ES2472542A1 - Directional tissue ablation device - Google Patents

Abstract

Directional tissue ablation device. The present invention describes a tissue ablation device that allows directing electromagnetic radiation and irradiating a cylindrical volume by controlling the radius and height of the cylinder, which comprises an electromagnetic radiation guide and a body that protects said guide and facilitates penetration into the tissue. knitting.

Description

DIRECTIONAL TISSUE ABLATION DEVICE TECHNICAL FIELD OF THE INVENTION The present invention is framed in the field of surgery and refers to a medical device or instrument, more specifically to an invasive device that allows to drive a laser beam for tissue ablation. BACKGROUND OF THE INVENTION There are currently many patents in the world related to tumor ablation. Most are related to radiofrequency (RF) tumor removal and are endoscopes. EP0437183, "Light diffuser for a photodynamic therapy of tumors in the oesophagus of a patient" describes a device used only in esophageal cancers. The optical fiber of this device is only used to diffuse visible light within the esophagus and to detect the location of the tumor with greater reliability.W09824513A1, 'Multiple guide for laser fibers in the treatment of tumors in parenchymatous organs', describes another device that lacks optical fiber for laser guidance and only eliminates parenchymal tumors. One of its limitations is that the maximum tumor size cannot exceed 2cm in diameter. Nor is it able to focus the laser beam, so it could destroy surrounding healthy tissue. Two patents, 'Tumor ablation apparatus "[US5928229] and" Method and system for trans-lumenal radio-frequency ablation throught an endoscope "[W09955244] describe devices in which the method used is radiofrequency. In both, endoscopes that work as electrodes are used. These electrodes are fixed and have no movement within the patient. Other devices that use radiofrequency to eliminate tumors are described in the 'Method for biopsy and ablation of tumor cells "[US6162216] and" Ablation treatment of bone metastases "[EP1059067] patents. The latter is applicable in 6seo fabric and not in any type of fabric. The 'Gynecological ablation procedure and system using an ablation needle' [W00211639] patent uses the term 'needle' to describe the ablation device although, really, the device is not a needle as such, but a pointed end electrode so that it can penetrate best. Like all of the above, the device produces RF ablation. This patent is designed only for gynecological tumors, but not for tumors in general. The 'Modular biopsy and microwave ablation needle delivery apparatus adapted to in situ assembly and method of use "[US20022058932] patent describes a device that uses needles, but they are made of microwave antennas that are inserted into the body. To insert said needle, a small hollow tube is previously introduced and into it, the needles that will be used as an antenna.In the case of being used as an instrument to extract tissue and perform biopsies, the needle is reintroduced and the tissue is aspirated. with a harpoon-shaped needle. 0 RF tumor ablation devices are described in the patents' Electrosurgical device for treatment of tissue ', [US2005177211] and' Flexible endoscope for endo luminar access radio frequency tumor ablation ", [W02006000888 ] Non-surgical methods (although invasive) based on radiofrequency are the most used but have not given all the expected good results, since it is almost impossible, by radiofrequency, irradiating a certain and very limited portion of tissue, devices have been invented to minimize the effects produced outside the irradiated area such as those described in 'Apparatus and method for shielding tissue during tumor', patent [W00219895] and ' Percutaneous surgical instruments and methods using the same "[US2004133195].

US2005131399A1, entitled 'Devices and methods for directed, interstitial ablation of tissue "describes a device that cannot focus, and to vaporize the area, the laser it uses has to emit different energies, to penetrate more into the tumor. Therefore If the tumor does not have symmetry of revolution, the device has to be introduced at several points of the tumor, causing the patient to be subjected to more than one penetration. Patent EP1145686, entitled 'Ablation catheter with a directional HF irradiator', describes a Device of the type described above in the signal that is introduced into the patient's body is a radiofrequency (of the order of GHz) with the problems that this entails and which have been explained above. Obviously, as two antennas are introduced, in one session, only the part of the tumor that is between the two antennas can be eliminated. In the invention described in US2008071256A1, 'Cancer treatment using low energy lasers', the laser beam used is not directional nor can the beam be focused in any particular place. An additional problem with this invention is that the optical fiber is introduced into the patient directly, with the danger of breaking inside since these types of fibers are, in general, fragile. W02008068789A1, 'A kit of optical fibers for percutaneous ablative treatment' describes a system in which the optical fiber is introduced no protection inside the patient. The ablation that is performed is not directional either. Patent W02009108956A1, "Endoluminal laser ablation device and method for treating veins" describes a device that emits radiation in a 3600 field and the specific area of radiation cannot be controlled, but the walls of the blood vessels are expected to absorb it. The patent entitled 'Device for Localized Thermal Ablation of Biological Tissue, Particularly Tumor Tissues or the Like "(US20070305973) describes a device performing heat ablation but is not able to focus the heating zone and only one probe is inserted without it remaining protected from liquids or tissue that may remain in the form of waste impeding the output of electromagnetic waves. Other devices use optical fiber, but this is used to transport visible light to the tissue so that the healthcare professional can see. An example is the patent, '0ptical apparatus for guided liver tumor treatment and methods ", W02004028353, which describes a device that has an optical fiber, but in this case, uses it to transport light to illuminate the liver when, by different methods, tumors are studied in this organ.In that same line, the document EP2067447A1 entitled 'Steerable catheter device and method for the chemoembolization and / or embolization of vascular structures, tumors and / or organs' describes a device in which the Light conduction is only to visualize the tumor.

OBJECT OF THE INVENTION

A subject of the present invention is a device for performing tissue ablation, hereinafter referred to as a 'directional tissue ablation device', which allows directing electromagnetic radiation and irradiating a cylindrical volume by controlling the radius and height of the cylinder, which comprises a guide for electromagnetic radiation and a body that protects said guide and facilitates tissue penetration.Unlike other modes of radiation such as those that use radiofrequency, this device prevents burns and adverse effects in non-tumor areas that could lead to side effects not wanted.

DESCRIPTION OF THE FIGURES

Figure 1.-Scheme of the device object of the invention. A represents the main body of the device, Ep represents its proximal end, Ed its distal end, O1 represents the longitudinal cavity in which the guide is embedded, F, of electromagnetic radiation, O2 indicates the hole through which the beam of the electromagnetic radiation and R represents a reflective surface that reflects the beam of electromagnetic radiation.

DETAILED DESCRIPTION OF THE INVENTION

The device (Figure 1) object of the present invention comprises an electromagnetic radiation guide (F) that is embedded in the main body (A) of the device. Said main body is an elongated element, in which in turn a distal end (Ed) and a proximal end (Ep) are distinguished and is characterized in that it has a longitudinal recess (O1) practiced at its proximal end with a depth less than the length of said main body; a second transverse cavity (O2) practiced substantially perpendicular to the first and communicating with said first cavity; and a reflective surface (R) located at the intersection of both cavities to reflect a beam of electromagnetic radiation.

The diameter of the longitudinal recess (O1) is determined by the diameter of the electromagnetic radiation guide (F), preferably optical fiber, which slides inside and conducts the electromagnetic radiation, preferably a laser light, which will perform the ablation.

Preferably the distal end of the main body (A) comprises a sharp point to penetrate the tissues. This tip is solid and beveled with an angle small enough to facilitate penetration.

The length of the device will depend on the depth to which the structure to which access is needed is located.

The second recess (O2), through which the electromagnetic radiation beam, preferably a laser beam, will be guided, will be practiced at a short distance from the distal end (Ed) and is exactly matched with a reflective surface (R), whose inclination will preferably be 450 with respect to the direction of the guide, so as to allow the electromagnetic radiation beam to exit in a direction substantially perpendicular to the direction of the guide (F).

This second recess (O2) must have a sufficient diameter so that at the exit, the electromagnetic radiation beam does not present diffraction and will be sealed with transparent materials at the wavelengths used and biocompatible, since it will be in contact with human tissues . Transparency is necessary since, if it were not, or the materials had a high transmittance at these wavelengths, the emitted power would have to be greater and therefore, the structures and parts that make up the device, could suffer deterioration.

The electromagnetic radiation guide (F) will be embedded, but not fixed, in the main body (A), thus being protected and avoiding its possible rupture. Said guide (F) will have a connector placed at one of its ends to be able to connect it to an electromagnetic radiation generator. Its other end, closer to the distal end of the device, will carry an optical quality polish. The polishing will be carried out in such a way that it has the same properties as a lens (spherical, astigmatic, sphercylindrical, etc.) depending on the desired focal point for each type of irradiation.

The electromagnetic radiation guide (F), which has a diameter slightly smaller than the diameter of the longitudinal recess (O1), slides inside so that, having a carved tip in the form of a lens, allows focusing the electromagnetic beams at a certain distance by moving the guide inside the device.

At the proximal end (Ep), a cone made of a material compatible with the standards used for syringes with hypodermic needles is preferably placed.

Once the device has penetrated the tissue, turning it results in the ablation of a circular plane whose center is the device itself and will have a diameter that will depend on distance from the tip of the radiation guide to the reflective surface (R) .

Thus, by moving the device, the ablation of a chosen height and radius cylinder is achieved.

Depending on the structure, shape or depth of the tumor that you want to remove from the body, the structure of the device does not vary.

To carry out tissue ablation, the described device is part of a more complex system that also includes

•

an electromagnetic radiation generator,

•

and a coupler to which the electromagnetic radiation guide is connected

The electromagnetic radiation generator can radiate at any wavelength, depending on the components and devices. With this you can select the frequency range for each specific case.

The coupler is used to connect the electromagnetic radiation guide, preferably optical fiber, to the emitting source, preferably a laser emitter.

MODE OF EMBODIMENT OF THE INVENTION

To construct the directional tissue ablation device, capable of deflecting electromagnetic radiation perpendicular to its main axis, it is based on a hollow cylindrical rod made of stainless steel. This rod will give rise to the main body of the device once machined.

A hole is drilled near one end of the rod and in the direction of the rod radius as follows� the rod is completely immersed in a paraffin rod so that it is completely covered on the outside and inside , and the paraffin melts in an area where the hole will be made using a low intensity laser. Once this part has been exposed of the paraffin, the rod is immersed in acid so that, through chemical corrosion, the necessary hole is made.

Subsequently, it is extracted from the acid, washed, dried and immersed in a solvent to completely remove the paraffin.

The following process involves the manufacture of the mirror and the placement inside the rod. For which another solid stainless steel rod whose outside diameter is equal to the inside diameter of the previous rod is used. Said rod is cut at an angle of 450 and subsequently polished to obtain an optical quality finish. This part will mirror inside the rod and deflect the beam at an angle of 450 that will come out perpendicularly to it, for which, the mirror will have to be centered later and that it coincides with the hole made in the hollow rod.

The termination of the hollow main rod, together with the protruding part of the solid rod, is cut and polished with an angle that allows intramuscular penetration and does not cause tissue tearing.

To prevent the entry of cellular tissue into the device, the hole must be covered with some biocompatible material, with this we prevent the inside of the rod from penetrating tissue when the hole is sealed.

The connection with the optical fiber is made by placing a standard female cone at the base of the rod, similar to that used for hypodermic needles, and sealing it with biocompatible ultraviolet curing resin for medical use.

The laser light generator, the light guide, as well as the optical fiber connector necessary to carry out the ablation, will be chosen according to the needs of the process, which will be defined by the electromagnetic radiation (wavelength and emission power).

Other characteristics, such as the type of guide, refractive indices or numerical aperture, will also depend on the laser chosen and the tumor to be treated.

Claims (4)

1.- Directional tissue ablation device comprising an electromagnetic radiation guide that is embedded in the main body of the device in which said main body is an elongated element, in which in turn a distal end and a proximal end and has a longitudinal cavity practiced at its proximal end with a depth less than the length of said main body, a second transverse cavity practically perpendicular to the first and communicating with said first cavity, and a reflective surface located in the 10 intersection of both cavities to reflect a beam of electromagnetic radiation. 2. Device according to previous claim characterized in that the distal end of the main body comprises a sharp point to penetrate the tissues 3. Device according to any of the preceding claims characterized in that the reflective surface is positioned at an angle of 450 with respect to the direction of the guide. 4. Device according to any of the preceding claims characterized in that the electromagnetic radiation guide is optical fiber. Figure 1 SPANISH OFFICE OF THE PATENTS AND BRAND Application No.: 201232079 SPAIN Date of submission of the application: 12.31.2012 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61B18 / 24 (2006.01) RELEVANT DOCUMENTS

Category

56 Documents cited Claims Affected

X

US 7306588 B2 (TRIMEDYNE INC.) 11.12.2007, 1-4

summary; column 2, lines 33-59; column 3, lines 3-22; column 4, line 61 - column 5,

line 2; column 11, lines 27-48; figure 17.

X

WO 9312728 A1 (TRIMEDYNE INC.) 08.07.1993, 1.3-4

page 9, lines 4-29; page 11, line 21 - page 15, line 15; page 20, lines 7-27;

Figures 1-6.

X

US 5836941 A (OLYMPUS OPTICAL CO. LTD.) 17.11.1998, 1.3-4

column 2, lines 37-42; column 4, lines 19-65; column 5, line 17 - column 6, line 31;

column 9, lines 9-22; Figures 1.6-7D.

X

US 5688261 A (PREMIER LASER SYSTEMS INC.) 18.11.1997, 1.3-4

column 1, line 63 - column 2, line 48; column 5, line 60 - column 6, line 45; column 10,

lines 46-67; Figures 5.9.

X

US 5562657 A (GRIFFIN) 08.10.1996, 1.4

column 3, lines 3-40; column 4, lines 4-14; column 5, line 46 - column 6, line 17;

Figures 1-2,6A-6D.

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of completion of the report 22.10.2013

Examiner J. Square Prados Page 1/4

REPORT OF THE STATE OF THE TECHNIQUE Application number: 201232079 Minimum documentation sought (classification system followed by classification symbols) A61B, A61N. Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, PAJ. State of the Art Report Page 2/4  WRITTEN OPINION Application number: 201232079 Date of Completion of Written Opinion: 22.10.2013 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 1-4 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1-4 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base. This opinion has been made on the basis of the patent application as published. State of the Art Report Page 3/4  WRITTEN OPINION Application number: 201232079 1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

US 7306588 B2 (TRIMEDYNE INC.) 11.12.2007

D02

WO 9312728 A1 (TRIMEDYNE INC.) 08.07.1993

D03

US 5836941 A (OLYMPUS OPTICAL CO. LTD.) 17.11.1998

D04

US 5688261 A (PREMIER LASER SYSTEMS INC.) 18.11.1997

D05

US 5562657 A (GRIFFIN) 08.10.1996

2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The application refers to a device for performing tissue ablation, which allows to direct the electromagnetic radiation and radiate a cylindrical volume by controlling the radius and the height of the cylinder, the device comprising an electromagnetic radiation guide and a body that protects said guide and facilitates tissue penetration. In the state of the art there is a multitude of antecedents of directional tissue ablation devices, of the type presented in the application, and many of them anticipate the structural configuration proposed by the device of the application. The documents cited in the State of the Art (IET) Report can be considered relevant in relation to the object of protection of the application. Thus, the invention as defined in claim one lacks novelty because it is comprised in the state of the art. Choosing D01 as the basis for the analysis, considering the state of the art closest to the object of the main claim, it is described (see parts cited in the EIT, references in brackets apply to that document) a:

-

Directional tissue ablation device (column 3, lines 10-22, column 4, lines 61-64) comprising an electromagnetic radiation guide (1, figure 17) that is embedded in the main body of the device (5, Figure 17) in which said main body is an elongated element (Figure 17), in which in turn a distal end (6) and a proximal end (Figure 17) are distinguished and has a longitudinal recess (30, Figure 17 ) practiced at its proximal end with a depth less than the length of said main body (figure 17), a second transverse cavity (8, figure 17) practiced substantially perpendicular to the first and communicating with said first cavity (figure 17 ), and a reflective surface (40, 41, figure 17) located at the intersection of both cavities (figure 17) to reflect a beam of electromagnetic radiation (column 11, lines 30-42).

Thus, document D01 contains all the technical characteristics of the first claim, so it is not new, and therefore does not meet the requirements of article 6.1 of the Patent Law (LP 11/1986). As indicated, documents D02 to D05 cited in the EIT would also be relevant when prosecuting the novelty and inventive activity of the object of the request. The second to fourth dependent claims add optional features that, because they are not included in the main one, are considered non-essential, and give rise to particular embodiments. It is estimated that these claims, in combination with the main claim on which they depend, do not contain additional features of novelty with respect to the state of the art represented by document D01, for the following reasons: Second claim: it is considered to be novel in view of D01, since "the distal end of the main body comprises a sharp point to penetrate the tissues" (column 11, lines 33-34, reference 6, figure 17 ). Third claim: it is considered that it lacks novelty in view of D01 (column 11, lines 38-39), because in this "the reflective surface is placed at an angle of 45 ° with respect to the direction of the needle". Fourth claim: it is considered that it lacks novelty in view of D01, since in this the "guide of electromagnetic radiation is optical fiber" (column 11, lines 39-40). State of the Art Report Page 4/4