CN102048593B - Introducer manufacturing method - Google Patents
Introducer manufacturing method Download PDFInfo
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- CN102048593B CN102048593B CN 200910209455 CN200910209455A CN102048593B CN 102048593 B CN102048593 B CN 102048593B CN 200910209455 CN200910209455 CN 200910209455 CN 200910209455 A CN200910209455 A CN 200910209455A CN 102048593 B CN102048593 B CN 102048593B
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Abstract
The invention relates to a guide and a manufacturing method thereof, wherein an invasion position of an implant body implanted in an affected part is planned, an invasion path of the implant body from the invasion position to the affected part is planned, and a guide is manufactured according to the invasion position, the invasion path, an implant body model and the affected part model, so that the guide is provided with a combination part which is in accordance with the affected part model and a guide part which is in accordance with the implant body model, the invasion position and the invasion path.
Description
Technical Field
The present invention relates to a method for manufacturing a guide, and more particularly, to a method for manufacturing a guide that assists in accurately implanting an implant into an affected part.
Background
In the conventional orthopedic surgery, a physician uses an X-ray or Computed Tomography (CT) image of a patient's bone and his own anatomical knowledge and clinical surgery experience to evaluate the surgery, and the surgery cannot be performed precisely according to the preoperative surgical plan due to lack of an accurate guiding device, so the conventional orthopedic surgery has the following four problems:
1. the precision of the pre-operative diagnosis and the surgical path planning is not high, and if the affected part or tissue near the invasive path is damaged, the patient will be seriously damaged. Further, since the physician cannot accurately know the relative relationship between the affected part or the invasion path and the surrounding tissues, the physician is forced to abandon the operation.
2. As described above, since the positioning accuracy during the operation is not high, a physician may open a large opening at the affected part of the patient to allow an error in the position where the surgical instrument invades the affected part or an error in the position where the implant is placed. However, the aforementioned errors cause injury to the patient, even serious injury that cannot be compensated for. In recent years, the concept of minimally invasive surgery is gradually applied to various clinical surgeries, and as the surgical wounds become smaller and smaller, the tolerable error is reduced, so that the traditional surgical instruments are limited in use.
3. Before operation, an orthopedic operation clinician with abundant experience needs to plan the invasion position and the invasion path in the operation. Therefore, the quality of the operation (e.g., accuracy, safety and reliability) is more difficult to be determined by the physician with less experience.
4. Because the traditional operation method mostly depends on the experience of doctors, only a clinical teaching mode is available in the teaching of relevant operations, and relevant patient defect teaching models cannot be provided for auxiliary learning.
Based on the above-mentioned problems, the conventional orthopedic surgery method is extremely dependent on the clinical experience of the physician, and has the problems of inaccuracy, insecurity and unreliability, and cannot evaluate the relative relationship between the affected part or the tissue near the invasion path, so that the uncertainty in the surgery process is very high, and therefore, how to provide a technique capable of improving the accuracy, safety and reliability of the surgery, and reducing the operation error rate and the clinical stress of the physician without excessively depending on the personal experience of the physician is an extremely slow and urgent problem to be solved.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a method for manufacturing a guide, which solves the problem of extremely high uncertainty in the operation process of the traditional orthopedic operation, and achieves the purposes of small operation incision, small infection chance, and improvement of the accuracy, safety and reliability of the operation.
In accordance with an object of the present invention, there is provided a method for manufacturing a guide, comprising the steps of planning an invasion position where an implant is implanted into an affected part, planning an invasion path where the implant invades the affected part from the invasion position, and manufacturing a guide based on the invasion position, the invasion path, a shape of the implant, and a shape of a tissue of the affected part. The guide has a combination part conforming to the shape of the affected part and a guide part conforming to the shape of the implant, the invasion position and the invasion path, so that when the combination part of the guide is placed on the affected part, the guide part is attached to the affected part, and the guide part is aligned to the invasion position, and the implant is implanted into the tissue of the affected part through the guidance of the invasion path.
In view of the above, the method for manufacturing the guide of the present invention has the following advantages:
(1) the guide can be used to assist the operation, so that the tissue with important functions (such as nerves or major arteriovenous) except the affected part can be prevented from being damaged, thereby improving the accuracy, safety and reliability of the operation.
(2) The guide can shorten the time for a student to learn the operation method in the teaching of the operation method, and can make an intern or a student in a medical college more easily know the implementation process of the operation method.
Drawings
FIG. 1 is a schematic view of the guide of the present invention installed in the affected part (left hip joint);
FIG. 2 is a combined view of the guide of the present invention installed in the affected part (cervical vertebrae);
FIG. 3 is a schematic view showing the guide of the second embodiment of the present invention installed in another affected part (left hip joint);
FIG. 4 is a flow chart illustrating the manufacturing process of the introducer manufacturing method of the present invention;
FIG. 5 is a flow chart of the creation of an implant database according to the present invention; and
fig. 6 is a flow chart of the creation of the affected part model database according to the present invention.
Wherein,
1: a guide;
10: a bonding section;
12: a guide part;
120: implanting an aperture;
2: a tissue mass;
4: a first introducer;
40: a first coupling portion;
42: a first guide part;
420: a first implant hole;
44: a second guide part;
440: a second implant hole;
5: a second introducer;
50: a second joint part;
52: a third guide part;
520: a third implant hole;
6: a third introducer;
60: a third joint part;
62: a third guide part;
620: a fifth implant hole;
7: the femoral head;
c1: the first cervical vertebra;
c2: the second cervical vertebra;
S10-S30: a step of;
s101 to S103: a step of; and
s201 to S203: and (5) carrying out the following steps.
Detailed Description
Referring to fig. 1, fig. 1 is a schematic view of the introducer of the present invention. In the figure, the guiding device 1 comprises a combining part 10 and at least one guiding part 12, wherein the shape of the combining part 10 corresponds to the surface structure of a tissue 2 of an affected part and an invasion position of an implant (not shown) into the tissue 2, furthermore, the guiding part 12 is connected to the surface of the combining part 10, the guiding part 12 is provided with an implantation hole 120 through, and the shape of the hole of the implantation hole 120 is in accordance with an invasion path of the implant into the tissue 2. Thus, when the connecting portion 10 is placed on the surface of the tissue 2, the connecting portion 10 will be attached to the surface of the tissue 2, and the implantation hole 120 faces one end of the tissue 2 to the position just corresponding to the invasion position of the tissue 2 to be implanted into an implant, and the other end of the implantation hole 120 corresponds to the surgical opening of the affected part.
Referring to fig. 2, fig. 2 is a combination view illustrating the guide of the present invention installed in an affected part (cervical vertebra), in a first embodiment of the present invention, the guide is applied to a cervical vertebra pedicle screw implantation operation, and the tissue to be operated is left and right vertebral arches of a first segment C1 of the cervical vertebra and a second segment C2 of the cervical vertebra, and two implants (in this embodiment, an implant is a bone screw) are implanted respectively. Therefore, in the first embodiment of the present invention, a first guide 4 and a second guide 5 are respectively installed at the first cervical vertebra segment C1 and the second cervical vertebra segment C2, wherein the first guide 4 is provided with a first coupling portion 40 having a shape conforming to the shape of the surface structure of the installation site of the first cervical vertebra segment C1 and a first bone screw and a second bone screw invade the invasion site of the first cervical vertebra segment C1. And the shape of the second coupling part 50 of the second guide 5 conforms to the shape of the surface structure of the installation site of the second cervical vertebra segment C2 and an invasion site where a third bone screw and a fourth bone screw invade the second cervical vertebra segment C2.
Also, the first guide 4 includes a first guide portion 42 and a second guide portion 44, and the second guide 5 includes a third guide portion 52 and a fourth guide portion (not shown in fig. 2). Wherein the shape of the hole of the first implanting hole 420 formed in the first guiding part 42 is in accordance with the invasion path of the first bone screw into the first section C1 of cervical vertebrae, and the shape of the hole of the second implanting hole 440 formed in the second guiding part 44 is in accordance with the invasion path of the second bone screw into the first section C1 of cervical vertebrae. Furthermore, the shape of the third implant hole 520 formed in the third guide portion 52 corresponds to the invasion path of the third bone screw into the second section C2 of the cervical vertebrae, and the shape of the hole of the fourth implant hole formed in the fourth guide portion corresponds to the invasion path of the fourth bone screw into the second section C2 of the cervical vertebrae. The invasion path refers to the angle and depth of the surgical instrument to drill the cervical spine.
Accordingly, the first guide 4 and the second guide 5 can be attached to the left and right vertebral arches of the first cervical vertebra segment C1 and the second cervical vertebra segment C2, and the first to fourth implantation holes (420, 440, 520, not shown in fig. 2) of the first to fourth guide portions (42, 44, 52, not shown in fig. 2) can be exactly corresponding to the invasive positions of the left and right vertebral arches of the first cervical vertebra segment C1 and the second cervical vertebra segment C2, so that the surgical instruments (e.g., surgical drills can be inserted into the left and right vertebral arches of the first cervical vertebra segment C1 and the second cervical vertebra segment C2 to the depth, angle and position of the invasive path preset by the first to fourth implantation holes (420, 440, 520, not shown in fig. 2) through the guidance of the first to fourth implantation holes (420, 440, 520, not shown in fig. 2). After the first and second guides (4, 5) are removed from the cervical vertebrae, the first to fourth bone screws can be installed at the correct depth, angle and position of the invasion path, so as to avoid invasion to other important tissues (such as the nerve plexus around the cervical vertebrae). Thereby improving the operation accuracy, safety and reliability of the cervical vertebra arch bone nail implantation operation.
Referring to fig. 3, fig. 3 is a combined schematic view of the guide of the second embodiment of the present invention installed in another affected part (left hip joint), and the guide of the present embodiment is applied to a left hip joint femoral head surface replacement surgery (HipResurfacing arthrodesis), in which the tissue to be operated is the femoral head of the left hip joint. During operation, a central shaft extending along the axis of the femoral neck is drilled in the femoral head, the central shaft is used in conjunction with a rotary grinding instrument to grind out necrotic tissue in the femoral head, and finally a semicircular implant with a central column is implanted along the central shaft, wherein the implant is an artificial joint (such as a surface metal ball head). Thus, in the second embodiment of the invention, a third guide 6 is provided in the left hip joint. The shape of the third joint 60 provided in the third guide 6 is adapted to the shape of the surface structure of the left hip joint mounting position and the position of the artificial joint mounted on the left hip joint. The shape of the hole of the fifth implantation hole 620 provided in the third guide part 62 provided in the third guide 6 conforms to the invasion path of the hip joint of the left foot for installing the artificial joint. Thus, when a surgical instrument (e.g., an electric surgical drill) is guided through the fifth implantation hole 620, the depth, angle and position of the predetermined invasion path can be drilled, and the rotating and grinding instrument is used to remove the necrotic femoral head 7 tissue and avoid invasion of other important tissues (e.g., normal femoral head), and then the artificial joint is fixed on the femoral head of the left foot. Thereby improving the operation accuracy, safety and reliability of the femoral head surface replacement operation of the left foot hip joint.
In summary, in the first and second embodiments of the present invention, the guide is applied to the cervical vertebra arch nail implantation operation and the left foot hip joint femoral head surface replacement operation as an example, but the present invention is not limited thereto in practical implementation, and the guide may be applied to the spine fixation, Total Knee Replacement (TKR) or half knee replacement (UKR), Total Hip Replacement (THR) or half hip joint replacement and fracture reconstruction, and may also be applied to the dental implant operation or other plastic surgeries. Therefore, the tissue object can be one of cervical vertebral arch, vertebra, femoral head of hip joint and bone of total knee joint.
Referring to fig. 4, fig. 4 is a flow chart illustrating a method for manufacturing a guide according to the present invention. In the figure, the manufacturing process of the introducer includes the following steps. Step (S10): planning an invasion position of a tissue object implanted into a diseased part by an implant; step (S20): planning an invasion path of the implant body from the invasion position to the tissue of the affected part; in the present invention, it is not necessary to perform the step (S20) after the step (S10) is performed, and the step (S20) may be performed before the step (10). Step (S30): an introducer is made according to the invasion position, invasion path and the shape of the tissue of the affected part of the implant. Thus, the guide device manufactured by the method has a combination part which is in accordance with the shape of the tissue and a guide part which is in accordance with the invasion position and the invasion path of the implant, so that when the combination part of the guide device is placed on the affected part, the guide device is attached to the affected part, at the moment, the guide part is aligned to the invasion position, and the surgical instrument is guided by the invasion path to complete the surgical procedure before the implant is installed, so that the implant can be accurately implanted on the tissue of the affected part.
In the method for manufacturing the guide of the present invention, before the step of planning the invasion position of the implant into the affected tissue or before the step of planning the invasion path of the implant from the invasion position into the affected tissue, an implant database is further established, please refer to fig. 5, and fig. 5 is a flow chart for establishing the implant database of the present invention. The implant database is established according to the following steps: step (S101): three-dimensional scanning is carried out on a plurality of implants one by one; step (S102): respectively generating an implant three-dimensional image according to the three-dimensional scanning result of each implant; step (S103): classifying and marking the three-dimensional images of the implants according to the characteristics of the implants such as types, sizes, shapes and the like so as to respectively generate implant data and establish an implant database.
In the method for manufacturing the introducer of the present invention, before the step of planning the invasion position of an implant into an affected tissue or the step of planning the invasion path of the implant from the invasion position into the affected tissue, an affected image data may be established, referring to fig. 6, fig. 6 is a flow chart for establishing the affected image data of the present invention, the affected model database is established according to the following steps, and the steps include: step (S201): obtaining an image of an affected part of a patient; in the present invention, the affected part image may be any one of a computed tomography image or an X-ray radiographic image of the patient with respect to the affected part; step (S202): performing two-dimensional contour capture on the tissue object according to the affected part image to obtain two-dimensional contour data of the tissue object; step (S203): and reconstructing a three-dimensional medical image according to the two-dimensional contour data, and taking the three-dimensional medical image as affected part image data.
In the present invention, the three-dimensional medical image for reconstructing the model of the tissue object according to the two-dimensional profile data is an implant three-dimensional image in an implant database, and is used for planning an invasion position and an invasion path, and a three-dimensional image of the guide is generated according to the three-dimensional medical image and the implant three-dimensional image, so that the guide three-dimensional image is used for generating a customized guide by using a three-dimensional engraving machine, a rapid prototyping machine (such as a three-dimensional printer), a three-dimensional modeling method, and the like.
As described above, in the present invention, when planning an invasion position at which an implant is implanted into an affected part or planning an invasion path through which the implant invades the affected part from the invasion position, an implant that is most suitable for the characteristics such as the size and shape of a tissue of the affected part is planned using the implant database and the affected part image data, and the invasion position and the invasion path of the implant are planned to avoid damage to the tissue other than the affected part, and a guide for the tissue most suitable for the affected part can be produced in accordance with the implant model, the invasion position, and the invasion path.
In summary, the present invention finds out the proper implant according to the size and shape of the affected part of the patient, and plans the customized guide according to the structure and relative position relationship of the tissue of the affected part of the patient, so that the accuracy, safety and reliability of the operation can be improved by the aid of the guide during the operation. In addition, the invention can utilize the structure model of the guide and the tissue of the affected part to carry out the teaching of the operation, improve the efficiency of learning the relevant operation, shorten the teaching time, and can be used as the evaluation of the operation exercise and the effect before the operation.
The foregoing is by way of example only, and not limiting. It is intended that all equivalent modifications or variations without departing from the spirit and scope of the present invention shall be included in the scope of the appended claims.
Claims (9)
1. A method of making an introducer comprising the steps of:
three-dimensional scanning is carried out on a plurality of implants one by one;
generating three-dimensional images of the implants according to the three-dimensional scanning results of the implants respectively;
classifying and marking the three-dimensional images of the plurality of implants according to the characteristics of the three-dimensional images to establish an implant database;
planning an invasion position of the implant implanted into an affected part;
planning an invasion path of the implant from the invasion position to the affected part; and
and manufacturing a guide according to the invasion position of the implant, the invasion path, the implant shape and the shape of a group of fabrics of the affected part.
2. The method of manufacturing of claim 1, wherein the features of the three-dimensional image include one or more of a type, a size, and a shape of the three-dimensional image.
3. The method of claim 1, further comprising creating an image of the diseased portion prior to planning the invasive site for implantation of the implant at the diseased portion or prior to planning the invasive pathway for the implant to invade the diseased portion from the invasive site.
4. The manufacturing method according to claim 3, wherein the step of creating image data of the affected part comprises:
obtaining an image of an affected part of a patient;
performing two-dimensional contour capture on the tissue object according to the affected part image to obtain two-dimensional contour data of the tissue object; and
and reconstructing a three-dimensional medical image according to the two-dimensional contour data, and taking the three-dimensional medical image as the affected part image data.
5. The method of claim 4, wherein the affected part image is a computed tomography image or an X-ray image of the patient with respect to the affected part.
6. The manufacturing method according to claim 3, wherein when the planning of the invasion position of the implant into the affected part or the planning of the invasion path of the implant from the invasion position into the affected part, the implant database and the affected part image data are further used to acquire the implant in accordance with the characteristics of the tissue of the affected part, thereby planning the invasion position and the invasion path of the implant.
7. The method of claim 6, wherein the characteristics of the affected area of tissue include a size and a shape of the tissue.
8. The method of manufacturing according to claim 4, further comprising creating an introducer three-dimensional image of the introducer based on the three-dimensional medical image and the implant three-dimensional image.
9. The method of claim 8, wherein when the guide is fabricated, the guide is fabricated using a three-dimensional engraving machine, a rapid prototyping machine, or by three-dimensional modeling based on a three-dimensional image of the guide.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910209455 CN102048593B (en) | 2009-10-30 | 2009-10-30 | Introducer manufacturing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910209455 CN102048593B (en) | 2009-10-30 | 2009-10-30 | Introducer manufacturing method |
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| Publication Number | Publication Date |
|---|---|
| CN102048593A CN102048593A (en) | 2011-05-11 |
| CN102048593B true CN102048593B (en) | 2013-10-30 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200910209455 Expired - Fee Related CN102048593B (en) | 2009-10-30 | 2009-10-30 | Introducer manufacturing method |
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| Country | Link |
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| CN (1) | CN102048593B (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2840938Y (en) * | 2005-07-29 | 2006-11-29 | 太原市绿波机电科技有限公司 | Vertebral body internal fixation guider and depthkeeping drill bit and pedicle screw device |
| CN101390773A (en) * | 2007-09-19 | 2009-03-25 | 陆声 | Manufacturing method of navigation template for positioning vertebral pedicle |
-
2009
- 2009-10-30 CN CN 200910209455 patent/CN102048593B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2840938Y (en) * | 2005-07-29 | 2006-11-29 | 太原市绿波机电科技有限公司 | Vertebral body internal fixation guider and depthkeeping drill bit and pedicle screw device |
| CN101390773A (en) * | 2007-09-19 | 2009-03-25 | 陆声 | Manufacturing method of navigation template for positioning vertebral pedicle |
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| Publication number | Publication date |
|---|---|
| CN102048593A (en) | 2011-05-11 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
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| TR01 | Transfer of patent right |
Effective date of registration: 20191216 Address after: 5 / F, 555 Guangfu South Road, Xinyi District, Taipei, Taiwan, China Patentee after: Insight Information Co.,Ltd. Address before: No. 259, Wenhua 1st Road, Guishan Township, 333 Taoyuan County, Taiwan, China Patentee before: CHANG GUNG University |
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20131030 |