Patent Application
20250127539
This patent application claims priority of Italian Patent Application No. 102021000023285 filed on Sep. 9, 2021, the entire disclosure of which is incorporated herein by reference.
The present invention relates to a device for the placement of organic tissue and a relative apparatus.
In particular, the present invention finds advantageous, but not exclusive application in the orthotopic or heterotopic placement of endocrine tissue, in particular ovarian, to which the following description will make explicit reference without thereby losing generality.
In the field of reproductive medicine for the preservation of fertility and ovarian function, techniques are known for reimplantation of ovarian tissue in patients undergoing, for example, oncological therapy, which determines, in multiple cases, at least a partial suppression of the ovarian function, which is a potential cause of infertility and/or premature menopause (pathologies that are known in themselves and therefore not further detailed here).
For some years, patients waiting to undergo oncological therapy with a risk of suppression of the ovarian function are usually subjected to a preventive biopsy of ovarian tissue, which is preserved by cryopreservation. At the end of chemo-and/or radiotherapy therapy, patients may undergo reimplantation of the previously harvested tissue, with subsequent restoration of the hormonal and gametogenic (particularly ovogenic) function.
In detail, considering the increase in life expectancy, it is important to guarantee to the aforesaid type of patients an improvement in the quality of life, with particular attention to the field of oncofertility, i.e. that area of interest of the reproductive medicine that aims at safeguarding the fertility of patients undergoing cancer treatments. In particular, ovarian tissue cryopreservation plays an important role in this context and is currently the main mode of preservation of hormonal function and fertility in this type of patients.
In detail, according to the prior art, at the end of the oncological therapy, the previously harvested ovarian tissue is reimplanted either orthotopically (i.e. in the area of the retroperitoneal pelvic space) by endoscopy or heterotopically (e.g. in the subcutaneous tissue) by transcutaneous incisional route.
Therefore, both in the case of a transcutaneous incisional approach, and in the case of a laparotomic/endoscopic approach (e.g. laparoscopic), analgesia/anaesthesia techniques must be used (with the known relative risks, possible hospitalisation and costs for the patient and/or for the healthcare system).
Moreover, the method according to the known art presents non-negligible surgical risks, which often also cause a strong psychological impact on the patient (e.g. due to the surgery itself and/or the consequent aesthetic result that may result).
Aim of the present invention is to realise a device for the placement of organic tissue and relative apparatus, which are at least partially free of the drawbacks described above and, at the same time, are simple and inexpensive to manufacture.
In accordance with the present invention, there are provided a device for the placement of organic tissue and a relative apparatus as claimed in the following independent claims and, preferably, in any one of the claims directly or indirectly dependent on the independent claims.
The claims describe preferred embodiments of the present invention forming an integral part of the present disclosure.
The present invention will now be described with showing some non-reference to the enclosed drawings, limiting embodiments thereof, wherein:
With reference to the accompanying Figures, number 1 denotes a device for the placement of an organic tissue 2.
In particular, the organic tissue 2 is endocrine tissue, i.e. belonging to glands/organs suitable for the production of hormones. For example, the organic tissue 2 is ovarian, pancreatic, or thyroid tissue.
In the following description, the same numbers and the same reference letters in the figures identify the same elements or components with the same function.
In the context of this disclosure, the term “second” component does not imply the presence of a “first” component. These terms are in fact used as labels to improve clarity and should not be understood in a limiting way.
The elements and features shown in the various preferred embodiments, including the drawings, may be combined with each other without thereby departing from the scope of protection of the present application as described below.
The device 1 comprises a hollow tubular base element 3, which determines, on the inside thereof, a primary duct 4 configured to house in a seat 5 at least one portion of the organic tissue 2 to be positioned/implanted in a patient P. The base element 3 comprises an end 6 and an end 7 opposite the end 6 relative to the primary duct.
Advantageously, the base element 3 is configured to at least partially penetrate a target tissue 8.
Preferably but not in a limiting way, the end 6 of the base element 3 comprises a cutting profile for at least partially (in particular completely and therefore crossing) pierce a tissue that covers the target tissue 8.
Preferably but not in a limiting way, the end 6 of the base element 3 comprises a cutting profile for at least partially piercing the target tissue 8.
In particular, the base element is a needle element, that is, with the tip (at the end 6) cut obliquely to obtain a cutting profile capable of piercing the tissues of a patient P (with minimum trauma) to reach the site where the organic tissue 2 to be positioned/implanted in a patient P is to be deposited. In this way, it is possible to avoid having to cut the tissues (for example cutaneous ones) that cover the target tissue 8 (and part of the target tissue 8 itself) in advance to be able to deposit the organic tissue 2 in the desired position, thus reducing the risks of infection and/or imperfections for the patient P.
According to the non-limiting embodiment of
In the non-limiting embodiment of
In particular, the device 1 is controlled by an operator O, who performs the surgery with the aid of the OC optics of a video camera (known in itself and therefore not further detailed) (or without, in the case of percutaneous placement).
Obviously, the dimensions of the device 1 for percutaneous use and of the device 1 for endoscopic use can be different and in particular vary in length and diameter in light of the different dimensions allowed by the two modes of use. In particular, the device 1 for percutaneous use has at least one dimension which is smaller than the device 1 for endoscopic use.
In some non-limiting cases, the base element 3 has a substantially circular cross-section, in other non-limiting cases, in order to increase the dimensions (width) of the organic tissue 2 to be positioned (usually supplied as strips), the base element 3 has an oval cross-section.
Advantageously, the device 1 further comprises a pushing element 14, which can be inserted or is inserted on the inside of the base element 3 (in particular from the end 7) and is coupled to it in a sliding manner along a longitudinal axis A.
Furthermore, the device 1 comprises an opening 15 which is arranged in a distal zone DZ towards the end 6. The opening 15 is configured to let out and, hence, position the organic tissue 2 in the target tissue 8 through the action of the pushing element 14.
In particular, the pushing element 14 is operable by an operator O (e.g., a surgeon) to position the organic tissue 2 once the opening 15 has reached the desired point in the target tissue 8.
Preferably, the device 1 comprises a protection element 16 for the organic tissue 2 which is configured to protect the organic tissue 2 while the device 1 (i.e. the base element 3) penetrates towards the target tissue 8. In particular, the protection element 16 is configured to assume at least one closed configuration (shown for example in
Advantageously but not necessarily, the device 1 comprises at least one injection device 17 which is configured to inject into the target tissue 8 a culture liquid 18 (of known composition and therefore not more detailed below), which is configured to enhance the activity and/or the reproduction of the organic tissue 2 in the target tissue 8, enhancing implantation.
In particular, the injection device 17 comprises a channel 19 on the inside of the primary duct 4 through which the culture liquid 18 flows. In some non-limiting cases, the inner channel 19 is defined by the primary duct 4 itself. In other non-limiting cases, such as those shown in
Advantageously but not necessarily, the injection device 17 is configured to be operated before and/or after and/or during the placement of the organic tissue 2. In this way, a suitable housing can be created inside the target tissue 8 to accommodate the organic tissue 2.
According to some non-limiting embodiments, for example those shown in
According to other non-limiting embodiments, for example those shown in
According to further non-limiting and non-illustrative embodiments, the pushing element 14 comprises both a pushing member 20 and the culture liquid 18 as described.
In some non-limiting cases, such as those shown in
Alternatively (
In some non-limiting and not shown cases, the organic tissue 2 is divided into different portions that are placed through the same opening 15 or through different openings 15 arranged in the area of the distal zone DZ.
According to some non-limiting embodiments, the base element 3 defines an outer shell 23. In particular, the protection element 16 of the organic tissue 2 is defined at least partially by a hollow tubular inner shell 24 which is arranged inside the outer shell 23 in a concentric manner and is configured to house the seat 5 (thus the portion of the organic tissue 2 to be positioned) and the pushing element 14. More precisely, the inner shell 24 comprises an opening 25 which is available in the distal zone DZ (adjustable towards the opening 15) and configured to let out the organic tissue 2 towards the opening 15.
In particular, the inner shell 24 is at least capable of translating along and/or of rotating around the longitudinal axis A so as to cause the opening 15 and the opening 25 to become complementary to (i.e. facing) one another, thus determining a connection between the inside of the inner shell 24 and the outside of the outer shell 23 in the target tissue 8. In other words, preferably, in such embodiments the shells 23 and 24 are spaced from each other, that is, provided with two degrees of freedom, one of which is linear (they are free to slide mutually along the longitudinal axis A) and one is rotatable (they are free to rotate mutually around the longitudinal axis A).
Advantageously but not necessarily, the inner shell 24 can be inserted on the inside of the outer shell 23 from the end 7.
According to some non-limiting embodiments, the shell 24 comprises a cup-shaped body 26, which is configured to contain the organic material 2 and/or the culture liquid 18. In this way, before inserting the shell 24 inside the shell 23, the operator O fills the cup-shaped body 26, which in this case defines the seat 5, with the organic material 2 surrounded by the culture liquid 18.
Advantageously but not necessarily, the primary duct has a diameter D which is smaller than or equal to 3 mm (i.e. with gauge greater than or equal to 8), in particular smaller than 2 mm (i.e. with gauge greater than or equal to 12), more particularly, especially in the case of percutaneous use, lower than 1.5 mm (i.e. with gauge greater than or equal to 14), in detail lower than 1 mm (i.e. with gauge greater than or equal to 18).
Advantageously but not necessarily, the base element 3 has a diameter which is smaller than 5 mm, in particular smaller than 3 mm, more particularly, especially in the case of percutaneous use, smaller than 2 mm, in detail smaller than 1.5 mm.
Advantageously but not necessarily, and as shown in the non-limiting embodiments of the accompanying figures, the protection element 16 comprises an obstructing body 27.
In the non-limiting embodiment of
In the non-limiting embodiment of
In the non-limiting embodiment of
Advantageously but not necessarily, the pin 33 also acts as an end stop for the cup-shaped body 26 and/or for the piston 21.
In the non-limiting embodiment of
In the non-limiting embodiment of
In the non-limiting embodiment of
Advantageously but not necessarily, the seat 5 can be loaded by the operator O with the organic tissue 2 and/or the liquid 18 immediately before proceeding with the placement of the tissue in an orthotopic or heterotopic site. In this way, the organic tissue 2 can easily be cryopreserved and brought to room temperature only a few hours after placement.
In some non-limiting cases, the device 1 is reusable and the seat 5 can be loaded and loaded again multiple times.
In other non-limiting cases, the device 1 is disposable.
In accordance with a further aspect of the present invention, there is provided an apparatus 40 for the placement of organic tissue 2 comprising at least one device 1 as previously described.
In particular, the apparatus 40 also comprises the portion of organic tissue 2 housed in the seat 5.
In some non-limiting cases, the organic tissue 2 comes from the same patient P who receives it (as indicated above, for example, previously recovered and cryopreserved ovarian tissue) thus carrying out an autotransplant.
In other non-limiting cases, the organic tissue 2 comes from an individual other than the patient P who receives it (for example, whose organic tissue 2 is healthy and compatible), thus carrying out an allograft.
Advantageously but not necessarily, the apparatus further comprises a system 41 for the culture liquid 18, which is configured to inject the liquid 18 from the opening 7 or from an opening that is arranged on the side wall 22 of the base element 3 or of the inner shell 24 as shown in
According to some non-limiting embodiments, such as those shown in the accompanying figures, the device 1 (i.e. the base element 3) has a rectilinear conformation, in particular along the longitudinal axis A.
According to other non-limiting and non-illustrative embodiments, the device 1 (i.e. the base element 3) has a conformation which is at least partially curved, in particular ergonomic. In such embodiments, the longitudinal axis A is an axis of central symmetry of the primary duct 4, in particular curved. In other words, the course of the axis A follows the curved conformation of device 1.
In particular, in further non-limiting cases, the device 1 (i.e. the base element 3) has a partially rectilinear (on the side of the end 7) and partially curved, in particular ergonomic, conformation in the area of the distal zone DZ, i.e. of the end 6.
In use, the operator O prepares the device 1 (if it is not already ready) by housing in the seat 5 the organic tissue 2 to be implanted, for example ovarian tissue, and possibly culture liquid 18. Subsequently, in the orthotopic/endoscopic site (
Although the invention described above makes particular reference to very precise embodiment examples, it is not to be considered limited to such embodiment examples, all those variants, modifications or simplifications covered by the accompanying claims, such as for example a different dimension of the device, a different type of organic tissue, a different type of protection element, a different material, etc. falling within its scope.
The device and the apparatus described above have numerous advantages.
Firstly, the invention to overcome the transcutaneous incisional approach (i.e. with surgical incision that allows access to the target tissues) currently in use for the heterotopic reimplantation of ovarian tissue, by using a percutaneous approach.
Furthermore, in the case of an orthotopic approach, the device 1 can be used:
In addition, the invention would allow to reduce the time of hospitalization, the invasiveness of the procedure, and would guarantee a better aesthetic result for the patient.
In addition, the organic tissue (for example ovarian) would be damaged to a lesser extent than according to the prior art, as it would suffer less trauma (there is no need to handle it with forceps except for the placement thereof inside the device 1, which is possible with an extremely simple and delicate gesture compared to the placement thereof in the target tissue by means of surgical equipment).
A further advantage of the present invention lies in simplifying the reimplantation of ovarian tissue in patients of childbearing age undergoing cancer treatments at risk of iatrogenic ovarian failure. In particular, the device 1 can be used for the placement/release of endocrine tissues other than ovarian tissue or for reimplantation of ovarian tissue in menopausal patients, so as to prolong hormone support.
Advantageously, compared to the known techniques, the instrument would be atraumatic on the tissue 2 and minimally invasive for the patient (so much so that local anaesthesia is sufficient for the heterotopic approach). In particular, the presence of the protection element 16 allows to prevent the organic tissue 2 from being damaged during penetration, avoiding the entry of fat and other soft tissues into the primary duct.
Finally, compared to the known techniques, in particular in the heterotopic approach, the device 1 can be used individually without the need for additional instruments.
| Number | Date | Country | Kind |
|---|---|---|---|
| 102021000023285 | Sep 2021 | IT | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/058418 | 9/7/2022 | WO |
