US20190076164A1 - Minimally invasive methods and apparatus for target-tissue excision - Google Patents

Abstract

Methods and apparatus are provided to facilitate the minimally invasive removal of tissue and to facilitate the direct approach to anesthetizing a body wall of a patient. A pull-type cutting device also is disclosed to introduce an opening into the body wall to provide access for intra-chest surgical interventions, for example a minimally invasive biopsy technique as also described for excising target tissue from within a patient, including a nodule from within the patient's lung.

Description

RELATED APPLICATION
• This application claims the benefit of U.S. Provisional application Nos. 62/453,672 filed on Feb. 2, 2017 and 62/463,312 filed on Feb. 24, 2017, both of which are in their entirety incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention is related to surgical tools and methods.
BACKGROUND
• According to the American Lung Association, each year over 344,000 Americans die of lung disease, making it the third most frequent cause of death in this country. An even more staggering statistic is that an additional 35 million Americans are living with chronic, debilitating lung diseases. Not uncommonly, patients with lung disease or at risk for lung disease undergo various forms of thoracic imaging. This has led to an unprecedented number of patients presenting to lung specialists with nodular abnormalities suspicious for cancer or interstitial abnormalities suspicious for various forms of Interstitial Lung Disease (ILD). When a patient is found with these abnormalities, it is often necessary to biopsy the tissue to establish the diagnosis, the prognosis, and guide further therapy.
• One of the factors that contribute to lung disease is smoking. According to the Center for Disease Control, there are 94 million past and current smokers in the US. Half are over the age of 45 (the age at which lung cancer incidences increase). Many smokers are concerned about the risk of developing lung cancer, which explains the growing success of CT based lung cancer screening programs. The problem with these programs is that about 30% of the screened patients will have suspicious nodules suggestive of cancer, but only a small percentage are ultimately proven to be cancer. While there is considerable evidence to suggest that CT based lung cancer early detection programs are beneficial in detecting early stage lung cancer, the area of biggest clinical unmet need is in the ability to differentiate between a benign and malignant nodule. The currently available lung biopsy techniques, such as CT guided biopsy, bronchoscopy, thoracoscopy or thoracotomy are either too insensitive or too invasive, limiting their usefulness and making the determination difficult at best. Thus one of the most significantly limiting factors that has prevented success of lung cancer screening programs has been a lack of safe and effective ways to sample lung tissue in a minimally invasive fashion.
• A similar dilemma exists for the diagnosis of interstitial lung disease. In a number of cases where there is a suspicious imaging pattern suggestive of ILD or cancer, it is desirable to sample the tissue so that a pathologist can establish the exact cause of the abnormality. The problem is that the current lung biopsy techniques are invasive, painful and many require general anesthesia, which is not always well tolerated in patients with impaired lung function. Many patients are judged “not a surgical candidate,” due to the patient's degree of medical disability and lung dysfunction. Both thoracotomy (a large incision through the chest muscles and between the ribs) and thoracoscopy (the use of a scope and other working ports through the ribs to operate in the space around the lung) can be very disabling and painful. In fact, these forms of surgery are generally much more painful and disabling than other forms of surgery, such as heart surgery and abdominal surgery due to the manipulation of the chest wall muscles, ribs and intercostal nerves between the ribs. Currently, thoracotomy and thoracoscopy often require long hospital stays and even longer recovery times. Both procedures can lead to chronic pain syndromes in a surprisingly high percentage of patients.
• When a determination is made to biopsy alung nodule510, there are several options, as illustrated inFIG. 1. One option is to use a bronchoscopic approach. This, however, is most useful for larger, more central tumors. Generally, a central approach is not a useful option for the more common small nodules sincemost lung nodules510 are in theperiphery501 of thelung502 and not connected to theairway503. Another option is to use a CT guidedneedle biopsy522 of thelung502. While this approach can be useful in larger, more peripheral tumors, it is not particularly helpful forsmaller nodules510 that are deeper in thelung502. Furthermore, only a small core sampling of the tissue can be taken, and thus false negative biopsies are common. Additionally, since there is no mechanism to seal thelung502, bleeding complications and pneumothorax are frequent concerns, occurring in nearly 20% of patients.
• Thoracic surgical approaches to biopsy lung nodules can be divided into two categories: thoracotomy and thoracoscopy. Athoracotomy530 is a 300 to 450 mm (12 to 18 inches)incision532 on thechest wall skin304, followed by division or dissection of the major back muscles to move them out of the way, partial removal of therib42, and the placement of arib spreader534 to provide intra thoracic access to the operating surgeon. The advantage of a thoracotomy is that the surgeon has excellent access to the intrathoracic structures, and can see and manually feel thelung502 and other structures directly. This is especially important when targeting atiny lung nodule510. The major disadvantage is the degree of pain and the potential for complications related to the magnitude of the incision. A thoracotomy is well known to be a very painful operation for the patient, with significant acute and chronic pain issues. Because of the degree of invasiveness, it is reserved only for the most optimal surgical candidates as many patients with significant lung disease cannot tolerate a thoracotomy and recover without significant morbidity and mortality. For these reasons it is recognized that there is a need in the art to lessen the invasiveness of thoracic surgery.
• One approach that has been around for many years is to utilize anendoscope542 to facilitate visualization within in the chest, thereby precluding the need for a large thoracotomy incision.Thoracoscopy540 is the use of a specialized viewing instrument, usually arigid endoscope542, introduced through a thoracostomy, or a small hole placed in between theribs42. Once theendoscope542 is placed in the space that surrounds thelung502, known as the pleural space, usually two to three additional thoracostomy holes are made to introduceadditional instruments544.Additional instruments544 include grasping instruments, cutting instruments, and in the case of a thoracoscopic lung biopsy, a cutting stapler, such as the Ethicon Endosurgery Endo GIA 45 mm stapler. Using theendoscope542 and theother instruments544, a “triangulation” technique is utilized where, for example, theendoscope542 is used to view as the grasping instrument is brought in from one direction, and the stapler is brought in from another, and tissue is cut with the stapler and removed through one of the ports.
• One of the major disadvantages of this approach is the number and size of ports needed to triangulate in order to carry out the biopsy. While this approach is commonplace in most laparoscopic operations carried out in the abdomen, such as the laparoscopic cholecycstecomy, there are unique features of an endothoracic operation that make this approach undesirable. First, it is almost always necessary to utilize a general anesthetic to perform a thoracoscopic lung biopsy. In addition, it is nearly always necessary to utilize a specially placed, and more complicated dual lumen endrotracheal tube so that artificial ventilation can be delivered to the opposite lung, and excluded to the side of the lung that is being biopsied. This technique, known as single lung ventilation, is needed for nearly all current thoracoscopic operations. Many patients with end stage lung disease, however, are unable to tolerate a general anesthetic, and of those that tolerate a general anesthetic, many cannot tolerate single lung ventilation because their respiratory reserve is so limited. Additionally, the intercostal spaces are particularly sensitive to pressure, as there is a fixed and limited space between the ribs, and the intercostal nerve runs underneath each rib in the intercostal space. Each time a thoracostomy is performed, pain can be severe and prolonged. This is especially the case with larger thoracostomy port sizes, such as 10 mm and 12 mm ports that are commonly used for contemporary thoracoscopy. Some studies have estimated that as many as one third of patients have chronic pain in their chest wall up to one year after thoracoscopy, and it is believed this is due to intercostal nerve irritation that occurs when multiple, large ports are introduced into the pleural space between the ribs. Single port procedures have been reported in the literature for very limited procedures, but they generally require very large incisions, 30 mm or more, to get multiple instruments through a single port.
• Because of the drawbacks of bronchoscopy, open lung biopsy, and thoracoscopy, a large percentage of patients are simply not referred for lung biopsy because the referring physician is uncomfortable with the degree of invasiveness coupled with the accuracy of the available techniques. Given the advancements in imaging and the improved appreciation of the value of tissue diagnosis in lung disease, new techniques are needed to biopsy the lung in a precise, minimally invasive manner.
BRIEF DESCRIPTION OF THE DRAWINGS
• Like reference numbers generally indicate corresponding elements in the figures.
• FIG. 1 is an illustration showing various prior art methods to biopsy a lung nodule;
• FIGS. 2A and 2B are side cross-sectional views of a pull-type cutting device in an expanded and deflated configuration, respectively, in accordance with an embodiment of the present invention;
• FIGS. 3A-3E are cross-sectional views showing an embodiment of a method of the present invention, wherein a body space, such as, but not limited to, a pleural space, is accessed and provided with a microport;
• FIG. 4 is a side view of an anesthesia delivery catheter comprising a shaft having a shaft distal end and a shaft proximal end, a guide wire lumen extending there through, and a fluid lumen extending there through, in accordance with an embodiment of the present invention;
• FIG. 5 is a side view of an anesthesia delivery catheter wherein the treatment head comprises delivery elements in the form of micro-needles, in accordance with another embodiment of the present invention;
• FIG. 6 is a side view of the wherein the anesthesia delivery catheter is engaged such that the delivery elements are delivering fluid to the tissue of the intercostal space, in accordance with another embodiment of the present invention;
• FIGS. 7A-7C are cross-sectional views showing an embodiment of a method of the present invention, wherein a body space, such as, but not limited to, a pleural space, is accessed and the intercostal space is provided with a local anesthesia, in accordance with another embodiment of the present invention;
• FIGS. 8A and 8B are side views of an anesthesia delivery catheter, in a pre-deployed and deployed state, respectively, comprising a shaft having a shaft distal end and a shaft proximal end, in accordance with an embodiment of the present invention;
• FIG. 8C is a side view of an anesthesia delivery catheter, in accordance with an embodiment of the present invention;
• FIGS. 9A and 9B are side cross-sectional views of a delivery element, in accordance with embodiments of the present invention;
• FIG. 10 is a side cross-sectional view of a delivery element, in accordance with an embodiment of the present invention;
• FIG. 11 is a side cross-sectional view of a delivery element, in accordance with an embodiment of the present invention;
• FIGS. 12A-C are side cross-sectional views of a biopsy tool for gathering a biopsy sample, such as lung tissue, in accordance with an embodiment of the present invention;
• FIGS. 13A-C illustrates a method for obtaining a biopsy of lung tissue using the biopsy tool, in accordance with the present invention;
• FIGS. 14A and 14B are side cross-sectional views of a biopsy tool comprising a hollow needle and a deployable and retractable snare in a retracted and deployed state, respectively, in accordance with an embodiment of the present invention;
• FIGS. 15A-F illustrate a method for obtaining a biopsy of lung tissue using the biopsy tool of the embodiment ofFIGS. 14A and 14B, in accordance with an embodiment of the present invention;
• FIGS. 16A and 16B are side cross-sectional and front views of a needle, respectively, suitable for advancing along the snare shaft and cutting a tract in the tissue, in accordance with an embodiment of the present invention;
• FIGS. 17A-E illustrate a method for obtaining a biopsy of lung tissue using a biopsy tool in combination with a pull-type cutting device, in accordance with an embodiment of the present invention;
• FIGS. 17F-17G illustrate a method for obtaining a biopsy of lung tissue using the biopsy tool in combination with a pull-type cutting device, in accordance with an embodiment of the present invention;
• FIGS. 18A and 18B are side cross-sectional and end views, respectively, of a pull-type cutting device in a deployed or expanded configuration, in accordance with an embodiment of the present invention;
• FIGS. 18C and 18D are side cross-sectional views of a pull-type cutting device in a deployed or expanded configuration and a snare, in accordance with an embodiment of the present invention;
• FIG. 19 is a side cross-sectional view of a tract in body tissue made in accordance with an embodiment of the present invention;
• FIG. 20 is a cross-sectional view of a body space tube that has been advanced over a guide wire left in the tract after the target tissue has been extracted, in accordance with an embodiment of the present invention;
• FIGS. 21A and 21B are side cross-sectional views of sealing devices, in accordance with embodiments of the present invention;
• FIGS. 22A-F illustrate a method for obtaining a biopsy of target tissue that is adjacent a body lumen using embodiments of biopsy tools provided above, and a method for sealing the body lumen after the target tissue, or a portion thereof, is excised, in accordance with an embodiment of the present invention;
• FIGS. 23A and 23B are side cross-sectional views of a sealing device adapted for sealing apertures in body lumens, in a pre-finished and finished configuration, respectively, in accordance with an embodiment of the present invention;
• FIG. 24 illustrates a working port in communication with a vacuum source, in accordance with an embodiment of the present invention; and
• FIGS. 25-40 are cross-sectional views illustrating a method for obtaining an excision of lung tissue from a patient, in accordance with the present invention.
DETAILED DESCRIPTION
• Reference will now be made to embodiments illustrated in the drawings and specific language which will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated devices, as such further applications of the principles of the invention as illustrated therein as being contemplated as would normally occur to one skilled in the art to which the invention relates.
• Methods and apparatus are provided to facilitate the minimally invasive removal of tissue biopsies, in accordance with embodiments of the present invention.
• Methods and apparatus are provided to facilitate the direct approach to anesthetizing the chest wall, in accordance with embodiments of the present invention.
• Methods and apparatus are provided to create a microport channel to introduce instruments through a channel in the chest wall.
• Methods, devices and apparatus to secure and excise lung tissue, in accordance with embodiments of the present invention.
• Methods, devices, and apparatus to dilate an access tract within the lung tissue accordance with embodiments of the present invention.
• Methods, devices, and apparatus to utilize suction/vacuum to suck down the dilated tract within the lung tissue to minimize bleeding and air leak during the procedure accordance with embodiments of the present invention.
• Methods, devices, and apparatus to utilize suction/vacuum to suck or draw down the dilated tissue tract within the lung tissue to minimize bleeding and air leak during the procedure accordance with embodiments of the present invention.
• Methods, devices, and apparatus to utilize cut out and excise the target tissue Methods and apparatus are provided to determine if an air leak is present from a lung biopsy, in accordance with embodiments of the present invention.
• Methods and apparatus are provided to drain and seal a lung tract, in accordance with embodiments of the present invention.
• Methods and apparatus are provided to seal or plug a body space defect or defect in an internal lumen of the bronchus or gut, in accordance with embodiments of the present invention.
• One of the challenges in performing a minimally invasive lung biopsy is how to create a small hole or port in the chest wall. In traditional thoracoscopy, when it is desired to place a thoracostomy port across the chest wall into the pleural space, or when placing a chest tube to drain fluid from the pleural space surrounding the lung, it is commonly taught that a big enough incision be made to allow the operator to finger dissect through the intercostal space, the space between adjacent ribs, into the pleural space so that any lung that is adhered to the chest wall can be dissected free prior to placing the chest tube. This will not suffice when one wishes to place 3 to 5 mm ports, as a finger dissection usually requires at least a 12 to 15 mm port. Thus, in order to make a small sized port that is far smaller than the operator's finger, currently the operator must make an incision, dissect down with a sharp instrument, and blindly push through the chest wall without feeling the underlying tissue or structures. This adds considerable risk to the procedure, as it potentially endangers the underlying critical structures such as the lung itself, the large blood vessels in the chest, the diaphragm and liver, and the heart. Thus it is commonly taught that one should never advance an instrument into the chest without manually feeling and dissecting the underlying structures to make sure they are not in proximity to the incoming sharp instrument.
• Apparatus and methods are provided to create measured microports of predetermined size through body tissue, in accordance with embodiments of the present invention. The apparatus provides access to a body space through one or more small incisions, for example, but not limited to, less than 10 mm (0.4 inch), without endangering underlying structures in the space. The apparatus provides tissue cutting directed away from the critical internal structures, and towards the operator. The apparatus creates a cutting action when pulled on, and therefore, can be referred to as a pull-type cutting device.
• FIGS. 2A and 2B are side cross-sectional views of a pull-type cutting device1 in a deployed or expanded configuration and in an undeployed, deflated configuration, respectively, in accordance with an embodiment of the present invention. The pull-type cutting device1 comprises anelongated shaft20 having a shaftdistal end22 and a shaftproximal end21 and ashaft lumen23 extending there through. The pull-type cutting device1 comprises two coaxially nested tubes, each extending from theproximal end21 to thedistal end22; afirst tube61 and asecond tube63. Thefirst tube61 defines aguide wire lumen23 extending there through adapted to slidingly receive a guide wire therein. Thesecond tube63 extends over the first tube60 and coupled thereto at the shaftdistal end22. Thesecond tube63 defines anexpandable portion13 adjacent the shaftdistal end22. Thesecond tube63 defines aninflation lumen25 extending from the shaftproximal end21 to theexpandable portion13. Theinflation lumen25 is adapted to communicate inflation fluid from the shaftproximal end21 to theexpandable portion13 so as to inflate and deploy theexpandable portion13 to a diameter larger than that of the deflated or pre-deployed position. Disposed adjacent the shaftdistal end22 is a cuttinghead10. The cuttinghead10 comprises theexpandable portion13 having a cuttingportion11 distal from the shaftdistal end22.
• In an embodiment, the pull-type cutting device1 comprises an over-the-wire balloon catheter, wherein theexpandable portion13 is a balloon, and theshaft lumen23 is adapted to pass over a guide wire. Over-the-wire balloon catheters are known in the cardiovascular art. The cuttingportion11 is adapted to be pulled into contact with the inner wall of a body space. Extending from the cuttingportion11 are a plurality of cuttingelements12. Examples of cuttingelements12 include, but are not limited to, blades, radiofrequency, laser, and electrocautery cutting elements, that are adapted to create an incision when pulled against tissue. Since the pulling and cutting action is towards the operator, this results in an improved safety profile as it lessens the risk that an internal organ or other structure can be damaged as the body space opening is created.
• In an embodiment, thedevice1 is referred to as a microthoratome, adapted to make measured microports through the chest wall and adjacent or into the thoracic cavity, in accordance with embodiments of the present invention.
• Other embodiments are anticipated that are directed to procedures outside of the thoracic cavity, such as, but not limited to, for accessing the peritoneal space for laparoscopy, abscess cavities, the GU tract, the air way for a tracheostomy, and blood vessels.
• FIGS. 3A-3E are cross-sectional views showing an embodiment of a method of the present invention, wherein abody space47, such as, but not limited to, a pleural space, is accessed and provided with amicroport48. Utilizing the known over-the-wire Seldinger technique, aneedle30 is advanced from the chest wallouter surface41 between tworibs42 and into the body space47 a predetermined distance and position. Aguide wire32 is passed through theneedle30 and into the body space47 (such as the pleural space). Theneedle30 is advanced and removed from theguide wire32. The deflated pull-type cutting device1 is advanced over theguide wire32 by passing thelumen23 over theguide wire32. The cuttinghead10 is placed beyond thetissue45 to be cut. The cuttinghead10 is deployed such that the cuttingportion11 is adjacent thetissue45 to be cut. The pull-type cutting device1 is pulled into contact with theinner surface45 of thebody space47 such that the cuttingelements12 are pulled into contact with theinner surface45 of thebody space47. The operator pulls the cuttinghead10 towards the chest wallouter surface41, whereby cutting amicroport48 through the tissue of theintercostal space44 towards the chest wallouter surface41 of thebody space47. In this fashion amicroport48 is created where the cutting direction is towards the chest wallouter surface41 of abody space47, rather than towards the chest wallinner surface45. This results in an improved safety profile as it lessens the risk that an internal organ or other structure can be damaged as the microport is created.
• One of the biggest areas of unmet need in thoracic surgery relates to pain control. Embodiments of the present invention are adapted to very precisely anesthetize the patient with local anesthesia prior to putting in the microports. Unlike traditional thoracotomy and thoracoscopy which is usually done on a patient under general anesthesia, embodiments of the present invention allow the formation of microports and subsequent procedures to be done on awake patients to minimize risks and facilitate a speedier recovery.
• Apparatus and methods are provided for safe and precise access to the intercostal space for the infiltration of fluids or substances for diagnostic or therapeutic purposes, such as an anesthetic agent, in accordance with embodiments of the present invention.
• FIG. 4 is a side view of ananesthesia delivery catheter2 comprising ashaft20 having a shaftdistal end22 and a shaftproximal end21, aguide wire lumen23 extending there through, and afluid lumen25 extending there through, in accordance with an embodiment of the present invention. Disposed adjacent the shaftdistal end22 is atreatment head50. Thetreatment head50 comprises anexpandable portion53 in the form of a balloon. Theexpandable portion53 includes atreatment portion51. Theexpandable portion53 is in fluid communication with thefluid lumen25 and is adapted to fill with a fluid that is introduced into afluid lumen25 at the shaftproximal end21. Thetreatment portion51 comprises a plurality ofdelivery elements52, such as, but not limited to, hollow tines and micro introducer needles, that are adapted to extend from thetreatment portion51 and to come into contact with thepleural surface45 of theintercostal space44 when theexpandable portion53 is deployed, as shown inFIG. 6.FIG. 6 is a side view of theanesthesia delivery catheter2 wherein theanesthesia delivery catheter2 is engaged such that thedelivery elements52 are delivering fluid to the tissue of theintercostal space44.
• Thedelivery elements52 comprise anaperture54 that is in fluid communication with thefluid lumen25. Theapertures54 are adapted to communicate a fluid from thefluid lumen25 directly into thetissue45 of theintercostal space44 from “the inside out”. Possible fluids for infusion into thetissue45 include, but are not limited to, short or long acting local anesthetic agents, steroids, and neurolytic ablative agents such as alcohol or phenol.
• Referring again to the embodiment ofFIG. 4, thedelivery elements52 are in the form of a hollow cone, in accordance with an embodiment of the present invention.FIG. 5 is a side view of ananesthesia delivery catheter3 wherein thetreatment head50 comprisesdelivery elements55 in the form of micro-needles, in accordance with another embodiment of the present invention.
• FIGS. 7A-7C are cross-sectional views showing an embodiment of a method of the present invention, wherein abody space47, such as, but not limited to, a pleural space, is accessed and theintercostal space44 is provided with a local anesthesia. In an embodiment of a method of the present invention, amicro-introducer needle30 is advanced between tworibs42 into thepleural space47. Aguide wire32 is advanced through theneedle30 to a predetermined location beyond theneedle30. Theneedle30 is removed from theguide wire32 leaving theguide wire32 in place. Theguide wire lumen23 of theanesthesia delivery catheter2 is advanced over theguide wire32 with thetreatment head50 advanced into thepleural space47. Thetreatment head50 adjacent thedistal end22 of theanesthesia delivery catheter2 is then insufflated with a fluid, including, but not limited to, air, gas, or liquid, such as saline, water, or therapeutic substances including local anesthetic agents. Theanesthesia delivery catheter2 is then pulled back towards the operator pulling thetreatment portion51 in urging contact with theinner surface45 of theintercostal space44. Thedelivery elements52 penetrate theinner surface45 so as to infuse fluid into the tissue of theintercostal space44.
• This method is superior to a standard intercostal nerve block due to the precise delivery of therapeutic agent into the intercostal space. In a standard intercostal nerve block, the operator has to guess how deep to insert the needle. When it is too shallow, the nerve is missed and the therapeutic benefit is not achieved. When the needle is too deep, the therapeutic agent is instilled into the pleural space, and the therapeutic benefit is not achieved. Furthermore, if the needle is put in too deep, the lung, or other intrathoracic structures can be injured, such as the heart and great vessels, leading to a pneumothorax. While this is a risk any time a needle is inserted between the ribs into the pleural space, it is a particular concern in an intercostal nerve block when the needle is moved in and out of the space in an attempt to maximally infiltrate the space around the intercostal nerve. A needle that is too deep or too shallow is particularly a problem when infusing a neurolytic agent with the aim of ablating the nerve permanently. To minimize misplacement of the needle in the course of an intercostal nerve block, image guidance in the form of fluoroscopy is used to help guide the needle. Even with image guidance, however, it is nearly impossible to be sure that the needle is appropriately placed in a location where the treating substance can come in contact with the intercostal nerve without injuring the deeper structures, such as the lung.
• In another embodiment of a method of the present invention, tumescent anesthesia is used to infiltrate intercostal tissue. Tumescent means swelling or distention. Tumescent anesthesia is commonly employed in outpatient, office-based procedures such as liposuction or endovenous saphenous vein ablation. With tumescent anesthesia, the tissues are flooded with dilute liquid anesthetic and become distended. The unique feature of tumescent anesthesia is that it involves the use of a very low concentration of local anesthetic. The large volume of fluid causes vessels to be compressed resulting in minimal bleeding. The anesthesia achieved by this technique is excellent and has a prolonged duration. This approach has allowed procedures to be employed in the out-patient setting that formerly required a general anesthetic or major regional anesthesia.
• A critical component in utilizing tumescent anesthesia in a thoracic procedure is the precise infiltration of the anesthetic agent into the proper location around the intercostal nerve, without going too deep where the lung can be injured by the needle or the pleural space can be infused.
• General anesthesia with single-lung ventilation is considered mandatory for any open or thoracoscopic thoracic procedure. Both thoracotomy and Video-assisted thoracoscopy surgery (VATS) are classically performed using general anesthesia, usually with a double-lumen endrotracheal tube to allow collapse of the operated lung. While thoracoscopic surgery has been performed in awake patients, the adequate delivery of anesthetic agent to the intercostal space can be challenging, even with image guidance.
• FIGS. 8A and 8B are side views of an anesthesia delivery catheter4, in a pre-deployed and deployed state, respectively, comprising ashaft20 having a shaftdistal end22 and a shaftproximal end21, in accordance with an embodiment of the present invention. The delivery catheter4 comprises three coaxially nested tubes, each extending from theproximal end21 to thedistal end22; a first tube60, asecond tube62, and athird tube64. The first tube60 defines aguide wire lumen23 extending there through adapted to slidingly receive a guide wire therein. Thesecond tube62 extends over the first tube60 and coupled thereto at the shaftdistal end22. Thesecond tube62 defines anexpandable portion53 adjacent the shaftdistal end22. Thesecond tube62 defines aninflation lumen61 extending from the shaftproximal end21 to theexpandable portion53. Theinflation lumen61 is adapted to communicate inflation fluid from the shaftproximal end21 to theexpandable portion53 so as to inflate and deploy theexpandable portion53 to a diameter larger than that of the deflated or pre-deployed position.
• Thethird tube64 extends over thesecond tube62 and coupled thereto at the shaftdistal end22. Thethird tube64 defines atreatment portion51 collocated with theexpandable portion53. Thethird tube64 defines afluid delivery lumen63 extending from the shaftproximal end21 to thetreatment portion51. Thetreatment portion51 comprises a plurality ofdelivery elements52, such as, but not limited to, hollow tines and micro introducer needles, that are adapted to extend from thetreatment portion51 and to come into contact with thepleural surface45 of theintercostal space44 when theexpandable portion53 is inflated. Thedelivery elements52 comprise anaperture54 that is in fluid communication with thefluid delivery lumen63.
• FIGS. 9A and 9B are side cross-sectional views of adelivery element52, in accordance with an embodiment of the present invention. Thedelivery element52 comprises extendingresilient members58 that are adapted to open under a predetermined fluid pressure to form anaperture54 in fluid communication with thefluid delivery lumen63 so as to allow fluid to exit thedelivery element52. Thefluid delivery element52 acts as a one-way valve to allow fluid to exit theaperture54 but not enter.
• FIG. 10 is a side cross-sectional view of adelivery element52, in accordance with an embodiment of the present invention. Thedelivery element52 comprises a micro-needle55 having aneedle lumen57 in fluid communication with thefluid delivery lumen63. Avalve56 between theneedle lumen57 and thefluid delivery lumen63 is adapted to open at a predetermined pressure within thefluid delivery lumen63, so as to allow fluid to exit thedelivery element52.
• FIG. 11 is a side cross-sectional view of adelivery element52, in accordance with an embodiment of the present invention. Thedelivery element52 comprises anaperture54 or pore defined by thetreatment portion51. Theapertures54 are placed in urging contact with theinner surface45 of theintercostal space44 when the anesthesia delivery catheter4 is pulled back towards the operator when theexpandable portion53 is inflated. Therapeutic fluid, such as anesthesia, is introduced into thefluid delivery lumen63 at a predetermined pressure so as to expel the therapeutic fluid out of thedelivery elements52 and into theinner surface45 under hydrostatic pressure. This type of delivery may take the form of tumescent anesthesia, used to infiltrate intercostal tissue with anesthesia fluid. Tumescent means swelling or distention. Tumescent anesthesia is commonly employed in outpatient, office-based procedures such as liposuction or endovenous saphenous vein ablation. With tumescent anesthesia, the tissues are flooded with dilute liquid anesthetic and become distended. The unique feature of tumescent anesthesia is that it involves the use of a very low concentration of local anesthetic. The large volume of fluid causes vessels to be compressed resulting in minimal bleeding. The anesthesia achieved by this technique is excellent and has a prolonged duration. This approach has allowed procedures to be employed in the out-patient setting that formerly required a general anesthetic or major regional anesthesia.
• Referring again toFIGS. 7A-7C, in accordance with a method of the present invention, wherein abody space47, such as, but not limited to, a pleural space, is accessed and theintercostal space44 is provided with a local anesthesia. Amicro-introducer needle30 is advanced between tworibs42 into thepleural space47. Through the needle30 aguide wire32 is advanced to a predetermined location beyond theneedle30. Theneedle30 is removed from theguide wire32 leaving theguide wire32 in place. Theguide wire lumen23 of the anesthesia delivery catheter4 is advanced over theguide wire32 with thetreatment head50 advanced into thepleural space47. An inflation fluid is introduced into theinflation lumen61 under a predetermined pressure to inflate theexpandable portion53 so as to inflate and deploy theexpandable portion53, and thus thetreatment head50. The anesthesia delivery catheter4 is then pulled back towards the operator pulling thetreatment portion51, and thus thedelivery elements52, in urging contact with theinner surface45 of theintercostal space44. Thedelivery elements52 penetrate theinner surface45 so as to infuse fluid into the tissue of theintercostal space44. Therapeutic fluid, such as anesthesia, is introduced into thefluid delivery lumen63 at a predetermined pressure so as to expel the therapeutic fluid out of thedelivery elements53 and into theinner surface45. Upon completion of the treatment, the introduction of therapeutic fluid is terminated and the inflation fluid is extracted from theinflation lumen61 adapted to cause theexpandable portion53 to deflate and substantially conform to the pre-expanded state. The anesthesia delivery catheter4 is withdrawn from theguide wire32. Theguide wire32 is left in place.
• After the intercostal space is anesthetized, a cutting catheter is advanced over theguide wire32 and a micro-port is created substantially as provided inFIGS. 3B-3E.
• In another embodiment of the present invention, this method and device is used to instill tumescent anesthesia into an awake patient for the purpose of anesthetizing an intercostal spaces. This could be used clinically for the placement of a chest tube, or the placement of intercostal ports for awake thoracoscopy. In another embodiment, the method and device is used to treat acute or sub acute rib fractures with pain or anti-inflammatory agents such as steroids. In another embodiment, the method and device is used to instill a neurolytic agent for the permanent ablation of a nerve for the purpose of chronic pain management.
• FIG. 8C is a side view of another embodiment of a treatment catheter5 comprising ashaft20 having a shaftdistal end22 and a shaftproximal end21, a guide wire lumen extending there through, and a fluid lumen extending there through, in accordance with an embodiment of the present invention. Disposed adjacent the shaftdistal end22 is atreatment head250. Thetreatment head250 comprises anexpandable portion213 in the form of a balloon. Theballoon213 has a distal end252 proximate thedistal end22 of theshaft20 and a proximal end212 distal from thedistal end22 of theshaft20, and a ballooncentral portion253 there between. The distal252 and proximal251 ends of theballoon213 are larger than the ballooncentral portion253; resembling a dumbbell. Theballoon213 is in fluid communication with the fluid lumen and is adapted to fill with a fluid that is introduced into a fluid lumen at the shaft proximal end. Theballoon213 has a plurality ofdelivery elements52 adapted to release fluid from within theballoon213 to external theballoon213 at a predetermined pressure.
• In another embodiment of a method of the present invention, the treatment catheter5 is collapsed and advanced over a placed guide wire. Theballoon213 is preferentially placed within the intercostals space. Theballoon213 is pressurized with an anesthetic agent, such as, but not limited to, a tumescent anesthesia utilizing a dilute lidocaine solution. Once the intercostal space has been infiltrated with the anesthetic agent, the fluid expanding theballoon213 is withdrawn and theballoon213 is deflated, and the catheter5 is removed.
• In other embodiments of the present invention, the treatment catheter comprises a combination of the anesthetic instilling embodiments withdelivery elements52 with the cutting embodiments with a cuttingportion11 so that as soon as the chest wall is very precisely anesthetized, a small port can be cut by pulling the cutting element out towards the operator.
• FIGS. 12A-12C are side cross-sectional views of abiopsy tool6 for gathering a biopsy sample, such as lung tissue, in accordance with an embodiment of the present invention. Thebiopsy tool6 comprises anouter sheath71 housing atissue cutting element72, anendoscope75 withlight source74, and atissue grasping element76. Thetissue cutting element72 and thetissue grasping element76 are adapted to extend from and retract into the outer sheathdistal end71, suitable for a particular purpose.
• FIG. 12A shows thebiopsy tool6 wherein thetissue cutting element72 and thetissue grasping element76 are stowed within theouter sheath71. When stowed, thebiopsy tool6 may be inserted through a microport and into the body space, such as, but not limited to, the pleural space to adjacent the lung.FIG. 12B shows thebiopsy tool6 wherein thetissue grasping element76 is extended from the outer sheathdistal end71 so as to couple with target tissue to be biopsied.FIG. 12C shows thebiopsy tool6 where thetissue cutting element72 extends beyond thetissue grasping element76 so as to sever and contain the target tissue.
• In accordance with an embodiment of the present invention, thebiopsy tool6 has an outer diameter between 2 and 5 mm, suitable for insertion into microports as described above. It is anticipated that other elements may be housed within theouter sheath71.
• FIGS. 13A-13C illustrate a method for obtaining a biopsy of lung tissue using thebiopsy tool6, in accordance with the present invention. Thechest wall40 is anesthetized and a microport is created as provided in the embodiments above. The outer sheathdistal end77 is inserted through themicroport48 and placed in thepleural space47 adjacent thetarget tissue45 to be biopsied. Thetissue grasping element76 is extended and coupled with the tissue, as shown inFIG. 13A. Thetissue grasping element76 is retracted and/or thebiopsy tool6 is withdrawn a predetermined amount so as to stretch, elongate and thin out the tissue in preparation for severing. Thetissue cutting element72 is extended over the stretched tissue so that the target tissue is contained between thetissue cutting element72 and thetissue grasping element76, as shown inFIG. 13B. Thetissue cutting element72 severs the target tissue from the lung as well as seals the lung at the surgical site, as shown inFIG. 13C. Thebiopsy tool6 is withdrawn from the microport with the target tissue contained within thetissue cutting element72 and held by thetissue grasping element76.
• In an embodiment of a method for obtaining a biopsy of lung tissue using thebiopsy tool6, the method andbiopsy tool6 are adapted to sample lung tissue non-specially, as is done for a biopsy for ILD. The method to sample lung tissue utilizes a minimally invasive, direct approach where the viewing, grasping, and cutting mechanisms are all combined into one instrument that can be inserted through a small thoracoscopy. Because the approach is direct, and therefore does not require triangulation, single lung ventilation is not an absolute requirement as it is in traditional thoracoscopy. Furthermore, because thebiopsy tool6 is small, this approach can be carried out with the aid of a local anesthetic rather than a general anesthetic.
• Embodiments of theendoscope75 of thebiopsy tool6 include, but are not limited to, wherein theendoscope75 is flexible, theendoscope75 is rigid, wherein theendoscope75 is fixed in theouter sheath71, and wherein theendoscope75 is adapted to be advanced in and out of theouter sheath71 and fixed in a desired position to offer maximal visualization of the target tissue to be biopsied. In another embodiment, the distal end ofendoscope75 can have a variety of configurations allowing it to view from 0 degrees to 180 degrees.
• It is appreciated that thetissue grasping element76 can comprise many configurations suitable for the particular purpose. In the embodiment ofFIGS. 12A-C and13A-C,tissue grasping element76 is a hook. In this embodiment, the hook is advanced out of the outer sheathdistal end77 towards thetarget tissue45 and the tissue is “hooked” by the hooked shapedtissue grasping element76. Once thetarget tissue45 is hooked, thetissue grasping element76 is pulled back towards the outer sheathdistal end77, stretching thetarget tissue45 towards the optical system of the endoscopic75. Thetissue cutting element72 is then used to shear off thetarget tissue45 and thetissue grasping element76 is adapted to pull thetarget tissue45 into a channel where it is protected as thebiopsy tool6 is removed.
• Other embodiments of apparatus and methods suitable to grasp the target tissue include, but not limited to, the use of suction to stabilize the tissue, the use of cryogenic freezing, and the use of a highly sticky polymer substance, among others.
• It is appreciated that thetissue cutting element72 can comprise many configurations suitable for the particular purpose. In embodiments of the present invention, thetissue cutting element72 cuts the tissue while a separate element seals the surgical site. Embodiments oftissue cutting elements72 where cutting is followed by sealing include cutting mechanisms, such as, but not limited to, a fitted scalpel blade that follows a predetermined loop beyond the extension of thetissue grasping element76 from the outer sheathdistal end77 to cut tissue. Thebiopsy tool6 further comprises a sealing element, such as, but not limited to, a stapling device, crimping device, and a compression device, such as but not limited to, an elastic band and a suture.
• In other embodiments, thetissue cutting element72 is adapted to cut the tissue and seal the surgical site. Apparatus suitable for cutting the tissue and sealing the surgical site include, but not limited to, elements incorporating radiofrequency, laser, high frequency ultrasound, and electrocautery.
• When the purpose of the operation is to specifically sample a lung nodule or a very localized, specific interstitial abnormality, a thoracoscopy is of limited utility since there is no way to manually palpate the lung and localize the nodule or interstitial abnormality as is done in open surgery at thoracotomy. While some surgeons have attempted to localize tissue abnormalities with a coil or wire localized by CT, and then perform a generous wedge resection of tissue using standard lung stapling techniques, this technique is of limited utility due to the logistical challenges, as well as due to the continued need to wedge out a large area of lung so that a small nodule can be removed. Thus, an additional technical concern of the current methods of lung tissue excision is the need to create a wedge type incision in the lung to remove a nodule or interstitial abnormality. Generally the deeper the nodule in the lung parenchyma, the more lung tissue that must be removed due to the wider cut of the staples to form the wedge. As the wedge is cut, larger blood vessels and airways are cut, some of which can leak.
• Leakage of air after lung stapling is a very common occurrence, and is especially common in deep wedge resections where the staple lines end up under great tension. When a lung leaks air after a lung wedge resection the patients hospital stay is considerably lengthened and their complication rate goes up significantly. Thus great attention is directed intra operatively to positioning staplers and technically managing the risk of air leak, but despite these efforts deep wedge resections can be difficult and the risk of air leak increases significantly the deeper the nodule, and the more technically challenging the wedge resection. When this occurs during thoracoscopy, the case is converted to a thoracotomy to provide the operating surgeon more access to mitigate these delicate issues.
• In accordance with apparatus and methods of the present invention, there is provided a way to specifically excise lung tissue which provides a mechanism to locate a nodule or tissue abnormality, excise the tissue and a rim of normal lung around the tissue, and seal the cutting tract. Since the number and size of the ports utilized for thoracic surgery is directly related to the amount of acute and chronic pain, desirable features include the ability to thoracscopically sample lung tissue where a single, small port, or microport, is utilized, without utilizing standard triangulation methods. In accordance with the embodiments ofFIGS. 12A-C and13A-C, methods are adapted to sample lung tissue utilizing a minimally invasive, direct approach where the viewing, grasping, and cutting mechanisms are all combined intobiopsy tool6 adapted to be inserted through a small thoracoscopy port. Because the approach is direct, and therefore does not require triangulation, single lung ventilation is not an absolute requirement as it is in traditional thoracoscopy where the lung must be deflated to allow room in the pleural space for the instruments to work. Furthermore, because thebiopsy tool6 is small, this approach can be carried out with the aid of a local anesthetic, rather than a general anesthetic.
• FIGS. 14A and 14B are side cross-sectional views of abiopsy tool7 comprising ahollow needle80 and a deployable andretractable snare81 in a retracted and deployed state, respectively, in accordance with an embodiment of the present invention. The needledistal end85 is sharpened so as to pass through tissue. Theneedle80 defines a needle bore86. Thesnare81 comprises asnare shaft84 and asnare head82 at a distal end of thesnare shaft84. Thesnare head82 is adapted to collapse to a low-profile state when housed within the needle bore86, and thesnare head82 is adapted to deploy to a higher profile when extended from the needle bore86.
• Thesnare81 is adapted to be advanced beyond the needledistal end85 after the needledistal end85 is advanced beyond the target tissue as explained below.
• FIGS. 15A-F illustrate a method for obtaining a biopsy oflung tissue46 using thebiopsy tool7, in accordance with the present invention. Thebiopsy tool7 is advanced through thetarget tissue43, a shown inFIG. 15A. Thesnare81 is advanced beyond the needledistal end85 and thesnare head82 is deployed, as shown inFIG. 15B. Thetarget tissue43 is therefore, between thesnare head82 and the operator. Theneedle80 is slidably withdrawn along thesnare shaft84 and removed there from, leaving thesnare81 in place, as shown inFIG. 15C. One or morehollow needles80A,80B of increasing outer diameter, respectively, are advanced and withdrawn along thesnare shaft84 to adjacent thesnare head82 and adapted to dilate alarger tract49 by cutting through thelung tissue46 to thetarget tissue43, as shown inFIGS. 15D and 15E. The tract having been dilated to at least the diameter of thetarget tissue43, thetarget tissue43 is excised and thesnare81 removed, as shown inFIG. 15F. Atract49 cored from thelung tissue46 can be left as is to heal or sealed to prevent bleeding and/or air leakage, as provided below.
• In another embodiment of a method of the present invention, the patient has specific lung abnormality imaged. Aneedle80 is passed through the chest wall and into and just beyond the lung abnormality to be biopsied,target tissue48, such as a lung nodule or an abnormal tissue. In an embodiment, theneedle80 has a tip that imparts energy to the tissue to cauterize or seal the tissue as theneedle80 is advanced. A securing or anchoring mechanism is deployed from within the needle just beyond the nodule. In one embodiment, the securing mechanism is attached to a guide wire within in the needle and running from the proximal part of the needle to the distal securing or anchoring location. From within needle, the expandable member is advanced just beyond the nodule. The expandable member comprises a cutting mechanism that when pulled backwards towards the operator, is adapted to cut a diameter of tissue that includes the nodule. In an embodiment, as the cut occurs, the tissue is sealed with an energy mechanism, such as, but not limited to, RF, Laser, HIFU, polymer sealant. The cutting member comprises a catch assembly attached to its inner diameter. The needle is removed over a wire and a series of dilating sheaths are advanced and retracted to dilate the tract up to the desired diameter. In an embodiment, each dilating sheath contains a distal tip with a mechanism to impart energy to seal the tissue as it dissects the channel. As the cutting member is pulled back towards the operator, a core of tissue that contains the nodule is excised and deposited into a catch assembly. Once the catch assembly contains the biopsy material, it is pulled in close proximity to the sheath which compresses the material to a smaller volume to aid in extraction through the tissue. Once the tract is sufficiently dilated, the catch assembly containing the biopsy material is extracted by pulling towards the operator. In another embodiment, as the catch assembly is extracted, the tissue tract is impregnated with sealant I the form of laying a core of sealant that fills the tract and prevents tissue bleeding or air leak.
• FIGS. 16A and 16B are side cross-sectional and front views ofneedle80A,80B, respectively, suitable for advancing along thesnare shaft84 and cutting a tact in the tissue, in accordance with an embodiment of the present invention. Theneedle80A,80B comprises anouter tube90 with anouter tube lumen97, aninner tube94 coaxial with theouter tube90, and a plurality ofblades95 there between. Theblades95 couple with and space apart theinner tube94 with theouter tube90 within theouter tube lumen97. Theouter tube90 includes an outer tubedistal edge91 that is suitable for cutting through tissue. Theinner tube94 includes an inner tubedistal edge93 that is suitable for cutting through tissue. Theblade95 includes a bladedistal edge96 that is suitable for cutting through tissue. Theinner tube lumen94 is adapted to slidingly receive thesnare shaft84 such that theneedle80A,80B can track over thesnare shaft84 to the target tissue. Tissue cut by the outer tubedistal edge91, the inner tubedistal edge93, and the bladedistal edge96 is contained within theouter tube lumen97 as theneedle80A,80B is advanced through the tissue.
• In an embodiment, theneedle80A,80B comprises means for cauterizing the tissue as it is cut, such as, but not limited to, RF energy.
• In an embodiment of the methods in accordance with the present invention, thetract49 is plugged with a biodegradable material so as to seal and promote healing of thelung tissue46. In another embodiment of the methods of the present invention, thetract49 is compressed closed. In another embodiment, thetract49 is sutured closed. Where drainage is required, in another embodiment, a drainage tube is placed in thetract49 and in communication with the peritoneal space to provide for drainage.
• In another embodiment in accordance with the present invention, one or more of the hollow needles of increasing diameter incorporate means for sealing the tissue. The hollow needles may incorporate means for sealing the tissue, including, but not limited to, RF, laser, cryo, among other.
• In an embodiment in accordance with the present invention, methods and apparatus are adapted to sample a very specific nodule within the lung parenchyma. In accordance with an embodiment of a method of the present invention, the nodule or specific localized interstitial abnormality is localized. It is anticipated that a number of image guidance techniques can be combined with these methods to localize the abnormality.
• In an embodiment of the present invention, a patient is placed in a CT scanner and the nodule is imaged. Using standard CT guided interventional techniques commonly used in CT guided biopsy of the lung, thebiopsy tool7 is advanced through the skin, chest wall, pleural space and lung and through to thetarget tissue43 to be sampled. Once the distal end of thebiopsy tool7 is passed through the nodule or interstitial abnormality, a snare in the form of a compressed wire hook, such as that comprised of shape memory metal such as Nitinol, is advanced out of the distal end of theneedle80. Once thesnare head82 is advanced out of the needle, it expands to a predetermined configuration just beyond thetarget tissue43.
• In an embodiment, thesnare head82 has the shape of a threepronged treble hook83. At the base of thehook83 is thesnare shaft84, comprising, such as, but not limited to, guide wire, nylon, braided cotton string, and other flexible filaments. Theneedle80 is removed, leaving the attachment filament intact in the tract to the treble hook now just beyond thetarget tissue43. Once theneedle80 is removed, the operator pulls on thesnare shaft84. This engages thetreble hook83 to the target tissue, with thesnare shaft84 traversing thetarget tissue43, nodule or interstitial structure, to be sampled. Once thesnare shaft84 andtreble hook83 are engaged with thetarget tissue43, a sheath is passed over thesnare shaft84 and thetarget tissue43 viewed with the imaging device, such as, but not limited to, CT, MRI, Ultrasound, and Fluoroscopy.
• By way of example, but not limited thereto, in one embodiment the patient has a specific lung abnormality imaged. Possible techniques to image the lung include, but not limited to, CT, Ultrasound, Fluoroscopy, MRI, PET, and PET/CT. Theneedle80 is passed through chest wall into and just beyond the lung abnormality to be biopsied, such as a lung nodule. In an embodiment, aneedle80 is provided comprising a tip adapted to impart energy to the tissue to cauterize or seal the tissue as it is advanced. From within theneedle80, anexpandable snare81 is extruded just beyond nodule. Theexpandable snare81 is attached to asnare shaft84, such as, but not limited to, a guide wire or guide filament, that is within theneedle80. Theneedle80 is removed, leaving thesnare shaft84 coupled to thesnare head82 in place. A sheath is passed over thesnare shaft84 to dilate the track through the tissue to the distal end just before the target tissue. More than one sheath can be utilized to progressively dilate the tract. A sealing mechanism can be utilized as the tract is developed to the target tissue. Once the tract is developed to sufficient diameter, the dilating sheath is replaced with a sheath that has a distal end that can core out the target tissue or the tissue around the target tissue, and lock into thesnare head82 just beyond the area to be encompassed between the distal end of the sheath and thesnare head82. Thesnare head82, now locked into the distal end of the sheath and encompassing the biopsy material,target tissue43, the assembly is pulled back towards the operator. As the assembly is withdrawn, the surrounding tissue is cauterized. As this is done an inner channel of the guide sheath, now connected to the expandable member is utilized to deliver tissue sealant material or core plugs to fill the space and prevent air leakage.
• In another embodiment of a method of the present invention, the patient has specific lung abnormality imaged. Aneedle80 is passed through the chest wall and into and just beyond the lung abnormality to be biopsied,target tissue43, such as a lung nodule. In an embodiment, theneedle80 has a tip that imparts energy to the tissue to cauterize or seal the tissue as theneedle80 is advanced. Asnare head82 is deployed from within the needle just beyond the target tissue. In an embodiment, thesnare head82 is attached to asnare shaft84 that runs through the length of theneedle80. From within needle, the expandable member is advanced just beyond the nodule. The expandable member comprises a cutting mechanism that when pulled backwards towards the operator, is adapted to cut a diameter of tissue that includes the nodule.
• In an embodiment, as the cut occurs, the tissue is sealed with an energy mechanism, such as, but not limited to, RF, Laser, HIFU, polymer sealant. The cutting member comprises a catch assembly attached to its inner diameter. The needle is removed over a wire and a series of dilating sheaths are advanced and retracted to dilate the tract up to the desired diameter. In an embodiment, each dilating sheath contains a distal tip with a mechanism to impart energy to seal the tissue as it dissects the channel. As the cutting member is pulled back towards the operator, a core of tissue that contains the nodule is excised and deposited into a catch assembly. Once the catch assembly contains the biopsy material, it is pulled in close proximity to the sheath which compresses the material to a smaller volume to aid in extraction through the tissue. Once the tract is sufficiently dilated, the catch assembly containing the biopsy material is extracted by pulling towards the operator. In another embodiment, as the catch assembly is extracted, the tissue tract is impregnated with sealant I the form of laying a core of sealant that fills the tract and prevents tissue bleeding or air leak.
• FIGS. 17A-E illustrate a method for obtaining a biopsy oflung tissue46 using thebiopsy tool7 of the embodiment ofFIGS. 14A and 14B, in combination with the pull-type cutting device1 of the embodiment ofFIG. 2, in accordance with an embodiment of the present invention. Thebiopsy tool7 is advanced through to thetarget tissue43, a shown inFIG. 17A. Thesnare81 is advanced beyond the needledistal end85 and thesnare head82 is deployed, as shown inFIG. 17B. Thetarget tissue43 is therefore, between thesnare head82 and the operator. Theneedle80 is slidably withdrawn along thesnare shaft84 and removed there from, leaving thesnare81 in place. The pull-type cutting device1 is slidably advanced along thesnare shaft84 such that the cuttinghead10 is adjacent thetarget tissue43. Theexpandable portion13 including the cuttingportion11 is deployed, as shown inFIG. 17C. The pull-type cutting device1 is pulled toward the operator cutting atract49 into thelung tissue46, as shown inFIG. 17D. Thetract49 having been made to at least the diameter of thetarget tissue43, thetarget tissue43 is excised and thesnare81 removed, as shown inFIG. 17E. Atract49 cored from thelung tissue46 can be left as is to heal or sealed to prevent bleeding and/or air leakage, as provided below.
• A variety of biopsy techniques commonly employ a small bore needles to sample tissue deep within an internal organ, or the surrounding lymph nodes for the diagnosis of cancer and other diseases. One major limitation is the amount of tissue, and thus the quantity and quality of the tissue sample for analysis. It is desirable to sample larger tissue specimens, but there are a number of difficulties in introducing large bore devices into an organ or lymph node to obtain a larger tissue sample with better preserved tissue architecture. Furthermore, while it is possible to stick a needle into most body organs with an acceptable, but not negligible complication profile, as the diameter of the access device goes up, so does the complication rate. This is especially the case in the lung, where it is desirable to sample lung nodules that are less than 1.5 cm, but the risk of bleeding and air leakage is significant. Furthermore, the proximity of major vascular structures in the lung, liver, and other locations makes the process of pushing large diameter cutting elements into the body dangerous. It is therefore also desirable to gain access deep within a solid organ or body space containing lymph nodes without endangering the tissues and vital structures around the target tissue for biopsy.
• In one embodiment of the invention an instrument is provided whereby a small bore needle is advanced to a target tissue, such as a lung nodule deep in the lung, using image guidance. The needle passes through the desired tissue, and a catch and stabilization element is actuated. The nodule is secured, and cut free. With the nodule now free, the catheter traversing the specimen has the following features. The distal tip has a sealing mechanism that can include laser, RF, other energy sources, or a mechanism to deliver specific tissue sealants or plugs. Just proximal to the tissue specimen, mounted on the catheter, is an expandable cutting member that when expanded exposes a cutting element on the proximal side. The operator pulls the device back towards the outer surface of the body, along the original needle tract. As the operator pulls back, the tissue is cut, making a precisely cut channel so that the biopsy specimen, which is larger than the original needle tract, can be pulled out through the newly cut channel. As the tract is cut, the catch device enclosing the biopsy specimen is pulled out, the distal end of the catheter is utilized to seal the tract left behind.
• FIGS. 18A and 18B are a side cross-sectional and end view of a pull-type cutting device8 in a deployed or expanded configuration, in accordance with an embodiment of the present invention. The pull-type cutting device8 comprises ashaft20 having a shaftdistal end22 and a shaftproximal end21 and alumen23 extending there through. Disposed about the shaftdistal end21 is a cuttinghead100. The cuttinghead100 comprises anexpandable portion113 having a cuttingportion111 proximal from the shaftdistal end22. Theexpandable portion113 is in fluid communication with afluid lumen25 which is adapted to supply fluid to theexpandable portion113 so as to inflate theexpandable portion113. Thelumen23 is adapted to pass over a guide wire or snareshaft84. Extending from the cuttingportion111 are a plurality of stand-offblades116 supporting aloop cutting element112. Examples of cuttingelements112 include, but are not limited to, blades, radiofrequency, laser, and electrocautery cutting elements, that are adapted to create an incision when pulled against and through tissue. As the pull-type cutting device8 is pulled through the tissue, the cuttingelement112 cores the tissue, wherein the core of tissue can be pushed out by the subsequent pull-out of thesnare80, substantially as shown inFIG. 17D. Since the pulling and cutting action is towards the operator, this results in an improved safety profile as it lessens the risk that an internal organ or other structure can be damaged as the body space opening is created. In an embodiment, any pieces of cut tissue are deposited intocavity115.
• FIGS. 18C and 18D are side cross-sectional views of a pull-type cutting device9 in a deployed or expanded configuration and asnare81A, in accordance with an embodiment of the present invention. The pull-type cutting device9 comprises ashaft20 having a shaftdistal end22 and a shaftproximal end21 and alumen23 extending there through. Disposed about the shaftdistal end21 is a cuttinghead10A. The cuttinghead10A comprises anexpandable portion13 having a cuttingportion11 proximal from the shaftdistal end22. Theexpandable portion13 is in fluid communication with afluid lumen25 which is adapted to supply fluid to theexpandable portion13 so as to inflate theexpandable portion13. Thelumen23 is adapted to pass over a guide wire or snareshaft84. At the shaftdistal end22, theexpandable portion13 defines acavity115. Extending from the cuttingportion11 are a plurality of cuttingelements12. Examples of cuttingelements12 include, but are not limited to, blades, radiofrequency, laser, and electrocautery cutting elements, that are adapted to create an incision when pulled against and through tissue. As the pull-type cutting device9 is pulled through the tissue, the cuttingelements12 cut through the tissue. Thesnare81A comprises asnare head83 having aproximal end89 comprising a coupling element. The expandable portiondistal end114 comprises a coupling element adapted to couple with the coupling element on the snare headproximal end89, as shown inFIG. 18D. Thesnare head83 further comprises a sealingelement87 adapted to seal the tissue as it is drawn past and through tissue.
• Referring again toFIGS. 17A-17B andFIGS. 17F-17G illustrate a method for obtaining a biopsy oflung tissue46 using thebiopsy tool7,7A of the embodiment ofFIGS. 14A and 14B andFIGS. 18C and 18D, in combination with the pull-type cutting device9 of the embodiment ofFIGS. 18C and 18D, in accordance with an embodiment of the present invention. Thebiopsy tool7 is advanced through to thetarget tissue43, as shown inFIG. 17A. Thesnare81A is advanced beyond the needledistal end85 and thesnare head82 is deployed, as shown inFIG. 17B. Thetarget tissue43 is therefore, between thesnare head82 and the operator. Theneedle80 is slidably withdrawn along thesnare shaft84 and removed there from, leaving thesnare81A in place. The pull-type cutting device9 is slidably advanced along thesnare shaft84 such that the cuttinghead10 is adjacent thetarget tissue43. Theexpandable portion13 including the cuttingportion11 is deployed, as shown inFIG. 17F. Thesnare81A is pulled towards the cuttinghead10A with the snare headproximal end89 placed into engagement with and coupled to the expandable portiondistal end114. The pull-type cutting device9 and thesnare81A are pulled as a unit toward the operator cutting atract49 into thelung tissue46, as shown inFIG. 17G. Thetract49 is sealed by the activation of the sealingelement87 on thesnare81A to prevent bleeding and/or air leakage.
• In the following embodiments of methods in accordance with the present invention, any of the previous methods may be taken to gain image guided access to the target tissue, dilate the tract, excise the target tissue, and pull the target tissue out through the dilated tract. After the procedure, there remains a tissue tract or channel deep into the lung which potentially can bleed and leak air.
• In an embodiment, a method and device is provided to drain thetract49 while it heals from the dissection, dilation and excision from the body wall, through the pleural space to the lung parenchyma. As the lung is penetrated with the needle, and as thetract49 is dilated and the target tissue excised, the cut surface of the lung parenchyma is prone to bleed when blood vessels are cut, and leak air when airways are cut. The method and device are adapted to provide hemostasis (no bleeding) and pneumostasis (no air leaking).
• In accordance with the methods provided above, target tissue is excised resulting in atract49 in the tissue, as shown inFIG. 19. Upon removal of the biopsy device, aguide wire32 is left behind in thetract49. Theguide wire32 can be placed in thetrack49 by passing theguide wire32 through a guide wire lumen in the biopsy device, such as a guide wire lumen provided in thesnare shaft84, an accordance with an embodiment of thesnare shaft84.
• FIG. 20 is a cross-sectional view of abody space tube120 that has been advanced over theguide wire32 left in thetract49 after the target tissue is extracted, in accordance with an embodiment of the present invention. Thebody space tube120 comprises a plurality ofapertures121 that are positioned in thetract49 in thelung tissue46. Thebody space tube120 is left in thetract49 and attached to a suction apparatus to provide suction to the lung and pull the tissue in close apposition to thebody space tube120. Over a period of time, the lungtissue extraction tract49 heals, and any blood or air is exited through the tube to an external receptacle, such as, but not limited to, a chest tube canister.
• In an embodiment of the present invention, the external receptacle has a mechanism to insert a test strip into the line of air and fluid drainage, and if the test strip reacts with carbon dioxide, the color changes. If no carbon dioxide is present, the test strip does not change. The sample of gas/liquid is taken from within the pleural space to determine if air, containing carbon dioxide, is leaking out of the cut surface of the internal diameter of the tract. If it is, the tube needs to stay in place. If it is not, the tube can be removed.
• This method and apparatus has applications beyond use with the lung, such as, but not limited to, cases where a chest tube is used and the question is if an air leak remains.
• In an embodiment of the present invention, thebody space tube120 is biodegradable and can be cut off at the skin and left in situ.
• In another embodiment of the present invention, thebody space tube120 is made of a pro-inflammatory substance that encourages inflammation and tissue in growth to limit potential for subsequent hemothorax, pneumothorax or bronchopleural fistula.
• In an embodiment, thebody space tube120 is a very thin filament with multiple channels on the side. The multi channel filament left behind in the tissue tract and placed to an external suction source to drain any blood and air from the biopsy tract while the healing process takes place.
• In another embodiment of the present invention, the tube with multi channels to the surrounding tract is filled with a porous sponge-like material. Suction is applied to the external lumen of the tube. The tissue around the tube is sucked down onto the tube. The porous sponge-like material keeps the lung and coagulum, fibrous material, and other material from clogging the internal diameter of the small tube while the tissue around it heals.
• In another embodiment of the present invention, thebody space tube120 is drained internally to the bronchus, esophagus or peritoneal space.
• FIG. 21A is a side cross-sectional view of asealing device200, in accordance with the present invention. In an embodiment of the present invention, after the target tissue is extracted and aguide wire32 is left behind in thetract49, asealing device200 is passed over theguide wire32 into thelung tissue tract49. Thesealing device200 comprises adistal tip201 that can impart physical energy, such as that associated with RF or Laser. Examples include, but are not limited to, diode laser, a laser of any of a number of frequencies designed to impart heat to the surrounding tissue that seals the tract. Another example provides adistal tip201 comprising a cryogenic mechanism adapted to seal thetract49 using cryoablation. Thedistal tip201 is actuated and pulled back towards the operator. As it is pulled back the energy is imparted to the surroundingtract49 and thetract49 is burned and sealed, preventing the egress of blood or air.
• In another embodiment, since there is no fluid in thetract49 to be sealed, fluid is expelled through thedistal tip201 as the fluid heated with RF (i.e. Tissuelink Wet Electrode) or laser (so that the fluid becomes heated beyond the temperature of the surrounding tissue) and the tissue is sealed. The combination of the fluid and the RF seals the surrounding tissues and prevents the leakage of blood, air, lymph tissue, etc.
• In another embodiment of the present invention, the sealing mechanism is contained on the outer lumen of a balloon tipped catheter. The balloon is expanded to fill the tissue tract and as the balloon is retracted towards the operator, the energy is imparted to the surrounding tissue and the tissue is sealed.
• FIG. 21B is a side cross-sectional view of asealing device200, in accordance with the present invention including a tissue sealing substance is extruded to fill thetract49. In an embodiment the tissue sealing substance is a polymer that increases in size or generates heat as it is actuated with an activating substance, such as external ultrasound.
• In another embodiment, a spiral suture is wrapped around just under the surface of the tract29 as it is weaved in a spiral fashion around thetract49, and then actuated in such a fashion that the tract is pulled down upon itself and closed so there is no remaining space for blood or air to escape. In other embodiments of the present invention, other mechanisms are actuated to pull the walls of the tract down upon itself, eliminating the space for blood or air to escape.
• FIGS. 22A-F illustrate a method for obtaining a biopsy oftarget tissue47 that is adjacent abody lumen130, such as, but not limited to, the esophagus and bronchus, using embodiments ofbiopsy tools140 provided above, and a method for sealing thebody lumen130 after thetarget tissue47, or a portion thereof, is excised, in accordance with an embodiment of the present invention. Using endoscopic ultrasound or other imaging techniques, aguide wire32 is advanced through thebody lumen130, piercing thewall133 of thebody lumen130 and placed adjacent thetarget tissue47. Thebiopsy tool140 is advanced along theguide wire32 creating anaperture132 in thebody lumen130, as shown inFIGS. 22A and 22B. Thetarget tissue47 is removed using methods described above and theguide wire32 is left behind, as shown inFIG. 22C. Asealing device142 is provided comprising anexpandable sealing element143 at adistal end144. Thesealing device142 is advanced over theguide wire32 with thedistal end144 passing through theaperture132 in the wall of thebody lumen130. Theexpandable sealing element143 is expanded and pulled back against thewall133 of thebody lumen130, covering theaperture132.
• FIGS. 23A and 23B are side cross-sectional views of asealing device146 adapted for sealingapertures132 inbody lumens130, in a pre-finished and finished configuration, respectively, in accordance with an embodiment of the present invention. Thesealing device146 comprises a distal end having a double-phalange plug148. The sealing device is advanced over theguide wire32 via aguide wire lumen150 traversing anaperture132 in abody lumen130. Afirst phalange149 is positioned adjacent one side of theaperture132 and asecond phalange148 is position on the opposite side of theaperture132. The first andsecond phalanges149,148 are brought together to impinge upon and seal theaperture132 capturing a portion of thewall133 adjacent theaperture132 there between. Theguide wire lumen150 is self-sealing upon removal of theguide wire32 there from. This embodiment can be used for esophageal perforations as well.
• When a device or tube is removed from the chest, it leaves a tract from the external skin, through the chest wall to the pleural space. As the patient breaths, air can be entrained back into the pleural space, as the process breathing requires creating negative pressure within the chest relative to the external environment. When air is sucked back into the chest it creates a condition known as pneumothorax, which can be life threatening. It is generally taught to tunnel obliquely from one level to another to create a tissue flap to collapse upon itself when a tube is removed so that air cannot be sucked back into the chest. When performing thoracoscopy, however, it is desirable to tunnel directly to the pleural space, without traveling obliquely, as it facilitates the introduction and removal of the operating instruments.
• In an embodiment, a method and apparatus are provided whereby a plug or series of stitches are on a wire within the chest in a compressed configuration. When it is desired to seal the pleural space, the wire is pulled back towards the operator, bringing the plug or stitches in apposition to the internal opening of the body space. The device is then actuated to insert the plug or stitches into the internal body space opening, and the wire breaks away, thereby closing the hole and preventing fluid from leaking out or air from getting sucked back in.
• This embodiment could be used to seal a variety of body spaces, including surgically created internal to external port sites (such as is seen with thoracoscopy, laparoscopy), as well as to seal the bronchus, when a deep parenchymal lung biopsy is carried out from an end bronchial position. Likewise, this could be used to seal the esophagus when a transesophageal biopsy is performed, as is done for Endoscopic Ultrasound guided biopsy of mediastinal lymph nodes and other structures. This could be used for other procedures where the pleural, peritoneal or other space (GU, GYN, etc) are accessed through the gut.
• One of the difficulties of CT guided biopsy of the lung is the fact that the ribs and other chest wall structures can get in the way and not provide an adequate window from which to biopsy the lung. Thoracoscopy can overcome this by starting within the pleural space, but one cannot currently localize a nodule within the lung by thoracoscopy. In this embodiment, a thorascope is fitted with an ultrasound probe on its distal tip. The tip has a lubricious covering that allows the operator to run the ultrasound probe over the surface of the lung until the nodule is localized. Once the nodule is localized, a suction apparatus around the perimeter of the ultrasound probe is actuated so that lung is sucked into the scope/probe, thus securing the area and locking the probe into place. The operator then advances a needle through the lung under ultrasound guidance to access the nodule. Then the nodulectomy can be carried out in a variety of ways, including as have been described above.
• Embodiments providing methods and apparatus to excise lung tissue and nodules are presented. These embodiments are less-traumatizing than conventional biopsy approaches, and utilize a single-port, minimally invasive technique. These embodiments may be practiced in conjunction with the anesthesia and port-cutting technology described above. That technology and the associated methods can be used to provide access for carrying out a procedure to excise lung tissue as described here, using image guidance to allow precise, directed lung nodule excision. These techniques utilize suction within the pleural space and lung tissue excision tract after dilation to remove blood, air and prevent lung collapse during the procedure. The disclosed embodiments also utilize a balloon-dilation technique to dilate the entire excision tract from the port in the chest wall to the location of the nodule to be excised (for example within the lung), which provides a robust and simple approach to facilitate excision of a large sample of target tissue. Integrated sealing also is used to minimize complications of bleeding and air leak. The procedures may be performed with CT guidance. CT is particularly well suited for solid organ interventions. Recent advancement of technology has brought about CT fluoroscopy, which shows the motion of organs and devices in real time. With CT fluoroscopy the trajectory of a needle can be tracked in real time, which allows the physician to make adjustments as appropriate. This advantage has made procedures shorter with equivalent or better success rates than those with standard intermittent CT imaging, though standard CT imaging may still be used.
• In accordance with an embodiment, a workingport151 as shown inFIGS. 24 and 25 can be introduced through an intercostal space through the chest wall to provide access to the pleural cavity of a patient. The workingport151 comprises ahollow tubular member163 having a proximal end with one ormore apertures153, which can be inserted through an opening in the chest wall introduced via the technology and techniques described hereinabove. A distal end of theport151 is in communication with avacuum source152. Thevacuum source152 can be used to drain the pleural space (between the chest wall and the lung), the lung excision tract (within the lung parenchyma), or both. Thetubular member163 is of a predetermined length such that the proximal end can extend into the chest, e.g. within the pleural space, when inserted through the opening in the chest wall and the distal end resides outside of the body. For example, the length of thetubular member163 of the workingport151 can be 5, 10, 15, 20, or 25 cm. As the size and shape of each patient is unique, the depth that the workingport151 is inserted into the patient's chest may vary. For example, the distal (away from patient) end of the workingport151 may not be in contact with the chest wallouter surface41 of the patient. Thetubular member163 of the workingport151 has a predetermined diameter to accommodate insertion therein of devices and surgical tools for performing an operation or surgery within the chest cavity (e.g. within the pleura), for example the devices described herein and used in the excision process here described. For example, the inner diameter of thetubular member163 of the workingport151 can be 3, 5, 7, 10, 12, 15, 18, or 20 mm. Thevacuum source152 is coupled to the distal end of the workingport151 that resides outside of the body, and is effective to draw a vacuum on the workingport151. The resulting vacuum drawn through the aperture(s)153 therein maintains a negative pressure within the chest to keep the lungs fully expanded during an operation. In one embodiment, the vacuum drawn through the aperture(s)153 is −5 cmH₂O to −100 cmH₂O.
• As shown inFIG. 25, in an initial stage of an exemplary procedure for excising lung tissue, first theport151 is inserted through the opening in the chest wall as described herein, preferably until its proximal end reaches or is located in the vicinity of the pleura. Then with theport151 installed, aneedle154 is advanced from outside the chest through the workingport151 and toward thetarget tissue43 within the lung. Theneedle154 is advanced until its proximal (toward patient) end has advanced through the pleura, into the lung and beyond thetarget tissue43. Advancement of theneedle154 can be accomplished under CT fluoroscopy in order to track and adjust its trajectory in real time, which allows for adjustments to be made when necessary. In an embodiment, theneedle154 has a feature at its tip that imparts energy to tissue to cauterize or seal the tissue as theneedle154 is advanced. For example, the needle tip may be configured to deliver thermal, radio-frequency or electrical energy to tissue with which it comes into contact along its advance, in order to cauterize that tissue as the tip is advanced. In particular, theneedle154 may be configured as a radio-frequency transducer, or it may be connected to a voltage source to supply thermal and/or electrical energy during use. In a preferred technique, theneedle154 is inserted until its tip reaches, or preferably arrives beyond, thetarget tissue43 relative to theport151. Thereafter, as seen inFIG. 26 atrocar needle155 is advanced through the workingport151 and over the already emplacedneedle154, which guides thetrocar needle155 along a trajectory so that its proximal end arrives adjacent, preferably beyond, thetarget tissue43 relative to theport151. In one embodiment, once thetrocar needle155 is in place theneedle154 is then withdrawn. However, theneedle154 may also remain in place to serve as a guide for later-inserted implements (i.e. an excision device, a sealing device, balloon catheters or other implements for dilation, a suction apparatus, etc.). In another embodiment, once thetrocar needle155 is in place, a guide wire can be advanced through it so the track to the target tissue is preserved for the subsequent advancement and removal for later inserted implements, for example over the guide wire. If desired, theneedle154 can be withdrawn once such guide wire is in place. In another embodiment, a guide wire is advanced through the workingport151 and over the already emplacedneedle154, which guides the guide wire along a trajectory so that its proximal end arrives adjacent, preferably beyond, thetarget tissue43 relative to theport151. In this embodiment, the guide wire itself would include a longitudinally extending bore to accommodate theneedle154 therein, and use of thetrocar needle155 is optional. Instead, the guide wire can preserve a track to thetarget tissue43 for the subsequent advancement and removal of later-inserted implements.
• With thetrocar needle155 now in place and providing a channel from outside the patient to a location just beyond thetarget tissue43, acatch wire156 is advanced through thetrocar needle155 until its proximal end arrives just beyond thetrocar needle155 and thetarget tissue43. In an embodiment, thecatch wire156 comprises (e.g.) nylon, braided cotton string, and/or other flexible filaments. At that point atissue anchor157 attached to or adjacent the proximal end of thecatch wire156 can be deployed as shown inFIG. 27. In an embodiment, thetissue anchor157 is in the form of a compressed wire hook comprised of a shape memory metal such as Nitinol. In another embodiment, thetissue anchor157 is in the form of a three pronged treble hook. Once thetissue anchor157 of thecatch wire156 is advanced out of thetrocar needle155 and just beyond the target tissue43 (i.e. after it is no longer constrained within the bore of the trocar needle155), it can expand to its predetermined, deployed configuration. For example, thetissue anchor157 can be elastically deformed to an undeployed configuration while it is constrained within the diameter of thetrocar needle155. But once advanced beyond thetrocar needle155, thetissue anchor157 then can elastically expand to its deployed, unconstrained state as shown in the call-out inFIG. 27. Thecatch wire156 is then retracted away from thetarget tissue43, thereby tensioning thecatch wire156 from thetarget tissue43 with thecatch wire156 being anchored from behind (i.e. the proximal side of) thetarget tissue43 via thetissue anchor157. In this manner, thecatch wire156 can be used to provide a distal (i.e. away from the patient) counterforce against subsequent operative steps that involve advancement toward thetarget tissue43 from the outside (i.e. dilating, coring, etc.). Thetarget tissue43 is thus localized and anchored at the proximal end of a tissue-excision tract that extends from outside the body, through the pleural space, and into the lung up to thetarget tissue43, using thetissue anchor157.
• Thetrocar needle155 is then withdrawn, leaving behind thecatch wire156 whose proximal end is secured at thetarget tissue43 via thetissue anchor157. Adilation catheter159 is next advanced through the workingport151 and over thecatch wire156 against a counterforce applied by tensioning thecatch wire156 in a distal direction from outside the chest. Thedilation catheter159 is advanced through the pleural space and into the lung over thecatch wire156, up to thetarget tissue43 now positioned adjacent thetissue anchor157 as seen inFIG. 28. Optionally, as also seen in the figure the workingport151 can be withdrawn prior to insertion of thedilation catheter159 so as not to obstruct dilation of the channel along the tissue tract between the chest wall and thetarget tissue43. In other embodiments, the workingport151 remains positioned within the chest wall. Thedilation catheter159 can be a balloon catheter that extends at least from the chest wall through the pleural space and into the lung, up to thetarget tissue43 along the tract followed by thecatch wire156.
• Thedilation catheter159 may be a balloon catheter made of any appropriate flexible material for use as an inflation balloon, such as nylon, polyester, polytetrafluoroethylene (PTFE), latex, rubber, and mixtures thereof. In one embodiment, thedilation catheter159 is made from a low or non-compliant material, such as for example, nylon or polyester. A low or non-compliant catheter will increase in diameter by up to a maximum of about 5% of its unexpanded diameter in response to increasing the pressure for inflating thedilation catheter159 to 5, 10, 15, 20, 25, 30, 35, or 40 atmospheres. Alternatively, thedilation catheter159 may be made from a hybrid or highly compliant material where the diameter of the balloon may increase as much as about 40% during inflation. The hybrid or highlycompliant dilation catheter159 may proportionally increase in diameter in response to increases in inflation pressure which may allow for fewer balloon sizes to be used. In one embodiment, theinflated dilation catheter159 has an outside diameter of 1 mm to 30 mm, preferably 3 mm to 25 mm, more preferably 5 mm to 20 mm, and more preferably 8 mm to 15 mm. In any event, it is desirable that thedilation catheter159 dilate the tract to a greater overall diameter than the target tissue to be excised; preferably up to 5%, 10%, 15%, or 20% greater than the target-tissue diameter.
• Thedilation catheter159 may be coated with a pharmacologic material, an anti-thrombogenic material, prothrombogenic material, an anti-infective material, anti-neoplastic material, radiation, any material used to seal tissue or any combination of these.
• A carbon dioxide sensor can be positioned on thedilation catheter159 to sample gas/liquid within the pleural space to determine if air (containing carbon dioxide) is leaking out of the lungs, which may indicate an unintended puncture or laceration of an airway or an improper or incomplete seal at the point where the catheter or other operative instruments penetrate the lung to reach thetarget tissue43 therein.
• As shown inFIG. 29, thedilation catheter159 is inflated to dilate a channel along the tissue tract from the chest wall to thetarget tissue43. The diameter of the channel corresponds to the inflation diameter of thedilation catheter159. Thedilation catheter159 is adapted to communicate inflation fluid to the expandable (balloon) portion thereof so as to inflate and deploy the expandable portion to a desired diameter for the channel, corresponding to a particular inflation pressure. That is, the inflation pressure can be continually increased until the desired channel diameter has been achieved. In an embodiment, an ablation device (not shown) is provided on the outer surface of thedilation catheter159. As thedilation catheter159 inflates, the ablation device introduces energy to the surrounding tissue to stem bleeding and seal against air leakage while expanding the tissue tract.
• Once the desired channel diameter has been achieved by any form of dilation, a cylindrical sleeve, for example thetubular member163 of the workingport151, can be advanced over thedilation catheter159 until the proximal end thereof is positioned adjacent thetarget tissue43 within the lung, through the pleura and the adjacent portion of the lung along the tissue tract leading from the chest-wall opening as shown inFIGS. 30 and 31. In an embodiment, the proximal end of thetubular member163 of the workingport151 has a sharpenededge167 to facilitate advancement thereof over theinflated dilation catheter159 and past the surrounding tissue, through the pleural space and into the lung up to thetarget tissue43. After that tubular member163 (or other sleeve) is advanced to thetarget tissue43, thedilation catheter159 is deflated and withdrawn from the patient, leaving behind a fixed-diameter channel extending from the opening in the chest wall all the way to thetarget tissue43 to be excised. The vacuum provided at the aperture(s)153 of the workingport151, in addition to maintaining negative pressure in the pleural space, also draws the tissue tract against the workingport151 to facilitate prevention of air leak leading to lung collapse or bleeding prior to sealing.
• In another embodiment, once the desired tissue-tract diameter has been achieved thedilation catheter159 is deflated and withdrawn from the patient without or prior to the emplacement of any sleeve about the dilation catheter. Thetubular member163 of the workingport151 can be advanced through the open tract until the proximal end thereof is positioned adjacent thetarget tissue43 within the lung, through the pleura and the adjacent portion of the lung along the tissue tract leading from the chest-wall opening. In an embodiment, the proximal end of thetubular member163 of the workingport151 has a sharpenededge167 to facilitate advancement thereof, through the pleural space and into the lung up to thetarget tissue43. Notably, although a dilation catheter is disclosed for dilating the tissue tract, other modes of dilation also could be used; for example the successive advancement of increasingly larger diameter needles as disclosed in earlier embodiments.
• Anexcision device160 is then advanced through the tissue tract (e.g. a fixed-diameter channel provided by thetubular member163 of the workingport151 or other sleeve, or within an unsheathed tract if no sheath or sleeve is emplaced), over thecatch wire156, until it reaches thetarget tissue43 as shown inFIGS. 32-34. Theexcision device160 is advanced against the distal counterforce exerted against thetarget tissue43 from behind by tensioning thecatch wire156, which is fixed to thetarget tissue43 by thetissue anchor157. This prevents thetarget tissue43 from being pushed further into the patient by advancement of theexcision device160, possibly toward larger vascular or airway structures. It also fixes thetarget tissue43 in place to assist in the subsequent coring step.
• Preferably theexcision device160 comprises a hollow tubular member orsleeve164 that terminates in a sharpcircumferential cutting edge165 at its proximal end, which is advanced toward thetarget tissue43. In this manner thesleeve164 of theexcision device160 is configured to core out a plug of tissue via simultaneous advancement and rotation through the tissue. Theexcision device160 preferably is connected at its distal end to arigid actuation rod166 by which it is advanced from outside the body, and can be rotated via rotation of theactuation rod166. To excise thetarget tissue43, theexcision device160 is advanced through the fixed-diameter sleeve (e.g. thetubular member163 of the working port151) until its sharpenedcutting edge165 arrives adjacent thetarget tissue43. Preferably the diameter of its tubular member164 (and that of the surrounding sleeve) has (have) been selected to accommodate at least a portion of thetarget tissue43, more preferably the full dimensions of thetarget tissue43 as well as some surrounding tissue. Upon arriving adjacent thetarget tissue43, theexcision device160 can be alternately rotated clockwise and counterclockwise via manipulation of theactuation rod166 from outside the body, while simultaneously pressing it forward toward thetarget tissue43 against the counterforce applied thereto by tensioning thecatch wire156. By this operation, the sharpenededge165 of theexcision device160 makes a circular slice of the tissue surrounding thetarget tissue43, and is advanced over thetarget tissue43 through that slice, preferably until its proximal cutting edge reaches thetissue anchor157. At that point theexcision device160 has cored out thetarget tissue43 as well as some surrounding tissue, with the core located within thehollow tubular member164 of theexcision device160. Thetarget tissue43 then is excised and removed from the body by simultaneously withdrawing both thecatch wire156 and theexcision device160 through the fixed-diameter channel (or through the tissue tract if no fixed-diameter sleeve was placed), through the opening in the chest wall to the outside. This can be seen inFIG. 35. Then thetarget43, enclosed within the tissue core that is located within theexcision device160 can be delivered to a specimen collection vessel, Petri dish or other receptacle for ex vivo testing and analysis, such as pathological or microbiological analysis.
• After thetarget tissue43 is excised, a sealingguidewire162 can be passed through the channel or tissue tract (e.g. through thetubular member163 of the workingport151 if still in place), until its proximal end reaches the vicinity from which thetarget tissue43 was excised, as shown inFIGS. 35 and 36. Asealing device200 is then advanced over the sealingguidewire162. In another embodiment, thesealing device200 is advanced over theneedle154 that was advanced through the pleura and maintained in place to serve as a guide for thesealing device200. The vacuum provided at the aperture(s)153 of the working port151 (if present), in addition to maintaining negative pressure in the pleural space or within the parenchymal track through the lung to prevent lung collapse from air leak or bleeding, also draws the tissue tract against the sealingdevice200 to facilitate uniform, robust sealing. Thesealing device200 comprises a proximal tip that can impart energy to facilitate sealing, such as thermal energy, electrical energy, RF or from a laser. Examples include, but are not limited to, a diode laser, a laser of any of a number of frequencies designed to impart heat to the surrounding tissue that seals the tract. Another example includes a proximal tip comprising a cryogenic mechanism adapted to seal the tract using cryoablation. Further examples provide asealing device200 that utilizes steam/vapor or microwave sealing. Thesealing device200 is actuated and pulled back towards the operator to initiate sealing the tract. If a fixed-diameter sleeve (such as thetubular member163 of the working port151) is present, then the proximal end of thesealing device200 is advanced beyond the proximal end of that sleeve, and both can be withdrawn together. In this manner, as the sleeve is withdrawn exposing fresh tissue, the proximal end of thesealing device200 arrives at and supplies energy to that tissue to cauterize it. This procedure may be followed until the entire assembly has been withdrawn and the entire length of the tissue tract cauterized or sealed. The energy is imparted to the surrounding tissue tract as thesealing device200 cauterizes (e.g. burns and seals) that tissue, preventing the egress of blood or air.
• In another embodiment, fluid can be expelled through the proximal end of thesealing device200 as it is withdrawn. Example fluids that can be expelled through the proximal end of thesealing device200 include: natural/biological adhesives (such as polypeptide/protein-based adhesives, fibrin-based adhesives, gelatin-based adhesives, collagen-based adhesives, albumin-based adhesives, polysaccharide-based adhesives, chitosan-based adhesives, human blood-based adhesives, and animal-based adhesives) and synthetic and semi-synthetic adhesives (such as cyanoacrylates, polyethylene glycol hydrogels, urethane-based adhesives, and other synthetic adhesives). The fluid can fill the volume of the tract and can be heated with RF energy (e.g. wet electrode) or laser beyond the temperature of the surrounding tissue, to a temperature sufficient to cauterize and seal the surrounding tissue. The combination of the fluid and the RF seals the surrounding tissues and prevents the leakage of blood, air, lymph tissue, etc.
• After the tract has been sealed, the wound is assessed for bleeding or air leakage. If a leak is found, the tract can be retreated, or alternatively a chest tube can be inserted to drain fluid from the pleural space surrounding the lung and/or from the chest outside the pleura. Advantageously, the chest tube may be inserted in the already extant tract, thus eliminating the need to introduce an additional wound to the patient. The chest tube can be left in the tract and attached to a suction apparatus to provide suction to the lung and pull the tissue in close apposition to the chest tube in the conventional manner. Over a period of time, as the tract heals and internal bleeding subsides, the chest tube can be removed in the conventional manner and the wound dressed.
• In an embodiment, a carbon dioxide sensor is positioned within or in communication with the workingport151 during the entire procedure to sample gas/liquid within the pleural space to determine if air containing carbon dioxide is leaking out of the cut surface of the tract in real time. In this embodiment such a CO₂sensor can provide an indication if the lung has been nicked and is therefore leaking air, or if the operative puncture through the lung to reach the operative site adjacent thetarget tissue43 has not been completely or properly sealed.
• In an alternative method, anexcision device160 can be advanced over theinflated dilation catheter159, as shown inFIGS. 30 and 31 to excise the target tissue located proximally of theinflated dilation catheter159. In this embodiment theexcision device160 can take the form of the workingport151 above described, but withtubular member163 of the workingport151 configured to core out a plug of tissue via simultaneous advancement and rotation through the tissue. That is, the workingport151 serves as the excision device to core out the target tissue beyond the inflated dilation catheter. To excise thetarget tissue43, theexcision device160/workingport151 is advanced until its sharpenededge167 arrives adjacent thetarget tissue43. Preferably the diameter of itstubular member163 has been selected to accommodate at least a portion of thetarget tissue43, more preferably the full dimensions of thetarget tissue43 as well as some surrounding tissue. Upon arriving adjacent thetarget tissue43, theexcision device160/workingport151 can be alternately rotated clockwise and counterclockwise from outside the body, while simultaneously pressing it forward toward thetarget tissue43 against the counterforce applied thereto by tensioning thecatch wire156. By this operation, the sharpenededge167 makes a circular slice of the tissue surrounding thetarget tissue43, and is advanced over thetarget tissue43 through that slice, preferably until its proximal sharpenededge167 reaches thetissue anchor157. At that point theexcision device160/workingport151 has cored out thetarget tissue43 as well as some surrounding tissue, with the core located within thetubular member163. Thetarget tissue43 then is excised and removed from the body by simultaneously withdrawing both thecatch wire156 and theexcision device160/workingport151 through the tissue tract and through the opening in the chest wall to the outside. As will be appreciated, in this embodiment thedilation catheter159 also should be withdrawn in tandem with the withdrawal of the workingport151 acting as the excision device, in order to permit the core oftarget tissue43 therein to be withdrawn distally through the tissue tract. To achieve this thedilation catheter159 can be deflated, slightly or completely, to facilitate its withdrawal together with the workingport151 and the core oftarget tissue43 beyond thedilation catheter159 proximal end. Asealing device200 may thereafter be inserted into the tissue tract, optionally along or over the needle if it has remained in place since the beginning of the procedure, and then actuated to seal the tract upon withdrawal thereof in the manner above described. Thetarget43, enclosed within the tissue core that is located within thetubular member163 can be delivered to a specimen collection vessel, Petri dish or other receptacle for ex vivo testing and analysis, such as pathological or microbiological analysis.
• In another embodiment, rather than advancing adilation catheter159 through the workingport151 and over thecatch wire156 as illustrated inFIG. 28, theexcision device160 is advanced directly over thecatch wire156, until it reaches thetarget tissue43 as shown inFIG. 37. To facilitate this theexcision device160 includes a central bore through which thecatch wire156 can pass in order to guide theexcision device160 through the tissue tract to the target tissue. Theexcision device160 is advanced against the distal counterforce exerted against thetarget tissue43 from behind by tensioning thecatch wire156, which is fixed to thetarget tissue43 by thetissue anchor157. This prevents thetarget tissue43 from being pushed further into the patient by advancement of theexcision device160, possibly toward larger vascular or airway structures. It also fixes thetarget tissue43 in place to assist in the subsequent coring step, as described regardingFIGS. 32-35.
• In another embodiment, after thecatch wire156 is anchored from behind thetarget tissue43 via thetissue anchor157, asuction catheter168 can be advanced over thecatch wire156, as illustrated inFIG. 38. Thesuction catheter168 can be advanced against the counterforce applied to thetarget tissue43. Thesuction catheter168 is a hollow tubular member having a proximal end with one ormore apertures169. A distal end of thesuction catheter168 is in communication with a vacuum source. Thesuction catheter168 is of a predetermined length such that the proximal end can extend into the chest, e.g. within the pleural space and through the lung up to thetarget tissue43, when inserted through the opening in the chest wall and the distal end resides outside of the body. The inner diameter of thesuction catheter168 is greater than the outer diameter of thecatch wire156. The vacuum source coupled to the distal end of thesuction catheter168 resides outside of the body, and is effective to draw a vacuum on thesuction catheter168. The resulting vacuum drawn through the aperture(s)169 therein maintains a negative pressure within the chest to keep the lungs fully expanded during an operation, and further pulls the lung tract down toward thesuction catheter168. This suction allows the removal of blood, fluid, and air that could otherwise collapse the lung away from the chest wall (i.e. prevent an intra procedural hemopneumothorax). In one embodiment, the vacuum drawn through the aperture(s)169 is −5 cmH₂O to −100 cmH₂O. With thesuction catheter168 in place, the remaining steps (dilation of tract with thedilation catheter159, excision oftarget tissue43 with theexcision device160, and sealing of the tract with the sealing device200) can be performed while vacuum is maintained within the tissue tract.
• In another embodiment, thedilation catheter159 with an elongated toroidal configuration is advanced over thecatch wire156 in a deflated state against a counterforce applied by tensioning thecatch wire156 in a distal direction from outside the chest, as shown inFIGS. 39 and 40. Thedilation catheter159 is advanced through the pleural space and into the lung over thecatch wire156, up to thetarget tissue43 positioned adjacent thetissue anchor157. Thedilation catheter159 can be a balloon catheter that extends at least from the chest wall through the pleural space and into the lung, up to thetarget tissue43 along the tract followed by thecatch wire156. Thedilation catheter159 inFIG. 39 is illustrated as including concentric first (outer) and second (intermediate)tubes202 and203, respectively, as shown in the cross-section of line A-A andFIG. 40. When thedilation catheter159 is inflated the first andsecond tubes202 and203 have constant diameters and define therebetween an annular space such that thedilation catheter159 has the form of an elongated toroid whose volume is a ring-shaped cylindrical projection defined between thefirst tube202 and thesecond tube203. Preferably one or both of thetubes202 and203 (preferably at least the outer tube202) is/are formed a part of the continuous flexible wall of thedilation catheter159, such that it is ordinarily collapsed or collapsible when thecatheter159 is not inflated, and attains its expanded, fixed diameter as shown inFIG. 40 only upon inflation of thecatheter159 with inflation fluid. In this embodiment a channel is formed at the center of thedilation catheter159 extending along its length. Thecatch wire156 extends through the channel of thedilation catheter159. Once the dilation catheter has been inserted and dilated, theexcision device160 can be advanced through the channel over thecatch wire156, until it reaches thetarget tissue43. Theexcision device160 is advanced against the distal counterforce exerted against thetarget tissue43 from behind by tensioning thecatch wire156, which is fixed to thetarget tissue43 by thetissue anchor157. This prevents thetarget tissue43 from being pushed further into the patient by advancement of theexcision device160, possibly toward larger vascular or airway structures. It also fixes thetarget tissue43 in place to assist in the subsequent coring step, as described regardingFIGS. 32-35. Upon reaching the target tissue theexcision device160 can be actuated to core out the target tissue or a part thereof, and withdrawn as disclosed for preceding embodiments. Thereafter, asealing device200 as previously described can be inserted through the channel in order to seal the tract upon deflation and withdrawal of thedilation catheter159, preferably in tandem with actuation and withdrawal of thesealing device200 at a location just beyond the proximal end of the deflateddilation catheter159. As will be appreciated, this embodiment will be effective only if the target tissue to be excised (or that portion thereof that is to be excised) is small enough to fit through the channel at the center of the dilation catheter. That size can be determined ahead of time via CT fluoroscopy or other appropriate technique as noted above, so that a properlysized dilation catheter159 can be selected for the procedure.
• While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification, and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth, and as fall within the scope of the invention and the limits of the appended claims.

Claims (14)

1-11. (canceled)

12. A method of excising a nodule within a lung of a patient, comprising anchoring a catch wire from the nodule, tensioning the catch wire through a tissue tract extending between the nodule and an opening in a body wall, dilating the tissue tract via inflation of a dilation catheter within said tract that extends through a pleura surrounding the lung and into the lung up to the nodule, and advancing an excision device along the catch wire to excise the target tissue against a counterforce applied by tensioning the catch wire.

13. The method ofclaim 12, the dilation catheter being inserted into the tissue tract over and along the catch wire and advanced toward the nodule against a counterforce supplied by tensioning the catch wire.

14. The method ofclaim 13, the excision device comprising a hollow sleeve having a circumferential cutting edge, and advancing the excision device until the nodule is disposed within the excision device, and thereafter withdrawing the excision device.

15. The method ofclaim 14, further comprising simultaneously withdrawing the catch wire and the excision device until they emerge from the opening in the body wall, the catch wire being anchored from the nodule via a tissue anchor engaged against the nodule at a side opposite the body-wall opening.

16. The method ofclaim 13, further comprising, after the tissue tract is dilated, inserting a fixed-diameter sleeve over the inflated dilation catheter to provide a fixed-diameter passageway along the tissue tract, thereafter deflating and withdrawing the inflation catheter from the tissue tract, and thereafter inserting therein an excision device up to the nodule, the excision device comprising a hollow sleeve having a circumferential cutting edge, and advancing the excision device until the nodule is disposed within the excision device.

17. A method of excising target tissue, comprising:

tensioning a catch wire from a proximal end thereof located adjacent a target tissue within a patient;

dilating a tissue tract between a body wall of the patient and the target tissue via inflation of a dilation catheter extending therebetween;

inserting an excision device through the dilated tissue tract and over the inflated dilation catheter; and

advancing the excision device along the catch wire and toward the target tissue against a counterforce applied by tensioning the catch wire, thereby making a slice in tissue surrounding the target tissue via a cutting edge of the excision device and advancing the excision device over the target tissue through the slice until the target tissue is located within the excision device.

18. The method ofclaim 17, further comprising withdrawing the tissue anchor, the excision device and the dilation catheter in tandem until the target tissue arrives outside a body of the patient.

19. A method of excising target tissue, comprising:

tensioning a catch wire from a proximal end thereof located adjacent a target tissue within a patient;

dilating a tissue tract between a body wall of the patient and the target tissue via inflation of a dilation catheter extending therebetween;

inserting an excision device through the dilated tissue tract via a channel at the center of the inflated dilation catheter; and

advancing the excision device along the catch wire toward the target tissue against a counterforce applied by tensioning the catch wire, thereby making a slice in tissue surrounding the target tissue via a cutting edge of the excision device and advancing the excision device over the target tissue through the slice until the target tissue is located within the excision device.

20. The method ofclaim 12, further comprising inserting the excision device over the inflated dilation catheter and advancing the excision device toward the target tissue against the counterforce, making a slice in tissue surrounding the target tissue via a cutting edge of the excision device and advancing the excision device over the target tissue through the slice until the target tissue is located within the excision device.

21. The method ofclaim 19, further comprising withdrawing the tissue anchor, the excision device and the dilation catheter in tandem until the target tissue arrives outside a body of the patient.

22. The method ofclaim 12, further comprising inserting the excision device through a channel at the center of the inflated dilation catheter and advancing the excision device toward the target tissue against the counterforce, making a slice in tissue surrounding the target tissue via a cutting edge of the excision device and advancing the excision device over the target tissue through the slice until the target tissue is located within the excision device.

23-37. (canceled)

38. An apparatus configured to excise target tissue, the apparatus comprising:

a catch wire tensionable from a proximal end thereof from a target tissue within a patient;

a dilation catheter configured to be inflatable to dilate a tissue tract between a chest wall of the patient and the target tissue;

an excision device configured such that in use it can be advanced along the catch wire and over the inflated dilation catheter against a counterforce applied by tensioning the catch wire, to make a slice in tissue surrounding the target tissue via a cutting edge of the excision device, and to advance over the target tissue through the slice until the target tissue is located within the excision device.

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