Targeting implant for external beam radiation

A radiation targeting system is provided. The system can include an introducer and an implant. The implant can be disposed within a cannula of the introducer and the implant can include a wire stem and multiple different wire branches each extending outwardly from a proximal portion of the wire stem. A radiation source can then be used to target the implant so that radiation therapy can be delivered to a patient. Optionally, a loader and a trocar can be included with the system.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a medical device and more particularly to an in-vivo medical device for use during external beam radiation therapy (EBRT).

2. Description of the Related Art

Radiation for breast cancer is most often accomplished by the use of full breast radiation. This imparts radiotherapy to the entire area of the breast. Radiation of the breast will necessarily involve surrounding structures such as, but not limited to, the heart, lungs, esophagus, chest wall, ribs and other structures that are in close proximity to the breast. Thus, a new concept of only partial breast radiation has grown in popularity and involves the use of balloon catheters to treat cancer in the lumpectomy cavity. Studies thus far indicate that it is as effective as full breast radiation and eliminates damage to the surrounding organs.

Partial breast radiation is currently being delivered through balloon catheters placed into the lumpectomy cavity at the time of surgery or later under ultrasound guidance. This process of using a balloon catheter for radiation treatment involves placing a radioactive seed or source down the indwelling catheter for a brief period of time. Unfortunately, this method of utilizing a catheter and radioactive seed has a number of drawbacks. For instance, utilizing a concentrated dose of radiation over a short period of time in the form of a radioactive seed planted through means of the catheter creates a multitude of side effects such as fat necrosis, seromas, hematomas, infection and undesirable cosmetic outcomes. The use of partial breast radiation balloon catheters also requires additional expensive equipment to maintain and direct the source of the radiation into the partial breast balloon catheter, which is not available at all radiation sites.

Currently, the other source of breast radiation is full breast radiation by external beam equipment. The external beam radiation equipment is excellent for solid organs such as the liver that contains a small tumor or the head of the pancreas that contains a small tumor. These tumors are most effectively treated with external beam radiation by placing a target or a metallic marker into the area of the tumor, which allows the external beam to be focused on this tumor and avoid damage to the surrounding tissue. These solid organs are rigid and do not move during the radiation treatment. But the breast is an external structure, consisting primarily of fatty tissue, unlike the liver and pancreas.

Of note, the use of metallic markers in the breast tissue creates an unstable environment for the marker, and the marker does not necessarily remain in place or in a constant location. Consequently, in fatty tissue, these small seeds or targets may move from the intended target site, rendering the therapy ineffective. Thus, in order to utilize external beam radiation on the breast, a stable target must be available.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention address deficiencies of the art in respect to radiation treatments for cancer and provide a new and novel system for delivering radiation to a target. In an embodiment of the invention, a radio-opaque implant can be disposed within the cannula of an introducer. The radio-opaque implant can include a wire stem and multiple different wire branches each extending outwardly from a proximal portion of the wire stem towards the proximal portion of the wire stem. The system can further include a trocar and a loader.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention provide for a radiation targeting system used during external beam radiation therapy (EBRT) that can be delivered though a multi-directional stereotactic radiation source. The radiation targeting system can include an introducer with an implant disposed within the introducer. The implant can further include a wire stem with multiple different wire branches extending from the wire stem. In this way, the implant can be a target for EBRT for organs that are composed of primarily fatty tissue, such as the breast, where a stable environment for placement of a non-moving target is needed. In addition, the implant can be inserted into the breast at the time of a lumpectomy, but radiation can be delayed. Of further note, the radiation targeting system can be used to aspirate the lumpectomy cavity causing it to collapse and conform to the size and shape of the implant. In this way, the implant shape may guide the external beam source in order to target a more specific area of the cavity. In addition, with cavity collapse, there is a decrease in hematoma, seroma, and other defects within the site of the lumpectomy to develop due to the use of an external radiation source opposed to a concentrated internal seed in close proximity to the tissue in the cavity.

In illustration,FIG. 1is a perspective view of one embodiment of a radiation targeting system. The system can comprise an introducer125and an implant150. The introducer125can include a cannula135. On one end of the cannula135can be a port145. The implant150can be disposed within the cannula135of the introducer125and can include a wire stem160and multiple different wire branches170, each extending outwardly from a proximal portion171of the wire stem160towards the proximal portion171of the wire stem160. The implant150can be radio-opaque and may or may not be biodegradable. Both the introducer125and the implant150can be manufactured by any technique now known or later developed. In addition, both the introducer125and the implant150can be made of any metallic material, suitably sterilized, or other biocompatible material, including but not limited to stainless steel, gold, ceramic, titanium, and nickel titanium.

If further illustration,FIG. 2is a perspective view of another embodiment of a radiation targeting system, which can include an introducer225comprising a cannula235. The cannula235can include a port245at one end and an aperture in which an implant250can be inserted into the port245of the introducer225. The introducer225can also include a side port215. The side port215can be used to introduce fluids, such as saline, or to aspirate fluid or air from a lumpectomy cavity. Of note, in this way, by aspirating any fluid or air from the cavity, the tissue surrounding the cavity can collapse around the implant250and conform to the size and shape of the implant250. The implant250can comprise a wire stem260and multiple different wire branches270.

In yet further illustration,FIG. 3Ais an isometric view of one embodiment of an implant350for use in a radiation targeting system of the present invention. The implant350can be radio-opaque and can comprise a wire stem360and multiple different wire branches370, each extending outwardly from a proximal portion of the wire stem360towards the proximal portion of the wire stem360. Of note, the wire branches370can be arched. Of further note, an implant350can be manufactured in a variety of size and shapes. In addition, an implant350is not limited to a specific number of wire branches370, for instance, there can be one wire branch370that is helical-shaped, multiple wire branches370that are spherical-shaped, multiple wire branches370that are helical-shaped, etc. Optionally, the implant350can include growth stimulators and/or stem cells. In addition, the implant350can be treated in any way now known or later developed so that tissue does not stick to it; in one instance, the implant350can be highly polished. Of note, the implant350can be placed, with or without an introducer, in the body during surgery (following a lumpectomy or other procedure) or after any procedure using ultrasound guidance.

In even further illustration,FIG. 3Bis a top view of the implant350ofFIG. 3A. At a proximal portion371of a wire stem360, multiple wire branches370can extend outwardly. As illustrated inFIG. 3B, the implant can be ten inches in length with a first set of branches comprising a length of at least ten and one-half millimeters, a second and fourth set of branches comprising a length of at least fifteen and one-half millimeters, and a third set of branches comprising a length of twenty three millimeters.

In even yet further illustration,FIG. 3Cis a side view of the implant350ofFIG. 3A. The wire stem360can have a diameter of at least 0.024 inches and the multiple different wire branches370can have a diameter of at least 0.013 inches. The wire branches370can be coupled to the wire stem360at a variety of distances; in one instance, the distance from a tip373of the wire stem360to a first set of branches can be at least fifteen millimeters, from the tip373to a second set of branches can be at least twenty five millimeters, from the tip373to a third set of branches can be at least thirty five millimeters, and from the tip373to a fourth set of branches can be at least forty five millimeters. Of note, the wire branches370can be attached to the wire stem360by any method now known or later developed, including but not limited to welding and crimping. Of further note, individual wire branches370can be directly coupled to the wire stem360or individual wire branches370can be grouped together to form sets of wire branches370, which can then be attached to the wire stem360using any method now known or later developed. In one instance, four individual wire branches370can form a set of wire branches370and there can be four sets of wire branches370coupled to the wire stem360.

FIG. 3Dis a front view of the implant350ofFIG. 3A. Wire branches370can be positioned around a wire stem360so that there is about a sixty degree rotation between each wire branch360. In addition, there can be a split of about one hundred twenty degrees.

In further illustration,FIG. 4Ais an isometric view of another embodiment of an implant450for use in a radiation targeting system of the present invention. The implant450can be radio-opaque and can comprise a wire stem460and multiple different wire branches470, each extending outwardly from a proximal portion of the wire stem460towards the proximal portion of the wire stem460. Coupled to one end of at least one wire branch470can be a marker490. Of note, the marker490is not limited to attachment at an end of each wire branch470. In addition, a marker490does not need to be coupled to every wire branch; a marker490can be coupled to all wire branches480, one, or somewhere in between. The marker490is not limited to a specific size or shape; for instance the marker490can be a non-radioactive seed, which can be made from any radio-opaque material, including but not limited to gold and titanium. The marker490can also be round, like a ball. Of note, multiple different marker materials can be contained within an implant450; for instance, an implant450may be comprised of a nickel titanium wire stem460and wire branches470with gold seeds coupled to the ends of the wire branches470. Of further note, the wire branches470can be arched. Of even further note, an implant450can be manufactured in a variety of size and shapes. In addition, an implant450is not limited to a specific number of wire branches470, for instance, there can be one wire branch470that is helical-shaped, multiple wire branches470that are spherical-shaped, multiple wire branches470that are helical-shaped, etc. Optionally, the implant450can include growth stimulators and/or stem cells. In addition, the implant450can be treated in any way now known or later developed so that tissue does not stick to it; in one instance, the implant450can be highly polished.

In yet even further illustrationFIG. 4Bis a top view of the implant450ofFIG. 4A. At a proximal portion471of a wire stem460, multiple wire branches470can extend outwardly. The wire stem460can be at least ten inches in length and can have a diameter of at least 0.024 inches. As illustrated inFIG. 4B, the implant can have a first set of branches comprising a length of at least ten and one-half millimeters, a second and fourth set of branches comprising a length of at least fifteen and one-half millimeters, and a third set of branches comprising a length of twenty three millimeters. In addition, a marker490can be coupled to one end of at least one wire branch470; in other words, a marker490does not need to be coupled to each wire branch470.

FIG. 4Cis a side view of the implant450ofFIG. 4A. The multiple different wire branches470can have a diameter of at least 0.018 inches. A marker490can be coupled to the wire branch470; the marker490can be of any shape and size; in one embodiment, the marker490can be a ball with a diameter of at least 0.030 inches. In another embodiment, the marker490can be a non-radioactive seed. The wire branches470can be coupled to the wire stem460at a variety of distances; in one instance, the distance from a tip473of the wire stem460to a first set of branches can be at least fifteen millimeters, from the tip473to a second set of branches can be at least twenty five millimeters, from the tip473to a third set of branches can be at least thirty five millimeters, and from the tip473to a fourth set of branches can be at least forty five millimeters. Of note, the wire branches470can be attached to the wire stem460by any method now known or later developed, including but not limited to welding and crimping. Of further note, individual wire branches470can be directly coupled to the wire stem460or individual wire branches470can be grouped together to form sets of wire branches470, which can then be attached to the wire stem460using any method now known or later developed. In one instance, four individual wire branches470can form a set of wire branches470.

In yet even further illustration,FIG. 4Dis a front view of the implant450ofFIG. 4A. Wire branches470can be positioned around a wire stem460so that there is about a sixty degree rotation between each wire branch460. Attached to at least one of the wire branches460can be a marker480. In addition, there can be a split of about one hundred twenty degrees.

In further illustrationFIG. 5is a perspective view of one embodiment of an introducer525for use in a radiation targeting system of the present invention. The introducer525can be comprised of a cannula535. On one end of the cannula535can be a port545and on the opposite end of the cannula535can be an aperture536. Of note, in use, it is generally the end of the cannula535with the aperture536that enters a body to enable an implant to be placed within the body. An implant can be disposed within the cannula535of the introducer525. An implant can also be adapted for insertion into a port545of the introducer525. A side port545can also coupled to the cannula535. Of note, in one instance, the cannula535can be bifurcated, where one port545is coupled to one part of the bifurcation fork and a side port515is coupled to a second part of the bifurcation fork. In another instance, a tube can be coupled to the cannula535and the side port515can be coupled to the end of the tube not attached to the cannula535. In either case, a channel is maintained between the fork where the side port515is coupled and the cannula535to allow materials to pass, including but not limited to air, fluid, and medical instruments. Of further note, the introducer525can be made of any metallic material, suitably sterilized, or other biocompatible material, including but not limited to stainless steel, gold, ceramic, titanium, and nickel titanium

In further illustration,FIG. 6Ais an isometric view of one embodiment of an introducer625for use in a radiation targeting system of the present invention. The introducer625can include a cannula635. The cannula635can include a port645at one end of the cannula635and an aperture636at an opposite end of the cannula635. The port645can include a locking apparatus, for instance a lever lock, which can secure an instrument to the introducer625; for instance, a trocar can be instructed through the port645and secured in place to the introducer625. More specifically, the trocar can contain a male component on one end that can be screwed into a female component on the port645, thus securing the trocar in the introducer625. Optionally, a side port615can be coupled to a tube617, which can be coupled to the cannula635of the introducer625. The tube617can be coupled to the cannula635using any method now known or later developed, including but not limited to welding. In addition, the cannula635with the coupled tube617can be manufactured as one piece. The side port615can include a seal. In this way, an instrument can be coupled to the seal so as to aspirate air or fluid from a cavity. In addition, an instrument can be coupled to the side port615, with or without a seal, which can introduce fluids into the cavity or into a component, for instance a balloon, attached to an implant or the introducer625. The side port615can also include a locking apparatus. The introducer625can be made from any metallic material, suitably sterilized, or other biocompatible material, including but not limited to stainless steel, gold, ceramic, titanium, and nickel titanium

In yet further illustration,FIG. 6Bis a top view of the introducer625ofFIG. 6A. The introducer can include a cannula635coupled to a tube617. The tube617can have a length of at least 1.375 inches and can have an inner diameter of at least 0.060 inches and an outer diameter of at least 0.079 inches. A side port615can be coupled to on one end of the tube617. In addition, the distance from the attachment point between the tube617and the cannula635to the end of a port645coupled to one end of the cannula can be at least two and one-half inches. Also, the angle between the cannual635and the tube617can be at least thirty degrees. The cannula635can include an aperture636at an opposite end of the port645. Of note, the end of the cannula635defining the aperture636can be pointed or can be flat; in other words, the end of the cannula635can be sharp in order to make an opening in skin so that an implant can be introduced to the body or the end of the cannula635can be dull requiring another instrument, such as a trocar, be used, whether or not in conjunction with the introducer.

FIG. 6Cis a side view of the introducer625ofFIG. 6A. The introducer635can include a cannula635having a length of at least eight and one-half inches and an inside diameter of 0.060 inches and an outer diameter of 0.070 inches. Attached to the cannula635on one end can be a port645. A side port615can also be coupled to the cannula635.

In yet even further illustration,FIG. 6Dis a front view of the introducer635ofFIG. 6Ashowing a port645and a side port615coupled to a tube617.

In further illustration,FIG. 7Ais an isometric view of a loader730for use in a radiation targeting system of the present invention. The loader730can include a tube731with an aperture733at one end of the tube731and a tip732at an opposite end of the tube731. The loader730can be made of any material now known or later developed, including but not limited to stainless steel, ceramic, and titanium. Of note, the tip732can include an outer diameter that tapers from a distal end of the tip732with a diameter smaller than a diameter of the cannula of the introducer, towards the opposite end of the tip732with a diameter that is equal to or greater than the diameter of the cannula of the introducer. In use, the loader730can be used to load the implant into the introducer. Of note, if the optional loader730is used, a portion of the implant remains on the outside of the loader730; in other words, only a portion of the implant is inserted into the loader730.

In further illustration,FIG. 7Bis a top view of the loader730ofFIG. 7A. A tube731can have an inner diameter of at least one and one-half millimeters and an outer diameter of at least two millimeters. The tube731can include an aperture733on one end and at an opposite end a tip732. The tip732can include an inner diameter of at least 0.150 inches. The tip732can also include an outer diameter of at least 0.150 at a distal end of the tip732that tapers to a diameter smaller than a diameter of the cannula of the introducer towards the opposite end of the tip732with a diameter that is equal to or greater than the diameter of the cannula of the introducer. In this way, the loader730is adapted to fit into the port of the introducer and because of the size difference between the tapering of the outer diameter of the loader and the inner diameter of the port of the introducer, the loader is stop from moving further into the port of the introducer; this allows the implant to be inserted through the port of the introducer into the cannula of the introducer.

FIG. 7Cis a side view of the loader730ofFIG. 7Aillustrating that the loader can be at least four inches in length with the tip732having a length of 0.3 inches, thus making the length of the tube731about 3.7 inches.

In yet even further illustration,FIG. 7Dis a front view of the loader730ofFIG. 7A.

In further illustration,FIG. 8is a perspective view of a trocar840for use in a radiation targeting system of the present invention. The trocar840can include a wire stem860with a tip842at one end and a top844at an opposite end of the wire stem860. Of note, the top844can be locking so as to securely attach to a port of an introducer. In other words, the trocar840can include a male locking component that locks into a female receiver on the introducer. Of note, the female receiver can be part of the port on the introducer. The trocar840can be of any length so that it can be inserted into the introducer of the radiation targeting system; the trocar840is adapted for insertion through the cannula of the introducer. The trocar840can be made of any material now known or later developed, including but not limited to stainless steel, ceramic, and titanium. Of note, the trocar840would normally not be used if an implant is placed, using an introducer, in a body during surgery, though a trocar840would like be used when placing the implant using ultrasound guidance post operation.

In even further illustration,FIGS. 9A and 9Bare each perspective views of embodiments of a radiation targeting system that can include an introducer925that can further include a cannula935. The introducer925can include a plurality of finger rings905and a valve955. The valve955can be used to inflate a balloon980. The balloon980can be coupled to a plurality of wire branches970and a wire stem960. In other words, there can be at least two wire branches970. Optionally, the wire branches970can be coupled to at least one marker990, as shown inFIG. 9B. The marker990can be coupled to each and every wire branch970, just one wire branch970, or somewhere in between. In addition, the marker990can be coupled anywhere on the wire branch970; for instance, the marker990can be coupled toward an end of the wire branch970, in the middle of the wire branch970, or somewhere in between. Also, there can be multiple markers990on each wire branch970, no marker990on a wire branch970, or any combination thereof. For instance, if there are a total of eight wire branches970, there may be one marker990on four wire branches970, no marker on two wire branches970, and two markers990on the remaining two wire branches970. A marker970is not limited to a specific size or shape; for instance the marker970can be a non-radioactive seed, which can be made from any radio-opaque material, including but not limited to ceramic, gold, and titanium. The marker990can also be round, like a ball. The balloon980, the wire branches970, the wire stem960, and the marker990, if present, can be components of an implant950in an embodiment of a radiation targeting system. Further, the balloon980, the wire branches970, the wire stem960, and the marker990can each be any size (length, diameter, width, etc.). Of further note, the balloon980can provide support to a lumpectomy cavity. In addition, the balloon980can be coated with a material to prevent tissue from “sticking” to the balloon980.

In yet even further illustration,FIGS. 10A and 10Bare line drawings of embodiments of implants1050for use in a radiation targeting system of the present invention can include a needle1026coupled to an implant1050, the implant1050can be further coupled to a marker1090. The needle1026is not limited to a particular type, size, shape, or material. In one instance, the needle1026can be a cannula. In one embodiment, the implant1050can be suture thread made from any material now known or later developed, including but not limited to catgut, silk, nylon, and polypropylene. The implant1050can be absorbable or non-absorbable. The length and diameter of the implant1050are not specifically defined, so long as the implant1050can be securely fastened in place in a body cavity. In this way, the implant1050serves to stabilize a marker1090, which enables the marker1090to serve as a stable target for EBRT in a breast, body cavity or other organ. The marker1090is not limited to a specific diameter or shape; for instance, in one embodiment the marker1090can be a non-radioactive seed. In another embodiment, the marker1090can be round, like a ball. The marker1090can be made from any radio-opaque material, including but not limited to ceramic, gold, and titanium. Of note, each implant1050can have at least one marker1090; in other words, multiple markers1090can be coupled to each implant1050, as shown inFIG. 10B. Of further note, multiple implants1050, each coupled to at least one marker1090, can be attached in a body cavity. Regardless of the number of implants1050, an implant1050can be used to stabilize any markers1090coupled to the implant1050, so that the markers1090can serve as a target for the radiation beam during EBRT. The marker1090can be coupled to the implant1050in any method now known or later developed. In addition, the marker(s)1090can be coupled to the implant1050at any position along the implant1050. Of further note, in another embodiment, the implant1050can be radio-opaque with no marker1090attached to it; in other words, the implant1050(the suture thread itself) can serve as the target. Of even further note, the needle1026along with the implant1050can be pushed into tissue by hand or may be loaded, including back loaded, into an applicator, loader, introducer, or other component; in other words, the implant1050may be inserted directly into tissue or a body cavity without using another component, such as an applicator, loader, or introducer.

In even further illustration,FIG. 10Cis a line drawing of one embodiment of an implant1050for use in a radiation targeting system of the present invention can include a barb1027coupled to an implant1050, the implant1050can be further coupled to a marker1090. The barb1027is not limited to a particular type, size, shape, or material. Of note, the barb1027along with the implant1050can be pushed into the tissue by hand or may be loaded, including back loaded, into an applicator, loader, introducer, or other component. In one embodiment, the implant1050can be suture thread made from any material now known or later developed, including but not limited to catgut, silk, nylon, and polypropylene. The implant1050can be absorbable or non-absorbable. The length and diameter of the implant1050are not specifically defined, so long as the implant1050can be securely fastened in place in a body cavity. In this way, the implant1050serves to stabilize a marker1090, which enables the marker1090to serve as a stable target for EBRT in a breast, body cavity or other organ. The marker1090is not limited to a specific diameter or shape; for instance, in one embodiment the marker1090can be a non-radioactive seed. In another embodiment, the marker1090can be round, like a ball. The marker1090can be made from any radio-opaque material, including but not limited to ceramic, gold, and titanium. Of note, an implant1050can have no markers1090or as shown inFIG. 10C, at least one marker1090; in other words, multiple markers1090can be coupled to each implant1050, as shown inFIG. 10C. Of further note, multiple implants1050, each coupled to at least one marker1090, can be attached in a body cavity. Regardless of the number of implants1050, an implant1050can be used to stabilize any markers1090coupled to the implant1050, so that the markers1090can serve as a target for the radiation beam during EBRT. The marker1090can be coupled to the implant1050in any method now known or later developed. In addition, the marker(s)1090can be coupled to the implant1050at any position along the implant1050. Of further note, in another embodiment, the implant1050can be radio-opaque with no marker1090attached to it; in other words, the implant1050(the suture thread itself) can serve as the target.

Of note, in use, following a lumpectomy or other procedure, an implant can be placed into the body cavity during surgery or post-operation under ultrasound guidance or other radiographic modality. After placement of the implant, optionally, the body cavity can be aspirated via the introducer, allowing the cavity to collapse and conform to the size and/or shape of the implant. A radiation beam from an external beam radiation source can then be used to target the implant or any markers coupled to the implant, so radiation therapy can be delivered to the body at the location of the implant or markers. After the completion of the radiation therapy, the implant can be removed from the body under ultrasound guidance or any other radiographic modality.