Guide device and manufacturing method thereof

Manufacturing method of introducer

The present invention relates to a manufacturing method of an introducer, in particular to a manufacturing method of an introducer that assists in accurately implanting an implant into an affected part.

According to the traditional orthopedic surgery method, doctors use X-ray or computerized tomography (CT) images of the patients bones, as well as their own anatomical knowledge and clinical surgical experience to evaluate the method of surgery. Due to the lack of precise guidance devices, it is impossible to perform operations accurately based on the preoperative surgical planning. Therefore, this traditional orthopedic surgery method has the following four problems:

1. The accuracy of pre-surgery diagnosis and surgical path planning is not high. If the affected area or tissues near the invasion path are damaged, it will cause significant damage to the patient. In addition, because the doctor cannot accurately know the relative relationship between the affected part or the invasion path and the surrounding tissues, he is forced to give up the operation.

2. As mentioned above, because the positioning accuracy during surgery is not high, the doctor usually cuts a larger opening in the affected part of the patient during the operation to allow the position error of the surgical instrument invading the affected part, or implant The error of the body setting position. However, the aforementioned errors will cause harm to the patient, and even irreparable major harm. In recent years, the concept of minimally invasive surgery has gradually been applied to various clinical operations. When the surgical wound becomes smaller and smaller, the allowable error is also reduced. Therefore, the use of traditional surgical instruments will be restricted.

3. Before the operation, a clinician with extensive experience in orthopedic surgery is required to plan the invasion location and path during the operation. Therefore, if planning is carried out by an inexperienced physician, the quality of the operation (such as accuracy, safety and reliability) will be more difficult to grasp.

4. Because traditional surgical methods mostly rely on the experience of doctors, there are only clinical teaching methods in the teaching of related surgery, and it fails to provide related patient defect teaching models for auxiliary learning.

Based on the above problems, it can be seen that traditional orthopedic surgery methods rely heavily on the clinical experience of physicians, and have problems of inaccuracy, insecurity and unreliability, and cannot assess the relative relationship between the affected area or the tissues near the invasion path, making the surgical process There is a high degree of uncertainty in the process. Therefore, how to provide a method that can improve the accuracy, safety and reliability of surgery, and does not have to rely too much on the personal experience of the physician, while reducing the error rate of surgery and reducing the clinical pressure of the physician Technology is an urgent problem to be solved without delay.

In view of the above-mentioned problems of the prior art, the purpose of the present invention is to provide a method for manufacturing an introducer to solve the problem of high uncertainty in the traditional orthopedic surgery process, and to achieve a small surgical incision and a chance of infection. Small, and improve the accuracy, safety and reliability of the operation.

According to the object of the present invention, a method for manufacturing an introducer is provided, which includes the following steps: planning an invasion position for implanting an implant into an affected part, and planning an invasion path for the implant to invade the affected part from the invasion position, and according to the invasion position and invasion The path, the shape of the implant, and the shape of the tissue of the affected area are used to make an introducer. This introducer has a joint part that conforms to the shape of the affected part, and a guide part that conforms to the shape of the implant, the invasion position and the invasion path. In this way, when the joint part of the introducer is placed on the affected part, the introducer is in contact with the affected part. Fit, at this time, the guiding part is aligned to the invasion position, and the implant is guided by the invasion path to be implanted on the tissue of the affected part.

In summary, according to the manufacturing method of the introducer of the present invention, it can have one or more of the following advantages:

(1) The use of this introducer to assist in the operation will prevent damage to the tissues with important functions outside the affected area (such as nerves or main arteries and veins... etc.), thereby improving the accuracy, safety and reliability of the operation .

(2) Using this introducer in the teaching of surgical methods will shorten the time for students to learn this surgical method, and make it easier for interns or medical students to understand the operation process of this surgical method.

<p>1Introducer</p><p>10Joint</p><p>12Guiding Department</p><p>120Implant hole</p><p>2Organization</p><p>4First Introducer</p><p>40First joint</p><p>42First Guiding Department</p><p>420The first implant hole</p><p>44Second Guide</p><p>440Second implant hole</p><p>5Second Introducer</p><p>50Second Joint</p><p>52The third guide</p><p>520Third implant hole</p><p>6Third Introducer</p><p>60The third joint</p><p>62The third guide</p><p>620Fifth implant hole</p><p>7Femoral head</p><p>C1The first section of the cervical spine</p><p>C2Second section of cervical spine</p><p>S10~S30Step</p><p>S101~S103Step</p><p>S201~S203Step</p>

Figure 1 is a schematic diagram of the joint of the introducer of the present invention installed on the affected part (left hip joint); Figure 2 is a schematic diagram of the joint of the introducer of the present invention installed on the affected part (cervical spine); Figure 3 is this The second embodiment of the invention is a schematic diagram of the joint installation of the introducer on another affected part (left hip joint); Figure 4 is a manufacturing flow chart of the method for manufacturing the introducer of the present invention; Figure 5 is the implant of the present invention The flow chart of the establishment of the body database; and Figure 6 is the flow chart of the establishment of the model database of the affected part of the present invention.

Please refer to Figure 1, which is a schematic diagram of the introducer of the present invention. In the figure, the introducer 1 includes a joint 10 and at least one guide 12, wherein the shape of the joint 10 corresponds to the surface structure of the tissue 2 of an affected part, and an implant (not shown) invades An intrusion position of the tissue 2, and the guide portion 12 is connected to the surface of the joint 10, and an implant hole 120 is penetrated through the guide portion 12. The shape of the implant hole 120 is consistent with that of an implant. An invasion path for invading the tissue object 2. In this way, when the bonding portion 10 is placed on the surface of the tissue 2, the bonding portion 10 will fit on the surface of the tissue 2. At this time, the implant hole 120 faces one end of the tissue 2 and corresponds exactly to the tissue. 2 The invasive position where an implant needs to be implanted, and the other end of the implant hole 120 corresponds to the surgical opening where the affected part is incised.

Please refer to Figure 2, which is a schematic diagram of the joint of the introducer of the present invention installed on the affected part (cervical spine). In the first embodiment of the present invention, the introducer is applied to the cervical spine pedicle screw implantation operation, and the tissues to be operated are the left and right sides of the first cervical spine C1 and the second cervical spine C2 The vertebral arch, and two implants are respectively implanted (in this embodiment, the implant system is a bone nail). Therefore, in the first embodiment of the present invention, a first guide 4 and a second guide 5 are attached to the first cervical spine C1 and the second cervical spine C2, respectively, wherein the first guide The shape of the first connecting portion 40 provided by the instrument 4 is in accordance with the shape of the surface structure of the installation position of the first cervical spine C1, and the intrusion position of a first bone nail and a second bone nail invading the first cervical spine C1. The shape of the second joint 50 of the second introducer 5 is in accordance with the shape of the surface structure of the installation position of the second cervical spine C2, and a third bone nail and a fourth bone nail invade the second cervical spine C2 An intrusive location.

In addition, the first guide 4 includes a first guide 42 and a second guide 44, and the second guide 5 includes a third guide 52 and a fourth guide 54. Wherein, the shape of the first implant hole 420 provided by the first guide portion 42 conforms to the intrusion path of the first bone nail into the first cervical spine segment C1, and the second guide portion 44 is provided for the second The shape of the implanted hole 440 conforms to the intrusion path of the second bone nail into the first segment C1 of the cervical spine. Furthermore, the shape of the third implant hole 520 provided by the third guide part 52 is in line with the intrusion path of the third bone nail into the second cervical segment C2, and the fourth implant hole provided by the fourth guide part The shape of the hole conforms to the intrusion path of the fourth bone screw into the second cervical spine C2. The above-mentioned invasion path refers to the angle and depth of the neck cone drilled by the surgical instrument.

According to the above, the first introducer 4 and the second introducer 5 can fit on the left and right vertebral arches of the first cervical spine section C1 and the second cervical spine section C2, and the first to fourth guides The first to fourth implant holes (420, 440, 520) of the part (42, 44, 52) correspond to the intrusion positions of the left and right vertebral arches of the first cervical spine C1 and the second cervical spine C2, so , With the guidance of the first to fourth implant holes (420, 440, 520), surgical instruments (such as surgical electric drills) can be drilled into the left and right vertebral arches of the first cervical spine C1 and the second cervical spine C2 , Until the depth, angle and position of the invasion path preset by the first to fourth implant holes (420, 440, 520). After removing the first and second introducers (4, 5) from the cervical vertebrae, the first and second introducers (4, 5) can be removed One to four bone screws are installed to the correct depth, angle and position of the intrusion path to avoid invading other important tissues (such as the nerve plexus around the cervical spine). In order to improve the surgical accuracy, safety and reliability of the cervical vertebral arch bone nail implantation operation.

Please refer to Figure 3, which is a schematic diagram of the second embodiment of the present invention where the introducer is installed on another affected part (left hip joint). The introducer is applied to the left hip joint femoral head surface replacement surgery (Hip Resurfacing Arthroplasty), the tissue to be operated on is the femoral head of the hip joint of the left foot. During the operation, a central shaft extending along the axis of the femoral neck is drilled from the femoral head, and this central shaft is used to grind away the necrotic tissue of the femoral head with a rotating grinding instrument. Finally, a semicircular implant with a central column is implanted along the central shaft. In this embodiment, the implant system is an artificial joint (such as a surface metal ball head). Therefore, in the second embodiment of the present invention, a third introducer 6 is attached to the hip joint of the left foot. The shape of the third joint 60 provided by the third introducer 6 conforms to the shape of the surface structure of the hip joint of the left foot, and the artificial joint is installed at the invasive position of the hip joint of the left foot. The shape of the fifth implant hole 620 provided by the third guide portion 62 provided by the third introducer 6 conforms to the intrusion path of the left hip joint of the artificial joint. In this way, when a surgical instrument (such as a surgical electric drill) is guided through the fifth implant hole 620, it can be drilled to the depth, angle, and position of the predetermined invasion path. In addition, it can be used with a rotating grinding instrument to remove the necrotic femoral head 7 To avoid damage to other important tissues (such as normal femoral head), then fix the artificial joint on the femoral head of the left foot. In order to improve the surgical accuracy, safety and reliability of the left hip joint femoral head surface replacement surgery.

In summary, in the foregoing first and second embodiments of the present invention, the introducer is applied to the cervical spine pedicle screw implantation operation and the left hip joint femoral head surface replacement operation as an example. The actual implementation of the invention is not limited to this. The introducer system can be used in spinal fixation, total knee replacement (TKR) or uni-knee replacement (Uni-knee replacement, abbreviated: UKR), total hip replacement surgery (Total hip Replacement (abbreviation: THR) or hip replacement surgery and fracture reconstruction surgery... and other orthopedic surgery, and can also be used in dental implant surgery or other plastic surgery. Therefore, the tissue system referred to in the present invention can be one of cervical vertebral arches, spine, femoral heads of hip joints, and bones of total knee joints.

Please refer to FIG. 4, which is a manufacturing flow chart of a manufacturing method of the introducer of the present invention. In the figure, the manufacturing process of this guide includes the following steps. Step (S10) plan the invasion position of the tissues of an implant implanted in an affected part; step (S20) plan the invasion path of the tissues of the implant from the invasion position into the affected part; in the present invention, it is not necessary to perform step (S10) first. ), then step (S20) can be performed, or step (S20) can be performed first, and then step (10) can be performed. In step (S30), an introducer is made according to the implant's invasion position, the invasion route and the shape of the tissue of the affected part. In this way, the introducer manufactured according to the aforementioned method has a joint part conforming to the shape of the tissue, and a guide part conforming to the implant invasion position and path. In this way, when the joint part of the introducer is placed On the affected part, the introducer is attached to the affected part. At this time, the guiding part is aligned to the invasion position, and the surgical instrument is guided by the invasion path to complete the surgical procedure before installing the implant, so that the implant can be accurately It is implanted into the tissue of the affected area.

In the method of manufacturing the introducer of the present invention, before the step of planning the invasion position of the tissue in which an implant is implanted in an affected part, or the step of planning the invasion path of the tissue in which the implant invades the affected part from the invasion position, It also includes the establishment of an implant database. Please refer to Figure 5, which is a flowchart of the establishment of the implant database of the present invention. The implant database is established according to the following steps: step (S101) performs a three-dimensional scan of a plurality of implants one by one; step (S102) generates a three-dimensional implant based on the results of the three-dimensional scan of each implant Image; step (S103) classify and mark the three-dimensional images of each implant according to the type, size, shape and other characteristics of the implant, so as to generate an implant data, and build an implant database accordingly.

In the method of manufacturing the introducer of the present invention, the invasion of tissues in an affected part is planned for implanting an implant Before the step of entering the position, or planning the intrusion path of the implant from the invasion position into the tissues of the affected part, it also includes the establishment of an image data of the affected part. Please refer to Figure 6, which is the flow chart of establishing the image data of the affected part of the present invention. The affected part model database is established according to the following steps, and the steps include: step (S201) to obtain the patient's affected part image; in the present invention, the method of obtaining the affected part image can be a computer tomography of the patient's affected part Either scan image or X-ray image. Step (S202) performs a two-dimensional contour capture of the tissue according to the image of the affected part to obtain two-dimensional contour data of the tissue; step (S203) reconstructs a three-dimensional medical image based on the two-dimensional contour data, and uses it as the image data of the affected part.

Furthermore, in the present invention, the three-dimensional medical image of the shape of the tissue reconstructed according to the two-dimensional contour data and the three-dimensional image of the implant in the implant database are used to plan the invasion position and the invasion path, and according to the three-dimensional medical image And implant 3D images to make the guide 3D image, and then the guide 3D image can be customized using 3D engraving machine, rapid prototyping machine (such as 3D printer) and 3D modeling method, etc. Of the introducer.

As mentioned above, in the present invention, when planning the step of implanting an implant into an affected part, or planning the step of intruding the implant from the invasion position into the affected part, the implant database and The image data of the affected area is used to plan the implant that is most suitable for the size and shape of the tissue of the affected area, and the invasion position and path of the implant are planned to avoid damage to the tissues other than the affected area, and can be in accordance with the shape and invasion of the implant The position and the path of invasion are made into an introducer that fits most closely to the tissues of the affected area.

In summary, the present invention finds an appropriate implant according to the size and shape of the affected part of the patient, and plans a customized introducer according to the structure and relative position of the tissue of the affected part of the patient. During the operation, with the assistance of the introducer, the accuracy, safety and reliability of the operation can be improved. In addition, the department can use the introducer and the structure model of the tissue of the affected part to teach surgery, improve the efficiency of learning related surgery, shorten the teaching time, and can be used as a preoperative Surgical drill and effect evaluation.

The above descriptions are merely illustrative and not restrictive. Any equivalent modifications or alterations that do not depart from the spirit and scope of the present invention should be included in the scope of the appended patent application.