Devices, methods and systems for immobilizing breast tissue

Abstract

Various embodiments are described herein of devices, systems, and methods for immobilizing a breast. The devices include a first ring sized to fit circumferentially around a base of the breast. The first ring is configured to be coupled to a first end of a rigid rod. The devices also include a second ring sized to fit circumferentially around an upper portion of the breast. The second ring is configured to be coupled to a second end of the rigid rod. The rigid rod connects the first ring to the second ring and immobilizes the breast in a tensed position when the second ring is affixed to the upper portion of the breast.

Description

TITLE: DEVICES, METHODS AND SYSTEMS FOR IMMOBILIZING BREAST TISSUECROSS-REFERENCE

[0001] The present application claims the priority of United States Provisional Patent Application No. 63 / 661 ,351 entitled “Devices, Methods and Systems for Immobilizing Breast Tissue” filed on June 18, 2024, the contents of which are hereby incorporated by reference in their entirety.FIELD

[0002] The present disclosure pertains to medical devices, methods and systems for immobilizing breast tissue, and more specifically relates to devices, methods and systems for immobilizing breast tissue for mapping during breast surgery or reconstruction.BACKGROUND

[0003] Breast cancer treatment frequently involves the surgical removal of tumors through procedures such as mastectomies or lumpectomies. One of the major complications associated with these surgical excisions is the significant failure rate of 20 to 40% in completely removing the tumor during the first surgery. This high failure rate not only imposes additional physical and emotional strain on the patient but also increases the overall cost burden on the healthcare system. Furthermore, delays in complete tumor removal can postpone reconstruction efforts, which often involve the use of silicone implants. These implants themselves have a notable failure rate of up to 10% per year, frequently necessitating re-operations.

[0004] The current standard procedure for identifying and marking the tumor site involves several steps. Initially, women who detect a lump through self-examination or mammography undergo an X-ray of the breast. A radiologist then interprets the images and inserts a wire into the suspected cancerous area. This wire is intended to remain in place until the patient undergoes surgery, where the surgeon relies on the wire to locate and excise the tumor. However, this method has several significant drawbacks.

[0005] One major issue is that the wire can move or dislodge in 10% to 20% of cases, complicating the surgeon's task of accurately locating the tumor. This is particularly problematic for types of cancer such as Ductal Carcinoma In Situ (DCIS), which cannot be palpated and therefore are more challenging to locate and remove. Surgeons aim to excise a margin of 2 mm of normal tissue around the tumor, but due to the imprecise nature of wire localization, they often fail to achieve clear margins, necessitating further excisions. In some instances, this can lead to a conversion to a full mastectomy when the location of positive margins is uncertain.

[0006] Another method of breast cancer localization involves placing a radio-frequency identification (RFID) seed close to where the radiologist sees the tumor on an X-ray image. The surgeon uses a probe to stay a set distance away from the seed while removing to where the tumor tissue is thought to be located to resect the tumor. This system has a high failure rate because the physical three dimensions of the tumor are not known to the surgeon at the time of resection.

[0007] The high rate of re-operations not only escalates the cost of treatment but also increases the physical and emotional toll on the patient. Additionally, the use of a wire for tumor localization presents practical challenges. The wire, which protrudes from the breast, must remain in place from the time of insertion until surgery. This can be uncomfortable for the patient and poses a risk of displacement. Furthermore, the presence of the wire can interfere with the surgical excision process, making it more difficult for the surgeon to remove the tumor effectively.

[0008] The current approach to breast lesion treatment involves several problematic steps: identifying the abnormal tissue, accurately locating it within the breast, and maintaining the position of the identifying wire or device until surgical excision. The standard method of mammography, followed by wire insertion and subsequent surgical removal, is fraught with issues, including wire displacement, surgical interference, patient discomfort, and a high likelihood of incomplete tumor removal. These challenges underscore the need for animproved device that can more effectively immobilize breast tissue during surgery and improve surgical outcomes by allowing for the real time three- dimensional (3D) visualization of the tumor up to and including resection.SUMMARY OF VARIOUS EMBODIMENTS

[0009] In accordance with a broad aspect, a device for immobilizing a breast is described herein. The device includes a first ring sized to fit circumferentially around a base of the breast. The first ring has at least one lower connection point for receiving a first end of a rigid rod. The device also includes a second ring sized to fit circumferentially around an upper portion of the breast. The second ring includes at least one upper connection point for receiving a second end of the rigid rod. The rigid rod connects the first ring to the second ring and immobilizes the breast in a tensed position when the second ring is affixed to the upper portion of the breast.

[0010] In at least one embodiment, the first ring further comprises a plurality of apertures for affixing the first ring to the base of the breast.

[0011] In at least one embodiment, the second ring further comprises a plurality of apertures for affixing the second ring to the upper portion of the breast.

[0012] In at least one embodiment, the first ring comprises at least two lower connection points positioned on opposing sides of the first ring, the second ring comprises at least two upper connection points aligned with the two lower connection points and the device further comprises at least two rigid rods for connecting the first ring to the second ring at each of the at least two lower connection points and at least two upper connection points.

[0013] In at least one embodiment, the first ring comprises at least four lower connection points positioned at each quarter of the first ring, the second ring comprises at least four upper connection points aligned with the four lower connection points and the device further comprising at least four rigid rods for connecting the first ring to the second ring at each of the at least four lower connection points and at least four upper connection points.

[0014] In at least one embodiment, the navigation markers are located on at least one of the group consisting of: the first ring, the second ring, and the rigid rod.

[0015] In at least one embodiment, the first ring further comprises at least one navigation marker.

[0016] In at least one embodiment, the second ring further comprises at least one navigation marker.

[0017] In at least one embodiment, the device further comprising at least three navigation markers for triangulating a location for mapping the breast.

[0018] In at least one embodiment, the device is constructed from a radiolucent material such that the device is transparent to radiation from an X- Ray.

[0019] In at least one embodiment, an inner circumference of the first and second ring comprises notches.

[0020] In accordance with another broad aspect, a method for immobilizing breast tissue is described herein. The method includes placing a first ring circumferentially around a base of a breast, the first ring having at least one base connection point for receiving a first end of a rigid rod. The method also includes affixing a second ring to an upper portion of the breast to circumferentially surround the upper portion of the breast. The second ring includes at least one upper connection point for receiving a second end of the rigid rod. The method also includes coupling the first end of the rigid rod to at least one base connection point and coupling the second end of the rigid rod to at least one upper connection point. The rigid rod connects the first ring to the second ring to immobilize the breast tissue in a tensed position when the second ring is affixed to the upper portion of the breast.

[0021] In at least one embodiment, after placing the first ring circumferentially around the base of the breast, the method further includes affixing the first ring to the base of the breast using sutures that connect a plurality of apertures on the first ring to the base of the breast.

[0022] In at least one embodiment, affixing the second ring to the upper portion of the breast includes using sutures to connect a plurality of apertures on the second ring to the upper portion of the breast.

[0023] In accordance with another broad aspect, a system for imaging breast tissue is described herein. The system includes a breast immobilizing device having a first ring sized to fit circumferentially around a base of the breast. The first ring has at least one lower connection point for receiving a first end of a rigid rod. The device also includes a second ring sized to fit circumferentially around an upper portion of the breast. The second ring includes at least one upper connection point for receiving a second end of the rigid rod. The rigid rod connects the first ring to the second ring and immobilizes the breast in a tensed position when the second ring is affixed to the upper portion of the breast. The device also includes at least one navigation marker comprising a radiopaque material positioned on each of the first and second rings to provide a mapping of the breast immobilization device.

[0024] In at least one embodiment, the system also includes a needle having a fibrous thread. The fibrous thread may be placed to surround at least a portion of the breast tissue to form a fibrous thread network within the breast tissue. The fibrous thread network supports the portion of the breast and the breast immobilizing device supports the fibrous thread network to immobilize the breast tissue. The fiber thread network can be continuous or discontinuous.

[0025] In at least one embodiment, the fibrous thread is a natural fiber thread.

[0026] In at least one embodiment, the needle comprises at least one navigation marker comprising a radiopaque material.

[0027] In at least one embodiment, the breast immobilizing device includes at least three navigation markers for triangulating a location for mapping the breast.

[0028] In at least one embodiment, the breast immobilizing device is constructed from a radiolucent material such that the breast immobilizing device is transparent to radiation from an X-Ray.

[0029] In accordance with another broad aspect, a method of determining a position of a lesion within breast tissue is described herein. The method includes placing a breast immobilization device on the breast by: placing a first ring circumferentially surrounding the base of a breast, the first ring having at least one base connection point for receiving a first end of a rigid rod, the first ring further comprises at least one navigation marker consistent with current and navigation technologies. Placing the breast immobilization device on the breast also includes affixing a second ring to an upper portion of the breast to circumferentially surround the upper portion of the breast, the second ring comprising at least one upper connection point for receiving a second end of the rigid rod, the second ring further comprising at least one navigation marker consisting of a radiopaque material. Placing the breast immobilization device on the breast also includes coupling the first end of the rigid rod to at least one base connection point and coupling the second end of the rigid rod to at least one upper connection point. The method of determining a position of a lesion within breast tissue also includes capturing an image of the breast with the breast immobilization device using an imaging device and based on the captured image, determining a position of the lesion within the breast tissue based on a position of one or more navigation markers of the breast immobilization device.

[0030] In at least one embodiment, the method also includes placing a needle having a fibrous thread within the breast to surround at least a portion of the breast tissue to form a fibrous thread network, the fibrous thread network supporting the portion of the breast tissue.

[0031] In at least one embodiment, the needle comprises at least one needle navigation marker consisting of a radiopaque material and the method further comprises, detecting the at least one needle navigation marker on animaging device to navigate a location of the needle with respect to the lesion within the breast.

[0032] In at least one embodiment, the method includes triangulating a location for mapping the breast using at least three navigation markers.

[0033] In at least one embodiment, the breast immobilizing device is constructed from a radiolucent material such that the breast immobilizing device is transparent to radiation from an X-Ray.

[0034] In accordance with another broad aspect, a method for restructuring breast tissue is described herein. The method includes applying a breast immobilizing device to a breast, the breast immobilizing device having: a first ring sized to fit circumferentially around a base of the breast; the first ring having at least one base connection point for receiving a first end of a rigid rod. The device also has a second ring sized to fit circumferentially around an upper portion of the breast; the second ring comprising at least one upper connection point for receiving a second end of the rigid rod. The rigid rod connects the first ring to the second ring, and the method also includes immobilizing the breast in a tensed position. The method also includes, with a suture having a needle and a fibrous thread, placing the fibrous thread within the breast tissue, the fibrous thread being placed to surround at least a portion of the breast tissue to form a fibrous thread network, the fibrous thread network supporting the portion of the breast tissue.

[0035] In accordance with another broad aspect, a system for determining a position of a lesion within breast tissue is described herein. The system includes a breast immobilizing device, an imaging device and a computing device communicatively coupled to the imaging device. The computing device is configured to direct the imaging device to capture an image of the breast tissue with the breast immobilization device thereon, and, based on the captured image, determine a position of the lesion within the breast tissue based on a position of one or more navigation markers of the breast immobilization device.

[0036] In at least one embodiment, the breast immobilization device is a breast immobilization device according to at least one embodiment described herein.

[0037] Other technical features may be readily apparent to one skilled in the art from the following figures, descriptions, and claims.

[0038] Other features and advantages of the present application will become apparent from the following detailed description taken together with the accompanying drawings. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the application, are given by way of illustration only, since various changes and modifications within the spirit and scope of the application will become apparent to those skilled in the art from this detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0039] For a better understanding of the various embodiments described herein, and to show more clearly how these various embodiments may be carried into effect, reference will be made, by way of example, to the accompanying drawings which show at least one example embodiment, and which are now described. The drawings are not intended to limit the scope of the teachings described herein.

[0040] FIG. 1 is a front perspective view of a breast immobilization device, according to an example embodiment.

[0041] FIG. 2 is a top view of a breast immobilization device, according to another example embodiment.

[0042] FIG. 3 is a top view of the base ring and the upper ring of a breast immobilization device, according to another example embodiment.

[0043] FIG. 4 is a top view of the breast immobilization device, according to an example embodiment.

[0044] FIG. 5 is a table comparing expected effectiveness rates and costs of the devices described herein for immobilizing breast tissue to effectiveness rates and costs of current approaches for immobilizing breast tissue.

[0045] FIG. 6 is a flowchart showing a method of immobilizing breast tissue, according to an example embodiment.

[0046] FIG. 7 is a flowchart showing a method of immobilizing breast tissue, according to an example embodiment.

[0047] FIG. 8 is a flowchart showing a method of immobilizing breast tissue, according to an example embodiment.

[0048] Further aspects and features of the example embodiments described herein will appear from the following description taken together with the accompanying drawings.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0049] Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems or methods having all of the features of any one of the devices, systems or methods described below or to features common to multiple or all of the devices, systems or methods described herein. It is possible that there may be a device, system or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0050] Furthermore, it will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thoroughunderstanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein may be practiced without these specific details. In other instances, well- known methods, procedures and components have not been described in detail so as not to obscure the embodiments described herein. Also, the description is not to be considered as limiting the scope of the embodiments described herein.

[0051] It should also be noted that the terms “coupled”, or “coupling” as used herein can have several different meanings depending in the context in which these terms are used. For example, the terms coupled, or coupling can have a mechanical, electrical or fluidic connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via an electrical signal, electrical connection, fluidic pathway or a mechanical element depending on the particular context.

[0052] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to”.

[0053] It should also be noted that, as used herein, the wording “and / or” is intended to represent an inclusive-or. That is, “X and / or Y” is intended to mean X or Y or both, for example. As a further example, “X, Y, and / or Z” is intended to mean X or Y or Z or any operable combination thereof. Accordingly, the term “any combination thereof” is meant to cover any operable combination of the elements which precede the phrase. For example, the phrase “A, B, C, D or any combination thereof” includes A; B; C; D; A and B; A and C; A and D; B and C; B and D; C and D; A, B and C; A, B and D; A, C and D; B, C and D as well as A, B, C and D assuming that all such combinations are operable (i.e., they can be used together in practice in a working embodiment).

[0054] It should be noted that terms of degree such as "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term, such as by 1 %, 2%, 5% or 10%, for example, if this deviation does not negate the meaning of the term it modifies.

[0055] Furthermore, the recitation of numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about" which means a variation of up to a certain amount of the number to which reference is being made if the end result is not significantly changed, such as 1 %, 2%, 5%, or 10%, for example.

[0056] Reference throughout this specification to “one embodiment”, “an embodiment”, “at least one embodiment” or “some embodiments” means that one or more particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, unless otherwise specified to be not combinable or to be alternative options.

[0057] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its broadest sense, that is, as meaning “and / or” unless the content clearly dictates otherwise.

[0058] Throughout this specification and the appended claims, infinitive verb forms are often used. Examples include, without limitation: “to detect,” “to provide,” “to transmit,” “to communicate,” “to process,” “to route,” and the like. Unless the specific context requires otherwise, such infinitive verb forms are used in an open, inclusive sense, that is as “to, at least, detect” “to, at least, provide,” “to, at least, transmit,” and so on.

[0059] As mentioned above, the current approach to breast lesion treatment involves several problematic steps: identifying the abnormal tissue, accurately locating it within the breast, and maintaining the position of the identifying wire or RFID seed until surgical excision. The standard method of mammography, followed by wire insertion and subsequent surgical removal, has issues, including wire displacement, surgical interference, patient discomfort, and a high likelihood of incomplete tumor removal. These challenges underscore the need for a device that can more effectively immobilize breast tissue from imaging to cancer resection surgery and other breast reconstruction surgeries to improve patient outcomes. A breast immobilization device that improves these challenges is provided herein.

[0060] The various embodiments described herein generally relate to medical devices, methods and systems for immobilizing a breast. The breast immobilization devices described herein may be used for performing various treatments, such as, but not limited to, immobilization of breast tissue, reconstruction of breast tissue and breast imaging applications including mammography and / or other imaging applications.

[0061] Various method and system embodiments described herein provide for positioning of the breast immobilization device on a breast, such as a human breast. The positioning of the breast immobilization device is crucial to restricting movement of the breast tissue and maximizing surgical efficacy.

[0062] The breast immobilization devices described herein include an external frame or cage-like structure designed to be attached to the breast or breast tissue and hold the breast in such a way that the process of imaging, surgery and reconstruction can be done effectively, such as within the same day. The breast immobilization devices described herein can provide the ability to hold a breast in place for up to a week or more without significant analgesics.

[0063] The breast immobilization device can be used together with common imaging techniques (e.g., magnetic resonance imaging (MRI), ultrasound, X-ray, etc.) to localize a lesion, such as but not limited to a cancerous tissue, three-dimensionally within the external frame, allowing aprecision excision of the lesion with either robotic assist or guidance to the surgical knife. As a result, less normal or healthy breast tissue is removed than conventional excision techniques. The exact area of concern from a positive margin within the breast can be re-excised. This increases the likelihood for the patient to keep more of the healthy breast tissue and prevent or reduce the need for a mastectomy, or for radiotherapies. The breast reconstruction after excision can then start immediately thereafter.

[0064] Systems for imaging a lesion within a breast are also provided herein. The imaging systems provide for a three-dimensional (3D) localization of the lesion in the breast so surgeons can use the imaging system to navigate or use robotic assistance to accurately remove the lesion, whilst getting clear margins. Furthermore, images captured, for example by an X-Ray or MRI, can be linked to the imaging system for 3D localization. The imaging system can also be positioned in place from image to reconstruction and provide for surgical access.

[0065] The purpose of breast immobilization devices described herein is to hold the breast tissue in firm dimensions in a 3D manner, to provide for the breast to be visualized using the above imaging techniques, without interference, and to provide access for surgeons to remove the abnormal tissue (e.g., cancer) from the breast, and then, optionally, reconstruct a defect in the breast and hold the breast while the reconstruction heals.

[0066] The device is designed to provide a soft tissue stabilization of the breast. The device is designed to be applied to the breast in such a way that the soft tissues are held in shape, and that a navigation device can be therefore used within the soft tissues, navigation being based upon imaging modalities used to access the breast, such as mammography, MRIs, CT scans, and ultrasounds.

[0067] A system that provides for identification, imaging and excision of abnormal tissues such as lesions or cancerous tumors from the breast stands to be of great benefit through decreasing the incidents of positive margins, increasing the surgeon’s ability to remove the cancer with clear margins,decreasing the impact of multiple operations on the patient, and decreasing the burden on the healthcare system as a whole.

[0068] Referring now to FIG. 1 , shown therein is a breast immobilization device 100 according to at least one embodiment described herein. Breast immobilization device 100 includes a base ring 126 sized to fit circumferentially around and configured to be affixed to a base 128 of the breast 106. Base 128 of breast 106 is a portion of the breast 106 nearest the torso of the patient. Breast immobilization device 100 also comprises an upper ring 116 sized to fit circumferentially around and configured to be affixed to an upper portion 104 of the breast 106.

[0069] The base ring 126 can include at least one lower connection point 124 for receiving a first end of a rigid rod 108. The upper ring 116 can include at least one upper connection point 114 for receiving the second end of the rigid rod 108. Herein, the term “lower” is used in association with the base portion 128 of breast 106 and the term “upper” is user in associate with the upper portion 104 (i.e., nearest the areola) of breast 106. Upper connection points 114 and lower connection points 124 can be configured in any manner to receive at least a portion of rigid rod 108. For instance, in the embodiment shown in the drawings, each of upper connection points 114 and lower connection points 124 defines a respective aperture or cavity sized and shaped to receive rod 108. However, it should be understood that other mechanisms of coupling rods 108 to respective upper connection points 114 and lower connection points 124 may also be possible.

[0070] Base ring 126 can include for example, two, three, four, five, six, or more lower connection points 124. The upper ring 116 can include for example, two, three, four, five, six, or more upper connection points 114. In at least one embodiment, the number of upper connection points 114 equal the number of lower connection points 124. In at least one embodiment, the upper 114 and lower 124 connection points are aligned concentrically such that a respective rod 108 can be inserted into corresponding upper 114 and lower 124 connection points simultaneously.

[0071] Rod 108 can be rigid, or semi-flexible. Rod 108 has a diameter sized to fit within the upper 114 and lower 124 connection points. A bulbous cap can also be added or provided at either end of the rod 108 to prevent the rod 108 from falling or slipping off. A length of rod 108 can be determined based on the distance between the upper 114 and lower 124 connection points when the breast immobilization device 100 is in place. For example, the physician or surgeon may measure the distance between the upper ring 116 and the base ring 126 and choose a rod 108 having a length that best fits the distance or is slightly larger than the measured distance. Rod 108 may also be cut or snipped at its ends to fit the breast 106 appropriately. Generally, rod(s) 108 connect the base ring 126 to the upper ring 116 and immobilize the breast 106 in a tensed position when the upper ring 116 is affixed to the upper portion 104 of the breast 106.

[0072] Base ring 126 can be affixed to the base 128 of the breast 106, such as by suturing or adhesion. In at least one embodiment, the base ring 126 can include a plurality of apertures 122 to suture the base ring 126 to the base 128 of the breast 106, by stitches 120. In at least one embodiment, a bottom surface of the base ring 126 can include an adhesive or an adhesive strip to affix the base ring 126 to the base 128 of the breast.

[0073] Upper ring 116 can be affixed to the upper portion 104 of the breast 106, such as by suturing or adhesion. In at least one embodiment, the upper ring 116 can include a plurality of apertures 112 to suture the upper ring 116 to the areola or upper portion 104 of the breast 106, by stitches 110. In at least one embodiment, a bottom surface of the upper ring 116 can include an adhesive or an adhesive strip to affix the upper ring 116 to the upper portion 104 of the breast.

[0074] Upper ring 116 may optionally include one or more ridges to guide a surgeon who is inserting a needle 102 or wire into the breast tissue.

[0075] In at least one embodiment, the breast immobilization device 100 consists of two rings 116, 126. The base ring 126 can be in the form of two halves, or semi-circular portions that are applied together on the base 128 ofthe breast 106. The rings 116, 126can be made of non-metallic material. In at least one embodiment, the rings 116, 126are made of a material that does not interfere with imaging by x-rays, MRIs, CT scans, or ultrasounds. The base ring 126 can be assembled around the base 128 of the breast 106, for example by clipping or adjoining two half portions of the ring 126 together. The upper ring 116 can be applied to the top portion 104 of breast 106, for example at the margins of the areola, by clipping or adjoining the two half portions of the ring 116 together.

[0076] The rings 116, 126 can be placed by a surgeon, after the skin has been anesthetized with a local anesthetic. The base ring 126 or upper ring 116 can be sutured in place with a running suture going therethrough and through the underlying skin and back to the ring again. Perforations 112, 122 on the periphery of the upper ring 116 and the base ring 126, respectively, can be designed to allow for easy placement of the sutures, such as a nylon to 2-0 suture or 3-0 suture 102.

[0077] The upper 116 and base 126 rings may be provided in different sizes to allow for the variabilities in sizes and shapes of breasts in the general population. The upper 116 and base 126 rings can be accommodated for small to large breasts.

[0078] Turning now to FIG.2, provided therein is a top view of an upper ring 216 and a lower ring 226 of a breast immobilization device 200, according to another embodiment. In the embodiment shown in FIG. 2, there are four connection points 214a-d and 224a-d on each of the upper 216 and lower 226 rings, respectively. The connection points 214a-d and 224a-d can be evenly spread out and attached to the rings at 90 degree points, for example at 0°, 90°, 180°, and 270°.

[0079] The connection points 214a-d and 224a-d can include receptacles into which rods 108 (e.g., threaded rods) can be placed. A base 108b of the rod 108 can be placed into the lower receptacle and aligned with an upper receptacle on the upper ring 116, which provides for the rod 108 to be placed in between the upper ring 116 and the lower ring 126, therebyimmobilizing the rings 116, 126 with respect to each other. The rods 108 can be rotated 360° directions, being inserted through a rotating captured device, like a gimbal, attached to the rings 116, 126.

[0080] Each rod 108 can optionally include a pair of threaded nuts 130a, 130b, that provide for the use of the threads of the rod 108 and push the upper ring 116 away from the base ring 126, thereby applying tension to the breast tissue. The top nuts 130a can be locked in position by a secondary nut 130c, for example. With all of the rods 108 in place, the breast 106 becomes firm. The rods 108 can be individually adjusted so as to allow the tissues to resume the regular shape of the breast 106. For instance, if the breast 106 has a significant degree of ptosis, the rods 108 can be elongated or shorted to allow the breast 106 to assume its normal position. However, the breast 106 can also be held in such a shape that an abnormal lesion can be imaged and accessed between the rods 108 by the operating surgeon.

[0081] Therefore, when the device 100 is used to identify and remove an abnormal lesion, all of the rods 108 can be placed in equal tension, allowing the breast 106 to be held secure. The breast 106 can then be imaged, and images of the lesion can be taken. The data that comes from the mammography or from the MRIs, x-rays, CT scans, or ultrasounds, or other examinations of the breast 106 is then fed into one or more computers that control a navigation device and / or surgical robot in the operating room.

[0082] In another embodiment, an alternate radiology device may be connected to a portion of the device 100, such as but not limited to at the upper ring 116. For example, a camera suitable for conducting molecular breast imaging may be attached to the upper ring 116 and used to provide improved visualization of the breast 106 tissue and / or any abnormal lesions therein.A circular mammography radiological unit can be designed similar to a CT scanner but of small size and reduced radiation output that links to the upper part of device 100 and provides a 3D picture of the breast and upper chest wall only, in distinction to current technology that views the complete upper body including the breasts.

[0083] Turning now to FIG. 3, shown therein is a top view of a base ring 300a and the upper ring 300b of another breast immobilization device, according to an example embodiment.

[0084] For the purposes of navigation, one or more navigation beads 302 may be placed in different areas of the base ring 126 and upper ring 116 and a navigation pointer can be used to identify various parts of the breast immobilization device used by the navigation apparatus.

[0085] Base ring 300a further comprises at least one navigation marker 302. Navigation marker 302 may be any navigation marker that can provide a reference point in medical imaging to precisely locate an anatomical structure and / or surgical instrument. Navigation marker(s) 302 may be small, reflective objects, or fiducials, that appear on both imaging scans (like CT or MRI) during surgery. These markers may provide for a surgeon to track an instrument position in relation to the patient's anatomy in real-time. In at least one embodiment, navigation marker(s) 302 may include a radiopaque material. In at least one embodiment, navigation marker(s) 302 may include small reflective spheres that are tracked by infrared cameras. In at least one embodiment, navigation marker(s) 302 may be visible on multiple imaging modalities (e.g., CT and MRI). In at least one embodiment, navigation marker(s) 302 may emit a signal (e.g., electromagnetic or radiofrequency) that is tracked by a navigation system. Upper ring 300b can also include at least one navigation marker 302 including a radiopaque material.

[0086] The systems described herein may include at least three navigation markers 302 for triangulating a location for mapping the breast 106. In at least one embodiment, the breast immobilizing devices described herein can be constructed from a radiolucent material such that the breast immobilizing device is transparent to radiation from an X-Ray.

[0087] Once imaging of the breast 106 is completed and a location of a lesion, for example, desired to be removed from the breast 106 is ascertained, the patient can be taken to the operating room and put under anesthesia to remove the lesion from the breast 106. The surgeon can use a cautery devicethat is navigated that cuts the skin in the appropriate area and then cuts out the lesion with a margin of normal tissue. In at least one embodiment, the removal of the lesion may be guided by direct navigation of a robotic arm, or guided by image placement on a screen by which the surgeon can access and control the cautery device. In these embodiments, location of the lesion is determined using triangulation of location data collected by the imaging device of each of the lesion and one, two, three, four or more than four of the navigation markers on the device 100.

[0088] With the removal of the lesion, the specimen can be taken to an on-site pathological area forexamination, where the pathologist can assess the margins. Further cancerous lesions can be removed at the time of surgery until the margins are deemed clear by the pathologist.

[0089] The reconstructive surgeon can then enter the room and, using a navigated probe, identify the volume of tissue that has been removed. The reconstructive surgeon can replace the volume of tissue that has been removed into the cavity which is now being classified as tumor free. The replacement tissue can be taken from another area of the patient, such an iliac crest, adipose tissue, etc.

[0090] The surgeon can then take the soft tissues in an appropriate manner based upon the patient’s characteristics and a prior assessment of the patient. That soft tissue is then placed appropriately, vascularized in the defect in the breast.

[0091] To hold the breast and soft tissue reconstruction together, the breast immobilization device according to at least one embodiment described herein can remain in place while a needle is used to place suture material into the reconstructed breast.

[0092] T urning now to FIG.4, a top view of a breast immobilization device 400 according to an example embodiment is shown therein. In FIG. 4, a suture 402 is shown, optionally being guided by navigation, passing from an edge of the areola down through the subcutaneous tissues of breast 106 below the skintowards the base ring 126, where the needle exits the skin and the suture material protrudes through the skin. This process can be repeated until there is a line of sutures 402 underneath the base ring 126 and the superior aspect of the breast, all of which can be placed under tension so as to maintain the breast shape desired by the patient and surgeon. In at least one embodiment, the needles can be guided by the navigation program.

[0093] Once all of the reconstruction material has been placed to allow for the tensioning effect, the loops of suture passing through the skin are either sutured in place or held in place by a curved rod that is placed along the top of the breast and held in place by sutures at each end of the rod.

[0094] Similarly, at the areola entrance of the material into the breast, the sutures can be tied off individually or tied around a rod that skirts the margins of the areola holding all of the sutures in place.

[0095] The use of the breast immobilizing devices described herein may decrease a number of sutures that go into the skin, and therefore may be used for cosmetic purposes. The use of sutures adds more strength to each individual fiber that is used in the reconstruction, however, this can be up to surgeon’s preference. The tension placed in the material is again determined by the surgeon at the time of surgery and based upon the desires of the patient with respect to the cosmetic appearance desired for the particular breast after reconstruction. FIG. 5 is a table comparing expected effectiveness rates and costs of the devices described herein for immobilizing breast tissue to effectiveness rates and costs of current approaches for immobilizing breast tissue.

[0096] In at least one embodiment a system for immobilizing a breast is taught herein. The system can comprise a breast immobilizing device as explained above, as well as a needle having a fibrous thread. The fibrous thread can be placed to surround at least a portion of the breast tissue to form a fibrous thread network. The fibrous thread network may be formed to support the portion of the breast tissue. The breast immobilizing device can support the fibrous thread network to immobilize the breast tissue. The fibrous thread canbe made from any natural fiber, including, but not limited to collagen fibers, chitin fibers, silk, cotton, and linen fibers. The fibrous thread can be made from a synthetic fiber, including, but not limited to nylon fibers, PDS fibers, PET fibers, etc.

[0097] T urning now to FIG. 6, which provides a flowchart showing a method 600 of immobilizing breast tissue, according to an example embodiment. In step 602, a user places a first ring circumferentially surrounding the base of a breast. The first ring has at least one base connection point for receiving a first end of a rod. In step 604, the user affixes a second ring to an upper portion of the breast to circumferentially surround the upper portion of the breast; the second ring comprising at least one upper connection point for receiving a second end of the rod. In step 606, the user couples the first end of the rod to at least one base connection point. In step 608, the user couples the end of the rigid rod to at least one upper connection point. In at least one embodiment, the rod connects the first ring to the second ring to immobilize the breast tissue in a tensed position when the second ring is affixed to the upper position of the breast.

[0098] T urning now to FIG. 7, which provides a flowchart showing a method 700 of detecting a location of a lesion within a breast, according to an example embodiment. In block 702, the user places a first ring circumferentially surrounding the base of a breast; the first ring having at least one base connection point for receiving a first end of a rigid rod; the first ring comprising at least one navigation marker consisting of a radiopaque material. In block 704, the user affixes a second ring to an upper portion of the breast to circumferentially surround the upper portion of the breast; the second ring having at least one upper connection point for receiving a second end of the rigid rod; the second ring further having at least one navigation marker consisting of a radiopaque material. In block 706, the user couples the first end of the rigid rod to at least one base connection point. In block 708, the user couples the second end of the rigid rod to at least one upper connection point.In block 710, the user detects the at least one navigation marker on an imaging device to navigate a location of a lesion within the breast.

[0099] T urning now to FIG. 8, which provides a flowchart showing a method 800 of immobilizing tissue of a breast, according to an example embodiment. In block 802, the user places a breast immobilizing device ion the breast. Placing the breast immobilization device includes, as shown in block 804, placing on a person, by a user, a first ring sized to fit circumferentially around a base of the breast. The first ring has at least one base connection point for receiving a first end of a rigid rod. In block 806, the user places a second ring sized to fit circumferentially around an upper portion of the breast. The second ring has at least one upper connection point for receiving a second end of the rigid rod. In block 808, the user couples the rigid rod to the first ring and to the second ring. Once the breast immobilization device is placed on the patient, a user, using a needle having a fibrous thread, places the fibrous thread to surround at least a portion of the breast tissue to form a fibrous thread network. In this method, as described in greater detail above, placing the first and / or second ring may include affixing the first and / or second ring to the base and an upper portion of the breast, respectively, by, for example, suturing.

[0100] While the applicant's teachings described herein are in conjunction with various embodiments for illustrative purposes, it is not intended that the applicant's teachings be limited to such embodiments as the embodiments described herein are intended to be examples. On the contrary, those of skill in the art will appreciate that the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments described herein, the general scope of which is defined in the appended claims.

Claims

ClaimsWhat is claimed is:1 . A device for immobilizing a breast, the device comprising: a first ring sized to fit circumferentially around a base of the breast, the first ring having at least one lower connection point for receiving a first end of a rigid rod; a second ring sized to fit circumferentially around an upper portion of the breast, the second ring comprising at least one upper connection point for receiving a second end of the rigid rod; and the rigid rod connecting the first ring to the second ring and immobilizing the breast in a tensed position when the second ring is affixed to the upper portion of the breast.

2. The device of claim 1 , wherein the first ring further comprises a plurality of apertures for affixing the first ring to the base of the breast.

3. The device of claim 2, wherein the second ring further comprises a plurality of apertures for affixing the second ring to the upper portion of the breast.

4. The device of claim 2 or claim 3, wherein: the first ring comprises at least two lower connection points positioned on opposing sides of the first ring; and the second ring comprises at least two upper connection points aligned with the two lower connection points; and the device further comprises at least two rigid rods for connecting the first ring to the second ring at each of the at least two lower connection points and at least two upper connection points.

5. The device of claim 4, wherein the first ring comprises at least four lower connection points positioned at each quarter of the first ring; and the second ring comprises at least four upper connection points aligned with the four lower connection points;and the device further comprising at least four rigid rods for connecting the first ring to the second ring at each of the at least four lower connection points and at least four upper connection points.

6. The device of any one of claims 1 to 5, wherein the navigation markers are located on at least one of the group consisting of: the first ring, the second ring, and the rigid rod.

7. The device of claim 6, wherein the first ring further comprises at least one navigation marker.

8. The device of claim 6 or claim 7, wherein the second ring further comprises at least one navigation marker.

9. The device of any one of claims 6 to 8, further comprising at least three navigation markers for triangulating a location for mapping the breast.

10. The device of any one of claims 1 to 9, wherein the device is constructed from a radiolucent material such that the device is transparent to radiation from an X-Ray.11 . The device of any one of claims 1 to 10, wherein an inner circumference of the first and second ring comprises notches.

12. A method for immobilizing breast tissue, the method comprising: placing a first ring circumferentially around a base of a breast, the first ring having at least one base connection point for receiving a first end of a rigid rod; affixing a second ring to an upper portion of the breast to circumferentially surround the upper portion of the breast, the second ring comprising at least one upper connection point for receiving a second end of the rigid rod; coupling the first end of the rigid rod to at least one base connection point; andcoupling the second end of the rigid rod to at least one upper connection point; wherein the rigid rod connects the first ring to the second ring to immobilize the breast tissue in a tensed position when the second ring is affixed to the upper portion of the breast.

13. The method of claim 12 further comprising, after placing the first ring circumferentially around the base of the breast, affixing the first ring to the base of the breast using sutures that connect a plurality of apertures on the first ring to the base of the breast.

14. The method of claim 12 or claim 13, wherein affixing the second ring to the upper portion of the breast includes using sutures to connect a plurality of apertures on the second ring to the upper portion of the breast.

15. A system for imaging breast tissue, the system comprising: a breast immobilizing device comprising: a first ring sized to fit circumferentially around a base of the breast, the first ring having at least one lower connection point for receiving a first end of a rigid rod; a second ring sized to fit circumferentially around an upper portion of the breast, the second ring comprising at least one upper connection point for receiving a second end of the rigid rod; the rigid rod connecting the first ring to the second ring and immobilizing the breast in a tensed position when the second ring is affixed to the upper portion of the breast; and at least one navigation marker positioned on each of the first and second rings to provide a mapping of the breast immobilization device.

16. The system of claim 15, further comprising a needle having a fibrous thread, the fibrous thread being placed to surround at least a portion of the breast tissue to form a fibrous thread network, the fibrous thread network supporting the portion of the breast tissue; wherein the breast immobilizingdevice supports the fibrous thread network to immobilize the breast tissue; and wherein the fiber thread network can be continuous or discontinuous.

17. The system of claim 16, wherein the fibrous thread is a natural fiber thread.

18. The system of any one of claims 15 to 17, wherein the needle comprises at least one navigation marker comprising a radiopaque material.

19. The system of any one of claims 15 to 18, wherein the breast immobilizing device includes at least three navigation markers for triangulating a location for mapping the breast.

20. The system of any one of claims 15 to 19, wherein the breast immobilizing device is constructed from a radiolucent material such that the breast immobilizing device is transparent to radiation from an X-Ray.

21. A method of determining a position of a lesion within breast tissue, the method comprising: placing a breast immobilization device on the breast by: placing a first ring circumferentially surrounding the base of a breast, the first ring having at least one base connection point for receiving a first end of a rigid rod, the first ring further comprises at least one navigation marker consisting of a radiopaque material; affixing a second ring to an upper portion of the breast to circumferentially surround the upper portion of the breast, the second ring comprising at least one upper connection point for receiving a second end of the rigid rod, the second ring further comprising at least one navigation marker consisting of a radiopaque material; coupling the first end of the rigid rod to at least one base connection point; andcoupling the second end of the rigid rod to at least one upper connection point; and capturing an image of the breast with the breast immobilization device using an imaging device; and based on the captured image, determining a position of the lesion within the breast tissue based on a position of one or more navigation markers of the breast immobilization device.

22. The method of claim 21 , further comprising placing a needle having a fibrous thread within the breast to surround at least a portion of the breast tissue to form a fibrous thread network, the fibrous thread network supporting the portion of the breast tissue.

23. The method of claim 21 , wherein the needle comprises at least one needle navigation marker consisting of a radiopaque material; and the method further comprises, detecting the at least one needle navigation marker on an imaging device to navigate a location of the needle with respect to the lesion within the breast.

24. The method of any one of claims 21 to 23, further comprising triangulating a location for mapping the breast using at least three navigation markers.

25. The method of any one of claims 22 to 24, wherein the breast immobilizing device is constructed from a radiolucent material such that the breast immobilizing device is transparent to radiation from an X-Ray.

26. A method for restructuring breast tissue, the method comprising: applying a breast immobilizing device to a breast, the breast immobilizing device comprising: a first ring sized to fit circumferentially around a base of the breast; the first ring having at least one base connection point for receiving a first end of a rigid rod;a second ring sized to fit circumferentially around an upper portion of the breast; the second ring comprising at least one upper connection point for receiving a second end of the rigid rod; and the rigid rod connecting the first ring to the second ring; and immobilizing the breast in a tensed position; and with a suture having a needle and a fibrous thread, placing the fibrous thread within the breast tissue, the fibrous thread being placed to surround at least a portion of the breast tissue to form a fibrous thread network, the fibrous thread network supporting the portion of the breast tissue and anchoring the breast and fibrous network to the fascia that overlies the pectoral muscles under the breast.

27. A system for determining a position of a lesion within breast tissue, the system comprising: a breast immobilizing device; an imaging device; and a computing device communicatively coupled to the imaging device, the computing device configured to: direct the imaging device to capture an image of the breast tissue with the breast immobilization device thereon; and based on the captured image, determine a position of the lesion within the breast tissue based on a position of one or more navigation markers of the breast immobilization device.

28. The system of claim 27, wherein the breast immobilization device is the breast immobilization device of any one of claims 1-11.

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