JP4468849B2 - Artificial joint stem - Google Patents

Description

  The present invention relates to a cementless artificial joint stem, and more particularly to an artificial joint stem that can promote early fixation to bone.

  2. Description of the Related Art Conventionally, as a method for fixing a stem of an artificial joint to an insertion hole drilled in a bone, a cement type that is fixed to a bone using a predetermined adhesive (cement) is known. In this cement type, the stem is quickly fixed by hardening of the cement, so that the patient can be returned quickly and the burden on the patient can be reduced.

  However, the cement type uses cement that hardens by mixing the main agent and hardener, and if unreacted monomers remain in the cement due to poor stirring or poor mixing ratio, the human body may be adversely affected. There is. In addition, there have been reports of cases in which fat embolism is caused when cement is filled into an insertion hole formed in a bone. Furthermore, if fatigue breakage occurs in the cement with long-term use and it becomes necessary to re-operate (refix), the stem cannot be easily removed from the bone, leaving the existing bone The work to remove the cement was difficult and re-operation was difficult.

  Therefore, a cementless type that fixes the stem without using cement is also known. This cementless type stem is manufactured by creating a file with the same shape as the outer shape of the stem, and by using the file to drill a stem insertion hole in the bone, the outer shape of the stem and the inner shape of the insertion hole And the stem grows on the stem side so that the stem is fixed to the bone. Thereby, the problem resulting from using the above-mentioned cement can be solved.

  However, in the cementless type stem, the stem is fixed by the growth of bone, so it takes a long rest period of several months until the gap between the bone and the stem is completely filled. In the case of the elderly, there was a problem that the muscle strength and the like declined due to long-term rest and became bedridden. Moreover, the outer surface shape of the stem is not the same shape as the inner surface shape of the bone marrow cavity due to restrictions such as processability and insertability, and the stem is fixed to the cancellous part of the bone. Therefore, there is a problem that the stem cannot be firmly fixed and the stem is loosened. Therefore, in order to return to society at an early stage, it has been known that a predetermined unevenness is applied to the surface of the stem and it is driven into a bone insertion hole to obtain an initial fixation that does not loosen in normal life. Yes.

  By the way, burying the stem in the bone may cause living body rejection or infectious diseases caused by bacteria, etc .. After applying the drug on the surface of the stem and inserting it into the bone, A method of burying is known. However, when a drug is applied to the stem surface, the amount of the adhering drug is very small and consumed quickly, making it difficult to maintain the drug effect for a long time. In view of this, it has been proposed that a reservoir filled with a drug is provided at the top of the stem so that a larger amount of drug can be held and the drug effect can be sustained over a long period of time (Patent Document 1).

  In addition, due to the implantation of stems, especially when infections occur, it is desirable to administer antibiotics to a site closer to the affected area, because it is not possible to suppress bacteria even if oral administration of antibiotics is carried out. There is a known method of removing the stem, inserting bone cement containing an antibiotic in the form of an artificial joint, and then inserting a new stem once the infection has been cured by the antibiotic. As this bone cement, a porous ceramic impregnated with an antibiotic has been proposed (Patent Document 2).

JP 2004-277421 A Japanese Patent Laid-Open No. 2000-350779

  However, in the conventional cementless type stem, the stem is driven into the bone to fix the anchor effect by the wedge and friction. However, there is a risk that the bone may be damaged and cause pain. In addition, for elderly people with weak bone strength and osteoporosis patients, the bone marrow cavity is enlarged and the dense part of the bone surface is thin, so it cannot withstand the operation of driving the stem into the bone with a hammer. The cementless type stem could not be used.

  In addition, the conventional stem is required to have a predetermined strength and rigidity and has little influence on the human body, and titanium alloys such as cobalt alloys and Ti-6Al-4V are mainly used. Is a difficult-to-cut material, especially when used in cementless stems, it is difficult to machine the outer shape into a shape that substantially matches the inner shape of the bone insertion hole (bone marrow cavity). Disagreement causes local one-sided phenomenon, and a concentrated load acts on a part of the bone, resulting in damage to the bone or poor rotational stability and looseness. It was.

  By the way, bones are normally constantly resorbed and regenerated, and are not fixed in a fixed shape like ordinary structures. Therefore, when the force acts on the bone, it becomes thicker, and when it does not act, it becomes gradually thinner. Then, by embedding the artificial joint stem in the bone, no force acts on the upper end of the bone and the like, and the bone becomes thin and easily fractures. In this way, the phenomenon that stress does not act on bone and the bone becomes thin is called stress shielding, and there is a problem peculiar to artificial joints. In order to improve this, it is necessary to make the force act on the upper epiphysis of the bone as much as possible. However, it is difficult to shorten the length of the cement type because the strength of the cement is low. In the stem, the force is transmitted to both ends of the adhesive part, and as a result, it is fixed at the distal part far from the epiphysis (distal fixation), preventing the occurrence of stress seal desing. It was difficult.

  On the other hand, even with a cementless type, when a long thing like a conventional stem is brought into close contact, it is fixed distally and the above-described stress shielding occurs. Therefore, in the conventional cementless type stem, the surface of the stem facing the upper end of the bone called the “proximal part” is made uneven, and the force is transmitted by a frictional force called an anchor effect, and the lower end part thereof A method called “proximal fixation” is adopted in which the surface is smooth and mirror-finished, and is fixed at the proximal end of the epiphysis by eliminating the joint with the bone. However, in reality, the force was not transmitted as planned, and the occurrence of stress shielding could not be suppressed.

  The above-described problem is caused by a mismatch between the inner shape of the insertion hole formed in the bone and the outer shape of the stem. Specifically, although the insertion hole in the bone can be drilled with high accuracy in recent years due to the appearance of a surgical robot, it is still drilled manually by a doctor in most operations. Therefore, even if the stem is finished with high accuracy, the accuracy of the insertion hole is poor. For example, if there is a gap of 2 mm or more between the bone and the stem, it is almost permanent that the gap is filled in normal bone growth. I couldn't expect it. In addition, since the bone marrow cavity is enlarged for elderly people, a stem that is larger than the size of the patient's body is required, so that the shape balance of the joint is lost and the stiffness of the stem relative to the bone is reduced. It became relatively high, causing stress shielding and causing pain.

  Therefore, it is conceivable to administer a drug that promotes bone growth and fix the stem to the bone at an early stage. However, in Patent Document 1, the opening of the reservoir opens toward the joint cavity. Therefore, it is difficult for the drug to penetrate between the bone and the stem, and it is difficult to promote the growth of the bone, so that it cannot be applied to the cementless type stem. Moreover, in the thing of patent document 1, by filling the reservoir | reserver with chemical | medical agents, such as an antibiotic, the prevention effect of the infection by bacteria etc. can be anticipated with respect to a joint space, but with respect to between a bone | frame and a stem. The preventive effect of all infections could not be expected for the same reason as described above.

  Therefore, when infected with bacteria, etc., after removing the infected stem and inserting the one of Patent Document 2, an operation to insert a new stem after the infection has subsided is performed twice. There was a problem of giving a large burden to the patient by performing the operation over a long period. Moreover, since the thing of patent document 2 uses the porous ceramics, while the strength rigidity is inadequate to make the stem embedded permanently, the stem by a porous ceramic is also compared with a metal stem. Since molding by special firing is required, there is a problem that the cost of the stem increases.

  In addition, it is possible to combine the thing of patent document 1 and the thing of patent document 2 to make a metal stem of a porous body, but special firing is required in order to make a metal a porous body like ceramics. At the same time, the strength and rigidity are lower than those of conventional metal stems, making it difficult to use as a permanent stem. Moreover, even if the material of the stem is replaced with a metal to form a composite material, it is not easy to form the composite material into a porous body, and any desired combination of Patent Documents 1 and 2 can provide a desired stem. The current situation was not possible.

  Then, in view of the above-mentioned situation, the present invention aims to provide an artificial joint stem that can promote early fixation to bone and can maintain the effect of a drug or the like over a long period of time.

In order to solve the above-mentioned problems, the artificial joint stem according to the present invention is provided with a “ neck portion provided on the proximal end side for attaching a spherical head portion in the artificial joint, which is continuous with the neck portion and is drilled in a bone. The outer layer has an outer surface shape that substantially matches the inner surface shape of the insertion hole and has increased torsional rigidity, a main structural layer that is disposed inside the outer layer and has increased bending rigidity, and is disposed inside the main structural layer. An innermost layer, and a main body portion formed of a composite material, including a hollow portion formed in the vicinity of the distal end side by the innermost layer and the outer layer, and an outer surface in contact with the inner surface of the insertion hole in the main body portion a plurality of communication holes for communicating with the cavity, the inner surface bones of the insertion hole in contact with the main body portion through the communication hole, and applies a predetermined physiological action, action imparted that will be disposed within the cavity and means, the tip of the body portion While it is inserted into the insertion hole from the one in which a fixed is "composed of cementless the bone.

  Here, as the “action imparting means”, for example, “a drug using a BMP (Bone Morphogeneic Protein) called a growth factor that promotes bone growth”, “TGFβ”, “an antibiotic that suppresses infection” , “A micromachine capable of transmitting an ultrasonic wave that promotes bone growth”, “an analgesic for alleviating pain”, and the like. Hereinafter, the term “drug” is used as a general term for those including the aforementioned BMP, antibiotics, analgesics and the like.

  Moreover, as a method of disposing the action applying means in the cavity, a method of forming the main body portion with the action applying means embedded in advance, a structure in which the main body portion can be divided and the main body portion is divided. Examples thereof include a method of arranging the action applying means in the cavity, a method of opening the cavity at the end (for example, the tip) of the main body, and disposing the action applying means in the cavity from the opening.

  According to the artificial joint stem of the present invention, a hollow portion is provided in the vicinity of the distal end side of the main body portion of the artificial joint stem, and the action imparting means is disposed in the hollow portion. Thus, the action applying means can be brought as close as possible to the position where the inner surface of the insertion hole and the outer surface of the main body portion are in contact with each other, and can be reliably acted on the inner surface of the insertion hole. For example, as an action imparting means that promotes bone growth, it is possible to promote bone growth on the inner surface of the insertion hole and completely fill the gap between the bone and the artificial joint stem in a short period of time. The patient can be returned to society in a short period of time. Also, since bone growth can be promoted, even if the accuracy of the insertion hole is poor and the gap with the artificial joint stem becomes large, the gap can be filled. Therefore, even in a medical institution that does not include a surgical robot or the like, the artificial joint stem can be used satisfactorily.

  In addition, since the action applying means is arranged in the cavity of the main body, when the action applying means is a predetermined drug, it is more than in the case where the drug is applied to the surface of the stem as in the prior art. Since the medicine can be held, the medicinal effect can be maintained for a longer period (for example, several months (2 to 4 months)), and the artificial joint stem can be reliably fixed to the bone.

  Furthermore, since the artificial joint stem can be fixed to the bone at an early stage, it is not necessary to drive the stem into the bone when fixing it, unlike conventional cementless type stems. Can also be used.

  By the way, in the past, it was common to administer antibiotics for about 48 hours from the implantation operation of the artificial joint stem in order to prevent infection, but sufficient administration effect is sufficient only by administration within that period. May not be obtained. However, according to the artificial joint stem of the present invention, the medicinal effect can be maintained over a long period of time, so that bacteria and the like can be almost completely killed, and the occurrence of infectious diseases can be prevented.

  The artificial joint stem of the present invention is also suitable for use as a replacement stem for a conventional stem in which an infection has occurred. In this case, since the infectious disease can be suppressed and cured for the same reason as described above, a conventional operation for removing the infected stem and treating the infectious disease, and a new one after healing of the infectious disease. Even if the operation for implanting the stem is not performed twice, it is possible to treat the infection only by removing the infected stem and implanting the artificial joint stem of the present invention. This can reduce the burden on the patient.

  The artificial joint stem is not particularly limited to a hip joint, a knee joint, or the like, but is preferably applied to an artificial joint stem used for a hip joint and embedded in a femur. In addition, it is desirable that the insertion hole to be drilled in the bone has a shape substantially in line with the inner shape of the bone marrow cavity. Furthermore, as a material of the artificial joint stem, a titanium alloy such as a cobalt alloy or Ti-6Al-4V may be used as in the conventional stem, or a composite material such as a fiber reinforced resin (for example, a carbon fiber reinforced resin). Also good.

  Here, as the “communication hole”, the diameter is preferably within a range of about 0.1 to 2 mm, and even if the diameter is smaller or larger than this, there is a possibility that the action imparting means cannot be sufficiently operated. Further, if it is smaller than this, it becomes difficult to process, and if it is larger than this, the strength of the artificial joint stem may be lowered.

  According to the artificial joint stem of the present invention, the action imparting means can be directly acted on the bone in contact with the artificial joint stem through the communication hole, so that the action effect of the action imparting means can be further increased, and in a shorter period of time. The artificial joint stem can be fixed to the bone. In addition, if the bone grows into the communication hole, the mechanical connection between the bone and the artificial joint stem becomes stronger, and the artificial joint stem is more firmly fixed to the bone, thereby reliably preventing the occurrence of loosening. Can do.

  Further, when the action imparting means is a predetermined drug, the drug in the artificial joint stem is leached into the bone through the communication hole, or a body fluid such as intercellular fluid or bone marrow fluid passes through the communication hole in the artificial joint stem. The drug can be mixed with the drug and then leached out of the artificial joint stem through the communication hole to supply the drug into the insertion hole, that is, the bone marrow cavity.

  In addition to the above-described configuration, the artificial joint stem according to the present invention may have a configuration that “the outer surface of the main body portion further includes a plurality of grooves in which the communication holes are opened in the bottom portion”.

  Here, as the “groove”, its width and depth are preferably within a range of about 0.25 to 1 mm, and if it is smaller than this, an effect as an anchor cannot be expected. This is because the period until the anchor effect is exhibited becomes too long. Although the number and direction of the grooves are not particularly limited, it is desirable to include at least grooves substantially along the fiber direction of the bone, and in the grooves along the axial direction of the artificial joint stem, In the grooves along the direction perpendicular to the axis, the prevention of slipping out can be improved, and these grooves may be appropriately provided depending on the position of the artificial joint stem. Further, the groove may be provided obliquely or spirally with respect to the axial direction of the artificial joint stem.

  According to the artificial joint stem of the present invention, the bone grows in the groove, so that the mechanical connection between the bone and the artificial joint stem can be further strengthened. In addition, since the communication hole is opened at the bottom of the groove, the drug leached out from the communication hole diffuses more widely through the groove, further enhancing the action effect of the drug, etc. Can be fixed to the bone to allow the patient to return to society early.

  In addition, for example, when the groove along the axial direction is provided as a whole, and many grooves along the direction perpendicular to the axis are provided on the proximal side, the artificial joint stem can be fixed proximally and the axial direction The drug as the action imparting means can be diffused by the groove along the line.

  The prosthetic joint stem according to the present invention has, in addition to the above-described configuration, “an opening for disposing the action applying means in the cavity portion is formed at the tip of the main body portion, and a cap for closing the opening is further provided. It is also possible to have a configuration.

  According to the artificial joint stem of the present invention, since the opening continuing to the cavity is formed at the tip of the main body, the action applying means can be easily disposed in the cavity through the opening and the opening is closed. Since the cap is provided, it is possible to prevent the action imparting means disposed in the cavity from falling out of the cavity during surgery or the like.

  The prosthetic joint stem according to the present invention has, in addition to the above-described configuration, “the action imparting means is a predetermined drug, and the drug can be leached to the outer surface of the main body part through the communication hole. ".

  Here, “leaching is possible” means, for example, “a medicine that is wrapped with an osmotic membrane, and the medicine is leached to the outside by the osmotic pressure of an external body fluid”, “a liquid-soluble solid (eg, powder) Or granules, etc.) that are leached by being dissolved in body fluids ”,“ to be leached by absorbing the drug in a polymer absorber or the like to form a gel and eluting it with body fluids ” "A solid or liquid drug is enclosed in a container that is dissolved by a body fluid, and the drug is leached when the container is dissolved by a body fluid".

  According to the artificial joint stem of the present invention, the action imparting means is a drug and can be leached through the communication hole, whereby the drug directly acts on the outer surface of the main body, that is, the bone in contact with the main body. Therefore, the drug efficacy can be increased. In particular, when bone growth is promoted as a drug, bone growth in contact with the artificial joint stem can be directly promoted, so that the artificial joint stem can be fixed to the bone in a shorter period of time.

  In addition to the above-described configuration, the artificial joint stem according to the present invention has a configuration in which “the action applying means is a micromachine capable of transmitting a predetermined ultrasonic wave”.

  Here, as the “micromachine”, any device that can transmit a predetermined ultrasonic wave (for example, a sound wave of 1 to 2 MHz) that promotes bone growth may be used. A type of supplying power by irradiating high frequency from the outside may be used.

  According to the artificial joint stem of the present invention, a micromachine capable of transmitting a predetermined ultrasonic wave is built in the artificial joint stem, thereby causing the ultrasonic wave to act on the bone in contact with the main body from the micromachine as the action imparting means. Thus, bone growth can be promoted and the artificial joint stem can be fixed to the bone at an early stage. In addition, it is desirable that the material of the artificial joint stem is a composite material, so that the ultrasonic wave from the micromachine can be transmitted to the bone well. Further, when the material of the artificial joint stem is made of an alloy such as titanium as in the conventional case, it is difficult for ultrasonic waves from the micromachine to be transmitted to the bone, so it is desirable to provide a plurality of the above-described communication holes.

  Here, as the “composite material”, a fiber reinforced resin can be used, and it is particularly preferable to use a material obtained by reinforcing polyether ether ketone (PEEK) with carbon fibers.

  According to the artificial joint stem of the present invention, the main body portion and the neck portion are formed of a composite material, and the main body portion is formed with an outer layer having increased torsional rigidity, a main structure layer having increased bending rigidity, and a cavity. The torsional rigidity of the outer layer, the bending rigidity of the main structure layer, and the ratio between the outer layer and the main structure layer can be set as appropriate. And an artificial joint stem with optimal rigidity.

  Moreover, since it can be molded using a mold, for example, a patient's bone to which the artificial joint stem is fixed is photographed by using a non-destructive sectional imaging apparatus such as CT or MRI, and the sectional images are taken. Based on the three-dimensional CAD, three-dimensional CAD is used to create numerical data, and an insertion hole with a predetermined inner surface shape is drilled in the patient's bone using a computer-controlled surgical robot based on the numerical data. At the same time, by creating a mold based on the same numerical data and molding the outer shape of the stem based on the mold, the outer surface shape of the artificial joint stem and the inner surface shape of the insertion hole are substantially the same. In addition, it is possible to achieve higher initial fixation, and it is possible to realize proximal fixation, and to prevent the occurrence of stress shielding.

  As described above, according to the present invention, it is possible to provide an artificial joint stem that promotes early fixation to a bone and can maintain the effect of a drug or the like over a long period of time.

  Hereinafter, an artificial joint stem that is the best mode for carrying out the present invention will be described in detail with reference to FIGS. 1 and 2. FIG. 1 is a front view showing an example of an artificial joint stem according to the present invention together with an enlarged sectional view of a main part. 2A is a side cross-sectional view of the artificial joint stem shown in FIG. 1, and FIG. 2B is a view showing a state where a cap at the tip is removed. The artificial joint stem of this example is a cementless artificial joint stem that can be fixed to an insertion hole formed in a bone without using an adhesive (cement).

  As shown in the figure, the artificial joint stem 1 of this example includes a main body portion 4 having an outer surface shape substantially matching the inner surface shape of the insertion hole 3 formed in the bone 2, and the vicinity of the distal end side of the main body portion 4. A cavity portion 5 formed inside the body, an action imparting means 6 which is disposed in the cavity portion 5 and imparts a predetermined physiological action to the bone 2 on the inner surface of the insertion hole 3 at least in contact with the body portion 4, and a main body And a neck portion 7 which is provided on the proximal end side of the portion 4 and attaches a spherical head portion (not shown) in the artificial joint.

  The artificial joint stem 1 includes a plurality of communication holes 8 that allow the outer surface of the main body portion 4 to communicate with the cavity portion 5, and a plurality of grooves 10 that are formed in the outer surface of the main body portion 4. And a cap 12 for closing the opening 11 for disposing the action imparting means 6 formed at the tip of the main body portion 4 in the cavity portion 5.

  The main body 4 includes an outer layer 13 that is in contact with the inner surface of the insertion hole 3 of the bone 2 and has increased torsional rigidity, a main structure layer 14 that is arranged on the inner side of the outer layer 13 and continues from the neck portion 7, An innermost layer 15 that is disposed inside the structural layer 14 and serves as an inner wall of the cavity 5 is provided. As shown in the drawing, the main body 4 and the neck 7 are integrally formed and formed of a carbon fiber reinforced resin using PEEK or the like as a resin.

  The action imparting means 6 includes a predetermined medicine 16 and a permeable membrane 17 that wraps the medicine 16. Examples of the drug 16 include BMP that promotes bone growth, and antibiotics that suppress infection such as bacteria (for example, Basic FGF, gentamicin, dibekacin, cannendomycin, libidomycin, tobramycin, amikacin, fradiomycin, sisomycin, tetracycline. , Hydrochloride, oxytetracycline, hydrochloride, loritetracycline, doxycycline hydrochloride, ampicillin, piperacillin, ticarcine, cephalothin, cephaloridine, cefothiam, cefthrodine, cefmenoxime, cefmetazole, cefazoline, cefotaxime, cefoperaxam, cefoperaxam Sulfazecin, aztreonam), pain relievers (eg, bupivacaine, ropivacaine, dibucaine, Chidokain, tetracaine, lidocaine, xylocaine, procaine, chloroprocaine, Mepibikain, cinchocaine, prilocaine, cocaine, benzocaine, butamben and morphine), or the like can be used alone or in combination as appropriate. As the osmotic membrane 17, a known one can be used.

  This is because the communication hole 8 has a diameter in the range of about 0.1 to 2 mm, and even if the diameter is smaller or larger than this, there is a possibility that the action imparting means 6 cannot be sufficiently operated. . Moreover, it is because a process will become difficult when it is smaller than this, and when it is larger than this, there exists a possibility that the intensity | strength of the artificial joint stem 1 may fall.

  In this example, as shown in the figure, the groove 10 is configured by a portion extending in the axial direction of the artificial joint stem 1 and a portion extending in a direction perpendicular to the axis, and the cross-sectional shape thereof is rectangular or semicircular. It is desirable to do. The width and depth of the groove 10 are in the range of about 0.25 to 1 mm, and if it is smaller than this, the effect as an anchor cannot be expected. If it is larger than this, bone grows. This is because the period until the anchor effect is exhibited becomes too long.

  In this example, the cap 12 is locked by a locking portion formed at the tip of the main body portion 4 by an elastic force, and is formed of a carbon fiber reinforced resin like the main body portion 4. . The cap 12 may be formed by injection molding using a resin such as PEEK.

  Next, the operation of the artificial joint stem 1 of the present embodiment will be described. In this artificial joint stem 1, first, a bone 2 of a patient to which the artificial joint stem 1 is fixed is photographed using a non-destructive sectional photographing apparatus such as CT or MRI, and three-dimensionally based on the sectional images. A numerical data is created by three-dimensionally combining with CAD, and an insertion hole 3 having a predetermined inner surface shape is drilled in the patient's bone 2 by a computer-controlled surgical robot or the like based on the numerical data. To do. On the other hand, by creating a predetermined mold based on the same numerical data and molding the artificial joint stem 1 using the mold, the outer shape of the artificial joint stem 1 substantially matches the inner shape of the insertion hole 3. It can be of shape.

  The cavity 5 may be formed by inserting a deformable mandrel from the distal end side of the main body 4 when the artificial joint stem 1 is molded, or The filler 5 or the foaming material that can be taken out after molding may be arranged at the position of the cavity 5, and the cavity 5 may be formed by taking out the filler or the like after molding. You may make it form by cutting the part 5. FIG.

  The action imparting means 6 having a predetermined medicine 16 is inserted into the hollow portion 5 of the artificial joint stem 1 formed as described above through the opening 11 formed at the tip thereof, and the opening 11 at the tip is formed. The cap 12 closes. Then, the artificial joint stem 1 is inserted into the insertion hole 3 formed in the bone 2. At that time, since the tip of the cap 12 has a round shape as shown in the figure, the cap 12 can be easily inserted into the insertion hole 3 without being caught. That is, the cap 12 serves as a guide when inserted into the insertion hole 3 of the bone 2. The artificial joint stem 1 inserted into the insertion hole 3 has an outer surface shape that is substantially the same as the inner surface shape of the insertion hole 3, so that the artificial joint stem 1 is accurately positioned without rattling and embedded in the bone 2 of the patient. Will be.

  After the artificial joint stem 1 embedded in the bone 2, body fluid such as bone marrow fluid in the bone marrow cavity enters the cavity 5 through the plurality of communication holes 8 formed on the surface of the main body 4. The action imparting means 6 in the cavity 5 is immersed in the body fluid. Then, the drug 16 passes through the osmotic membrane 17 due to a difference in osmotic pressure with body fluid, etc., and is further leached into the cavity portion 5 and further through the communication hole 8 to the surface of the main body portion 4. It diffuses over the entire surface of the main body 4. Thereby, the growth of the bone 2 on the inner surface of the insertion hole 3 is promoted, and the bone 2 grows toward the surface of the main body portion 4.

  The bone 2 that grows toward the surface of the main body 4 comes into contact with the surface of the main body 4 and enters the groove 10, so that the bone 2 and the artificial joint stem 1 are mechanically firmly coupled. In addition, the patient can return to daily life because it can be fixed so as not to loosen in normal life.

  In addition, since the medicine 16 of the action imparting means 6 in the hollow portion 5 continues to be leached from the artificial joint stem 1 for several months (2 to 4 months), the growth of the bone 2 is further promoted and stronger. Thus, the artificial joint stem 1 is fixed to the bone 2.

  Thus, according to the artificial joint stem 1 of the present embodiment, the action imparting means 6 is disposed as close as possible to the position where the inner surface of the insertion hole 3 and the outer surface of the main body portion 4 are in contact. The medicine 16 of the action imparting means 6 can be reliably applied to the inner surface of the insertion hole 3 through the communication hole 8, and the growth of the bone 2 on the inner surface of the insertion hole 3 is promoted, so that the bone 2 and the artificial joint stem can be accelerated in a short period of time. It is possible to completely fill the gap with 1 and to return the patient to society in a short period of time.

  In addition, as compared with a conventional case where a drug is applied to the surface of the stem, more drug 16 can be held in the cavity 5, so that it is longer (for example, several months (2 to 4 months)). ) And the artificial joint stem 1 can be reliably fixed to the bone 2. Moreover, since it is possible to suppress the occurrence of infectious diseases such as bacteria due to the implantation operation of the artificial joint stem 1 over a long period of time by using the medicine 16 containing an antibiotic, the bacteria can be almost killed. , Can prevent the occurrence of infection.

  Furthermore, since the groove 10 having the communication hole 8 opened in the bottom portion 9 is formed on the outer surface of the main body portion 4, the bone 2 grows in the groove 10, thereby mechanically coupling the bone 2 and the artificial joint stem 1. The drug 16 and the like leached out from the communication hole 8 can be diffused more widely along the groove 10, and the effect of the drug 16 and the like can be further enhanced. The artificial joint stem 1 is fixed to the bone 2 at an early stage, so that the patient can be returned to society early.

  Moreover, since the main-body part 4 and the neck part 7 are formed with the composite material which consists of carbon fiber reinforced resin, while being able to set it as the artificial joint stem 1 provided with the optimal rigidity according to the patient, using a type | mold Since it is molded, the shape of the outer surface of the artificial joint stem 1 and the shape of the inner surface of the insertion hole 3 can be easily matched, and the initial fixing property can be made higher. Proximal fixation can be achieved and the occurrence of stress shielding can be prevented.

  Note that the artificial joint stem 1 of the present embodiment may be used as a replacement stem for a conventional stem in which an infection has occurred. In this case, the infection can be suppressed and cured for the same reason as described above. As before, the infected stem can be removed without having to perform two operations: removing the infected stem to treat the infection, and implanting a new stem after the infection has been cured. Infectious diseases can be treated simply by removing and implanting the artificial joint stem of the present invention, so that only one operation is required and the burden on the patient can be reduced.

  The present invention has been described with reference to a preferred embodiment. However, the present invention is not limited to this embodiment, and various improvements and modifications can be made without departing from the scope of the present invention, as described below. Design changes are possible.

  That is, in the artificial joint stem 1 of the present embodiment, the artificial joint stem 1 using the composite material is shown. However, the artificial joint stem 1 is not limited to this. For example, as in the conventional stem, a cobalt alloy or Ti-6Al— A titanium alloy such as 4V can also be used, and the same effects as described above can be achieved.

  In the present embodiment, the hollow portion 5 is opened at the tip of the main body portion 4. However, the present invention is not limited to this. For example, the main body portion 4 is configured to be separable, A cavity portion may be formed in the inside of the chamber, and the agent of the action imparting means in the cavity portion may be leached to the surface via a plurality of communication holes. Specifically, as shown in FIG. 3, the artificial joint stem 20 is configured such that the main body portion 4 can be divided into a proximal end portion 21 and a distal end portion 22 in the middle of the axial direction. 21 and the tip 22 are screwed together. In addition, about the thing of the structure substantially the same as the above-mentioned artificial joint stem 1, the same code | symbol is attached | subjected and detailed description is abbreviate | omitted. A cavity portion 5 having an opening 11 on the proximal end portion 21 side is formed inside the distal end portion 22, and a plurality of communication holes 8 for communicating the outer surface of the distal end portion 22 and the cavity portion 5 are provided. . The action applying means 6 is inserted and arranged in the cavity 5. This artificial joint stem 20 can also provide the same effects as described above. Note that the artificial joint stem 20 may be made of a metal such as a titanium alloy or a composite material as in the conventional case. Moreover, you may make it provide the some groove | channel 10 on the surface similarly to said embodiment. Further, the distal end portion 22 may be regarded as the cap 12, and the cavity portion 5 that holds the action applying means 6 may be formed in the cap 12. In the artificial joint stem 20, the hollow portion 5 is provided on the distal end portion 22 side, but the hollow portion 5 may be provided on the proximal end portion 21 side.

  Furthermore, in the above-described embodiment, the action imparting means 6 is shown in which the drug 16 is wrapped with the osmotic membrane 17, but the present invention is not limited to this. For example, the drug is a liquid-soluble solid (for example, powder or In a container that is placed directly in the cavity 5 as a granule or the like and dissolved in a body fluid, or a drug is absorbed in a polymer absorber or the like so as to be eluted in a body fluid or dissolved in a body fluid Alternatively, a solid or liquid drug may be sealed and the container may be dissolved by body fluid, and the same effects as described above can be achieved. Note that the leaching time may be changed depending on the type of the medicine, whereby the medicine according to the change after the operation can be supplied.

  Moreover, in said embodiment, although the medicine 16 such as BMP that promotes the growth of the bone 2, an antibiotic that suppresses infection, and an analgesic that relieves pain, was shown as the action imparting means 6, this is limited to this. For example, a micromachine capable of transmitting an ultrasonic wave that promotes bone growth may be used, so that the artificial joint stem can be fixed to the bone at an early stage as described above. In addition, it is desirable to set it as the thing of 1-2 MHz as an ultrasonic wave to transmit, and it is desirable to use the composite material with a sufficient ultrasonic permeability as a material of an artificial joint stem.

  Further, in the above embodiment, the insertion hole 3 for inserting the artificial joint stem 1 is shown as being drilled by a surgical robot. However, the present invention is not limited to this, and the insertion hole 3 drilled manually is used. Also good. Even in this case, it is desirable to match the inner shape of the insertion hole 3 with the outer shape of the artificial joint stem 1 as much as possible, and the insertion hole 3 is formed using a file manufactured in the same shape as the shape of the artificial joint stem 1. It is further desirable to drill. This also provides the same operational effects as described above, and the artificial joint stem 1 of this example can be suitably embedded in the bone 2 of the patient even when no surgical robot is provided.

It is a front view showing an example of an artificial joint stem concerning the present invention with an important section expanded sectional view. (A) is side sectional drawing of the artificial joint stem shown in FIG. 1, (B) is a figure shown in the state which removed the cap of the front-end | tip. It is a front view which shows an example of the artificial joint stem of this invention different from FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Artificial joint stem 2 Bone 3 Insertion hole 4 Main body part 5 Cavity part 6 Action imparting means 7 Neck part 8 Communication hole 9 Bottom part 10 Groove 11 Opening 12 Cap 13 Outer layer 14 Main structure layer 15 Inner layer 16 Drug 17 Osmotic membrane 20 Artificial Joint stem

Claims (5)

A neck portion for mounting a spherical head portion in an artificial joint provided on the proximal end side, and an outer surface shape that is continuous with the neck portion and substantially coincides with an inner surface shape of an insertion hole that is drilled in a bone, thereby improving torsional rigidity. An outer layer, a main structure layer arranged on the inner side of the outer layer to increase bending rigidity, an innermost layer arranged on the inner side of the main structure layer, and an inner portion near the tip side by the innermost layer and the outer layer. A body portion comprising a cavity formed and formed of a composite material ;
A plurality of communication holes for communicating the outer surface of the main body portion with the inner surface of the insertion hole and the cavity portion;
The inner surface bones of the insertion hole through the communication hole in contact with the main body, to impart a predetermined physiological activity, comprising a working application means that will be disposed within the cavity,
The artificial joint stem is inserted into the insertion hole from the distal end side of the main body and fixed to the bone without cement. The artificial joint stem according to claim 1, further comprising a plurality of grooves in the outer surface of the main body portion, in which the communication holes are opened in a bottom portion . 3. The device according to claim 1, wherein an opening for disposing the action applying means in the cavity is formed at a tip of the main body , and a cap for closing the opening is further provided . Artificial joint stem. The action applying means is a predetermined medicine;
The artificial joint stem according to any one of claims 1 to 3, wherein the drug can be leached to the outer surface of the main body portion through the communication hole . The effect applying means, artificial joint stem according to any one of up to claims 1 to 4, characterized in that the transmittable micromachine predetermined ultrasound.

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