CN104546132A - Detachable image-guided puncture device - Google Patents

Abstract

The invention relates to a novel detachable image-guided puncture device and a production method and application thereof. The device can be directly used for directional positioning of tumor ablation, percutaneous puncture tumor biopsy, intra-tumor intrathecal injection, intervertebral disc puncture decompression, intervertebral disc puncture ablation and the like and can be used for focuses with the depth being more than 10cm. The device can be used for performing next clinical operation flexibly and is more convenient for radio-frequency ablation and seed implantation; the device is reusable but only suitable for single-diameter needles. The device is safe, effective, easy to control, highly practical, simple in production process, low in production cost and remarkable in effect, is a significant improvement on the existing puncture device, is higher in usability and safety and easy to popularize and apply, is more suitable for large-scale production of the pharmaceuticals industry and clinical application of interventional therapy and has good application prospect, the application of the product system in the prior art is expanded, and significant social and economic benefits can be created within short time.

Description

The image-guided pricking device of a kind of dismountable type

Technical field

The present invention relates to medical art, specifically relate to interventional therapy to learn a skill a kind of direction and location equipment in field, more particularly relate to a kind of image-guided lower can the dismountable type pricking device of direction and location, more specifically relate to a kind of can the image-guided pricking device of dismountable type of direction and location.

Background technology

One, the overview of interventional therapy

Interventional therapy (Interventional treatment) is the emerging therapeutic method between surgery, medical treatment, comprises intravascular intervention and Non-vascularized iliac bone treatment.Through developing rapidly of decades, clinical three large pillar subjects are become now together with surgery, internal medicine.Simply, interventional therapy is exactly when not operating on exposure focus, blood vessel, skin are done the minim channel of diameter several millimeters, or through the original pipeline of human body, to the Therapeutic Method that the focus local wound for the treatment of is minimum under the guiding of image documentation equipment (angiography machine, fluoroscopic machine, CT, MR, B ultrasonic).

(1) advantage

Interventional therapy is characterized in that wound is little, easy, safe, effective, few intercurrent disease and obviously shorten the hospital stays.

1, for needing medical treatment class disease, interventional therapy relatively and medical treatment advantage be:

Medicine can directly act on diseased region, not only can greatly improve diseased region drug level, also can greatly reduce drug dose, reduces drug side effect.

2, for needing surgical intervention class disease, interventional therapy relatively and surgical intervention advantage be:

(1) it is without the need to operating on exposure focus, the general skin incision only needing several millimeters, just can completed treatment, and epidermis injury is little, specious;

(2) as long as most patients local anesthesia but not general anesthesia, thus the danger of anesthesia is reduced;

(3) damage little, recover fast, good results, little on the impact of health normal organ;

(4) for the malignant tumor that treatment difficulty is at present large, interventional therapy can be confined to medicine the position of pathological changes as far as possible, and reduces the side effect to health and other organs; Partial tumors is equivalent to surgical excision at PTCA or and STENTS;

Just due to above plurality of advantages, many interventional therapy methods are becoming one of some diseases (as: liver cirrhosis, hepatocarcinoma, pulmonary carcinoma, prolapse of lumbar intervertebral disc, aneurysm, vascular malformation, hysteromyoma etc.) topmost Therapeutic Method.

(2) common technology

The path entering focus by medical apparatus and instruments is divided into: get involved in intravascular intervention and non-vascular.

Intravascular intervention refers to: use the puncture needle that 1 ~ 2mm is thick, by the shallow arteriovenous of puncture people's body surface, enter human blood circulatory system, doctor relies on the vascular anatomy knowledge grasped, and under the guiding of angiography machine, conduit is delivered to the position at focus place, by tube injection contrast agent, display focus blood vessel situation, in the method that Ink vessel transfusing is treated focus, comprises arterial embolization, angioplasty etc.Conventional body puncture point has arteriovenous, neck arteriovenous etc. under a burst arteriovenous, radial artery, clavicle.

Non-vascularized iliac bone refers to: simply say to be exactly do not enter human blood circulatory system, under the monitoring of image documentation equipment, directly enter focus through skin penetrating to focus or through the existing passage of human body, to the method for focus treatment, comprise percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation etc.

In addition also have use puncture needle directly through body puncture to the Therapeutic Method of focus feeding artery.Temporarily be classified as Non-vascularized iliac bone.

(3) Therapeutic Method

1, support technology

1. Esophageal Stent: when late esophagus cancer patient is difficult to feed, through oropharynx, Esophageal Stent can be inserted lesion, improve patients diet's situation, support has certain contention effect to tumor simultaneously, causes tumor ischemia, delays tumor growth;

2. biliary tract rack: being suitable for the obstructive jaundice because the region tumors such as hepatic portal, pancreas compressing bile duct causes, taking percutaneous liver to wear, biliary tract rack is placed in narrow section, make bile directly enter duodenum, is solve the yellow prefered method of resistance at present.

2, embolotherapy

1. the thromboembolism of tumor: suppository is all injected feeding artery by conduit by the region tumors such as hepatocarcinoma, pulmonary carcinoma, pelvic cavity, blocks its blood fortune, reaches the object of " tumor hungry to death ";

2. hemorrhage thromboembolism: late tumor often causes massive hemorrhage, as controlled not in time, often causing other complication, causing death.As pulmonary carcinoma, bladder cancer, Esophageal varices break, such patient should row emergency intervention treatment, and its supply vessels of thromboembolism, Bleeding control, as arteriae bronchiales, internal iliac artery, coronary vein of stomach etc.

(4) classify

1, non-vascular interventional therapy

Going out in the plasty (comprising the narrow expansion such as urinary tract, digestive tract, respiratory tract, biliary tract and support) of various percutaneous biopsy art, various non-vascular tract, solid tumor local can art (percutaneous puncture Intratumoral injection art, radio-frequency ablation procedure), drainage, fistulation (stomach, bladder etc.) fistula Embolization, fallopian tube sticky stifled and logical art, intervention treatment of protrusion of intervertebral disc, vertebroplasty, neurolytic celiac plexus block art treatment chronic pain etc. again.

2, vascular interventional technique

Angiopathy aspect: comprise percutaneous Endovascular angioplasty, intravascular stent, thromboembolism treatment, non-thrombotic ischemia, Bleeding control (acute and chronic wound, puerperal, inflammation, varicosis etc.), vascular malformation and arteriovenous fistula and hemangioma embolotherapy, inferior vena cava filter, TIPSS, Revascula rization, various angiographic diagnosis, venous blood sampling are diagnosed etc.

Neoplastic disease aspect: comprise tumor for blood embolization and the perfusion such as drug infusion, intra-arterial irradiate, the prevention of radiation injury, chemotherapy, Arterial embolization tumor vessel, vasoactive drug and ethanol.

(5) interventional radiology

1, brief introduction

Briefly it adopts the high technology equipments such as TV monitor, by opening a duck eye at a certain position of human body, then gos deep into blood vessel in patient body with a conduit, carries out Wicresoft's intracavity operation treatment of repairing, expanding, dredge work.Be main shaft by clinical interventional therapy, this special disciplines of interventional radiology also defines thereupon.

Interventional radiology, also known as interventional therapy, is that of in recent years developing rapidly melts radiodiagnostics and clinical therapeutics in the subject of one.It is under the guidance of radiodiagnostics equipment (Digital image subtracting X-ray machine, CT machine, nuclear magnetic resonance machine and orthovoltage x-ray machine etc.), by small wound, specific apparatus is imported the clinical practice subject carrying out treating in human lesion position.Interventional therapy adopts " non-surgical, Minimally Invasive Surgery " method to treat various diseases.

2, origin and the development

" interventional radiology " one word proposed first by U.S. radiologist Margulis.Margulis to recognize observantly that in radiation field a brand-new specialty is just in shaping and development, the commentary that what he write is entitled as " interventional radiology: a new specialty " in March, 1967, internationally famous academic journals " AJR " is delivered, in this section of commentary, he is defined as interventional radiology the operating technology of carrying out Diagnosis and Treat under guide of fluoroscopy.Lay special stress on is engaged in the doctor of interventional radiology, needs the training through interventional procedure technology, clinical skill, and with Medicine and Surgery doctor hand-in-glove.But interventional radiology (InterventionalRadiology) word is extensively approved it is in 1976 by academia, Wallace is on " cancer " (Cancer) magazine, with " Interventional Radiology " for after the topic formulate concept of interventional radiology, and thematic introduction has been done in the European Society of Radiology first time interventional radiology academic conference held in Portugal in 1979, this name is just by international academic community formal approval.

The translation of Chinese scholar to " Interventional Radiology " this title is also varied, such as " intervention radiology ", " interference capability radiology ", " interventional radiology ", " invasive radiology " etc., also have and be " catheter treatment ", but now be generally ready to accept " interventional radiology " this title.China intervention radiation scholar has also done concrete definition to this title.Interventional radiology is based on diagnostic imaging, under the guiding of medical imaging diagnosis equipment (DSA, US, CT, MRI etc.), makes independently Diagnosis and Treat to disease.Treat at the intracavity operation of clinical treatment attribute Shang Shi Wicresoft.

3, feature

Easy, safe, effective, Wicresoft and few intercurrent disease.To a certain extent, interventional therapy equals the operation that need not operate on.Interventional therapy is relative to traditional surgical operation, and advantage is:

1. it is without the need to operating on, and post-operative recovery is fast, and interventional therapy adopts minimally-invasive treatment mode, only has the puncture of a 2 ~ 3mm at thigh root place;

2. damage little, recover fast, effective, little to the interference of health, protect normal organ to the full extent;

3. for the malignant tumor that there is no radical cure method at present, interventional therapy can be confined to medicine the position of pathological changes as far as possible, and reduces the side effect to health and other organs;

4. interventional therapy only needs local anesthesia, and side effect is little, is more applicable to old, weak patient;

5. success rate of operation is high, and mortality rate is low; According to ASSOCIATE STATISTICS, the success rate of current interventional therapy is up to 90%, and mortality rate is almost nil.

Just due to above plurality of advantages, many interventional therapy methods become one of some disease (such as: hepatocarcinoma, pulmonary carcinoma, prolapse of lumbar intervertebral disc, aneurysm, vascular malformation, hysteromyoma etc.) topmost Therapeutic Method, even replace or have eliminated original surgical operation.

Two, the progress of image-guided puncture

(1) summarize

Image-guided puncture refers to comprising under X-ray examination, B ultrasonic, computed tomography (be called for short: CT) and magnetic resonance MR) (be called for short: under the guiding of the various image documentation equipment such as, focus is punctured, completes the treatments such as pathological biopsy, drain, tumour ablation or radioactive prospecting instrument.

Image-guided puncture plays an important role in the treatments such as pathological biopsy, drain, tumour ablation or radioactive prospecting instrument, tumour ablation art is an important branch and Non-vascularized iliac bone Therapeutic Method in the interventional therapy of tumor, but video imaging mode is different, and various guidance mode differs from one another; Wherein, CT is high with its resolution, unmatched rear image overlap, by force three-dimensional, is suitable for the whole body advantage such as focus everywhere, is widely used as guiding puncture equipment.

(2) Advance of Interventional Therapy of tumor

Interventional therapy under image-guided has targeting, Wicresoft, safety, efficiently feature, therefore day by day obtains accreditation and the welcome of extensive patients and clinicist, is just playing more and more important effect in the Comprehensive Treatment of tumor.The interventional therapy of tumor comprises intravascular intervention and Non-vascularized iliac bone, the former mainly refers to through Intraarterial Chemotherapy (as: medicine carrying microballoons) and radiotherapy Embolization, and the latter mainly refers to that the capable tumour ablation art of percutaneous puncture is as methods such as radio-frequency (RF) ablation, microwave ablation, cryoablation, energy focusing ultrasonic-high, irreversible electroporation technologies.

1, medicine carrying microballoons

(transcatheterarterialchemoembolization is called for short: TACE) be the rich blood for the treatment of for one of the Main Means of tumor especially mid and late liver cancer, its curative effect gains public acceptance TACE operation.The suppository that classical TACE treatment adopts is the mixed emulsion of Liquid lipiolol (lipiodol) and various chemotherapeutics, iodized oil carries chemotherapeutics and enters inside tumor performance local lethal effect, but this mixed emulsion is unstable, chemotherapeutics will discharge into systemic blood circulation within a few hours to a couple of days, the object of the slow release that is difficult to really to play stably.Other suppositories that TACE is conventional also comprise absorbable gelatin sponge particle, PVA microgranule, three propylene gelatin corpuscles (embospheremicrospheres) etc., but these microgranules all can not load chemotherapeutics, can only play the effect of mechanical plug supply artery of the tumor.If chemotherapeutics and microsphere can be combined, by selective arterial intubate, be transported to tumor by local, the dual function of high concentration topical chemotherapy and supply artery of the tumor mechanical plug will be played, curative effect can be improved in theory, the research original intention of Here it is medicine carrying microballoons.

Medicine carrying microballoons is also known as medicament elution microsphere (drug-elutingbead, be called for short: DEB), carried out the microsphere matrices studied and carrying medicament kind a lot, but real form product and be used successfully to clinical little, that investigation and application is more deep is the DCbead (Chinese commodity name " reaches celestial ball ") gone on the market in Europe for the end of the year 2004.

International research is in progress: DCbead is adsorbed in conjunction with anthracene nucleus antineoplastic hydrochloride drug (as amycin, epirubicin and daunorubicin) or camptothecin derivant (as irinotecan and topotecan) by ion exchange.Drug loading efficiencies high (>99%), the amycin of every milliliter of microsphere portability 37.5mg and 50mg irinotecan, the microsphere of usual amounts can carry the chemotherapeutics of enough therapeutic doses.

The research of experiment in vitro, pharmacokinetics and artery model all confirms that DCbead can enoughly carry and slow releasing chemotherapeutics, in tumor tissues, drug level can reach and keep fatal dose a couple of days to several weeks, and drug level in systemic blood circulation is very low, such Tumor necrosis rate is high and systemic chemotherapy side reaction is slight.

DCbead (DEBDOX) treatment completed at present or carrying out multinomial working load amycin can not excise the clinical trial of primary hepatocarcinoma, to evaluate its safety and effectiveness, compare the prospective random control study of DEB-TACE and conventional TACE (c-TACE) comprising one, namely PRECISION V studies.This research shows to use the hepatotoxicity of DEBDOX embolization group patient and whole body side reaction all lower than c-TACE group, and 6 months time objective response rate (OR) the DEBDOX group of tumor a little more than c-TACE group (52%vs.44%).Other combine about DEBDOX application in the patient waiting for liver transplantation, DEBDOX associating radio-frequency (RF) ablation, DEBDOX the clinical research well afoot that Sorafenib is treated.For neuroendocrine carcinoma hepatic metastases and intrahepatic cholangiocellular carcinoma, DEBDOX thromboembolism also tentatively shows good curative effect.

DCbead load chemotherapeutics needs manually to complete by intervention doctor in the preoperative a few hours, the further study hotspot of medicament elution microsphere be prepackage chemotherapeutics microsphere and can the microsphere of load Treated with Chemotherapeutic Drugs thing, develop Prefilled microsphere DEBDOX (PrecisionBead) and DEBIRI (ParagonBead) at present, but not yet come into the market.Clinical research aspect, the mainly treatment of other tumors beyond DEB thromboembolism and the other treatment means use in conjunction for the treatment of as systemic chemotherapy, local ablation therapy, molecular targeted agents and liver of next step research contents.

Chinese research and application present situation: DCbead not yet ratifies to enter Chinese market at present, but be one of the focus in Chinese pharmacy and intervention radiation field to the research of medicine carrying microballoons always, the kind developed is a lot, comprise 5-fluorouracil polylactic acid microsphere, amycin sodium alginate micro ball, the ion-exchange type microsphere carrying Bleomycin A5, cisplatin Microspheres and the compound zedoary oil microsphere etc. containing Chinese medicine ingredients, certain curative effect is tentatively shown in zoopery, but be all in the preclinical study stage, apart from real clinical practice, also there is a big difference.

2, radiotherapy thromboembolism

General introduction: radiotherapy thromboembolism is a kind of brachytherapy, injects 90Y microsphere through intra-arterial, is mainly used in Hepatoma therapy and metastatic liver cancer.Its principal indications comprises: 1. because tumor is huge or multiple and be unsuitable for row TACE person; 2. tumor invading Ye Duan branch person; 3. can reduce neoplasm staging after treatment, likely obtain excision, melt or liver transplantation chance person; 4. TACE or the rear progression of disease person of Sorafenib treatment.

Different from TACE, the Main Function of radiotherapy thromboembolism is plesioradiotherapy, but not the tumor ischemia necrosis that supply artery of the tumor thromboembolism causes.There are two kinds of commercialization Radiolabeled microsphere in the market: resin microsphere SIR-Spheres and glass microsphere TheraSphere.90Y launches pure β ray, the half-life short (2.67d), penetration range short (average 2.5mm, maximum 11mm).

Toleration and safety: the side reaction after radiotherapy thromboembolism is slight, generally there will not be the post embolizatiou syndrome as TACE, mainly comprise weak (54% ~ 61%), stomachache (23% ~ 56%), nausea and vomiting (20% ~ 32%) and low grade fever (3% ~ 12%), only continue a few hours.Light moderate lymphopenia is common, but does not increase infection chance.Radiotherapy thromboembolism is to Portal Venous Obstruction or there is leaf section obstruction of biliary tract but the normal patient of bilirubin is also safe.Radiate by non-target organ the side reaction caused and comprise cholecystitis, gastrointestinal ulceration, pneumonia and hepatotoxicity.

Therapeutic outcome and latent effect: support the perspective study (II-2 or II-3 class evidence) being retrospective study or non-control on evidence using radiotherapy chemoembolization for treatment of liver cancer at present, the randomized controlled trial that there is no about radiotherapy thromboembolism and other treatment means is studied.But still can obtain positive conclusion according to 3 the large case researches delivered in the recent period (nearly 700 examples).

For early metaphase hepatocarcinoma, multinomial research all shows that the effect of radiotherapy thromboembolism and TACE are similar to.To early stage patient, the treatment that radiotherapy thromboembolism is mainly used in liver transplantation waiting time maybe can not be performed the operation or the palliative treatment of ablation lesion; To patient in mid-term, radiotherapy thromboembolism is mainly used in being not suitable for carrying out TACE therapist.After radiotherapy thromboembolism, great majority treatment focus can reduce, and remaining liver volume can increase, and therefore likely making original unresectable pathological changes become can radical resection, and this effect is more obvious than TACE.

Treatment status and prospect: the status of radiotherapy thromboembolism in liver cancer treatment is between TACE and Sorafenib.At present, the multinomial randomized control study well afoot about radiotherapy thromboembolism, such as Sorafenib combined radiotherapy thromboembolism for wait for the liver cancer patient Therapy study (NCT00846131) of liver transplantation, radiotherapy thromboembolism and radio-frequency (RF) ablation or TACE be used for excising liver cancer treatment comparative study (NCT00956930) and Europe carry out compare TACE and radiotherapy embolotherapy after the SIRTACE (NCT00867750) of quality of life study.

Because radiotherapy thromboembolism toleration is good, be therefore also applicable to alternative Sorafenib or with its use in conjunction.At present, two RCT study well afoots: Asia-Pacific SIRveNIB clinical trial (NCT01135056) is intended to compare radiotherapy thromboembolism with Sorafenib to the therapeutical effect without extrahepatic metastases focus patient, European SORAMIC test (NCT01126645) then compare both use in conjunction and Sorafenib alone to can not the therapeutical effect of row TACE patient.To neuroendocrine tumor hepatic metastases, hepatic metastasis of colonic carcinoma, radiotherapy thromboembolism also can be achieved good results.

China's applicable cases: China is few about the research of Radiolabeled microsphere chemoembolization for treatment of liver cancer, more than ten sections are only had to use a small amount of clinical case report of 90Y glass microsphere and 32P glass microsphere chemoembolization for treatment of liver cancer, and the research mostly be before 5 ~ 10 years, this may prepare with Radiolabeled microsphere and use more difficult relevant with complexity.

3, tumour ablation

Tumour ablation comprises chemical ablation and physics melts.Chemical ablation refers to through puncture needle directly to intra-tumoral injection dehydrated alcohol or acetic acid, thus make the technology of neoplasm necrosis, certainly, but ablated volume is less for simple to operate, inexpensive, curative effect, is mainly used in the treatment of small liver cancer and part because of position particular row physics and melts the supplement therapy of Complex cases.In the treatment of kinds of tumors, satisfied curative effect is achieved based on warm the melting of radio frequency and microwave ablation, become the main flow of tumour ablation technology, and laser ablation, cryoablation and energy focusing ultrasonic-high (are called for short: HIFU) treatment have also been obtained increasingly extensive application, new ablation techniques overcomes the shortcoming of conventional warm ablation techniques as irreversible electric cheesing techniques, has wide potential application foreground.

Radio-frequency (RF) ablation (radiofrequencyablation): radio-frequency (RF) ablation is that research is at present goed deep into the most, most widely used tumour ablation treating method, has multimodality treatment and electrode type.According to whether RF electrode can be divided into single electrode (monopolarelectrodes) and bipolar electrode (bipolarelectrodes) two type by external electrode plate, the former comprises again straight rod-shaped electrode and with the umbrella of sub-pin or anchor-shaped electrodes, bipolar electrode mainly refers to the CelonRF electrode that Olympus company produces, and is nearly new product developed for 5 years.The major advantage of bipolar electrode be puncture simple, without the need to negative plate and can spininess combination melt, thus disposablely can melt the large tumor that diameter reaches 7cm.Radio-frequency (RF) ablation all achieves good therapeutic effect to entity tumors such as liver, lung, kidney, adrenal gland, metastatic bone cancer, and can comparing favourably with surgical resection to early hepatocarcinoma and I phase nonsmall-cell lung cancer, is also the important means of Advanced cancers palliative treatment.

Microwave ablation: microwave ablation is mainly in China and Japan application, less in America and Europe's application.Compare with radio-frequency (RF) ablation, there is the advantages such as the speed of melting is fast, efficiency is high, scope is large, but also there is the shortcoming of ablation range instability.The microwave ablation therapeutic equipment that Chinese market is applied is a lot, in basic research and clinical practice, be all in world lead level.

Cryoablation: cryoablation (cryoablation) utilizes Joule-Thomson effect, is successively filled with argon and helium, thus forms freeze-thaw cycle in the cryoprobe inserted in tumor, makes tumor tissues produce freeze thawing and apoptosis.Be widely applied in the treatment of carcinoma of prostate, hepatocarcinoma, pulmonary carcinoma.The Chinese kind in cryoablation treatment tumor and quantitative aspects are in international most advanced level.

The Technical comparing that HIFU:HIFU treats tumor is ripe, and China have developed the HIFU therapy system with independent intellectual property right, is called " cutter is held up in sea ", achieves certain achievement in the treatment of liver, pancreas and bone tumor.For solving the problem of monitoring in tumor-localizing and therapeutic process better, Insightec company of Israel and GE company of the U.S. have developed focus supersonic (MRgFUS) system of tumor treatment InsightecExablate2000 under guided by magnetic resonance cooperatively, be used for the ablation of hysteromyoma by U.S. FDA approval, in the treatment of liver, mammary gland, the cerebral tumor and metastatic bone cancer, have also been obtained Preliminary Applications.This system current China carries out clinical verification.

Irreversible electroporation technology (irreversibleelectroporation, be called for short: IRE): impulse electric field cell being applied to doses, its double-layer of lipoid cell membrane there will be many micropores and of short duration permeability increases, and this bioelectromagnetics phenomenon is called electroporation (electroporation).If applying pulse electric field cancels rear cell membrane can not return to normal physiological condition, be namely called IRE (also known as irreversible electrical breakdown), irreversible cell membrane damage can cause apoptosis, and this is the main mechanism that IRE treats tumor.

Different from radio-frequency (RF) ablation etc., IRE treats tumor can not produce heat, is therefore more applicable for the ablation of trunk Tumors, and for containing the more tissue of collagen and nerve, IRE not easily produces damage, is therefore more suitable for the warm treatment of melting dangerous focus of tradition.IRE treatment time is short, only needs the several seconds, but can bring out muscle contraction and arrhythmia due to the high voltage pulse of KV level, therefore needs general anesthesia and of flaccid muscles.Current IRE treats tumor and is in the preclinical study stage, but has achieved good effect in zoopery.

China's applicable cases: in the basic research and clinical practice of tumour ablation, China situation and international most advanced level gap little, some aspect is even also in the leading level in the world, as the clinical practice aspect of microwave ablation and cryoablation, HIFU and the independent research aspect of micro-wave therapeutic equipment and the basic research aspect of IRE all achieve the achievement attracted people's attention.Weak point is that the level of China regions tumour ablation treating differs, and lacks standardization, there is the tendency blindly expanding indication; In addition, the multicenter prospective randomized comparative study with other treatment Measures compare is still lacked.

4, the PTCA or and STENTS imaging evaluation of tumor

Due to reducing of gross tumor volume can't be caused rapidly after TACE or tumour ablation, gross tumor volume also can increase even in a short time, therefore traditional RECIST standard be not exclusively applicable to tumor intervention therapeutic post-evaluation, the imaging examination of main display morphological change such as ordinary ultrasonic, CT and MRI can not show the therapeutic effect of tumor quickly and accurately.The functional imaging of inside tumor blood flow, perfused tissue and metabolic alterations and molecular imaging method can be shown day by day for curative effect evaluation after tumor intervention therapeutic, tentatively show good effect.Middle foreign scholar has done much fruitful work to this.

Radio frequency, microwave, laser and HIFU make tumor produce coagulation necrosis by high temperature, and therefore after its treatment, Radiologic imaging is similar.It is generally acknowledged that, after successfully carrying out heating ablation to tumor, tumor coagulation necrosis region is not all strengthened on contrast-enhanced ultrasound, enhanced CT or MRI, and PET shows as low metabolic regions; Can occur around early stage ablation areas " halo " that a circle is obviously strengthened, represent reactive hyperemia and inflammatory tissue, but this " halo " should be of uniform size, if still exist within the scope of tumour ablation or reappear nodositas strengthening, general prompting Tumoral survival or recurrence.Due to the appearance of complication, the Findings complexity after ablation may be made various, correct understanding Findings not contributes to processing complication, in time treatment Tumoral survival and recurrence in time, thus improves the therapeutic effect of tumour ablation.

Kim etc. summed up more than the Radiologic imaging after the liver neoplasm radio-frequency (RF) ablation of 4000 examples between its 10 years, find: common Findings is zone of ablation is circular or oval low density area on CT, wherein can there be the minute bubbles that the high density area representing needle track and interstitial fluid vaporization occur, enhanced ct scans zone of ablation is not strengthened, and around congested " halo " is everlasting in 1 month and is disappeared; On MRI, zone of ablation in early days on T1 in height clutter, T2 be even low signal, extend in time, T1 signal raise gradually and become evenly, T2 is still even low signal, enhanced ct scans is without strengthening.

Different from the heating ablation such as radio-frequency (RF) ablation, cryoablation can not make tumor produce coagulation necrosis, therefore its melt after Radiologic imaging also different.The discoveries such as Shyn, successfully carry out 24h after cryoablation to liver neoplasm, the tumor of 51% still there will be strengthening on MRI enhancement scanning, and after this along with time lengthening, quantity and the degree of tumor strengthening decline gradually.This phenomenon significant, does not think residual tumor by mistake.

5, the interventional therapy prospect of tumor

Carcinoma intervention is one of field extremely important and active in interventional radiology.Along with the continuous rising of tumor incidence and being rooted in the hearts of the people of minimally-invasive treatment theory, the theory of tumor intervention therapeutic, technical method and clinical research also deepen continuously, and achieve significant progress.Basic research aspect, new material, new technique and new equipment continue to bring out as medicament elution microsphere, radiotherapy microsphere, IRE, New-type radio-frequency and microwave ablation equipment etc., improve safety and the effectiveness of local treatment of tumor further; Clinical research aspect, pay attention to adopting the method for evidence-based medicine EBM to carry out some extensive, polycentric RCT researchs on the one hand, thus verify the effect of different tumor therapeuticing method, on the other hand the combined therapy of tumour of having carried out in a deep going way centered by minimally-invasive treatment, as the associating of different ablation techniques, the combining of tumour ablation and TACE, the combining of TACE and chemicotherapy, the combining of tumour ablation and chemicotherapy, combining between interventional therapy with molecular targeted therapy; Further, in the guide means of tumor intervention therapeutic and image are followed up a case by regular visits to, also there is the trend of multiple image check means use in conjunction, improve safety and the accuracy of interventional therapy.Chinese scholar should follow the tracks of International Development forward position, gives full play to the resourceful advantage of Chinese case, actively participates in international co-operation, uses the method for evidence-based medicine EBM, carries out some extensive polycentric RCT researchs; Meanwhile, actively develop basic research and translational medicine research, research and develop interventional therapy medicine, equipment and the equipment with independent intellectual property right.

Except above-mentioned tumour ablation art needs to use pricking device in Non-vascularized iliac bone iatrotechnics, pricking device is also required equipment to percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation etc.

Therefore, find safer, more efficiently pricking device particularly the image-guided pricking device of dismountable type is significant, and there is significant Social benefit and economic benefit.By literature search etc., up to now, the technology report of the image-guided pricking device aspect of Novel dismountable type is not yet found.

Summary of the invention

The required technical problem solved of this discovery discloses interventional therapy to learn a skill a kind of new pricking device in field, the i.e. image-guided pricking device of Novel dismountable type, can be used in the image-guided pricking device of Novel dismountable type of 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., to overcome the above-mentioned defect that prior art exists.

That is, the present invention is directed to the deficiencies in the prior art, by theory study and concrete technical research, object is intended to structure of a kind of new pricking device and its production and use, namely provides the embody rule that structure of the image-guided pricking device of a kind of Novel dismountable type and preparation method thereof and interventional therapy learn a skill field.

The image-guided pricking device of dismountable type of the present invention refers to that interventional therapy learns a skill in field, a kind of be directly used in the technology such as tumour ablation art, percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation can the image-guided pricking device of Novel dismountable type of direction and location;

What be preferably directly used in tumour ablation art can the image-guided pricking device of Novel dismountable type of direction and location, described tumour ablation art comprise in the methods such as radio-frequency (RF) ablation, microwave ablation, cryoablation, energy focusing ultrasonic-high, irreversible electroporation technology one or more.

One, technical conceive

Independent development innovation clinical technique equipment is a Chinese current urgent task, Chinese medicine particularly clinical therapeutics has very long history, also rich experience is have accumulated in disease prevention, Drug therapy etc., but find modern treatment technology means be promote medical development, the effective ways of more preferably patient service, particularly improving existing treatment technology means and equipment is more efficient, faster, more economical approach, is also the place of the advantage playing Chinese Clinical work.

The interventional therapy of interventional therapy particularly tumor is study hotspot in recent years and development priority, but about the progress of infrastructure device, lag behind clinical needs still far away, cause the Expected Results that the application of clinical technology can't reach satisfied, therefore comprehensive technical research needs to be carried out further.

At present for the research of interventional therapeutic technique, countries in the world mainly concentrate on the development of the supporting complex electronic equipment of existing image documentation equipment, still seldom have the research of quick, easy, safe mechanicalness corollary equipment to report.

Therefore, research worker, from the puncture technique angle under image-guided, is studied the operation difficulties of prior art.For CT Conducted Puncture, its specific operation process is as follows:

1. CT conventional sweep, specifies focus;

2. according to lesions position, structures surrounding, selected puncture aspect, determines point of puncture, needle angle and the degree of depth;

3., after sterilization, at selected point of puncture under local anaesthesia, puncture with the angle determined and the degree of depth;

Whether 4. CT multiple scanning, specify puncture needle and put in place, as put in place, can carry out next step operation; As not in place, need readjust, then puncture, then scan, repeat this step, until puncture needle position suitable, then carry out next step operation.

This shows, CT scan really can accurate localised puncture point, needle angle and the degree of depth, but it is emphasized that this location is only the location in image, and is not that the angle of manipulation in vitro guides.

In actual piercing process, can operator be the successful primary factor of puncture by predetermined angle inserting needle.In vitro on point of puncture, numerous puncture angle can be had, operator relies on the memory of focus in CT picture position, according to the needle angle that CT scan image provides, roughly estimate adopted angle to puncture, therefore, operator proficiency level, to the pre-estimation of needle angle all can become puncture successful key factor.As less in focus or position is darker time, the deviation that needle angle is little all greatly can affect the accuracy of puncture, produces larger error, causes repeatedly puncturing, even unsuccessfully.

At present, when not having external guiding puncture system, what adopt clinically is exactly above-mentioned piercing method always.This proposes higher requirement to operation doctor and such as punctures experienced, and correctly can estimate needle angle, puncture technique is skilled, ensures the stability and accuracy etc. of inserting needle when puncturing.For abecedarian or the person of being lacking in experience, it is very difficult for accomplishing to operate accurately, and puncture success rate is very low, adds the misery of patient, adds simultaneously and occurs malpractice insurance accident probability, and the medical-risk born and pressure are very large.

So how improve puncture success rate? adopt localised puncture in recent years, namely utilize orientation angle at point of puncture, limit the thinking of needle angle, the error of needle angle can be reduced in theory, improve the accuracy of puncture.According to this thinking, have the design of CT puncture apparatus, but this instrument utilizes two angulometers, by connections such as substrate, screw, handles.Volume is comparatively large, complex operation, does not obtain clinical accreditation, and clinical not application, only as a research contents.

Recent numerical control puncture apparatus completes clinical trial, its mechanism utilizes Digit Control Machine Tool and CT to link, according to the image of CT scan, carry out Digital location, this to some extent solves the inaccurate problem in location, but this instrument can only be connected with fixing CT, bulky, complex structure, expensive, clinically and inapplicable.

In a word, based on above-mentioned situation, research worker further investigated also introduces new innovation and improved though, starts to design new mechanical equipment, increases Product's Ease of Use, reduces production cost, be convenient to large-area applying.

According to this idea and thinking, research worker is by experimentation repeatedly and analysis and theory study, by existing image-guided equipment and supporting pricking device, inquire into science and the feasibility of mechanicalness pricking device, successfully obtain result of study and the application product of expection.

Two, the design principle of the image-guided pricking device of dismountable type and structure

Research worker devises the image-guided pricking device of brand-new dismountable type.

1, the principle of design

The most basic principle is the principle that can rotate arbitrarily according to sphere in universal bearing.

2, the dismountable type image-guided pricking device problem that can solve further

On the Research foundation of image-guided pricking device (i.e. the image-guided pricking device of I type), research worker further developed the image-guided pricking device of II type and the image-guided pricking device of dismountable type

The shortcoming of the image-guided pricking device of I type is, in piercing process, pricking device is placed on puncture needle all the time, causes following problem:

1) if focus is very dark, when being greater than 10cm, pricking device occupies the position of a part of pin, can not reach lesions position.

2) although the very light in weight of pricking device, but when puncture angle is larger, the equipment multiple scannings such as CT, determine puncture needle position time, hang over the pricking device on puncture needle, due to the weight of himself, can have a certain impact to the position of puncture needle.

3, the image-guided pricking device main member of dismountable type and annexation thereof

The image-guided pricking device of this dismountable type by guiding spheroid (1), universal pedestal (2), puncture tunnel (3) three part forms, guide spheroid (1) be embedded in universal pedestal (2), can 360 degree rotate freely; Puncture tunnel (3) is guiding the joint portion central authorities at spheroid (1) center, and pin (4) is inserted into guide in the puncture tunnel (3) of spheroid (1) joint portion, center central authorities and relatively fixes;

1. described guiding spheroid (1) is united two into one by two hemisphere (11), guides spheroid (1) joint portion, center central authorities to leave the puncture tunnel (3) that can hold pin (4);

Wherein, the diameter 4 ~ 6cm of two hemisphere (11) of described guiding spheroid (1), preferably 5 ~ 6cm, most preferably 5cm; Two hemisphere (11) preferred heights 2 ~ 5cm, further preferably 2 ~ 3cm, most preferably 2.5cm, namely upper and lower thickness; Two hemisphere (11) combine with inner buckle; Angle index line (9) is carved with on ball surface, by 0 degree to 90 degree, and 0 degree of starting point; Preferably center diametric plane level phase or be vertically carved with latitude line mark mutually;

Described pin (4) comprise in puncture needle, biopsy needle, radio frequency needle etc. one or more, its specification comprises 22G ~ 14G etc., and namely the diameter of pin (4) is 0.7 ~ 2.0mm; During use, pin (4) inserts in puncture casing (3), and pin (4) just can be guided to operate;

Puncture tunnel (3) diameter of described guiding spheroid (1) is slightly larger than pin (4) diameter, be excellent with bigger 0.05 ~ 0.10mm, namely after inserting puncture tunnel (3) with pin (4), obviously do not rock and insert, when taking out without obvious friction sense as well: puncture tunnel (3) diameter 0.75 ~ 2.05mm, preferably 1.05 ~ 1.45mm, most preferably 1.05mm;

2. described universal pedestal (2) to be united two into one the circular ring part formed by two semicircular ring (10), two semicircular ring (10) combine with buckle, mark is carved with in level phase mutually with vertical in surface, and horizontal columns (6) position is left in side; Ring Zhou Keyou angle index line (8), 0 ~ 360 degree, preferably 0 ~ 180 degree of point of two parts, further preferred 0 ~ 90 degree of point of four part; Be provided with adjusting nut (5) in the middle part of pedestal, it is by the duct (7) of reserved adjusting nut (5), fixing guiding spheroid (1);

After described guiding spheroid (1) puts in place by the predetermined angle adjustment of the device scan images such as CT, turn adjusting nut (5), fixing guiding spheroid (1), can keep angle constant;

The top cover of described horizontal columns (6) is the airtight lid that clear glass or other transparent materials make, and inside have liquid and minute bubbles, when bubble is positioned at center, this instrument is horizontal position.

With the image-guided pricking device of I type unlike, the image-guided pricking device of II type and the image-guided pricking device of dismountable type do not have puncture casing, replace the puncture tunnel (3) of constant aperture, guide the combination buckle of spheroid (1) and universal pedestal (2), can dismantle at any time.

4, operation instruction

Pricking device is selected according to pin (4) model, hand-held pricking device, according to the angle designed by the device scan images such as CT, rotate and guide spheroid (1), be adjusted to this angle, after being adjusted to instrument level by horizontal columns, through puncture tunnel (3), introduce pin (4), puncture by the predetermined degree of depth.Puncture, to focus or after reaching certain depth, opens buckle, universal pedestal (2) and guiding spheroid (1) is unloaded by pin (4).Carry out next step operation again.

Four, the purposes of the image-guided pricking device of dismountable type

1, summarize

The present invention study the image-guided equipment of the image-guided pricking device of dismountable type and the interventional therapy related to and supporting pricking device relevant, and carried out further experimentation and theory study.

The image-guided pricking device of dismountable type of the present invention be can be directly used in the technology such as tumour ablation art, percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation can the image-guided pricking device of Novel dismountable type of direction and location.

For ultrasonic image guided puncture pathological examination, now set forth the embody rule of the image-guided pricking device of dismountable type at relevant technical field.

False negative affects axillary fossa SLND (to be called for short: the SLNB) key technical index of technology clinical practice safety, by the impact of factors in sport technique segment.Controlling false-negative various influence factor well, is the key ensureing that SLNB technical security is implemented.The indication of strict control SLNB technology clinical practice is exactly such work.

American Society of Clinical Oncology (be called for short: ASCO) about the guide of axillary fossa SLNB also relates to Status of axillary lymph node: SLNB indication is the primary breast cancer of axillary gland clinical examination feminine gender, and clear and definite axillary lymphatic metastasis is the contraindication of this technology of application.

Ultrasonic advantage one judges lymph node status by morphological change., for judging the clinical examination method poor reliability of Status of axillary lymph node, there is the error of 23% ~ 33% in result of study prompting in the past.And by morphological changes such as lymph junction configuration, structures, Ultrasonic tomography inspection judges that whether axillary gland is normal, Sensitivity and Specificity is respectively 42% ~ 56% and 70% ~ 90%.In the document delivered at present, the ultrasonic image criterion of abnormal axillary gland disunity, wherein the standard of general character is that normal " scoring ring " shape structure disappearance, cortex asymmetry or tumor sample thicken, and the tumor load at this moment in lymph node is even as big as causing the degree can having recognized structural change.

The result prompting of several correlational studyes, when sentinel node (is called for short: when the tumor load SLN) is larger, comes from the impact on structure and phagocytic function, may have influence on detecting of the SLN that gets involved.And if the case that there is suitable tumor load in these lymph nodes is picked out, will likely improve the reliability of SLNB technology.

Ultrasonic advantage two is that guided puncture biopsy obtains specimen.Another advantage of Ultrasonic tomography method is also can guided puncture biopsy, to obtain the sample for pathological examination.Coarse needle bioptic can obtain sample and carry out histopathological examination, and reliability is high.But because the action of puncture needle has certain uncertainty when puncture rifle excites, there is certain Accessory injury risk, and check that whether can affect on the damage of lymph node and surrounding tissue the SLN video picture may carried out subsequently is also a kind of well-founded worry.In addition, the sample that fine needle aspiration obtains only can be used for cytopathology inspection, but due to should not epithelial cell be there is in the background of Normal Lymph Nodes sample, judge whether to there is cancerous cell not difficult (cytological samples relative to mammary gland tissue) drawing materials under satisfied prerequisite.Visible, ultrasonic image guides the abnormal lymph node puncture cytolgical examination method of lower axillary fossa simply, not need the optional equipment of complexity, relatively low to the requirement of Pathology Doctors ', should be a kind of inspection method be worthy to be popularized.

After adopting ultrasonic image inspection to find that axillary gland is abnormal, image-guided lower biopsy checks that positive susceptible of proof axillary gland exists transfer, and then avoids axillary fossa SLNB, directly presses node positive breast cancer process; Negative patient then accepts SLNB with clear and definite lymph node status.But it should be noted, because biopsy inspection exists Problem of False Negative, whether the image abnormal lymph node not being proved transfer is bound to be included in obtain in SLN waits to confirm.The false negative case of existing significant proportion there occurs this type of situation, relevant perspective study well afoot.

In sum, the image-guided pricking device of dismountable type of the present invention be can be directly used in the technology such as tumour ablation art, percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation can the image-guided pricking device of Novel dismountable type of direction and location, be preferably directly used in tumour ablation art.

Five, technology speciality

The present invention be the interventional therapy field of learning a skill provide a kind of be directly used in the technology such as tumour ablation art, percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation can the image-guided pricking device of Novel dismountable type of direction and location, thus to existing interventional therapy learn a skill product systems particularly pricking device carried out improvement, improved, thus expanded prior art products systematic difference, improve ease for use and safety.

The present invention is safe and effective, be easy to operation, practical, its preparation technology is easy, and production cost is low, Be very effective, can be used for the fields such as tumour ablation art, percutaneous puncture tumor biopsy art, Intratumoral injection art, intervertebral disc puncture decompression, intervertebral disc puncture ablation, make beyond thought achievement, use safety, play the effect of product to greatest extent.

The image-guided pricking device of two profiles number compares: the image-guided pricking device of I type compared with the puncture of II type image-guided pricking device apart from short about 4cm, and after puncture completes, instrument can not disassemble from pin (4), if any subsequent operation, can bring impact.

Because pin (4) is directly fixed on to guide in spheroid (1), when Clinical practice after pin determination lesions position direction of insertion, universal pedestal (2), guiding spheroid (1) can be dismantled successively, now this pin is without any additional restriction, one is can continue to arrive darker lesions position, generally can arrive the focus that the degree of depth is more than 10cm; Two is the clinical manipulations carrying out next step flexibly, and such as radio-frequency (RF) ablation, seeds implanted are convenient.

The advantage of the image-guided pricking device of I type is, it has puncture casing, and a pricking device can be applicable to the puncture needle of different-diameter, and the image-guided pricking device of II type is only suitable for the puncture needle of single diameter.

In a word, dismountable type of the present invention image-guided pricking device result of use is obvious, control easy, active adaption modern medical service and the job demand of scientific research field and the needs of human nature service, be more suitable for the large-scale production of pharmaceuticals industry and the clinical practice of interventional therapy, the scope of application is wide especially, easily applies, can haveing a tremendous social and economic benefits in the short period of time, to improving existing interventional therapy level, there is important value.

Accompanying drawing explanation

Fig. 1: the schematic diagram of the image-guided pricking device of a kind of dismountable type;

Fig. 2: the schematic diagram guiding a hemisphere (11) of spheroid (1);

Fig. 3: the schematic diagram of a semicircular ring (10) of universal pedestal (2);

Fig. 4: the schematic diagram of adjusting nut (5).

Wherein, 1---guides spheroid 2---universal pedestal 3---puncture tunnel

4---pin 5---adjusting nut 6---horizontal columns

7---duct 8---angle index line 9 of universal pedestal---the angle index lines on ball surface

10---semicircular ring 11---hemisphere

Detailed description of the invention

The present invention have studied the existing pricking device technology in interventional therapy field, provide a kind of can the image-guided pricking device of Novel dismountable type of direction and location, be convenient to the safe handling of medical industry.

The present invention finally needs to be prepared into the image-guided pricking device of dismountable type and applies, and will enumerate embodiment below and be further described.If you have questions, 13386272938 can be contacted directly with research worker.Several medical device product structural requirement and using method thereof and some experimental study contents is provided by foregoing summary in above-mentioned some experimental datas of providing and the following example, but the research contents that the place that should be appreciated that the present invention is not limited to this is listed, should also be appreciated that term as used herein only for describing specific embodiment, and be not limitation of the invention.

Below for dismountable type image-guided pricking device specific experiment research contents, by embodiment, the present invention is described in detail, sets forth the novelty teabag of the image-guided pricking device of dismountable type of the present invention further.Instrument and equipment etc. used in the experiment of following examples is all from above-mentioned description or meets above-mentioned requirement.

In the present invention, described detailed description of the invention and embodiment are all to set forth the present invention better, are not for limiting the scope of the invention.

A kind of utility structure of the image-guided pricking device of embodiment 1, dismountable type

The image-guided pricking device of this dismountable type by guiding spheroid (1), universal pedestal (2), puncture tunnel (3) three part forms, guide spheroid (1) be embedded in universal pedestal (2), can 360 degree rotate freely; Puncture tunnel (3) is guiding the joint portion central authorities at spheroid (1) center, and pin (4) is inserted into guide in the puncture tunnel (3) of spheroid (1) joint portion, center central authorities and relatively fixes;

1. guide spheroid (1) to be united two into one by two hemisphere (11), guide spheroid (1) joint portion, center central authorities to leave the puncture tunnel (3) that can hold puncture needle (4);

Wherein, the diameter 6cm of two hemisphere (11) of spheroid (1) is guided; Two hemisphere preferred heights 3.0cm, namely upper and lower thickness; Two hemisphere (11) combine with inner buckle; Angle index line (9) is carved with on ball surface, by 0 degree to 90 degree, and 0 degree of starting point; Center diametric plane level phase or be vertically carved with latitude line mark mutually;

The diameter of pin (puncture needle, biopsy needle, radio frequency needle etc.) (4) is 0.7mm; During use, pin (4) inserts in puncture tunnel (3) fixing, and namely bootable pin (4) operates;

Guide puncture tunnel (3) the diameter 0.75mm of spheroid (1);

2. universal pedestal (2) to be united two into one the circular ring part formed by two semicircular ring (10), two semicircular ring (10) combine with buckle, mark is carved with in level phase mutually with vertical in surface, and horizontal columns (6) position is left in side; Ring Zhou Keyou angle index line (8), 0 ~ 90 degree, point four parts; Be provided with adjusting nut (5) in the middle part of pedestal, it is by the duct (7) of reserved adjusting nut (5), fixing guiding spheroid (1);

After guiding spheroid (1) to put in place by the predetermined angle adjustment of ultrasonic device scanogram, turn adjusting nut (5), fixing guiding spheroid (1), can keep angle constant;

The top cover of horizontal columns (6) is the airtight lid that clear glass makes, and inside have liquid and minute bubbles, when bubble is positioned at center, this instrument is horizontal position.

The image-guided pricking device of dismountable type does not use puncture casing, replaces the puncture tunnel (3) of constant aperture, guides the combination of spheroid (1) and universal pedestal (2) all to come with buckle, can dismantle at any time.

The structure of the image-guided pricking device of embodiment 2, dismountable type and clinical practice thereof

1, concrete structure

For Ultrasound-guided Biopsy, use the image-guided pricking device of following dismountable type.

The image-guided pricking device of this dismountable type by guiding spheroid (1), universal pedestal (2), puncture tunnel (3) three part forms, guide spheroid (1) be embedded in universal pedestal (2), can 360 degree rotate freely; Puncture tunnel (3) is guiding the joint portion central authorities at spheroid (1) center, and pin (4) is inserted into guide in the puncture tunnel (3) of spheroid (1) joint portion, center central authorities and relatively fixes;

1. guide spheroid (1) to be united two into one by two hemisphere (11), guide spheroid (1) joint portion, center central authorities to leave the puncture tunnel (3) that can hold puncture needle (4);

Wherein, the diameter 5cm of two hemisphere (11) of spheroid (1) is guided; Two hemisphere preferred heights 2.5cm, namely upper and lower thickness; Two hemisphere (11) combine with inner buckle; Angle index line (9) is carved with on ball surface, by 0 degree to 90 degree, and 0 degree of starting point; Center diametric plane level phase or be vertically carved with latitude line mark mutually;

The diameter of pin (puncture needle, biopsy needle, radio frequency needle etc.) (4) is 1mm; During use, pin (4) inserts in puncture tunnel (3) fixing, and namely bootable pin (4) operates;

Guide puncture tunnel (3) the diameter 1.05mm of spheroid (1);

2. universal pedestal (2) to be united two into one the circular ring part formed by two semicircular ring (10), two semicircular ring (10) combine with buckle, mark is carved with in level phase mutually with vertical in surface, and horizontal columns (6) position is left in side; Ring Zhou Keyou angle index line (8), 0 ~ 90 degree, point four parts; Be provided with adjusting nut (5) in the middle part of pedestal, it is by the duct (7) of reserved adjusting nut (5), fixing guiding spheroid (1);

After guiding spheroid (1) to put in place by the predetermined angle adjustment of ultrasonic device scanogram, turn adjusting nut (5), fixing guiding spheroid (1), can keep angle constant;

The top cover of horizontal columns (6) is the airtight lid that clear glass makes, and inside have liquid and minute bubbles, when bubble is positioned at center, this instrument is horizontal position.

The image-guided pricking device of dismountable type does not use puncture casing, replaces the puncture tunnel (3) of constant aperture, guides the combination of spheroid (1) and universal pedestal (2) all to come with buckle, can dismantle at any time.

2, applicable cases

Peripheral pulmonary nodules occupies certainty ratio in Pulmonary Diseases, pass by often to rely on the positive lateral radiograph of lung CT sheet, x-ray and sputum chemical examination clinically, the wherein method that relies on often can not be made Ultrasound-guided Biopsy of clarifying a diagnosis and diagnose the Peripheral pulmonary nodules of nearly thoracic wall disposablely can make level diagnosis, provides reliable diagnosis basis to clinical diagnosis diagnosis and treatment.Introduce the experience that using ultrasound Conducted Puncture diagnoses nearly thoracic wall pulmonary masses below, be now reported as follows.

(1) data and method

1. Peripheral pulmonary nodules patient all certain institute's inpatients of the nearly thoracic wall of this group of physical data 20 example, man 19 example, female 1 example, at 47 ~ 69 years old age, average 58 years old, is the chemical examination of breast CT sheet, the positive lateral radiograph of x-ray and sputum and fails to make the patient clarified a diagnosis.Lump diameter: 1.0 ~ 2.5cm 17 example, 2.6 ~ 3.5cm 3 example, instrument is that the U.S. produces the most advanced and sophisticated ultrasonic image system of HP, linear array probe, frequency 7.5MHz, convex array probe 3.5,5.0MHz, probe is furnished with corresponding puncture needle fixed mount, and puncture needle used is the 21G aspiration biopsy C1 pin that smooth company of Japan eight produces.

2. the preoperative strict sterilization probe of method, puncture needle fixed mount, the patient accepting biopsy gets dorsal position, lateral position or ventricumbent position as required.According to the pathological changes position shown by preoperative done breast CT sheet, the positive lateral radiograph of x-ray, select the site of puncture caused, to sterilize skin herein, surface is coated with couplant, along intercostal space scanning, after display lump, confirm this lump and the surrounding relation compared with trunk, gassiness lung tissue, select the shortest puncture path and optimum puncturing point, infiltration anesthesia is done in local, point of puncture place, puncture needle is inserted in the hole slot of puncture needle fixed mount, under fluorescent screen monitors, insert patient skin, thoracic wall, advise patient to cease breathing to hold one's breath, and quick needle insertion is inner to the lump of predetermined puncture.Needle point is done in lump carry slotting 3 ~ 4 times by a small margin, then remove negative pressure, pin is extracted, aspirate in lump is placed on clean microscope slide, pulls open gently with another microscope slide under maintenance negative pressure state, make smear thin as far as possible and even.With aspirate on 95% alcohol fixation microscope slide, send Pathology Deparment's check result.

(2) result

20 routine patients affected by inspection, make a definite diagnosis lung squamous cancer 4 example, adenocarcinoma of lung 6 example, undifferentiated carcinoma 3 example, alveolar cell carcinoma 2 example, pulmonary abscess 2 example, pulmonary tuberculosis 2 example, inflammatory pseudotumor: one case.Recall rate is 100%.19 example 1 time quick puncture biopsy successes, 1 example first time did not obtain tumor tissue, second time aspiration biopsy success, and disposable puncture treatment success rate is 95%.

3, conclusion

Because pulmonary's major part ultrasonic energy of gassiness is returned by tissue gas boundary reflection, can not penetrate to deep lung tissue, Gu and can not for shown by ultrasonic, once due to lung tumor tissue infiltration or occupying lesion be material alterations, and when producing new organizational interface, ultrasonicly show the features such as its extent of disease, degree and form.Two-dimentional audiovideo picture and x-ray plain film, the same energy of CT sheet lesions showed directly perceived, especially Peripheral pulmonary nodules does not disturb by the strong echo of gas, it is clear that ultrasonogram display adds, colored general strangling can show lump inside and blood circumstance around thereof, thus make puncture path avoid trunk, the Peripheral pulmonary nodules guiding the nearly thoracic wall of descending percutaneous puncture at Color Doppler flow image is on fluorescent screen, the position that the path of real-time display puncture and needle point arrive, thus strictly control the process of puncture, needle point is made to remain in lump, the lower puncture of approximate direct-view, therefore percutaneous does ultrasonic image and guides the Peripheral pulmonary nodules percutaneous biopsy of nearly thoracic wall not to be blindly, safe.

As being full of inflammatory exudate, edema or pulmonary consolidation between the lung neoplasms of nearly thoracic wall and thoracic wall, lump will more easily shown by ultrasonic image, and puncture diagnosis one-time success rate will be higher.This group 1 example first time puncture diagnosis is unsuccessful is owing to understanding caused by deficiency the performance of C1 pin and using method.Chandraseker adopted the image-guided lower percutaneous lung biopsy of B ultrasonic in the world first in 1976, identify 4 routine lungs to swell the pathologic feature of thing, then Izumi, OttO, the yellow mediate people etc. report many cases percutaneous lung biopsy respectively, recall rate reaches more than 90.2%, they think that percutaneous guides descending lung diagnostics to be feasible at ultrasonic image, and patient can be made to exempt to do bronchoscopic misery.This is organized organizing that 20 routine patient's puncture diagnosis obtain and all obtains clear and definite pathological examination, contributes to clinical diagnosis and treatment.

In a word, the diagnosis of ultrasonic image Guided Percutaneous capable lung lesion has higher clinical value to the lung neoplasms near thoracic wall, its advantage be without x-ray radiation, easy and simple to handle, accurate positioning, safety is good, diagnosis rate is high, the deficiency of the positive lateral radiograph of breast x-ray, CT sheet and sputum chemical examination can be made up, the misery that bronchoscope brings to patient can be exempted, be worthy to be popularized.

Above-mentioned clinical practice result display, the image-guided pricking device of dismountable type be can be directly used in the technology such as percutaneous puncture tumor biopsy art can the image-guided pricking device of Novel dismountable type of direction and location, effectively can solve clinical problem, prevent mistaken diagnosis etc., crucial assosting effect is played to clinical diagnosis, treatment etc.

Claims (7)

1. the image-guided pricking device of dismountable type, is characterized in that, this described equipment by guiding spheroid 1, universal pedestal 2, puncture tunnel 3 three part forms, and guides spheroid 1 to be embedded in universal pedestal 2, can 360 degree rotate freely; Puncture tunnel 3 is guiding the joint portion central authorities at spheroid 1 center, and pin 4 is inserted into guide in the puncture tunnel 3 of spheroid 1 center joint portion central authorities and relatively fixes;

Described guiding spheroid 1 is united two into one by two hemisphere 11, guides joint portion, spheroid 1 center central authorities to leave the puncture tunnel 3 that can hold pin 4;

Described universal pedestal 2 to be united two into one the circular ring part formed by two semicircular ring 10, and two semicircular ring 10 combine with buckle, and mark is carved with in level phase mutually with vertical in surface, and horizontal columns 6 position is left in side; Ring Zhou Keyou angle index line 8; Be provided with adjusting nut 5 in the middle part of pedestal, it is by the duct 7 of reserved adjusting nut 5, fixing guiding spheroid 1;

After described guiding spheroid 1 puts in place by predetermined angle adjustment, turn adjusting nut 5, fixing guiding spheroid 1, can keep angle constant.

2. the image-guided pricking device of dismountable type according to claim 1, is characterized in that, the diameter 4 ~ 6cm of two hemisphere 11 of described guiding spheroid 1, high 2 ~ 5cm; Two inner buckles of hemisphere 11 combine; Angle index line 9 is carved with on ball surface, angle 0 ~ 90 degree;

The puncture tunnel 3 diameter 0.75 ~ 2.05mm of described guiding spheroid 1,0.05 ~ 0.10mm larger than pin 4 diameter;

The diameter of described pin 4 is 0.7 ~ 2.0mm; During use, pin 4 inserts in puncture tunnel 3 fixing, and pin 4 namely can be guided to operate.

3. the image-guided pricking device of dismountable type according to claim 1 and 2, is characterized in that, the diameter 5 ~ 6cm of two hemisphere 11 of described guiding spheroid 1, high 2 ~ 3cm, center diametric plane level phase or be vertically carved with latitude line mark mutually;

The puncture tunnel 3 diameter 1.05 ~ 1.45mm of described guiding spheroid 1.

4. the image-guided pricking device of dismountable type according to claim 3, is characterized in that, the diameter of two hemisphere 11 of described guiding spheroid 1 is 5cm, high 2.5cm;

The puncture tunnel 3 diameter 1.05mm of described guiding spheroid 1.

5. the image-guided pricking device of dismountable type according to claim 1 and 2, is characterized in that, angle index line 8 angle in the ring week of described universal pedestal 2 is 0 ~ 360 degree;

The top cover of described horizontal columns 6 is airtight lids that clear glass or other transparent materials make, and inside has liquid and minute bubbles.

6. the image-guided pricking device of dismountable type according to claim 5, is characterized in that, angle index line 8 angle in the ring week of described universal pedestal 2 is 0 ~ 180 degree, point two parts.

7. the image-guided pricking device of dismountable type according to claim 6, is characterized in that, angle index line 8 angle in the ring week of described universal pedestal 2 is 0 ~ 90 degree, point four parts.