WO2005077290A1

WO2005077290A1 - Thermally isolated medical apparatus used for the treatment of tumours

Info

Publication number: WO2005077290A1
Application number: PCT/EP2004/001278
Authority: WO
Inventors: László SZÉKELY
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-02-11
Filing date: 2004-02-11
Publication date: 2005-08-25
Anticipated expiration: 2006-08-11

Abstract

An apparatus for applying a composition into a body of a human or animal. An isolation means is provided in the apparatus for thermally isolating the composition from the body during insertion of the apparatus into the body and application of the composition. The composition is used for treating tumours in a human or animal and has a temperature in a range such that the tumourous cells are destroyed. A system is provided for treating tumours in a human or animal comprising: a composition for treating the tumour; an apparatus for an application of the composition wherein the apparatus is thermally isolated such that an isolating means is provided for thermally isolating the composition from the body during insertion of the apparatus into the body and application of the composition.

Description

Thermally Isolated Medical Apparatus Used for the Treatment of Tumours

Description

The invention relates to an apparatus for applying a composition into a body of a human or animal and the composition is for treating tumours in a human or animal. Further, the invention relates to a system for treating tumours in a human or animal.

It is known to treat benign prostate hypertrophy (BPH) using various surgical techniques, for example, transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), visual laser assisted prostatectomy (VLAP), balloon dilation and stenting, transurethral microwave therapy (TUMT), high intensity focused ultrasound (HIFW) and transurethral needle ablation (TUNA). Most of these techniques use various forms of energy, including radio frequency (RF), microwave, laser, and ultrasound, to achieve the final desired effect of thermal therapy, that is to create heat inside the specific areas of the prostate and have a destructive effect on the tumour.

For example, in transurethral needle ablation (TUNA), the TUNA instrument is inserted into the urethra in the male pelvic region adjacent to the prostate and the RF needles are inserted into the prostate and the RF is energised.

However, there are many drawbacks of these known techniques for treating BPH including complexity of design, control, expense and complications. Moreover, the inability to focus the energy source at the prostatic tissue is most problematic since this results in the destruction of desirable healthy tissue in the vicinity of the diseased tissue. It is important for a technique to selectively treat an appropriate region of the prostate, while preserving other areas. It is an object of this invention to provide a medical apparatus for applying a composition into a body of a human or animal that allows selective treatment of the diseased tissue while preserving other areas.

It is a further object of this invention to provide an apparatus with low complication rates.

It is a still further object of this invention to provide an apparatus which is simple in construction, convenient to use and cheap to manufacture.

The present invention has low complication rates resulting in less suffering and inconvenience. Selective treatment of diseased tissue without harming adjacent healthy tissue is very desirable and achievable with the present invention. The present invention allows for the direct application of a composition to the diseased tissue. Thus, for example, heat injury is avoided to the urethra, bladder neurovascular bundles and rectum.

The apparatus of the present invention is simple in construction. For example, the present invention does not require incorporation of built in optical systems, aspiration systems, etc., or complex mechanisms for manoeuvring RF needles, as is the case for TUNA instruments. As a result, the apparatus of the present invention is relatively inexpensive to manufacture.

With the present invention, the urologist is able to control efficiently with regard to time and resources. The present invention requires a minimally invasive therapy which can be performed within a relatively short time frame in the urologist's practice without the need of elaborate operating room facilities, for example, an anaesthesia team, laboratory testing etc...... Further, the present invention is simple to operate and easy to learn. Optimal control of time and resources also results in cost savings in application.

The invention will now be described by way of example and with reference to the accompanying drawings in which: Figure 1(a) is a side view of a conventional needle and syringe;

Figure 1(b) is an exploded view of the apparatus according to an embodiment of the present invention in disassembled form; Figure 1(c) is a side view of an apparatus according to an embodiment of the present invention in assembled form; Figure 2(a) is a cross-sectional view of a normal healthy bladder and prostate of a male pelvic region; Figure 2(b) is a cross-sectional view of a diseased bladder and prostate of the male pelvic region;

Figures 2(c) to (e) are sectional views illustrating a first application of the apparatus according to an embodiment of the present invention; Figure 2(f) is a further view illustrating a first application of the apparatus according to an embodiment of the present invention; Figure 3(a) is a front view of female breasts illustrating a second application of the apparatus according to an embodiment of the present invention; Figure 3(b) is a cross-sectional view of female breasts illustrating a second application of the apparatus according to an embodiment of the present invention; Figure 3(c) is an enlarged cross-sectional view of a tumourous breast of Figures 3(a) and 3(b); Figure 4 is a sectional view of a human brain illustrating a third application of the apparatus according to an embodiment of the present invention; Figures 5(a) and (b) are side views of the spine of a human illustrating a fourth application of the apparatus according to an embodiment of the present invention; and Figure 6 is a schematic illustrating a removal means for removing tumours in a human or animal according to an embodiment of the present invention.

Figure 1(a) is a side view of a standard syringe 1 and a needle part 2 shown detached from the syringe 1 as found in the art. A conventional syringe comprises a tubular syringe body 1' and a plunger 1" inserted therein which can be detached from the syringe body 1'. The syringe 1 is usually hand-held and can be operated using one hand. The syringe body 1' is filled with liquid and the plunger 1" is depressed to expel liquid from the syringe 1. A measured quantity of liquid can be expelled according to a scale depicted on the outer surface of the syringe body 1'.

Figure 1(b) illustrates the syringe 1 and needle part 2 of Figure 1(a) and a first cover 3. Both the first cover 3 and needle part 2 are shown detached respectively and detached from the syringe 2.

The first cover 3 has preferably a tapered section 3' which may conform to the shape or outline of the needle part 2. In particular, the inner diameter of the first cover 3 conforms to the outer diameter of the needle part 2 in order to obtain a snug fit.

The first cover 3 acts as an isolation means and can be made from any suitable insulating material, and is preferably thermally insulating, for example by use of any suitable plastic, rubber or composite material.

Figure 1(c) illustrates the syringe 1, the needle part 2 and first cover 3 of Figure 1(b) in assembled form together with a second cover 4. The second cover 4 is shown in the Figure to take a form which conforms to the syringe body 1'. In particular, the inner diameter of the second cover 4 conforms to the outer diameter of the syringe body 1' in order to obtain a snug fit.

The second cover 4 in Figure 1(c) is shown arranged on the exterior surface of the syringe body 1', but may also be arranged on the interior surface to form a lining (not shown). The outer surface of the lining would conform to the inner diameter of the syringe body 1' in order to obtain a snug fit. The syringe body 1' may comprise any number of covers or linings which are external and/or internal to the outer or inner walls of the syringe body 1' respectively.

The second cover 4 also acts as an isolation means and can be made from any suitable insulating material, and is preferably thermally insulating, for example by use of any suitable rubber, plastic or composite material. The isolation means, exemplified by the first cover 3 and/or second cover 4, serve to thermally isolate the composition from the body during insertion of the apparatus into the body and application of the composition. The isolating means ensure that heat from the composition or any part of the apparatus, for example, the needle part 2 and/or syringe 1, does not transfer beyond the isolation means to nearby or adjacent healthy tissue. This results in the composition for treating the tumour being thermally isolated from nearby or adjacent healthy tissue during application.

The isolation means may be arranged on the walls of the apparatus and can be either temporarily or permanently detachable. A temporary or detachable fixation would enable the insulation means to be detached when necessary allowing, for example, the advantage of cleaning the detachable part. A permanent or un-detachable fixation would not allow detachment. The fixation can be achieved by any suitable adhesive or mechanical means. For example, any suitably epoxy, glue or clamping means. Alternatively, the isolation means may simply rest on the exterior of the apparatus to treat the tumour.

In operation, the syringe body 1' is filled with a composition, preferably a fluid. When the plunger 1" is depressed the composition exits from the syringe 1 via the needle 2 to the diseased tissue. Upon the expulsion of the composition, the plunger 1" is removed to introduce a further quantity of composition for further application to the diseased tissue. This operation may be repeated any number of times, at any suitable time interval, sufficient to destroy all the diseased tissue.

The composition may have any temperature in a range such that tumourous cells are destroyed. Preferably, the temperature range is about 40°C to about 100°C, more preferably about 45°C to about 95°C, and most preferably about 50°C to about 90°C. Alternatively, the desired temperature ranges may fall within any of the following ranges: about 40°C to about 50°C, about 50°C to about 60°C, about 60°C to about 70°C, about 70°C to about 80°C, about 80°C to about 90°C and about 90°C to about 100°C. The temperature of the composition may be held at any of these temperatures for any sufficient interval of time suitable to destroy the tumour. In order to accommodate the temperature ranges of the composition, the material used for the various components of the apparatus, particularly the syringe 1, needle 2 and isolation means 3, 4, must withstand these desirable temperature ranges and sufficiently isolate. In particular, the material may comprise any suitable heat resistant plastic material capable of withstanding temperatures above about 40°C.

The composition may comprise distilled water. More preferably, the composition comprises distilled water with adrenalin; therein a mixture of distilled water with up to about lOμg/lml adrenalin is preferred. Even most preferably distilled water with about 5μg/lml adrenalin is utilised. The adrenalin can also be used in combination with hydrocortisone and/or a Roentgen contrast solution. Preferably, the Roentgen contrast solution is water-soluble.

The composition may be heated by any suitable heating means including any suitable energy source for example, microwave, radio wave, laser, ultrasound or high electric voltage sources.

The apparatus depicted in Figure 1 illustrating syringe 1 and needle 2 combined with isolation means 3, 4, may be substituted by any other suitable apparatus for accessing a part of the body and allowing application of heat and/or a fluid. For example, the needle 2 and syringe 1 may be replaced by a catheter, endoscope or tubular entity. Further, the isolation means 3, 4 may take any other shape suitable to conform to the shape of any other apparatus or part thereof for accessing a part of the body and allowing application of heat and/or a fluid, for example, a catheter, endoscope or any other suitable tubular entity.

The composition may be used to treat any number of suitable diseased tissue, for example any form of tumour or malign tumour. Other examples include prostate tumour, prostatic hypertrophy, breast tumour, liver tumour, brain tumour or bone metastasis, pancreas tumour, myoma, uterus tumour, sarcoma or malign seminoma. Figures 2 to 5 illustrate examples of the applications of the apparatus according to various embodiments of the present invention which will now be described.

Figure 2(a) is a cross-sectional view of a normal healthy bladder containing urine 5 and prostate 6 of a male pelvic region 7.

Figure 2(b) is a cross-sectional view of a diseased bladder and prostate of the male pelvic region. The tumour 8 is illustrated schematically within the prostate. Increased thickness or enlargement of the bladder is otherwise known as hypertrophy of the prostate and is a benign, non-cancerous tumour.

Figures 2(c) to (e) are sectional views illustrating a first application of the apparatus according to an embodiment of the present invention.

Figure 2(c) is an enlarged view of a male pelvic region illustrating the various positions of the urinary organs, for example, the urethra 10, bladder 11, penis 12 and rectum 13, near the prostate 9. The urethra 10 is a duct leading from the bladder 11, through the prostate 9 and out of the penis 12. In order to treat the tumour the apparatus of the present invention 13 (only needle part shown) must be directed into the tumour in the prostate 9. The direct application into the tumour in the prostate avoids damage to the neighbouring organs, for example, urethra 10, bladder 11, penis 12, rectum 13, and adjacent or nearby healthy tissue. In this manner only diseased tissue is destroyed by disintegrating the cells of the diseased tissue.

Figure 2(d) illustrates the insertion of the needle part 2 of the apparatus of the invention through a different path whereby insertion takes place at the rear end of the male anatomy compared to Figure 2(c). Figures 2(e) and (f) are different views illustrating the insertion of the needle part 2 of apparatus of the invention to the tumour in the prostate 9.

Figure 3(a) shows the front view of the right (Dx) and left (Sin) female breasts illustrating a second application of the apparatus according to an embodiment of the present invention. A tumour is depicted schematically in the right breast and the needle part 2 of the apparatus of the invention is directed into the tumour.

Figure 3(b) is a cross-sectional view of one female left breast with its mirror image adjacent thereto. A tumour is depicted in the mirror image right breast and the needle part 2 of the apparatus of the invention is directed into the tumour.

Figure 3(c) is an enlarged cross-sectional view of the breast with the tumour of Figures 3(a) and (b). The Figure illustrates schematically a series of injections in and around the tumour (see arrows). In the case of a breast tumour, it may be necessary to inject composition around the tumour before injecting the tumour directly. However, if circulation systems are blocked around the tumour, then the tumour may be injected with composition directly.

Figure 4 is a sectional view of a human brain illustrating a third application of the apparatus according to an embodiment of the present invention. When the needle part 2 of the apparatus of the present invention is in position A, then the composition of the invention can be injected into the tumour (see inward arrow). After injection, then the undesired treated tissue can be suitably removed (see outward arrow) as shown by the needle part 2 of the apparatus of the present invention in position B. While the needle part 2 in positions A or B may be the same apparatus of the present invention, the apparatus at positions A or B may also be different. For example, wherein the apparatus at position A is used solely for application, this apparatus may be different from the apparatus at position B which is used solely for removing diseased tissue.

Figure 5(a) is a side view of the spine of a human illustrating a fourth application of the apparatus according to the embodiment of the present invention.

Figure 5(b) is a portion of the spine as shown in Figure 5(a). The needle part 2 of the apparatus of the present invention is inserted into the tumour at position A and the tumour is removed with the needle part 2 in position B. The apparatus at position A, for application of the composition, may be the same or different from the apparatus at position B for removal of diseased tissue.

Figure 6 shows an apparatus for removing diseased tissue according to an embodiment of the invention. The apparatus can be used together with the system of the present invention comprising the composition for treating the tumour and an apparatus for an application of the composition, wherein the apparatus is thermally isolated such that an isolation means is provided for thermally isolating the composition from the body during insertion of the apparatus into the body, an application of the composition.

The syringe 1 of the present application may be replaced by the removing apparatus of Figure 6. The removing apparatus comprises: a pump means 17 for removing the unwanted tissue; a container means 18, 19 for storing and discarding the unwanted tissue; a barometer 15 to measure the pressure in the pump means 17; a heating/coagulation means, for example, diathermy apparatus 20; and a control panel 21 to control the operation of flow tissue by a series valves 13, 14, 16 and 19.

In operation, an isolated needle part 2 of an apparatus may be injected into the area of the diseased tissue which requires removal. With the pump 17 turned on the diseased tissue is forced to enter the container 18 when valves 13, 14, 16 are open.

The pressure of the pump is regulated by the barometer and application of the vacuum is regulated by the opening/closing of the valves 13, 14, 16. The diathermy apparatus 20, via the application of a high electric voltage, causes carbonisation/necrosis of the tissue and prevents unnecessary bleeding after, for example, an arterial rupture. The unwanted tissue is finally discarded from the contained 18 through opening 19.

While various features and embodiments of the invention are described above, they can readily be combined with each other resulting in further embodiments of the invention.

Claims

1. An apparatus for applying a composition into a body of a human or animal characterized in that an isolation means is provided for thermally isolating the composition from the body during insertion of the apparatus into the body and application of the composition.

2. The apparatus of claim 1, wherein the isolation means comprises thermally insulating the apparatus, either internally or externally, by an insulating material.

3. The apparatus of claim 2, wherein the apparatus is, internally or externally, thermally insulated such that the insulation surrounds the inner and outer walls of the instrument respectively.

4. The apparatus of claim 3, wherein the internal or external insulation is either temporarily or permanently detachable.

5. The apparatus of any of claims 2 to 4, wherein the insulation is attached to the various exterior or interior portions of the apparatus, and most preferably to the needle part 2 and the syringe body 1'.

6. The apparatus of any of claims 1 to 5, wherein the apparatus is selected from the group comprising needle, syringe, catheter, endoscope, or tubular entity.

A composition for treating tumours in a human or animal characterized in that the composition has a temperature in a range such that the tumourous cells are destroyed.

8. The composition of claim 7, wherein the temperature is in the range of about 40°C to about to 100°C, preferably about 45°C to about 95°C, and most preferably about 50°C to about 90°C.

9. The composition of claims 7 or 8, wherein the composition comprises distilled water, and more preferably distilled water with adrenalin, most preferably distilled water with up to lOμg/lml adrenalin, even most preferably distilled water with about 5μg/lml adrenalin, wherein adrenalin can also be used in combination with hydrocortisone and/or a Roentgen contrast solution, and preferably the Roentgen contrast solution is water soluble.

10. The composition of any of claims 7 to 9, wherein the composition is used to treat prostate tumour, prostatic hypertrophy, breast tumour, liver tumour, brain tumour or bone metastasis, pancreas tumour, myoma, or uterus tumour.

11. The composition of any of claims 7 to 10, wherein the composition is applied directly to the diseased site.

12. The composition of any of claims 7 to 11, wherein the composition is heated by microwave, radio wave, laser, ultrasound or high electric voltage sources.

13. A system for treating tumours in a human or animal comprising: a composition for treating the tumour; an apparatus for an application of the composition wherein the apparatus is thermally isolated such that an isolating means is provided for thermally isolating the composition from the body during insertion of the apparatus into the body and application of the composition.

4. An apparatus for sucking out the tissue treated with the composition of any of claims 7 to 12 from the body of a human or animal characterized in that an isolation means is provided for thermally isolating the sucked out tissue during insertion of the apparatus into the body and removal of the sucked out tissue.