Patent Application
20060122535
The present invention relates to a percutaneous biopsy device that cuts a suspicious desired tissue specimen, leaving undesired tissue unharmed. This application claims priority to U.S. Ser. No. 60/634,386, which incorporated herewith by reference.
Medical biopsy is a technique to obtain tissue samples for pathologic diagnostics. Open surgical biopsies are still the standard techniques in many medical fields. There are basically two principle percutaneous biopsy techniques for the interventional or minimally invasive biopsy market, which are fine needle aspiration and core biopsy. Approximately two million biopsies are performed in the United States each year.
The core biopsy technique—also known as Temno technique—is the oldest and most common biopsy technique on the market. Core biopsy devices are available as manually operated spring loaded or as fully automatic systems. All devices use a coaxial needle set consisting of an inner solid needle (obdurator) in which a little pocket (notch) is grinded and an outer hallow needle, which is beveled to have a sharp tip. The obdurator is pushed into the lesion and the surrounding tissue fills up the notch. Then, the hallow outer needle moves fast forward cutting the tissue to leave a sharp cut specimen in the notch. Core biopsy devices have a couple of disadvantages:
Bending: Due to the beveled tip of the obdurator and the thin notch strap, which makes the design unstable, the obdurator bends during its forward movement through the tissue towards the opposite side of the tip bevel. This bending makes the core biopsy devices imprecise in targeting smaller lesions.
Overshoot: Due to its mechanical design, core biopsy needles overshoot the targeted area by the length of the obdurator tip. A typically 18-gauge prostate biopsy device will overthrow the lesion by 5-10 millimeters and perforate the tissue on the distal other side of the lesion. Prostate cancer sites for instance are most likely been found in the peripheral zone of the prostate. Because the prostate has a diameter of minimum 3 to 5 centimeters, core biopsies are limited to the inner portion if one wants to leave the prostate attaching tissue intact. The same problem occurs, when targeted breast tumor lesions are close to the lung pleura. In brain tissue every needle penetration in healthy tissue may cause serious cognitive defects of the patient.
Artifact of needle tip under Magnetic Resonance Imaging (MRI): Due to the mechanical design of core biopsy needles, the tip of the obdurator needle is a solid piece of metal. Even if more MRI compatible material like titanium alloys are used for the material, this solid part causes a rather large artifact at the tip of the obdurator, especially when the needle is used in higher magnetic flux MRI tomographers, like 1.5 or 3.0 Tesla.
Half Volume Sample: Due to the notch pocket of the core biopsy needle, the sample volume is only half the diameter of the column shaped obdurator. While this is not considered a serious problem, it does lead to the use of larger sized biopsy needles to obtain the desired sample volume, while one could use a smaller needle size if the tissue sample where full column sized.
Torn Sample: While core biopsy devices work well in fatty tissue, they often have difficulties in more dense tissue. Here the cutting needle often rather tears the tissue resulting in an insufficient tissue sample for the pathological analysis.
Fine needle aspiration (FNA) biopsy techniques use a simple hallow needle, which is placed into the tissue. Vacuum to perform the aspiration is either applied by a vacuum pump or in the simplest form by an expanded syringe. Vacuum aspiration biopsy devices lack the disadvantage that they tear out the tissue and give imprecise specimen cuts. Further this type of biopsy can only be accomplished with softer and easier to tear tissue. Prostate, breast or brain tissue is not recommended for biopsy via aspiration.
The object of the here presented invention is to overcome above stated disadvantages of today's biopsy devices. The invention provides a biopsy mechanism which penetrated straight through the tissue without being bended, does not overshoot the tissue lesion, does not create an abnormal image artifact and precisely cuts the desired tissue piece as a full circle specimen.
The suggested biopsy mechanism will cut the specimen in front of the tip of the guiding needle. The device may be guided by Magnetic Resonance Imaging (MRI), x-ray based techniques or ultrasound.
The new cutting mechanism cuts at the tip of a needle a dome like specimen.
a shows the access tube 2 in which an inner stylet 1 with a trocar like tip is positioned. This needle set is percutaneously pushed through the patients tissue until the tip of the stylet 1 is positioned at the location of planned biopsy.
In
c to 1e now show how the specimen is planned to be cut at the distal end of the instrument.
In
The difference in specimen quality of a conventional core biopsy system and one as here proposed considering the same needle diameter and length is explained using
The device may be made from stainless steel, Nivaflex®, titanium-vanadium-alloy, plastic, carbon fibre or nickel-titanium (NiTi). Typically the wall-thickness of any tube is between 0.01 millimetres and 0.5 millimetres. The access tube comprises a relative to its tube diameter small cutting blade. The cutting blade of the cutting tube may be made from different material as the cutting tube. The cutting blade of the cutting tube is pre-bend inwards to the centre of the cutting tube and its tip locates at the centre or beyond of the cutting tube. The cutting blade is welded or glued onto the cutting tube. The cutting blade is bending backwards when the cutting tube is sliding over the access tube. The movements of any tube are manually operated or motor driven. The gathered specimen has a typical diameter of 1 mm to 4 mm and length of 10 mm to 12 mm in length.
| Number | Date | Country | |
|---|---|---|---|
| 60634386 | Dec 2004 | US |
