CN204655094U - A kind of image-guided pricking device - Google Patents

Abstract

This utility model relates to a kind of image-guided pricking device newly and its production and use.This equipment can be directly used in the direction and location of tumour ablation art, percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation etc., and can be used for the degree of depth is focus within 10cm.This equipment is reusable, can change the pin of different size as required at any time.This utility model is safe and effective, controls easy, is easy to operation, practical, its preparation technology is easy, and production cost is low, Be very effective, be that significant improvement has been carried out to existing pricking device, improve ease for use and safety, easily apply, expand prior art products systematic difference, be more suitable for the large-scale production of pharmaceuticals industry and the clinical practice of interventional therapy, there is applications well prospect, significant social benefit, economic benefit can be produced in the short period of time.

Description

Image guide puncture equipment

Technical Field

The utility model belongs to the technical field of the medical technology and specifically relates to a directional positioning device who relates to interventionalism technical field, more specifically says so and relates to a puncture equipment that can directional location under the image guide, and specifically says so again relates to an image guide puncture equipment that can directional location.

Background

Overview of interventional therapy

Interventional therapy (Interventional treatment) is an emerging therapeutic approach between surgical and medical treatments, including both intravascular and non-vascular interventions. After decades of rapid development, the three clinical branches of the medical science have become together with the surgery and the internal medicine. In brief, the interventional therapy is a minimally invasive treatment method in which a small channel with a diameter of several millimeters is made on a blood vessel and a skin or an original pipeline of a human body under the guidance of an imaging device (an angiography machine, a fluoroscopy machine, a CT, an MR, a B-ultrasound) to treat a local part of a lesion without operating to expose the lesion.

Advantages of the

The interventional therapy is characterized by small trauma, simplicity, convenience, safety, effectiveness, few complications and obviously shortened hospitalization time.

1. For the diseases needing internal medicine treatment, the interventional therapy has the advantages relative to the internal medicine treatment:

the medicine can directly act on the pathological change part, thereby not only greatly improving the medicine concentration of the pathological change part, but also greatly reducing the medicine dosage and reducing the side effect of the medicine.

2. For the diseases needing surgical treatment, the relative advantages of interventional therapy and surgical treatment are as follows:

(1) the treatment can be completed without cutting to expose the focus, generally only a skin incision of a few millimeters is needed, the damage to the epidermis is small, and the appearance is attractive;

(2) most patients only need local anesthesia but not general anesthesia, so that the risk of anesthesia is reduced;

(3) the injury is small, the recovery is fast, the effect is satisfactory, and the influence on normal organs of the body is small;

(4) for the malignant tumor with great treatment difficulty at present, the interventional therapy can limit the medicine to the lesion part as much as possible, so that the side effect on the body and other organs is reduced; part of the tumor after interventional therapy is equivalent to surgical resection;

due to the advantages, many interventional therapies become one of the most important therapies for some diseases (such as liver cirrhosis, liver cancer, lung cancer, prolapse of lumbar intervertebral disc, aneurysm, vascular malformation, hysteromyoma, etc.).

(II) general technique

The method is divided into the following steps according to the path of the medical appliance entering the focus: intravascular interventions and non-intravascular interventions.

Intravascular intervention refers to: the method comprises the steps of using a puncture needle with the thickness of 1-2 mm, puncturing superficial arteriovenous vessels on the body surface of a human body, entering the vascular system of the human body, sending a catheter to the position of a focus by a doctor with the help of mastered vascular dissection knowledge under the guidance of an angiography machine, injecting a contrast agent through the catheter, displaying the vascular condition of the focus, and treating the focus in a blood vessel, wherein the method comprises arterial embolization, angioplasty and the like. Commonly used body surface puncture points include femoral artery and vein, radial artery, subclavian artery and vein, jugular artery and vein, etc.

Non-vascular intervention refers to: the method for treating the focus comprises percutaneous puncture tumor biopsy, intratumoral injection, intervertebral disc puncture decompression, intervertebral disc puncture ablation and the like.

In addition, a treatment method of directly puncturing the focus blood supply artery through the body surface by using a puncture needle is also provided. Temporarily classified as a non-vascular intervention.

(III) methods of treatment

1. Stent technology

Firstly, an esophageal stent: when the late stage esophageal cancer patient is difficult to eat, the esophageal stent can be placed into the pathological change part through the oropharynx, the eating condition of the patient is improved, and meanwhile, the stent has a certain compression effect on the tumor, so that the tumor ischemia is caused, and the tumor growth is delayed;

secondly, biliary tract stent: the method is suitable for obstructive jaundice caused by the pressing of tumors at the hepatic portal, pancreas and other parts on the bile duct, adopts percutaneous liver puncture, places the biliary tract stent at a narrow section, and enables bile to directly enter duodenum, and is the first choice method for solving the jaundice obstruction at present.

2. Embolism treatment

Embolism of tumor: tumors of liver cancer, lung cancer, pelvic cavity and the like can be injected into blood supply arteries through catheters to block blood circulation, so that the purpose of 'starving the tumors' is achieved;

② embolism of bleeding: advanced tumors often cause massive bleeding, if not timely controlled, often cause other complications, and result in death. For example, lung cancer, bladder cancer, esophageal varices and rupture, etc., the patients need emergency intervention treatment, embolism of blood supply vessels, and bleeding control, such as bronchial artery, internal iliac artery, gastric coronary vein, etc.

(IV) Classification

1. Non-vascular intervention

Various percutaneous biopsies, various non-vascular cavity forming operations (including the expansion and support of strictures of urinary tract, digestive tract, respiratory tract, biliary tract and the like), local solid tumor killing operations (percutaneous intratumoral injection and radiofrequency ablation), drainage operations, fistulization (stomach, bladder and the like) fistula embolization, tubal adhesion and recanalization operations, intervertebral disc herniation interventional therapy, vertebroplasty, nerve plexus blocking operations for treating chronic pain and the like.

2. Vascular intervention

Vascular disease: including percutaneous transluminal angioplasty, vascular stenting, thrombolytic therapy, nonthrombotic ischemia, control of bleeding (acute and chronic trauma, postpartum, inflammation, varicose veins, etc.), vascular malformations, treatment of arteriovenous fistulas and aneurysm embolization, inferior vena caval filters, TIPSS, vascular reconstruction, various angiographic diagnostics, venous access diagnostics, and the like.

And (3) neoplastic diseases: including blood supply embolism and medicine perfusion of tumor, intra-arterial irradiation, prevention of radioactive injury, chemotherapy, preoperative embolization of tumor blood vessel, vasoactive medicine and alcohol perfusion.

(V) interventional radiology

1. Brief introduction to the drawings

In brief, it adopts high-tech equipments such as TV monitor, etc. to make a small hole on a certain position of human body, then uses a catheter to go deep into the blood vessel of patient body to make the minimally invasive intracavity operation treatment of repairing, expanding and dredging operation. The clinical interventional therapy is the main axis, and the professional discipline of interventional radiology is formed.

Interventional radiology, also called interventional therapeutics, is a subject combining radiodiagnosis and clinical therapeutics, which has rapidly developed in recent years. It is a clinical application subject that a specific instrument is guided into a human body lesion part through a tiny wound for treatment under the guidance of a radiodiagnostic device (a digital subtraction X-ray machine, a CT machine, a nuclear magnetic resonance machine, a conventional X-ray machine and the like). Interventional therapeutics can treat a variety of diseases using "non-surgical, minimally invasive surgery" approaches.

2. Initiation and development of

The term "interventional radiology" was first introduced by the american radiologist Margulis. Margulis keenly realized that a completely new specialty in the radiology field is developing, and he writes the title "interventional radiology: a new specialty is published in International academic publication AJR, 3.1967, in which interventional radiology is defined as the procedure for diagnosis and treatment under fluoroscopic guidance. It is particularly emphasized that physicians engaged in interventional radiology need to be trained in interventional procedures, clinical skills, and in close cooperation with internal and external physicians. However, the term Interventional Radiology was widely recognized by academia in 1976, Wallace was in the journal of Cancer (Cancer), and after systematically describing the concept of Interventional Radiology on the subject of "Interventional Radiology", a monograph was made at the first Interventional Radiology conference of the european Radiology conference held by portugal in 1979, and this name was officially recognized by the academia.

Chinese scholars also have various translations for the name "Interventional Radiology", such as "surgical Radiology", "Interventional Radiology", "therapeutic Radiology", "invasive Radiology", etc., also called "catheter therapeutics", but are generally willing to accept the name "Interventional Radiology". This name is also specifically defined by chinese interventional radiologists. Interventional radiology is based on image diagnosis and provides independent diagnosis and treatment of diseases under the guidance of medical image diagnostic equipment (DSA, US, CT, MRI, etc.). The clinical treatment property is minimally invasive intracavity surgery treatment.

3. Characteristics of

Simple, safe, effective, minimally invasive and less complicated. To a certain extent, the intervention is equivalent to a non-invasive operation. Compared with the traditional surgery, the intervention treatment has the advantages that:

firstly, the operation is not needed, the postoperative recovery is fast, the interventional therapy adopts a minimally invasive treatment mode, and only a puncture wound of 2-3 mm is arranged at the root of the thigh;

the injury is small, the recovery is fast, the effect is good, the interference to the body is not large, and the normal organs are protected to the maximum extent;

for the malignant tumor without a radical treatment method at present, the interventional therapy can limit the medicine to the lesion part as much as possible, so that the side effect on the body and other organs is reduced;

the interventional therapy only needs local anesthesia, has small side effect and is more suitable for the aged and the weak patients;

the success rate of the operation is high, and the death rate is low; according to relevant statistics, the success rate of the current interventional therapy is as high as 90%, and the death rate is almost zero.

Due to the advantages, many interventional therapies become one of the most important therapies for certain diseases (such as liver cancer, lung cancer, lumbar intervertebral disc protrusion, aneurysm, vascular malformation, hysteromyoma, etc.), and even replace or eliminate the original surgical operation.

Second, the research progress of image-guided puncture

Brief description of the drawings

The image-guided puncture is to puncture the focus under the guidance of various imaging devices including X-ray fluoroscopy, B-ultrasound, Computed Tomography (CT) and Magnetic Resonance (MR) to complete the treatment of pathological biopsy, drainage, tumor ablation or radioactive particle implantation.

The image-guided puncture plays an important role in the treatment aspects of pathological biopsy, drainage, tumor ablation or radioactive particle implantation and the like, the tumor ablation is an important branch in the interventional treatment of tumors, namely a non-vascular interventional treatment method, but the image imaging modes are different, and various guiding modes have characteristics; among them, CT is widely used as a puncture guide apparatus because of its high resolution, no overlapping of front and rear images, strong three-dimensional property, and suitability for each focus of the whole body.

(II) Adaptation progress of tumors

The interventional therapy under the guidance of the image has the characteristics of targeting, minimally invasive, safety and high efficiency, so the interventional therapy is increasingly accepted and popular by patients and clinicians, and plays an increasingly important role in the comprehensive treatment of tumors. The intervention treatment of the tumor comprises intravascular intervention and non-vascular intervention, wherein the former mainly refers to transcatheter arterial perfusion chemotherapy (such as drug-loaded microspheres) and radiotherapeutic embolization, and the latter mainly refers to a percutaneous puncture tumor ablation method such as radio frequency ablation, microwave ablation, cryoablation, high-energy focused ultrasound, irreversible electroporation technology and the like.

1. Drug-loaded microspheres

Transcatheter hepatic artery chemoembolization (TACE) is one of the main means for treating blood-rich tumors, especially in middle and late stage liver cancer, and its curative effect has been well recognized. The embolization agent that classic TACE treatment adopted is the mixed emulsion of ultra liquid iodine oil (lipiodol) and various chemotherapeutic drugs, and iodine oil carries the chemotherapeutic drug and gets into inside the tumor and exert local killing effect, but this mixed emulsion is unstable, and the chemotherapeutic drug will release and get into systemic blood circulation within several hours to several days, is difficult to really exert the purpose of stable slow release. Other common embolizing agents for TACE include gelatin sponge particles, PVA microparticles, and triacrylate gelatin microparticles (embosopheromones), but none of these microparticles can carry chemotherapeutic drugs, and only can mechanically embolize the blood supply artery for tumor. If can combine chemotherapy medicine and microballon, through selective artery intubate, carry it to tumour part, will exert the dual function of high concentration local chemotherapy and tumour blood supply artery mechanical embolism, the curative effect can obtain improving theoretically, and this is the research of medicine carrying microballon is original intention.

Drug-loaded microspheres, also called drug-eluting microspheres (DEB), have been studied in a wide variety of microsphere matrices and drug-loaded microspheres, but have been rarely produced and successfully used in clinical applications, and have been studied and applied extensively in DCbeads (sold under the name "Daxian" in Europe since 2004).

International research progress: DCbead adsorbs and binds anthracycline antitumor hydrochloride drugs (such as adriamycin, epirubicin and daunorubicin) or camptothecin derivatives (such as irinotecan and topotecan) through ion exchange. The drug loading efficiency is extremely high (> 99%), 37.5mg of doxorubicin and 50mg of irinotecan can be carried per ml of microspheres, and the usual amount of microspheres can carry a sufficient therapeutic dose of chemotherapeutic drug.

In vitro experiments, pharmacokinetics and artery model studies all confirm that DCbead can carry and slowly release chemotherapeutic drugs in sufficient quantity, the drug concentration in tumor tissues can reach and maintain lethal dose for days to weeks, and the drug concentration in systemic blood circulation is very low, so that the tumor necrosis rate is high and systemic chemotherapy side effects are slight.

Several clinical trials for treatment of unresectable primary liver cancer with doxorubicin-loaded DCbead (DEBDOX) have been completed or are underway to evaluate its safety and efficacy, including a prospective randomized controlled study comparing DEB-TACE to conventional TACE (c-TACE), i.e., PRECISION V study. The study showed that patients with DEBDOX embolization group had lower hepatotoxicity and systemic side effects than the c-TACE group, while the objective response rate (OR) of tumors at 6 months was slightly higher in the DEBDOX group than in the c-TACE group (52% vs. 44%). Other clinical studies are underway regarding the use of DEBDOX in patients awaiting liver transplantation, DEBDOX in combination with radiofrequency ablation, DEBDOX in combination with sorafenib treatment. The DEBDOX embolism also shows a better curative effect for liver metastasis of neuroendocrine cancer and intrahepatic cholangiocellular carcinoma.

The DCbead loading of chemotherapeutic drugs needs to be manually completed by an interventionalist within hours before operation, the focus of further research on drug eluting microspheres is microspheres preloaded with chemotherapeutic drugs and microspheres loaded with multiple chemotherapeutic drugs, and drug preloaded microspheres DEBDOX (PrecistBead) and DEBIRI (ParagnoBead) have been developed but have not yet entered the market. In clinical research, the next research content is mainly the combined application of DEB embolism and other treatment means such as systemic chemotherapy, local ablation treatment and molecular targeted drug treatment and the treatment of other tumors except liver.

The current situation of Chinese research and application: at present, DCbead is not approved to enter the Chinese market, but the research on drug-loaded microspheres is one of the hot spots in the fields of Chinese pharmacy and interventional radiology, and the developed types of the drug-loaded microspheres comprise 5-fluorouracil polylactic acid microspheres, adriamycin sodium alginate microspheres, pingyangmycin-loaded ion exchange type microspheres, cisplatin microspheres, compound zedoary turmeric oil microspheres containing traditional Chinese medicine components and the like.

2. Radiotherapeutic embolism

To summarize: radiotherapeutic embolism is a kind of brachytherapy, which injects 90Y micro-ball into artery, and is mainly used to treat liver cancer and liver metastatic cancer. Its main indications include: firstly, the tumor is huge or numerous, so that the tumor is not suitable for TACE; ② tumor invades the branch of the leaf segment; after treatment, the tumor stage can be reduced, and patients with operative resection, ablation or liver transplantation opportunities can be obtained; and fourthly, the disease progressor after TACE or sorafenib treatment.

Unlike TACE, the primary effect of radioembolization is brachytherapy, rather than ischemia necrosis of tumors caused by arterial embolization to blood supply to tumors. There are two commercial radioactive microspheres on the market today: resin microsphere SIR-Spheres and glass microsphere Therasphere. 90Y emits pure beta radiation, has a short half-life (2.67d) and a short penetration distance (average 2.5mm, maximum 11 mm).

Tolerance and safety: the side effect after radiotherapy embolism is slight, post-embolism syndrome like TACE can not appear generally, and mainly comprises hypodynamia (54-61%), bellyache (23-56%), nausea and vomiting (20-32%) and low fever (3-12%), and the side effect lasts for only a few hours. Mild to moderate lymphopenia is common but does not increase the chance of infection. Radiotherapeutic embolization is also safe for patients with portal vein occlusion or segmental biliary obstruction but normal bilirubin. Side effects caused by irradiation of non-target organs include cholecystitis, gastrointestinal ulcers, pneumonia and hepatotoxicity.

Treatment outcome and potential effects: all evidence currently supporting the use of radioemboli for treatment of liver cancer is a retrospective study or a non-controlled prospective study (evidence class II-2 or II-3), and there is no randomized controlled trial study on radioemboli with other therapeutic approaches. But positive conclusions can still be drawn from the recently published 3 bulk case studies (nearly 700 cases).

For early and medium-term liver cancer, multiple studies show that the effect of radiotherapeutic embolism is similar to TACE. For early patients, radioembolisms are mainly used for treatment during waiting periods for liver transplantation or palliative treatment of inoperable or ablative lesions; for mid-term patients, radioembolisms are mainly used for those who are not suitable for TACE treatment. After radiotherapeutic embolization, most of the treated lesions shrink and the residual liver volume increases, so that the original unresectable lesions may become radical resectable, which is more obvious than TACE.

Therapeutic status and prospect: the position of radiotherapeutic embolism in liver cancer treatment is between TACE and sorafenib. Currently, several randomized controlled studies on radioembolization are underway, such as the sorafenib in combination with radioembolization for treatment of liver cancer patients awaiting liver transplantation (NCT00846131), the study of comparing radioembolization with radiofrequency ablation or TACE for unresectable liver cancer treatment (NCT00956930), and the study of SIRTACE comparing TACE and quality of life after radioembolization treatment (NCT00867750) conducted in europe, among others.

Because of the good radioembolic resistance, it is also suitable for use in place of or in combination with sorafenib. Currently, two RCT studies are in progress: the asia-pacific SIRveNIB clinical trial (NCT01135056) aimed to compare the therapeutic effects of radioemboli and sorafenib on patients without extrahepatic metastases, while the european SORAMIC trial (NCT01126645) compared the therapeutic effects of the combination of sorafenib alone on patients who were unable to perform TACE. Can also have good effect on neuroendocrine tumor liver metastasis, colon cancer liver metastasis and radiotherapeutic embolism.

The Chinese application situation is as follows: the researches on the treatment of liver cancer by radioactive microsphere embolism in China are few, only ten small clinical cases of liver cancer treatment by 90Y glass microspheres and 32P glass microspheres are reported, and most of the researches are conducted 5-10 years ago, which may be related to the difficulty and complexity in preparation and use of radioactive microspheres.

3. Tumor ablation

Tumor ablation includes chemical ablation and physical ablation. The chemical ablation is a technology for directly injecting absolute ethyl alcohol or acetic acid into a tumor through a puncture needle so as to cause tumor necrosis, has simple operation, low price and definite curative effect, but has smaller ablation volume, and is mainly used for treating small liver cancer and supplementing treatment of partial cases with physical ablation difficulty due to special parts. The warm ablation mainly based on radio frequency and microwave ablation obtains satisfactory curative effect in the treatment of various tumors, becomes the mainstream of tumor ablation technology, laser ablation, cryoablation and high energy focused ultrasound (HIFU) treatment are increasingly widely applied, and new ablation technology such as irreversible electroporation technology overcomes the defects of the conventional warm ablation technology and has wide potential application prospect.

Radio frequency ablation (radio frequency ablation): radio frequency ablation is the most deeply studied and widely applied tumor ablation therapy method at present, and has a plurality of treatment modes and electrode types. The RF electrode can be classified into a single electrode (monopolarectrodes), which includes a straight rod electrode and an umbrella or anchor electrode with a sub-needle, and a double electrode (bipolarectrodes), which is mainly a celon RF electrode manufactured by Olympus, and is a new product developed in recent 5 years, according to whether an external electrode plate is used. The main advantages of the double electrodes are that the puncture is simple, negative plates are not needed, and the multi-needle combined ablation is realized, so that large tumors with the diameter of 7cm can be ablated at one time. The radiofrequency ablation has good treatment effect on solid tumors such as liver, lung, kidney, adrenal gland, bone metastasis cancer and the like, can be comparable to surgical resection on early liver cancer and stage I non-small cell lung cancer, and is also an important means for palliative treatment on middle and late stage tumors.

Microwave ablation: microwave ablation is mainly applied in China and Japan, and is less applied in Europe and America. Compared with radio frequency ablation, the method has the advantages of high ablation speed, high efficiency, large range and the like, but has the defect of unstable ablation range. Many microwave ablation therapeutic instruments are applied in the Chinese market, and are in the leading level in the world in the aspects of basic research and clinical application.

Freezing and ablating: cryoablation (cryoablation) is to utilize Joule-Thomson effect to sequentially fill argon and helium into a cryoprobe inserted into a tumor so as to form a freeze-thaw cycle and to generate freeze-thaw and apoptosis of tumor tissues. Is widely applied to the treatment of prostate cancer, liver cancer and lung cancer. China is at an internationally advanced level in the kind and number of cryoablation-treated tumors.

HIFU: the technology of HIFU treatment of tumors is mature, China develops an HIFU treatment system with independent intellectual property rights, which is called a sea supporting knife, and achieves certain achievement in the treatment of liver, pancreas and bone tumors. To better address the issues of tumor localization and monitoring during therapy, Israel Insightec corporation and GE corporation in the United states have collaborated to develop a magnetic resonance guided focused ultrasound (MRgFUS) tumor therapy system, InsighteExablate 2000, which has been approved by FDA in the United states for the ablation therapy of uterine fibroids, and has also been primarily used in the treatment of liver, breast, brain tumors and bone metastases. Currently, the system is undergoing clinical verification in China.

Irreversible electroporation (IRE): when a pulsed electric field is applied to a cell at a certain dose, the lipid bilayer cell membrane shows many micropores and transient permeability is increased, and the bioelectromagnetic phenomenon is called electroporation (electroporation). If the cell membrane is not restored to normal physiological state after the applied pulse electric field is removed, namely IRE (also called irreversible electric breakdown), irreversible cell membrane damage can cause cell apoptosis, which is the main mechanism of IRE for treating tumor.

Different from radio frequency ablation and the like, the IRE for treating the tumor does not generate heat, so the IRE is more suitable for the ablation treatment of the tumor around the large blood vessel, and the IRE is not easy to damage tissues and nerves containing more collagen, so the IRE is more suitable for the treatment of the traditional warm heat ablation dangerous focus. IRE treatment is short, requiring only seconds, but requires general anesthesia and muscle relaxation because high voltage pulses in the kilovolt range induce muscle contraction and arrhythmias. IRE is currently in preclinical research phase for treating tumors, but has achieved good results in animal experiments.

The Chinese application situation is as follows: in the aspects of basic research and clinical application of tumor ablation, the Chinese situation is not much different from the international advanced level, and some aspects are even at the international advanced level, such as the clinical application aspects of microwave ablation and cryoablation, the autonomous research and development aspects of HIFU and microwave treatment equipment and the basic research aspect of IRE all achieve remarkable performances. The defects are that the level of tumor ablation treatment in each region of China is different, the standardization is lacked, and the tendency of blindly expanding the indications exists; in addition, there is a lack of multicenter prospective control studies compared to other therapeutic approaches.

4. Post-interventional imaging evaluation of tumors

Since TACE or tumor ablation does not rapidly cause a decrease in tumor volume, and even a tumor volume increases in a short period of time, the conventional RECIST standard is not completely suitable for post-tumor interventional evaluation, and imaging examinations that mainly show morphological changes, such as normal ultrasound, CT, and MRI, cannot rapidly and accurately show the therapeutic effect of tumors. Functional imaging and molecular imaging methods capable of displaying blood flow, tissue perfusion and metabolic changes inside tumors are increasingly used for evaluating the curative effect after tumor interventional therapy, and a good effect is preliminarily displayed. Foreign chinese scholars have done a lot of work with great success.

Radio frequency, microwave, laser and HIFU all produce coagulation necrosis of tumors by high temperature, so their post-treatment imaging performance is similar. Generally, after the tumor is successfully thermally ablated, the tumor coagulative necrotic region is not strengthened on contrast enhanced ultrasound, enhanced CT or MRI, and is represented as a hypometabolic region on PET; a ring of significantly strengthened "halo" can appear around the early ablation zone, representing reactive hyperemia and inflammatory tissue, but this "halo" should be uniform in size, generally suggesting tumor survival or recurrence if nodular strengthening still exists or reoccurs within the tumor ablation zone. Due to the occurrence of the complications, the images after the ablation operation can be presented in a complex and various way, and the correctly known images are helpful for timely treating the complications and the residual and recurrent tumors, thereby improving the treatment effect of tumor ablation.

Kim et al summarized their imaging performance after rf ablation of over 4000 cases of liver tumors over 10 years and found that: the common image shows that the ablation area is a circular or elliptical low-density area on the CT, wherein small bubbles which represent the vaporization of the high-density area of the needle channel and interstitial fluid can exist, the enhanced scanning ablation area is not strengthened, and the surrounding hyperemia 'halo' usually disappears within 1 month; on MRI, the ablation zone was early in high-low confounding signal at T1 and uniform low signal at T2, with time increasing, the T1 signal gradually increased and became uniform, the T2 was still uniform low signal, and the enhancement scan was not enhanced.

Unlike thermal ablation such as rf ablation, cryoablation does not produce coagulation necrosis of the tumor, and thus the imaging performance after ablation is different. Shyn et al found that 24h after successful cryoablation of liver tumors, 51% of the tumors still developed a tumor enhancement on the MRI scan, after which the amount and extent of tumor enhancement gradually decreased over time. This phenomenon is considerable and should not be mistaken for tumor residues.

5. Interventional therapy prospect for tumors

Tumor intervention is one of the very important and active areas in interventional radiology. With the continuous increase of the incidence of tumor and the deepening of the minimally invasive treatment concept, the theory, the technical method and the clinical research of the tumor interventional treatment are also deepened, and the great progress is made. In the aspect of basic research, new materials, new technologies and new devices, such as drug eluting microspheres, radiotherapy microspheres, IRE, novel radio frequency and microwave ablation devices and the like, are continuously emerged, so that the safety and the effectiveness of local treatment of tumors are further improved; in the aspect of clinical research, on one hand, the RCT research of a plurality of large-scale and multi-center methods by adopting a evidence-based medical method is considered to be important, so that the effects of different tumor treatment methods are verified, and on the other hand, the comprehensive tumor treatment taking minimally invasive treatment as the center is deeply carried out, such as the combination of different ablation technologies, the combination of tumor ablation and TACE, the combination of TACE and radiotherapy and chemotherapy, the combination of tumor ablation and radiotherapy and chemotherapy, the combination of interventional therapy and molecular targeted therapy medicines and the like; in addition, in the aspects of guiding means and image follow-up of tumor interventional therapy, the trend of combined application of a plurality of image examination means also appears, and the safety and the accuracy of interventional therapy are improved. Chinese scholars should track the international development frontier, give full play to the advantage of abundant Chinese case resources, actively participate in international cooperation, and develop some large-scale multi-center RCT researches by applying a evidence-based medical method; meanwhile, fundamental research and transformed medical research are actively conducted to develop interventional therapy drugs, equipment and equipment with proprietary intellectual property rights.

In addition to the above-mentioned tumor ablation, the non-vascular interventional therapy requires the use of a puncture device, which is also an essential device for percutaneous needle tumor biopsy, intratumoral drug injection, intervertebral disc puncture decompression, intervertebral disc puncture ablation, and the like.

Therefore, the search for safer and faster puncture equipment, particularly image-guided puncture equipment, is significant and has remarkable social and economic benefits. Through literature search and the like, no technical report on a novel image-guided puncture device is found so far.

Disclosure of Invention

The technical problem that this discovery needs to be solved discloses a new puncture equipment of intervention therapentic science technical field, novel image guide puncture equipment promptly, can be used for the novel image guide puncture equipment of the directional location of tumour ablation art, percutaneous puncture tumour biopsy art, intratumoral injection art, intervertebral disc puncture decompression art, intervertebral disc puncture ablation art etc. in order to overcome the above-mentioned defect that prior art exists.

That is to say, the utility model discloses to prior art not enough, through theoretical exploration and concrete technical research, the purpose is intended to provide a new puncture device and preparation method and use thereof, provides a novel image guide puncture device's structure promptly and preparation method and the concrete application of interventionalism technical field.

The utility model relates to an image-guided puncture device which is a novel image-guided puncture device capable of directional positioning and directly used for the technologies of tumor ablation, percutaneous puncture tumor biopsy, intratumoral injection, intervertebral disc puncture decompression, intervertebral disc puncture ablation and the like in the technical field of interventional therapeutics;

the novel image guide puncture device capable of being directionally positioned is preferably directly used for tumor ablation, and the tumor ablation comprises one or more of radio frequency ablation, microwave ablation, cryoablation, high-energy focused ultrasound, irreversible electroporation technology and the like.

First, technical conception

The independent development, research and development of innovative medical clinical technical equipment is an urgent task at present in China, Chinese medicine and particularly clinical therapeutics have a very long history, and abundant experiences are also accumulated in the aspects of disease prevention, drug treatment and the like, but the search for modern treatment technical means is an effective method for promoting medical development and better serving patients, and particularly the improvement of the existing treatment technical means and equipment thereof is a more efficient, faster and more economic way and is also a place for exerting the advantages of Chinese clinical work.

The interventional therapy, especially the interventional therapy of tumor, is the research focus and development focus in recent years, however, the research progress of the basic equipment is still far delayed from the clinical requirement, so that the application of clinical technology cannot achieve the satisfactory expected effect, and therefore comprehensive technical research needs to be further developed.

At present, for the research of interventional therapy technology, countries in the world mainly focus on the development of complex electronic equipment matched with the existing imaging equipment, and few research reports of fast, simple and safe mechanical matched equipment exist.

Therefore, from the viewpoint of the image-guided puncture technique, researchers have studied the operational difficulties of the prior art. Taking CT guided puncture as an example, the specific operation process is as follows:

CT conventional scanning is carried out to define focus;

secondly, selecting a puncture layer according to the position of the focus and the surrounding tissue structure, and determining a puncture point, a needle inserting angle and depth;

thirdly, after disinfection, puncturing at a selected puncture point with a determined angle and depth under local anesthesia;

fourthly, repeatedly scanning by CT to determine whether the puncture needle is in place, and if so, carrying out the next operation; if the puncture needle is not in place, readjustment is needed, puncture is carried out again, scanning is carried out again, the steps are repeated until the puncture needle is in a proper position, and the next operation is carried out.

It can be seen that CT scanning does provide accurate positioning of the puncture site, needle insertion angle and depth, but it is emphasized that this positioning is only an intra-image positioning and not an angular guidance of the extracorporeal procedure.

Whether the operator can insert the needle at a preset angle is the primary factor of successful puncture in the actual puncture process. There are numerous puncture angles on the external puncture point, and the operator can roughly estimate the adopted angle to puncture according to the needle insertion angle given by the CT scanning image by means of the memory of the focus on the CT image position, so that the proficiency of the operator and the pre-estimation of the needle insertion angle can become the key factors for successful puncture. If the focus is smaller or the position is deeper, the accuracy of puncture is greatly influenced by the small deviation of the needle inserting angle, and larger errors are generated, so that multiple punctures are caused, and even the puncture fails.

At present, the puncture method is adopted clinically when no extracorporeal puncture guide system exists. This puts high demands on the operating physician, such as the experience of puncturing is rich, the needle insertion angle can be correctly estimated, the puncturing technique is skilled, and the stability and accuracy of the needle insertion can be ensured during puncturing. For beginners or people with poor experience, accurate operation is very difficult, the puncture success rate is low, the pain of patients is increased, the probability of medical liability accidents is increased, and the borne medical risk and pressure are high.

How to improve the puncture success rate? In recent years, positioning puncture, that is, the idea of using a positioning angle and limiting a needle insertion angle at a puncture point, is adopted, so that theoretically, the error of the needle insertion angle can be reduced, and the accuracy of puncture can be improved. According to the thought, the CT puncture instrument is designed, but the CT puncture instrument utilizes two angle gauges and is connected through a base plate, a screw, a handle and the like, so that the CT puncture instrument is large in size, complicated to operate, not accepted by clinic, not applied to clinic and only used as a research content.

The recent numerical control puncture instrument completes clinical tests, the mechanism of the recent numerical control puncture instrument utilizes a numerical control machine tool to be linked with a CT, and digital positioning is carried out according to CT scanned images, so that the problem of inaccurate positioning is solved to a certain extent, but the instrument can only be connected with a fixed CT, and is large in size, complex in structure, high in price and not suitable for clinical use.

In a word, based on the above situation, researchers deeply discuss and introduce new innovations and improved ideas, and manually design new mechanical equipment, so that the usability of products is improved, the production cost is reduced, and the method is convenient for large-area popularization and application.

According to the idea and thought, researchers have successfully obtained expected research results and application products through repeated experimental research and analysis and theoretical exploration and through the scientificity and feasibility of the existing image guidance equipment and the matched puncture equipment.

Second, design principle and structure of image-guided puncture device

Researchers have designed entirely new image-guided puncture devices.

1. Principle of design

The most basic principle is based on the principle that the spherical surface can rotate freely in the universal bearing.

2. The main components of the equipment and the connection relation thereof

The device consists of a guide ball body (1), a universal shaft bracket (2) and a puncture cannula (3), wherein the guide ball body (1) is embedded in the universal shaft bracket (2) and can freely rotate in 360 degrees; the puncture cannula (3) is inserted into a hole (12) at the central part of the guide sphere (1) for relative fixation;

the structure of the guide sphere (1) is as follows:

the guide ball body (1) is formed by combining two hemispheres (11) into a whole, and the center of the combination part is provided with a hole (12) for accommodating the puncture cannula (3);

wherein the diameter of two hemispheres (11) of the guide sphere (1) is 4-6 cm, preferably 5-6 cm, and most preferably 5 cm; the height of the two hemispheres (11) is preferably 2-5 cm, more preferably 2-3 cm, and most preferably 2.5cm, namely the thickness of the upper part and the lower part; the surface of the ball is provided with angle scale lines (9), the angle is at least 0-90 degrees, preferably 0-45 degrees, and the starting point is 0 degree; preferably, latitude line marks are engraved on the horizontal phase or the vertical phase of the central diametric plane;

the diameter of the hole (12) of the guide ball body (1) is slightly larger than the outer diameter of the puncture sleeve (3) and is preferably 1-2 mm larger, namely after the puncture sleeve (3) is inserted into the hole (12), the guide ball body does not obviously shake and has no obvious friction feeling when being inserted and taken out: the diameter is 0.9-1.7 cm, preferably 1.1-1.4 cm, and most preferably 1.1 cm;

the needle (4) comprises one or more of a puncture needle, a biopsy needle, a radio frequency needle and the like, and the specification of the needle comprises 22G-14G and the like, namely the diameter of the needle (4) is 0.7-2 mm; when in use, the needle (4) is inserted into the puncture cannula (3) to guide the needle (4) to operate;

the universal shaft bracket (2) is a circular component formed by combining two semicircular rings (10), marks are engraved on the upper surfaces of the semicircular rings (10) horizontally and vertically, and horizontal columns (6) are reserved on the side surfaces of the semicircular rings; angle scale marks (8) are carved on the periphery of the ring, and the angle scale marks are 0-360 degrees, preferably 0-180 degrees and further preferably 0-90 degrees; the side surface of the universal shaft bracket (2) is also provided with an adjusting nut (5) which is used for fixing the guide ball body (1) through an adjusting nut (5) pore channel (7) reserved on the side surface;

after the guide ball body (1) is adjusted in place according to the preset angle of a scanned image such as CT and the like, the adjusting nut (5) is rotated to fix the guide ball body (1), so that the angle can be kept unchanged;

the top cover of the horizontal column (6) is a closed cover made of transparent glass or other transparent materials, liquid and a small bubble are arranged in the closed cover, and when the bubble is positioned at the central position, the instrument is in a horizontal position.

The puncture cannula (3) is used in the prior conventional technology, and the puncture cannula (3) is embedded into the hole (12) at the central part of the guide ball body (1); puncture cannula (3) of different specifications can be replaced: in actual use, the proper puncture cannula (3) can be replaced according to different puncture requirements; the center of the puncture cannula (3) is provided with a needle inserting tunnel, and the puncture cannula (3) of the needle inserting tunnels with different diameters is designed according to the thickness of the needle (4);

the puncture cannula (3) is a columnar object with a hole in the center, and the length of the columnar object is 3-5 cm, preferably 3-4 cm, and most preferably 3 cm; the outer diameter of the column is 0.8-1.5 cm, preferably 1.0-1.2 cm, and most preferably 1.0 cm; the inner diameter is 0.75-2.05 mm, preferably 1.05-1.45 mm, and most preferably 1.45 mm; the diameter of the hole at the central part of the puncture cannula (3) is 0.75-2.05 mm.

Use method of image-guided puncture device

Selecting a puncture cannula according to the type of the puncture needle, embedding the puncture cannula into a guide ball, holding a puncture device by hand, rotating a guide ball according to the designed angle of a CT scanning image, adjusting the angle to the angle, adjusting the horizontal column to the instrument level, introducing the puncture needle through the puncture cannula, and puncturing according to the preset depth.

Since the length of the needle is typically 15cm, the device can be routinely used for lesions with a depth of up to 10 cm. The advantage is that needles of different specifications can be replaced at any time as required, and the device can be reused, but needs to be disinfected and the like according to medical regulations.

Fourth, the purpose of the image guide puncture equipment

The utility model discloses the image guide puncture equipment that the research involves is relevant with the image guide equipment of intervenient therapentic science and supporting puncture equipment thereof to further experimental research and theoretical exploration have been carried out.

The utility model discloses image guide puncture equipment is can directly be used for the tumour to melt the technique such as art, percutaneous puncture tumour biopsy art, intratumoral injection art, intervertebral disc puncture decompression art, intervertebral disc puncture ablation art can the directional novel image guide puncture equipment of location.

Taking the ultrasound image guided puncture pathology examination as an example, the specific application of the image guided puncture device in the related technical field is now described.

False negative is a key technical index influencing the clinical application safety of axillary sentinel lymph node biopsy (SLNB for short) technology and is influenced by a plurality of factors in the technical link. The control of various influencing factors of false negative is the key for guaranteeing the safe implementation of the SLNB technology. One such task is to tightly control the indications for clinical application of SLNB technology.

The American Society for Clinical Oncology (ASCO) guidelines for axillary SLNB also relate to axillary lymph node status: the SLNB indication is primary breast cancer negative to axillary lymph node clinical examination, while definite axillary lymph node metastasis is contraindication for applying the technology.

The advantage of ultrasound is that lymph node status is judged by morphological changes. The previous research results suggest that the clinical examination method for judging the axillary lymph node status has poor reliability and has an error of 23-33%. And the ultrasonic imaging examination can judge whether the axillary lymph nodes are normal or not through morphological changes of the shape, the structure and the like of the lymph nodes, and the sensitivity and the specificity are respectively 42-56% and 70-90%. In the currently published literature, the criteria for ultrasound imaging of abnormal axillary lymph nodes are not uniform, with common criteria being disappearance of normal "target ring" like structures, cortical asymmetry or neoplastic thickening, when the tumor burden in the lymph nodes is already large enough to induce recognizable structural changes.

The results of several related studies suggest that when the tumor burden is high in Sentinel Lymph Nodes (SLNs), the detection of affected SLNs may be affected due to the influence on the structure and phagocyte function. It is possible to improve the reliability of the SLNB technique if cases with considerable tumor burden already exist in these lymph nodes are selected.

The advantage of ultrasound is that the biopsy is guided to obtain a specimen. Another advantage of ultrasound imaging methods is also that needle biopsies can be guided to obtain samples for pathological examination. The coarse needle puncture can obtain samples for histopathology examination, and the reliability is high. However, there is a certain risk of collateral damage due to a certain uncertainty of the movement of the puncture needle when the puncture gun is activated, and there is a reasonable concern about whether the damage to the lymph node and surrounding tissues will affect the subsequent possible SLN imaging. In addition, the sample obtained by fine needle puncture can be used only for cytopathology examination, but since epithelial cells should not be present in the background of the normal lymph node sample, it is not difficult to judge whether cancer cells are present or not on the premise of obtaining a satisfactory material (as compared with a cytological sample of breast tissue). Therefore, the axillary abnormal lymph node puncture cytology examination method guided by the ultrasonic image is simple, does not need complex additional equipment, has relatively low requirements on pathologists, and is an examination method worth popularizing.

After the axillary lymph nodes are found to be abnormal by adopting ultrasonic image examination, the axillary lymph nodes are proved to have metastasis by image-guided puncture pathology examination positive, so that the axillary SLNB is avoided, and the axillary lymph nodes are directly treated according to lymph node positive breast cancer; negative ones received SLNB to clarify lymph node status. However, it should be noted that, since the puncture pathology examination has a false negative problem, it has yet to be confirmed whether an image-abnormal lymph node with metastasis not confirmed is necessarily included in the acquisition of SLN. Such cases have occurred in a significant proportion of false negative cases and relevant prospective studies are ongoing.

Five, technical speciality

The utility model discloses an intervention therapentic science technical field provides the novel image guide puncture equipment that can the directional location that can directly be used for techniques such as tumour ablation art, percutaneous puncture tumour biopsy art, intratumoral injection art, intervertebral disc puncture decompression art, intervertebral disc puncture ablation art to improve current intervention therapentic science technical product system especially puncture equipment, improve and improve, thereby extended the application of prior art product system, improved ease of use and security.

The utility model discloses safe effective, easily operation, the practicality is strong, and its preparation technology is simple and convenient, low in production cost, and the effect is showing, can be used to fields such as tumour ablation art, percutaneous puncture tumour biopsy art, intratumoral injection art, intervertebral disc puncture decompression art, intervertebral disc puncture ablation art, has made unexpected score, and is safe in utilization, furthest has played the effect of product.

Taking the ultrasound image guided puncture pathology examination as an example, the ultrasound image examination and the puncture pathology examination method under ultrasound image guidance are used for screening the case suitable for SLNB, and the method has the following advantages: the purpose of judging the axillary lymph node state can be achieved by a simpler method than SLNB for some cases, so that the diagnosis and treatment procedures of a patient group are simplified; secondly, the SLNB is prevented from being accepted by a case with a large lymph node tumor load, so that the reliability of the application of the technology is improved; and the other subsidiary advantage is that for the case of receiving new adjuvant therapy, the pathological remission condition of the positive lymph nodes is an objective index which can be used for evaluating the curative effect. Statistically, ultrasound image-guided puncture pathology examinations of axillary abnormal lymph nodes of over 380 patients have been cumulatively completed. The preliminary analysis results showed that 10.5% of lymph node metastasis cases were screened by ultrasound imaging in combination with the puncture pathology in the case of lymph node negative clinical examination, while the negative rate of the final pathology was 10.7% in the case of lymph node positive clinical examination.

In a word, the utility model discloses image guide puncture equipment result of use is obvious, and control is simple and convenient, has actively adapted to the work needs and the needs of humanized service in modern medical treatment and scientific research field, more is suitable for the clinical application of the large-scale production and intervention therapentic science of medical industry, and application range is wide very much, and easy popularization and application can produce huge social and economic benefits in shorter time, has important value to improving and improving current intervention treatment level.

Drawings

FIG. 1: a schematic diagram of an image-guided lancing apparatus;

FIG. 2: schematic views of two semi-circular rings (10) of the cardan shaft stand (2);

FIG. 3: schematic representation of two hemispheres (11) of the guiding sphere (1);

FIG. 4: a schematic view of the adjusting nut (5);

FIG. 5: schematic representation of the puncture cannula (3).

Wherein, 1-guide ball 2-universal shaft bracket 3-puncture cannula

4-needle 5-adjusting nut 6-horizontal column

7-pore channel 8-angle scale mark 9 of universal shaft bracket-angle scale mark on ball surface

10-semi-circle ring 11-hemisphere 12-hole

Detailed Description

The utility model discloses research the current puncture equipment technique in intervention therapentic science field, provided a novel image guide puncture equipment that can directional location, be convenient for medical industry's safe handling.

The utility model discloses finally need prepare into image guide puncture equipment and use, will list the embodiment below and further explain. If there is a problem, the researcher may be contacted 13386272938 directly. The above experimental data and the following examples are provided to illustrate the structural requirements of the medical device and its method of use and experimental studies, but it is to be understood that the present invention is not limited to the details of the study set forth herein and that the terms used herein are used to describe specific examples and are not intended to limit the present invention.

The following takes the specific experimental research content of the image-guided puncturing device as an example, and the embodiment of the present invention is used to describe the present invention in detail, so as to further explain the new use of the image-guided puncturing device. The instrumentation and the like used in the experiments of the following examples were derived from or meet the above description.

In the present invention, the specific embodiments and examples are all for better explaining the present invention, and are not intended to limit the scope of the present invention.

Embodiment 1, practical structure of image guide puncture device

The device comprises a guide ball body (1), a universal shaft bracket (2) and a puncture cannula (3), wherein the guide ball body (1) is embedded in the universal shaft bracket (2) and can freely rotate in 360 degrees; the puncture cannula (3) is inserted into a hole (12) at the central part of the guide sphere (1) for relative fixation;

the structure of the guiding sphere (1) is as follows: two hemispheres (11) are combined into a whole, and the center of the combination part is provided with a hole (12) for accommodating the puncture cannula (3);

wherein,

the diameter of two hemispheres (11) of the guide sphere (1) is 6cm, the preferred height of the two hemispheres (11), namely the upper and lower thickness of the two hemispheres is 4cm, angle scale lines (9) are engraved on the surface of the sphere and consist of 0-90 degrees, and the starting point of 0 degree; latitude line marks are vertically carved on the central radial surface;

the diameter of the hole (12) of the guide ball (1) is 1.6cm, which is 1mm larger than the outer diameter of the puncture cannula (3), namely, after the puncture cannula (3) is inserted into the hole (12), the guide ball does not shake obviously and has good friction feeling during insertion and removal;

the needle (puncture needle, biopsy needle, radio frequency needle, etc.) (4) has the specification of 22G-14G, namely the diameter of the needle (4) is 0.7-2 mm; when in use, the needle (4) is inserted into the puncture cannula (3), and the needle (4) can be guided to operate;

the universal shaft bracket (2) is circular, two semicircular rings (10) are combined into a whole, marks are engraved on the upper surfaces of the semicircular rings (10) in the horizontal and vertical directions, and the positions of horizontal columns (6) are reserved on the side surfaces; angle scale lines (8) are carved on the periphery of the ring, and the angle scale lines are 0-360 degrees; the side surface of the shaft bracket is provided with an adjusting nut (5) which is used for fixing the guide ball body (1) through a pore passage (7) of the adjusting nut (5) reserved on the side surface;

after the guide ball body (1) is adjusted to the position according to the preset angle of the CT scanning image, the adjusting nut (5) is rotated to fix the guide ball body (1), so that the angle can be kept unchanged;

the top cover of the horizontal column (6) is transparent glass, liquid and a small bubble are arranged in the top cover, and when the bubble is positioned at the central position, the instrument is in a horizontal position.

The puncture cannula (3) is embedded into the middle shaft of the guide ball body (1) and can be replaced at will, a needle inserting tunnel is arranged in the center of the puncture cannula (3), the puncture cannula (3) with different diameter needle inserting tunnels is designed according to the thickness of the puncture needle (4), and the proper puncture cannula (3) is replaced according to different puncture requirements;

the puncture cannula (3) is a column with a hole in the center, and the length of the column is 4 cm; the outer diameter of the column is 1.5cm, and the inner diameter is 2.05 mm; the diameter of the hole at the central part of the puncture cannula (3) is 2.05 mm.

Embodiment 2 another practical structure of image-guided puncture device

The device comprises a guide ball body (1), a universal shaft bracket (2) and a puncture cannula (3), wherein the guide ball body (1) is embedded in the universal shaft bracket (2) and can freely rotate in 360 degrees; the puncture cannula (3) is inserted into a hole (12) at the central part of the guide sphere (1) for relative fixation;

the structure of the guiding sphere (1) is as follows: two hemispheres (11) are combined into a whole, and the center of the combination part is provided with a hole (12) for accommodating the puncture cannula (3);

wherein,

the diameter of two hemispheres (11) of the guide sphere (1) is 4cm, and the height, namely the upper and lower thicknesses of the two hemispheres (11) is preferably 2 cm; angle scale lines (9) are carved on the surface of the ball, the angle scale lines range from 0 degree to 90 degrees, and the starting point of 0 degree is marked; latitude line marks are engraved on the horizontal plane of the central radial surface;

the diameter of the hole (12) of the guide ball (1) is 1.4cm, which is 2mm larger than the diameter of the puncture cannula (3), namely, after the puncture cannula (3) is inserted into the hole (12), the guide ball does not shake obviously and has good friction feeling during insertion and removal;

the needle (puncture needle, biopsy needle, radio frequency needle, etc.) (4) has the specification of 22G-14G, namely the diameter of the needle (4) is 0.7-2 mm; when in use, the needle (4) is inserted into the puncture cannula (3), and the needle (4) can be guided to operate;

the universal shaft bracket (2) is circular, two semicircular rings (10) are combined into a whole, marks are engraved on the upper surfaces of the semicircular rings (10) in the horizontal and vertical directions, and the positions of horizontal columns (6) are reserved on the side surfaces; angle scale lines (8) are marked on the periphery of the ring, and the angle scale lines are divided into two parts from 0 to 180 degrees; the side surface of the shaft bracket is provided with an adjusting nut (5) which is used for fixing the guide ball body (1) through a pore passage (7) of the adjusting nut (5) reserved on the side surface;

after the guide ball body (1) is adjusted to the position according to the preset angle of the CT scanning image, the adjusting nut (5) is rotated to fix the guide ball body (1), so that the angle can be kept unchanged;

the top cover of the horizontal column (6) is transparent glass, liquid and a small bubble are arranged in the top cover, and when the bubble is positioned at the central position, the instrument is in a horizontal position.

The puncture cannula (3) is embedded into the middle shaft of the guide ball body (1) and can be replaced at will, a needle inserting tunnel is arranged in the center of the puncture cannula (3), the puncture cannula (3) with different diameter needle inserting tunnels is designed according to the thickness of the puncture needle (4), and the proper puncture cannula (3) is replaced according to different puncture requirements;

the puncture cannula (3) is a column with a hole in the center, and the length of the column is 5 cm; the outer diameter of the column is 1.2cm, and the inner diameter is 2.0 mm; the diameter of the hole at the central part of the puncture cannula (3) is 2.0 mm.

Embodiment 3 Structure and clinical application of image-guided puncture device

1. Concrete structure

Taking CT guided puncture as an example, the device comprises a guide ball body (1), a universal shaft bracket (2) and a puncture cannula (3), wherein the guide ball body (1) is embedded in the universal shaft bracket (2) and can freely rotate in 360 degrees; the puncture cannula (3) is inserted into a hole (12) at the central part of the guide sphere (1) for relative fixation;

the structure of the guiding sphere (1) is as follows: two hemispheres (11) are combined into a whole, and the center of the combination part is provided with a hole (12) for accommodating the puncture cannula (3);

wherein,

the diameter of two hemispheres (11) of the guide sphere (1) is 5cm, and the height of the two hemispheres (11) is 2.5 cm; the surface of the ball is marked with angle scale lines (9) which start from 0-45 degrees and 0 degree at least; latitude line marks are engraved on the horizontal plane of the central radial surface;

the diameter of the hole (12) of the guide ball body (1) is 1.1cm, which is 1mm larger than the diameter of the puncture cannula (3), so that the puncture cannula (3) can be ensured not to obviously shake after being inserted into the hole (12) and has no obvious friction feeling during insertion and removal;

the needle (puncture needle, biopsy needle, radio frequency needle, etc.) (4) has the specification of 22G-14G, namely the diameter of the needle (4) is 0.7-1.45 mm; when in use, the needle (4) is inserted into the puncture cannula (3), and the needle (4) can be guided to operate.

The universal shaft bracket (2) is circular, two semicircular rings (10) are combined into a whole, marks are engraved on the upper surfaces of the semicircular rings (10) in the horizontal and vertical directions, and the positions of horizontal columns (6) are reserved on the side surfaces; angle scale lines (8) are carved on the periphery of the ring, and the four parts are divided by 0-90 degrees; the side surface of the shaft bracket is provided with an adjusting nut (5) which is used for fixing the guide ball body (1) through a pore passage (7) of the adjusting nut (5) reserved on the side surface;

after the guide ball body (1) is adjusted to the position according to the preset angle of the CT scanning image, the adjusting nut (5) is rotated to fix the guide ball body, so that the angle can be kept unchanged;

the top cover of the horizontal column (6) is transparent glass, liquid and a small bubble are arranged in the top cover, and when the bubble is positioned at the central position, the instrument is in a horizontal position.

The puncture cannula (3) is embedded into the middle shaft of the guide ball body (1) and can be replaced at will, a needle inserting tunnel is arranged in the center of the puncture cannula (3), the puncture needles (4) have different thicknesses, and the puncture cannula matched with the needle inserting tunnels with different diameters can be replaced by the proper puncture cannula (3) according to different puncture requirements;

the puncture cannula (3) is a column with a hole in the center, and the length of the column is 3 cm; the outer diameter of the column is 1cm, and the inner diameter is 2.0 mm; the diameter of the hole at the central part of the puncture cannula (3) is 2.0 mm.

2. Application case

The retrospective analysis of the clinically complete 105 clinical data of the puncture biopsy under image guidance in 2013, 03-08 months was performed to summarize the possible causes of the complications and to propose preventive measures to reduce the occurrence of the complications, which are recorded as follows.

(1) Data and method

Firstly, the general data CT and other imaging examinations find 105 patients with peripulmonary space occupation, pleural space occupation and pulmonary diffuse lesion, 72 men and 33 women. The age is 30-81 years, and the median age is 55 years. 32 cases of right peripulmonary lesions, 30 cases of left peripulmonary lesions, 8 cases of right pleural occupancy, 15 cases of left pleural occupancy, and 20 cases of diffuse changes in both lungs and multiple nodules. The size of the lump is 0.5-5 cm, and the distance from the edge of the nearest edge of the lump to the pleura is 0-6 cm.

② method 105 cases before operation, chest enhanced CT examination is carried out for blood supply condition analysis in the lump. To eliminate hemorrhagic diathesis, severe cardiopulmonary insufficiency and severe pulmonary bullae. If the patient has severe cough, 30mg of codeine is orally taken 30min before operation, and the patient with emotional stress takes the Andin tablet orally. And detecting the focus under CT positioning, measuring the distance from a needle inserting point to the edge and the center of the tumor, puncturing by using an ARROW (ARROW instruments) puncture biopsy needle, and taking 2-4 biopsies to send pathology. And (3) performing routine breath sound auscultation after the puncture, and performing routine scanning and observing whether pneumothorax or pulmonary hemorrhage exists after the puncture under the guidance of CT. Symptoms such as shortness of breath and hemoptysis are closely observed after operation. If symptoms of shortness of breath, cough increase or respiratory sound decrease occur, chest examination is immediately performed, and closed drainage of the thoracic cavity or hemostat is performed if necessary.

(2) Results

11, 69 and 25 model 21G needles, and 18G needles were used under CT guidance. The puncture times is 2-5 needles, the distance between the skin of the puncture needle and the center of the tumor is 2.5-8 cm, and the size of the tumor is 0.5-5 cm. Pathological results are as follows: 61 malignant tumors, 15 inflammatory tumors and 25 tuberculous tumors. In 3 cases, the cause was not clarified because of the report of heterotypic cell mass, and in 1 case, the puncture failed. After puncture 20 pneumothorax cases were developed, common to elderly patients, 20 patients aged 65 years of mean age, of which 2 cases of closed drainage were required. After the first needle puncture, pneumothorax failure occurs in 1 case, the original chronic obstructive pulmonary disease and multiple large lung blebs occur, and after local anesthesia, a large amount of pneumothorax occurs, and the lung compression is 90% to cause puncture failure. In case 1, multiple lung nodules were undiagnosed by TBLB and the lungs were compressed 35% after biopsy of the densely distributed upper lobes of the nodules after CT localization. Both were passed through a thoracotomy closed drainage. After another 4 cases of puncture, the lung is compressed by 45-50%, and the medicine is absorbed after 4 days of conservative treatment such as air suction and oxygen inhalation after biopsy. In 14 cases, the lung compression is only 5% -15%, and the treatment is improved after oxygen inhalation. After puncture, 17 cases of bleeding (including a small amount of oozing blood) were found by imaging, but only 12 cases of hemoptysis were observed. In 17 cases, the blood supply was relatively abundant in 10 cases before operation, and in 1 case, the color doppler examination was not performed before operation, which is bilateral lung local consolidation, and hemoptysis appeared after direct lung biopsy under B-ultrasound. Hemoptysis reaches 800ml, and the hemoptysis is relieved after hemostatic treatment by administration of hypophysin and the like, and is pathologically proved to be infiltration in lungs of hematopathy. In the other 16 cases, there is a small amount of bleeding in the lung parenchyma, and 7 cases have hemoptysis symptoms, with a small amount of hemoptysis, about 3-5 mouths of hemoptysis. All through the conservative treatment of hemostasis to the symptom internal medicine. The above results indicate whether bleeding occurred or not and how much bleeding occurred, and the blood supply condition of the tumor in the lung indicated by the chest enhanced CT has a certain correlation.

3. Conclusion

Complications of percutaneous aspiration biopsy include pneumothorax, hemorrhage, air embolism, local tumor implantation and the like. Air embolism and local planting are rare. The most common complication is pneumothorax, which occurs in approximately 30% of patients with fine needle biopsy or after examination, and can occur as high as 50% when there is a change in pulmonary emphysema. Bleeding followed by approximately 5% during or after fine needle biopsy, with a 0.15% mortality rate. The data set showed that the most common complications were also pneumothorax and bleeding. The factors that contribute to the ease of pneumothorax are: the chronic obstructive pulmonary disease, intractable cough, deep lesion position, thick biopsy needle or incisional biopsy needle, multiple pleura puncture, long biopsy operation time, unskilled examination and operation doctor, inaccurate CT positioning guidance, multiple pleura puncture times and the like of elderly patients. The age of the patient, the number of punctures, the size of the mass, the underlying lung disease and the distance of the mass from the skin are good factors when combining this group of data. However, scholars believe that pneumothorax occurs regardless of the distance of the mass from the pleura. Hemoptysis is related to rich blood flow of focus, thickness of puncture needle and puncture position, and if the lump is close to the inner side, the blood vessel is rich and easy to bleed. However, unless the patient has pulmonary hypertension or underlying blood coagulation dysfunction, or the patient has injury to the internal mammary artery or intercostal artery during the procedure, bleeding is mostly self-limiting.

The most dangerous complications of lung puncture are: tension pneumothorax, major hemorrhage, air embolism, cardiac arrest. These complications, such as mishandling, can lead to patient death. However, cardiac arrest caused by air embolism and local anesthesia accidents is less reported and the incidence rate is low. In this group, 2 cases showed tension pneumothorax and 1 case showed major hemorrhage. The 1 case is the original chronic obstructive pulmonary disease and the multiple lung bullae, a cavity space occupying lesion exists at a position 1cm close to the pleura, pneumothorax appears after local anesthesia, and the compression is about 90 percent, which causes puncture failure. Another 1 cases are the localized solid changes of both lungs, with a large amount of hemoptysis appearing after puncture, which is about 800 ml. Relief was achieved after administration of posterior pituitary maintenance therapy after puncture.

Tension pneumothorax is considered and forms a one-way valve with a puncture needle channel after basic emphysema, and gas in the thorax is greatly increased in a progressive manner, so that mediastinum displacement is caused, and a respiratory circulation system is influenced to endanger life. The generation of the hemoptysis is related to the abundance of blood supply at the lung excess change part and the damage of the puncture needle to the thicker blood vessel. Some of the lumps are tumor in nature, and bleeding may be related to the abundant blood supply and abnormal structure of tumor tissues.

The reasons for hemoptysis are mainly related to abundant blood supply of tumor mass, thick puncture needle, and puncturing of thick blood vessels. In order to reduce the occurrence of major hemorrhage, chest enhanced CT or blood supply observation under color Doppler should be carried out before puncture. If the blood supply is abundant, puncture or fine needle is not needed to avoid heavy bleeding. The needle insertion is not too deep as much as possible because the pulmonary blood supply is the bronchial and pulmonary arteries. The lung tissue near the pleura is mostly derived from the blood supply of the pulmonary artery. The blood supply of the bronchial artery is mainly near the center, and the pressure of the bronchial artery is higher than that of the pulmonary artery, so the needle insertion of the patient with diffuse lesion cannot be too deep to avoid heavy bleeding. At the same time, the bedside should be prepared with drugs such as posterior pituitary. After bleeding, the affected side is recommended to lie down. While paying attention to the blood pressure situation.

The clinical application results show that the image-guided puncture device is a novel image-guided puncture device which can be directly used for the technology of percutaneous puncture tumor biopsy and the like and can be directionally positioned, can effectively solve the clinical problem, prevent misdiagnosis and the like, and plays a key auxiliary role in clinical diagnosis, treatment and the like.

Claims (10)

1. The image-guided puncture device is characterized by comprising a guide ball body (1), a universal shaft bracket (2) and a puncture cannula (3), wherein the guide ball body (1) is embedded in the universal shaft bracket (2) and can freely rotate in 360 degrees; the puncture cannula (3) is inserted into a hole (12) at the central part of the guide sphere (1) for relative fixation;

the guide ball body (1) is formed by combining two hemispheres (11) into a whole, and the center of the combination part is provided with a hole (12) for accommodating the puncture cannula (3);

the universal shaft bracket (2) is a circular component formed by combining two semicircular rings (10) into one, marks are engraved on the upper surfaces of the semicircular rings (10) in the horizontal and vertical directions, and the positions of horizontal columns (6) are reserved on the side surfaces; angle scale lines (8) are carved on the periphery; the side surface is also provided with an adjusting nut (5) which is used for fixing the guide ball body (1) through a pore passage (7) of the adjusting nut (5) reserved on the side surface;

after the guide ball body (1) is adjusted to the position according to the preset angle, the adjusting nut (5) is screwed to fix the guide ball body (1), so that the angle can be kept unchanged;

the center of the puncture cannula (3) is provided with a needle inserting tunnel, and the puncture cannula (3) of the needle inserting tunnels with different diameters is designed according to the thickness of the needle (4).

2. The image guided pricking device of claim 1, wherein the two hemispheres (11) of the guiding sphere (1) have a diameter of 4-6 cm and a height of 2-5 cm; angle scale lines (9) are carved on the surface of the ball, and the angle is 0-90 degrees;

the diameter of the hole (12) of the guide sphere (1) is 0.9-1.7 cm, and is 1-2 mm larger than the diameter of the puncture cannula (3);

the diameter of the needle (4) is 0.7-2 mm; when in use, the needle (4) is inserted into the puncture cannula (3) to guide the needle (4) to operate.

3. The image guided puncturing device according to claim 1 or 2, wherein the two hemispheres (11) of the guiding sphere (1) have a diameter of 5-6 cm and a height of 2-3 cm, the angle of the graduation mark on the surface of the sphere is 0-45 degrees, and a latitude mark is marked on the horizontal phase or the vertical phase of the central radial plane;

the diameter of the hole (12) of the guide sphere (1) is 1.1-1.4 cm.

4. The image-guided puncture device according to claim 3, wherein the two hemispheres (11) of the guiding sphere (1) have a diameter of 5cm and a height of 2.5 cm;

the diameter of the hole (12) of the guide sphere (1) is 1.1 cm.

5. The image-guided pricking device of claim 1 or 2, wherein the angle of the circumferential angular scale (8) of the gimbal (2) is 0 to 360 degrees;

the top cover of the horizontal column (6) is a closed cover made of transparent glass or other transparent materials, and liquid and a small bubble are filled in the closed cover.

6. The image-guided lancing apparatus according to claim 5, wherein the angle of the circumferential angle scale (8) of the gimbal (2) is 0 to 180 degrees, divided into two parts.

7. The image-guided lancing apparatus according to claim 6, wherein the angle of the circumferential angle scale (8) of the gimbal (2) is in the range of 0 to 90 degrees in four parts.

8. The image guided pricking device of claim 1 or 2, wherein the pricking cannula (3) is a cylindrical body with a hole in the central portion, the cylindrical body has a length of 3-5 cm, an outer diameter of 0.8-1.5 cm, an inner diameter of 0.75-2.05 mm, and the hole in the central portion has a diameter of 0.75-2.05 mm.

9. The image-guided penetration device of claim 8, wherein the penetration cannula (3) has a cylindrical body length of 3-4 cm and an outer diameter of 1.0-1.2 cm.

10. The image guided puncture device according to claim 9, wherein the puncture cannula (3) has a column length of 3cm and an outer diameter of 1.0 cm.