixing the space forming member 2 at the bone A around the bone defect site B, wherein the space forming member 2 is provided with an introduction port 5 for introducing a fluid implant material into the implant space. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to an implant introduction device.

Conventionally, a bone filling material made of a biomaterial such as hydroxyapatite for filling a bone defect such as the iliac bone is known (for example, see Patent Document 1).
This bone grafting material is a bioabsorbable material containing a bioactive bioceramic powder on a part of the surface of a block-like porous body made of a bioabsorbable polymer having continuous pores and containing a bioactive bioceramic powder. The polymer skin layer is layered and integrated, and by changing the content of the bioceramic powder in the porous body and the skin layer, the skin is not weakened, and within a relatively short period of time. The porous body is replaced with bone tissue.
Japanese Patent Publication No. 2004-121301

  However, since the bone grafting material disclosed in Patent Document 1 is a standard one, in order to compensate for a bone defect formed in the iliac bone, the size of the bone defect is adjusted at the time of filling. Therefore, there is an inconvenience that the bone prosthetic material must be shaved or the bone defect part must be expanded according to the size of the bone prosthetic material. In particular, since the bone defect portion does not have a fixed shape, it is difficult to cut the bone prosthetic material so as to exactly match the shape of the bone defect portion. In addition, when the bone defect portion is cut in accordance with the shape of the standard bone substitute material, it is also not preferable because the bone defect portion is increased unnecessarily because the bone tissue is also cut. Further, when the bone defect portion is large, there is a disadvantage that a gap is formed between the bone defect portion and the bone prosthetic material supplemented in the bone defect portion.

  The present invention has been made in view of the above-described circumstances, and is capable of reliably filling a bone defect portion of an arbitrary shape and improving the strength of regenerated bone tissue by a simple operation. The object is to provide a material introduction device.

In order to achieve the above object, the present invention provides the following means.
The present invention includes a space forming member that surrounds a bone defect portion and forms a transplantation space in the bone defect portion, and a fixing means that fixes the space formation member to bone around the bone defect portion. The transplant material introducing device is provided with an introduction port for introducing a fluid transplant material into the transplant space.

  According to the present invention, when the space forming member is fixed to the bone by the operation of the fixing means, the space forming member surrounds the bone defect portion, and a transplantation space is formed in the bone defect portion. Since the space forming member is provided with the introduction port, by introducing the fluid transplant material into the transplant space through the introduction port, the transplant space is filled with the fluid transplant material. As a result, the bone defect is sufficiently filled with the graft material. Therefore, it is possible to fill the bone defect part of any shape with the graft material without cutting the block-shaped bone filling material or cutting the bone defect part.

In the said invention, it is good also as providing the injection apparatus which can be detachably connected to the said inlet and can inject the transplant material introduce | transduced in the space for transplant.
By doing in this way, by operating the injection device connected to the inlet, the transplant material can be easily filled into the transplant space.

Moreover, in the said invention, it is good also as providing the operation part which operates the said fixing means.
By doing in this way, a fixing means can be operated by operation of an operation part, and a space formation member can be simply fixed to a bone.

Further, in the above invention, the space forming member is configured in a substantially U shape that sandwiches the bone, and the fixing means includes the space forming member made of an elastic material and has a bone thickness dimension in a free state. It is preferably configured by being formed to be narrower and wider than the thickness dimension of the bone in the expanded state.
By doing so, it is possible to place the bone inside the space forming member made of an elastic material by elastically deforming and expanding, and by releasing the space forming member, the bone can be sandwiched using the elastic restoring force . In this case, since the space forming member is formed to be narrower than the bone thickness dimension in a free state, a predetermined pressing force is applied to the bone by an elastic restoring force, and the space forming member can be easily fixed by a frictional force. become. Thereby, the space for transplants can be easily formed in a bone defect part.

Moreover, in the said invention, it is preferable that the said space formation member is comprised with the transparent material.
By doing in this way, it becomes possible to visually check the state inside the bone defect formed inside the space forming member via the space forming member. Thereby, it can operate, confirming the introduction amount of a transplant during introduction of a transplant.

Moreover, in the said invention, it is preferable that the said space formation member is comprised with the biodegradable material.
By doing in this way, after introduce | transducing a transplant material in a bone grafting material, a space formation member can be left in the living body as it is. Therefore, the removal operation is unnecessary, and the transplantation operation can be completed even before the transplant material is completely cured.

In the above invention, the space forming member may be composed of polylactic acid as a main component.
By doing in this way, it can have elasticity, can have biodegradability, and can provide a transparent space formation member.

In the above invention, the injection device includes a container having a connection portion detachably connected to the introduction port, and a container that accommodates the transplant material therein, and a pressing unit that extrudes the transplant material in the container. It is good.
By doing in this way, the connection part provided in the container containing the transplant material is connected to the introduction port provided in the space forming member, and the transplant material in the container is pushed out by the operation of the pressing means. In addition, the bone defect can be filled with the graft material.

Moreover, in the said invention, the sealing member which can be opened in the state connected to the inlet may be provided in the connection part of the said container.
By doing in this way, the fluid transplant material can be hold | maintained in a container by sealing with a sealing member. Moreover, by opening the sealing member in a state where the connection portion is connected to the introduction port, the graft material can be easily introduced into the bone defect portion via the introduction port.

Moreover, in the said invention, the said injection apparatus is good also as accommodating the granular or powdery transplant material which has a calcium phosphate as a main component.
By doing so, in the bone defect part, the growth of cells such as mesenchymal stem cells is promoted using calcium phosphate as a scaffold, and the bone defect part can be regenerated at an early stage and with high strength. .

Further, in the above invention, the injection device includes a first injection device containing a granular or powdery first graft material mainly composed of calcium phosphate, blood, platelet-rich plasma, poor platelet plasma, It is good also as providing the 2nd injection apparatus which accommodates the 2nd transplant material which consists of a liquid component of either a fibrinogen concentrate, a bone marrow fluid, or a cell suspension.
By doing so, the first injection device fills the bone defect with the granular or powdery first transplant material, and then the second injection device operates to make the second component made of the liquid component. The bone defect can be filled with the graft material. Thereby, it becomes possible to promote bone regeneration in the bone defect portion and repair the bone defect portion at an early stage.

Furthermore, in the said invention, the said injection apparatus is good also as providing the 3rd injection apparatus which accommodates the coagulation promoter which solidifies the said 2nd transplant material.
By doing in this way, the 2nd transplant material with which the bone defect part is filled is solidified by the action | operation of a 3rd injection apparatus, and it solidifies with the 1st transplant material with which it fills in the space for a transplant. be able to. As a result, it is possible to manufacture a bone filling material that exactly matches the shape of the bone defect.

  According to the present invention, it is possible to reliably fill a bone defect portion having an arbitrary shape and improve the strength of a regenerated bone tissue by a simple operation.

An implant introduction device according to an embodiment of the present invention will be described below with reference to FIGS.
The transplant material introduction apparatus 1 according to the present embodiment is an apparatus that introduces a transplant material into a bone defect part B such as a bone collecting part formed in the iliac bone A, for example, as shown in FIG. A forming member 2, a fixing means 3, and an operation member 4 for operating the fixing means 3 are provided.

The space forming member 2 is formed as an integral thin plate formed in a substantially U-shaped form by two opposing flat plates 2a and a bent plate 2b connecting the two flat plates 2a. The member is composed of a biocompatible elastic material such as silicone, polyurethane, polytetrafluoroethylene, or the like.
The fixing means 3 opens the U-shaped form of the space forming member 2 when the distance between the two opposing flat plates 2a is widest, and when it is wider than the thickness dimension of the iliac A sandwiched therebetween, The iliac bone A is configured so as to be closed smaller than the thickness dimension of the iliac A.

  The operation member 4 includes two handles 4a and 4b that extend along the surfaces of the two flat plate portions 2a of the space forming member 2 and protrude on the opposite side to the tip of the flat plate portion 2a. The two handles 4a and 4b constituting the operation member 4 are arranged with a space between each other in a state where the flat plate portion 2a of the space forming member 2 is closed. By pressing the two handles 4a and 4b in the approaching direction, the distance between the tips of the two flat plate portions 2a can be easily increased by the lever principle.

  One flat plate portion 2a of the space forming member 2 is provided with an introduction port 5 penetrating the flat plate portion 2a in the plate thickness direction. The introduction port 5 is formed in a cylindrical shape so that an injection device 6 to be described later can be connected.

  As shown in FIGS. 5 and 6, the injection device 6 includes a first syringe 7 and a second syringe 8. The first syringe 7 accommodates a granular calcium phosphate porous body (transplant) 10 in a cylinder 9 and includes a tapered portion 9 a connected to the introduction port 5 at the tip. In addition, a piston 11 is inserted at the rear end of the cylinder 9, and the transplantation formed in the space forming member from the introduction port 5 connected through the taper portion 9a by pressing the piston 11. The calcium phosphate porous body 10 can be introduced into the working space C.

  Further, as shown in FIG. 6, the second syringe 8 has an inside of the cylinder 12 divided into two spaces by a partition wall 13, and platelet rich plasma (transplant) 14 and thrombin (transplant) in each space. 15 and so on. A tapered portion 12 a connected to the introduction port 5 is provided at the tip of the cylinder 12, and a piston 16 is inserted into the rear end of the cylinder 12. The piston 16 is inserted into each of the two spaces defined by the partition wall 13, and is formed in the space forming member 2 from the introduction port 5 connected via the taper portion 12 a by pressing the piston 16. Platelet rich plasma 14 and thrombin 15 are injected simultaneously into the transplantation space C.

The operation of the implant introduction device 1 according to this embodiment configured as described above will be described below.
In order to introduce the graft material into the bone defect B formed in the bone collecting portion of the iliac A using the graft material introduction apparatus 1 according to the present embodiment, first, as shown in FIG. To apply a force in the direction in which the two handles 4a and 4b are brought close to each other, thereby widening the interval between the two flat plate portions 2a constituting the space forming member 2 to be larger than the thickness dimension of the iliac A. Then, as shown in FIG. 4, the iliac bone A is disposed between the flat plate portions 2 a so as to cover the bone defect B of the iliac bone A, and the force applied to the operation member 4 is released. Thereby, the space forming member 2 is displaced in the direction of narrowing the interval between the flat plate portions 2a by the elastic restoring force, and the iliac bone A is sandwiched between the flat plate portions 2a, thereby being fixed to the iliac A. At this time, the bone defect B formed in the iliac bone A is completely covered by the space forming member 2, and is closed for transplantation except for the introduction port 5 between the bone defect B and the space forming member 2. A space C is formed.

  In this state, the tapered portion 9 a of the first syringe 7 is inserted into the introduction port 5. As a result, the cylinder 9 of the first syringe 7 is connected to the introduction port 5, so that the granules of the calcium phosphate porous body 10 are introduced and filled into the transplantation space C from the introduction port 5 by pressing the piston 11. The

  Thereafter, the first syringe 7 is removed from the introduction port 5, and the second syringe 8 is connected to the introduction port 5. Even in this case, the cylinder 12 and the inlet 5 can be connected in a liquid-tight state by inserting the tapered portion 12 a of the second syringe 8 into the inlet 5. In this state, by pressing the piston 16, the platelet-rich plasma 14 and the thrombin 15 are simultaneously injected into the transplantation space C filled with the calcium phosphate porous body 10 from the introduction port 5.

  Thereby, in the transplantation space C, the calcium phosphate porous body 10, the platelet-rich plasma 14 and the thrombin 15 are filled in a mixed state. Since the thrombin 15 has a coagulation promoting action of the platelet-rich plasma 14, the platelet-rich plasma 14 is coagulated with the passage of a predetermined time after the injection, and the mixture is gelled.

  Then, after the mixture in the transplantation space C is completely gelled, the operation member 4 is operated to remove the space forming member 2 from the iliac A. As a result, the graft material composed of the gelled mixture remains in the bone defect B formed in the iliac bone A, and the introduction of the graft material is completed.

According to the transplant material introduction apparatus 1 according to the present embodiment, instead of introducing a fixed shape transplant material having a predetermined shape into the bone defect B, the granular calcium phosphate porous body 10, liquid platelet-rich plasma 14 and thrombin 15 are gelated after being introduced into the bone defect B, so that it is not necessary to reshape the graft material or bone defect B prior to filling, and the operation site can be easily filled. it can.
Further, the space forming member 2 made of an elastic material can be used like a clip to form the transplant space C simply by sandwiching the iliac bone A, thereby further simplifying the supplementing operation.

  In the above embodiment, the space forming member 2 that is opened and closed by the operation member 4 including the handles 4a and 4b extending outward from the bent plate portion 2b is adopted. Instead, as shown in FIG. You may employ | adopt space formation member 2 'opened and closed by the operation part 17 like the protrusion or hole provided in 2a. In FIG. 7, the introduction port 5 is provided not in the flat plate portion 2a but in the bent plate portion 2b. In addition, you may provide the inlet 5 in the flat plate part 2a.

The space forming member 2 is made of a biocompatible elastic material such as silicone, polyurethane, polytetrafluoroethylene, etc., but instead of this, a biodegradable material, for example, an elastic material mainly composed of polylactic acid. You may comprise by. By doing in this way, it can leave in a body, without removing the space formation member 2 after introduction of the transplant material to the space C for transplant.
Moreover, even when there is no bridge part like the bone defect part B of FIG. 7, the strength of this part can be maintained. And when it is not necessary to gelatinize a transplant material, the process of gelatinizing a transplant material can also be skipped, and there exists an advantage that the removal operation | work of the space formation member 2 becomes unnecessary.

  In addition to a material mainly composed of polylactic acid, a transparent material may be used as the space forming member 2. By doing so, during the introduction of the calcium phosphate porous body 10, the platelet-rich plasma 14 and the like, it is possible to work while visually observing the degree or state of the introduction. Therefore, the introduction work can be facilitated.

Further, as shown in FIG. 8, the cylinder 12 is sealed at the tip of the cylinder 12 containing liquid material such as platelet-rich plasma 14 and thrombin 15, and is indicated by, for example, a chain line by the pressure applied by the piston 16. It is preferable that the sealing member 18 whose sealing state is broken is attached. By doing in this way, the liquid leakage during conveyance and storage can be prevented.
In addition, since the material can be enclosed in the cylinders 9 and 12 by doing in this way, the syringes 7 and 8 containing the necessary amounts of the calcium phosphate porous body 10, the platelet-rich plasma 14 and the thrombin 15 in advance are packaged (not shown). ) Can be provided in a form encapsulated in a).

Further, the tip ends of the cylinders 9 and 12 are tapered portions 9a and 12a and are fitted into the introduction port 5 in a sealed state. Instead, the cylinders 9 and 12 are connected to the introduction port 5 by connection by a luer connector or screw fastening. It is good as well.
Note that other embodiments configured by partially combining the above-described embodiments and the like also belong to the present invention.

It is a perspective view which shows the transplant material introduction apparatus which concerns on one Embodiment of this invention. It is a longitudinal cross-sectional view of the transplant material introduction apparatus of FIG. It is explanatory drawing explaining operation which attaches the transplant material introduction apparatus of FIG. 1 to an iliac bone. It is a longitudinal cross-sectional view which shows the state which attached the transplant material introduction apparatus of FIG. 1 to the iliac, and surrounded the bone defect part. It is a longitudinal cross-sectional view which shows the state which introduce | transduces a calcium-phosphate porous body with the transplant material introduction apparatus of FIG. It is a longitudinal cross-sectional view which shows the state which introduces platelet-rich plasma and thrombin by the transplant material introduction apparatus of FIG. It is a perspective view which shows the modification of the transplant material introduction apparatus of FIG. It is a fragmentary sectional view which shows the modification of the cylinder front-end | tip part of the transplant material introduction apparatus of FIG.

Explanation of symbols

A iliac bone
B Bone defect portion C Transplant space 1, 1 'transplant material introduction device 2 Space forming member 3 Fixing means 4 Operation portion 5 Inlet 7, 8 Injection device 9, 12 Cylinder (container)
9a, 12a Tapered part (connection part)
10 Calcium phosphate porous material (transplant: first transplant)
11, 16 piston (pressing means)
14 Platelet rich plasma (transplant: second transplant)
15 Thrombin (transplant: coagulation promoter)
18 Sealing member

Claims (12)

A space forming member that surrounds the bone defect and forms a space for transplantation in the bone defect;
Fixing means for fixing the space forming member to the bone around the bone defect,
A transplant material introduction device, wherein the space forming member is provided with an introduction port for introducing a fluid transplant material into the transplant space.   The transplant material introduction device according to claim 1, further comprising an injection device that is detachably connected to the introduction port and capable of injecting the transplant material introduced into the transplant space.   The transplant material introduction apparatus according to claim 1, further comprising an operation unit that operates the fixing means. The space forming member is configured in a substantially U shape sandwiching a bone,
The fixing means is configured by forming the space forming member with an elastic material and forming the space forming member so as to be narrower than the bone thickness in a free state and wider than the bone thickness in an expanded state. The transplant material introduction device according to any one of claims 1 to 3.   The transplant material introduction device according to any one of claims 1 to 4, wherein the space forming member is made of a transparent material.   The transplant material introducing device according to any one of claims 1 to 5, wherein the space forming member is made of a biodegradable material.   The transplant material introduction device according to claim 6, wherein the space forming member is composed mainly of polylactic acid.   3. The injection device according to claim 2, wherein the injection device includes a connection portion that is detachably connected to the introduction port, and includes a container that accommodates the transplant material therein, and a pressing unit that pushes out the transplant material in the container. Implant introduction device.   The transplant material introduction device according to claim 8, wherein a sealing member that can be opened in a state of being connected to the introduction port is provided at a connection portion of the container.   10. The transplant material introduction device according to claim 2, wherein the injection device accommodates a granular or powdered transplant material containing calcium phosphate as a main component.   A first injection device in which the injection device contains a granular or powdery first graft material mainly composed of calcium phosphate; blood, platelet-rich plasma, poor platelet plasma, fibrinogen concentrate, bone marrow fluid; The transplant material introduction device according to any one of claims 2, 8, and 9, further comprising: a second injection device that houses a second transplant material made of any liquid component of the cell suspension.   The transplant material introduction device according to claim 11, wherein the injection device includes a third injection device that houses a solidification promoting material that solidifies the second transplant material.

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