HK1110762A - Disposition introduced to sample collector for biopsy and similars - Google Patents

Description

Device for integration into biopsy sampler and the like

Technical Field

The present invention relates to a practical and innovative biopsy sampler, belonging to the medical field, more particularly to the diagnostic medical field, which biopsy sampler is integrated into an apparatus of existing construction and is intended to improve the use and performance of other types of biopsy samplers commonly distributed on the market.

Background

Diagnostic medicine is a field of medical science and has extremely important value in a wide variety of pathologies. One of the pathologies most of interest to physicians and patients among the various pathologies is the tumor, i.e. cancer.

Cancer is characterized by a disturbed (or deregulated) cell proliferation, i.e., the growth of the cells is not controlled and no longer adheres to (or begins to invade) tissue structures.

Later, when cells enter the blood circulation through vessels and arteries, and enter mainly the lymphatic circulation, the cancer spreads to other organs. This stage of the disease is known as metastasis and results in organ failure which can lead to death.

The diagnosis of this type of pathology has been a challenge to medicine. With the advent of computed tomography and image examination, advances in treatment have become apparent. However, there is a diagnostic resource that is even more indispensable than those examinations, namely biopsies.

Biopsy is a clinical examination modality consisting of removal of a tissue sample as a small section of a living body and evaluation of the pathology. Tissue samples are extremely important for the physician to develop a diagnosis and to observe the progress of the treatment. Tissue samples are used not only for diagnosing cancer but also for monitoring the condition of organ transplantation, suspicion of organ and tissue dysfunction, follow-up of drug therapy, and the like.

Currently, there are two types of biopsies: cytological biopsy and histological biopsy. Cytological biopsy is a suction puncture performed by using a small needle. Advantageously the aspiration penetration sampling procedure is typically guided by ultrasonography to aspirate the capsule or contents of the node or tumor. Histological biopsy consists of a percutaneous sampling procedure in which a small tissue sample is taken at the site of injury by a system of coaxial needles. The advantages of histological biopsy compared to cytological biopsy are: by obtaining a sample of removed material, rather than aspirated material, a complete set of cells can be obtained rather than isolated cells. In addition, the harvested material is highly concentrated and, unlike in suction biopsies, is not diluted by interstitial fluid and blood. This facilitates microscopy and provides more reliability for such biopsy.

Histological biopsy uses a device for protecting the needle and assisting the manipulation of the needle, i.e. a handle, consisting of a body that acts as a guide to slide the sleeve and the collecting needle. The needle and the sleeve used in this sampling process are disposable and intended for single use, in order to guarantee the effectiveness of the result, sterility and absolute safety against accidental inoculations of any kind. The instrument handle can be of two types: disposable and reusable.

In the single-use version, the needle is handled by a semi-automatic ring cutter (guillotine cutter), which is a structurally simpler instrument because it is the handle into which the needle itself has been mounted. The type commonly used is a single use handle. The commonly used, single use handle follows the same principle as needles are handled by semi-automatic ring cutters.

The handle of the reusable type is similar to the handle of the disposable type; the reusable type is made of a corrosion-resistant and sterilizing material that allows the handle to be reused after sterilization by heat or gas.

Disadvantages of the prior art

It is well known that medical personnel need to be accurate and quick, particularly in the surgical field. To help meet these requirements, surgical materials have emerged, such as the aforementioned handles for taking biopsy samples. However, current devices are deficient, which hampers the surgeon's work, especially when performing biopsies.

The single use version is practical and more cost effective than other devices. They do not provide the surgeon with the accuracy necessary for the sampling process, especially when used in the case of tissue damage near skin tissue.

The reusable version is more reliable due to the coaxial sliding system of the needle. Although reusable after sterilization, it is a more expensive device. There are a large number of various needles available on the market, of different sizes and lengths, suitable for taking samples from organs. There are also various brands and manufacturers of these needles and handles. The main problem with these styles is that the handle is not adaptable to various types of needles and the physician needs to have a compatible style for a variety of different brands, sizes and lengths so that multiple types of tissue can be sampled.

In addition to the inconvenience, the drive system for the control knob also has disadvantages. The physician also feels difficulty in use due to the complexity of the system. Because the surgical field to be performed is in millimeters, qualified personnel in the surgical field recognize that taking a biopsy sample is a sampling procedure that requires the surgeon's attention to a highly focused and accurate sampling procedure. The diagnosis of the minimum deviation is also detrimental. In prior systems, the triggering and positioning of the drive system by the spring system was difficult and caused higher risks when taking tissue samples.

Disclosure of Invention

In view of this, it is an aspect of the present invention to provide a device for a biopsy sampler in which not only the number of operations is taken into account in the manufacturing design, but also the form, arrangement and location of the parts and components of the device which, when correctly positioned, will provide more safety and no added cost to the sampling process.

In view of this, one version that has been developed to be more sophisticated and efficient is to provide a biopsy sampler that is more reliable in its operating characteristics and easier to operate.

The device of the invention, which is also the subject of the invention, comprises a discharge mechanism located on the front part of the body of the device. This discharge mechanism allows the surgeon to actuate the device using his index finger or thumb and place the needle accurately into the tissue at the target location. Because the device can be operated with one hand, it is advantageous for use during sampling where other viewing instruments, such as ultrasound devices, are required.

The triggering and positioning of the needle by the handle is delicate and high risk, as any deviation would be detrimental to the sampling process. In view of the above, the present invention proposes a safety lock system that avoids accidental discharge and provides more comfort and reliability for the surgeon's operation when triggering and positioning the needle in the position necessary for collection.

The needle slide system allows the sample to be removed without the need to remove the instrument needle, which further reduces the risk of an insult to the sample that could contaminate the sample, thereby compromising the results of the examination. The size of the instrument is optimized to reduce trauma and increase stability during the sampling operation. This second factor is of paramount importance in order to provide sample collection accuracy, since this approach avoids unnecessary insertion of the cartridge in several directions.

The head fit system does not require the use of screws or locks because they are held in place by cylindrical fittings and strong magnets. The lid may be hinged and provided with a magnetic locking system. This difference can be small, which is extremely important when referring to instruments used in surgical procedures (e.g. biopsy sampling). The use of pins, locks or screws requires holes formed in the components. These holes may be entrances for bacteria and microorganisms which may contaminate the sample and compromise the examination results, or even infect the patient himself, which causes irreversible damage to his/her health.

The head replacement system allows the use of needles of several different styles, brands, sizes and diameters available in the market without having to replace the entire part. Only the exchangeable elements located on the upper surface of the movable base are exchanged, i.e. instead of exchanging the handle for each type of needle, only a small part is exchanged, which can be fitted into the handle for each type of needle. Because it is part of the handle that can be changed to suit each type of needle, constant movement of the pin, lock and screw can result in excessive wear of the device. This is an additional advantage for the consumer of a fastening system using magnets.

The handle of the present invention is made of sterilizable materials and the sterilization process is performed by a conventional method after each sampling process. In addition to reducing the cost of the device, this allows the handle to be reused on another patient efficiently and without contamination. In the case of the presence of another type of needle with a different engagement from the ones existing in the market, it is possible to form a new head with an appropriate engagement system suitable for each type, and which is an innovative and highly adapted device to the market requirements.

Drawings

FIG. 1 shows an upper rear perspective view of a handle assembled with a needle and a hub;

FIG. 2 shows a side view of the handle assembled with the needle and hub;

FIG. 3 shows a top view of the handle assembled with the needle and hub;

FIG. 4 shows a rear view of the handle as viewed from the grip;

FIG. 5 shows a side perspective view of the handle with the cover open and without the needle and sleeve;

FIG. 6 shows a front perspective view of the handle assembled with the needle and hub;

FIG. 7 shows an upper front perspective view of the needle and sleeve movement system and shows the engagement of the interchangeable components of the handle;

FIG. 8 shows a front upper perspective view of the needle and sleeve movement system and shows the engagement of the interchangeable components, and the needle and sleeve are different from the needle and sleeve shown in FIG. 7;

FIG. 9 shows a side perspective view of the needle and sleeve movement system and shows the engagement of the interchangeable components and the engagement of the needle and sleeve on the handle;

FIG. 10 shows a side perspective view of the needle and sleeve movement system and shows the engagement of the needle and sleeve on the handle;

FIG. 11 shows a side perspective view of the needle and sleeve movement system and shows the engagement of the interchangeable components and the engagement of the needle and sleeve on the handle;

FIG. 12 shows an upper perspective view of the base, and shows the position of the magnetic insert;

FIG. 13 shows a front upper perspective view of the base;

FIG. 14 shows a front view of the base;

FIG. 15 shows a front lower perspective view of the base;

FIG. 16 shows a front upper perspective view of the base of the exchangeable element, showing mating;

FIG. 17 shows a side up perspective view of the rectangular shaft and shows the safety lock mating groove and retaining slide element;

FIG. 18 shows a side upper perspective view of the cylindrical shaft and shows a protrusion on a central portion of the cylindrical shaft and a slightly larger diameter on one end of the cylindrical shaft;

FIG. 19 shows a side down perspective view of the needle and sleeve positioning and retaining system;

FIG. 20 shows a side view of the needle and sleeve positioning and locking system;

FIG. 21 shows a side up perspective view of the handle with a longitudinal cut showing the position of the rectangular shaft relative to the base;

FIG. 22 shows a side upper perspective view of a partial detail of the safety lock system of the handle;

FIG. 23 shows an exploded side upper perspective view of the handle;

FIG. 24 shows an exploded side down perspective view of the handle;

FIG. 25 shows a front upper perspective view of the handle assembled with a needle and hub of some type; and

FIG. 26 shows a front upper perspective view of a handle assembled with a needle and hub of a different type than that shown in FIG. 25.

Detailed Description

The object of the present invention consists of an improvement to a living tissue sample collecting instrument consisting of a handle 1, said handle 1 serving as a base for the connection of a needle 3 and a disposable sleeve 4 for collecting tissue samples.

The handle 1 is made of a hard and sterilizable material and the handle 1 consists of a quadrilateral 5, the quadrilateral 5 having a hinged lid 6, the lid 6 having strong magnetism at its ends to achieve effective locking. A main single section (monoblock)7 is formed inside, and the components of the handle mechanism 1 are fixed to the main single section 7.

The instrument is movable by means of a system consisting of two parallelepiped-shaped movable bases 8A and 8B, the bases 8A and 8B being arranged with side guides formed on both sides by longitudinal cuts 24 of rectangular section and fitting into rectangular longitudinal projections 25 formed on the single zone 7 side. Three cylindrical protrusions 10 are formed on the upper surfaces of the base portions 8A and 8B, the protrusions 10 being linearly positioned and gradually becoming larger in size in the longitudinal direction. This structural arrangement is idealized to reduce high costs with available equipment. As mentioned above, current sample collectors of better instrument quality require the surgeon to have a handle that is suitable for every type or brand of needle 3 currently in the market.

Holes 12 are formed on the upper surface of the base, the holes 12 having a strong magnet on their inner sides. On the upper surface of the base there are fitted interchangeable elements called intermediate connectors 9A and 9B, said intermediate connectors 9A and 9B having holes 34 matching the cylindrical projections 10. The upper surface of the intermediate connectors 9A and 9B has mating elements 2A and 2B, said mating elements 2A and 2B being in accordance with the standard of the devices (or kits) of the sleeve 4 and the needle 3 currently on the market, i.e. the surgeon needs only to obtain a single handle 1 and only two parts of the intermediate connectors 9A and 9B to be able to use conveniently the new brand or type of needle 3 necessary to carry out the sampling process. Specifically, the exchangeable elements 9A and 9B have fitting positions defined by holes 34 formed on their bodies, and the exchangeable elements 9A and 9B are fixed by the magnets 11 fitted on the base portions 8A and 8B through the cylindrical protrusions 10 of the base portions 8A and 8B.

The handle 1 is designed to be able to connect various types of sets of needles 3 and sleeves 4 existing on the market, by using intermediate connectors 9A and 9B adapted to the set of sleeves and needles to be used. Fig. 9 and 11 are examples of different types of needles 3 and sleeves 4, which different types of needles 3 and sleeves 4 can be connected to the handle by correct use of the intermediate connectors 9A and 9B.

The base 8B has a hole 19, said hole 19 being located on the center and longitudinal axis of the circular portion and having two opposite rectangular openings beside the center. The bases 8A and 8B are positioned longitudinally by a cylindrical element 17, said cylindrical element 17 extending like the handle 1 and having, in its central region, two cylindrical projections 18, said two cylindrical projections 18 being opposite each other and perpendicular to the cylindrical element 17, and said cylindrical element 17 being slightly larger in diameter at its front end 23. This mechanism is actuated by pulling on the handle 16 and causes the bases 8A and 8B to move to their locked or working positions.

Two coil spring-type elastic means 20A and 20B are provided around the cylindrical element. Positioned on the rear of each movable base 8A and 8B are a spring 20A and a spring 20B, wherein the spring 20A is adjusted by a rectangular element 26 with a circular hole positioned laterally near the center of the handle 1 and the spring 20B is adjusted by a back face 27. A handle 16 is attached to the rear end of the cylindrical member 17.

Near the front of the single zone, on its side, a set of cut-outs 28 is formed, where rectangular shaped limiting elements 29 cooperate with semicircular shaped openings 28. And, a set of cut-outs 30 is formed on the middle area of the single zone, where rectangular shaped restriction elements 31 cooperate with semicircular form openings at said cut-outs 30. The restriction element is another feature with this type of device because it allows the surgeon to control the size of the perforation (1, 2, 2, 2mm or more). The limiters 29 and 31 are attached to the single zone to adjust the distance to certain types of needles.

The triggering and positioning system of the needle 3 and the sleeve 4, consisting of a rectangular partial shaft 15, is located externally below the single zone 7, said rectangular shaft 15 having a length within the single zone 7, and said rectangular shaft 15 having a trapezoidal shaped side cut 14A in one third from its rear end and a V shaped side cut 14B in one third from its front end. Retaining slide U-shaped elements 13A and 13B are located in these cutouts. This system gives the surgeon greater accuracy when inserting and positioning the needle 3 at the desired acquisition position. The difference in geometry of the openings 14A and 14B provides a difference in discharge time between the sleeve 4 and the needle 3 in milliseconds. This time difference is crucial for the success of the sampling process, since it allows the needle 3 to leave the sleeve 4 only when it is necessary to take a sample, which eliminates the risk of contamination of the sample by other tissues.

At the rear end of the shaft 15 is a safety lock 21, said safety lock 21 being formed by a rectangular base with a cylinder perpendicular to the surface of the rectangular base, said cylinder passing internally through the distal end of the rectangular shaft 15 portion, and said cylinder having a vertical projection forming an L-shape (21) on the other side, said vertical projection fitting into a lateral opening 22. When the lock is turned, the system is fully braked, which allows the surgeon to enter the patient without the risk of accidental discharge of the needle in an inappropriate position, which could cause injury to the patient. But when the injury is located and the needle needs to be sampled, the surgeon unlocks the system and actuates the front or rear free portion of the lateral longitudinal portion 15 so that the system moves and the needle can then perform its task. Another great advantage offered by this movement system is that it enables the surgeon to operate the handle with only one of his hands. The need for a one-handed handle is of extreme importance because this type of sampling procedure is typically performed with the aid of some other type of device, such as an ultrasound device, that helps the surgeon find the exact location to sample.

The triggering is performed in two stages, the first stage effecting triggering of the sleeve by pulling the handle to its extreme position; and the second phase is needle activation by returning the handle to its rest position and rotating the handle 90 degrees in any direction and finally by pulling the handle again to its extreme position, the needle is activated.

The handle actuation is performed by a spring force and in order to trigger the discharge system of the device a force should be applied which is larger than the spring force actuating the needle set.

In conventional handles, the sleeve and needle activation system are simultaneous, which determines that a large force is required for activation.

On said handle, the sleeve and the needle triggering take place in an independent manner, which makes the handling process easier due to the simple fact that less force is applied for handling.

Thus, we can verify from the above description that the "device incorporating biopsy sampler and the like" referred to now has important uses, namely that it increases user safety in addition to cost savings, and exhibits practical qualities and functions, which fully prove the utility of this patent application.

Claims (1)

1. A device to be incorporated into biopsy samplers and the like, which is an improvement to be incorporated into instruments for biopsy sampling, said device consisting of a handle (1) serving as a base, said handle (1) serving as a base for the connection of a single-use needle (3) and a sleeve (4) for taking a tissue sample; said handle (1) is made of a hard and sterilizable material and consists of a quadrangular structure (5), said quadrangular structure (5) having a hinged lid (6); a main single area (7) is formed inside, at which main single area (7) components are fixed to the handle mechanism (1); the device performs its operation based on a linear movement by two parallelepiped-shaped bases (8A and 8B), the bases (8A and 8B) having side guides formed on both side walls by a longitudinal cut (24) of a rectangular portion and a central cylindrical element (17) fitted into a rectangular longitudinal track (25) formed on the monodomain (7) side, the central axis of the central cylindrical element (17) extending like the handle (1) passing longitudinally through the bases (8A and 8B) and having a diameter slightly greater at the front end (23); forming two elastic means (20A, 20B) of the helical spring type around the central cylindrical element (17), positioned on the rear of each movable base (8A) and (8B) are a spring (20A) and a spring (20B), wherein the spring (20A) is adjusted by a rectangular element (26) with a circular hole positioned opposite near the central handle (1) and the spring (20B) is adjusted by a back face (27); a handle (16) is connected to the rear end of the central cylindrical element (17); the triggering and positioning system of the needle (3) and the sleeve (4) is located outside and below the single zone (7), consisting of a rectangular part shaft (15), said rectangular part shaft (15) having a length within the single zone (7), and said rectangular shaft (15) having a V-shaped side cut (14B) in one third from its rear end and a trapezoidal shaped side cut (14A) in one third from its front end; the U-shaped retaining slide elements (13A, 13B) are respectively located in these cutouts; a safety lock (21) is located at the rear end of the shaft (15), said safety lock (21) being formed by a rectangular base with a cylinder perpendicular to the surface of the rectangular base, said cylinder passing internally through the distal end of the rectangular shaft (15) portion, and said cylinder having a vertical projection forming an L-shape (21) at the other end, said vertical projection protruding through a lateral opening (22) and fitting by a rotary motion within the rectangular opening of the single sector (33) to provide locking of the rectangular portion shaft (15);

the instrument is characterized in that:

said bases (8A, 8B) having on their upper surface (10) three cylindrical projections arranged linearly and having a gradually increasing size in the longitudinal direction; and holes (12) are formed on the upper surfaces of the base portions (8A, 8B), the holes (12) having a ferromagnetic body (11) on their inner sides; on the upper surface of the base (8A, 8B) there is fitted an interchangeable element called an intermediate connector (9A and 9B), said intermediate connector (9A, 9B) having a hole (34) matching the cylindrical protrusion (10); and the upper surface of the intermediate connector (9A, 9B) has a mating element (2A, 2B), the mating element (2A, 2B) being in accordance with the standard of the sleeve (4) and needle (3) sets available on the market; the base (8B) has a hole (19), said hole (19) being located on the center and longitudinal axis of the circular portion and having two opposite rectangular openings beside the center, said central cylindrical element (17) passing through said hole (19) of the base (8B) and having, near its intermediate zone, two cylindrical protrusions (18), said two cylindrical protrusions (18) being opposite each other and perpendicular to the central cylindrical element (17) and being shaped to fit the longitudinal hole (19) of the base (8B); a set of cut-outs (28) is formed on the one-zone side near the front of the handle (1), in which cut-outs (28) the limiting element (29) can be fitted, and a set of cut-outs (30) is formed near the middle region of the longitudinally extending one-zone, in which cut-outs (30) the limiting element (31) can be fitted, said cut-outs (30, 31) having a rectangular shape with a semicircular opening; on the upper end of the cover (6) connected to the outside, the strong magnet (32) is preferably configured in a circular shape.