Disclosure of Invention
In order to solve the problems in the prior art, the invention provides an implantable bone cyst windowing drainage system.
The technical scheme adopted by the invention for solving the technical problem is as follows:
the utility model provides an implanted bone cyst drainage system that windows, bores, self tapping formula cyst stopper, silica gel stopper and four parts of torque wrench by windowing and constitute, wherein:
the window drill consists of a drill bit, a drill rod and a connector, wherein the diameter of the drill bit is d;
the self-tapping cyst plug is integrally in a hollow pipeline shape, has an inner diameter of d and a length of L, and consists of a degradable plug head, a pure titanium main body and a smooth tail part;
the degradable plug is made of polylactic acid, the outer surface of the degradable plug is in a conical column shape, the degradable plug is gradually narrowed from the tail to the head, the polymerization degree is 3 degrees, the diameter of the head is equal to the inner diameter of the hollow pipeline and is d, and the diameter of the tail is d +0.6 mm; the surface of the degradable plug is provided with threads, and a plurality of through holes are formed at the threads;
the outer surface of the pure titanium main body is provided with double threads, and the thread pitch of the double threads is smaller than that of the surface of the degradable plug head; the pure titanium main body is gradually narrowed from the tail part to the head part, the polymerization degree is 5 degrees, and the diameter of the tail part is d +1.2 mm; the surface of the pure titanium main body is subjected to sand blasting and acid etching treatment by using 250-500 mu m large-particle corundum, so that the surface of the pure titanium main body obtains a micron/submicron double-layer structure;
the tail part of the degradable plug head is in conical butt joint with the head part of the pure titanium main body, and the connecting surface of the degradable plug head and the head part of the pure titanium main body is subjected to frosting treatment;
the smooth tail is made of pure titanium, the surface is smooth, the height is high, and the height is h; the side surface is round, the section of one side close to the pure titanium main body is circular, the section of the other side is regular hexagon, the outer diameter is D, and D is D +5 mm;
the silica gel plug consists of a plug head, a retention pad and a plug tail, wherein the diameter of the plug head is equal to the inner diameter of the self-tapping cyst plug body part, and the diameter is d; the diameter of the retention pad is d +3 mm;
the torque wrench consists of a head part, a connecting rod and a tail part, and the total length is H; the head part is matched with the tail part of the self-tapping cyst plug in shape and size, and the outer diameter k of the head part is D +4 mm; the head inner diameter is equal to the smooth tail outer diameter of the self-tapping cyst plug, and is D.
Furthermore, the bottom of the drill is in a disc shape, the edge of the drill is provided with an edge-shaped sheet, the length of the edge-shaped sheet is b, and b is 5 mm.
Further, drilling rod and connector are general type, and the connector can link to each other with the planter, and torque wrench's connecting rod and afterbody are planted with general type and are driven the cooperation to use with general type planting torsion booster.
Further, the self-tapping cyst plug has an inner diameter d of 8mm and a length L of 7mm, or an inner diameter d of 11mm and a length L of 9mm, or an inner diameter d of 14mm and a length L of 11 mm.
Further, the preparation method of the polylactic acid comprises the following steps: reacting L-ammonium lactate obtained by fermentation with ethanol at 90-100 deg.C, separating, and collecting ethanol; removing water in the reaction at 120 ℃; the ethyl lactate obtained is purified by distillation, condensed at 160 ℃ in the presence of octyl tin and freed from ethanol. Distilling the obtained reaction liquid at 200 ℃ to obtain lactic acid; the polylactic acid is prepared by polymerizing lactic acid in the presence of octyl tin.
Further, the preparation method of the degradable plug comprises the following steps: adding polylactic acid into an extruder for melting, and cutting the polylactic acid into a required shape by laser after forming a pipe.
Further, the thread pitch of the degradable plug is 1.1mm, and the thread pitch of the pure titanium main body is 0.3 mm.
Further, the aperture of the through hole of the degradable plug is 0.5mm, and the space between the pores is 0.8 mm.
Further, the sand blasting and acid etching treatment method of the surface of the pure titanium main body comprises the following steps: carrying out sand blasting treatment on the surface of the smooth pure titanium main body by using 250-type 500 mu m large-particle corundum sand, carrying out ultrasonic treatment on the sand-blasted pure titanium main body for 15 minutes by using acetone, ethanol and pure water respectively, then washing by using a large amount of pure water, and drying by using nitrogen; then, treating the titanium by using a mixed solution of sulfuric acid and hydrochloric acid, and directly washing the treated pure titanium main body by using a large amount of water; next, secondary acid etching is performed: treating for 30 minutes by using a mixed solution of sulfuric acid and hydrogen peroxide to form a multi-scale micro-nano composite structure; and directly treating the acid-etched pure titanium main body at 450-550 ℃ for 30 minutes, and naturally cooling at room temperature after treatment to obtain the surface of the sand-blasting acid-etched pure titanium main body.
Further, the threads of the pure titanium body are at near right angles.
Compared with the prior art, the invention has the beneficial effects that:
1. the cyst plug is stably fixed, and the possible damage to adjacent teeth is avoided.
2. The self-tapping cyst plug has good biocompatibility and is beneficial to bone formation and gum formation.
3. The operation and the cyst plug are put into the operation bag at one time, thereby saving the operation time, avoiding the second-stage operation and reducing the number of times of the patient's double-diagnosis.
4. The material that need not frequent change is used, and medical staff and patient wash by oneself of being convenient for, wash more thoroughly, the drainage is more abundant.
5. The X-ray radiation-resistant material is used, so that the position, the angle, the relation with the cyst cavity and the like of the cyst plug can be observed conveniently through the X-ray sheet.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and examples.
As shown in fig. 1 to 8, the implantable bone cyst windowing drainage system provided by the present invention is composed of a windowing drill, a self-tapping cyst plug, a silica gel plug and a torque wrench, wherein:
(1) fenestration drill (shown in fig. 1):
is made of tungsten steel and comprises a drill bit 1, a drill rod 2 and a connector 3.
The bottom of the drill 1 is in a disc shape, the edge of the drill is provided with an edge-shaped slice, the diameter of the drill 1 is d, the length of the drill is b, and b is 5 mm. The drill rod 2 and the connector 3 are universal, and the connector 3 can be connected with a planting machine.
(2) Self-tapping cyst plug (shown in fig. 2, 3, and 4):
the whole body is in a hollow pipeline shape, the inner diameter is d, and the length is L. Because different patients age, position of windowing, size of the cystic cavity and anatomical situation, etc. are different, so d and L respectively set three different numerical values, which are: the inner diameter d is 8mm and the length L is 7mm, or the inner diameter d is 11mm, the length L is 9mm, or the inner diameter d is 14mm and the length L is 11 mm. In clinical application, the appropriate model is selected according to the specific situation of a patient. D of different models is larger than the outer diameter of the disposable suction tube which is commonly used clinically, when medical staff washes the cyst, the disposable suction tube can be inserted into the self-tapping cyst plug hollow pipeline to reach the cyst cavity, and cyst fluid and washing fluid are sucked out, so that the washing is more thorough.
A self-tapping cyst plug consists of three parts: degradable plug 4, pure titanium main body 5 and smooth tail 6.
The degradable plug 4 is made of polylactic acid. Polylactic acid is a novel synthetic biodegradable medical polymer biomaterial, is prepared by using a starch raw material provided by renewable plant resources (such as corn), and has good biological safety. It can be degraded in vivo by simple hydrolysis of ester bond, the degradation product lactic acid can participate in vivo circulation, and the final products of metabolism are carbon dioxide and water, and can be metabolized and discharged in vivo. In the initial stage of degradation, the degradation reaction is carried out slowly, the shape and weight of the material are not changed greatly, the degradation speed is gradually accelerated along with the reduction of the molecular weight, the material is obviously weightless and dissolved until the material completely disappears, and the degradation time is 1-2 years. After the operation, the cavity is gradually reduced along with the gradual formation of a new bone, the degradable plug head is gradually degraded, the self-tapping cyst plug does not need to be frequently taken out to be subjected to grinding adjustment or replacement, the effect of the self-tapping cyst plug matched with the gradually reduced cavity in size can be achieved, and the number of times of the patient for the re-diagnosis can be reduced.
The method for preparing the polylactic acid comprises the following steps: reacting L-ammonium lactate obtained by fermentation with ethanol at 90-100 deg.C, separating, and collecting ethanol; removing water in the reaction at 120 ℃; the ethyl lactate obtained is purified by distillation, condensed at 160 ℃ in the presence of octyl tin and freed from ethanol. The resulting reaction solution was distilled at 200 ℃ to obtain lactic acid. The polylactic acid is prepared by polymerizing lactic acid in the presence of octyl tin.
The preparation method of the degradable plug 4 comprises the following steps: adding the prepared polylactic acid into an extruder for melting, and cutting the polylactic acid into a required shape by using laser after forming a pipe, wherein the specific steps are as follows:
the outer surface of the degradable plug head 4 is in a cone column shape, the degradable plug head gradually narrows from the tail part to the head part, the polymerization degree is 3 degrees, the diameter of the head part is equal to the inner diameter of the hollow pipeline, d is the diameter of the tail part, and the diameter of the tail part is d +0.6 mm. The surface of the degradable plug is provided with threads, the thread pitch is 1.1mm, and excellent initial stability can be provided. The thread and the conical design enable the cyst plug to have certain self-tapping performance, and the self-tapping cyst plug can be quickly screwed into a bone after a windowing drill is used for windowing in an operation, so that the cyst plug is more convenient to implant, and the operation time can be saved.
The degradable plug 4 is in a net shape and is provided with a plurality of round pores, and through earlier measurement and test, the outer diameter of the selected pores is 0.5mm, and the space between the pores is 0.8mm, so that the purpose of full drainage can be achieved while the strength of the degradable plug is ensured. Because the existence in hole, flush fluid and bag liquid both can be followed the head business turn over of degradable chock plug, can follow the side business turn over of degradable chock plug again, compare with the head business turn over that prior art flush fluid and bag liquid can only follow the chock plug, wash more thoroughly, and the drainage is more abundant.
The pure titanium main body 5 is made of pure titanium, the pure titanium is light in weight, low in elastic modulus, large in damping force to vibration and excellent in passivation performance, can be quickly oxidized in body fluid, and a thin, compact and insoluble oxide film with a crystal structure is formed on the surface of the pure titanium. Because of the protection of the oxidation film, the continuous oxidation speed of the metal is reduced, so that the metal has good corrosion resistance, biocompatibility and biomechanical adaptability with a human body.
The outer surface of the pure titanium main body 5 is provided with double threads, the thread pitch is 0.3mm, and the implantation time can be effectively shortened. The screw thread is designed to be nearly right-angled, and a bone forming space is additionally created. The excellent retention thread can effectively reduce the stimulation to the marginal cortical bone, reduce the bone absorption, and can ensure that the cortical bone and the pure titanium main body obtain good initial stability and optimal sealing. The pure titanium main body is gradually narrowed from the tail part to the head part, the polymerization degree is 5 degrees, and the diameter of the tail part is d +1.2 mm. The thread and taper design enables the implant to have certain self-tapping property, the implant is more convenient, and the operation time can be saved.
SLA (Sand-blasted Large-grain Acid-etched Sand etching) surface treatment is carried out on the surface of the pure titanium main body 5, and the specific method comprises the following steps: carrying out sand blasting treatment on the surface of the smooth pure titanium main body by using 250-type 500 mu m large-particle corundum sand, carrying out ultrasonic treatment on the sand-blasted pure titanium main body for 15 minutes by using acetone, ethanol and pure water respectively, then washing by using a large amount of pure water, and drying by using nitrogen; then, treating the titanium by using a mixed solution of sulfuric acid and hydrochloric acid, and directly washing the treated pure titanium main body by using a large amount of water; next, secondary acid etching is performed: treating for 30 minutes by using a mixed solution of sulfuric acid and hydrogen peroxide to form a multi-scale micro-nano composite structure; and directly treating the acid-etched pure titanium main body at 450-550 ℃ for 30 minutes, and naturally cooling at room temperature after treatment to obtain the stable and high-performance pure titanium main body surface. The treatment can enable the surface of the titanium to obtain a micron/submicron double-layer structure, and the micron/submicron double-layer composite structure can enlarge the specific surface area of the titanium, so that the contact area of the surface with adhesion cells and a body fluid environment is increased, and the adhesion, proliferation and differentiation of osteoblasts are facilitated. On the other hand, a rough surface may also improve the mechanical interlocking of the bone-implant interface, thereby improving the initial stability of the implant. The osteogenesis at the fenestration position can be promoted to form biological fixation. It is used by implanting into bone to the position of SLA rough surface edge. Mechanical and biological fixation provides good retention of the self-tapping cyst plug without the need for other means such as clasps or the like to be placed adjacent the teeth.
The tail of the degradable plug 4 is in conical butt joint with the head of the pure titanium main body 5, the two connecting surfaces are both subjected to abrasive treatment, the connecting surface becomes rough after the abrasive treatment, the contact area is increased, the friction force is increased, and the retention is stable.
The smooth tail 6 is made of pure titanium, has a smooth surface and is highly polished, so that bacterial adhesion can be reduced. The smooth tail part 6 is round and blunt in side surface, the cross section of one side close to the pure titanium main body is round, the shape can not cause damage to the gum, and the gum forming is facilitated. The cross-section of opposite side is regular hexagon, and the external diameter is D, and D is D +5mm, and torque wrench arranges in it, again with the cooperation of general type planting torsion booster use, can be with in the bone is screwed into to self tapping formula cyst stopper, the simple operation saves the operation time. Smooth 6 high h in afterbody, because the difference of gum biotype, establish three different numerical values, do respectively: h is 2.1mm, h is 2.6mm, and h is 3.1mm, and the appropriate model is selected clinically according to specific conditions.
(3) Silica gel plug (as shown in fig. 5):
is integrally made of silica gel and comprises a plug head 7, a retention pad 8 and a plug tail 9. The diameter of the plug head 7 is equal to the inner diameter of the self-tapping cyst plug body part, and is d; the diameter of the retention pad is d +3 mm.
(4) Torque wrench (as shown in fig. 6, 7, 8):
made by the steel, including head 10, connecting rod 11 and afterbody 12, total length is H, and H sets up three numerical value, is respectively: h12 mm, H19 mm and H26 mm to meet the requirements of different anatomical parts. The shape and the size of the head 10 are matched with those of the tail of the self-tapping cyst plug, and the inner diameter of the head 10 is equal to the outer diameter of the tail of the self-tapping cyst plug, namely D; the head outer diameter k is D +4 mm. The connecting rod 11 and the tail part 12 are matched with a universal planting wrench and can be used with a universal planting torque assistor.
The use method of the implantable bone cyst windowing drainage system comprises the following steps:
the lower corresponding part of the cyst cavity is selected to cut the mucous membrane, the valve is turned, the bone is drilled by a windowing drill to reach the cyst cavity, a small cyst wall is taken to send pathology, the cyst cavity is alternately flushed by physiological saline and 3 percent hydrogen peroxide solution, and after the cyst cavity is flushed completely, the self-tapping cyst plug is screwed into the bone by a torque wrench. And plugging a silica gel plug. The rest is the same as the conventional operation of windowing drainage.
Compared with the prior art, the implantable bone cyst windowing drainage system has the following beneficial effects:
1. is convenient for medical staff to wash. The inner diameter of the self-tapping cyst plug is larger than the outer diameter of a disposable suction tube which is commonly used clinically, when medical staff washes the cyst plug, the disposable suction tube can be inserted into a hollow pipeline of the self-tapping cyst plug to reach a cyst cavity, cyst fluid and washing fluid are sucked out, and the washing is more thorough.
2. The number of times of the patient's return visits is reduced.
(1) The degradable plug is made of polylactic acid. The polylactic acid is a synthetic biodegradable medical polymer biomaterial and has good biological safety. After the operation, the cavity is gradually reduced along with the gradual formation of a new bone, the degradable plug head is gradually degraded, the self-tapping cyst plug does not need to be frequently taken out to be subjected to grinding adjustment or replacement, the effect of the self-tapping cyst plug matched with the gradually reduced cavity in size can be achieved, and the number of times of the patient for the re-diagnosis can be reduced.
(2) The operation and the cyst plug can be put into the operation and the cyst plug.
3. The flushing is more thorough and the drainage is more sufficient. The degradable chock plug is netted, has a great deal of hole, because the existence in hole, the head business turn over of degradable chock plug both can be followed to flush fluid and bag liquid, can follow the side business turn over of degradable chock plug again, can only follow the head business turn over of chock plug with prior art flush fluid and bag liquid and compare, wash more thoroughly, the drainage is more abundant.
4. Saving operation time.
(1) The window drill can quickly remove bone substances.
(2) The self-tapping cyst plug is pre-formed and provided with various different types, and the proper type can be selected according to different ages, windowing parts, sizes of cyst cavities and different anatomical conditions of different patients.
(3) The thread of degradable chock plug and pure titanium main part adds the toper design and makes it have certain self tapping nature, and self tapping formula cyst stopper afterbody be hexagonal prism form, and torque wrench arranges on it, uses with the cooperation of general type planting torque booster again, can be fast with self tapping formula cyst stopper in screwing into the bone, the simple operation, implant rapidly.
(4) The gingival suture is not needed in the operation.
5. The self-tapping cyst plug has good biocompatibility.
(1) The degradable plug is made of polylactic acid. The polylactic acid is a synthetic biodegradable medical polymer biomaterial and has good biological safety. It can be degraded in vivo by simple hydrolysis of ester bond, the degradation product lactic acid can participate in vivo circulation, and the final products of metabolism are carbon dioxide and water, and can be metabolized and discharged in vivo.
(2) The pure titanium main body and the smooth tail part are made of pure titanium, the passivation performance of the titanium is excellent, the titanium can be quickly oxidized in body fluid, and a thin, compact and insoluble oxide film with a crystal structure is formed on the surface. Because of the protection of the oxidation film, the continuous oxidation speed of the metal is reduced, so that the metal has good corrosion resistance, biocompatibility and biomechanical adaptability with a human body.
6. The retention is stable.
(1) The degradable plug surface thread pitch is 1.1mm, which provides excellent initial stability.
(2) The excellent retention thread of the pure titanium main body can effectively reduce the stimulation to the marginal cortical bone, reduce the bone absorption and ensure that the cortical bone and the pure titanium main body obtain good initial stability and optimal sealing.
(3) The surface of the pure titanium main body is subjected to SLA surface treatment, and the rough surface can improve the mechanical embedding of a bone-implant interface, so that the initial stability of the implant is improved.
Mechanical and biological fixation provides good retention of the self-tapping cyst plug without the need for other means such as clasps or the like to be placed adjacent the teeth.
7. Is beneficial to bone formation.
The pure titanium main body threads are designed to be approximately right angles, and a bone forming space is additionally created. SLA (Sand-blasted Large grain Acid-etched Large grain Sand blasting and Acid etching) surface treatment is carried out on the surface of the pure titanium main body, the treatment can enable the titanium surface to obtain a micron/submicron double-layer structure, and the micron/submicron double-layer composite structure can enlarge the specific surface area of titanium, so that the contact area of the surface with adhesion cells and a body fluid environment is increased, and the adhesion, proliferation and differentiation of osteoblasts are facilitated.
8. Is beneficial to the formation of gum. Smooth afterbody is made by pure titanium, and the surface is smooth, high polishing, and the side round is blunt, and the cross-section of the one side that is close to the pure titanium main part is circular, and this kind of design can not cause the injury to the gum, and is favorable to the gum to take shape.
9. Avoiding the second stage operation. The cyst windowing operation and the cyst plug placing operation are completed at one time, and the secondary operation required by wound healing can be avoided.
10. Is convenient for the patient to wash by himself. The jaw is selected to be windowed at a low position, and after the silica gel plug is taken off, the sac liquid is easy to flow out due to the action of gravity, so that the patient can wash the sac liquid by himself.
11. The titanium has strong X-ray radiation resistance, and the position, the angle, the relation with the cyst cavity and the like of the cyst plug can be observed through an X-ray sheet.
While embodiments of the invention have been disclosed above, it is not intended to be limited to the uses set forth in the specification and examples. It can be applied to all kinds of fields suitable for the present invention. Additional modifications will readily occur to those skilled in the art. It is therefore intended that the invention not be limited to the exact details and illustrations described and illustrated herein, but fall within the scope of the appended claims and equivalents thereof.