GB2478127A

GB2478127A - Tumour encapsulation device

Info

Publication number: GB2478127A
Application number: GB1003155A
Authority: GB
Inventors: Fouad Mounir Elias Kaldas
Original assignee: Individual
Current assignee: Individual
Priority date: 2010-02-25
Filing date: 2010-02-25
Publication date: 2011-08-31
Also published as: GB201003155D0

Abstract

The device comprises an applicator for applying a sheath 3 to encapsulate a breast lesion T. The applicator may be in the form of a ring or have rotating blade structures (figs 24-30). The ring may have an adjustable diameter which cuts through breast tissue whilst unfolding the sheath. The sheath may be expandable, impermeable and cause no tissue reaction. The sheath may be retained in the body to be drained or later refilled with a suitable material to act as a prosthesis that conforms to the previous tumour cavity.

Description

I

TUMOUR SIEGE DEVICE

This invention relates to a device designed to achieve local control over breast lesions mainly tumours as well as other radiologically detected abnormalities for example Disseminated Carcinoma in Situ.

The concept of this invention could sit an example to follow in dealing with some of the malignant lesions that affects other organs or tissues for example the liver.

BACKGROUND

In the exhausting fight between Surgeons and breast cancer; surgical excision in the form of mastectomy or wide local excision remains the main method for local control of breast carcinoma.

N.B. Regional control of the axilla is not the subject of this invention.

Other modalities of therapy as radiotherapy, chemotherapy and hormonal manipulations do also have a place in local control of primary breast cancer yet their role is mainly adjuvant to surgical excision. These modalities can precede or follow surgical excision to improve survival and lower the chances of local recurrence but rarely suffice on their own merits. Therefore, surgical excision remains the main method for local control of breast carcinoma.

A PROBLEM THAT THE INVENTION SOLVE

However, surgical excision is not without difficulties; A] General anaesthesia is required for the majority of cases. General anaesthesia is associated with a higher morbidity and mortality.

B] The length of the incision required for excision of a lesion has to be proportional to the size of that lesion. Therefore, patients undergoing larger excisions may require or end up having mastectomies. The chance to develop both wound complications and problematic scarring is proportional to both the size of the excision and the length of the wound.

C] A decrease in the breast volume and hence asymmetry will invariably follow excision procedures. The degree of asymmetry is proportional to the excised volume of breast tissue. Larger excisions may even result in disfigurement and distortion of the breast.

D] For the above reasons a wide array of plastic surgical techniques were designed to improve the aesthetic outcome of surgical excisions of breast tumours and mastectomies. A new generation of oncoplastic breast surgeons is currently under construction to aid that purpose.

That does not completely solve the problem. Still it has to be realized that most of these plastic and reconstructive procedures are performed at a latter stage following adjuvant therapy especially when radiotherapy is indicated.

This means a second procedure, another general anaesthetic, more chance to develop complications and a higher cost burden on the health service provider. Not mentioning the negative psychological impact on the patient whose dissociation time from family and work well be further extended.

Oncoplastic and reconstructive breast surgery needs a higher level of specialised training, therefore, the number of available surgeons to carry on these sensitive procedures is much less than the demand. Still, even in the best hands, cosmetic results are not always successful or satisfactory to the patient.

WHAT IT DOES? To overcome some of these drawbacks, the proposed invention aims primarily at avoiding excision breast surgery of any form while still achieving effective mechanical local control over the malignant breast lesion. The invention second goal is to achieve a superior cosmetic outcome for these patients in a much easier and less invasive way than the current approaches.

In his long fierce wars against the Ghouls; Caesar managed ultimately to achieve victory through the siege that he tightly applied on the Ghouls rather than the classic direct open confrontation. Under siege an object is unable neither to survive within the borders of confinement nor inflict harm beyond them.

Likewise, a breast malignant lesion could be dealt with in the same manner.

The cancer does not necessarily have to be excised or the breast removed.

Instead, the tumour could be encapsulated within the confinement of a sealed sheath. Thus, the tumour will be suddenly deprived of its blood supply i.e. becomes acutely ischemic, then infarct with circumscribed necrosis. Being isolated within the confinement of the capsule i.e. not in continuity with the surrounding living tissue, means that gangrene can not follow tissue necrosis.

Thus, the tumour will be under siege and left to die with no local or systemic adverse effects.

The ease of the procedure together with its cosmetic superiority is tremendous when compared to classical approach.

STATEMENT OF INVENTION

The present invention proposes a surgical device for the use in breast surgery mainly comprising an applicator that is capable of applying a rather permanent sheath to encapsulate a breast malignant lesion instead of excising that lesion, a concept accompanied by a procedure designed to achieve local control over breast malignancy.

The applicator could be in the form of a ring, blade like structures or even robotic controlled arms.

The sheath is an integral part of the device; its material is preferably expandable, impermeable and able to cause no or the least possible tissue foreign body reaction.

The applied breast capsule whether left alone or drained then refilled with a suitable material in a later stage, could act as mini-prosthesis that conforms to the previous tumour cavity thus, capable of proportionally replacing any breast tissue volume loss. This could potentially give an excellent as well as superior cosmetic outcome in a simple way that does not require any subsequent plastic surgical intervention or even any form of anaesthesia.

OPTIONAL FEATURES

Optional features In theshape of the sheath: There is a possibility that the pressure within the capsule can mount up from the effect of putrefaction of its enclosed material, thus creating a pressure on the surrounding breast tissue and start causing symptoms in a later stage.

The optional feature of having a catheter leading from the capsule through the breast tissue into a subcutaneous port is extremely useful. If needed, the encasing envelop could be drained-in later stages-of its enclosed liquefied necrotic/putrefied contents and then become filled with a suitable amount of liquid/gel thereby acting as a prosthesis that conforms to the previous tumour cavity.

The catheter like extension could be a built in feature [figures 19 & 201 or created during the procedure (figure 15].

Ontiojial features in the tvDe ofthe aDplicator: Another option is using another form of sheath applicator. The key difference between this version of the device and the classic version lies in the advancing segment (A). The advancing ring that cuts through the breast tissue while simultaneously fitting the sheath around the tumour is replaced by blades or arm like structures that protrude forwards from the advancing segment towards the tumour in a grabbing like fashion [figure 24]. The blades will cut forward deeper into the breast tissue while applying the sheath around the tumour. The advancing segment is preferably able to rotate so that the blades as a unit can rotate around their axis of origin. This combination of forward and rotation movement aids the drilling into the breast tissue and facilitates the process of applying the sheath onto the transacted breast tissue [figures 26 (b) & 27 (b)].

ADVANTAGES AND INDICATIONS

The proposed device and method will have the following advantages: 1] The whole procedure could be performed under local anesthesia; thus most of the known complications of general anesthesia could be avoided. Patients can easily go home soon after the procedure is carried out.

2] The procedure is relatively much minor in comparison to open surgery, thus carrying fewer burdens of complications as wound infections, haematomas and seromas, than open operative intervention.

3] The device is designed for the per-cutaneus use under radiological guidance, therefore needs only a very small skin incision whatever is the size of the tumour, this means a smaller scar with a better cosmetic outcome.

4] The applied breast capsule whether left alone or drained then refilled with a suitable material in a later stage, could act as mini-prosthesis that conforms to the previous tumour cavity thus, capable of proportionally replacing any breast tissue volume loss. This could potentially give an excellent as well as superior cosmetic outcome in a simple way that does not require any subsequent plastic surgical intervention or even any form of anesthesia.

5] Financially, the total cut down in costs for the health service provider is obvious and needs no much explanation. It will dramatically lower all costs especially those concerning preoperative preparations, operative intervention and postoperative recovery. Moreover, it will completely strike off the cost of another conventional plastic surgical intervention.

Indications: Being a relatively minor procedure, that can be performed under a local anaesthetic using a smaller incision that causes much less scarring resulting in a superior cosmetic outcome and still with lower cost and a very rapid recovery; can make the device and this approach the standard and the way to go forwards In the local management of breast tumoure.

Yet, the following are few more straightforward indications: 1] The elderly group could still receive effective local control on their cancers without being subjected to a general anesthetic or a major procedure.

2] Provides an initial handy protection and local control over the malignant tumour when circumstances do not favor classical intervention in a healthy patient for example during pregnancy.

3] Provides an initial handy protection and local control over the malignant tumour when circumstances do not favor classical intervention because of a recent acute illness for example patients who just recently recovered from a myocardial infarction or a minor stroke.

4] Provides an alternative management to classical intervention to a wide variety of unfit and fragile patients that currently may miss the opportunity of any surgical intervention at all because of their co-morbidities.

5] Provides a transitional but early solution to the group of patients with breast cancer that have to start their journey of treatment with systemic management in the way of chemotherapy or hormonal therapy. Those patients usually have an aggressive focal tumour and applying the tumour capsule for local control also in an early time of the journey can buy the patient precious time until finishing with her systemic therapy.

6] Provides an alternative approach to patients with breast cancer who refuses or fear surgery due to rational or irrational reasons.

7] Areas that are very poor or stricken by prolong catastrophic circumstances e.g. civil war and famines as what happens in some parts of Africa; has only few or no facilities for elective surgical interventions. The proposed device and approach can help thousands of women with breast cancer that live in these areas through shortly visiting well trained medical personal that will need only few inexpensive facilities. Those teems could be simply equipped by; an US scan; the device; and a diathermy machine.

THE INVENTION WILL NOW BE DESCRIBED SOLELY BY WAY

OF EXAMPLE AND WITH REFERENCE TO THE

ACCOMPANYING DRAWINGS IN WHICH: (A) For the original version of the device Figures 1 and 2. two views (lateral and posterior) demonstrating the main parts of the device to be; the advancing segment (A); body (B); control buttons (C) and or pedals (E); and connection (D) to a cutting /coagulation power source (P). The advancing segment (A) terminates into the advancing ring (1).

Figure 3. demonstrates the advancing ring (1) closed in the default position at the top figure 3 (a), then the diameter is gradually increased in the lower 3 figures when it reaches its maximum in figure 3 (d). The ring is disconnected from the advancing segment for the purpose of demonstration.

Figure 4. demonstrates the attachment of the neck of the sheath (2) to the advancing ring (1). The neck of the sheath is shown to stretch in parallel to the increase in the diameter of the neck of the sheath. The ring is disconnected from the advancing segment for the purpose of demonstration.

The rest of the sheath body (3) is not shown in the figure.

Figure 5. demonstrates an unfolded sheath; the parts of which are the neck (2) and body (3).

Figure 6. demonstrates the default position of the sheath when the body of the sheath (3) is preferably folded within or rolled behind the neck (2).

Figure 7 (a). demonstrates the instrument ready for use prior to insertion through the breast skin (8) where the advancing segment (A) is retracted within the body (B) and the advancing ring (1) is narrowed to its minimum diameter.

Figure 7 (b). demonstrates the instrument in the closed default position at its initial entry into the breast tissue through the skin (S) prior to the advancement of the advancing segment (A) towards the tumour (T).

Figure 7 (c). demonstrates the advancing ring (1) remaining in the closed default position during the early advancement of the advancing segment (A) through the breast tissue towards the tumour (1).

In these figures the advancing ring is detached from the neck of the sheath for the purpose of demonstration.

Figure 8 (a). (b) and jc1 demonstrates the gradual increase in the ring's diameter (1) during the advancement of the advancing segment (A) until it reaches the maximum diameter at the level of the maximum tumour diameter infigure8(c).

The sheath has been detached for the sake of demonstration.

Figure 9 (a). {bIand (cj demonstrates the gradual decrease in the ring's diameter (1) as it cuts through the breast tissue past the tumour's major bulk in figure 9 (a), and then continue further decrease in diameter in figures (b) & (c).

The sheath has been detached for the sake of demonstration.

Figure 10 (a). demonstrates the gradual increase in the ring's diameter (1) as it cuts through the breast tissue while fitting the neck of the sheath (2) around the transacted breast tissue. The remainder of the sheath (3) is shown to start unfolding to harbour the breast tissue that is being circumferentially cut through.

Figure 10 (b). demonstrates more widening of the ring as it encircles the tumour. Further unfolding of the sheath body (3)is shown to take place as part of the tumour (T) being received within the body of the sheath.

Figure 10 Id. demonstrates the ring as it reaches the maximum desired diameter at the level of the maximum tumour (T) diameter. Further unfolding of the sheath is shown to take place as more of the tumour substance being received within the body of the sheath.

Figure liLa). demonstrates the gradual decrease in the ring's diameter (1) as it cuts through the breast tissue past the tumour's (T) major bulk while further unfolding of body of the sheath (3) is taking place.

I9pure 11(b). demonstrates further narrowing of the ring as it is cutting through the breast tissue past the tumour. The unfolded sheath is shown to harbour the whole of the tumour (T).

Figure 11(c). demonstrates the advancing ring (1) as it occludes to seal the neck of the sheath (2). The sealed sheath is shown completely encapsulating the tumour (T).

Figure 12: demonstrates the continuous change in diameter of the ring (1) during the procedure in one virtual drawing where there is gradual increase in the diameter of the ring until it reaches its maximum at the level of the maximum tumour (1) diameter then there is gradual decrease of ring's diameter until it returns to the closed default position.

The sheath has been detached for the sake of demonstration.

Figure 13. This drawing is a section through the breast demonstrating the tumour (T) encapsulated by the sheath body (3) where the neck of the sheath (2) has been completely sealed. (El) is the point of device entry through the skin (S). The direction of the arrow is the direction of the advancement of the device into the breast tissue.

Figure 14. This drawing demonstrates a modification in the procedure where the neck of the sheath is not sealed within the breast tissue. The narrowed ring continues to be advanced through the breast tissue, dragging the narrowed neck of the sheath (2) towards (E2) on the opposite side to the point of entry (El). This will create a catheter-like extension (h) stretching from the sheath body (3) to the neck (2). The tumour (T) is encapsulated by the sheath body (3).

Figure 15. demonstrates the option of fixing a port (0) to fit into the neck of the sheath (2). This will take place at point E2 at the end of the catheter like extension -that stretches from the sheath body (3) to the neck (2) -on the surface of breast skin (S) at point (E2).

Figure 16. demonstrates the port (0) placed in a subcutaneous plan and a suture (U) is taken in the overlying skin (S) at point (E2).

Figure 17. demonstrates a vacuum suction pressure applied to the Port (G) to drain the liquefied contents of the capsule. The capsule will consequently shrink and decrease in size.

Figure 18. demonstrates the feasibility of re-expanding the capsule using a suitable filler material injected through port (0) so that the tumour capsule can act as mini-prosthesis.

Figure 19, demonstrates a modification in the shape of the sheath where there is a built in catheter like extension (H) extending from the body of the sheath (3).

Figure 20. demonstrates the modified sheath in the folded default position where (H) is the built in catheter like extension.

Figure 21. demonstrates the terminal end of the built in catheter like extension (H) emerging from the skin incision at (El). The neck of the sheath (2) has been sealed and the instrument withdrawn.

Figure 22. demonstrates the option of fixing a port (G) to the end of the catheter like extension (H) at the point of entry (El).

Figure 23. demonstrates port (0) left in the subcutaneous plan and a suture (U) is taken in the overlying skin (S) at point of entry (El).

B) For the modified version of the device Figure 24. shows the main parts of the modified device to be; the advancement segment (A), body (B), control buttons (C) and or pedals (E); and connection (D) to cutting /coagulation power source (P). The blades (R) are shown during their projection from the advancing segment (A).

The number of the blades can vary; in this figure 6 blades are drawn for the purpose of demonstration.

Fiqure 25. demonstrates the blades (R) in their default position being retracted within the advancing segment (A).

Figure 26 (al& Figure 27 (a). demonstrate that at a suitable point prior to encountering the tumour, the blades (R) will be advanced forwards out of the advancing segment (A). It is demonstrated that initially, as they protrude forwards from the advancement segment, the blades will diverge away from each other.

Figure 26 (b) & Figure 27 (b), demonstrate that at one point along their journey through the breast tissue, further divergence of the blades will cease.

This point should correspond to the level of maximum tumour (1) diameter.

These figures also demonstrate that the advancement segment (A) is able to rotate around its axis in order to add a drilling functionality to the forward movement of the blades.

Figure26lcl& Figure 27 Cc). demonstrates that form that point of maximum tumour (T) diameter onwards, the blades will converge with the further forward protrusion.

Figure 26 (d) & Figure 27 (d). the terminal ends of the blades finally meet at a point past the tumour.

In figures (26) & (27) the sheath has been detached for the sake demonstration.

The number of the blades can vary; in figure (26) only two blades are drawn; while in figure (27) four blades are drawn, this is for the purpose of demonstration.

Figure 28, a section through the instrument that demonstrates that the neck of the sheath (2) is attached to the blades (R) near to their terminal ends at point (N).

Fiaure 29 (a) & 30 La). demonstrates the blades (R) initially diverging away from each other as they project from the advancing segment (A) while fitting the neck of the sheath (2) around the transacted breast tissue. The remainder of the sheath (3)is shown to start unfolding in order to harbour the breast tissue that is being circumferentially cut through.

Figure 29 (b) & 30 (b). demonstrates that further forward protrusion and diversion of the blades is associated with further stretch the neck of the sheath. Further unfolding of the sheath is shown to take place as the tumour being received within the body of the sheath.

Figure 29(c) & 30 (c). demonstrates the neck of the sheath narrowing gradually during the forward conversion movement of the blades past the point of maximum tumour diameter. Further unfolding of the sheath is shown to take place as most of the tumour is received within the body of the sheath.

Figure 29(d) & 30 (d). demonstrates meeting of the terminal ends of the blades and sealing of the neck of the sheath. The tumour with a surrounding rim of normal breast tissue is shown enclosed within the sheath.

The number of the blades can vary; in figure (29) only two blades are drawn; while in figure (30) four blades are drawn, this is for the purpose of demonstration.

DETAILED DESCRIPTION

Description of the device (the classic version):

The device is described solely by way of example.

The device [figures 1 & 2] mainly comprises; an advancing segment (A); body (B); connection (D) to a cutting /coagulation power source (P); control buttons (C); and optional control pedals (E). The advancing segment (A) terminates into the advancing ring (1).

In the default position, the advancing segment (A) is retracted within the body (B). The advancing segment (A) can be advanced to protrude from the body (B) into the breast tissue [Figures 7, 8 & 9]. The advancing segment (A) can also be retracted back to slide into the body (B) prior to withdrawing the device out of the breast.

The advancing ring (1) is located at the terminal end of the advancing segment (A) [Figures 1 and 2]. The substance of the advancing ring allows it to acquire different diameters during its use within the breast tissue. Thus, the diameter of the advancing ring (1) can be increased or decreased [Figures 3 & 12]. Changing the ring's diameter is achieved through the control buttons (C) or control pedals (E) (Figures 1 and 2].

In the default position the ring is narrowed to its minimum diameter. Within the breast tissue, the diameter of the ring can be gradually increased or decreased while the advancing segment (A) being projected deeper into the breast (Figures 7, 8 & 9].

The advancing ring (1) is able to cut through tissues and seal bleeding points during its advancement through the breast owing to its connection (D) to a cutting /coagulation power source (P) [Figures 1 and 2]. The on and off control of the cutting /coagulation power is achieved through the control buttons (C) or control pedals (E) [Figures 1 and 2).

The device is designed to apply a rather permanent sheath that encapsulates a breast tumour or lesion. Therefore, the sheath is an integral part of the device.

For the purpose of description the sheath is divided to 2 parts; neck (2) and body (3) [Figure 5].

In the default position the body of the sheath (3) is preferably folded within or rolled behind the neck (2) in a fashion similar to that of a protective condom in its default position [Figure 6].

Preferably the material of sheath should be expandable, impermeable and able to cause no or the least possible tissue foreign body reaction. Also, preferably the neck of the sheath (2) should be elastic. The neck of the sheath (2) is fixed to the advancing ring (1) prior to using the device [figure 4] therefore; in the default position the neck of the sheath is also at its minimum diameter similarly to that of the advancing ring. The neck of the sheath (2), being elastic and attached to the advancing ring (1), is able to stretch and skew in parallel to the increase and decrease of the ring's diameter [Figure 4].

Once the neck of the sheath starts to widen in parallel to the increase of the ring's diameter during their advancement deeper into the breast tissue, the remainder of the sheath will be subjected to the mass of the transacted breast tissue and therefore, will start to unfold in order to harbour that breast tissue [Figures 10 &1 1].

After the tumour has been completely contained within the sheath, the advancing ring has the ability to occlude in order to seal the neck of the sheath, thus complete encapsulation of the lesion is achieved [Figure 11(c)].

Occluding the ring and sealing the sheath is achieved through the control button (C) or Pedals (E) [Figures 1 and 2].

Description of the device (the modified version):

The key difference between this version of the device and the classic version lies in the advancing segment (A). The advancing ring that cuts through the breast tissue while simultaneously fitting the sheath around the tumour is replaced by blades or arm like structures that protrude forwards from the advancing segment towards the tumour in a grabbing like fashion. The blades will cut forward deeper into the breast tissue while applying the sheath around the tumour. The advancing segment is preferably able to rotate so that the blades as a unit can rotate around their axis of origin. This combination of forward and rotation movement aids the drilling into the breast tissue and facilitates the process of applying the sheath onto the transacted breast tissue.

The device mainly comprises; an advancing segment (A); body (B); connection (0) to a cutting /coagulation power source (P); control buttons (C); and optional control pedals (E) The blades (R) are located at the distal end of the advancing segment [figure 24].

In the default position the blades (R) of the instrument are retracted within the advancing segment (A) and in the closed position [figure 25].

The number, size and shape of the blades can vary.

The properties and shape of the sheath are essentially the same as that described with the classic version including the option of using a modified sheath that has a built in catheter like extension.

The neck of the sheath (2) is attached to the blades (R) near to their terminal ends at point (N) [figure 28]. In the default position; the blades of the grabber are closed and the body of the sheath is folded into or rolled behind the neck.

The blades are able to cut through tissues and seal bleeding points during their advancement through the breast, being connected to cutting /coagulation power source (P) via connection (D) [figure 24]. The on and off control of the cutting /coagulation power is achieved through the control buttons (C) or control pedals (E).

Initially, as they protrude forwards from the advancement segment, the blades will diverge away from each other, ready to grab the tumour [figure 26 (a)].

Then, at one point along their journey through the breast tissue, further divergence will cease and the blades will bend to make an inward curve. This point should ideally correspond to the level of maximum tumour diameter [figure 26 (b)]. From this point onwards, the blades will converge with the further forward protrusion [figure 26 (c)] until the terminal ends of the blades meet at a point calculated to be past the tumour [figure 26 (d)] All manipulations to the blades and the advancing segment are done through the control buttons (C) or pedal (E) (figure 24].

The neck of the sheath (2) being elastic and attached to the terminal ends of the blades; will stretch and narrow with the divergence and convergence of the blades respectfully. As the blades moves forward they will apply the neck of the sheath onto the transacted breast tissue. Consequently, the remainder of the sheath will start to unfold to harbour that transacted breast tissue (figure 29 demonstrates 2 blades while figure 30 demonstrates 4 blades].

The blades are able as a unit to rotate (R) around their axis of origin; which adds a drilling thrust to their forward movement. This enables complete clean cutting through the tissues thereby facilitating the process of applying the sheath onto that transacted tissue with no resistance (figures 26 (b) & 27 (b)].

As the terminal ends of the blades meet past the tumour, sealing of the neck of the sheath can take place through the control buttons (C) or pedal (E). By now, the tumour with a surrounding rim of normal breast tissue should be enclosed within the sheath (figures 29 (d) & 30 (d)].

Modifications in the shape of the sheath: There are many possible variations involving the shape of the sheath for example, the sheath can have an already built in prefixed catheter or tube.

[Figure 19], demonstrates the unfolded sheath where (H) is the pre-fixed catheter or tube which is emerging from the body (3) of the sheath. [Figure 20], demonstrates the modified sheath in the folded default position where (H) is the pre-fixed catheter or tube.

In this variety, the same skin incision will provide passage of two structures, the device inwards into the breast and the catheter outward [figure 21]. This is in contrast to-when using the modified procedure in the classic device version-where the device gains entry to the breast tissue from one side while the exit of the sheath catheter like extension is from the opposite side requiring two incisions (figure 14].

Again, it is feasible to fix a port like structure to the end of the pre-fixed catheter or tube.

[Figure 22], demonstrates the option of fixing a port (G) to the end of the pre-fixed catheter (H).

(Figure 23], demonstrates port (G) left in the subcutaneous plan with a suture is taken in the overlying skin (U).

Further manipulations through the port are also possible as will be described with the classic version of the sheath to decompress or refill the capsule so that it acts as mini-prosthesis.

PROCEDURE AND METHOD

Steps using the classic version: The procedure is suitable for local anaesthesia but can also be performed under general anaesthesia.

Idealiy, the procedure is performed under radiological guidance, for example ultrasound scan.

1) Small skin incision (5) is made at a suitable point that is considered to give the shortest and or the easiest access to the breast lesion.

2) Checking that the instrument is ready for use in the default position prior to insertion through the breast skin (S) where: the advancing segment (A) is retracted; the advancing ring (1)is narrowed to its minimum diameter; the neck of the sheath (2) is attached to the ring (figure 4]; and the body of the sheath (3) is preferably folded within or rolled behind the neck (2) [figure 6].

3) The device is introduced into the breast tissue directly through the skin incision or through a housing tube. The direction of entry is towards the breast tumour [figure 7].

4) As the device exits the housing tube (not demonstrated in the figure), the advancing segment (A) is projected from the body (B) into the breast tissue towards the lesion [figure 7 (c)]. The advancement through the breast tissue is aided by the cutting coagulation function of the advancing ring through the device's connection (D) to a cutting coagulation power source (P) e.g. diathermy or laser machine [figure 1].

5) The advancing ring (1) initially remains in the closed default position at its initial entry into the breast tissue while it is being advanced through the breast tissue prior to encountering the tumour zone [figure 7 (b) & (c)].

6) As the advancing segment (A) approaches the tumour, the ring's diameter (I) is graduafly increased while it is cutting through the breast tissue and fitting the neck of the sheath (2) around the transacted breast tissue. Thus, the remainder of the sheath (3) will start to unfold to harbour the breast tissue that is being circumferentially cut this way [figures 8 (a) & (b) and figures 10 (a) & (b)].

7) The advancing ring should reach the maximum desired diameter at the level of the maximum tumour diameter in away that it entirely encircles the tumour as well as a rim of surrounding normal breast tissue [figure 8 (c)].

Further unfolding of the sheath will be simultaneously taking place as it is receiving more of the tumour tissue [figure 10 (c)].

8) When the major part of the tumour is contained within the sheath, the diameter of the ring should now be gradually decreased as it is cutting through the breast tissue around the remainder of the narrower part of the tumour (figure 9 (a)].

9) Further narrowing of the advancing ring should take place as it is cutting through the breast tissue past the tumour for a short distance until the ring occludes to seal the neck of the sheath [figure 9 (b) & (c)].

10) The advancement segment (A) is retracted back to the body (B) then the device is withdrawn. This will leave the tumour completely transacted and isolated within the sealed sheath (figure 13]. The breast capsule is now fully applied.

11) Alternatively, in step 9, the advancing ring is not to be totally occluded but to be further advanced through the breast tissue to the opposite side towards (E2). During that advancement; the ring and consequently the neck of the sheath, will be narrowed into a diameter similar to that of a catheter or a drain [Figure 14]. That extension of the sheath (h) can act like a catheter or a drain emerging from point E2 via a 2 incision made at this point. Otherwise, a port like structure (G) fixed to the terminal end of the extension (h) (figure 151 and left subcutaneously at point (E2) with a suture (U) taken in the overlying skin [figure 16].

12) Various possible manipulations to the capsule can take place in a later stage through the port (G). Applying a vacuum suction negative pressure to the Port (G) for example by using a syringe will drain the liquefied contents of the capsule and prevent any possible building pressure within the capsule [figure 17].

It is also feasible to re-expand the capsule through injecting suitable filler through port (G) to replace and compensate for any breast volume loss, now the capsule itself will act as mini-prosthesis [figure 18].

Steps using the modified version: The procedure is suitable for local anaesthesia but can also be performed under general anaesthesia.

Ideally, the procedure is performed under radiological guidance, for example ultrasound scan.

1) Small skin incision is made at a suitable point that is considered to give the shortest and or the easiest access to the breast lesion.

2) Checking that the instrument is ready for use in the default position prior to insertion through the breast skin (S) where: The blades (R) of the instrument are retracted [figure 25]; the neck of the sheath(2) is attached to the blades near their terminal ends at point (N) [figure 28];the blades of the grabber and consequently the neck of the sheath (2) are both in the closed default position; and the body of the sheath (3) is preferably folded within or rolled behind the neck (2) [figure 6].

3) The device is introduced into the breast tissue directly through the skin incision or through a housing tube. The direction of entry is towards the breast tumour.

4) The instrument remains in the closed default position at its initial entry into the breast tissue whether a housing tube was used or not.

5) At a suitable point prior to encountering the tumour (T)) and through the control button (C) or pedal (E), the blades are project forwards out of the advancing segment (A). Initially, as the blades protrude forwards from the advancement segment, they will diverge away from each other while fitting the neck of the sheath around the transacted breast tissue [figures 26 (a), 27 (a), 29 (a) & 30 (a) ]. Applying, the rotatory movement function of the blades around their axis of origin (achieved through the control button or pedal) will add a drilling thrust to their forward movement and enables complete clean cutting through the tissues thereby facilitating the process of applying the neck of the sheath onto that transacted tissue with no resistance [figures 26 (b) & 27 (b)]. As a result, the remainder of the sheath will start to unfold in order to harbour the breast tissue that is being circumferentialty cut through as the instrument being advanced further into the breast [figures 29 (a) & 30 (a) . 6) As the blades approaches the tumour, further forward movement associated with diversion should continue to take place through the control button (C) or pedal (E) [figures 26 (b), 27 (b)]. This will further stretch the neck of the sheath while it is being fitted to the transacted breast tissue.

Consequently, further unfolding of the sheath will take place as more breast tissue is received within the body of the sheath [29 (b) & 30 (b)J.

7) The blades will continue to diverge as they encircle the tumour. At one point along their journey through the breast tissue, further divergence will cease and the blades will bend to make an inward curve. This point should be pre-calculated to correspond to the level of maximum tumour diameter [figures 26 (C) &27 (c)].

8) Form this point onwards; the blades will converge with the further forward protrusion until the terminal ends of the blades meet at a point past the tumour (figures 26 (c) & (d) and 27 (c) & (d)]. At this stage, the tumour with a surrounding rim of normal breast tissue will be contained within the unfolded sheath [figures 29 (C) & (d) and 30 (c) & (d)].

9) As the terminal ends of the blades meet past the tumour, the neck of the sheath returns to the closed default position and sealing of the neck of the sheath can take place through the control button or pedal. Now, the tumour together with a surrounding rim of normal breast tissue will be enclosed within the sealed sheath [figures 29 (c) & (d) and 30 (C) & (d)].

10) The blades are detached of the neck of the sheath before being retracted back to the advancement segment.

11) The device is withdrawn from the breast leaving the encapsulated tumour behind [figure 1 3J.

12) If the modified sheath that has an already built in catheter like extension was used, it is feasible to fix a port like structure to the end of the catheter like extension figure.

The port (G) could be left in the subcutaneous plan with a suture taken in the overlying skin (S) figures.

13) Various possible manipulations to the capsule can take place in a later stage through the port (G). Applying a vacuum suction negative pressure to the Port (G) for example by using a syringe will drain the liquefied contents of the capsule and prevent any possible building up pressure within the capsule figures.

It is also feasible to re-expand the capsule through injecting suitable filler through port (G) to replace and compensate for breast tissue volume loss, now the capsule itself will act as mini-prosthesis figures

Claims

CLAIMS1) A surgical device for the use in breast surgery mainly comprising an applicator that is capable of applying a rather permanent sheath to encapsulate a breast malignant lesion instead of excising that lesion, a concept and a procedure designed to achieve local control over breast malignancy.
2) Within claim 1, a sheath that is an integral part of the device; its material is preferably expandable, impermeable and able to cause no or the least possible tissue foreign body reaction.
3) Within claim 1, the applicator could be an advancing ring where the main parts of the device are: the advancing segment (A) that terminates into the advancing ring (1); body (B); control button (C); pedals (E); and connection (D) to a cutting coagulation power source (P).
4) Within claim 3, the advancing segment (A) can be advanced to protrude from the body (B) into the breast tissue or retracted back to slide into the body (B).
5) Within claim 3, the diameter of the advancing ring (1) can be increased or decreased through the control button (C) or pedal (E).
6) Within claim 3, the advancing ring (1) is able to cut through tissues and seal bleeding points dunng its advancement through the breast owing to its connection (D) to cutting coagulation power source (P).
7) Within claim 3, the neck of the sheath (2) is elastic and attached to the advancing ring (1) so it stretches and skews in parallel to the increase and decrease of the ring diameter.
8) A method for claim 3, comprising: a) administrating local or general anesthesia; b) performing a small skin incision (S) at a suitable point that is considered to give the shortest and or the easiest access to the breast lesion; c) checking that the instrument is ready for use in its default position prior to insertion through the breast skin (S) where: the advancing segment (A) is retracted within the body (B); the advancing ring (1) is narrowed to a minimum diameter; the neck of the sheath (2) is attached to the ring and narrowed to a minimum diameter; and the body of the sheath (3) is preferably folded within or rolled behind the neck (2); d) inserting the device into the breast tissue towards the breast tumour directly through the skin incision or via a housing tube; e) projecting the advancing segment (A) out of the body (B) into the breast tissue towards the lesion(T) aided by the cutting coagulation function of the advancing ring (1); f) keeping the advancing ring (1) in the closed default position while it is being advanced through the breast tissue prior to encountering the tumour zone; g) increasing the ring's diameter gradually as it approaches the tumour while it is cutting through the breast tissue and fitting the neck of the sheath around the transacted breast tissue which will cause the remainder of the sheath to start unfolding in order to harbor the breast tissue that is being circumferentially cut this way; h) reaching the maximum desired diameter of the advancing ring should be achieved at the level of the maximum tumour diameter in a way that the ring entirely encircles the tumour as well as a rim of surrounding normal breast tissue while further unfolding of the sheath is simultaneously taking place as it receives more of the tumour tissue; i) decreasing the ring's diameter gradually as it is cutting through around the remainder of the narrower part of the tumour; j) narrowing of the advancing ring should further take place as it is cutting through the breast tissue past the tumour for a short distance; k) occluding the ring and sealing the neck of the sheath; I) detaching the ring from the neck of the sheath; m) retracting the advancement segment back into the body; and n) withdrawing the device leaving the tumour completely transacted and isolated within the sealed sheath.
9) Within claim 8 a modification to the method of claim 3, instead of the step of occluding the ring and sealing the neck of the sheath, could be further including the steps of: a. advancing the narrowed advanced segment through the breast tissue to the opposite side towards (E2) instead of occluding the ring; b. narrowing the ring and consequently the neck of the sheath into a diameter similar to that of a tube catheter during the ring advancement; c. incising the skin and detaching the ring from the neck of the sheath at the point of exit (E2); d. retracting the advancement segment (A) back into the body prior to withdrawing the device; e. delivering the terminal end of the catheter like extension (h) out of the breast wound (E2); f. fixing a port like structure (0) to the terminal end of the catheter like extension(h); g. placing the port like structure in a subcutaneous plan; and h. suturing the overlying skin.
10) Within claim 1, the applicator could be in the form of blades or arm like structures that protrude forwards from the advancing part of the device towards the tumour in a grabbing like fashion where the main parts of the device are: the advancing segment (A) harboring the retracted blades(R) with the neck of the sheath attached near to the terminal ends of the blades (N); body (B); control button (C); pedal (E) and connection (0) to cutting coagulation power source (P).
11) Within claim 10; the various manipulations of the blades movements and actions are achieved through the control buttons and or pedal.
12) Within claim 10, the blades are capable of two forms of movement: forward movement as they protrude from the advancing segment; and a rotating movement around their axis of origin.
13) Within claim 10, the forward movement of the blades is associated initially with divergence of the blades until a certain point along their length when the blades will bend to make an inward curve so that further forward protrusion is associated with convergence of the blades.
14) Within claim 10, the neck of the sheath (2) is elastic and attached to the terminal ends of the blades which will cause it to stretch and narrow with the divergence and convergence of the blades respectfully.
15) A method for claim 10, comprising: a) administrating local or general anesthesia; b) performing a small skin incision at a suitable point on the breast circumference that is considered to give the shortest and or the easiest access route to the breast lesion; c) checking that the instrument is ready for use in its default position prior to insertion through the breast skin (S) where; the blades (R) of the instrument are retracted within the advancement segment (A); the neck of the sheath is attached to the blades near their terminal ends(N); the blades of the grabber and hence the neck of the sheath (2) are both in the closed default position; and the rest of the sheath (3) is folded into or rolled behind the neck (2); d) entering the device into the breast tissue towards the breast tumour directly through the skin incision or through a pre-inserted housing tube; e) keeping the instrument in the closed default position at its initial entry into the breast tissue whether a housing tube was used or not; f) initiating forward protrusion associated with diversion of the blades as the device approaches the tumour with the aid of the cutting coagulation function provided by the connection (D) to cutting coagulation power source; g) initiating simultaneous rotating movement of the blades around their axis of origin will add a drilling thrust to the forward movement and achieve complete clean cutting through the tissues thereby facilitating the process of applying the neck of the sheath onto that transacted tissue so the remainder of the sheath starts unfolding to harbor the breast tissue that is being circumferentially cut this way; h) continuing forward diversion and rotation of the blades as they encircle the tumour until reaching a pre-calculated point corresponding to the level of maximum tumour diameter when further divergence will cease and the blades will bend to make an inward curve; i) proceeding with forward conversion and rotation of the blades as they cut through around the remainder of the narrower part of the tumour which is being received within the unfolded sheath; j) sealing the neck of the sheath when the terminal ends of the blades meet at a point past the tumour; k) detaching the blades from the neck of the sheath; I) retracting the blades back into the advancing segment; and m) withdrawing the device leaving the tumour completely transacted and isolated within the sealed sheath.
16) Within claim 2, a modified sheath that has a built in catheter-like extension (H) opposite to the neck of the sheath (2) and emerging from the body (3), could be used with any of the applicator varieties.
17) Within claim 16, a port like structure (G) could be fixed to the terminal end of the catheter like extension (H).
18) Within claim 17, the port like structure could be placed in the subcutaneous plan to be accessible for future manipulations involving the capsule.
19) Within claim 18, it is possible to apply a vacuum suction negative pressure to the port in order to drain the liquefied contents of the capsule and prevent any possible building pressure within the capsule.
20) Within claim 19, the breast capsule may function as mini-prosthesis when being re-expanded through injecting suitable filler through the port like structure.
21) Within claim 20, further future adjustments to the size of the mini-prosthesis are possible through repeated aspirations and or injections of the filler material until exact volume replacement is achieved.Amendments to the Claims have been filed as follows:CLAIMS1) A surgical device for the use in breast surgery mainly comprising an applicator that fits a securely sealed membranous structure onto the breast tumor to lay siege to that tumor rather than to excise it.2) Within claim 1, a membranous structure that is expandable, impermeable and able to cause no or the least possible tissue foreign body reaction.3) Within claim 1, the applicator of the membranous structure could be in the shape ofa ring.4) Within claim 3, the advancing segment of the applicator can be advanced to project from the body into the breast tissue or retracted back to slide into the body.5) Within claim 3, the diameter of the advancing ring can be increased or decreased through control buttons or pedals.6) Within claim 3, the advancing ring is able to cut through tissues and seal bleeding points during its advancement through the breast owing to its connection to cutting coagulation power source.7) Within claim 3, the neck of the membranous structure is elastic and attached to the advancing ring so it stretches and skews in parallel to the increase and decrease of the ring diameter.8) Within claim 1, the applicator could be in the form of blades or arm like structures that projects forwards from the advancing part of the device towards the tumor in a grabbing like fashion.9) Within claim 8, the blades are capable of two forms of movement; forward movement as they protrude from the advancing segment; and a rotating movement around their axis of origin.10) Within claim 8, the neck of the membranous structure is elastic and attached to the terminal ends of the blades which enable it to stretch and narrow with the * : : divergence and convergence of the blades respectfully.: 11) Within claim 2, a modified membranous structure that has a built in catheter-like extension could be used with any of the applicator varieties.*: 12) Within claim 11, a port like structure could be fixed to the terminal end of the catheter like extension.13) Within claim 12, it is possible to apply a vacuum suction negative pressure to the port in order to drain the liquefied contents of the membranous structure : * and prevent any possible building up of pressure within the meinbranous 0 structure.14) Within claim 12, the membranous structure may function as a small prosthesis as it is re-expandable by injecting suitable filler substance through the port like structure.