WO2019011843A1

WO2019011843A1 - Apparatus for the treatment of cancers involving the insertion of needles

Info

Publication number: WO2019011843A1
Application number: PCT/EP2018/068510
Authority: WO
Inventors: Serge Mordon; Pascal Deleporte
Original assignee: (Inserm) Institut National De La Santé Et De La Recherche Médicale; Université de Lille; Centre Hospitalier Regional Universitaire De Lille
Priority date: 2017-07-10
Filing date: 2018-07-09
Publication date: 2019-01-17

Abstract

This invention relates to an apparatus for cancer treatment. This apparatus comprises mesh links assembled with each other to form a flexible grid (1) adapted to be placed over a non-planar biological tissue surface and at least one guiding element (8,9).The grid (1) comprises an array of openings and the guiding element (8,9) comprises a guiding hole. The apparatus is arranged to detachably hold the guiding element (8,9) in an insertion position in which said guiding hole is aligned with a corresponding opening of the flexible grid (1) in such a way that said guiding hole and said corresponding opening allow a needle to pass therethrough and to maintain this needle aligned in an insertion direction.

Description

Apparatus for the treatment of cancers involving the insertion of needles

Field of the invention

The present invention relates to an apparatus for the treatment of cancers involving the insertion of needles into an organism, in particular a human body. Applications might include, but are not limited to, interstitial laser treatment of cancer by laser interstitial thermal therapy (LITT) or photodynamic therapy (PDT), or brachytherapy for treating breast or penis or prostate cancers.

Background of the invention

Interstitial laser treatments involve insertion of optical fibres, through needles, into a pathological tissue to selectively deliver radiation to a target "lesional" area.

The good positioning and immobilization of the fibres within the tissue is critical for the success of the therapy. In addition, a poor positioning of the fibres in PDT can lead to damage of healthy cells due to the activation of photosensitizer outside the target area.

For the treatment of prostate tumours, it is known to position and guide the needles using a grid, for instance the product "Sterile 17GA Grid" marketed by "CIVCO Medical Solutions". Such a grid comprises an array of openings allowing needles to pass therethrough. However, such a grid is not adapted to be placed over a non-planar tissue surface, in particular for treatment of head and neck cancer.

The following documents describe several techniques for interstitial laser treatment of head and neck cancer:

Jerjes W, Upile T, Hamdoon Z, Nhembe F, Bhandari R, Mackay S, Shah P, Mosse CA, Brookes JA, Morley S, Hopper C. Ultrasound-guided photodynamic therapy for deep seated pathologies: prospective study. Lasers Surg Med.

2009 Nov; 41(9):612-21 (hereinafter "Jerjes 2009");

- Karakullukcu B, van Veen RL, Aans JB, Hamming-Vrieze O, Navran A, Teertstra

HJ, van den Boom F, Niatsetski Y, Sterenborg HJ, Tan IB. MR and CT based treatment planning for mTHPC mediated interstitial photodynamic therapy of head and neck cancer: description of the method. Lasers Surg Med. 2013 Oct; 45(8):517-23 (hereinafter "Karakullukcu 2013");

- Jerjes W, Upile T, Akram S, Hopper C. The surgical palliation of advanced head and neck cancer using photodynamic therapy. Clin Oncol (R Coll Radiol).

2010 Nov; 22(9):785-91 (hereinafter "Jerjes 2010");

Oakley E, Bellnier DA, Hutson A, Wrazen B, Arshad H, Ouon H, Shafirstein G. Surface markers for guiding cylindrical d iff user fiber insertion in interstitial photodynamic therapy of head and neck cancer. Lasers Surg Med. 2017 Feb (hereinafter "Oakley 2017").

Both in Jerjes 2009 and in Karakullukcu 2013, needles are inserted without guiding element. Those techniques do neither allow a precise positioning of the needles nor provide an adequate support for maintaining the needles in the position required during the laser illumination.

In Jerjes 2010, the needles are guided using a prefabricated grid. However, this grid is specific to a particular patient and does not allow repositioning of a fibre which could be required for ultrasound monitoring.

Another technique disclosed in Oakley 2017 consists in finding the points of insertion of the needles using a flexible adhesive grid. This technique does not allow an adequate support for maintaining the needles in the position required during the laser illumination.

Object of the invention

It is an object of the present invention to provide an apparatus for cancer treatment that is capable of treating head and neck cancer or other cancers without the drawbacks associated with the prior art.

Summary of the invention

In that respect, the present invention relates to an apparatus for cancer treatment, this apparatus comprising mesh links assembled with each other to form a flexible grid adapted to be placed over a non-planar biological tissue surface. Said grid comprises an array of openings allowing needles to pass therethrough. This apparatus also comprises a guiding element comprising a guiding hole allowing a needle to pass therethrough. Said guiding hole extends along an insertion direction. This apparatus is arranged to hold said guiding element in an insertion position in which said guiding hole is aligned with a corresponding opening of the flexible grid in such a way that said guiding hole and said corresponding opening allow a needle to pass therethrough and to maintain this needle aligned in said insertion direction.

The apparatus according to the invention thus comprises two distinct elements that cooperate together. On the one hand, it comprises said flexible grid, i.e. a grid which is conformable to a non-planar biological tissue surface likely to be used to treat a head and neck cancer. The word "flexible" relates to this conformable feature which results from the structure of the grid formed by mesh links that are articulated with each other. Of course, each mesh link is per se rigid enough to resist to manipulation and use of the apparatus. On the other hand, the apparatus comprises said guiding element which can cooperate with the grid in such a way that the guiding element is detachably held in said insertion position.

Thanks to the flexibility provided by the innovative structure of the grid and the associated guiding element, the apparatus according to the invention allows a precise positioning of needles and provide an adequate support for maintaining the needles in the position required during the laser illumination.

The grid can be easily adapted in size and shape to be placed over a surface having a complex shape, specifically a non-planar biological tissue surface under which is located a tumour in the head and neck region.

The apparatus according to the invention can thus be used for different patients and/or for treating tumours that are located in different regions.

According to an aspect of the invention, said array of openings may comprise at least one opening consisting of a through-hole provided in one of said mesh links.

According to another aspect of the invention, each mesh link forming the flexible grid may be provided with a through-hole, said array of openings comprising the through-holes of said mesh links.

In another aspect of the invention, said array of openings may comprise at least one opening consisting of an aperture between adjacent mesh links.

According to another aspect of the invention, said flexible grid may comprise at least one set of four mesh links assembled with each other in a square pattern so that each mesh link of said set is assembled with two other mesh links of said set. In this embodiment, said array of openings may comprise at least one opening consisting of an aperture between the four mesh links of said set.

In another aspect of the invention, said mesh links may comprise lateral rings arranged so that two lateral rings of two respective mesh links can be interlaced in such a way that those two mesh links are assembled with each other.

In the latter embodiment, each of said mesh links may comprise four lateral rings adapted so that each of said mesh links can be assembled with four adjacent mesh links.

According to another aspect of the invention, for at least a portion of said mesh links, each mesh link may comprise a centring pin extending along said insertion direction. The apparatus may be arranged so that said centring pin can cooperate with a housing provided in said guiding element in such a way as to hold said guiding element in said insertion position.

In an embodiment, said guiding element may be provided with one housing. The apparatus may be arranged so that said centring pin of one of said portion of said mesh links can cooperate with said housing so as to hold said guiding element in said insertion position.

In another embodiment, said guiding element may be provided with four housings. The apparatus may be arranged so that said centring pin of said portion of said mesh links respectively cooperate with one of said four housings so as to hold said guiding element in said insertion position.

Of course, the apparatus may comprise one or more guiding elements provided with one housing and/or one or more guiding elements provided with four housings according to the two latter embodiments.

According to another aspect of the invention, the apparatus may be arranged so that said centring pin cooperates with a corresponding housing in the manner of a snap- fitting connection.

In another aspect of the invention, said guiding element may comprise a first holding element and said mesh links may comprise a second holding element. The apparatus may be arranged so that said first holding element cooperates with said second holding element to hold said guiding element in said insertion position.

In an embodiment, said first holding element may comprise at least one magnet or at least one metal insert and said second holding element may comprise at least one metal insert or at least one magnet respectively.

In another aspect of the invention, the apparatus may comprise fiducial markers adapted to position said flexible grid over said non-planar biological tissue surface using image-based treatment planning techniques.

Image-based treatment planning techniques are well known in the prior art. The following document gives examples of such techniques:

- Strong EB, Rafii A, Holhweg-Majert B, Fuller SC, Metzger MC. Comparison of

3 Optical Navigation Systems for Computer-Aided Maxillofacial Surgery. Arch Otolaryngol Head Neck Surg. 2008 Oct; 134(10):1080-84.

According to another aspect of the invention, the apparatus may comprise a strap adapted to hold said flexible grid over said non-planar biological tissue surface around a human neck.

The invention also relates to a process for the manufacture of such an apparatus. This process comprises producing the flexible grid by the use of a 3D printer.

Brief description of the drawings

The above and others features, details and advantages of the present invention will become apparent from the following detailed description and the accompanying drawings in which: Figure 1 is a schematic view showing a flexible grid placed upon the neck of a patient, and needles passing through openings of the grid;

Figure 2 is a partial perspective view of an apparatus of the invention;

Figure 3 is a top view of an apparatus of the invention;

- Figure 4 is a perspective view of a mesh link of an apparatus of the invention;

Figure 5 is a cross-sectional view of the mesh link of figure 4;

Figure 6 is a partial cross-sectional front view of an apparatus of the invention receiving a needle;

Figure 7 is a partial top view of the apparatus of figure 6;

- Figure 8 is a front view of a guiding element of an apparatus of the invention;

Figure 9 is a side view of the guiding element of figure 8;

Figure 10 is a top view of the guiding element of figure 8;

Figure 11 is a cross-sectional front view of the guiding element of figure 8;

Figure 12 is a cross-sectional front view of the guiding element of figure 8 cooperating with a mesh link of an apparatus of the invention;

Figure 13 is a front view of the guiding element and the mesh link of figure 12;

Figure 14 is a cross-sectional front view of a guiding element of an apparatus of the invention;

Figure 15 is a front view of the guiding element of figure 14;

- Figure 16 is a top view of the guiding element of figure 15;

Figure 17 is a cross-sectional front view of the guiding element of figure 14 cooperating with mesh links of an apparatus of the invention;

Figure 18 is a front view of the guiding element and the mesh links of figure 17.

Identical or similar elements are marked with identical reference signs in all of the figures.

Detailed description of the invention

An embodiment of the apparatus of the invention is shown in figure 3. This apparatus comprises a grid 1 attached to a strap 2 and a guiding element 3.

As illustrated in figure 1, which schematically shows an apparatus of the invention without guiding element, the strap 2 is adapted to hold the grid 1 upon the neck 4 of a patient, said neck having a non-planar, complex, skin surface (herein generically referred to as "biological tissue").

This apparatus is specifically intended for cancer treatment, in particular for use in therapies such as LITT or PDT to treat head and neck cancer.

The grid 1 is flexible, that is conformable to a non-planar biological tissue surface such as the neck 4 of the patient illustrated in figure 1. To make the grid 1 flexible, the apparatus comprises mesh links assembled with each other to form the grid 1.

An example of one mesh link 11 is shown in figure 4. This mesh link 11 comprises lateral rings 111, 112, 113 and 114 having, in this embodiment, a helical shape. Those rings are arranged so that any ring of the mesh link 11 of figure 4, for example the ring 111, and a ring of another similar mesh link can be interlaced in such a way that those two mesh links are assembled with each other (not represented). More generally, two lateral rings of two respective mesh links can be interlaced in this way.

The mesh links may have rings having other shapes (not represented) as long as they provide the same function as the mesh links described in this document.

I n the embodiment of figure 4, the mesh link 11 comprises four lateral rings 111, 112, 113 and 114 that are arranged symmetrically. The mesh link 11 is thus adapted to be assembled with four other similar mesh links.

The mesh link 11 shown in figure 4 is provided with a through-hole 115 allowing a needle (not represented) to pass therethrough.

The grid 1 can comprise mesh links of the type shown in figure 4.

I n both embodiments, the grid 1 comprises an array of openings allowing needles to pass therethrough.

I n the example of figure 1, this array of openings comprises only the through- holes of the mesh links forming this grid 1.

Advantageously, the grid 1 is produced by a 3D printer.

Figure 1 shows three needles 41, 42 and 43 passing through openings of the grid 1. In this exam ple, those openings respectively consist in the through-holes of the three mesh links receiving the needles 41, 42 and 43.

It appears from this example that the grid 1 - and more specifically the openings of the grid 1 - provides a precise positioning of the needles 41, 42 a nd 43.

However, the grid 1 does not provide per se an adequate support for appropriately maintaining the needles 41, 42 and 43 in the position required during the laser illumination. I ndeed, without guiding element, the needles 41, 42 and 43 may shift during the therapeutic procedure and/or be inserted non-parallel to each other and/or be badly directed.

This problem is solved by the use of at least one guiding element 3 shown for example in figure 3. One guiding element 3 being intended to guide one needle, the apparatus preferably comprises as many guiding elements as required needles.

Referring now to the embodiment of figures 8 to 11, the guiding element 5 can comprise a guiding hole 51 allowing a needle (not represented) to pass therethrough. Said guiding hole 51 extends along an insertion direction Dl.

Another embodiment is shown in figures 14 to 16 in which the guiding element 6 also comprises a guiding hole 61 allowing a needle (not represented) to pass therethrough and extending along an insertion direction Dl.

Another embodiment is shown in figure 6 in which the guiding element 7 also comprises a guiding hole 71 allowing a needle 44 to pass therethrough and extending along an insertion direction Dl.

The apparatus is arranged to hold said guiding element 5 and/or 6 and/or 7 in an insertion position illustrated in figures 2, 3, 6, 7, 12, 13, 17, and 18.

In said insertion position, said guiding hole is aligned with a corresponding opening of the grid 1 in such a way that said guiding hole and said corresponding opening allow a needle to pass therethrough and to maintain this needle aligned in said insertion direction Dl.

For example, in the embodiment of figures 8 to 13, the guiding element 5 is aligned with the opening, through-hole 121 of the mesh link 12 in such a way that the guiding hole 51 and the corresponding opening 121 allow a needle (not represented) to pass therethrough and to maintain this needle aligned in said insertion direction Dl.

In the embodiment of figures 14 to 18, the guiding element 6 is aligned with the opening 131 which consists in an aperture between the adjacent mesh links 13 and 14. The guiding hole 61 and the corresponding opening 131 allow a needle (not represented) to pass therethrough and to maintain this needle aligned in said insertion direction Dl.

In the embodiment of figures 6 and 7, the guiding element 7 is aligned with the opening 151 which consists in an aperture between the adjacent mesh links 15, 16 and 17. The guiding hole 71 and the corresponding opening 151 allow the needle 44 to pass therethrough and to maintain this needle 44 aligned in the insertion direction Dl.

From the foregoing it appears that the array of openings of the grid 1 comprises, in some embodiments, at least one opening consisting of an aperture between adjacent mesh links. In those embodiments, the grid 1 comprise at least one set of four mesh links assembled with each other in a square pattern so that each mesh link of said set is assembled with two other mesh links of said set (not represented). As a consequence, in addition or in place of the through-holes of the mesh links, the array of openings comprises at least one opening consisting of an aperture between mesh links of the grid 1.

For example, in the embodiment of figure 7, the array of openings of the grid comprises both openings consisting of apertures 101, 102, 103 between mesh links and openings consisting of through-holes 104, 105, 106 of mesh links of the grid formed by those mesh links. It can be seen in the example of figure 7 that each aperture 101, 102, 103 consists in an aperture between four adjacent mesh links assembled with each other in a square pattern.

As described below, the guiding element(s) can cooperate with the grid in such a way that the guiding element or each of the guiding elements is detachably held in said insertion position.

In the embodiment of figure 12, the mesh link 12 comprises a centring pin 122 extending along the insertion direction Dl. The apparatus is arranged so that the centring pin 122 can cooperate with a housing 52 provided in the guiding element 5 in such a way as to hold said guiding element 5 in said insertion position.

In the embodiment of figure 17, the guiding element 6 is provided with four housings 62, 63 (only two of those housings are apparent in figure 17). The apparatus is arranged so that the centring pin 132, 142 of four mesh links 13, 14 (only two of those mesh links are apparent in figure 17) respectively cooperate with one of said four housings 62, 63 so as to hold said guiding element 6 in said insertion position.

The apparatus may comprise one or more guiding elements provided with one housing and/or one or more guiding elements provided with four housings according to the two latter embodiments. In the example of figure 2, the apparatus comprises:

- one guiding element 8 provided with one housing, according to the embodiment of figure 12, and

one guiding element 9 provided with four housings, according to the embodiment of figure 17.

In the embodiments of figures 8 to 18, the apparatus is arranged so that said centring pin cooperates with a corresponding housing in the manner of a snap-fitting connection.

Referring to figure 12, such a snap-fitting connection can be achieved by means of a protrusion formed by the guiding element 5 protruding inwardly, within the housing 52 provided in the guiding element 5, and of a corresponding groove in the centring pin 122 of the mesh link 12 (see reference 501 in figure 12). The size of said protrusion and of said groove may be adapted according to the holding force required to disengage the guiding element 5 from the mesh link 12. The same principle can be applied mutatis mutandis to the embodiment of figure 17.

In the embodiment of figure 6, the guiding element 7 comprises a first holding element 72, 73 and said mesh links 15, 16, 17 comprise a second holding element 152, 172.

In this embodiment, the apparatus is arranged so that said first holding element 72, 73 cooperates with said second holding element 152, 172 to hold the guiding element 7 in said insertion position. In this example, the first holding element 72, 73 comprises a magnet and the second holding element 152, 172 comprises a metal insert.

A second holding element 112 consisting in a metal insert is shown in the mesh link 11 of figure 5.

The size and the material of said first holding element and of said second holding element may be adapted according to the holding force required to disengage the guiding element 7 from the grid 1.

Referring back to the embodiments of figures 2 and 3, the apparatus comprises fiducial markers 29 adapted to position the flexible grid 1 over the non-planar biological tissue surface using image-based treatment planning techniques.

To attach the grid 1 to the strap 2, the apparatus may comprise specific mesh links which can be adapted to receive and maintain said fiducial markers 29.

Of course, the invention is not limited to the precise embodiments described hereinabove and various adaptations may be effected without departing from the scope of the invention as defined in the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiments.

Claims

1. Apparatus for cancer treatment, characterised in that it comprises:

mesh links (15-17) assembled with each other to form a flexible grid (1) adapted to be placed over a non-planar biological tissue surface, said grid (1) comprising an array of openings (101-106) allowing needles (44) to pass therethrough, a guiding element (7) comprising a guiding hole (71) allowing a needle (44) to pass therethrough, said guiding hole (71) extending along an insertion direction (Dl),

this apparatus being arra nged to detachably hold said guiding element (7) in an insertion position in which said guiding hole (71) is aligned with a corresponding opening (151) of the flexible grid (1) in such a way that said guiding hole (71) and said corresponding opening (151) allow a needle (44) to pass therethrough and to maintain this needle (44) aligned in said insertion direction (Dl).

2. Apparatus according to claim 1, in which said array of openings comprises at least one opening consisting of a through-hole (104-106, 115, 121) provided in one of said mesh links (11, 12).

3. Apparatus according to claim 1 or 2, in which each mesh link forming the flexible grid (1) is provided with a through-hole (104-106, 115, 121), said array of openings comprising the through-holes of said mesh links.

4. Apparatus according to anyone of claims 1 to 3, in which said array of openings comprises at least one opening consisting of an aperture (101-103, 131, 151) between adjacent mesh links.

5. Apparatus according to anyone of claims 1 to 4, in which said flexible grid (1) comprises at least one set of four mesh links assembled with each other in a square pattern so that each mesh link of said set is assembled with two other mesh links of said set, said array of openings comprising at least one opening consisting of a n aperture (101-103) between the four mesh links of said set.

6. Apparatus according to anyone of claims 1 to 5, in which said mesh links (11) comprise lateral rings (111-114) arranged so that two lateral rings of two respective mesh links ca n be interlaced in such a way that those two mesh links are assem bled with each other.

7. Apparatus according to claim 6, in which each of said mesh links (11) comprises four lateral rings (111-114) adapted so that each of said mesh links can be assembled with four adjacent mesh links.

8. Apparatus according to anyone of claims 1 to 7, in which, for at least a portion of said mesh links, each mesh link comprises a centring pin (122, 132, 142) extending along said insertion direction (Dl), the apparatus being arranged so that said centring pin (122, 132, 142) can cooperate with a housing (52, 62, 63) provided in said guiding element (5, 6) in such a way as to hold said guiding element (5, 6) in said insertion position.

9. Apparatus according to claim 8, in which said guiding element (5) is provided with one housing (52), the apparatus being arranged so that said centring pin (122) of one of said portion of said mesh links can cooperate with said housing (52) so as to hold said guiding element (5) in said insertion position.

10. Apparatus according to claim 8, in which said guiding element (6) is provided with four housings (62, 63), the apparatus being arranged so that said centring pin (132, 142) of said portion of said mesh links respectively cooperate with one of said four housings (62, 63) so as to hold said guiding element (6) in said insertion position.

11. Apparatus according to anyone of claims 8 to 10, arranged so that said centring pin (122, 132, 142) cooperates with a corresponding housing (52, 62, 63) in the manner of a snap-fitting connection.

12. Apparatus according to anyone of claims 1 to 10, in which said guiding element (7) comprises a first holding element (72, 73) and said mesh links (15, 17) comprise a second holding element (152, 172), the apparatus being arranged so that said first holding element (72, 73) cooperates with said second holding element (152, 172) to hold said guiding element (7) in said insertion position.

13. Apparatus according to claim 12, in which said first holding element (72, 73) comprises at least one magnet or at least one metal insert and said second holding element (152, 172) comprises at least one metal insert (112) or at least one magnet respectively.

14. Apparatus according to anyone of claims 1 to 13, comprising fiducial markers (29) adapted to position said flexible grid (1) over said non-planar biological tissue surface using image-based treatment planning techniques.

15. Apparatus according to anyone of claims 1 to 14, comprising a strap (2) adapted to hold said flexible grid (1) over said non-planar biological tissue surface around a human neck (4).