Disclosure of Invention
In order to solve the problem that the existing template puncture technology has positioning deflection before puncture and during puncture, the application provides a non-coplanar puncture template based on multi-point positioning, which is used for solving the problem of inevitable deflection error caused by positioning by utilizing muscles and/or fat cortex at a puncture part of the existing puncture template. Based on the principle of template puncture, the problem of deflection caused by bare-handed puncture of a doctor is reduced or even eliminated by limiting the puncture needle by the template. Since the shape of the puncture template is set in advance according to the puncture plan, and cannot be modified, the puncture template can limit the deflection of the puncture needle during the puncture process. Moreover, because the patient is sampling the tumor, the body positions before and during the designated puncture plan cannot be the same, and therefore, positioning between the device and the patient is not practical, and larger errors are introduced; therefore, the positioning of the puncture template and the human body is an unalterable factor, and the existing positioning error or deflection problem can not be effectively solved only because of the unalterable factor. Through the research of the applicant and the clinical test in hospitals, the body is soft, the body can be bent and deformed through joints, muscle tissues and fat tissues are easier to deform after being subjected to external force, but the deformation amount of different parts is greatly different. Especially along the axial direction of the spine of the human body, is relatively determined in the same time period, and the error range is in a fully controllable state. Based on the research, the applicant further improves the non-coplanar puncture template on the basis of the existing research results to achieve accurate positioning and eliminate the problems of errors and deflection caused by positioning the puncture template by soft tissues.
In order to achieve the purpose, the technical scheme adopted by the application is as follows:
the utility model provides a non-coplane puncture template based on multiple spot location, includes the puncture template body, the puncture template body still fixedly connected with a plurality of outwards extend the locating template that forms and human bony part surface laminating along puncture template body all around. The specific shape of the positioning template can be specifically set according to the actual puncture part, the set principle is to collect the axial bone point positioning point of the human spine, and the thinner part covered by soft tissues is the best. The puncture site varies depending on the specific puncture site.
For example, the puncture site is a chest and abdomen part, and the positioning template comprises three first positioning templates, a second positioning template and a third positioning template which are arranged in a triangular shape. Namely, the position of any one of the protruded bony point anterior superior iliac spine at the two ends of the shoulders and the hip bone is respectively adopted as a positioning point to set a corresponding positioning template. Of course, the first positioning point may be further added based on stability considerations, so that the positioning template further includes a fourth positioning template forming a quadrilateral layout with the first positioning template, the second positioning template and the third positioning template. The fourth positioning template and the third positioning template can be respectively positioned by taking the corresponding parts of the anterior superior iliac spines at the two ends of the hip bone as positioning points, and simultaneously, the corresponding parts of the greater tuberosity of the humerus are taken as the positioning points of the other two first positioning templates and the second positioning template. The most prominent technical bright point of the positioning mode of the three points or the four points is that the position error of the puncture template body relative to the target tumor can be reduced, and the principle is as follows:
in order to more intuitively and clearly illustrate that the positioning precision and stability of the invention are higher than those of the positioning of the existing puncture template, the applicant explains the principle of how stable positioning can be realized by matching non-coplanar puncture templates provided by the invention between bones capable of moving relatively.
The accuracy of positioning is mainly influenced by two factors:
the first factor is the change of the tumor body position relative to the body surface of the patient during positioning and puncture.
Because the puncture template body can only be positioned with the skin of the body surface of a patient, no relative motion occurs between the puncture template body and the body surface of the patient, but the deformation of muscle tissues and fat tissues between a tumor body and the body surface of the patient correspondingly positioned under the action of any external force brings positioning errors, so that the position deviation between the puncture template body and the tumor body is caused, and the factor is also the most important error introduction source of the existing positioning template.
The second factor is that under the condition that the puncture template body does not generate relative displacement with the body surface of the patient, a doctor cannot judge whether the position relation between the puncture template body and the tumor body is changed and introduced relative to the tumor body at the time of positioning the mark. That is, the mark point of the patient body surface at the time of the positioning mark coincides with the mark point on the puncture template body by 100%, and according to the prior art, the doctor regards the relative position of the puncture template body and the tumor body at the time as the same as the relative position at the time of the positioning mark; this is not the case, however, and for example, differences in tumor position are caused by differences in the position of the patient during preoperative tumor sampling (i.e., the position from which the surgical plan is based) and the position of the puncture during surgery. Especially for patients with thick epidermis fat layers, the change of the body experience can lead the puncture template body to be capable of lengthening, shortening or deflecting relative distance with the tumor body under the condition of keeping the marking point and the puncture template body unchanged, and the change of the epidermis fat can not drive the synchronous change of the tumor body position in the body, so the position deflection is generated.
After the position deviation factor between the puncture template body and the tumor body is clarified, the invention realizes the accurate positioning of the position by the following modes: the most prominent bony parts at the two ends of the shoulder of the upper limb of the human body can be the position of the greater tubercle of the humerus, and the most prominent bony parts at the abdomen of the human body can be the position of the anterior superior iliac spine at the two ends of the hip bone. Although the position of the tumor will change with the change of the posture due to the change of the position of the anterior superior iliac spine at one side or two sides of the greater tuberosity of the humerus and the bending of the spine and the two ends of the hip bone, the positioning point of the invention at least adopts three of the four parts, namely, after the position among the three bony points is determined, the patient only has the possibility of the same posture as the positioning, so that the position of the tumor is the same relative to the positioning position. Of course, the development of the internal organs and the tumor are different, which can cause the error of the tumor, but the growth of the tumor is unpredictable and controllable, so the uncontrollable factors caused by the tiny growth of the tumor are ignored from the time of planning the operation to the time of performing the operation.
That is to say, when the positioning mark is performed, the mark point set on the body surface corresponding to the position of the tumor body coincides with the mark position on the puncture template body, so that the mounting position of the puncture template body can be ensured to be the same as the mounting position during positioning, which can also be achieved by the prior art. At this time, if the body position (such as lying down or lying on side) of the patient is not consistent with the tumor body position sampling, the difference of the body position will change the position deviation between the tumor body and the puncture template body, i.e. the above-mentioned 'second factor' influence. When puncture is carried out, because only the body surface of the patient is contacted with the puncture template body, the external force applied to the puncture template body in the puncture process can cause the deformation of muscle tissues and fat tissues of the patient, thereby causing the position change between the puncture template body and the tumor body, namely the influence of the 'first factor'. The invention carries out positioning through the plurality of positioning templates fixedly connected with the puncture template body and the bony part of the patient, and because the relative positions among the plurality of positioning templates have uniqueness and the body position of the patient during preoperative tumor body sampling is taken as a basis, when puncturing is carried out, as long as the position of each positioning template is not deflected, the body position of the patient during puncturing is consistent with the body position during tumor body sampling before puncturing, thereby ensuring the maximum possible consistency of the environments of the tumor body in the two states. If any change occurs in the body position, at least one positioning template cannot be aligned, and then the doctor can eliminate the error caused by the body position factor by aligning each positioning template, namely, the negative influence of the second factor is eliminated. Furthermore, the plurality of positioning templates are fixedly connected with the puncture template body, and if the puncture template body is possibly deviated from the position of the tumor body due to external force, the plurality of positioning templates positioned at the bony part of the patient are driven to move, so that the puncture template body can be ensured not to be introduced with errors caused by the forced deformation of muscle tissues and fat tissues of the patient in the puncture process by fixing the plurality of positioning templates, and the negative influence of the 'first factor' is eliminated.
In order to take account of the manufacturing and processing of the preoperative puncture template body, meet the requirement that puncture operation in the operation is not influenced and provide excellent field-opening performance, preferably, the puncture template body is fixedly connected with any one of the positioning templates through a positioning rod, and the positioning rod consists of an integrally formed and horizontally arranged horizontal section, a first vertical section and a second vertical section which are respectively arranged at two ends of the horizontal section; the free end of the first vertical section is fixedly connected to the upper surface of the positioning template, and the free end of the second vertical section is fixedly connected to the upper surface of the puncture template body.
In order to further quickly position the patient in the operation and keep the body position of the patient consistent with the body position of the patient in the tumor sampling process, and quickly position the positioning template, preferably, the first positioning template, the second positioning template, the third positioning template and the fourth positioning template are all provided with cross positioning holes, and each cross positioning hole comprises a circular through hole and a cross line which is arranged by taking the circular through hole as the center and intersects with the circular through hole.
Simultaneously, in order to facilitate quick and accurate positioning of the puncture template body, the puncture template body is further preferably provided with a cross marking formed by a plurality of marking holes.
Preferably, the puncture template body is integrally provided with a plurality of needle tubes which are parallel or not parallel to each other on the upper surface, the inner diameter of any needle tube is adapted to the outer diameter of the needle puncture needle, and the axial length of the needle tube is not less than 20 mm.
Still further preferably, a bleeding hole recessed toward one side of the puncture template body is formed at the intersection of any one of the needle tube and the lower surface of the puncture template body, and a channel penetrating through the puncture template body or the side wall of the needle tube for blood to flow out is formed at the bottom of the bleeding hole.
In order to save the manufacturing cost of the puncture template body, improve the manufacturing efficiency and shorten the preoperative waiting time of a patient, preferably, a plurality of observation holes with different diameters are further arranged at the positions, which avoid the needle tube, on the puncture template body.
For the convenience of observation in operation, the puncture template body and the needle tube are both preferably made of transparent resin materials.
Has the advantages that:
according to the invention, by additionally arranging a plurality of positioning templates at the positions where the bony points of the patient are located, the problems of position errors or deflection caused by different body positions of the preoperative tumor body sampling and intraoperative puncture patient can be reduced or even eliminated; meanwhile, the problem of puncture deflection caused by soft tissue deformation including muscle tissue and fat tissue between the tumor body and the body surface of the patient can be reduced or even eliminated.
The invention can visualize the position error introduced by various factors, meanwhile, based on multi-point positioning, the positioning of the bony part is faster and more accurate, the judgment and the operation of doctors are convenient, the puncture is not influenced by the obesity constitution of the patient in the operation, the practicability and the stability are extremely high, and the puncture precision can be greatly ensured.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present application, presented in the accompanying drawings, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present application, it should be noted that if the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are used for indicating the orientation or positional relationship based on the orientation or positional relationship shown in the drawings or the orientation or positional relationship which is usually placed when the product of the application is used, the description is only for convenience and simplicity, and the indication or suggestion that the referred device or element must have a specific orientation, be constructed in a specific orientation and be operated, and thus, should not be construed as limiting the present application. Furthermore, the appearances of the terms "first," "second," and the like in the description herein are only used for distinguishing between similar elements and are not intended to be construed as indicating or implying relative importance.
Furthermore, the terms "horizontal", "vertical" and the like when used in the description of the present application do not require that the components be absolutely horizontal or overhanging, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the description of the present application, it should also be noted that, unless otherwise explicitly stated or limited, the terms "disposed," "mounted," "connected," and "connected" should be interpreted broadly, e.g., as being fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.
Example 1:
in order to more clearly illustrate the structure and the working principle of the invention, the following description is further described with reference to the drawings of the specification, specifically with reference to fig. 1 to 5 of the specification, and the non-coplanar puncture template based on multi-point positioning shown in fig. 3 comprises a puncture template body 1, wherein the puncture template body 1 is further fixedly connected with a plurality of positioning templates which extend outwards along the periphery of the puncture template body 1 to form a surface joint with the bony part of the human body. The specific shape of the positioning template can be specifically set according to the actual puncture part, the set principle is to collect the axial bone point positioning point of the human spine, and the thinner part covered by soft tissues is the best. The puncture site varies depending on the specific puncture site.
In this embodiment, the puncturing part is specifically the chest and abdomen part, and the positioning template includes four first positioning templates 7, second positioning templates 8, third positioning templates 9 and fourth positioning templates 10 arranged in a quadrilateral shape. The fourth positioning template 10 and the third positioning template 9 are positioned by respectively using the corresponding parts of the anterior superior iliac spines at the two ends of the hip bone as positioning points, and simultaneously using the corresponding parts of the greater tuberosity of the humerus as the positioning points of the other two first positioning templates 7 and the second positioning template 8. The most prominent technical points of the positioning method adopting the four points are that the position error between the puncture template body 1 and the target tumor can be reduced, and the principle is as follows:
in order to more intuitively and clearly illustrate that the positioning precision and stability of the invention are higher than those of the positioning of the existing puncture template, the applicant explains the principle of how stable positioning can be realized by matching non-coplanar puncture templates provided by the invention between bones capable of moving relatively.
The accuracy of positioning is mainly influenced by two factors:
the first factor is the change of the tumor body position relative to the body surface of the patient during positioning and puncture.
Because the puncture template body 1 can only be positioned with the skin of the body surface of a patient, no relative motion occurs between the puncture template body 1 and the body surface of the patient, but the deformation of muscle tissues and fat tissues between a tumor body and the body surface of the patient correspondingly positioned under the action of any external force brings positioning errors, so that the position deviation between the puncture template body 1 and the tumor body is caused, and the factor is also the most important error introduction source of the existing positioning template.
The second factor is that when the puncture template body 1 does not displace relative to the body surface of the patient, the doctor cannot determine whether the positional relationship between the puncture template body 1 and the positioning mark relative to the tumor body changes and introduces the puncture template body 1 and the positioning mark. That is, even if the mark point of the patient body surface at the time of the positioning mark coincides with the mark point on the puncture template body by 100%, according to the prior art, the doctor regards the relative position of the puncture template body 1 and the tumor body at this time as the same as the relative position at the time of the positioning mark; this is not the case, however, and for example, differences in tumor position are caused by differences in the position of the patient during preoperative tumor sampling, i.e., the position on which the surgical plan is based, and the position of the puncture during surgery. Especially for patients with thick epidermis fat layer, the change of experience can lead the puncture template body 1 to be capable of lengthening, shortening or deflecting the relative distance with the tumor body under the condition of keeping the marking point and the puncture template body 1 unchanged, and the change of the epidermis fat can not drive the synchronous change of the tumor body position in the body, so the position deflection is generated.
After the position deviation factor between the puncture template body 1 and the tumor body is clarified, the invention realizes the accurate positioning of the position by the following modes: the most prominent bony parts at the two ends of the shoulder of the upper limb of the human body can be the position of the greater tubercle of the humerus, and the most prominent bony parts at the abdomen of the human body can be the position of the anterior superior iliac spine at the two ends of the hip bone. Although the position of the tumor will change with the change of the posture due to the change of the position of the anterior superior iliac spine at one side or two sides of the greater tuberosity of the humerus and the bending of the spine and the two ends of the hip bone, the positioning point of the invention at least adopts three of the four parts, namely, after the position among the three bony points is determined, the patient only has the possibility of the same posture as the positioning, so that the position of the tumor is the same relative to the positioning position. Of course, the development of the internal organs and the tumor are different, which can cause the error of the tumor, but the growth of the tumor is unpredictable and controllable, so the uncontrollable factors caused by the tiny growth of the tumor are ignored from the time of planning the operation to the time of performing the operation.
That is to say, when the positioning mark is performed, the mark point set on the body surface corresponding to the position of the tumor body coincides with the mark position on the puncture template body, so that the installation position of the puncture template body 1 can be ensured to be the same as the installation position during positioning, which can also be achieved by the prior art. At this time, if the body position of the patient is inconsistent with the tumor position sampling, such as lying down or lying on the side, the difference in body position will change the position deviation between the tumor and the puncture template body 1, i.e. the above-mentioned 'second factor' influence. When puncture is carried out, because only the body surface of the patient is contacted with the puncture template body 1, the external force applied to the puncture template body 1 in the puncture process can cause the deformation of muscle tissues and fat tissues of the patient, thereby causing the position change between the puncture template body 1 and the tumor body, namely the influence of the 'first factor'. The invention positions the bony part of the patient through the plurality of positioning templates fixedly connected with the puncture template body 1, and the relative positions of the plurality of positioning templates are unique, and the body position of the patient during preoperative tumor body sampling is taken as a basis, so that when puncture is carried out, as long as the position of each positioning template is not deflected, the body position of the patient during puncture is consistent with the body position during tumor body sampling before puncture, and the consistency of the environment of the tumor body in the two states is ensured to be the maximum possible. If any change occurs in the body position, at least one positioning template cannot be aligned, and then the doctor can eliminate the error caused by the body position factor by aligning each positioning template, namely, the negative influence of the second factor is eliminated. Furthermore, the plurality of positioning templates are fixedly connected with the puncture template body 1, and if the puncture template body 1 is deviated from the position of the tumor body due to external force, the plurality of positioning templates positioned at the bony part of the patient are driven to move, so that the puncture template body 1 can be ensured not to be introduced with errors caused by the stress deformation of muscle tissues and fat tissues of the patient in the puncture process by fixing the plurality of positioning templates, and the negative influence of the first factor is eliminated.
When tumor body sampling is carried out, firstly, markers which can be imaged on a CT are arranged on four corresponding bony positions of the first positioning template 7, the second positioning template 8, the third positioning template 9 and the fourth positioning template 10; then the patient lies on the CT bed, and the marked positioning part and the target part where the tumor body is located are scanned; the tomographic image corresponding to the desired portion is obtained and modeled to customize the surgical plan, which belongs to the prior art and is not included in the scope of the present application, and will not be described in detail herein.
When the operation plan is finished and the patient is in accordance with the operation conditions before the operation, the prepared puncture template needs to be positioned and installed, and the installation operation is as follows:
firstly, aligning the positions of the first positioning template 7, the second positioning template 8, the third positioning template 9 and the fourth positioning template 10 corresponding to the markers. During alignment, since the lying position of the patient cannot be the same as the lying position during sampling, the first positioning template 7 should be first positioned, and after positioning is completed, the patient is adhered and fixed by using the adhesive tape 12, such as an existing medical adhesive tape, which is specifically shown in fig. 5.
And secondly, positioning the second positioning template 8 according to the method for positioning and fixing the first positioning template 7 in the first step, if the second positioning template cannot be directly aligned, adjusting the body position of the patient until the corresponding position of the second positioning template 8 is aligned with the marker, and finishing the fixation.
Thirdly, observing whether the marking position on the puncture template body 1 corresponds to the marking point position of the puncture part, and if the marking point of the puncture part corresponds to the marking position on the puncture template body 1, performing a fourth operation; if not, the soft tissue of the puncture part should be adjusted to correspond to the puncture template body 1, and then the fourth step is carried out. It is worth mentioning that, in order to ensure that the puncture template body 1 is attached to the body surface of the puncture site of the patient, before CT tomography, markers capable of imaging on CT images are arranged on the body surface, so that the puncture template body 1 can be positioned by aligning the markers when being installed in the later period. One or more markers may be provided, which belongs to the prior art and is not a point of improvement of the present invention, and thus, detailed description thereof is omitted.
And fourthly, finishing the positioning, mounting and fixing of the rest third positioning template 9 and the rest fourth positioning template 10 according to the operation of the first step. At the moment, the posture state of the patient is kept consistent with the posture state of the patient during tumor body sampling, so that the position deviation caused by different postures is eliminated.
Meanwhile, the whole puncture template is of an integral structure and has support for external force, so that even though external force is applied to the puncture template body 1 by a doctor, the puncture template body 1 cannot be deflected, and the position deviation caused by soft tissue sliding or shaking is eliminated.
After the positioning is finished, puncture can be carried out one by one according to the prior art, and the reflective particles are placed one by one according to the operation plan.
Example 2:
on the basis of embodiment 1, in order to consider the manufacturing and processing of the preoperative puncture template body 1 and meet the requirement that the puncture operation in the operation is not affected and provide excellent field-opening performance, this embodiment is further shown in fig. 1-convex 5, the puncture template body 1 is fixedly connected with any one of the positioning templates through a positioning rod 6, and the positioning rod 6 is composed of an integrally formed and horizontally arranged horizontal section 61, and a first vertical section 62 and a second vertical section 63 which are respectively arranged at two ends of the horizontal section 61; the free end of the first vertical section 62 is fixedly connected to the upper surface of the positioning template, and the free end of the second vertical section 63 is fixedly connected to the upper surface of the puncture template body 1.
In order to further quickly position the patient in the operation and keep the body position of the patient consistent with the body position of the patient in the tumor sampling process, so as to quickly position the positioning template, preferably, the first positioning template 7, the second positioning template 8, the third positioning template 9 and the fourth positioning template 10 are all provided with cross positioning holes 11, and each cross positioning hole 11 comprises a circular through hole and a cross line which is arranged by taking the circular through hole as a center and intersects with the circular through hole.
Meanwhile, in order to facilitate quick and accurate positioning of the puncture template body 1, it is further preferable that the puncture template body 1 is provided with a cross-shaped marking formed by a plurality of marking holes 2. The puncture template body 1 is characterized in that a plurality of needle tubes 3 which are parallel or not parallel to each other are integrally formed on the upper surface of the puncture template body 1, the inner diameter of any needle tube 3 is adapted to the outer diameter of the needle puncture needle, and the axial length of the needle tube 3 is not less than 20 mm. A bleeding hole 5 which is concavely arranged towards one side of the puncture template body 1 is formed in the intersection of any needle tube 3 and the lower surface of the puncture template body 1, and a channel which penetrates through the side wall of the puncture template body 1 or the needle tube 3 and is used for blood to flow out is formed in the bottom of the bleeding hole 5. In order to save the manufacturing cost of the puncture template body, improve the manufacturing efficiency, and shorten the preoperative waiting time of the patient, preferably, a plurality of observation holes 4 with different diameters are further formed in the puncture template body 1 at positions avoiding the needle tube 3. For the convenience of observation in operation, the puncture template body 1 and the needle tube 3 are both made of transparent resin materials through 3D printing.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.