CN114869432A - 3D printing customized surgical guide for myomectomy and its use - Google Patents

Abstract

The invention discloses a 3D printing customized surgical guide for uterine fibroids and a method for using the same. The surgical guide for uterine fibroids includes a base plate, the base plate is printed based on a uterus model, and the base plate is fitted with a patient's body tissue; There is a positioning hole in the inside of the bottom plate, and the fitting surface of the bottom plate is facing the direction of the patient's uterus. The method of use is: preoperatively carry out three-dimensional reconstruction according to the pelvic imaging data of patients with multiple uterine fibroids, and on this basis, design a guide plate and use 3D It is prepared by printing technology. After the guide plate is placed during the operation, the guide needle is attached with a positioning wire to locate the target fibroids through the positioning hole. After positioning, the guide plate and guide needle are taken out, and the target fibroids are probed through the positioning wire. Remove the positioning wire. The 3D-printed customized surgical guide for uterine fibroids and its use method aim to improve the surgical accuracy of the operator, reduce the trauma of the uterus, shorten the operation time, and reduce the postoperative residual rate and recurrence rate.

Description

3D printing customized surgical guide for myomectomy and its use

technical field

The invention relates to the related technical field of gynecology, in particular to a 3D printing customized surgical guide for uterine fibroids removal and a method for using the same.

Background technique

As the most common benign tumor of female reproductive system, uterine fibroids are composed of diseased smooth muscle and connective tissue, and are more common in women aged 30-50; the incidence of uterine fibroids in my country has increased significantly in recent years, affecting the fertility of women of childbearing age; Affected by the secretion of estrogen, the incidence of female population of childbearing age is 20%-40%;

Submucosal fibroids classified by uterine fibroids can reduce the pregnancy rate of pregnant women; intramural fibroids can increase the miscarriage rate during pregnancy and reduce the success rate of in vitro fertilization (IVF), even if the fibroids do not affect the uterine cavity shape, The IVF pregnancy rate and birth rate of women of childbearing age with two or more fibroids or the diameter of the fibroids greater than 3cm will also be significantly reduced;

For the above-mentioned patients with symptoms such as affecting fertility or menstrual disorders, surgical treatment is still the most effective treatment method;

The surgical treatment of uterine fibroids includes myomectomy and hysterectomy: hysterectomy can achieve radical effect, but it also brings some serious consequences, such as permanent loss of reproductive function, the risk of secondary pelvic organ prolapse Obviously, it does not meet the current needs of patients. Laparoscopic myomectomy has the advantages of wide range of surgical indications, minimal invasiveness and safety. It can not only preserve the reproductive function and organ integrity of the patient, but also maintain the pelvic cavity. Bottom function and ovarian blood supply are the preferred surgical methods in clinical practice;

At this stage, the localization and removal of fibroids with a diameter of >5 cm in multiple uterine fibroids is no longer a problem, but for the fibroids in the uterine muscle wall of type III-V (according to the classification method of the 9 types of uterine fibroids of the International Federation of Gynecology and Obstetrics) ), especially the localization and removal of fibroids with a diameter of ≤ 3 cm are very difficult, and the postoperative residual rate is high; studies have found that in women of childbearing age, the location and size of uterine fibroids are significantly related to the growth rate of fibroids, Ⅲ - Type V fibroids grow significantly faster than other types of uterine fibroids, and fibroids with a diameter of ≤ 3 cm and > 5 cm grow three times as fast as other fibroids; , resulting in a corresponding increase in the recurrence rate, which in turn increases the risk of reoperation; according to relevant reports, the recurrence rates at 1, 3, 5, and 8 years after laparoscopic myomectomy were 11.7%, 36.1%, 52.9%, and 52.9%, respectively. 84.4%. Multiple uterine fibroids are an independent risk factor for recurrence. The recurrence rate after laparoscopic myomectomy is significantly increased in patients with more than 2 fibroids. Removal of all fibroids during surgery can reduce the risk of secondary surgery.

In laparoscopic myomectomy, there are multiple wounds on the uterine surface after multiple myomectomy. The suture of the wound after the removal of type III-V intramural fibroids is a difficult point in laparoscopic myomectomy. Poor suturing will lead to poor healing of the hematoma and uterine incision, which may lead to uterine rupture during postoperative pregnancy, endangering the disease. The patient's life is safe; in addition, after multiple fibroids are sequentially removed, the anatomical shape of the uterus will change significantly, which makes it more difficult to locate the fibroids that are later in the removal order;

At present, the method of obtaining anatomical information using traditional two-dimensional tomographic images has great deficiencies in cases with complex lesions and special locations; for obstetricians and gynecologists, there is an urgent need for a method that can intuitively reflect the patient's condition before surgery. The location, size and adjacency of the uterine fibroids to the surrounding tissues can overcome the difficulty of changing the anatomical shape of the uterus during the operation, and guide the operator to accurately locate the Ⅲ-Ⅴ type uterine fibroids with a diameter of ≤3cm and a deep position, thereby improving the quality of the uterine fibroids. The surgical accuracy of the operator, reducing the trauma of the uterus, shortening the operation time, and reducing the postoperative residual rate and recurrence rate.

Therefore, we propose a 3D-printed custom surgical guide for myomectomy and its use method, in order to solve the problems raised above.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a 3D printing customized surgical guide for uterine fibroids and a method for using the same, so as to solve the urgent need for a method proposed by the above-mentioned background technology, which can intuitively reflect the position of the patient's uterine fibroids before surgery, The size and the adjacency to the surrounding tissue can overcome the difficulty of changing the anatomical shape of the uterus during the operation, and guide the operator to accurately locate the type III-V uterine fibroids with a diameter of ≤3cm and a deep position; thus improving the accuracy of the operator's operation , reduce the trauma of the uterus, shorten the operation time and reduce the postoperative residual rate and recurrence rate.

In order to achieve the above purpose, the present invention provides the following technical solutions: a 3D printing custom-made surgical guide for uterine fibroids removal that cooperates with a guide needle and a positioning wire, including a bottom plate, the bottom plate is printed based on a uterus model, and the bottom plate is connected with the patient. fit between body tissues;

Wherein, the interior of the bottom plate is provided with a positioning hole, and the operation surface of the positioning hole is protruded and provided with a boss integrated with the bottom plate, and the side of the positioning hole is printed with a hole depth dimension;

The sides of the bottom plate are provided with fixing holes, and the ends of the bottom plate are provided with in-position grooves.

Preferably, the abutment surface of the bottom plate is facing the direction of the patient's uterus when viewed from the top.

Preferably, the width of the bottom plate is not less than 1.5cm, to prevent breakage during operation and use, and damage to surrounding tissues and organs; and the width of the bottom plate is not greater than 2cm, to prevent difficulty in inserting and removing the abdominal cavity through the incision; at the same time, the bottom plate The thickness of the thinnest part is 3mm.

Preferably, the positioning hole is in the shape of a hollow cylinder as a whole, and the inner diameter and width of the positioning hole is 2.2-2.5 mm, and the height of the positioning hole is 4.8-5.8 mm.

Another technical solution provided in this solution is to provide a method of using a 3D printed custom-made surgical guide for uterine fibroids removal that cooperates with a guide needle and a positioning wire. The method of using the guide includes the following steps:

Step 1: Preoperative preparation, extract pelvic imaging data of patients with multiple uterine fibroids, and use color resin material to 3D print a 1:1 patient uterus model and its fibroids model;

Step 2: The deep and difficult fibroids that need to be positioned and removed are calibrated on the uterus model, each fibroid provides a corresponding surgical approach, and the surgical guide for uterine fibroids removal with positioning holes is printed;

Step 3: During the laparoscopic myomectomy, before the uterine fibroids are removed, the fibroids are placed with the in-place groove (the design of the in-place groove is based on the special positioning points identified by preoperative imaging). Strip the surgical guide to the preset position on the surface of the uterus;

Step 4: The guide needle carries the positioning wire and enters the uterine tissue through the positioning hole of the surgical guide for myomectomy. After reaching the preset puncture depth before surgery, it stops. The guide needle is taken out through the positioning hole, and the positioning wire will be embedded in the position of the fibroids. ;

Step 5: Repeat the above step 4 until all the target uterine fibroids planned before operation are embedded in the positioning wire, and then take out the guide plate;

Step 6: Peel off this type of uterine fibroids one by one according to the preoperative surgical plan, and remove the positioning wire at the same time.

Preferably, the 3D printed customized surgical guide for uterine fibroids is made of peek material, photosensitive resin, pp material or pc material.

Compared with the prior art, the beneficial effects of the present invention are as follows: the 3D printed customized surgical guide for uterine fibroids removal and its use method,

The 3D printed customized surgical guide for uterine fibroids is entirely made of implantable grade materials such as peek. The implantation grade materials have undergone complete biocompatibility tests in accordance with ISO10993 standards, and have excellent biocompatibility, no cytotoxicity, and no Mutagenic, non-carcinogenic and non-allergenic, it is safe to enter the body. In addition, implant-grade materials have X-ray penetrability and good visibility. During the implementation of myomectomy, doctors can also MRI or CT real-time adjustment;

This solution breaks through the traditional way of using the guide plate on the body surface, and realizes the application of 3D printing hard positioning guide plate in soft tissue (human organs);

The use of the guide plate can cooperate with the surgical plan based on the optimal myometrial incision and suture method formulated by the preoperative physician, and guide the operator to remove all uterine fibroids with a diameter greater than or equal to 1cm and less than or equal to 3cm to the greatest extent during the operation. , reduce postoperative residual rate and recurrence rate;

At the same time, an indeterminate number of fixed holes (1mm in diameter) are added to the edge of the bottom plate. The surgeon will thread a surgical thread on one of the holes before inserting the guide plate. After withdrawing the guide needle, the guide plate will be withdrawn. The surgical wire assists the guide to be pulled out easily;

For the rest of the fixation holes, the surgeon can sew the guide plate on the uterus through the perforation of the surgical thread after the guide plate is placed and the position of the guide plate is determined, before tying the guide needle;

And the end of the bottom plate is provided with an in-position groove, and the in-position grooves on both sides are designed with special positioning points of the uterus that can be recognized by imaging during preoperative planning;

It is beneficial to improve the accuracy of surgery, reduce the trauma of the uterus, reduce intraoperative bleeding, shorten the operation time, reduce the occurrence of postoperative complications, shorten the hospitalization time, and reduce the postoperative residual rate and recurrence rate; in addition, 3D printing customized uterus The surgical guide for myomectomy has a short production cycle, strong operability and repeatability, which can greatly reduce the difficulty of surgery, and is easy to popularize and promote to benefit more patients.

Description of drawings

Fig. 1 is the overall structure schematic diagram 1 of surgical guide plate for uterine fibroids stripping of the present invention;

FIG. 2 is a schematic diagram 2 of the overall structure of the surgical guide for uterine fibroids stripping according to the present invention.

In the figure: 1. Bottom plate; 2. Positioning hole; 3. Boss; 4. Fixing hole.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Please refer to Fig. 1-2, the present invention provides technical solutions: the 3D printed customized surgical guide for uterine fibroids and its use method, wherein the 3D printed customized uterine fibroids combined with the guide needle and the positioning wire The guide plate includes a base plate 1, the base plate 1 is printed based on the uterus model, and the base plate 1 is fitted with the patient's body tissue; wherein, the interior of the base plate 1 is provided with a positioning hole 2, and the operation surface of the positioning hole 2 is arranged in a protruding manner There is a boss 3 integrated with the bottom plate 1 .

The design of the surgical guide for myomectomy includes two aspects: the bottom plate 1 and the positioning hole 2 . The bottom plate 1 is in the shape of an irregular strip as a whole, which is based on the uterine model and accurately fits the actual tissue of the patient; the operation surface is designed so that the operator looks down on the uterus of the patient during the operation for operation; the length of the guide plate is determined according to the surgical approach, and the guide needle needs to be confirmed. Take the shortest route to reach all the deep and difficult fibroids to be removed. The excess length will make it difficult for the guide plate to enter the abdominal cavity through the incision; the width of each location is not strictly set, but the central positioning hole must be in the center position, and the narrowest should not be less than 1.5cm to prevent During operation and use, the surrounding tissues and organs will be damaged by fracture, and the maximum width should not be greater than 2cm to prevent difficulties in inserting and removing the abdominal cavity through the incision; the thickness of the thinnest part of the guide plate is 3mm (the principle is the same as above).

The number of positioning holes 2 is less than or equal to the number of difficult and difficult uterine fibroids planned to be removed, and the whole is hollow cylindrical. The design of the deflection angle is determined by the surgical approach proposed by the operator in step 2 to determine the puncture angle of the guide needle; The guide needle is punctured and withdrawn smoothly, and the maximum error of the final positioning point is within the acceptable range); the height is 4.8-5.8mm (the principle is the same as the width and thickness of the previous section).

Among them, the 3D printing customized surgical guide for uterine fibroids, which is matched with guide needles and positioning wires, is used. 1 patient's uterus and its fibroids model, which can visually and clearly observe the Ⅲ-V type uterine fibroids with a diameter of less than or equal to 3cm in the patient's body;

After the surgeon fully communicates with the patient and the surgical team determines the surgical plan, the above-mentioned types of fibroids that need to be removed are calibrated on the model, and the corresponding surgical approach, that is, the guide needle puncture point and the fibroid, is provided for each fibroids. The puncture angle and depth, this information is the basis for the modeler to design the 3D printed uterine fibroids guide;

According to the patient's pelvic imaging examination data, on the basis of 3D reconstruction, a 1:1 model of the patient's uterus and its fibroids will be 3D printed using colored resin materials, and then this model will be used to develop and design this program - 3D printing custom uterus myomectomy surgical guide,

For example, the surgical guide for uterine fibroids removal, its shape is shown in the accompanying drawings 1 and 2 of the specification, wherein the inner diameter of the positioning hole 2 is designed to be 2.2mm, and the depth of the positioning hole 2 corresponds to the size of the hole printed on the positioning hole 2. On the outside, the depths are 4.8mm, 5.3mm and 5.8mm respectively;

When used, it can be used with guide needle and positioning wire to locate and mark deep type III-V uterine fibroids with a diameter of ≤3cm during operation;

When in use, the operator places the uterine fibroid guide on the surface of the uterus and the uterine fibroids on the surface of the uterine wall. And the end of the bottom plate 1 is provided with an in-position groove, which is designed with a special positioning point of the uterus that can be recognized by imaging, to ensure that the guide plate is stably fixed on the surface of the uterine wall during the operation. Enter the guide needle on the operation surface (the side where the bottom plate 1 is flush with the positioning hole 2), and the guide needle with the positioning wire enters the uterine tissue through the positioning hole of the surgical guide for myomectomy, and reaches the preset puncture depth before surgery. After stopping, take out the positioning guide needle through the positioning hole, and the positioning wire will be embedded in the position of the fibroid. Repeat the above operation until all the target uterine fibroids planned before operation are embedded in the positioning wire,

Among them, the edge of the bottom plate 1 is provided with fixed holes 4 in an indefinite number. Before inserting the guide plate, the operator puts a surgical thread on one of the holes, and then withdraws the guide plate after withdrawing the guide needle. The patient can easily pull out the guide plate with the assistance of the surgical wire, and peel off this type of uterine fibroids one by one according to the preoperative plan, and remove the positioning wire at the same time.

With the above technical solution, the 3D printing customized surgical guide for uterine fibroids uses peek material, and the implantation grade peek has undergone a complete biocompatibility test in accordance with the ISO10993 standard, with excellent biocompatibility, no cytotoxicity, Non-mutagenic, non-carcinogenic and non-allergenic, it is safe to enter the body. In addition, peek has X-ray penetrability and good visibility. During the implementation of myomectomy, doctors can also adjust it in real time according to MRI or CT;

Among them, the 3D printing customized surgical guide for uterine fibroids can also use photosensitive resin, pp material or pc material and other materials that meet the surgical requirements such as biocompatibility and structural strength.

In addition, the use of the guide plate can cooperate with the surgical plan based on the best myometrial incision and suturing method formulated by the preoperative physician, and guide the operator to remove the uterine fibroids with a diameter greater than or equal to 1cm and less than 3cm to the greatest extent during the operation. Reduce postoperative residual rate and recurrence rate. This program is expected to improve the surgical accuracy of the operator, reduce the trauma of the uterus, shorten the operation time, and reduce the postoperative residual rate and recurrence rate.

The content not described in detail in this specification belongs to the prior art known to those skilled in the art. In addition, the positional nouns such as upper, lower, left, right, front and rear in the text only represent their relative positions rather than absolute positions.

Although the present invention has been described in detail with reference to the foregoing embodiments, for those skilled in the art, it is still possible to modify the technical solutions described in the foregoing embodiments, or to perform equivalent replacements for some of the technical features. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims (6)

1. The 3D printing customized surgical guide for uterine fibroids that cooperates with the guide needle and the positioning wire, including a bottom plate (1), characterized in that: the bottom plate (1) is printed based on a uterine model, and the bottom plate (1) ) and the patient's body tissue; Wherein, the bottom plate (1) is provided with a positioning hole (2), and the operating surface of the positioning hole (2) is protruded and provided with a boss (3) integrated with the bottom plate (1). The side printing of the hole (2) is provided with a hole depth dimension; A fixing hole (4) is provided on the side of the bottom plate (1), and an in-position groove is opened at the end of the bottom plate (1). 2. The 3D-printed customized surgical guide for uterine fibroids resection matched with a guide needle and a positioning wire according to claim 1, characterized in that: the abutment surface of the bottom plate (1) faces the patient's uterus when viewed from above . 3. The 3D-printed customized surgical guide for uterine fibroids resection matched with a guide needle and a positioning wire according to claim 1, characterized in that: the width dimension of the bottom plate (1) is not less than 1.5cm, preventing operation During use, it is broken, and the surrounding tissues and organs are injured; and the width of the bottom plate (1) is not more than 2cm, which prevents the difficulty of inserting and removing the abdominal cavity through the incision; meanwhile, the thickness of the bottom plate (1) is 3mm at the thinnest part. 4. The 3D printing customized surgical guide for uterine fibroids resection matched with a guide needle and a positioning wire according to claim 1, wherein the positioning hole (2) is a hollow cylinder as a whole, and the positioning hole is in the shape of a hollow cylinder. The inner diameter width dimension of (2) is 2.2-2.5mm, and the height dimension of the positioning hole (2) is 4.8-5.8mm. 5. A method of using a 3D printing custom-made surgical guide for uterine fibroids that is matched with a guide needle and a positioning wire as claimed in claim 1, characterized in that: the method of using the guide comprises the following steps: Step 1: Preoperative preparation, extract pelvic imaging data of patients with multiple uterine fibroids, and use color resin materials to 3D print a 1:1 model of the patient's uterus and its fibroids; Step 2: The deep and difficult fibroids that need to be positioned and removed are calibrated on the uterus model, each fibroid provides a corresponding surgical approach, and the surgical guide for uterine fibroids removal with positioning holes is printed; Step 3: During the laparoscopic myomectomy, before the uterine fibroids are removed, the myomectomy guide is placed at a preset position on the surface of the uterine wall; Step 4: The guide needle carries the positioning wire and enters the uterine tissue through the positioning hole of the surgical guide for uterine fibroids. After reaching the preset puncture depth before surgery, it stops. The guide needle is taken out through the positioning hole, and the positioning wire will be embedded in the target fibroids. Location; Step 5: Repeat the above step 4 until all the preoperatively planned target uterine fibroids are embedded in the positioning wire, and then take out the guide plate; Step 6: Peel off this type of uterine fibroids one by one according to the preoperative surgical plan, and remove the positioning wire at the same time. 6 . The method of using a 3D printing custom-made surgical guide for uterine fibroids resection that cooperates with a guide needle and a positioning wire according to claim 5 , wherein the 3D-printed custom-made uterine fibroids stripping surgical guide Using peek material, photosensitive resin, pp material or pc material.

Images