Patent Application
20240407770
The present invention relates to devices and methods for performing biopsies, more particularly, to a biopsy system featuring a deployable mechanism for cutting biopsy samples and cauterization. The present invention further provides multi-bioimpedance measurements for guiding a needle and directing electrical coagulation. The present invention also provides devices and methods for performing a minimally-invasive needle biopsy, more particularly to a biopsy needle system with a novel tangential cutting mechanism and an electrical means of controlling complications.
In patients suspected of having a disease with potentially harmful treatments, such as cancer, a small sample of tissue, termed a biopsy, is needed to make a correct diagnosis. In some cases, a biopsy is used to identify specific cancer characteristics to allow for a more personalized therapy. Large amounts of tissue (e.g., up to one gram) often need to be harvested in order to perform diagnostic and specialized testing (e.g., immunohistochemistry, molecular and genetic testing, etc.). Currently, standard core needle biopsies require multiple passes through tissue to collect enough tissue cores (e.g., cylinders of tissue dictated by the radius of the needle and the height of the core). However, more passes by the needle increases the likelihood of complications such as bleeding or even death. In addition, an increased number of passes may mean longer procedural times and longer post-procedural monitoring. Another means of obtaining more tissue is the use of a larger needle, but bigger needles also carry increased risk of complications, such as bleeding or other organ-specific complication (e.g. pneumothorax, etc).
In another aspect, guidance of needles (hollow in the case of aspiration, partially or semi-hollow in the case of biopsies, or solid as with thermal- or electrical-ablations) is essentially required to maximize efficacy and minimize complications of percutaneous needle-based procedures. While the current standard of external imaging-based guidance through, for example, x-rays/fluoroscopically/CT, medical ultrasound, or MRI, is very powerful, there are limitations. As an example, CT-guidance for lung biopsies is fraught with difficulties. Patients undergoing lung biopsy are often instructed to hold their breath while a CT scan is performed to determine if the trajectory of the needle is in line with the target lesion. However, many patients cannot reasonably hold their breath for the duration of the scan, let alone the brief time for interpretation of the scan including triangulating the trajectory of the needle and the target and then the time it takes for appropriate advancement of the needle to the target. During this interval from scan to needle advancement to the target, the needle tip moves with respirations and lung movement. Furthermore, despite the most proficient percutaneous intervention, complications related to bleeding do occur from the needle violating blood vessels.
Hence, there exists a need for safer and more efficient biopsy needles and procedures. In addition, better guidance and positioning of needles is desired.
A sample of tissue is required for a definitive histological diagnosis in most non-self-limited pathological conditions. While surgical sampling in the form of excisional biopsy was needed in centuries past, less invasive needle-based biopsy devices in the late 20th century changed this. In humans or animals needing a definitive diagnosis, a minimally-invasive biopsy is the first-line approach for obtaining tissue. Despite their minimally-invasive nature, needle biopsy procedures are not without risks. The main risks include an inadequate tissue sample and complications from mechanical damage to the tissue including blood vessels.
These risks are real. Risks of inadequate tissue samples occur in upwards of 20% of needle biopsy procedures (Dolgin E. Shoddy biopsies deny cancer patients a shot at personalized treatment. STAT. https://www.statnews.com/2016/01/22/precision-medicine-cancer-biopsies. Published Jan. 22, 2016. Accessed Jan. 20, 2023.) Inadequate tissue samples limit advanced molecular testing, subjecting patients to probability-based rather than personalized therapies due to an incomplete molecular-level diagnosis. Mechanical complications, particularly leakage of blood after needle biopsy (or leakage of gases in the case of lung biopsies) can result in morbidity in the form of anemia, mass effect (from hematoma or pneumothorax), and even mortality. Regarding the scope of uncontrollable leakage of blood or gas, a 2022 paper by Vachani et al. in the Journal of the American College of Radiology showed that approximately one fourth of patients undergoing lung biopsy will experience a complication with up to 31% of such requiring a second procedure to correct the first complication and 7% requiring hospitalization more than an overnight stay within 1 week after the procedure (J Am Coll Radiol 2022; 19:1121-1129).
Clearly, there is a need to reduce the incidence of needle biopsy complications while improving the yield of the sample. The parent application US 20190388073A1 aims at addressing both issues through a cutting tip that is intended to harvest substantially more tissue than current commercial hollow needles, and electricity to control leakage or bleeding, all while being faster for the operator.
One aspect of the invention pertains to a biopsy system for harvesting tissue, said system comprising:
Another aspect of the invention pertains to a method of harvesting tissue, said method comprising
A further aspect of the invention pertains to a biopsy system for harvesting tissue, said system comprising:
A further aspect of the invention pertains to a biopsy system for harvesting tissue, said system comprising:
In some aspects, the present invention features a biopsy system for harvesting a target tissue. The system may comprise a needle having a tip disposed at a distal end of the needle for insertion into tissue, a lumen disposed in the needle, an aperture disposed at or near the distal end of the needle and fluidly connected to the lumen, a cutting mechanism adapted to cut tissue, a mechanism for cauterizing contacting tissue, and a mechanism for rotating the needle. The cutting mechanism can have at least a portion thereof disposed in or on the aperture. In one embodiment, the cutting mechanism and aperture may be disposed on the needle shaft near the distal end. In preferred embodiments, when cutting the tissue, the cutting mechanism cuts tissue tangential to the biopsy needle shaft. As used herein, “tangential” refers to being located at a periphery or side of the needle shaft, but excluding the distal end such that the cutting mechanism does not cut along the axis of the needle. In other preferred embodiments, the cutting mechanism cuts the tissue and directs said cut tissue into the aperture and further into the lumen, while the contacting tissue is cauterized by the cauterizing mechanism. The biopsy system is adapted to cut tissue and harvest said tissue sample (in a corkscrew configuration) into the lumen. For example, the tissue that is being cut acquires a coil shape. As used herein, “contacting tissue” refers to the remaining tissue from which was harvested the cut tissue sample and that is in contact with the cauterizing mechanism.
In some embodiments, the cutting mechanism may be deployable such that it is adapted to move between an extended position where said portion projects from the needle, and a retracted position where said portion is not projecting from the aperture. When the needle, starting with the tip, is inserted into the target tissue, the cutting mechanism moves to the extended position and the needle is axially rotated via the rotation mechanism. In some embodiments, the system may further comprise a sheath slidably disposed around an exterior surface of the needle. The sheath is adapted to move between at least an open position where the aperture is exposed and the sheath is moved towards the proximal end of the needle, and a closed position where the aperture is covered by the sheath. When the sheath is moved to the open position, the deployable cutting mechanism expands and projects out from the aperture. In some embodiments, the deployable cutting mechanism may comprise at least one cylindrical or filament wire or an expandable dome-shape structure. In other embodiments, the deployable cutting mechanism comprises at least one flat wire with a first side for cutting and a second side for cauterization or coagulation. In still other embodiments, the deployable cutting mechanism may comprise a nitinol memory wire that is pre-configured to assume a conformation.
The device as taught in the parent application US20190388073A1 also claimed electrical cauterization and coagulation to decrease complications though without defining some terms. Others have proposed and are testing the use of high-energy or high-heat electrocautery or radiofrequency needle tract ablation to achieve similar ends of complication control (e.g. US20180132929A1 that discussed the need of a voltage pump to increase the voltage higher than 15V in their patent paragraph 0028 and claims requiring 500 kHz AC or higher; or US20210205015A1 where the tip temperature is “at least 1200° C.”). The term “electrocoagulation” was used in the parent application without definition or distinction from electrocautery or thermal ablation found in the prior art. Electrocoagulation (rather than high-energy electrocautery or high-voltage electrosurgery) was studied in the mid 20th century and deemed too slow to control bleeding for surgical procedures. For example, an experiment with heparinized blood and an electrode for 10 minutes at 10, 25 and 50V with 2, 4, 6 and 8 mA showed a dose-dependent clot forming on the electrode (see adjacent chart below). (Phillips, Joseph F. MD Transcatheter Electrocoagulation of Blood Vessels, Investigative Radiology: September 1973-Volume 8-Issue 5-p 295-304).
In another experiment, 5-15V for 10-20 mA over 2-7 minutes could stop skin bleeding in plastic surgery (Kravitz H M, Wagner K J. Applications Of Direct Current Coagulation In Plastic Surgery, Plastic and Reconstructive Surgery: April 1964-Volume 33-Issue 4-p 361-367). In another experiment, 6-9V and 5 mA for 6-7.5 minutes to stop a bleeding dog spleen was better than 3V and 12V (Hayashi H. Fundamental studies on the electrical potential difference across blood vessel walls and applications of direct current coagulation. Nagoya J Med Sci. 1968 March;30 (4): 399-418. PMID: 5662367.) In yet another experiment, an intra-arterial electrode for 75 minutes at 15 mA and unreported voltage (presumed to be less than 100V) showed clotting of the main artery of the leg in a dog; this time could be shortened to 36 min with 30 mA, and 19 min with 60 mA to clot the artery. (Effect of increasing current and decreasing blood flow for transcatheter electrocoagulation (TCEC). Ralston M D, Woodfield S, Halvorsen R, Pizzo S V, Thompson W M. Investigative Radiology, 1 Mar. 1982, 17 (2): 171-177. DOI: 10.1097/00004424-198203000-00011 PMID: 7076450). An intra-vascular positive electrode delivering 50V and 10 mA for 40-80 min clotted artificial arterio-venous connections in dogs. (Experimental Closure of Arteriovenous Fistula by Transcatheter Electrocoagulation. Joseph F. Phillips, Arvin E. Robinson, Irwin S. Johnsrude, and Donald C. Jackson. Radiology 1975 115:2, 319-321). Intra-arterial positive electrode delivering 10-15 mA for 30 min without mention of voltage could form a clot in a different setting. (Clinical Use of Transcatheter Electrocoagulation. Michael D. Miller, Irwin S. Johnsrude, Anthony J. Limberakis, Donald C. Jackson, Salvatore Pizzo, and William M. Thompson. Radiology 1978 129:1, 211-214). Other experiments required 6-60 minutes of electrical activity for coagulation (Thompson, W. M., Johnsrude, I. S. Vessel occlusion with transcatheter electrocoagulation. Cardiovasc Intervent Radiol 3, 244-253 (1980). https://doi.org/10.1007/BF02552734; and Piton, J., Billerey, J., Renou, A M. et al. Vascular thrombosis induced by direct electric current. Neuroradiology 16, 385-388 (1978). https://doi.org/10.1007/BF00395312). Thus, electrocoagulation requiring minutes to hours for effect was deemed too slow for endovascular or surgical bleeding control.
Electrocoagulation, electrocautery and electrosurgery were mentioned throughout the parent application US20190388073A1 (particularly paragraph 0101), and needle electrocoagulation will be further defined as an electron-dependent biochemical reaction resulting in coagulation or congealing of macromolecules (including those found in blood) with additional details in the claims. Through non-obvious empirical experimentation, we refined the claims regarding needle electrocoagulation. To model a needle and blood, ¼ lb 22 g stainless steel wires were placed approximately 1 cm apart approximately 1.5 cm deep in egg white diluted to mimic blood at 80 mg/ml protein at 0.9% sodium content in 4 ml aliquots in 12-well plates (on ice to fix the temperature). Fixed voltages were applied for 4 seconds and resulting floating oxidation/coagulum area was measured (N=6).
Given the minutes to hours electrocoagulation required for bleeding control in the endovascular and surgical literature, the above finding regarding electrocoagulation that worked in seconds was unexpected but has clear implication for benefiting needle biopsy patients as a fast and less-expensive (than electrosurgical or electrocautery) means of decreasing bleeding risk. One skilled in the art could apply this needle electrocoagulation method to more than just the biopsy needle itself, for example, an introducer needle or sheath system during a biopsy or aspiration, or with a minimally-invasive needle ablation procedure as possible methodological embodiments of the needle electrocoagulation system and method.
According to one embodiment, the biopsy system of the present invention may have a fixed-shaped cutting mechanism instead of the deployable cutting mechanism. As used herein, the term “fixed-shaped” is defined as non-deployable. This fixed-shaped cutting mechanism may extend from the needle. For example, the fixed cutting mechanism may be disposed at the aperture and extend from the needle surface. The sheath may be adapted to move between at least an open position where the aperture and cutting mechanism are exposed and a closed position where the aperture and cutting mechanism are covered by the sheath. In some embodiments, the cutting mechanism may comprise a fixed dome-shape structure having a leading cutting edge.
According to some embodiments, the biopsy system may further comprise a means for retracting the sheath to move between the open position and the closed position. For instance, a gear may be operatively coupled to the sheath and a motor for moving the sheath between the open position and the closed position. The gear may be operatively coupled to the sheath via a posterior connection. Alternatively, the gear may be operatively coupled to the sheath via a gear track disposed on an exterior surface of the sheath.
According to some embodiments, the rotating mechanism may comprise a gear operatively coupled to the needle and to a spring or motor for rotating the needle. The gear may be operatively coupled to the spring or motor via a rod or other connection capable of transferring rotational force. In other embodiments, the system may have at least two gear systems, where one gear set controls the sheath retraction and the other gear set controls the needle rotation. Alternatively, the system may have one or more gears that can simultaneously control the sheath retraction and needle rotation.
In some embodiments, the lumen is under negative pressure to allow the cut tissue to collect in the lumen. The negative pressure in the lumen can be generated using suction or a vacuum source. In other embodiments, a tissue collection chamber may be fluidly coupled to the needle lumen for storing the cut tissue. For example, suction may be applied to help withdraw the tissue into the lumen, which is then stored in the collection chamber.
According to one embodiment, the cauterizing mechanism may be operatively connected to the cutting mechanism, which is an electrocautery system. When the electrocautery system is activated, the cutting mechanism is activated to provide cauterization to contacting tissue. According to another embodiment, the cauterizing mechanism may comprise a cauterizing surface disposed on the cutting mechanism such that the cauterizing surface cauterizes the contacting tissue. In another embodiment, the cauterizing mechanism may comprise a cauterizing surface disposed on the needle tip such that the cauterizing surface cauterizes the contacting tissue. For example, the cauterizing surface of the needle tip can act as an exposed anode, and a shaft of the needle can act as a cathode. In other embodiments, the cauterizing mechanism may further comprise an insulator that protects the cut tissue from being cauterized. The cauterizing mechanism can be operatively coupled to a power source, such as a battery, power outlet, or any suitable electrical source.
In one embodiment, the cutting mechanism may utilize cutting, electromagnetic force, pressure, thermal energy, vibrational energy, or a combination thereof to cut the tissue. In other embodiments, the cutting mechanism may utilize high frequency electrical pulses to cut the tissue with minimal burning or damaging of the tissue.
In further embodiments, the biopsy system may include at least one additional lumen. In some embodiments, the lumen may have a cross section that is circular shaped, oval shaped, semicircular shaped, sectoral shaped, pie- or arc-shaped, rectangular shaped, elliptical shaped, teardrop-shaped, crescent-shaped, horseshoe-shaped, triangular shaped, square shaped, polygonal shaped, or a combination thereof. In other embodiments, the lumen is symmetric, oblong, or asymmetric relative to an axis of expansion or rotation. In one embodiment, the additional lumen is adapted for holding or administering a solution. The solution may be injectable into the tissue. For example, the solution may comprise a pro-coagulant, local anesthetic, or other injected medication desired by the operator.
In other embodiments, the tip of the needle is hollow, beveled, solid, or tapered. In some other embodiments, the tip of the needle may comprise symmetrical or asymmetrical conical tips, or other configurations. In yet other embodiments, the tip of the needle comprises a cutting edge or a reverse cutting edge.
In one embodiment, the tip or cutting mechanism may be removed from the needle. Without wishing to limit the present invention, the removed tip or cutting mechanism may function as a tissue biopsy marker or wire localizer for indicating a location of the biopsied tissue. In another embodiment, the needle lumen or the additional lumen may also be used for the insertion or withdrawal of a guide wire and/or the insertion of a radio-opaque marker.
In yet other embodiments, the biopsy system may further a mechanism for transmitting signals that enables a user to better visualize and locate the needle in the tissue. For example, the mechanism may emit signals that are ultrasonic vibrations. These ultrasonic vibrations can then be detected by an ultrasound machine.
According to preferred embodiments, the biopsy systems described herein may be employed in biopsy procedures. For example, in some embodiments, the biopsy procedure, or method of harvesting tissue, may comprise providing the biopsy system, inserting the needle, starting with the tip, into a tissue of concern, retracting the sheath to expose the cutting mechanism, rotating the needle and applying suction to the lumen, thereby cutting the tissue with the cutting mechanism and cauterizing contacting tissue via the cauterizing mechanism. The cut tissue is then directed into the lumen and optionally stored in the tissue collection chamber. In some embodiment, the method may further comprise injecting a solution, such as, for example, a medication into the tissue, through an additional lumen. In other embodiments, the cutting mechanism delivers vibrational, thermal, or electrical energy to assist in locating the needle in the tissue under image-guidance. In still other embodiments, the method may further comprise removing the tip (103) or cutting mechanism (104) from the needle and placing the removed tip or cutting mechanism in the biopsied tissue.
According to other embodiments, the present invention features a bio-impedance system for guiding a needle and providing positioning information. In some aspects, the system may comprise a needle having a tip disposed at a distal end of the needle for insertion into tissue, an outer sheath slidably disposed around an exterior surface of the needle, and a plurality of electrodes disposed on a surface of the outer sheath, on the needle, or both. The outer sheath is adapted to move between an open position away from the needle tip such that at least a portion of the needle is exposed, and a closed position where said needle portion is covered by the sheath. In one embodiment, the needle can function as an additional electrode. Each electrode is configured to apply electrical current to the immediate surroundings in contact with the electrode to achieve one or more of the following results: cauterizing tissue, coagulating blood, obtaining multiple bio-impedance measurements to guide needle insertion and positioning, or initiating electron-dependent biochemical processes.
In some embodiments, the plurality of electrodes may comprise about 3-128 electrodes that are electrically capable yet isolatable from the other electrodes. In one embodiment, the electrodes may comprise conductive strips, ribbons, or wires disposed axially along the surface of the outer sheath, the needle surface, or embedded and fixed within the needle. In another embodiment, the electrodes may comprise multiple concentric telescoping tubes each with an electrically-active exposed tip. In some embodiments, an insulating material may be partially covering the electrodes, a portion of the needle, or both.
In some embodiments, the needle may be hollow, partially hollow, or solid with more than one face that conducts electricity. In other embodiments, the contents inside the needle, such as saline or a wire disposed in the needle, are electrically conductive and may serve as additional electrode(s). In some other embodiments, the needle may have one or more electrically capable and isolatable connection dispose internally. In some embodiments, the needle may be circular or non-circular in cross-section. In one aspect, non-circular faces may improve diagnostic ultrasound guidance and/or enable alternative manufacturing.
One of the unique and inventive features of the present invention is the deployable cutting mechanism (e.g., filament or wire) with cauterization. Without wishing to limit the invention to a particular theory or mechanism, the present invention can harvest larger volumes of tissue as compared to standard core biopsy needles. This may help reduce the number of passes that are performed during a biopsy, thus potentially reducing biopsy-associated complications and procedure time. Furthermore, the system can harvest the tissues while cauterizing the contacting tissue (e.g. remaining tissue), which can also reduce biopsy-associated complications.
Another unique and inventive feature of the present invention is the multiple electrodes on the biopsy needle. This enables more than one impedance measurement to be obtained for providing spatial information. Without wishing to limit the invention to a particular theory or mechanism, this feature can allow for guided insertion of the biopsy needle using directional information from multiple bio-impedance readings by the electrodes, thereby further reducing the likelihood of biopsy-associated complications. None of the presently known prior references or works has these unique inventive technical features of the present invention.
Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.
The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:
Following is a list of elements corresponding to a particular element referred to herein:
As known to one of ordinary skill it the art, cauterization involves burning or singeing a target tissue typically to coagulate and stop bleeding and reduce or prevent infections. The cauterized area then heals.
As used herein, the term “electrocautery” refers to cauterization, preferably without significant tissue damage. In some embodiments, electrocautery applies high frequency alternating current by a unipolar or bipolar method. The high frequency alternating current may be applied intermittently to coagulate tissue. As used herein, the term “electrosurgery” refers to pulsating at higher frequencies to cut with little thermal damage. The high frequency alternating current may be applied in a continuous waveform to cut tissue. In some embodiments, this is the preferred method for cutting using the biopsy needle device of the present invention. The biopsy device may be operatively connected to an electrical generator or power source for cauterization and/or surgical cutting. In one embodiment, an example of the electrosurgical and/or electrocautery unit that may be used in accordance with the present invention include a unipolar unit with one polarity on or near the cutting element and a second polarity placed on the patient using an electrode pad and connected to the electrical unit/generator. In another embodiment, the electrosurgical and/or electrocautery may comprise a bipolar unit with one polarity on or near the cutting element and a second polarity placed on another part of the needle device within the patient. In preferred embodiments, the unit is capable of both cutting and coagulating the tissue.
As known to one of ordinary skill, bio-impedance is the measurement of resistance to alternating current flow in a biological organism or specimen. Bio-impedance can be used to provide information to a healthcare provider such as, for example, placement of a needle in the desired tissue given that the electrical conductivity of different tissue types is variable.
According to some embodiments, the present invention features a biopsy system (100) for collecting biopsy samples. The biopsy system (100) of the present invention comprises a needle (101) (e.g., a hollow shaft, a partially hollow shaft, a multi-lumened shaft, etc.) having a distal end, i.e. needle tip, for insertion into tissue under investigation and a proximal end opposite the distal end. The distal end may be pointed or tapered or configured in any appropriate shape for insertion into tissue under investigation. In some embodiments, the needle gauge may range from about 8-30 gauge. In other embodiments, the tip angle of the needle may range from about 0°-45°. The needle may be constructed from a stainless steel, other metal, or ceramic material; and may optionally be coated for insulation. In some embodiments, the needle surfaces are flat to increase echogenicity.
An aperture or opening aperture (102) may be disposed in the needle at or near the distal end. A sheath (105) may be disposed (e.g., slidably disposed, rotatably disposed, movably disposed) on and/or around at least a portion of the needle, e.g., over at least a portion of the aperture (102). The aperture (102) can be exposed if not covered by the sheath (105). For example, the sheath (105) can move between at least an open position wherein the aperture (102) is exposed and a closed position wherein the aperture (102) is covered. The aperture (102) may be used to house a (deployable) cutting mechanism for cutting tissue (as described below). During the cutting process, cut tissue may be directed from the originating tissue or mass into the needle (e.g., a lumen (106) in the needle) via the aperture (102). The system (100) may feature a single lumen (106) or multiple lumens (106), e.g., two, three, four, five, six, more than six, etc. In some embodiments, tissue may be aspirated or harvested into one lumen and a solution may be present in a second lumen.
The system (100) of the present invention also comprises a (deployable) cutting mechanism (104) for cutting tissue. The deployable cutting mechanism (104) may also cauterize tissue. In some embodiments, the deployable cutting mechanism (104), e.g., the cutting portion, is extendable from the aperture (102). The remaining portion of the deployable cutting mechanism (104) may optionally extend through at least a portion of the needle from the aperture (102), e.g., extend toward the proximal end of the needle. In some preferred embodiments, the proximal and distal ends of the cutting mechanism are secured and supported to stabilize the cutting element against improper movement. The present invention is not limited to this configuration. In some embodiments, when the sheath (105) is moved to the open position, the deployable cutting mechanism (104) extends (e.g., pops out from, is forced out from, etc.) from the aperture (102) into the surrounding tissue. Preferably, the inner diameter of the sheath may be sufficiently large to fit around the needle and allow for movement of the sheath about the needle, while also being sufficiently fitted to secure the cutting mechanism in a non-expanded configuration when the sheath is in the closed position. The length of the sheath may be shorter than the length of the needle to allow for movement of sheath between the closed and open position to expose the cutting mechanism.
In some embodiments, the deployable cutting mechanism (104) may be any appropriate component for surgical cutting (and optionally cauterizing) tissue to allow for tissue harvesting. In some embodiments, the deployable cutting mechanism (104) may comprise one or more wires or filaments. In other embodiments, the deployable cutting mechanism (104) may comprise one or more strips, e.g., a flat wire or flat shaft with side edges, e.g., one side edge is sharp for cutting, one side edge is a coagulating edge, etc. In some embodiments, a portion of the deployable cutting mechanism (104) functions as an insulator to help protect the tissue being harvested from the cauterization or burning. For example, one side edge of the deployable cutting mechanism (104) may be for cauterizing and the other side edge may be for cutting. In some embodiments, the deployable cutting mechanism (104) has features to allow for controlled deployment, e.g., notches, etc.
In some embodiments, the cutting mechanism (104) may not necessarily be a component that deploys or pops out of the aperture (120). For example, in some embodiments, the cutting mechanism (104) may comprise nitinol wire (memory wire) or a component that may make suction less necessary (e.g., like a scoop). In other embodiments, the cutting mechanism (104) may be dome-shaped. In some embodiments, the cutting mechanism (104) may be activated upon receiving a signal (e.g., an electrical stimulus, etc.), whereupon receiving the signal, the cutting mechanism (104) deploys, assuming a desired (e.g., pre-configured) conformation (e.g., deploys from the needle). In some embodiments, the deployable cutting mechanism (104) may be operatively connected to an electrocautery system that can activate the deployable cutting mechanism (104) (when desired) for cauterization.
The biopsy system (100) of the present invention is adapted to be rotated and to cut/cauterize tissue, harvesting the tissue in a spiral or corkscrew configuration. Suction may be applied to help withdraw tissue. Non-limiting examples of mechanisms for generating a suction or vacuum include a DC motor vacuum pump, a syringe created vacuum, or an external pump and tether. The distal end of the needle is inserted into the tissue needing a biopsy sample. The sheath (103) is withdrawn and the cutting mechanism (104) (e.g., a cauterizing wire in one embodiment) is exposed (e.g., springs out, extends out, is pushed or forced out, etc.) from the aperture (102). Suction is applied. With suction and cauterization underway, the needle (101) is retracted or advanced while being rotated, resulting in a spiral column or coil of tissue entering into the aperture (102) and lumen (106) of the needle.
Without wishing to limit the invention to a particular theory or mechanism, the system (100) can allow for harvesting larger amounts of tissue as compared to core biopsy needles. In some preferred embodiments, the volume of tissue may be calculated using the following equation: V=πr2*2πR*n, wherein r=radius of tissue, R=radius of coil (or expandable wire sweep radius), and n=number of coils or turns. In contrast, current biopsy devices can at maximum harvest volumes according to the equation V=πr2*h.
Again, without wishing to limit the present invention to any theory or mechanism, it is believed that the present invention is advantageous as more tissue can be harvested in a single pass, and more tissue may help provide more confident primary diagnoses, specialized testing for tailored therapy, and may allow for portions of specimen to be allocated toward research purposes for improved understanding of basic biology. Additionally, by having fewer passes through the tissue (and thus less bleeding risk but better yield), there may be less hesitation to order biopsies, and the increased frequency of tissue sampling may improve monitoring of treatment response so that patients aren't uselessly exposed to (possibly dangerous) therapies while enhancing our understanding of clinical biology. Lastly, the capabilities of the device may be enough to remove certain (small) lesions, resulting in both a diagnostic and therapeutic minimally-invasive procedure, especially in resource-limited areas where excisional biopsies with safe anesthesia and surgical facilities are limited.
As previously discussed, the present invention may feature more than one lumen (106). In some embodiments, the system comprises a lumen (106) for holding a solution (e.g., saline, medication, etc.). As a non-limiting example, in some embodiments, the solution may comprise a pro-coagulant slurry that may be used in combination with or in lieu of cauterization. In some embodiments, a lumen (106) is disposed in the needle and is fluidly connected to another part of the system, e.g., the aperture (102) and/or deployable cutting mechanism (104) and/or distal end of the needle, etc. In some embodiments, a lumen (106) is disposed outside of the needle but is fluidly connected to another part of the system, e.g., the aperture (102) and/or deployable cutting mechanism (104) and/or distal end of the needle, etc. The system (100) may further comprise mechanisms for moving the solution in the lumen to an area of interest. For example, a solution from the lumen may be injected into the biopsy site or other appropriate location (e.g. needle tract). In other embodiments, the lumen (106) can also be used for the insertion or withdrawal of a guide wire and/or the insertion of a radio-opaque marker.
In some embodiments, ultrasonic vibrations or other appropriate mechanisms may be used to help determine location of the system within the tissue or help guide the system in the tissue. For example, the system may be activated in a way (e.g., buzzing) so that it can be better visualized using ultrasound. In other embodiments, the system may transmit a different type of signal that can allow for better visualization and/or positioning.
The system of the present invention may be used in combination with cauterization. In some embodiments, the system comprises a component that helps reduce the amount of harvested tissue that is burned from cauterization. For example, the system may insulate the cauterization/coagulative surface from the cutting edge. In some embodiments, the deployable cutting mechanism (104) is shaped such that it two sides, a first side and a second side. In other embodiments, the deployable cutting mechanism (104) may comprise a first side that is a cutting edge and a second side that has a cutting coagulating edge. The coagulating edge may be a portion of the second side, e.g., the coagulating edge may be designed to only contact tissue that is the patient's remaining tissue and not the harvested tissue.
The cutting tip as disclosed herein may be used to harvest tissue beyond the cross-sectional area of the hollow needle, overcoming a fundamental limitation in current clinically-used needles. Existing side notch needle biopsy devices harvest approximately half the inner diameter of the cutting needle. Vacuum-assisted biopsy technology used exclusively in breast biopsies improves the yield by suctioning more tissue into the side notch, but are still limited in the volume that can be harvested and limitation into breast (a non-vital organ) due to the large size of vacuum needle systems. Full-core needle biopsy devices are meant to address the limitation in tissue yield, but are still limited to the inner diameter of the needle cutting along the long axis of the needle.
The parent application US20190388073A1 detailed a means of overcoming this limitation by an expandable dome-shape, semispherical cutting structure to direct cut tissue into the hollow inner needle, and also demonstrated embodiments without an expandable cutting structure particularly when the inner needle has a vacuum or negative pressure source to draw tissue into the needle biopsy system. As learned through multiple engineering iterations after manufacturing failures requiring empirical testing due to the non-obvious nature, we wish to further detail claims of the mechanical and functional aspects of the cutting mechanism, particularly of embodiments using a fixed cutting surface; and of the tissue collecting chamber and negative pressure system.
As taught in the parent application US20190388073A1 and demonstrated in that
In some embodiments, insulation of the harvested tissue from cauterization/coagulation may be achieved using vibration and a micro-serrated edge to cut. For example, a back-and-forth sawing motion cuts the tissue. The cauterization surface (161) on the top of the deployable cutting mechanism (104) cauterizes the top portion of the tissue, while the bottom portion of the issue is insulated. The cauterization surface (161) may be derived from a conducting wire extending through the deployable cutting mechanism. In some embodiments, the deployable cutting mechanism (104) comprises an insulating component (162) (e.g., insulating encasement). The cauterized or singed surface in the patient heals, and the clean-cut sample is suctioned or directed through the lumen in the needle.
In some embodiments, the system of the present invention is used with pulsed electrical currents that have been shown to burn only about a single cell-layer deep (see Plast Reconstr Surg. 2009 December;124 (6): 1849-59. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Loh S A, Carlson G A, Chang El, Huang E, Palanker D, Gurtner G C.). For example, the system may incorporate a device such as a Pulsed Electron Avalanche Knife (PEAK) PlasmaBlade or similar technology, which uses high frequency electrical pulses, to help cut without burning the tissue.
According to some other embodiments, the present invention also features methods for obtaining biopsies. The method may comprise inserting the system into the tissue of concern, exposing the (deployable) cutting mechanism, creating suction, and optionally preparing the needle for rotation (e.g., winding a spring to spin the rod). In one embodiment, these steps may be simultaneously performed in a single step, e.g., using a single motion or activation. In some embodiments, the method may further comprise activating cauterization, spinning the rod, and opening the suction/vacuum to start harvesting of the tissue. These steps may be simultaneously performed in a single step, e.g., using a single motion or activation. In some embodiments, the system can be loaded with two hands, or in some instances, just one hand is needed to activate the system. Alternatively, in some embodiments, the system utilizes a vacuum creation/winding motion to load, and the system utilizes a safety-type thumb trigger to deploy the needle, and finally the trigger to engage, which may only require one hand, and the other hand can be on an ultrasound probe. In some embodiments, the method is performed by the operator in three or four actions. In some embodiments, the method is performed by the operator in three or less actions. In other embodiments, the method is performed by the operator in more than four actions.
In some embodiments, the geometry and function of the deployable cutting mechanism may involve a filament with an insulating surface and a conductive surface ranging from 1 μm to 5 mm apart such that the tissue being cut would be spatially separated from the conductive surface delivering electocauterizing or electrosurgical current.
Additional features of the system include multi-lumen needle geometry and diameter, needle material, deployable cutting mechanism configuration, the deployable cutting mechanism material, the electrical current amplitude and frequency and potential inductance when coupled to a deployable cutting mechanism of to the needle, the resulting thermal/electrical injury or necrosis of the tissue sample after exposure to electrical current, the negative pressure of suction to aspirate tissue without inducing acute pressure-necrosis, the geometry of the deployable cutting mechanism and frequency of vibration/sound to enhance ultrasound localization, etc.
The present invention is not limited to the aforementioned configurations. For example, in some embodiments, the system features a needle that cauterizes as it leaves the biopsied tissue to help decrease bleeding. In some embodiments, the system features a deployable cauterization ring. In some embodiments, the system features a tip of the needle that pops out or off, after which the needle can be spun and tissue may be suctioned. In some preferred embodiments, the tip of the needle that pops out or off remains in the tissue as a biopsy tissue marker. Tissue biopsy markers or small metal clips may be placed within the tissue at the time of biopsy to help identify the location of the target tissue, e.g. lesion, in the future. Without wishing to limit the invention to a particular theory or mechanism, by having a needle tip that is removable, this may decrease procedural time and overall expenses.
In other embodiments, the system of the present invention may be constructed from a variety of materials. For example, in some embodiments, the needle and/or deployable cutting mechanism may be constructed from a material comprising metal and/or plastic and/or a ceramic material. The present invention is not limited to these materials.
Further details of the biopsy needle system of the present are presented in the following sections. It is to be understood that the system is not limited to the configurations that will be described herein. Equivalents or substitutes are within the scope of the invention.
Referring now to
As shown in
Referring to
Referring to
As shown in
Referring to
In one embodiment,
In some embodiments, A “vacuum collection chamber” was taught in the parent application US20190388073A1 and demonstrated in
In some embodiments,
In some embodiments, as shown in
Referring to
While the sheath provides for a method to inject clotting material, in other embodiments, electrocautery or electrosurgery may be employed to cause electrocoagulation during the biopsy procedure as a different means of stopping bleeding. In one embodiment,
Referring to
Referring to
An alternative mechanism to retract the sheath in shown in
With electrification of the needle, additional uses of electricity beyond the control of bleeding are enabled. According to some embodiments, instead of having a single electrode, the needle system may further comprise multiple electrodes incorporated into an outer aspect, such as the sheath/cannula, of a percutaneous needle device or on the percutaneous needle itself. The geometry of these electrodes determine the spatial information provided for guidance of needle-based, percutaneous procedures. In a non-limiting embodiment, the needle system of the present invention makes use of both the spatial information provided by the needle and also the relative low bioimpedance of electrolyte-rich blood as a means to direct current flow and resultant electrical coagulation in case of a bleeding complication.
Referring now to
While bio-impedance may be implemented with a biopsy needle, this feature is not limited to biopsy needles and procedures. For instance, in other embodiments, bio-impedance may be used with needles in an ablation procedure. As known to one of ordinary skill in the art, ablation is a procedure involving the application of energy to destroy tissue. Thus, without deviating from the scope of the present invention, bio-impedance may be used with any needle or procedure in which guidance of the needle and knowledge of the needle's position is desired.
Accordingly, in some embodiments, the present invention provides a method of guiding insertion of a needle (101) into a subject. The subject may be a human or other mammal such as a dog, cat, horse, etc. For example, the subject may be a in a medical or veterinary patient. In one embodiment, the method may comprise providing a bio-impedance guided needle system (100) as described herein, obtaining multiple bio-impedance measurements from the plurality of electrodes (164), and determining directional information and/or position of the needle based on the multiple bio-impedance measurements. For example, the directional information and/or position of the needle can be determined by isolating or summing the various electrodes relative to other electrodes.
In one embodiment, the plurality of electrodes (164) comprises about 3-128 electrodes that are electrically capable yet isolatable from the other electrodes. In conjunction with the other embodiments, the needle (101) may also function as an additional electrode. In further embodiments, an insulating material may be partially covering the electrodes, a portion of the needle, or both. In some embodiments, the plurality of electrodes (164) comprises conductive strips, ribbons, or wires disposed axially along the surface of the outer sheath, the needle surface, or embedded and fixed within the needle. In other embodiments, the plurality of electrodes (164) comprises multiple concentric telescoping tubes each with an electrically-active exposed tip.
In other preferred embodiments, the present invention may be used to provide real-time bioimpedance feedback on where the needle is in contact with blood and where to deliver electrocautery to address bleeding. As shown in
In some embodiments, a plurality of electrodes may be disposed axially on the surface of the outer sheath or needle. In alternative embodiments, as shown in
As has been described, the electrodes can be placed on an outer sheath of the needle, on the needle's surface, or embedded within the needle. With any of these configurations, the directional information of the needle can be obtained by isolating or summing the various electrodes relative to other electrodes.
Although multiple electrodes can be placed within the needle or on the surface of the needle or sheath, the overall diameter remains small, thereby reducing pain when the needle is inserted into a patient. For instance, the diameter at the thickest point may be less than 5 mm or about 7 gauge or higher. In some preferred embodiments, the diameter is less than 1.6 mm or about 16 gauge or higher. In other preferred embodiments, the diameter is less than 1 mm or about 20 gauge or higher.
The following is a non-limiting list of embodiments:
1. A biopsy system for harvesting tissue, said system comprising:
2. The system of embodiment 1, wherein the expanding cutting portion protrudes from the inner needle (301) at an angle of at least about 10° to about 90° or less, or (about 10° to about) 90° parallel to, or relative to, the long axis of the inner needle, or about 30° to about 60°.
3. The system of embodiment 1, the flexible expanding cutting portion protruding out from the inner needle (301) at least 1% to no more than 110% of the diameter of the inner needle (301), or protruding out about 20% to about 70% of the diameter of the inner needle (301), or about 30% to about 45% (with the absolute distance the flexible expanding cutting portion protrudes above the inner needle being dependent on the gauge of the needle system)
4. The system of embodiment 1, wherein the expanding cutting portion has a sharpened or curved surface perpendicular to the long axis of the needle;
5. A method of harvesting tissue, said method comprising
6. A biopsy system for harvesting tissue, said system comprising:
7. The system of embodiment 6, wherein the cutting edge (360) is positioned below the surface of the inner needle, recessed no more than about ¼th the inner diameter of the inner needle (304).
8. The system of embodiment 6, wherein the cutting edge (360) is positioned at about the surface of the inner needle (304).
9. The system of embodiment 6, wherein the cutting edge (360) is raised above, or beyond, the surface of the inner needle by no more than about the equivalent of half the inner diameter of the inner needle (304).
10. The system of embodiment 6, wherein the aperture (302) and the cutting element (304) are as narrow as about 50% the width of the inner diameter of the inner needle (301), or up to about 3.5 cm wide along the long axis of the inner needle (304), or about 2.5 cm wide along the long axis of the inner needle (304), or about 1.5 cm wide along the long axis of the inner needle (304), or about 0.5 cm wide along the long axis of the inner needle (304).
12. A method of harvesting tissue, said method comprising
13. The system of embodiment 1 or 2, wherein said system further comprises a sample collection system (e.g, system 200 in
14. The system of embodiment 13, wherein said collection system functionally separates the cut solid tissue sample component from harvested fluid tissue component.
15. The system of embodiment 14, wherein said collection system comprises an inner portion removable as a collection chamber capsule (e.g., 207), a solid tissue sample collection chamber and capsule thereof (e.g., 206) accessible via Luer connection (e.g., 204), and/or a fluid collection chamber (e.g., 210) being accessible via Luer connection.
16. The system of embodiment 15, wherein the fluid collection chamber (210), the solid tissue sample collection chamber (206) and/or a window thereunto (205) is at least 10% translucent to visible light.
17. The system of embodiment 14, wherein the sample collection system comprises a removable or fixed housing (200).
18. The system of embodiment 17, wherein at least an about 0.1 cm to about 1 cm by about 0.1 to about 1 cm window of the housing is translucent.
19. The system of embodiment 17, wherein at least 2 sides of the housing being translucent.
20. The system of embodiment 17, wherein from 45° to 360° but preferably 180° of the housing is translucent.
21. The system of embodiment 13, wherein said sample collection system comprises one or more components that allows the system to provide low-energy electrocoagulation along a needle tract.
22. The system of embodiment 22, wherein said components is chosen from a switch (e.g., battery switch), to enable cauterization/coagulation and/or suction (e.g., from an electric pump, manual pump, syringe, etc.), a voltage or electromotive source (e.g. battery(ies) and a vacuum tube.
23. The system of embodiment 22, wherein said components are arranged such that the electric pump is connected to the vacuum tube (203) which is connected to the solid tissue collection chamber (206) and removable collection capsule (207), and wherein the pump is in connection to the fluid collection chamber (210) and Luer lock to fluid collection chamber (204), with semi-permeable vent (209).
24. The system of embodiment 22, wherein the voltage or electromotive source is within a range of voltages from about 1.0V to about 30V,
25. The system of embodiment 24, wherein the voltage or electromotive source has amperages at about 0.01 mA to about 250 mA,
26. The system of embodiment 22, wherein the voltage or electromotive source provides applied voltages from about 0.01 cm to 15 cm span along the long axis of the needle (301) tract the needle created within the tissue for a bipolar configuration. As used herein, the term “bipolar configuration” refers to having both the positive and negative electrode within close approximation on the same device, unlike monopolar electrical systems that deliver electricity through one part of the device but require a completely separate grounding pad to complete the circuit.
27. The system of embodiment 22, wherein the voltage or electromotive source provides applied voltages over anywhere from about 0.01 cm to 15 cm (or about 0.05 cm to 5 cm or about 0.2 cm to 2 cm) span along a needle tract for a bipolar configuration.
28. The system of embodiment 22, wherein the voltage or electromotive source provides an electrical flow at low (about 60 Hz or less alternating current) to no frequency (direct current) over the order of seconds as the needle is removed from a subject.
29. The system of embodiment 22, wherein the voltage or electromotive source provides a monopolar configuration (e.g. the needle serving as one electrode, with external grounding pad as a second or return electrode) with voltages of about 3V to about 60V with low to no frequency effectively operating over the order of seconds as the needle is removed from a subject.
30. A method of harvesting tissue, said method comprising
The following are non-limiting examples of utilizing the systems of the present invention in a biopsy procedure. It is to be understood that the invention is not limited to the examples that will be described herein. Equivalents or substitutes are within the scope of the invention.
A non-limiting example of the biopsy needle device prototype of the present invention, herein referred to as the Triopsy needle, is shown in the top image of
The biopsy needle includes a sheath through which biopsy device and other accessories can be inserted. Accessories include electrocautery device, radioopaque marker insertion device, tissue sealant injector, device to inject filler material, etc.
1. Prepare device: use syringe to apply suction; turn stopcock to preserve vacuum.
2. Use ultrasound guidance to advance needle/outer sheath into patient and position at distal end of tumor.
3. Use mechanics to retract outer sheath to expose expandable curved cutting blade and needle lumen.
4. Use stopcock to apply vacuum to needle lumen.
5. Rotate device to collect tissue biopsy (manual, motor driven, spring driven).
6. Stop rotation and reposition outer sheath.
7. Collect biopsy using vacuum and store in collection chamber
8. Use stopcock to close vacuum
9. Disengage outer sheath (luer adapter) from biopsy needle unit, if desired
10. Remove needle unit; sheath (optionally) remains in place
1. Apply electrode pad to patient body and connect to electrocautery unit.
2. Connect electrocautery unit to biopsy device.
3. Insert electrocautery device into sheath and engage using luer adapter.
4. Advance electrocautery device tip into biopsy site.
5. Push activation button and hold to use electrocautery.
6. Rotate needle (mechanical, motor, or spring) while pulling the device towards the operator (or towards the entry site or through the tumor).
7. Release activation button to inactivate electrocautery.
8. Disengage sheath from electrocautery unit.
9. Remove electrocautery unit.
10. Remove sheath.
1. Apply grounding pad to patient and attach to electrocautery unit. Attach electrocautery unit to biopsy device.
2. Insert needle and sheath into patient under external imaging (e.g. ultrasound) visualization.
3. Position within the tumor, preferably distally for pullback biopsy.
4. Press start button to activate device. Solid green ready light appears.
5. Press start button to begin biopsy process. Green light begins to blink.
6. Outer sheath retracts.
7. Vacuum starts.
8. Electrosurgery signal directed to cutting blade.
9. Needle begins to rotate for n rotations (n=1-20).
10. Electrosurgery inactivated.
11. Outer sheath extends distally.
12. Vacuum continues to collect tissue.
13. Vacuum turns off.
14. Solid green light reappears-ready light.
15. Reposition biopsy device to starting position.
16. Depress and hold button to activate electrocautery.
17. Inactivate biopsy parts.
18. Withdraw outer sheath to expose electrocautery.
19. Blinking red light is activated, green light off.
20. Physician moves needle/sheath outward to cauterize biopsy tract.
21. Release button to stop electrocautery unit.
22. Blinking red light is inactivated.
23. Outer sheath advanced distally.
24. Electrocautery unit shuts down.
The disclosures of the following U.S. Patents are incorporated in their entirety by reference herein: U.S. Pat. Application No. 2002/0026188.
Various modifications of the invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. Each reference cited in the present application is incorporated herein by reference in its entirety.
Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. Reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawing. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting of”, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting of” is met.
This application is a continuation-in-part application and claims benefit of Ser. No. 16/559,402, a continuation-in-part application, filed Sep. 3, 2019, which claims the benefit of PCT/US2018/020851, filed Mar. 5, 2018, which claims benefit of U.S. Patent Application No. 62/466,549 filed Mar. 3, 2017, the contents of which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62466549 | Mar 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16559402 | Sep 2019 | US |
| Child | 18186146 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US18/20851 | Mar 2018 | WO |
| Child | 16559402 | US |
