WO2017161248A1 - Surgical mastectomy aid device - Google Patents

Abstract

A mastectomy device allows a surgeon to cut skin covering a patient's breast more uniformly. The mastectomy device includes: a vacuum well having a peripheral wall, a closed top and an open bottom which together define a well interior, a valve rotatably mounted to the vacuum well and provided with a through channel, and a cutting tip assembly having a telescoping cutting tip. The cutting tip assembly is connected to the vacuum well such that the cutting tip can be inserted into, and withdrawn from the well interior, via the through channel. Rotation of the valve controls the angular position of the through channel, and thus the orientation of the telescoping cutting tip.

Description

SURGICAL MASTECTOMY AID DEVICE

Cross-Reference to Related Applications

[0001] This application claims the benefit under 35 U.S. C, § 119(e) of US

Provisional Patent Application 62/310,658, entitled: "Surgical Mastectomy Aid Device," filed on March 18, 2016, which is incorporated herein by reference in its entirety.

Field of the Invention

The subject matter of the present application is directed to devices and systems for performing mastectomies. More particularly, it concerns mastectomy devices which facilitate preserving skin tissue for later reconstruction.

Background

The rate of mastectomies is increasing globally, as more women discover their genetic predisposition to breast cancer. This has led to an increase in prophylactic mastectomies for women who wish to take a proactive approach to their increased cancer risk. Additionally, more women and oncologic surgeons are choosing mastectomies over traditional lumpectomies to avoid radiation treatment, which may have significant complications that are often debilitating, both physically and mentally.

Contiguously, there has also been significant technical changes, as to how mastectomies are performed. Traditionally, a significant amount of skin (including the nipple areola complex) was removed along with the breast tissue, which leads to poor cosmetic outcomes. The modern approach is to only remove the breast tissue while leaving behind the entirety of the breast skin and nipple areola complex, leading to better reconstruction of the breast. However, the more limited incision required by the modem approach, is a more technically challenging operation for the surgeon, who may in turn, perform the more traditional procedure due to a lack of technical training. Complicating this picture, is that the outcome and complication rate of breast reconstruction following mastectomy for breast cancer is highly dependent on the execution of the careful excision of breast tissue while maintaining a uniform layer of breast skm and accompanying fat. Thus, the modern approach, although successful from a cancer perspective, can cause an imperfect dissection that compromises the subsequent reconstruction of the breast.

Up until this point, there has been no specially designed device that has facilitated this modern approach. The surgeon has been left to rely solely on traditional retractors, an electrosurgical instrument, and their judgment on how thick to create the remaining breast skin flap. This method can be imprecise and highly operator dependent. As alluded to above, the lack of technical training in the modern approach using traditional instruments, limits women's access to more modern, less morbid procedures, and by extension, prevents better outcomes in cosmesis and cancer treatment.

Summary of the Invention

The present device aids in the execution of a skin-sparing mastectomy that: (1) provides complete removal of breast tissue, while, (2) maintaining a uniform thickness of skin and subcutaneous tissue. This decreases the risk of significant complications such as partial skin necrosis, implant extrusion and palpability, and implant infection; all of which leads to repeat hospitalizations, surgeries, and increased costs.

The present device allows the surgeon to completely remove the breast skin flap from the underlying breast tissue in a percutaneous manner. Besides the advantage of creating a uniform thickness skin flap that ensures that ail breast tissue that could potentially transform into cancer is removed, this device and method also allows less traumatic handling and manipulation of the skm flap, which decreases the chance of skin flap necrosis or compromise, ultimately leading to decreased complications.

This technique and device can also be used in the treatment of other breast disorders, such as gynecomastia or male breast tissue. Traditionally, this procedure has been done through an incision around the nipple areola complex with direct excision of the breast tissue (similar to an oncologic mastectomy), liposuction of the breast tissue, or some combination of both. The scar from an incision itself, is easily noticeable and unacceptable in a male patient. Of further concern, the use of only liposuction to remove the breast tissue can leave the patient's chest appear "hollow" or "caved-in", if ail the fat is removed. Our device allows a percutaneous separation of the chest skin with the underlying breast tissue without creating an incision. The remaining breast tissue can then be removed with an appropriate amount of liposuction through a much smaller cannula incision which is far less noticeable.

The Device is used to facilitate the medical procedure of mastectomy in treating breast cancer. As more patients are seeking breast reconstruction following mastectomy for breast cancer, the success of the breast reconstruction increasingly depends on separating breast skin from breast tissue to form a skin flap of generally uniform thickness and substantially free of unsightly burns and lacerations. The Device is designed specifically to aid in separating underlying breast tissue from breast skin such that the skin flap meets these desirable qualities, and is suitable for better execution of subsequent breast reconstruction. The Device works by first placing a vacuum well over a targeted portion of the breast, and then elevating an area of targeted breast tissue by applying a vacuum to the vacuum well such that the targeted breast tissue presses against a fiat inner surface of the vacuum well. A tissue cutting device that is partially within the perimeter wall of the vacuum well is advanced and inserted through the skin. The tissue cutting device cuts below the elevated targeted skin tissue through the perimeter wail. The tissue cutting device separates the underlying breast tissue from the skin flap along with and parallel to the flat inner surface of the vacuum well. The separation leaves a skin flap of generally uniform thickness and substantially free of unsightly burns and lacerations. Field of the Invention

The subject matter of the present application may be best understood by the attached figures in which:

Fig. 1 shows a vacuum well in accordance with one embodiment of the subject matter of the present application, with the cylindrical valve removed.

Fig. 2 shows an isometric view of apportion of the vacuum well of Fig. 1 with a cylindrical valve installed..

Fig.3 shows a plan view of the vacuum well and illustrates the cylindrical valve in two rotational positions, in which rotation stops can be seen. .

Fig. 4 shows an isometric view of the assembled mastectomy device.

Fig. 5 shows the cylindrical valve in isolation.

Figs 6a to 6f show a telescoping bovie tip assembly and its subassemblies. Fig. 6a shows a bovie tip.

Fig. 6b shows an insulated bovie tip.

Fig. 6c shows a piston assembly which incorporates the insulated bovie tip of Fig. 6b.

Fig. 6d shows the piston assembly of Fig. 6c within a sleeve.

Fig. 6e and 6f show the telescoping bovie tip assembly in deployed and retracted positions.

Fig. 7 shows an isometric view of the assembled mastectomy device.

Fig. 8 shows a plan view of the assembled mastectomy device.

Fig. 9 shows a close-up of a locking screw for the lid of the mastectomy device

Fig. 10 shows an isometric view of an embodiment of the mastectomy device with a locking screw.

Detailed Description

Fig. 1 illustrates the vacuum well of the Device. The vacuum well includes a perimeter wall 1, a top/lid 2, a semi-circular groove for accommodating a cylindrical valve 4, and a nipple for connecting to a vacuum source 6. The top/lid may have a window through which one may see the breast tissue beneath 3. The device can have multiple different top/lids that decrease the volume in the vacuum well. This has the effect of altering the depth at which the electrocautery cutting tip cuts below the skin. An opening/pathway in the shape of horizontally extending slot is formed in the perimeter wall in a medial portion of the groove 5, to permit insertion of an electrocautery cutting tip ("Bovie Tip"), as discussed further below. When the vacuum well is connected to an external vacuum source, the targeted skin tissue is elevated and presses against the underside of the lid.

Fig. 2 shows a cylindrical valve 7 having a vertically extending cylinder axis occupies the groove. The cylindrical valve has a valve conduit 9 which passes diametrically through the valve and pivots about the cylinder axis on a pin mechanism 8. The valve conduit is aligned with the horizontal slot formed in the perimeter wall The cylindrical valve rotates along its vertically extending cylinder axis, causing the conduit to pivot about the cylinder axis so as allow the Bovie Tip, whose distal end is in the volume of the vacuum well, to undergo an arc movement. The arc of rotation is dictated by the position of valve rotation stoppers 10 on the cylindrical valve.

Fig. 3 shows a top view to illustrate the function of the valve rotation stoppers 10, which appear as longitudinally extending "tabs" provided on the cylindrical valve, one on each side of the valve conduit. The stoppers determine the maximum degree of rotation; and the cylindrical valve is stopped from rotating further in each direction as the stopper hits a shoulder wall adjacent the groove. As the cylindrical valve rotates within the semi-circular groove, the valve rotation stoppers limit the maximum degree of the valve rotation, and thereby limit the range of the Bovie Tip's arc motion. Fig. 4 illustrates the Device in its complete assembled condition, with the cylindrical valve 7 occupying the groove and a telescoping tip assembly 12 mated to the cylindrical valve 14 and occupying the latter 's conduit. As best seen in FIG.2, the cylindrical rotating valve occupies the semi-circular groove. A pin mechanism 8, found both on the top and the bottom of the cylindrical valve, connects the cylindrical valve to the vacuum well. Furthermore, the pin mechanism, having members extending from the both the top and bottom 11, allows the cylindrical valve to rotate along its cylinder axis within the semi-circular groove. As seen in FIGS. 4 and 8, the telescoping tip assembly occupies the valve conduit 15, with the distal end of the Bovie Tip protruding through the horizontal slot of the perimeter wall, and into the volume of the vacuum well. By rotating the cylindrical valve, by virtue of a pivoting motion centered about the cylinder axis, the Bovie Tip sweeps an angular extent within the volume of the vacuum well. The Bovie Tip may also be moved in an axial direction, thereby controlling the position of the distal end of the Bovie Tip within the volume of the vacuum well. FIG.5 shows a detailed image of an isolated cylindrical valve 7. The pin mechanism extending from the center of a top bracket and a corresponding bottom bracket (bottom bracket not seen in FIG. 5) attached the valve to the semi-circular groove 16, The pin mechanism allows the valve to rotate about its axis within the groove. The presence of valve rotation stoppers 10 set the degree to which the valve can rotate in either direction. Half-way down the perimeter wall of the valve, the horizontal slot 15 is occupied by the Bovie Tip. The horizontal slot opening 15 essentially extends the adjacent valve conduit, thereby allowing the Bovie Tip to be moved both in the longitudinal direction (in and out of the volume of the Vacuum Well), and also in arc shaped motion in a plane that is substantially parallel to the

FIG.6 shows details of the telescoping piston assembly 12, including the conductive Bovie Tip and piston mechanism. The Bovie Tip 17 (FIG.6a) is metallic, conductive, shaped like a needle, and has its distal end ("cauterizing end") is covered in insulating nonconductive material 18, illustrated by FIG. 6b. There is an extension of the insulating material 19 on the top side of the Bovie Tip needle. The positioning on the top side protects the underside of the skin from burning by the excessive heat produced by the Bovie Tip and to prevent unintentional thermal injur to the surrounding skin tissue. The insulated tip is fixed withm an inner piston 20 (FIG.6c) which occupies and moves in an axial direction within an outer cylinder ("outer sleeve") 21 (See FIG. 6d). The outer sleeve 21 is fixedly mounted within the valve conduit at one end 22. This allows the Bovie Tip (and the inner piston) to move in the axial direction within the outer sleeve to control the extent of insertion into the volume of the vacuum well, while also allowing the Bovie Tip to pivot about the valve's cylinder axis so that its distal end moves in an arc shape. The proximal end of the Bovie Tip 13 is configured to connect to a Bovie Handle. FIG.6e and 6f demonstrates the extension / retraction telescoping motion of the inner piston within the outer sleeve, which allows the insulated tip to move longitudinally. One end of the outer sleeve attaches and covers one end of the inner piston, which can then telescope in and out of the outer sleeve. This allows the Bovie Tip to move in and out the vacuum well The inner piston fits snugly within the outer sleeve so that vacuum can be maintained in the vacuum well 23, A tight connection between the horizontal slot and the valve's conduit further helps maintain the vacuum within the vacuum well. FIG. 7 shows the assembled device and FIG.8 shows the range of movement of the Bovie Tip within the vacuum well. When provided, line markings 30 on the clear plastic top/lid 24 provide a guide for users to see the extent of any cutting that can be performed beneath the skin. In the fully inserted position of the telescoping tip assembly (illustrated in this figure by "distal end" 25), the Bovie Tip extends as far as possible into the vacuum well. In this position, rotation of the cylindrical valve between its stopper limits, causes the Bovie tip to cut along an arc within the vacuum well

In the fully retracted position of the telescoping tip assembly, the Bovie Tip is fully withdrawn from the volume of the vacuum well, and rotation of the cylindrical valve has no cutting effect. Although not shown in detail in any of the figures, the top/lid 3 is removable, and a user can replace one lid with another to provide a different well height (and thus, well volume). For instance, one lid may have a first thickness on its inner-surface side, and another lid may have a different thickness on its inner surface side. A plurality of tops/lids, each with a different thickness may be manufactured, and then provided either individually or as a set for use.

Figs. 9 andlO show a locking screw 50 comprising a cylindrical thumb screw 52 at a first end thereof!, connected to a threaded post 54 found at a second, opposite end of the locking screw 50. In the shown embodiment, the cylindrical thumb screw 52 comprises a resilient pressing member 56 having a downwardly facing bottom abutment surface 58 located at the juncture between the thumb screw 52 and the threaded post 54. The resilient pressing member 58 is formed of a compressible material such as rubber or silicone which contacts the adjustable lid. The locking screw 50 can be rotated into and out of a threaded hole 60 formed in the top surface 64 of the well body. As it is screwed into the well body, the bottom abutment surface 58 compresses the adjustable lid and maintains the position of the lid and keeps it from moving. This helps ensure that the lid remains in position during the mastectomy procedure, thereby promoting uniform thickness in the resulting skin flap that is cut.

As seen in Fig. 10, the cutting tip assembly can further comprise a needle indicator 64 mounted thereon. The needle indicator 64 extends parallel to the cutting tip. As the cutting tip telescopes in and out of the sleeve, the needle indicator 64 travels over the lid, and indicates the extent of insertion of the cutting tip into the interior of the well. Thus, as the cutting tip is inserted into the skin, and the cylindrical valve is rotated, the needle indicator 64 is reflective of the position of the extreme end of the cutting tip within the skin. Thus, the needle indicator 64 can help the surgeon ascertain where the subcutaneous cutting is taking place, as the cutting progresses. . The mastectomy device can be considered to have three principal components. These include the vacuum well, the cutting tip assembly and the valve assembly. (A) Vacuum Well

The vacuum well provides a receptacle for the skin and attached tissue to be manipulated and sucked into. The well provides a flat surface in which the breast tissue can be separated from the overlying skin flap at a consistent, set depth. The well with applied suction takes a curved three-dimensional surface on the body and transforms it into a flat two-dimensional plane. The vacuum well consists of two main parts: (1) the body and (2) the cap. The depth of the well is adjusted by threading the cap over the body of the well. Rotating the cap clockwise sets a shallower depth for the cutting tip to enter and rotating the cap counter-clockwise sets a deeper depth for the cutting tip. The body and cap have corresponding hash markings with depth numbers so the user can adjust the cap to the desired depth. The cap is clear so that contact with the cap and the skin can be viewed when suction force is activated.

Once the cap depth is set, a locking mechanism is employed whereby the cap is locked into position so the cap does not inadvertently rotate and cause a change in depth. The locking mechanism works by applying a pressure force on the cap so it does not allow it to rotate.

The body of the well also consists of a connector to a vacuum tubing which provides the suction force for the skin and tissue to contact the cap. A pressure release valve is built in the body of the well. When the release valve is depressed, vacuum pressure is released, allowing the vacuum well to be removed or separated from the skin and tissue. The valve further serves to function as a safety release valve if vacuum pressure exceeds the desired amount. Because excessive suction can cause capillary damage, if the vacuum pressure exceeds the desired amount (usually 20-30 mmHg), the valve automatically opens to relieve the excess suction pressure. This pressure release valve can also be placed in line of the tubing versus on the body of the vacuum well. (B) Cutting Tip Assembly

The cutting tip assembly includes a telescoping cutting tip. The cutting tip can be any design that can cut through tissue, as multiple cutting modalities are used in the surgical profession. This could be a sharp thin blade with a movement in the "x" or "z" plane that is powered either in a mechanical fashion or with an alternate energy source. This ranges from electrosurgical cutting to harmonic cutting instruments. In one embodiment, the mastectomy device utilizes but is not limited to an electrosurgical cutting tip. This allows the connection to a standard "Bovie" electrosurgical cutting handle and power source that is already readily available in operating rooms.

In one embodiment, the cutting tip comprises a conducting cutting tip, and an insulated sleeve. The conducting cutting tip is retracted in the insulated sleeve until ready for use. Once it is ready to use, the conducting cutting tip extends just beyond the end of the insulated sleeve. Additionally, the insulated tip is designed with a sharp point so that it can percutaneously puncture the skin so the cutting tip can be deployed under the skin. The insulated tip is designed to provide heat and electrical insulation along the undersurface of the skin flap and thus minimizes the chance of creating a thermal injury to the skin flap which can lead to regional skin death.

An indicator pin fixedly mounted to the cutting tip assembly and extending parallel to the cutting tip, indicates the position of the far end of cutting tip, when under the skin. As the user moves the cutting tip forwards and backwards, the indicator pin moves in the same direction, exterior to the vacuum well, to show the position of the far end of the cutting tip.

(C) Valve Assembly

The valve assembly is a mechanism that: (1) mates with the cutting tip assembly, and (2) allows the cutting tip of the cutting tip assembly to move in predefined "x" and "z" planes. The valve assembly allows the operator to advance the cutting tip into the tissue to an extended position from a retracted position, and activate the eiectrosurgical cutting tip to separate the breast tissue from the overlying breast skin flap. The valve assembly limits the cutting tip in its motion in the x- and z-planes so that only a specified area in the tissue that is contained in the vacuum well is dissected. The valve assembly comprises a generally cylindrical swivel valve that rotates about a vertical cylinder axis. Rotation of the valve allows the far end of the cutting tip, when in the extended position, to move in an arc-like motion. There is also a telescoping feature that allows the cutting tip to be inserted forwards into the skin and also backwards to retract the cutting tip. The valve assembly connects to standard eiectrosurgical Bovie handle.

The valve is provided with means to limit its rotation. In one embodiment, the outer surface of the valve is provided with two circumferentially spaced apart rotation-limiting stops.

Guide pieces associated with the stops denote the limits of dissection allowable and act as a template for the user in a "v" shape. The angle between the two limbs can be increased and decreased. By adjusting the two limbs of the guide pieces, one may limit the arc of motion of a cut made by a cutting tip which has been extended into the vacuum well. Use of the Mastectomy Device

The device is assembled in its three pieces and the vacuum well is first connected to a vacuum source. This can either be a vacuum pump device or a built- in wall suction. Standard vacuum tubing is used to make this connection. A standard "Bovie" cautery handle is connected to the hand piece, which is then connected to a standard power unit to provide the electrical power for the cutting tip.

The breast is centered on the nipple areola complex and the device is placed on the breast with the cutting tip at the edge of the nipple areola complex. The vacuum is activated and the breast tissue is sucked up into the vacuum well, resulting in the skin 'rising' and coming into contact with the clear cap. The cutting tip is then pushed forward so the insulated tip penetrates through the skin in the tissue trapped in the vacuum well. The user then advances the cutting tip forward and depresses the button to activate the electrosurgical current to begin separating the breast tissue from the breast skin flap. The user then moves the cutting tip side to side and forward to extend the dissection of the breast tissue from the breast skin flap. The resulting area of dissection appears like a slice of pie.

The insulated sleeve and cutting tip is retracted out of the skin and vacuum well and the vacuum release valve is depressed to release suction force. The device is then separated from the patient. The device is repositioned adjacent to the area that was just dissected. The process is repeated circumferentiallv around the breast until the entire breast tissue has been dissected free from the overlying skin flap.

An incision either in a periareolar fashion or at the infra-mammary fold is made and the breast tissue is then separated off the chest wall using a standard electrosurgical instrument and retractors. This technique minimizes handling of the skin flap. Following complete removal of the breast tissue, the reconstructive aspect can begin.

While the present application has been described with reference to certain embodiments, it is to be understood that these are only exemplary, and the scope of the present invention is to be determined by the claims provided below. Thus, for example, while in a preferred embodiment, an electrocautery blade is used with the vacuum well, one may instead use a harmonic scalpel, a radio-frequency blade, an ultrasound cutting device, a bipolar energy device, a LIGASURE® device, and the like, all of which may be consider "cutting tips".

Claims

CLAIMS What is claimed is:

1. A surgical treatment device for facilitating a mastectomy procedure in a patient, comprising:

a vacuum well having a well interior, the vacuum well configured to engage tissue in a defined treatment region of the patient;

a cutting tip connected to the vacuum well and selectively insertable into the interior of the vacuum well, and

a handle connecting the cutting tip to a cutting power source.

2. The surgical treatment device according to claim 1 , wherein the vacuum well allows a variable amount of tissue to be sucked into the well by either a screw top that varies a volume in the well or by replacing a cap of the well with different inserts that varies the volume by a set amount wherein the volume of the well determines a depth at which the cutting tip is inserted under skin.

3. The surgical treatment device according to claim 2, wherein the screw top is secured with a locking mechanism that prevents movement of the cap.

4. The surgical treatment device according to any one of claims 1 or 2, wherein:

the vacuum well includes a connection to a vacuum source;

the connection comprises a release valve that regulates a maximum negative pressure; and

depressing the valve also releases a vacuum pressure.

5. The surgical treatment device according to any one of claims 1, 2 or 4 wherein the vacuum source comprises either a standard wail suction connected to a central vacuum source or a portable unit.

6. The surgical treatment device according to any one of claims 1, 2, 4 or 5 further comprising:

a rotatable valve connected to the vacuum well, the valve having a through channel in communication with an interior of the vacuum well: and a cutting yip assembly which includes the cutting tip, the cutting assembly being connected to the rotatable valve and arranged such that the cutting tip is configured to move in both lateral and forwards/backwards directions in a predefined shape;

wherein an area of dissection is determined by an extent to which the cutting tip enters the well interior via the valve's through channel , and an angular extent of rotation of the valve,

7, The surgical treatment device according to any one of claims 1, 2, 4, 5 or 6 further comprising:

a conducting portion housed in a non- co ductive sheath having a penetrative point to deliver the cutting tip subcutaneously;

wherein the non- conductive sheath protects a point of entry of the cutting tip into a patient's skin, and insulates a patient from electrical energy as well as heat.

8. A surgical treatment device according to any one of claims 1, 2, 4, 5, 6 or 7 further comprising:

an external guide which shows an operator a potential area of dissection; and a needle indicator provided on the cutting tip assembly, the needle indicator configured to move in correspondence with the cutting tip and indicate a position of a far end of a cutting tip, even when the cutting tip has been inserted subcutaneously and is hidden from view.

9. A mastectomy device for a facilitating a mastectomy procedure, comprising: a vacuum well having a longitudinal well axis (A) and comprising: a peripheral wall having a wall height (H) measured along the longitudinal well axis;

a closed top end covering the peripheral wall; and

an open bottom end spaced apart from the closed top end, along the longitudinal axis (A);

wherein the peripheral wall, the closed top end and the open bottom end together define a well interior having a well volume (V); a vacuum connector connected to the vacuum well and providing a fluid path between the well interior and a well exterior;

a recess formed in the peripheral wall, the recess having an access slot providing access to the well interior from the well exterior;

a cylindrical valve mounted to the vacuum well and occupying the recess, the valve being rotatable about a longitudinally extending valve axis (B) which is parallel to the longitudinal well axis (A), the valve comprising a through channel aligned with the access slot; and

a cutting assembly device connected to the valve, the cutting assembly comprising a telescoping cutting tip configured to move between a retracted position in which a cutting tip does not extend into the well interior, and an extended position in which the cutting tip extends through the access slot and into the well interior.

10. The mastectomy device according to claim 9, wherein:

the cy lindrical valve has an outer surface provided with a pair of outwardly projecting stops configured to limit angular rotation of the cylindrical valve.

11. The mastectomy device according to any one of claims 9 or 10, wherein the closed top comprises a removable lid.

12. The mastectomy device according to claim 11 , wherein:

the removable lid is provided with a first thread; the peripheral wall is provided with a second thread complementary to the first thread; and

the well volume (V) depends on a degree of threaded engagement between the first and second threads.

13. The mastectomy device according to claim 11 , further comprising:

a locking screw threadingly engaged to a top surface of the peripheral wall, the locking screw having lower abutment surface in contact with the lid to maintain the lid in position.

14. The mastectomy device according to claim 11, wherein the cutting assembly further comprises a needle indicator extending parallel to the cutting device;

wherein the needle indicator travels above the closed end of the lid, when the cutting device is inserted into the well, and

wherein the needle indicator indicates the position of a tip of the cutting device.