Device and method for treating cancerous lesions and like

Abstract

The present invention relates to devices and methods for treating cancerous lesions and the like. The device (1; 5) comprises: a protective sleeve (7); a tubular suction member (9) coaxially receivable in the protective sleeve (7); a conduit (21) coaxially housed in the tubular suction member (9) and adapted to internally house the optical fiber (23). The catheter is equipped, at its distal end (21A), with an inflatable balloon (25) adapted to be inflated by means of a fluid delivered through the catheter (21). A protective sleeve (7) is axially movable relative to the tubular suction member (9) and the conduit (21).

Description

[0001] This application is a divisional application of the invention patent application entitled "Apparatus and Method for Treating Cancerous Lesions, etc.", with an international application date of July 8, 2019, international application number PCT / IB2019 / 055787, and national application number 201980057337.7. Technical Field

[0002] This invention relates to surgical devices for treating cancerous lesions. The embodiments disclosed herein particularly relate to devices for minimally invasive treatment of breast lesions.

[0003] They also disclosed a method for minimally invasive treatment of cancerous lesions, particularly breast lesions. Background Technology

[0004] Breast cancer is the leading cause of cancer death among women and the leading cause of death at all ages, accounting for 30% of cancer deaths before age 50, 22% between age 50 and 69, and 15% after age 70 (Source: ISTAT). A continuously declining trend in breast cancer mortality has been observed (-2.2% / year), attributed to the greater dissemination of early diagnostic procedures and scientific advances along with the development of treatment procedures (Italian Association of Medical Oncology, 2017).

[0005] Increased focus on prevention has made it increasingly possible to diagnose early-stage breast cancer, particularly in clinical stages T1a and T1b, which include lesions smaller than 1 cm without signs of lymph node metastasis. This allows surgeons to perform increasingly conservative procedures.

[0006] The need for minimally invasive techniques and surgeries, coupled with advancements in diagnostic imaging, has become a necessity, further reinforced by the growing patient demand for conservative surgery.

[0007] For example, minimally invasive methods such as thermal ablation or laser thermotherapy have the advantage of achieving a pathological response that is completely equivalent to surgical treatment, and have significant improvements in aesthetics, patient comfort, and reduction of morbidity and cost.

[0008] Lasers offer an excellent means of inducing localized temperature increases within tissues, which can be used for minimally invasive tumor treatment through the resulting localized temperature rise and subsequent tissue necrosis. Laser-interstitial hyperthermia (LITT) is based on the localization of one or more applicators within the tumor tissue, which deliver a specific dose of laser energy over a given time using very small optical fibers (0.3 mm in diameter). In percutaneous approaches assisted by modern imaging techniques, guide needles of varying sizes are used to position the optical fiber or laser energy applicator. Following this initial step, the laser device is activated and energy is supplied to begin treatment. According to the laws of laser-tissue interaction, the radiation emitted by the applicator emitter diffuses into the surrounding tissue.

[0009] Currently, the diagnostic and treatment procedures involve the following sequence of operations:

[0010] A) Vacuum-assisted lesion biopsy performed by, for example, multiple extractions of tumor tissue using biopsy techniques performed with Mammotome (registered trademark) or similar systems;

[0011] B) Histological evaluation of biopsy cell membranes and tumor classification;

[0012] C) Perform a new surgical procedure to remove the lesion with healthy margins;

[0013] D) Postoperative surgical treatment (determined based on the results of histological analysis).

[0014] Bi-Rads classification performed prior to histological confirmation of biopsy samples yields five possible results: B1-B2-B3-B4-B5, where:

[0015] B1: Normal tissue

[0016] B2: Benign lesion

[0017] B3: Lesions with an uncertain probability of malignancy; the overall positive predictive value (VPP = number of malignant lesions found during surgery / number of surgical lesions) for this category is approximately 25-35%.

[0018] B4: Suspected lesion. This diagnostic category has a low frequency (<2%) in vacuum-assisted biopsy samples; the positive predictive value is 85%.

[0019] B5: Malignant neoplasm; it is a malignant lesion that may include carcinoma in situ, invasive carcinoma, and other rarer malignancies (lymphoma, sarcoma, etc.).

[0020] The same Bi-Rads classification applies to microcalcifications, which, like tumor lesions, require histological confirmation. The methods and apparatus described in this article can also be used for microcalcifications.

[0021] Currently, lesions classified as B4 and B5 are referred for surgery with the aim of completely eradicating the disease by achieving a healthy margin. Lesions in category B3 require a more comprehensive evaluation, the outcome of which may lead to subsequent or subsequent resection surgery (in more than 50% of cases).

[0022] Consultations during follow-up for B3 lesions often lead to anxiety in women carrying the lesion, who may subsequently experience a worsening of the condition and face the possibility of requiring more radical surgical treatment. Conversely, B3 lesions pointing to surgery for highly suspected malignancy occur in only 25% to 35% of malignant tumor types, and are therefore identified as overtreatment (resection surgery) in women in which it would not be necessary (65-75% of cases). In any case, in addition to vacuum-assisted biopsy procedures, a subset of women with a B3 biopsy classification and all women with B4-B5 classifications undergo a second surgical removal and extension of the biopsy margin.

[0023] The goal is to find new surgical techniques and new instruments for this purpose to reduce the drawbacks of the methods described above. Summary of the Invention

[0024] According to one aspect, an apparatus is provided, the apparatus comprising: a protective sleeve; a tubular suction member coaxially housed within the protective sleeve; a conduit coaxially housed within the tubular suction member and adapted to house an optical fiber therein; wherein the conduit is provided at its distal end with an inflatable balloon adapted to inflate by means of fluid transmitted through the conduit; and wherein the protective sleeve is axially movable relative to the tubular suction member and the conduit.

[0025] Other advantageous features and embodiments of the device are described below and pointed out in the appended claims, which form part of this specification.

[0026] A kit is also disclosed, comprising a biopsy needle, such as, but not exclusively, a vacuum-assisted biopsy needle, and a device as defined above and having an external cannula.

[0027] The device and kit allow for the resection of tumor tissue from lesions or other sites, as well as laser thermotherapy of the edges of cavities created by the resection. Therefore, minimally invasive procedures can be performed to treat lesions through resection followed by coagulation and / or ablation via laser radiation.

[0028] The coagulation and ablation processes serve a dual purpose. First, coagulation aims to stop any bleeding, whether intraoperative bleeding (which would lead to premature interruption of the biopsy procedure) or postoperative bleeding (which represents one of the most common complications requiring subsequent treatment). Ablation aims to destroy any tumor cells not extracted by vacuum-assisted biopsy procedures or other core needle biopsies. For this last reason, it is important to induce cell death in a portion of the tissue surrounding the area undergoing the biopsy in order to obtain a safe margin around the tumor lesion.

[0029] The procedure described may be particularly useful for treating tumors of the breast, but the possibility of applying the methods and apparatus disclosed herein to the treatment of other types of lesions (typically, but not exclusively, tumor types in humans and animals, and therefore within the medical and veterinary fields) is not excluded. The possibility of extending the treatment to the plant field is also not excluded.

[0030] In some applications, the method can include real-time, on-site histological analysis during the removal of diseased tissue to achieve rapid and minimally invasive treatment, which can also reduce the psychological and physical suffering of patients. Attached Figure Description

[0031] The invention will be better understood from the following description and accompanying drawings, which illustrate exemplary but non-limiting embodiments of the invention. More specifically, the drawings show:

[0032] Figure 1 Longitudinal section of a device for minimally invasive surgery on tumors, particularly but not exclusively breast tumors;

[0033] Figure 2 :according to Figure 1 The cross section of line II-II;

[0034] Figure 3A and 3B : respectively Figure 1 Enlarged views of the distal and proximal portions; and

[0035] Figures 4A-4F : can be used Figure 1 A series of steps in the surgery performed using a device up to 3. Detailed Implementation

[0036] In the embodiments described herein, the device may be combined with or be part of a kit for any type of core needle biopsy (e.g., for vacuum-assisted biopsy). The kit may also include an external cannula, which may be part of the device or the biopsy needle kit. The device is configured to perform laser treatment on the edges of a cavity created by the biopsy needle in the treated tissue. The biopsy needle can be used to remove cancerous lesions, etc., from an organ or tissue of the object to be treated, in the form of one or more tissue cell membranes. Once a cavity has been created in the tissue and the entire lesion tissue has been removed, a device with a catheter can preferably be inserted through the same cannula used for removing the lesion tissue by the biopsy needle. The catheter is adapted to accommodate an optical fiber and an expandable or inflatable balloon applied to or near the distal end of the catheter.

[0037] The catheter may have one or two channels for introducing and removing balloon-inflated fluid. Preferably, two channels are provided to achieve continuous or intermittent (i.e., discontinuous) circulation of the inflated fluid. A tubular aspiration member may be associated with the catheter. This tubular aspiration member may be coaxial with the catheter and located outside the catheter. One or more aspiration tubes may be formed in the wall of the tubular aspiration member, and one or more tubes may be formed for feeding cleaning fluid to clean the cavity before, after, or during treatment.

[0038] Using this type of kit, a treatment method can be performed that provides a first step of removing diseased tissue and a second step of laser treatment, ablation, and / or coagulation of the edges of the cavity created by the removal. As will become apparent from the following description, these two treatment steps can be performed in the same stage, particularly when the tissue extracted in the first step can undergo on-site (i.e., real-time) histological analysis. This allows for the introduction of a cannula, through which a biopsy needle and subsequent laser treatment device can be sequentially introduced without removing the cannula.

[0039] In practice, the kit may include an outer cannula, a biopsy needle, and a laser processing device. In other embodiments, the kit may simply include a laser processing device that can be configured to work in combination with a biopsy needle kit, which in turn may include an outer cannula.

[0040] Devices used for laser-assisted removal can be used in combination with devices or kits for Mammotome (registered trademark) type or other types of core needle biopsies.

[0041] Referring now to the embodiments shown in the accompanying drawings, Figure 1 , 2Figures 3A and 3B illustrate a processing device. This device is generally indicated by reference numeral 1. In the illustrated embodiment, device 1 includes or is associated with a main cannula or outer cannula 3, which may be made of, for example, metal. The outer cannula 3 may be part of a biopsy device (e.g., a device for performing a vacuum-assisted biopsy). The outer cannula 3 may be used, for example, to insert a biopsy needle into the tissue or organ to be processed. The outer cannula 3 includes a distal end 3A and a proximal end 3B.

[0042] Using the external cannula 3, a laser treatment device, hereinafter referred to as composite mechanism 5, can be inserted into the tissue to be treated, and its components will be described in detail below. Composite mechanism 5 is used to perform laser thermotherapy on cavities created in tissue to be treated by means of a biopsy needle or otherwise, preferably through the same external cannula 3 as described in the following example of the procedure.

[0043] In some embodiments, the processing device includes a composite member 5 and an outer cannula 3. In other embodiments, the outer cannula 3 may be part of a biopsy kit, and in this case, the device includes the composite member 5 instead of the outer cannula 3. In some embodiments, the device may be part of a kit that includes a biopsy needle, an outer cannula 3, and the composite member 5.

[0044] The composite component 5 includes a protective sleeve 7, which, under operating conditions, is inserted substantially coaxially into the outer sleeve 3. The protective sleeve 7 has a distal end 7A and a proximal end 7B located on the operator's side. For purposes explained below, the protective sleeve 7 is slidable within the outer sleeve 3 according to the double arrow f7.

[0045] According to an exemplary embodiment, the protective sleeve 7 houses a tubular suction member 9, which is generally coaxial with the protective sleeve 7 and has a cylindrical wall. The tubular suction member 9 is provided with one or more tubes 11 formed within the thickness of the cylindrical wall of the tubular suction member 9. Preferably, there are an even number of tubes 11. Preferably, the tubes 11 are equidistant from each other, i.e., they are arranged around the axis AA of the tubular suction member at a constant angular pitch. The tubes 11 can also be formed in different ways, for example, as thin tubes arranged around the axis of the protective sleeve 7. However, for example, for the sake of construction simplicity, it is particularly advantageous to manufacture the tubes 11 within a portion of the thickness of the tubular suction member 9.

[0046] In an advantageous embodiment, pipe 11 has anti-clogging features.

[0047] In the example shown, tube 11 has a distal end 11A aligned with the distal edge 9A of the tubular suction member 9. Figure 3AIn other embodiments not shown, tube 11 may have distal ends distributed at various locations, the distal ends being located both at the distal edge 9A and retracted relative to the distal edge on the outer surface of the tubular suction member 9. Each tube 11 may extend from the corresponding distal end 11A to the proximal end 11B, i.e., the end facing the operator. The proximal end 11B of at least one of the tubes 11 may be positioned to correspond with that indicated by reference numeral 13 (…). Figure 1 The suction components are schematically shown in fluid communication. In some embodiments, all tubes 11 may be positioned in fluid communication with the suction components or multiple suction components 13.

[0048] In other embodiments, the proximal end 11B of at least one of the tubes 11 may be positioned in fluid communication with the fluid feed member 15. Preferably, at least one of the tubes 11 may be connected to the suction member 13 and at least another of the tubes 11 may be connected to the fluid feed member 15 to generate fluid circulation, as described in more detail below and for the purposes set forth below.

[0049] The suction component can be fluidly connected to the collection tank 17, while the feed component 15 can be fluidly connected to the dispensing tank 19 for the cleaning fluid (e.g., physiological solution).

[0050] A conduit 21 is present and located coaxially with and inside the tubular suction member 9, the conduit 21 accommodating an optical fiber 23 extending substantially coaxially with respect to the conduit 21. The optical fiber 23 can be connected to a laser source 24.

[0051] The distal end 21A of the catheter 21 may be associated with an inflatable balloon 25. Specifically, in some embodiments, the inflatable balloon 25 may be secured to the distal end 21A of the catheter 21 via a sealing connection, such that the balloon 25 can be expanded by introducing fluid through the catheter 21, as described in more detail below. The distal end 23A of the optical fiber 23 may protrude from the distal end 21A of the catheter 21 and extend into the inflatable balloon 25. In some embodiments, the optical fiber 23 may slide within the catheter 21 such that its distal end or tip 23A protrudes more or less from the catheter 21 toward the interior of the inflatable balloon 25.

[0052] The proximal end 21B of catheter 21 can be connected to the feed circuit for the filling and expansion fluid of the inflatable balloon 25. In a possible embodiment, the proximal end 21B of catheter 21 may have an inlet connection 21C for the fluid (typically a biocompatible fluid). The biocompatible fluid can be fed via a pumping system and can originate from a feed trough. At the end of treatment, the same connection 21C can also be used to remove the filling and expansion fluid from the inflatable balloon 25 so that the inflatable balloon 25 can return to its minimum volume and be removed from the organ being treated.

[0053] In other embodiments, as shown in the figures, the filling and expansion fluid circulation of the inflatable balloon 25 can be configured to be continuous or discontinuous. For this purpose, as shown in the figures, the catheter 21 can be defined to have an outer tubular element 21y and an inner tubular element 21x that are substantially coaxial with each other (see in particular). Figure 2 , 3A (3B) The outer tubular element 21y and the inner tubular element 21x define an annular conduit therebetween. The optical fiber 23 is housed within the inner tubular element 21x. Thus, the conduit 21 has two channels for introducing and removing filling and expansion fluid into and from the inflatable balloon 25. For example, the filling and expansion fluid can be fed into the inflatable balloon 25 through the connector 21C and the annular channel located between the optical fiber 23 and the inner tubular element 21x, and can be removed from the inflatable balloon 25 through the annular channel located between the inner tubular element 21x and the outer tubular element 21y and through the outlet connector 21D.

[0054] Inlet connector 21C and outlet connector 21D are adapted to connect conduit 21 and thus inflatable balloon 25 to an expansion circuit, schematically indicated by 27, in which the filling and expansion fluid of inflatable balloon 25 circulates. Schematically, expansion circuit 27 includes a circulation pump 29 and may include a heat exchanger 31 to extract heat Q from the filling and expansion fluid circulating in the circuit.

[0055] The expansion circuit 27 is adapted to circulate the filling and expansion fluid of the expandable balloon 25 to maintain sufficient pressure in the expandable balloon 25 to inflate the expandable balloon 25 to the desired size and simultaneously extract heat from the tissue being treated by the circulating fluid.

[0056] In other embodiments not shown, the catheter 21 may be provided with a single connector 21C connected to a circuit for feeding filling and expansion fluid into the inflatable balloon 25. In this case, fluid is introduced into the inflatable balloon 25 to inflate it, but the fluid does not circulate. At the end of the treatment, the fluid is discharged from the inflatable balloon 25 through the same connector through which the fluid was introduced into the inflatable balloon to inflate it. In this case, the external tubular element 21y and the outlet connector 21D can be omitted due to the advantage of a smaller diameter catheter 21.

[0057] In some embodiments, the filling and expansion fluid supplied to the expandable balloon 25 may include diffusing particles, such as particles of hydroxyapatite, TiO2, Al2O3, or BaSO4, to achieve a more uniform diffusion of laser radiation emitted from the tip of the optical fiber 23. The use of diffusing particles may be particularly useful when the optical fiber 23 has a flat tip 23A. In other embodiments, other features are conceivable to achieve an approximately spherical distribution of light radiation from the optical fiber 23; for example, an optical fiber 23 with a conical tip may be used.

[0058] Having described apparatus 1, the steps of a possible treatment method will now be illustrated by examples. For instance, refer to a procedure for treating lesions in breast M. The possibility of using the apparatus and methods described herein to treat other types of lesions, particularly other neoplastic lesions, is not excluded.

[0059] by Figures 4A to 4F The sequence of steps is illustrated in the example.

[0060] In possible embodiments, the process may provide the first step of removing the tumor lesion using a vacuum-assisted biopsy system or other systems that typically use biopsy needles.

[0061] The resection can be performed by repeatedly extracting tumor tissue using a vacuum-assisted system, such as the Mammotome system (registered trademark). More generally, resection can be performed via a minimally invasive device introduced into the tissue of the breast (or other organ to be treated) through a cannula (such as the external cannula 3 described above).

[0062] Figure 4A , 4B The procedure is illustrated. A biopsy aspiration needle (denoted by 41), i.e., a needle for vacuum-assisted biopsy, or other suitable surgical instrument, is introduced into the tissue containing the tumor lesion T to be removed. Introduction can be made via an external cannula 3. The resection procedure can be performed under the control of an ultrasound device or other imaging system.

[0063] In the procedure described herein, the removal of tissue cell membranes can be repeated multiple times until all suspicious tissue is removed, thereby leaving an empty cavity CV in the tissue.

[0064] According to Figure 4A , 4B To understand this characteristic, follow the 4C sequence. Figure 4A , 4B Two successive operations are shown (since other operations can be performed at different angles of needle 41, they need not be sequential), thereby removing two tissue cell membranes. At the end of this first part of the procedure, designed for the removal of the mass ( Figure 4CThe biopsy needle 41 can be removed through an external cannula 3, which remains inserted into the tissue. A lumen CV is left anterior to the distal end of the external cannula 3, which was previously occupied by the removed tissue. Figure 4C In this case, the cavity CV is shown as an empty space, although this space may actually be temporarily occupied, wholly or partially, by surrounding tissue that fills the space previously occupied by the tissue removed by the biopsy needle 41 until the subsequent operations described below.

[0065] Each extracted cell membrane, or at least some of them, can undergo real-time, i.e., on-site histological analysis. Real-time or on-site analysis, in this context, refers to histological analysis performed during the surgical procedure. On-site histological analysis allows the operator to decide whether and to what extent to perform tissue resection to eliminate the entire tumor mass via a biopsy needle (or other suitable instrument) through an external cannula 3 using subsequent procedures.

[0066] During the first step of the operation, in some embodiments, it is conceivable, for example, to divide each cell membrane or sample (or at least some of them) of the extracted tissue into two parts according to a longitudinal plane to obtain a first part of the tissue sample and a second part of the same cell membrane or tissue sample, the first part undergoing real-time histological analysis, and the second part being used for delayed second histological analysis for prognostic factors and associated post-treatment. Figure 4A The cell membrane F is schematically shown divided into two parts, F1 and F2, along the longitudinal plane PP. One of the two parts, F1 and F2, was used for on-site histological analysis, while the other was preserved for subsequent histological analysis.

[0067] As described above, sample collection is repeated multiple times until complete resection of the tumor tissue is performed using a biopsy needle. Real-time histological analysis allows for immediate verification of the nature of the lesion. In practice, the next step is performed only if the histological analysis determines that the removed tissue falls within a lesion classified as B3, B4, or B5 as defined above.

[0068] If real-time histological analysis determines that the lesion is malignant or potentially malignant, it is preferable to perform the next debridement step, and possibly a coagulation step, by laser thermotherapy of the lesion margins (i.e., the residual cavity CV surface) during the same phase. Advantageously, this second step is preferably performed by inserting the laser treatment member 5 into the same external cannula 3 used to introduce the biopsy needle.

[0069] In the second step, the biopsy needle 41 is first removed from the outer cannula 3. Subsequently, the device 5 is introduced through the same outer cannula 3, or more precisely, the outer cannula 3 (which is already in place).

[0070] Figure 4D This introduction, schematically shown, can be performed under the control of an ultrasound device or other imaging device. The composite component 5 is... Figure 1 , 3A The arrangement of 3B is used, in which the inflatable balloon 25 is reduced and protected within the protective sleeve 7.

[0071] Once the distal portion 7A of the protective sheath 7 of the composite mechanism 5 has entered the cavity CV formed in the tissue of the breast M during the previous stage of tumor removal via the biopsy needle 41, the protective sheath 7 can be retracted into the outer sheath 3, wherein the catheter 21 and the inflatable balloon 25 remain axially fixed, allowing the protective sheath 7 to release the inflatable balloon 25 into the cavity CV. Figure 4E The step is illustrated schematically in the diagram.

[0072] Once this state is achieved, the inflatable balloon 25 located in the cavity CV can be inflated by the filling and expanding fluid from the expansion circuit 27. The pressure of the filling and expanding fluid, for example, causes the inflatable balloon 25 to adhere to the inner surface of the cavity CV, thereby compressing the surrounding tissue. Figure 4F The condition reached at the end of the inflation step of the inflatable balloon 25 is shown.

[0073] A filling and expansion fluid can be fed until a suitable pressure is reached and thus the inflatable balloon 25 is properly expanded. The fluid feed can then be interrupted to maintain the pressure within the inflatable balloon 25 at the reached pressure. Alternatively, in other embodiments, the filling and expansion fluid can be circulated continuously or discontinuously within the inflatable balloon 25, for example, to remove heat from the treated area, thereby avoiding localized overheating and any tissue carbonization that could slow or impede the propagation of laser radiation.

[0074] Once the balloon 25 has reached its inflated state, such as Figure 4F As shown, a cleansing step can be performed on the edges of the removed lesion, that is, the step of clearing the surface of the cavity CV formed in the previous resection step. For this purpose, laser radiation is injected into optical fiber 23 by laser source 24 and radiated through the tip or distal end 23A of optical fiber 23 into the internal space of the inflatable balloon 25. The radiation passes through the wall of the inflatable balloon 25 directly or after multiple reflections and diffusions by diffusing particles contained in the filling and expansion fluid, for which the wall is either diffusing radiation at the wavelength of the laser radiation or is permeable. The radiation emitted through the wall of the inflatable balloon 25 acts on the surrounding tissue.

[0075] The heat generated by the absorption of laser radiation in the tissue surrounding the cavitary CV causes denaturation and thus leads to the clearance of the tissue around the cavitary CV, creating a sufficient safety margin to eliminate any residual tumor cells. Furthermore, the thermal energy has a coagulation effect, which avoids, reduces, or stops potential bleeding that may have been caused by previous tumor tissue resection.

[0076] During one or more of the above steps, suction can be initiated through at least one, some, or all of the tubes 11 using the tubular suction member 9, for example, to remove debris in liquid, solid, or gaseous form generated in the cavity CV during laser processing. Figure 1 , 2 In embodiments 3A and 3B, all tubes 11 terminate at the same axial position, which is advantageously located (when the device is in the operating position) behind the tip of the optical fiber 23, i.e., rearward relative to the distal end 23A of the optical fiber 23, so as not to interfere with the transmission of laser energy. However, as mentioned above, the possibility of tubes 11 having different lengths and, for example, having variable extensions beyond the distal end of the tubular member 9 is not excluded.

[0077] Although in some embodiments all tubes 11 can be suction tubes, in other embodiments, such as in Figure 1 As schematically shown and described above, at least one of the tubes 11 is a suction tube, and at least one of them is configured to deliver cleaning fluid in order to perform continuous or intermittent cleaning of the cavity CV during one or more steps of the procedure described herein, and typically during the laser energy transfer step.

[0078] Once the laser treatment step is complete, the instrument can be removed and the patient can undergo postoperative treatment in the usual time and manner, determined by the results of delayed histological analysis performed on the sample not used for real-time histological analysis. Histological analysis can also be performed on any neoplasm obtained from the breast tissue surrounding the laser-removed portion during surgery. This is particularly appropriate in the validation and development steps of the methods described herein.

[0079] To retrieve the device, the reverse order of operations can be performed. First, once the transmission of laser radiation from laser source 24 has been interrupted, the inflatable balloon 25 is collapsed by aspirating fluid (previously used to inflate the balloon 25). Once the inflatable balloon 25 has collapsed, the distal portion 7A of the protective sheath 7 is advanced until the entire inflatable balloon 25 is protected therein. Then, the composite component 5, including the protective sheath 7, the tubular aspiration member 9, the catheter 21, the optical fiber 23, and the inflatable balloon 25, is retrieved by sliding within the outer sheath 3. Finally, the outer sheath 3 is removed.

[0080] Alternatively, the catheter 21, together with the inflatable balloon 25 attached thereto, can be retracted into the protective sheath 7, and the protective sheath 7 can subsequently be retracted from the outer sheath 3. In other embodiments, the retraction movements of the catheter 21 and the inflatable balloon 25, the protective sheath 7, and the outer sheath 3 can be performed in any other suitable sequence to avoid the risk of damage to tissues and / or device components.

[0081] As will be understood from the above description, in this way, a minimally invasive method is obtained, which uses the minimally invasive method to form a cavity CV within the organ M to be treated, and within the cavity CV, in the same operational phase, laser energy is subsequently distributed to remove an appropriate tissue thickness for therapeutic purposes—for example, from about 0.1 mm to about 20 mm, preferably from about 1 mm to about 10 mm—while preventing any bleeding originating from the cavity wall or from ducts or blood vessels within the treated biological tissue by coagulation.

[0082] The proposed method does not alter the postoperative treatment approach in any way (e.g., pharmacological treatments deemed necessary by oncologists).

[0083] In the Figures 4A-4F The description of the treatment method shown assumes that an on-site histological analysis is performed, and subsequent procedures for further excision and laser thermotherapy are performed based on the results of this histological analysis. However, the methods and apparatus described herein are also suitable for treating lesions where on-site histological analysis is not possible for any reason. This occurs, for example, with certain types of suspected microcalcifications requiring histological confirmation. In this case, a biopsy is initially performed in the first operational phase. Subsequently, histological analysis is performed in the laboratory.

[0084] It can be advantageously achieved through roughly as described above and in Figures 4A-4C The protective cannula 3 shown in the diagram utilizes a biopsy needle for vacuum-assisted biopsy or other types of instruments to perform a biopsy until a cavity CV is obtained in the tissue. An excision step can be performed until the lesion has been completely removed.

[0085] The removed tissue was then subjected to histological analysis in the laboratory. Based on the test results, a second step of the treatment could be performed, including laser ablation of the lesion margins. In this case, since histological analysis was performed after the biopsy, a second operational step was performed in the second stage, thereby reintroducing the external cannula 3 until it reached the previously formed cavity, and then introducing the composite member 5 through the external cannula 3 and performing... Figure 4D , 4E The above operations are shown in 4F.

[0086] The possibility of implementing this method with a different approach, where a first removal of tissue is performed in the first step, followed by histological analysis. If the histological analysis confirms the need for complete excision and laser treatment, the lesion can be excised in the second step, followed by laser treatment. In this case, the removal of tissue is essentially performed partly in the first step (the first stage of the procedure) and partly in the second step (the second stage of the procedure).

[0087] Ultimately, the minimally invasive nature of the procedure allows for easy application of the method in conjunction with biopsy procedures (i.e., by performing biopsies in real time or on-site) and in the case where histological analysis of the sample obtained in the first operational phase is performed in the laboratory and laser treatment is delayed until the second phase.

[0088] The inflatable balloon 25 can have a variable shape, which can be selected according to the shape of the cavity CV formed in the tissue to be treated. In some embodiments, the inflatable balloon can have a spherical or globular shape, i.e., an elliptical cross-section, in the expansion configuration, wherein the ratio of the minor axis to the major axis is close to 1, typically greater than about 0.7, for example greater than about 0.8. In other embodiments, the inflatable balloon 25 can have a cylindrical shape, a dog-bone shape, or any other suitable shape in the expansion configuration. The inflatable balloon 25 can be made of a flexible and substantially non-stretchable material, or it can be made of a stretchable material, for example, capable of stretching elastically or plastically under appropriate internal pressure. Although the use of the methods and apparatus described herein in treating neoplastic lesions of the breast has been specifically referenced in the foregoing description, it should be understood that at least some of the advantages of the apparatus and methods of this disclosure can also be used to treat other lesions of different organs, particularly neoplastic (i.e., tumorous) lesions, which are preferably soft tissues, such as, but not limited to, the liver, thyroid gland, prostate, kidney, or other soft tissues. Furthermore, the techniques, methods, and apparatus disclosed herein can be applied not only to human medicine but also to veterinary medicine to treat similar diseases in animals. The possibility of using the methods and apparatus illustrated in this application in the plant kingdom is not excluded.

[0089] Furthermore, although specific application examples have been illustrated with reference to examples of the use of vacuum-assisted biopsy needles (i.e., in which tissue resection is facilitated or advanced by using aspiration), it must be understood that different instruments, specifically biopsy needles, can be used based on different working principles to remove lesions, such as tumor tissue. Therefore, in the embodiments described herein, the biopsy needle can be any tissue resection device, particularly one that can be inserted, for example, through an external cannula, into the organ or other site where the lesion to be treated is located.

[0090] In this regard, it should be noted that the outer sheath, such as the sheath 3 described with reference to the accompanying drawings, can have any shape suitable for working with a particular biopsy needle, or any shape depending on the type of biopsy needle used. For example, in the case of a biopsy needle such as Mammotome (registered trademark) used for vacuum-assisted biopsy, the sheath 3 can have a non-circular cross-section. The protective sheath 7 and / or other components of the composite member 5 can be shaped to have a cross-section compatible with the cross-section of the sheath 3 of the biopsy needle, or used in combination with the biopsy needle.

[0091] This disclosure specifically relates to a method as defined in the following clauses:

[0092] Clause 1. A method for treating lesions in tissue, comprising the following steps:

[0093] Insert the external cannula (3) into the tissue until it is adjacent to the cavity (CV) obtained in the tissue by removing the lesion;

[0094] The laser thermotherapy device (1; 5) is inserted into the cavity (CV) through the external sleeve (3);

[0095] Laser energy is transmitted to the cavity (CV) via the optical fiber (23) of the device (1).

[0096] Clause 2: A method for treating lesions in tissue, comprising the following steps:

[0097] Insert the outer cannula (3) into the tissue;

[0098] A biopsy needle (41) is inserted toward the lesion (T) through the external cannula (3);

[0099] At least one tissue cell membrane (F) is removed from the lesion (T) by means of the biopsy needle (41), and preferably the largest portion of the lesion is removed to the extent permitted by the biopsy needle, thereby creating a cavity (CV) in the tissue.

[0100] The biopsy needle (41) is removed from the external cannula (3);

[0101] A laser thermotherapy device (1; 5) is inserted into a cavity (CV) obtained by extracting at least one tissue cell membrane.

[0102] Laser energy is transmitted to the cavity (CV) through the optical fiber (23) of the device (1) and the edges of the lesion are cleared by the laser energy.

[0103] Clause 3. The method according to Clause 2, wherein the step of inserting the laser thermotherapy device into the cavity includes the following steps:

[0104] After removing the biopsy needle from the external cannula (3), keep the external cannula in place;

[0105] Insert the laser thermotherapy device into the same sleeve held in place until the laser thermotherapy device reaches the cavity obtained through the biopsy needle.

[0106] Clause 4. The method according to Clause 2 or 3, wherein the step of removing at least one tissue cell membrane (F) from the lesion comprises the step of sequentially removing multiple cell membranes until the lesion is completely removed.

[0107] Clause 5. The method according to Clause 2, 3 or 4 further includes the step of performing a real-time, i.e., on-site histological analysis on the at least one cell membrane.

[0108] Clause 6. The method according to Clause 5 includes the step of: preferably dividing the at least one cell membrane into at least two parts along a separation plane parallel to the longitudinal unfolding of the cell membrane.

[0109] Clause 7. The method described in Clause 6 includes the steps of:

[0110] a. Perform real-time histological analysis on the first component of the at least two parts;

[0111] b. Retain the second of the at least two portions for delayed histological analysis.

[0112] Clause 8. The method according to one or more of the preceding clauses, wherein the step of removing at least one tissue cell membrane (F) comprises the following steps: sequentially removing a plurality of tissue cell membranes (F) by means of the biopsy needle (41), at least some of the cell membranes (F) undergoing real-time histological analysis.

[0113] Clause 9. The method according to Clause 8, wherein the step of sequentially removing a plurality of tissue cell membranes (F) by means of the biopsy needle (41) comprises the steps of: positioning the biopsy needle in a plurality of successive angular positions offset from each other about the axis of the biopsy needle; and collecting tissue cell membranes in each of the angularly offset positions.

[0114] Clause 10. The method described in one or more of Clauses 2 to 9, wherein the biopsy needle (41) is a biopsy needle for vacuum-assisted biopsy.

[0115] Clause 11. The method according to one or more of the preceding clauses, wherein the step of distributing laser energy to the cavity (CV) includes the following steps: removing liquid, solid or gas debris from the cavity by suction through a suction tube, said suction tube being, for example, adjacent to or coaxial with a conduit containing an optical fiber (23).

[0116] Clause 12. The method according to Clause 11, wherein the step of removing debris from the cavity by aspiration includes the steps of: dispensing cleaning fluid into the cavity and aspirating the cleaning fluid and debris from the cavity.

[0117] Clause 13. The method according to one or more of the preceding clauses, wherein the step of distributing laser energy to the cavity (CV) includes the following steps:

[0118] An expandable balloon (25) is inserted into the cavity, and the optical fiber (23) extends into the expandable balloon (25);

[0119] The inflatable balloon (25) is inflated in the cavity (CV) by filling and expanding fluid to stretch the walls of the cavity (CV);

[0120] Laser energy is transmitted through the expansion volume of the expandable balloon (25) and through the flexible wall attached to the cavity wall of the balloon.

[0121] Clause 14. The method according to Clause 13, wherein the expanding fluid contains diffusing particles to cause the laser energy delivered by the fiber tip to diffuse uniformly toward the wall of the expandable sac (25).

[0122] Clause 15. The method according to Clause 13 or 14 further includes the step of: continuously or discontinuously circulating the expansion fluid in the inflatable balloon (25).

[0123] Clause 16. The method according to one or more of the preceding clauses, wherein the step of inserting the device (1; 5) into the cavity (CV) includes the following steps:

[0124] A protective sleeve (7) is inserted into an outer sleeve (3), wherein the protective sleeve (7) accommodates a conduit (21), the conduit (21) having an inflatable balloon (25) at its distal end (21A); the conduit (21) accommodates the optical fiber (23); the distal end (21A) of the conduit (21) and the inflatable balloon (25) are integrally accommodated within the protective sleeve (7);

[0125] The end of the protective sleeve (7) and the inflatable balloon (25) contained therein extend beyond the distal end (3A) of the outer sleeve (3) into the cavity (CV);

[0126] The protective sleeve (7) is retracted into the outer sleeve (3) at the proximal end (3B);

[0127] Inflate the inflatable balloon (25) within the cavity (CV);

[0128] Laser energy is transmitted through an inflated balloon (25) using an optical fiber (23).

[0129] Clause 17. The method described in Clause 16 further includes the steps of:

[0130] Insert the tubular suction component (9) housed in the protective sleeve (7) into the outer sleeve (3);

[0131] During the step of distributing laser energy through optical fiber (23), suction is generated in the cavity (CV) by tubular suction member (9).

[0132] Clause 18. The method described in Clause 17 further includes the following steps:

[0133] The tubular suction member (9) housed in the protective sleeve (7) is inserted into the outer sleeve (3). The tubular suction member (9) is provided with a suction tube, which preferably has an anti-clogging structure and is provided with a cleaning fluid inlet tube; the conduit (21) is arranged in the tubular suction member (9).

[0134] During the laser energy supply step via optical fiber (23), cleaning fluid is fed into the cavity via a feed tube and cleaning fluid and debris are aspirated from the cavity via a suction tube.

Claims

1. An apparatus (1; 5) for treating cancerous lesions, etc., comprising: A protective sleeve (7); a tubular suction member (9) coaxially housed within the protective sleeve (7), the tubular suction member (9) having a distal edge (9A); a conduit (21) coaxially housed within the tubular suction member (9) and adapted to house an optical fiber (23) internally; wherein, at the distal end (21A) of the conduit (21), an inflatable balloon (25) is fixed by means of a sealing connector, such that the balloon (25) can be inflated by means of fluid transmitted through the conduit (21). The protective sleeve (7) is axially movable relative to the tubular suction member (9) and the conduit (21); the tubular suction member (9) includes a cylindrical wall, and at least one suction tube and at least one cleaning fluid inlet tube are provided in the thickness of the cylindrical wall; the at least one suction tube and at least one cleaning fluid inlet tube are provided with corresponding distal ends (11A) on the distal edge (9A) of the tubular suction member (9); the at least one suction tube and at least one cleaning fluid inlet tube are provided with corresponding distal ends (11A) on the distal edge (9A) of the tubular suction member (9). The distal end (11A) of the tube is adapted to be positioned behind the distal tip (23A) of the optical fiber (23) so as not to interfere with the transmission of laser energy from the optical fiber (23); wherein the conduit (21) includes an outer tubular element (21y) and an inner tubular element (21x) coaxial with each other, the outer tubular element and the inner tubular element defining a first annular channel therebetween; wherein the optical fiber is housed in the inner tubular element (21x), defining a second annular channel between the inner tubular element (21x) and the optical fiber (23), the first annular channel and the second annular channel being coaxial with each other; wherein an inflatable balloon (25) is secured to the distal end of the outer tubular element (21y) by the sealing connector; wherein the outer tubular element and the inner tubular element of the conduit (21) are designed to allow fluid intended to fill and inflate the inflatable balloon (25) to enter and exit through the first annular channel and the second annular channel, and to circulate the fluid in the inflatable balloon (25).

2. The apparatus according to claim 1 further includes an outer sleeve (3) adapted to slidably receive the protective sleeve (7).

3. The apparatus (1; 5) according to claim 1, wherein, Multiple suction tubes are set in the thickness of the tubular suction component (9).

4. The apparatus (1; 5) according to claim 2, wherein, Multiple suction tubes are set in the thickness of the tubular suction component (9).

5. The apparatus (1; 5) according to claim 1, wherein, Multiple cleaning fluid inlet pipes are set within the thickness of the tubular suction component (9).

6. The apparatus (1; 5) according to any one of claims 2 to 4, wherein, Multiple cleaning fluid inlet pipes are set within the thickness of the tubular suction component (9).

7. The apparatus (1; 5) according to claim 1, wherein, Each suction tube can be connected to a suction line, and each cleaning fluid inlet tube can be connected to a cleaning fluid inlet line.

8. The apparatus (1; 5) according to any one of claims 2 to 5, wherein, Each suction tube can be connected to a suction line, and each cleaning fluid inlet tube can be connected to a cleaning fluid inlet line.

9. A kit for treating cancerous lesions, comprising: The device (5) according to any one of claims 1-5 and 7 includes an outer sheath (3); and a biopsy needle (41) capable of being inserted into the outer sheath (3).

10. A medical device comprising a device (1) according to any one of claims 1-5 and 7, and a laser source capable of being coupled to an optical fiber (23) of said device (1).

11. The medical device according to claim 10, further comprising one or more of the following components: an aspiration member (13) capable of being connected to at least one aspiration tube of the tubular aspiration member (9); a cleaning fluid supply member capable of being connected to at least one supply tube of the tubular aspiration member (9); and an expansion circuit (27) adapted to supply expansion fluid to an inflatable balloon (25).

12. The medical device according to claim 11, wherein, The expansion circuit (27) is adapted to circulate the expansion fluid in the expandable balloon (25).

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