MEDICAL DEVICE FOR RADIOTHERAPY TREATMENT

Abstract

The invention relies on a medical device for an intracorporeal location, wherein: it comprises a deformable armature, at least partially made of a shape memory material and having an Ea end and an Eb end, said Ea end being larger than said Eb end, it has an essentially triangular, trapezoidal, ovally or diamond-shaped, the sides of which extending between said Eb end and the corners of said Ea end, said deformable armature optionally includes a middle rip extending from said Ea end to said Eb end and multiple cross elements extending between the middle rip and said sides, wherein said sides are formed by sides braces, it comprises at least one x-ray visible marker fixed at the deformable armature selected from the group consisting of gold, silver, platinum, tantalum, tungsten, niobium, palladium, iridium, it comprises a guide suited for the intracorporeal introduction of said medical device, and an extraction holder of the medical device.

The invention also relies on a device for the introduction, by an endoscopic or percutaneous way, of the medical device, and on a method for accurately targeting a target area during radiation treatment through image guidance comprising determining the location of the medical device in real time using at least one method of targeting selected from the group consisting of lasers, visual, infrared, MRI/MRS, RF and radiation; and modifying the radiation treatment beam path to adaptively compensate for a change in position of the target area.

Claims

1. A medical device for an intracorporeal location, the medical device comprising: a deformable armature, at least partially made of a shape memory material and having at least one Ea end being a longitudinal direction of the medical device and at least one Eb end being a lateral direction of the medical device, said Ea end being larger than said Eb end, a three-dimensional shape, having a triangular or a trapezoidal cross-section in a lateral view or an axial view, with the Eb end forming the top side of said triangular or trapezoidal shape, wherein the Ea end forms the base of said triangular or trapezoidal shape located opposite the Eb end and having sides extending between the Eb end and the corners of the Ea end, wherein a triangular or trapezoidal area spans between the sides, and the base is concavely curved so that the medical device has a concave curvature, wherein said deformable armature optionally includes a middle rip extending from said Ea end to said Eb end and multiple cross elements extending between the middle rip and said sides, wherein said sides are formed by 1 to 10 sides braces, the medical device further comprising: at least one x-ray visible marker fixed at the deformable armature selected from the group consisting of gold, silver, platinum, tantalum, tungsten, niobium, palladium, and iridium, and a guide suited for the intracorporeal introduction of said medical device, and an extraction holder of the medical device.

2. The medical device according to claim 1, including a deformable material forming a surface of the medical device.

3. The medical device according to claim 1, comprising a predetermined breaking point.

4. The medical device according to claim 3, comprising a means for at least one of fastening or opening providing said predetermined breaking point.

5. The medical device according to claim 4, in which said means for at least one of fastening or opening is constituted of a metal ball joint.

6. The medical device according to claim 2, in which said deformable material is micro-perforated.

7. The medical device according to claim 2, in which said deformable material comprises a fragility zone.

8. The medical device according to claim 2, in which said deformable material comprises an active substance chosen among the group comprising a therapeutic substance or a diagnostic substance.

9. The medical device according to claim 1, comprising a system of radio guidance or a transponder.

10. The medical device according to claim 1, having a height in the range of 2 to 50 mm, said height being measured along the Ea end.

11. A medical device for an intracorporeal location having an Ea end and an Eb end, comprising: a deformable armature, at least partially made of a shape memory material, constituted by a central element from which extend from 1 to 10 cross element(s); at least one x-ray visible marker fixed at the deformable armature selected from the group consisting of gold, silver, platinum, tantalum, tungsten, niobium, palladium, and iridium, and a guide suited for the intracorporeal introduction of said medical device, and an extraction holder of the medical device.

12. The medical device according to claim 11, wherein said central element is constituted of at least one filament or at least one cylinder.

13. The medical device according to claim 11, wherein said central element is hollow or solid.

14. The medical device according to claim 11, wherein said at least one cross element(s) is positioned all around the central element.

15. The medical device according to claim 11, wherein said at least one cross element(s) is made of a memory shape material, and/or be linked to the central element, so as to be able to be folded against the latter when a force is applied to the device, and to be able to deploy and adapt itself to the dimensions of the target area once the medical device is ejected from the introduction device.

16. The medical device according to claim 11, wherein said at least one cross element(s) comprise, over all or part of their length, asperities allowing the attachment of visible markers.

17. The medical device according to claim 11, comprising at least 3 cross elements, and having a three-dimensional shape having a triangular or trapezoidal cross-section in a lateral or an axial view.

18. A method for accurately targeting a target area during radiation treatment through image guidance, the method including the following steps: providing a medical device for an intracorporeal location as defined in claim 1, determining the location of the medical device in real time using at least one method of targeting selected from the group consisting of lasers, visual, infrared, MRI/MRS, RF and radiation, and modifying the radiation treatment beam path to adaptively compensate for a change in position of the target area.

19. A method for treating a patient in need thereof, said method including the following steps: providing a medical device for an intracorporeal location as defined in claim 1, and inserting the medical device into the body of the patient at a target area that needs to be treated.

20. A method for diagnosing a disease in a patient, said method including the following steps: providing a medical device for an intracorporeal location as defined in claim 1, and inserting the medical device into the body of the patient at a target area suspected to be affected by a disease.

Description

DESCRIPTION OF THE FIGURES

[0092] FIG. 1: shows a front view of the sail stent, with the Ea end and the Eb end.

[0093] FIG. 2: shows a front view of the sail stent, with X-ray visible markers (1), an memory shape armature (2) and a silicone membranous material (3) for the elution of active products or communicating systems.

[0094] The membranous material is pre-cut for its extraction (Real Eaze System).

[0095] FIG. 3: shows the delivery system of the stent. (a): catheter with handle for dropping of the stent. (b) front view of the catheter containing the stent and of the sail stent. (c): front view of the catheter after deployment of the stent.

[0096] FIG. 4: shows a view from the side of the sail stent.

[0097] FIG. 5: shows a view from the side of an ovaly stent of diamond shape, comprising a shape memory deformable armature, radiopage markers fixed on multiple cross elements and the extraction holder.

[0098] FIG. 6: shows the ovaly stent launched in a tumor, comprising a guide sheath outside a delivery device.

[0099] FIG. 7: shows an ovaly stent removal, with an extraction holder grabbed by a forceps to remove the stent, and forceps that is pulled for stent removal.

[0100] FIG. 8: shows perspective view of a medical device according to the invention, comprising a central element (4) and 3 cross elements (5) that are positioned all around the central element (4) and deployed. The 3 cross elements (5) comprise asperities (6) allowing the attachment of visible markers (7).

[0101] FIG. 9: shows a top view of the medical device shown in FIG. 8.

[0102] FIG. 10: shows a side view of the medical device shown in FIG. 8.

[0103] FIG. 11: shows a perspective view of the medical device shown in FIG. 8.

[0104] FIG. 12: shows a bottom view of the medical device shown in FIG. 8.

[0105] FIG. 13: shows a perspective view of the medical device shown in FIG. 8, but with the 3 cross elements (5) that are folded over the central element (4).

[0106] FIG. 14: shows a top view of the medical device shown in FIG. 8, with the 3 cross elements (5) that are folded over the central element (4) as on FIG. 13.

EXAMPLES

Example 1: Example of a Clinical Case

[0107] Patient of 58 years, smoking, with a chest opacity of the right upper lobe, is admitted.

[0108] PET is positive in the ipsilateral hilar and mediastinal. The rest of the staging does not find any extra thoracic lesion.

[0109] The diagnosis of squamous cell carcinoma is confirmed by flexible bronchoscopy using a technique of distal guide ultrasound mini probe. Mediastinal staging is made by an Endobronchial Ultrasound. Therapeutic decision making in multidisciplinary staff is a radio concomitant chemotherapy for stage IIIA disease classified.

[0110] Before the medical treatment, system sail stent is positioned within the tumor endoscopically.

[0111] The procedure is performed under general anesthesia. The bronchoscope goes through natural means. The same way as for the diagnosis, the lesion is found through ultrasound guidance system. The catheter is left in place within the tumor. The delivery system is inserted into the guide catheter. The sail stent is deployed within the tumor. Confirmation of correct positioning of the stent method is verified by fluoroscopy or ultrasound. The bronchoscope is removed. Procedure time did not exceed 20 minutes. The patient is awake and can enjoy a guided radiotherapy more precisely by the Sail Stent. After the treatment sequence, the stent is left in place or removed endoscopically.

[0112] The outlook is based on the possibility of increasing the intensity of radiation complications limiting the healthy tissue. In addition, the use of the stent chemotoxic by elution improve the performance of radiation.

Example 2: Animal Testing

[0113] The aim of this study is to evaluate:

(1) whether it is possible to implant the Sail fiducial markers using Sail Delivery Devices and standard endoscopic instruments (guide sheath, endoscope . . . ),
(2) whether it is possible to reach the target locations reachable,
(3) whether there any direct complications (bleeding, pneumothorax, migration) after the implantation of the Sail Stent,
(4) if the Sail fiducial markers are visible on radiographic images, and whether it is possible to differentiate the 3. Tantalum markers,
(5) whether there is a short term migration (already after few days) of the Sail implants.

Materiel and Methods

[0114] Pig is anesthetized and ready for the procedure (t=0). Then, an insertion of the video endoscope and the visualisation of the lung was realized. The determination of a proximal target location where it is possible to have a direct endoscopic vision was realized.

[0115] The delivery test was realized by performing the steps below: [0116] (1) Insertion of the guide sheath in the endoscopic operating channel, [0117] (2) Loading of the Sail fiducial markers in a Sail Delivery Device (DD), [0118] (3) Insertion of the Sail DD within the guide sheath, [0119] (4) Performing a Radiographic control to visualize the Sail DD tip position [0120] (5) Pushing the pusher to release the Sail fiducial marker, [0121] (6) Visualization simultaneously on the operating room screen how the Sail fiducial marker is released in the lung, [0122] (7) Removing the Sail DD and let the guide sheath in position, [0123] (8) Insertion of the Olympus biopsy Forceps FB-233D in the guide sheath, [0124] (9) Opening of the biopsy forceps and catching the Sail fiducial marker proximal handle, [0125] (10) Pull very carefully the biopsy forceps, [0126] (11) Then it is decided to let the Sail fiducial marker in place or to remove it.

[0127] Other proximal tests with the other Sail DD and/or others implants are performed the proximal tests should not last longer than 15/20 minutes.

[0128] Then, the distal targets location are determined and delivery tests are performed.

[0129] At the end of the procedure, 10 Sail fiducial markers (4 in the right and 6 in the left lung) were implanted.

[0130] Then, a fluoroscopy is performed.

[0131] The procedure is finished, and has lasted 1 hour 30.

[0132] Depending on the success of the intervention, the pigs are not euthanized and are kept alive for few days in order to evaluate eventual complications due to the Sail fiducial markers.

[0133] After this few days a fluoroscopy is performed to compare the position of the Sail fiducial markers and evaluate the migration risks. It is not possible to perform an endoscopic control.

RESULTS

[0134] The stent delivery was successful, even in the proximal or in the distal airways. We successfully tested the device withdrawal by removing the stent in the Guide Sheath with the forceps grabbing the extremity handle (Extraction holder).

[0135] The 10 stents were successfully implanted in the pigs. The control with fluoroscopy is satisfying. The pigs were awake and monitored (clinically) during one week.

[0136] At the end of the period, the animals were euthanized. Just before this step, we proceed a Fluoroscopy that confirmed the absence of stent migration. There were no clinical complications during the Week of monitoring (No pneumothorax, Hemoptysis, pneumonia, fever, or death . . . ).

LIST OF REFERENCES

[0137] U.S. Pat. No. 5,027,818. [0138] U.S. Pat. No. 5,954,647. [0139] US20080031414.