Biopsy Needle 

The Biopsy Needle is a medical device widely used to obtain samples of internal human tissues, aspirating cells, and other purposes in clinical diagnosis and research fields from various organs like the kidney, liver, lung, breast, thyroid, prostate, pancreas, testis, uterus, ovaries, and surface of the body. It comprises a set of needles, usually including a long hollow outer needle and a longer inner needle with a notch on the tip section, both featuring sharp tips.

Typically, the needle is inserted into the body through puncture or insertion methods to collect human tissue samples for cytology, pathological analysis, or other experiments. The surgery is safe and reliable, with a short procedure time and quick recovery.

▲ Biopsy Needle Components 

Categories

Common types of needle biopsy include: Core Needle Biopsy (CNB) and Fine Needle Aspiration (FNA). During fine needle aspiration, a thin, hollow needle is inserted into the suspicious area, and a syringe is utilized to draw out fluid and cells from human body for analysis.

▲ Fine Needle Aspiration in Process

During core needle biopsy, a wider needle than fine needle aspiration, with a cutting tip, is used to extract a sample of tissue out of a suspicious area for testing. Comparing the two types, The procedure of CNB may cause some bruising but usually without scars left. And it can collects more tissues and information about the suspicious area than FNA. But it needs a small incision to insert the needle. In practical application scenarios, CNB is most commonly used for breast, and FNA for several areas of human body.

▲ Core Needle Biopsy in Action

Applications

In the modern medical field, biopsy needles play an indispensable role, advancing clinical diagnosis, pathological research, and informed treatment decisions. Their primary purpose lies in clinical diagnosis, where these needles meticulously extract tissue samples, providing doctors with a tangible understanding of the inner workings of the human body, aiding in the identification of anomalies such as tumors, inflammation, and infections.

▲ Lung Biopsy Technique

Beyond that, they also works in pathological research. Researchers use biopsy needles to delve into cellular behavior and the underlying abnormalities of various health conditions. Additionally, biopsy needles directly influence the formulation of treatment strategies, with experienced medical professionals utilizing these samples to guide patient care directions. Manner Technology’s biopsy needles lay the foundation for developing more accurate and safer treatment plans, ensuring precise fulfillment of the unique needs of each individual.

A couple of typical application scenarios are as follows:

1. Breast Cancer

Firstly, breast cancer is the most common malignant tumor in women.

Mammography can reveal some small breast lesions, and surgical breast biopsy is done to determine the nature of these lesions. Stereotactic needle core biopsy (SCNB) is one of the diagnostic methods developed in recent years and has received widespread attention.

▲ Breast Biopsy Using Core Needle

2. Renal Puncture

Secondly, renal puncture is a method of pathological diagnosis of the kidneys. There are two main methods: open puncture renal biopsy and transcutaneous biopsy.

▲ Renal Biopsy Procedure

3. Liver Biopsy

Thirdly, liver biopsy is the main method of confirming the diagnosis of fatty liver. It is mainly used for:

1) Distinguish focal fatty liver from tumors.

2) To detect some rare diseases, such as cholesterol ester storage disease, glycogen storage disease, etc.

3) Asymptomatic suspected non-alcoholic steatohepatitis, liver puncture biopsy is one of the diagnostic means.

4) Alcoholic liver disease after abstinence from alcohol or with unexplained clinical or biochemical abnormalities.

5) Obese patients with persistent liver enzyme abnormalities even after a 10% reduction in body weight require liver puncture biopsy to look for other causes.

6) Anyone who is suspected of not having simple hepatocellular steatosis or multiple etiologies.

▲ Ultrasound-Guided Liver Biopsy

4. Prostate Biopsy

Fourth, transrectal ultrasound-guided prostate aspiration biopsy uses ultrasound to guide a biopsy needle to a specific location in the prostate gland to remove tissue needed for pathologic diagnosis.

Puncture biopsy is performed in the following cases:

1) Prostate Specific Antigen (PSA) greater than 4 ng/dl.

2) Nodules in the prostate gland on anal fingerprinting.

3) Abnormalities on ultrasound of the prostate.

4) Metastatic adenocarcinoma, if the primary focus is suspected to be prostate cancer.

▲ Ultrasound-Guided Prostate Biopsy

5. Lung Biopsy

Fifth, lung biopsy is safe, accurate, simple and reliable, providing a very scientific and practical method and means for differential diagnosis and treatment. It is mainly applicable to the following cases:

1) Anyone who can see abnormal echogenic masses in the tissues around the lungs and in the mediastinum by ultrasound.

2) peripheral lung or mediastinal disease fiberoptic bronchoscopy for various reasons biopsy failure.

3) Those for whom pathologic examination is necessary in order to select a therapeutic option.

4) To know the origin of the primary lesion of metastatic cancer.

5) Inflammatory masses in the lungs that need to be characterized pathologically and can be treated with drainage and injection.

6) Those who have systemic metastasis and inject chemotherapeutic drugs and biological agents in the mediastinum and peripheral lung mass to prolong the life of the patient.

▲ Diagnostic Lung Biopsy

Last but not least, there are also some other applications for biopsy of various unspecified lymph node masses.

Manufacturing

A biopsy needle requires a high degree of precision to ensure accurate tissue sample collection. Considering factors such as medical standards, ergonomics, and manufacturing feasibility, high-quality medical-grade stainless steel is chosen as the material, to ensue its corrosion resistance and biocompatibility.

Precision machining may involve controlling dimensions at the micron level, requiring the use of high-precision machining equipment and processes. The manufacturing process may involve several cutting and shaping steps. This can include CNC turning for geometric shape and dimensions of the components, grinding for the desired sharpness and penetration force of the needle tip, and wire-electrode cutting for making the notch on the tip section of the inner needle.

In the workshop, for the outer needle, the manufacturing process involves several key steps. It starts with material selection, followed by wire cutting to shape the material. The tip is then ground to achieve the desired dimensions and sharpness, and an expansion is made at the needle’s end. Subsequently, the needle tip is refined to create an inverted circular edge, and an electrolytic process is applied. Sandblasting enhances the surface quality, and marking is done for identification. Post-processing, the needle is thoroughly cleaned and subjected to quality checks before being appropriately packaged and shipped to customers.

For the inner needle, the process is distinct yet parallel. Starting with material selection and wire cutting, the needle’s tip is ground. Slotting is introduced for specific purposes, and electrolysis refines the surface. Sandblasting enhances the surface further, followed by a cleaning phase. Rigorous quality checks ensure compliance with standards, and then the needle is packaged suitably for distribution.

Throughout both processes, each step is followed by meticulous cleaning and inspection, assuring the adherence of the final products to quality benchmarks before they are packaged and dispatched to customers.

Precision machining with micron-level dimensional control, stringent quality control and inspection are conducted in Manners Technology throughout the manufacturing process. Manners will consistently ensure the integrity and reliability of these components, which require precise assembly.