Brachytherapy apparatus

The present invention relates generally to devices, methods and systems for performing brachytherapy on the human or mammalian body, and more specifically on tissues such as breast tissue and / or body cavity. It relates to a deployable device for performing brachytherapy treatment and a method for performing brachytherapy using such a device.

Brachytherapy is a type of radiation therapy used to treat malignant tumors such as breast or prostate cancer. Generally, in brachytherapy, the radiation source is placed directly on the target tissue, which includes the tumor and / or the tissue surrounding the cavity or cavity, and these cavity or cavity. May contain cancer cells (eg, if it is a cavity or cavity formed by removing the tumor).

Brachytherapy is often divided into two types: high dose rate (HDR) and low dose rate (LDR) brachytherapy. In HDR brachytherapy, a high-level source of radiation is often placed on the tissue of interest for a short period of time, eg, seconds to minutes, via a pre-embedded catheter. In contrast, in LDR brachytherapy, low-level radiation sources are installed over longer, sometimes indefinite periods of time.

Both forms of brachytherapy have advantages. For example, HDR brachytherapy allows for higher levels of irradiation delivered in shorter dose delivery times. On the other hand, in LDR brachytherapy, lower levels of radiation sources are used. The energy field at the LDR source makes it possible to deliver measurable and local doses to target tissue, such as tumors, glands and other tissues around the cavities or cavities. However, since the energy field subsequently declines, it is possible to prevent excessive irradiation of healthy tissue in the vicinity.

Although partly due to the low activity of the LDR source, brachytherapy offers several benefits. For example, for healthcare professionals, precautions in LDR brachytherapy may be somewhat less stringent than precautions in HDR brachytherapy. In addition, LDR brachytherapy has radiobiological advantages (such as dose rate effects) over HDR brachytherapy, which can help save normal tissue better during treatment. .. Furthermore, in LDR brachytherapy, the transplantation period is relatively long, so the number of visits to medical institutions during the irradiation treatment process is small, whereas in HDR brachytherapy, the patient receives the radiation normally supplied. It is necessary to return to the medical institution for each division, and this division is generally 8 to 10 times in brachytherapy for the breast.

Common sources of radioactivity used in LDR brachytherapy include radioisotopes such as palladium (Pd) -103, iodine (I) -125, gold (Au) -198 and iridium (Ir) -192. It is a waste. Although the size and shape of the isotopes may vary, in normal applications (eg brachytherapy of the prostate) the standard size of a conical capsule, eg 0.8 mm in diameter and 4.5 mm in length. It is prepared as having a size of about rice grains, and is often referred to as a "seed".

LDR seeds are often supplied via needles using guide templates. The guide template has a matrix of holes that guide the vertical progression of the needle so that the needle is correctly positioned with respect to the tissue of interest. Once the needle is correctly positioned with respect to the tissue of interest, the seed can be driven along the longitudinal axis of each needle and then the needle can be withdrawn.

<p> Although effective, there are potential drawbacks to current brachytherapy practices. For example, LDR seeds are easy to move because they are usually left in place and floating inside the target tissue. Furthermore, once transplanted, it is generally said that LDR seeds cannot be removed or rearranged. In addition, LDR brachytherapy requires careful dose distribution calculations and seed mapping before and during seed transplantation. Such calculations and mappings allow effective radiation delivery to the target tissue mass while minimizing irradiation to surrounding healthy tissue (eg, urethra and rectum in brachytherapy). .. However, while such dose calculation and seed mapping techniques are effective, they can be problematic, for example, there may be potentially significant variability in seed positioning accuracy among clinicians.</p><p> Yet another problem with traditional brachytherapy techniques is that many of these techniques often require individual handling of radioactive seeds at the time of transplantation, often. It takes a lot of time. Moreover, conventional LDR feed needles are generally limited to those that feed seeds linearly (along a relatively straight line). Therefore, in order to obtain the desired therapeutic profile, it is often necessary to make a large number of transplants (including approximately 50-100 seeds, as is usual in brachytherapy of the prostate, for example), and at the same time. Potentially complex dose distribution and mapping techniques and equipment are required.</p>

<p> The present invention generally relates to devices and methods for supplying brachytherapy to a local area of interest. Although the present invention is beneficial for almost all areas of the body, it is particularly advantageous in the treatment of breast tissue, such as breast tumors or cavities by tumor resection surgery. For example, the present invention can be used for the insertion and removal of local radioactive sources in neoadjuvant and post-resect therapy therapies.</p><p> Illustrative examples of the present invention relate to brachytherapy means and devices. These means and devices allow brachytherapy treatment to be applied to a target area (eg, such as a breast tissue area). Another embodiment relates to supplying brachytherapy means to the area of interest. Systems and methods for delivering brachytherapy to the target area are also provided.</p><p> In one embodiment, a brachytherapy treatment device is provided. The device comprises an extender having a proximate end and a distal end having dimensions suitable for introduction into a pathway through tissue. A plurality of elongated members are provided at the distal end and have a path for accommodating a radiation source along these members. These elongated members can be moved from a foldable shape to an unfolded shape for introducing the tissue path to the target position. It is also possible to introduce a radiation source along the path for irradiating the target position with radiation.</p><p> In another example, a method for brachytherapy treatment of tissues inside the body has been proposed. In this method, a step of forming a path through the tissue with respect to a target position adjacent to the tooth cavity and an elongated body supporting a plurality of elongated members are passed through the path in a state where the elongated member is in a folded shape. It has a step of advancing into the target position. The elongated member is formed into a developed shape so that the elongated member is arranged away from the central axis at the target position. This stretches the tissue at the target location (eg, surrounding the tooth cavity) between at least some of the adjacent elongated members. Radiation is supplied to the target position to treat the tissue at the target position.</p><p> The above overview is not intended to depict all embodiments or methods of the present invention. Rather, a more complete understanding of the present invention shall be clarified and understood by reference to the detailed description and claims below in light of the accompanying drawings.</p>

The present invention will be described in detail with reference to the drawings.

In the detailed description of the exemplary examples below, reference is made to the accompanying drawings which are part of the embodiments and exemplary the specific examples in which the invention may be practiced. .. It can be understood that it is possible to use another embodiment or make structural changes without departing from the scope of the present invention.

In general, the present invention relates to brachytherapy devices and methods. For example, in one embodiment, a system is provided for supplying one or more therapeutic elements (eg, a source of radiation) to a target tissue region. Once supplied, the source can be removed immediately (eg for HDR applications) or left for a given period of time, for example by transplantation (eg for LDR applications). .. In either case, the source is capable of treating the target tissue area according to a given therapy profile.

In some embodiments, the LDR source can be transplanted and immobilized on the human body or target tissue to prevent or substantially limit the movement of the source to the target tissue. Unlike conventional LDR brachytherapy, the devices and methods described herein serve as indwelling therapies using pre-prepared radiation source packages such as seeds, while brachytherapy. Allows easy removal of the source when is complete.

As used herein, "radioactive source" and "radioactive source" may include almost any therapeutic element that can be manipulated to deliver radiation. For example, this source can be one or more radioactive seeds or one or more LDR or HDR wire elements (eg, iridium wire, etc.).

As used herein, the term "transplantable" refers to peripheral tissue over a long period of time, including, for example, one hour or more, preferably several hours or more, and even several days or more after the means is inserted into the body. It indicates that it can be held in a relatively fixed or static position within.

Furthermore, as used herein, "target tissue," "target tissue area," "target area," and "target tissue mass" are those of humans (or other mammals) known to enjoy the benefits of radiation therapy. ) It includes almost all parts of the body. For example, such a target tissue region is the tumor or lesion itself, tissue near or around the tumor, or a cavity region formed by excision of the tumor (for example, peripheral tissue related to the cavity after tumor removal of the breast or). It can be a tooth cavity, etc.).

Although this specification mainly describes LDR brachytherapy, the devices and methods described in this specification are referred to as HDR brachytherapy (for example, HDR catheter) as described later. Can also be used. In addition, although described herein with respect to brachytherapy, these devices and methods may also be applicable to other treatment regimens that benefit from the removable implantation of the therapeutic element. ..

For brevity, these devices and methods described herein are used for the treatment of breast cancer. However, this particular application is not limiting. That is, one of ordinary skill in the art will readily appreciate that the systems, devices and methods described herein can be applied to any type of cancer that benefits from brachytherapy.

Through such an introduction, referring to the drawings, FIG. 1 shows an exemplary kit or device 100 for performing brachytherapy on a target tissue area of the body. The device 100 is a brachytherapy treatment means 102 (hereinafter, also referred to as "brachytherapy means 102") that is elongated, flexible, and removable and implantable, and is a treatment supply portion. It may comprise one with 104 and an elongated, flexible tail 106. As described below, the tail 106 allows the means 102 to be removed upon completion of treatment. Other, for example, locking members described below may also be included in the apparatus 100.

As used herein, the term "flexible" refers to a highly bendable element that can, for example, flex, bend and / or twist significantly and easily, without breakage or permanent deformation. Elements and so on.

The treatment supply portion 104 constitutes a carrier container for the treatment element and is a source of radiation, such as a radioactive seed 108, which is secured to each other and to the treatment supply portion 104. It is possible to selectively provide one or more spacers 110 between each seed 108 to obtain the desired seed separation.

These seeds 108 can be produced from currently known or later expressed radiation sources that meet all the conditions (eg, radioactive palladium, iodine, cesium or iridium). Typically, a myriad of seeds 108 are provided to correspond to the desired treatment supply regimen and are accurately positioned along the length of the treatment supply portion 104. These seeds 108 may have the same radiation intensity, or one or more seeds 108 in one container may have different radiation intensities from each other. In some applications, it is possible to obtain the desired dose effect by separating one or more seeds 108 with spacers of different lengths. Although the source of radiation is described herein as seed 108, the source of radiation can have other shapes, such as continuous filaments (or innumerable discontinuous segments) of radiation wire (eg, iridium wire). Is.

In some embodiments, the brachytherapy means 102 may have a flexible casing or casing member, which is illustrated as a tube or tube member 112 in the drawings, within this casing. The seed 108 and the optional spacer 110 are firmly held. In some embodiments, the casing is made of a tube material that is insoluble, flexible and heat shrinkable. As used herein, the "heat-shrinkable tube" is a tube such as various plastic tubes, in which the tube shrinks due to subsequent heat irradiation, causing the tube to firmly position the seed 108. Refers to something that can be held in. Exemplary heat-shrinkable materials include polyesters, fluorinated polymers, polyolefins and the like.

In one embodiment, the tube 112 may have an initial inner diameter of about 1 mm and a wall thickness of about 0.05 mm, although the dimensions of any tube can be assumed. Once heated, the tube 112 shrinks (unless constrained) until it has an outer diameter in the range of about 0.3 mm to 0.6 mm.

In this specification, the casing is described as having a tube shape in principle, but in another embodiment the casing is suitable for effectively fixing the individual seeds 108 to the casing and to each other. Can have a shape.

Once the seed 108 and any spacer 110 are positioned within the tube 112, it is possible to shrink the tube 112 around the seed 108 by also shrinking the tube by heat irradiation. The tail 106 is an integral part of the casing (tube 112), such as an extension, which can be formed from a portion that extends beyond the seed 108. The tail can also be heat treated (shrinked) in order to reduce the diameter of the tail 106. In other embodiments (discussed below), it is possible to use a two-part brachytherapy means, such as one with a separate filament tail attached to the treatment supply portion.

Regardless of the particular shape, the brachytherapy measures 102 described herein not only allow proper spacing between seeds 108, but also facilitate subsequent seed identification and removal. It is a thing. In addition, since the seeds are housed in a container defined by the treatment supply portion 104, the seeds do not need to be handled individually, thus facilitating storage and handling prior to and during transplantation.

The components of means 102, including the casing (tube 112) and tail 106, are preferably made of insoluble material. As used herein, the term "insoluble" refers to any material that does not substantially deteriorate or otherwise break during the transplant period.

Brachytherapy device 100 may further include a catheter or needle 114. Although illustrated here as the needle 114, any type of catheter or tube member, such as a cannula as described below, may be used without departing from the scope of the present invention. The needle 114 defines a well-sized lumen 115 through which the therapeutic means 102 can pass, as shown in FIG. In some embodiments, the needle 114 further has a hub 116 at the close end to assist, for example, in the operation of the needle and / or the insertion of the therapeutic means 102. The distal end of the needle 114 is capable of forming a pointed tip 117 capable of puncturing the body as described below. The needle 114 can be made of any suitable biocompatible material. The needle can be made of a metal such as stainless steel, titanium or nickel-titanium alloy. The needle may also have a removable exterior (not shown) made of plastic, such as a fluorinated polymer.

2A-2E are diagrams illustrating an exemplary method for using the brachytherapy device 100 of FIG. Once the target tissue region 202 (eg, tumor or tumor cavity) within the body 200 has been accurately determined, the needle 114 is inserted into the body 200 to a predetermined depth, as indicated by the arrow 203 in FIG. 2A. The relative position of the needle 114 and / or the tissue area 202 of interest can be determined by any method, such as ultrasound, CT scans or stereotactic X-rays. Further, it is also possible to adjust the needle 114 using, for example, a needle guide template as described below or other techniques.

Brachytherapy means 102 is then inserted into the lumen 115 of the needle 114, as indicated by arrow 205 in FIG. 2B, and the treatment supply portion 104 is relative to the tissue area 202 shown in FIG. 2C. It can be placed until it reaches a predetermined depth. A surveying segment 118 can be provided in the tail 106 to help determine the approximate insertion depth of the treatment means 102. Other positioning techniques such as X-rays and ultrasound may be used. Alternatively, the needle 114 can be inserted with the therapeutic means 102 at least partially attached to the lumen 115 of the needle 114.

Once the treatment means 102 is positioned at a predetermined depth, the treatment supply portion 104 of the means 102 is placed in the desired position of the body 200 while the needle 114 is pulled out of the body in the direction 207 shown in FIG. 2D. It is possible. The tail 106 preferably has a length sufficient to extend extracorporeally 200 as shown in FIG. 2E. That is, the tail 106 can extend outward through the puncture hole formed by the needle 114. In one embodiment, the tail 106 has sufficient column strength so that the treatment supply portion 104 can be held in the desired position by holding the tail 106 as the needle 114 is pulled out.

To prevent the treatment supply portion 104 from moving, the locking member 120 can be crimped or otherwise attached to the tail 106 of the treatment supply means 102 so that it is directly adjacent to the puncture hole in the body 200. Is. The locking member 120 helps maintain the position of the treatment supply portion 104 with respect to the target tissue area 202. Any locking member can be used, but in one embodiment a malleable hat or U-shaped lock, which is applied to the tail using clip appliers or similar tools. Use one that can be easily and firmly crimped. An enlarged view of an exemplary locking member 120 is shown in FIG.

For illustration purposes, only one treatment delivery means 102 is illustrated in FIGS. 2A-2E. However, in practice, it is possible to supply an appropriate dose to the target tissue area 202 using a plurality of means. The number of actual means 102 may vary depending on other parameters such as lesion size, radiation level of radiation source, and proximity to other organs / vulnerable tissues (eg skin, chest wall, etc.). However, in an array of exemplary therapeutic means 102, a number of means in the range of approximately 5-25 is envisaged.

FIG. 2F illustrates a variant of therapeutic means 102 in FIGS. 2A-2E, which may have yet another effect, especially in the treatment of breast cancer. In this embodiment, therapeutic means 152 that is in all respects similar to means 102 is provided. However, the means 152 can have both a first tail extending from the first end of the treatment supply portion 154 and a second tail extending from the second end, i.e. Means can include one tail 156 at each end of the treatment supply portion 154. At the time of implantation, the needle 114 can be extended to completely penetrate the body, eg, the breast 200, with one tail 156 exiting the opposite side of the breast 200. In this way, by fixing the locking member 120 at two points in the target tissue area 202, it is possible to prevent or substantially limit the movement of the treatment supply portion 154 with respect to the target tissue area 202.

Unlike conventional brachytherapy catheters, the diameter of which is 2 mm or more, the therapeutic means 102 may be about 1 mm or less in the treatment supply portion 104 and even smaller in the tail 106. This structure makes the means 102 relatively small and flexible, and thus less obtrusive to the patient. In fact, the dimensions and flexibility of the tail 106 may be similar to conventional sutures. As a result, fixation of the tail 106 can be performed in a number of ways, for example by bending the tail along the contours of the surrounding body, tying the ends together, and / or represented by the first aid bond 2600 in FIGS. 2E and 26. Therefore, it is possible to fix the end portion with an adhesive tape.

FIG. 3A is an enlarged view of the therapeutic means 102 of FIG. As clearly shown in this figure, the treatment means 102 may include a treatment supply portion 104 and a tail 106. As mentioned above, the treatment supply portion 104 comprises a radioactive seed 108 separated by one or more spacers 110 and placed in a casing such as, for example, a heat-shrinkable tube 112. The tail 106 can be formed by a portion of the tube 112 that does not surround the seed 108. In some embodiments, the insulation protection properties of the tube 112 make it possible to ensure sufficient seed spacing, eliminating the need for spacer 110. FIG. 3B shows a cross section through seed 108 and tube 112 along line 3B-3B of FIG. 3A.

In FIGS. 4A-4B, therapeutic means 402 in another embodiment is shown. This means 402 is similar to the above-mentioned means 102 in all respects. For example, as shown in FIG. 4A, means 402 may have a treatment supply portion 404 and a tail 406. A casing, such as a heat-shrinkable tube 412, is used to wrap the seed 108 and any spacer 110, further forming a tail 406. However, unlike the examples in FIGS. 3A-3B, the tube 412 is the radiation absorbing portion 414, which is, for example, a substance or liner arranged along a portion of the circumference of the treatment supply portion 404. It can have (see Figure 4B). The radiation absorbing portion 414 may include a radiation attenuating material, which reduces radiation irradiation to the tissue blocked by the radiation absorbing portion 414, as opposed to the tissue not blocked by the radiation absorbing portion 414. It becomes possible. Although not limited to specific embodiments, this radiation absorbing portion is a substance that is applied to or impregnated into a portion of the tube 412 (eg, tungsten, nickel-titanium alloys, stainless steel, etc.). Can be formed by Alternatively, the radiation absorbing portion can be formed by a liner that is secured within or to a portion of the tube. FIG. 4B shows a cross section through seed 108 and tube 412 along line 4B-4B of FIG. 4A.

As used herein, the term "radioactive" is more permeable to a portion of a device or means that is perceived to be permeable than a portion that is perceived to be "radioactive". It only shows that it is easy to make it.

5A-5B show therapeutic means 502 in yet another embodiment. This means 502 is similar to the above-mentioned means 102 in all respects. For example, as shown in FIG. 5A, means 502 may have a treatment supply portion 504 and a tail 506. A casing, such as a heat-shrinkable tube 512, is used to wrap the seed 108 and any spacer 110, further forming the tail 506. However, unlike the embodiments described above, the treatment means 502 comprises an anchor member, such as an anchor wire 514 having a flat or circular cross section, that extends along at least a portion of the treatment supply portion 504. It is possible. The anchor member 514 constitutes one or more hooks, barbs or other anchors 516 by projecting from one or both ends of the treatment supply portion and bending or forming into other shapes.

If the treatment supply portion 504 exits the needle 114 (see Figure 1) during implantation, these anchors 516 help to spread and lock the surrounding tissue to prevent the treatment means 502 from moving to the adjacent surface. It becomes. Although only one anchor is shown at each end of the treatment supply portion 504, in other embodiments multiple anchors are provided at one or both ends, such as rotation, twisting or distal movement. It is possible to further resist movement. FIG. 5B shows a cross section through the seed 108 and the tube 512 along line 5B-5B of FIG. 5A.

After the desired radiation dose has been delivered, the therapeutic means 102 (or any other therapeutic means described herein, such as means 402 or 502) can be removed by any method. For example, to remove means 102, first remove the bandage and locking member 120 (eg, first aid bond 2600 in FIG. 2E) and then apply a pulling force to one tail 106 that extends extracorporeally 200. Good. Alternatively, the means 102 can be removed before or during the removal surgery of the tumor 202 by a known method, for example a method similar to excision using a stereotactic wire.

If the therapeutic means 102 includes an internal retaining element, such as the anchor 516 (FIG. 5A) in means 502, it is possible to use a removal catheter 550 as shown in FIG. 5C. The removal catheter 550 is in all respects similar to the feed cannula described herein and needles such as needle 114. The catheter 550 is advanced beyond the tail 106 until it surrounds the treatment supply portion 104. For example, the distal end of the removal catheter 550 is advanced to the point where it locks into a distal holding element, such as the distal anchor 516 in FIG. 5A. Further advancing the removal catheter 550 allows the anchor to be fully bent and the treatment supply portion to slide into the removal catheter as shown by the dashed line in FIG. 5C. After that, the means 502 and the removal catheter 550 can be integrally removed from the body.

In all the methods described herein, the length of time that brachytherapy means can remain transplanted depends on the desired treatment regimen. Although we do not want to be tied to any fixed period, transplants over an hour for up to 8 weeks are scheduled for treatment. However, in brachytherapy of the breast, it is more likely that the transplant period will range from one day to several weeks, for example 4 to 10 days. Furthermore, depending on the structure of the means, such as means 102, it may be removed over a range of time frames after transplantation. Such cases are typically associated with shorter irradiation times in conventional LDR brachytherapy and conventional HDR brachytherapy compared to permanent installation. As a result, intermediate level radiation sources and more conventional low level and high level sources as described below can be used with the methods and devices described herein.

In FIG. 6, a brachytherapy kit or device 600 in another embodiment is shown. Unlike the device 100 in FIG. 1, the device 600 includes at least one removable and implantable brachytherapy therapeutic instrument (brachytherapy instrument 602), pusher or pusher member 620, eg, a pusher or pusher member 620, among others. It may include a catheter such as a cannula or cannula member 630 and a brachytherapy embolus 640.

Again, the therapeutic means 602 may have a therapeutic supply portion 604 and a removal or tail 606. The treatment feed portion 604 may have one or more seeds 108 and any spacer 110. The seed 108 may be placed in a casing, such as a heat-shrinkable tube or tube member 612, which is similar in all respects to the tube 112 described above.

However, the tail 606 in this example is formed from an elongated filament or wire, such as an insoluble surgical suture 614, which is connected to or otherwise attached to the treatment feed portion 604. Will be done. Although there are all possible ways to attach this suture 614 to the treatment feed portion 604, in one embodiment a knot 616 is tied to the suture. This knot 616 can be captured as the tube 612 is thermally contracted with respect to the treatment supply portion 604. In another embodiment, the suture 614 is tied or otherwise attached directly around the treatment supply portion 604. However, such suture attachment methods are merely exemplary, and any method of attaching suture 614 to the treatment feed portion 604 is possible. The suture 614 and the aforementioned tail 606 can be made of an insoluble material such as polypropylene, polyester or polyamide.

The pusher member 620 may have a lumen through which the therapeutic means 602 passes, as shown in FIGS. 6 and 7. The pusher member comprises a suture locking means 622, such as a lure hub, at the near end to aid in the attachment and fixation of the therapeutic means 602. The locking means 622 can secure the suture 614 to the pusher 620 as described below. Although described herein as a lure hub, the locking means 622 can be any known friction or tightening means. For example, the locking means may be an O-ring that can be selectively compressed to sandwich the suture 614.

The cannula member 630 may also have a lumen through which the pusher member 620 passes, as shown in FIG. The cannula member 630 is provided with a lure hub 632 at its close end, and the lure hub causes the cannula member to be sharpened if either the apex embolic 640 or the pusher member 620 slides through the lumen of the cannula member, as described below. It is fixed to the embolic or pusher member.

The apex embolus 640 may have a handle portion with a hub 642 at the near end and a tip 644 used to puncture body tissue at the distal end. The handle portion makes it possible to easily operate the embolic 640. The outer diameter of the embolic member 640 is sized so that the embolic element fits within the lumen of the cannula member 630, as shown in FIG.

The components of the device 600 can be manufactured using any suitable biocompatible material. For example, the cannula member 630, pusher member 620 and apex embolic 640 can be made of a metal, plastic or composite material such as stainless steel or titanium.

FIG. 7 is a diagram showing a device 600 that can be assembled before use. The apex embolus 640 is inserted into the cannula 630 so that the distal apex 644 of the embolus projects outward from the distal end of the cannula 630 as shown. As described above, the treatment means 602 including the treatment supply portion 604 and the suture 614 is placed in the pusher member 620, the treatment supply portion 604 extends from the distal end of the pusher member, and the suture 614 is the pusher member. Extend from hub 622 at the close end of the. The suture 614 is pulled from the close end of the pusher member 620 so that the treatment supply portion 604 is at or near the distal end of the pusher member 620 as shown. The locking means 622 is then locked to hold the suture 614, thus holding the treatment supply portion 604 in place with respect to the pusher member 620.

8A-8E illustrate an exemplary method for utilizing a system 600 for supplying brachytherapy to a part of the human body, such as the breast 200. Once the target tissue area 202, such as a tumor or tumor cavity, has been identified, the combination of cannula 630 and apex embolic 640 (see Figure 7) is the target tissue as indicated by arrow 802 in FIG. 8A. Advance into area 202. When the distal end of the cannula 630 reaches the desired depth, the cannula 630 is placed while removing the apex embolus 640 through the near end of the cannula (moving it in direction 804) as shown in FIG. 8B. To do.

The combination of pusher member 620 and therapeutic means 602 (see FIG. 7) is then inserted into the proximity end of the cannula 630 in direction 806 as shown in FIG. 8C. The pusher member 620 and the treatment means 602 can be inserted until the treatment portion 604 is in the desired position, for example at or near the distal end of the cannula 630. Positioning of the therapeutic portion 604 can be assisted by imaging guidance such as stereotactic X-ray, ultrasound or CT.

Once the treatment portion 604 is positioned, the cannula 630 is retracted (moved in direction 808), exposing the treatment portion 604 to the target tissue area 202 as shown in FIG. 8D. After that, the locking means 622 is released, and the pusher member 620 and the cannula 630 are completely pulled out from the body 200 (moved in the direction 810) as shown in FIG. 8E. The suture 614 extends out of the body while the treatment supply portion 604 remains implanted in the target tissue area 202.

The above steps can be repeated to place each brachytherapy means 602, but it is also possible to transplant multiple means substantially simultaneously as a group, as will be described later.

Although not shown, the end of one or both of the therapeutic means 602, eg, its tail 606, using a locking member, such as the locking member 120, as shown in FIGS. 2E and 27, for example. Can be fixed to. Alternatively, therapeutic means 602 may have a fixed element, such as the anchor 516, as shown, for example, in FIG. In addition, therapeutic means 602 can also be secured by simply bending the tail 606 and adhering it to the breast 200 (see Figures 2E and 26).

After the desired radiation dose has been supplied, the treatment supply means 102 can be removed using any of the methods already described, for example by using a removal member such as the tail 606 or a removal member such as a removal cannula. It is possible.

FIG. 9A is an enlarged view of the therapeutic means 602 in FIGS. 6-7. As clearly seen in this figure, the therapeutic means 602 may have a therapeutic supply portion 604 and a tail 606. The treatment feed portion 604 has one or more radioactive seeds 108 that are tightly held within a casing, such as a heat-shrinkable tube 612. The tail 606 can be formed by suture 614. The knot 616 of the suture 614 may be secured to the treatment supply portion 604 by a heat-shrinkable tube 612. Although illustrated as using spacer 110, spacers are not required in some embodiments, ensuring proper seed 108 spacing and storage if casing insulation properties such as tube 612 are present. May be enough to do. FIG. 9B is a cross-sectional view of the seed 108 and tube 612 along line 9B-9B of FIG. 9A.

10A-10B are diagrams of therapeutic means 1002 according to another embodiment. This means 1002 is in all respects similar to the aforementioned means 602. For example, this means 1002 may have a therapeutic supply portion 1004 and a tail 1006. It is possible to wrap the seed 108 and any spacer 110 using a casing such as the heat shrinkable tube 1012. Similar to means 602, the tail 1006 is composed of suture 614, the knot 616 of which may be heat shrinkable with respect to the treatment feed portion 1004. However, unlike means 602 in FIGS. 9A-9B, the tube 1012 may have at least a radiation absorbing portion 1014 provided along a portion of the treatment supply portion 1004 on the circumference (see FIG. 10B). ). The radiation absorbing portion 1014, which can be formed integrally or separately from the tube 1012, can limit the irradiation of tissue blocked by the radiation absorbing portion. FIG. 10B is a cross-sectional view of the seed 108 and tube 1012 along line 10B-10B of FIG. 10A.

11A-11B are diagrams of therapeutic means 1102 according to yet another embodiment. This means 1102 is similar in all respects to the aforementioned means 602. For example, this means 1102 may have a therapeutic supply portion 1104 and a tail 1106. It is possible to wrap the seed 108 and any spacer 110 using, for example, a casing such as a heat shrinkable tube 1112. Similar to the embodiments shown in FIGS. 5A and 5B, the treatment means 1102 has an anchor member, such as an anchor wire 1114, which extends along at least a portion of the treatment supply portion 1104, one or both. It protrudes from the end. The anchor wire 1114 is bent at one or both ends to form the anchor 1116. As the treatment supply portion 1104 exits the cannula 630 (see Figure 8D), the anchor 1116 stretches to capture the surrounding tissue, helping to prevent the treatment instrument 1102 from moving. FIG. 11B is a cross-sectional view of the seed 108 and tube 1112 along line 11B-11B of FIG. 11A.

It should be noted that the components of the various inventions described herein can be used interchangeably between any of the methods and systems described in detail. For example, means 102, 152, 402, 502, 602, 1002 and 1102 can be used with the methods detailed in FIGS. 2A-2E, 2F and 8A-8E without departing from the scope of the invention. Is.

In the above embodiment, a treatment supply portion (eg, portion 104 in FIG. 1 or portion 604 in FIG. 6) formed primarily by a contraction-fitted tube (eg, tube 612 in FIG. 9A) is used. is there. However, another embodiment of the treatment supply portion may have a different support member. Such a support member may be any element that supports the treatment supply portion, such as a piece of element such as stainless steel or a superelastic nickel-titanium alloy. Further, in order to partially support the seed 108, it is possible to separate the treatment supply portion into a radiation transmitting portion and a radiation absorbing portion by an element of the support member. That is, it is possible to attenuate or shield radiation to surrounding tissue to some extent by the element wrapping at least a portion of the seed. As a result, the structure on the support member side facing the seed 108 receives a lower radiation dose than the structure on the seed side. The support member may be wrapped by a casing such as, for example, a heat shrinkable tube 112 or 612.

For example, FIGS. 12A and 12B show therapeutic means 1202 with a tail 1206 and a therapeutic supply portion 1204 with multiple seeds 108 and a linear support member 1210 (see FIG. 12A). That). The support member 1210 may have a curved cross section, such as an arch (see FIG. 12B). Alternatively, it is possible to have a relatively flat cross section (not shown). In another embodiment, any cross-sectional shape is used, for example V-shaped. Further, the support member 1210 may have various tip shapes including the shovel-shaped tip shown in FIG. 12A. As described above, at least a part of the support member 1210 may be wrapped in a casing such as a heat-shrinkable tube 1212.

Although the support member 1210 in FIG. 12A is generally linear, it is also possible to use a curved support member, for example, having a certain degree of curvature. For example, FIG. 13A shows a treatment means 1302 having a treatment supply portion 1304 with a curvilinear support member 1310, the curvilinear support member imparting an arched or other curvilinear shape to the curvilinear support member 1304. To do. The support member 1310 may be formed to be curvilinear in the relaxed state, or may simply be flexible enough to allow curvilinear transplantation. Like the support member 1210 in FIGS. 12A-12B, the support member 1310 can have any cross-sectional shape, for example flat, curved or V-shaped (as shown in FIG. 13B). At least a part of the support member 1310 may be wrapped in a casing such as a heat-shrinkable tube 1312 as in the casing described above. FIG. 13B is a cross-sectional view taken along line 13B-13B of FIG. 13A.

Although not shown herein, these support members, optionally, allow seeds to be at least partially contained within the slots by having one or more slots, eg, along a centerline. As a result, radiation therapy is reliably performed on the tissues on both sides of the support member while obtaining a treatment supply portion that allows higher rigidity than the unsupported treatment supply portion described herein. It becomes possible.

14A-14B show another exemplary embodiment of the treatment supply portion 1404. In this embodiment, the therapeutic supply portion includes a catheter or casing, such as a tube 1412, which has one or more lumens. The first or main lumen 1408 may contain a seed (not shown) and the second lumen 1414 may have a damping or shielding element 1416 extending along the longitudinal length of the tube 1412. As a result, the tube 1412 has a radiation transmitting portion (a portion not blocked by the element 1416) and a radiation absorbing portion (a portion shielded by the element 1416). In one embodiment, the tube 1412 is obtained by coextrusion with a plastic (eg, fluorine polymer) and a damping material such as a series of fine metals (eg, stainless steel, gold, etc.). In another embodiment, the damping material can be a coextruded polymer with a damping material added, for example tungsten powder. The tube 1412 may or may not have heat shrinkage. In view of versatility, the shielding element 1416 may have a linear or curved preliminary shape. FIG. 14B is a cross-sectional view taken along line 14B-14B of FIG. 14A.

FIG. 15 is a partial view showing an exemplary brachytherapy device 1500 having a treatment means 1502 and a catheter such as a cannula 1501, which means the means 1502 has a curved treatment supply portion 1504 and a tail 1506. To be equipped. Other components in this system, such as pusher members and apex embolus, are omitted for clarity only. The curvilinear treatment supply portion 1504 may be composed of curvilinear support members, such as the support member 1310 of FIG. 13A. It is preferred that the cannula 1501 have a sufficient lumen diameter to accommodate the curved treatment supply portion 1504 if it is constrained to a linear shape during transport. Alternatively, the cannula 1501 may have dimensions to accommodate the treatment supply portion 1504 in a curved shape. In yet another embodiment, the treatment supply portion 1504 is generally linear yet flexible, and the cannula 1501 used to supply the treatment supply portion can be curved.

It is also possible to use a non-linear catheter (eg, curved) to supply and / or place the brachytherapy measures described herein in areas or locations inaccessible to the linear catheter. is there. For example, FIGS. 16A-16E show exemplary devices 1650 and methods used to implant brachytherapy means, such as means 102 in FIG. 1, along a non-linear axis. FIG. 16A shows a device 1650 with a first catheter member, such as a needle 1652, a second catheter member, such as a flexible catheter 1656, and a brachytherapy means 102. The needle 1652 has an off-axis opening 1654 at or near the distal end of the needle. The needle 1652 is inserted into the body 200 in the direction 1651 so that the distal end of the needle is located beyond the target tissue area 202 as shown in FIG. 16A. A flexible catheter 1656 is then inserted (in direction 1653) through the needle 1652 and the distal end 1667 of the catheter 1656 projects at an angle 1661 from the opening 1654 of the needle 1652, as shown in FIG. 16B. To do. That is, the axis of catheter 1656 intersects or is otherwise non-parallel to the axis of needle 1652.

The angles 1661 between the axes may vary, but angles in the range of about 0 degrees to about 90 degrees (0 to 90 degrees), more preferably about 5 degrees to about 35 degrees (5 to 35 degrees) are conceived. ..

The means 102 is then passed through the catheter 1656 (in direction 1655) as shown in FIG. 16C so that the treatment supply portion of the means 102 is located at or near the distal end 1667 of the catheter 1656.

In this regard, the treatment supply portion of means 102 is exposed by pulling out catheter 1656 slightly (in direction 1669), as shown in FIG. 16D. The needle 1652 and catheter 1656 can then be pulled out together (in the direction 1671) from the body 200 as shown in Figure 16E. The means 102 is thus implanted on a non-linear axis and the tail 106 of the means extends out of the body as described above in connection with other embodiments (see FIGS. 2A-2E).

The ability to implant means 102 along a non-linear axis can be advantageous in many applications. For example, if the tissue area 202 of interest is a breast lesion or a post-tumor cavity in the breast, the non-linear means 102 allows for more intensive radiation. In addition, the non-linear positioning allows implantation around obstacles in the body. For example, in brachytherapy, this area 202 can be the pubic arch, around which the clinician may place the radiation source. As mentioned above in the context of means 102, the non-linear arrangement of FIGS. 16A-16E may be used to implant individual radiation sources.

In yet another embodiment of the non-linear placement device and technique, it is possible to use the more spirally shaped needle 1675 shown in FIGS. 16F and 16G instead of the needle 1652 of FIGS. 16A-16E. Although the actual size of the needle depends on the amount of target tissue, a needle with a spiral diameter of about 3 cm is conceived. The needle 1675 can be advanced into the body 200 in much the same way that a corkscrew is inserted into the cork. That is, by rotating the needle 1675 in the direction 1678, the tip 1676 penetrates into the body 200 as shown in FIG. 16F. Figure 16G shows the fully inserted needle 1675. A flexible catheter (not shown) and a therapeutic means (also not shown) pass through the needle 1675 in much the same way as the catheter 1656 and means 102 described with reference to FIGS. 16A-16E. The needle 1675 is removed ("twisted out"), but a spiral-shaped therapeutic instrument is placed around the target tissue area 202 (not shown).

When using a non-linear treatment supply portion, such as off-axis, curved or spiral, the total number of treatment measures required to treat a given target tissue area is such that the treated portion is in the shape of the target tissue. As a result of matching, it is possible to potentially reduce. For example, in the case of a curved supply portion, a plurality of means are arranged so as to bend along the circumference of the target tissue region, and the radiation can be effectively concentrated in the central region. As a result, the dose irradiation outside the target tissue area is lowered, and the dose coverage rate inside the target tissue can be potentially improved. In the case of a spiral treatment supply portion, the appropriate treatment is given by a single treatment instrument of sufficient length moving in a spiral (eg, spiraling) around or within the area of interest tissue. Is possible.

17A-17B illustrate device 1600, which is similar to device 600 in FIG. 6 in all respects. For example, the device may include therapeutic means 1602 having a therapeutic supply portion 1604 containing a seed 108 and a tail formed by suture 1614. The suture 1614 can pass through the pusher member 1620 and the combination of the pusher member 1620 and the supply means 1602 can be placed in the cannula 1630. However, unlike the cannula 630, this cannula 1630 can have a notch 1634, and as more clearly shown in Figure 17B, for example, this cannula is at least part of the length of the cannula. It is possible to have a C-shaped cross section over. Although drawn linearly here, this cannula 1630 may be curved. This notch shape protects certain peripheral tissues / organs, such as the skin, chest wall, liver or heart, during transplantation. FIG. 17B is a cross section along line 17B-17B of FIG. 17A, and the treatment supply means 1602 is also illustrated with a dashed line.

When implanting any of the means described herein, the patient can optionally wear a protective garment, such as a bra covering the breast or band 1900, as shown, for example, in FIG. This brassiere / garment 1900 may be similar in all respects to the garments detailed, for example, in US Pat. No. 3,968,803 by Heimmann, 5,152,741 by Farnio and 5,538,502 by John Stone. For example, such a garment is a partial covering that is secured via a fixture, such as the shoulder strap 1904, that covers part of the breast (or any other area surrounding the area of tissue of interest). There may be. However, in addition to the cloth portion 1906, the strip 1900 may have a liner made of a radiation attenuating material 1902, for example lead, stainless steel or tungsten. Such garments increase the degree of occlusion and ensure wider patient motility, while an intrinsic radiation source, such as the seed 108, is held in place prior to transplantation into the patient. The garment 1900 may be provided separately or as part of a brachytherapy kit, such as Kit 100.

Although described above primarily in the context of LDR brachytherapy, the devices and / or methods described herein are also applicable to HDR. For example, tube 1412 in FIGS. 14A-14B can be used as a shielded feed catheter in HDR treatment, eg, a conventional HDR source with a smaller diameter (eg, afterload HDR cable) with tube 1412 placed in the body. Etc. can be passed through the main lumen 1408. The damping element 1416 in the wall of the catheter (eg, along the circumferential portion extending in the range of approximately 10 to 2 o'clock) attenuates radiation in areas that are vulnerable to radiation, whereas tube 1412 The unshielded area (along the circumferential area extending in the range of approximately 2 to 10 o'clock) allows irradiation of the target tissue.

In addition, it is possible, for example, to pass an HDR source through a catheter, such as the cannula 1630 in FIGS. 17A and 17B, whereby the HDR source is partially peripheralized by the shape of the cannula 1630, eg, notch 1634. Shielded from tissue.

Figures 19A-19C show that the HDR shielding catheter is built into the balloon-type brachytherapy treatment instrument 1800. This means 1800 may be similar to the means disclosed in US Pat. No. 5,913,813 by Williams et al. For example, this means comprises a brachytherapy catheter assembly 1802 with a catheter axis 1814 that includes a near-end and a distal end. An inflatable balloon 1806 can be coupled to the catheter shaft 1814 between the proximal and distal ends. An inflatable lumen 1830 extends along the catheter axis 1814 between the inflatable balloon 1806 and its close end to allow air infusion into the balloon. In addition, a dose supply lumen 1804 (see FIG. 19B) may also be provided and may extend from the near end to the distal end along the catheter axis 1814 (eg, in close proximity to the inflatable balloon 1806). It may be stretched between the ends.)

In use, the distal end of the catheter shaft 1814 is placed in a cavity, such as the post-tumor cavity 1808 of the breast 200, injecting air into the balloon 1806. A radiation source (not shown) is then passed through the dose supply lumen 1804 to deliver radiation along the dose supply portion of the catheter shaft, for example along the portion surrounded by the inflatable balloon 1806. To do. By incorporating a radiation absorbing portion (eg, the arched member 1811 clearly shown in FIG. 19C) over the dose feeding portion of the catheter shaft 1814, only a predetermined portion of the dose feeding portion, eg, the window portion 1817, is compared. It may have a target radiation permeability. As a result, means 1800 can attenuate radiation in selective areas, such as areas close to the skin or chest wall, but higher radiation to target tissue that is not blocked by radiation absorbing portion 1811. It becomes possible to supply levels. Although the radiation absorbing portion is described herein as a separate member 1811 extending along a portion of the catheter shaft 1814, in other embodiments the radiation absorbing portion may be incorporated into the catheter shaft 1814 itself. There are (various catheters described in different contexts herein, such as tubes 142 in FIGS. 14A-14B).

In some embodiments, the means 1800 further comprises a through-hole system in which one or more through-holes 1810 are arranged around at least a portion of the outer surface of the balloon 1806. These through holes 1810 allow air and liquid in the cavity 1808 to escape as the balloon 1806 expands. One or more vent lumens 1812 (shown in FIG. 19B) associated with the catheter shaft 1814 can extend between the close end of the catheter shaft 1814 and one or more through holes 1810. These through holes 1810 communicate with one or more vent cavities 1812 to allow air and liquid to flow out of the body during and after the balloon expands from the close end of the catheter shaft 1814.

In some embodiments, the external vent 1810 and vent lumen 1812 are formed by individual tube pieces 1816 attached to the balloon 1806 and the catheter shaft 1814. In the vicinity of balloon 1806, this tube 1816 is perforated to form an external vent 1810. The portion of the tube 1816 adjacent to the catheter shaft 1814 may or may not be perforated. The tube 1816 can be formed from any biocompatible material, for example a silicone tube, the material of which is attached to the balloon 1806 and the catheter shaft 1814, or to the material. It can be like a balloon or catheter being formed.

In FIGS. 20-22, exemplary LDR brachytherapy measures and related radiation sources as described above for transplantation into target tissue, such as the area around the tooth cavity after tumor removal in the breast. It is a figure which shows the system 1700. In the illustrated embodiment, the system has a catheter or needle guide template 1702 with a predetermined number and pattern (array) openings 1704 as shown in FIG. This template 1702 forms part of an adjustable catheter or needle guide by connecting the localization table 1720, which is outlined in the drawings by the base portion 1722, with the translational portion 1724 (with portion 1722). 1724 is shown as a developed view in FIG. 20). The localization table 1720 is preferably connected or attached to a table 1730 for loading or treating a patient, such as a patient table.

Template 1702 is coupled or otherwise associated with a first compression member 1726 located adjacent to opening 1732 in the treatment table 1730. The opposing second compression member 1728 may be located on the opposite side of the opening 1732. The compression members 1726 and 1728 can be placed at about 90 degrees (90 °) with respect to any set of compression plates 1727 (only one plate 1727 is shown).

One or both compression members 1726,1728 have a hole pattern similar to that of template 1702, as shown in FIG. 21, or in other ways at least the needle / cannula (eg, needle 114 in FIG. 1). It allows passage.

In use, the patient lies on the treatment table 1730, eg, with the patient's head facing direction 1731, so that the breast 200 passes through the opening 1732 of the treatment table 1730. The breast 200 can then be fixed using any compression plate 1727.

Once the breast 200 is fixed, the localization table 1720 is placed with the template 1702 attached and the translations 1724 are moved so that the compression members 1726 and 1728 are in contact with the breast 200. The positions of the localization table 1720 and the associated needle guidance template 1702 are aligned to the position of the target tissue area 202 using various imaging techniques including, for example, X-rays, ultrasound and CT scans. In some embodiments, it is possible to align the template 1702 with respect to the tissue area of interest based on the input provided below the breast 200, eg, by an imaging means such as an ultrasound device 1739 from the side. is there.

When the template 1702 is aligned with respect to the tissue area 202 and placed against the breast 200, one or more needles 114 are inserted into the opening 1704. In the treatment of breast lesions, the needle 114 is inserted so as to completely penetrate the breast 200 as shown in FIG. Alternatively, in the treatment of other cancers, it is possible to ensure that each needle 114 penetrates to the correct depth at each opening 1704 by varying the length of each needle 114, or simply the insertion depth of each needle 114. You may change it.

Certain embodiments of the system 1700 may optionally have a gauze bandage member 1750 associated with a first compression member 1726 and / or a gauze bandage member 1752 associated with a second compression member 1728. Preferably, these bandage members 1750 and 1752 are placed between each compression member and the breast 200. The bandage members 1750 and 1752 have, for example, adhesive tapes on each of the first surface 1754 and the second surface 1756, and have an opening (not shown) approximately corresponding to the opening 1704 of template 1702. Alternatively, the bandage members 1750 and 1752 may be punctured by the needle 114 when the needle is inserted. When the compression members 1726 and 1728 are pressed against the breast 200, the bandage members 1750 and 1752 adhere to the breast 200 to form a bandage for the puncture hole formed by the needle 114.

Once the needle 114 is inserted, the brachytherapy means described herein, such as means 102 or 602, are inserted and needles are inserted according to the various methods described and illustrated herein. Remove 114. For example, the brachytherapy means 102 (or means 602) is inserted and the needle 114 (or cannula 630) is inserted according to the method described herein and illustrated in FIGS. 2A-2E and 2F (or 8A-8E). ) Can be removed.

Once the needle 114 is removed, the template 1702 and contact plates 1726 and 1728 can be removed from the breast 200, leaving the bandage members 1750 and 1752 affixed to the breast by their respective first adhesive surfaces 1754. The tail 106 can then be fixed using, for example, a locking member such as the member 120 as illustrated in FIGS. 2E and 27.

The liner (not shown) can then be removed from each second adhesive surface 1756 of each bandage member 1750 and 1752. Once the second adhesive surface 1756 is exposed, the flexible tail 106 is bent against the second adhesive surface and adhered to the second adhesive surface. A second (not shown) single-sided adhesive member can be applied over the bandage members 1780 and 1752 to secure the tail and cover all adhesive surfaces exposed to the second adhesive surface side. As a result, the flexible tail can be bent and fixed to the contour of the breast.

In some embodiments, the opening 1704 of template 1702 can be grouped according to a particular amount of tissue of interest, such as the size of the lesion, as shown in FIG. For example, use the small square 5-hole pattern 1740 for a small target tissue area (for example, an area up to 1 cm in diameter) and the larger 9-hole pattern 1742 for a larger target tissue area (for example, an area up to 2 cm in diameter). To do. Larger 13-well patterns can be used for larger target tissue areas (eg areas up to 3 cm in diameter).

By aligning the central hole of template 1702 with the center of the tissue area of interest, the template may indicate a standard number of seeds, eg, a specific number of therapeutic instruments 102, based on a predetermined target amount. Good. This simplifies or in some cases eliminates the need for complex dose mapping calculations, usually associated with traditional brachytherapy methods.

Note that these patterns 1740, 1742 and 1744 are merely exemplary. In another embodiment, these patterns can have any number of openings 1704 in any shape pattern, for example a circular array with 5-50 catheters. In addition, these templates can have catheters or needles with one or more diameters (eg, 10, 15 and 20 mm diameters, etc.). Further, although illustrated to have three patterns, it is possible to have a template with any number of patterns without departing from the scope of the invention.

Another system for implanting brachytherapy means is illustrated in FIGS. 23 and 24. FIG. 23 illustrates a system 2300 similar to the system 1700 described above. For example, the system 2300 has a localization table 2320 that is fixed to a treatment table, such as a patient table (not shown). Table 2320 has a base portion 2322 and a translation portion 2324. System 2300 has a first or adjacent compression member 2326 and a second or distal compression member 2328. One or both compression members 2326 and 2328 are movable relative to each other and / or relative to the base portion 2322, eg, along the slide rail 2329.

However, unlike System 1700, System 2300 is equipped with a catheter or needle cartridge housing portion 2340 and is capable of accommodating an assembled needle cartridge 2342 with multiple needles 114 arranged in a predetermined array. .. The needle cartridge 2342 is shown as a developed view in FIG. Cartridge 2342 has a first holder 2344 and a second holder 2346 (second holder 2346 is not shown in FIG. 24). Holders 2344 and 2346 have holes 2348 to hold and guide a plurality of needles 114 in a desired predetermined array upon insertion. If the needle 114 has a hub 116, the hole 2348 in the holder 2346 is larger than the hole 2348 in the holder 2344 to allow passage through the hub 116 (see FIG. 23).

While the system 2300 is in operation, the localization table 2320 is aligned as described above in relation to the system 1700. Once aligned, the breast 200 is fixed using compression members 2326 and 2328. Depending on the amount of individual tissue area 202, a particular cartridge 2342 is selected and pre-combined with a corresponding number of catheters such as needle 114. For example, the cartridge in FIG. 24 has a 5-catheter shape. However, in other cartridges the number of catheters may be higher or lower (eg 9 catheter structures and 13 catheter structures). The cartridge 2342, including the holders 2344 and 2346 and the catheter 114, is then mounted within the cartridge housing portion 2340. The portions of holders 2344 and 2346 are designed to contact one or more inner surfaces of the cartridge housing portion 2340 so that they are aligned with the cartridge housing portion when the cartridge 2342 is inserted.

Once the cartridge 2342 is mounted, each needle 114 can be individually advanced manually through the proximity compression plate 2326 (with a hole pattern matching the holder 2344), breast 200 and distal compression member 2328. Is. The central needle 114 is capable of first advancing and locating (or rearranging) the needle within the subject tissue area 202 before advancing the other needles. Brachytherapy means, such as means 102 in FIG. 1, are then placed in the needle 114 as shown in FIGS. 2A-2E. Alternatively, the means 102 can be pre-installed in the cartridge 2342.

When the means 102 is fully inserted, for example, the distal end of the tail, similar to the tail 106 in FIG. 1, is temporarily secured to the distal compression member 2328. At this point, the needle 114 can be removed from the breast 200 and ultimately from the cartridge loader 2340. The proximity compression member 2326 is then removed and the proximity tail is fixed to the breast using, for example, the locking means 120 described above and illustrated in FIGS. 2E and 27. The distal compression member 2328 is then removed and the distal tail is similarly secured to the breast 200.

In FIGS. 25A-25D, yet another system and method for inserting brachytherapy means into the target tissue area is illustrated. Figure 25A shows a system 2500 that is in many respects similar to the systems 1700 and 2300 described above. For example, the system 2500 has a catheter or needle cartridge housing portion 2540 connected to a stereotaxic table (not shown). The localization table is preferably connected to a treatment table (also not shown). System 2500 includes a catheter or needle cartridge 2542. The needle cartridge 2542 comprises a plurality of needles 2514, eg, a 5, 9 or 13 needle array, the needles being mounted approximately fixedly and at right angles to the first plunger member 2550. In this embodiment, the needle does not have to have a hub because the close end of the needle 2514 is fixed to the first plunger member 2550 (eg press fit, stakeout, glue, etc.).

The cartridge 2542 further comprises a first or proximity compression member 2526, which member may constitute a needle guide template, a second plunger member 2552 and an optional backing plate 2554. In another embodiment, the backing plate 2554 may be part of the cartridge housing portion 2540. Similar to the systems described herein above, the system 2500 has a second or distal compression member 2528 to assist in the fixation of the breast 200.

During operation, the localization table is aligned so that the center of the needle cartridge housing portion 2540 is centered on the target tissue area 220. The cartridge 2542 is then mounted on the cartridge housing portion 2540 and the breast is secured by the first and second compression members 2526 and 2528. For example, a means for brachytherapy such as means 102 in FIG. 1 may be mounted in advance in the needle 2514 of the cartridge 2542. Then bring the first plunger member 2550 closer to the breast 200. Since the needle 2514 is fixedly connected to the first plunger member 2550, the needle 2514 is simultaneously advanced toward the target tissue area of the breast 200 in a predetermined parallel array. The first plunger member 2550 is manually or automatically advanced from outside the cartridge by having a slot in the cartridge housing portion 2540 or a tab 2560 along the surface 2561.

When the first plunger 2550 is fully advanced as shown in FIG. 25B, the second plunger member 2552 is advanced toward the breast 200. The proximity tail 106 of the brachytherapy means 102 is detachably secured to the second plunger 2552. Therefore, by advancing the second plunger member 2552, one or more brachytherapy means 102 are placed in place and the distal tail 106 is distal to the needle 2514 as shown in FIG. 25C. It may be made to go out from the end.

Brachytherapy means 102 is fixed in place by temporarily fixing these distal tails 106 to the distal compression member 2528. Once the distal tail 106 is secured, the proximity tail 106 is removed from the second plunger member 2552 and the first and second plunger members 2550 and 2552 are retracted as shown in FIG. 25D. Similarly, the cartridge accommodating portion 2540 can also be retracted to secure the proximity tail 106 (eg, locking member 120) by a method already described herein. The distal tail 106 can then be detached from the distal compression member 2528 to remove the latter distal compression member. Then, the distal tail 106 is fixed to the breast 200.

Therefore, System 2500 provides a device for simultaneously implanting multiple brachytherapy instruments into the body using a two-dimensional array. In addition, the system described herein simultaneously advances a two-dimensional array of catheters to a tissue area of interest to supply or implant one or more sources of radiation through at least one catheter in the array. Once the radiation source is implanted, the catheters in the catheter array can be removed sequentially or simultaneously from the tissue area of interest.

In the means described herein, each source of radiation, such as seed 108, may have substantially the same level of radioactivity as other seeds within the same means. However, in any of the examples described herein, it is possible to alter brachytherapy with seeds having different levels of radioactivity in the same brachytherapy instrument. In other words, the first source of radiation (eg, the first seed) in the means has a first level of radiation (eg, about 5 millicuries), whereas the second source of radiation in the same means (eg, the second). Seeds) can have a second radiation level (eg, approximately 1 millicurie) that is lower than the first radiation level. Similarly, in an application where multiple means are provided, each seed within a given means has the same radiation level, while different means within the array contain seeds with different radiation levels. May be good.

As mentioned above, in some embodiments, the tail 106 is secured to the breast with an adhesive pad or bandage 2600 as shown in FIG. Therefore, the bandage can be used with or in place of the locking member 120.

Compressing members 2526, 2528 can be configured as approximately as illustrated in FIG. 27 to help healthcare professionals secure the distal and / or proximity tail 106. For example, the opening 2570 in the plate through which the tail 106 passes (eg, plate 2528) may have a recess 257 for holding the locking member 120 against the skin. As a result, when the compression plate 2528 is removed, the locking member 120 is already mounted on the tail 106. The healthcare professional can then quickly crimp the locking member 120 along, for example, the deformable portion 2576.

Although many of the means and devices described herein relate to linear placement, it may be more advantageous to place the radiation source in a more complex shape within the tumor or cavity after tumor removal. .. For example, as described above with reference to FIGS. 16A-16G, it is possible to implant the means in a non-linear shape. The curved shape rather than the straight shape makes it more compatible with the target tissue (eg, better with the tissue surrounding the curved volume of the cavity after tumor removal).

In addition, in the devices, means and systems in another embodiment described herein, transplantation of brachytherapy means is performed in a first or folded, eg, substantially linear shape, eg. After being once placed in the target tissue area such as the tooth cavity after tumor removal, it can be made to have a second or expanded, for example, curved shape by external action. In other words, in such an embodiment, brachytherapy treatment devices that are inserted into a target tissue area in the body, such as the breast, are provided, and these devices are described above. Those having one or more brachytherapy means having such one, preferably more radiation sources (see, eg, means 102, etc.). Brachytherapy measures are generally inserted into the tissue area of interest in a linear shape. However, this brachytherapy measure may then be modified to form, for example, a curved radiation source array as detailed below.

Such devices and means allow implantation through an incision with only minimal size, and then deploy in the field to target tissue (eg, the tissue area surrounding the tooth cavity after tumor removal). Allows a dose delivery region that is more geometrically compatible with the curved shape of. In addition, the unfolded shape provides a wider array than the first folded shape, from which the radiation sources each supply their own dose.

In addition, field deployable devices, means and systems as described herein further enhance the fixation of the radiation source into a particular location in the tooth cavity after tumor resection. Fixation is beneficial in that it provides a substantially fixed structure between the implanted radiation source and the tissue of interest around it. Brachytherapy irradiation can then be more closely aligned with the pre-transplant dose planning regimen by minimizing the movement of the radiation source (to the target tissue) when the patient wants to be active.

An embodiment of such a deployable device is schematically shown in FIGS. 28A-28D as the squirrel-cage device 2800. In general, the intracavitary device 2800 is the treatment supply portion 2800a, which can be deployed at a target location within the patient's body, such as a tumor or breast or a tooth cavity within another body structure 200, and a tail 2800b. The tail 2800b has one protruding from the body structure 200, for example by extending from the treatment supply portion 2800a. As shown in FIGS. 28A-28D, the treatment supply portion 2800a has, for example, a folded shape for introduction into a target position through a tissue tube and, for example, a target position, as detailed below. Movable to and from the unfolded shape to provide a three-dimensional path array in 2802.

Optionally, the device 2800 has a sheath or other cover (not shown) that can cover the treatment supply portion 2800a until, for example, this cover is deployed. In addition to or in place of this, the device 2800 can be introduced into the target location by providing a tubular feeding means such as, for example, a catheter, a cannula or a needle 2804. A trocar or other (not shown) instrument is placed within the needle 2804 so that the tip of the trocar (also not shown) extends beyond the distal end 2804a of the needle 2804 and into the tissue of the needle 2804. It facilitates insertion and forms, for example, a tissue conduit from the patient's skin to the target location. The trocar can be removed after forming the conduit, thus allowing the device 2800 to be introduced into the needle 2804.

Alternatively, the needle 2804 can have a pointed distal tip (not shown). In this alternative, the trocar is omitted and, optionally, an embolus or other (not shown) instrument is first prepared to advance the needle 2804 through the tissue while closing the lumen. After removing the embolus, the device 2800 is introduced into the needle 2804, eg, directly or supported by a sheath or other cover (not shown).

In yet another alternative, the device 2800 may have a pointed distal tip (not shown), for example, as in other embodiments as described below. The distal tip extends beyond the distal end 2804a of the needle 2804 to form a conduit when both the needle 2804 and the device 2800 extend through the tissue. In yet another alternative, the device 2800 with a pointed distal tip can be advanced to pass directly through the tissue to form a tissue conduit, thus omitting the needle 2804.

In FIG. 28A, the brachytherapy device 2800 after being inserted into the body through the incision is shown. The device 2800 is positioned such that the treatment supply portion 2800a is located within a hollow target area, for example, the tooth cavity 2802 after tumor removal. As illustrated in FIG. 28A, a catheter or needle 2804 is inserted into the tooth cavity 2802 through body tissue such as breast 200. Once the device 2800 is in place, the needle 2804 can be retracted or removed, exposing the treatment supply portion 2800a.

As shown, the treatment supply portion 2800a has a plurality of radioactive brachytherapy means, which are, for example, flexible elongated members 2806 at the proximity and distal ends 2806a, It has 2806b and has a shape that carries one or more radiation sources. The device 2800 has a hub or outer body member 2807 to which the near end 2806a of the elongated member 2806 is secured as shown in FIG. 28B. The distal end 2806b of the elongated member 2806 is fixed or otherwise held to the distal end 2808 of the core member 2810. As shown, the core member 2810 extends through the body member 2807 so that the close end 2812 of the core member 2810 extends into the body structure 200. Alternatively, a handle (not shown) may be connected proximal to the core member 2810 or otherwise extended.

The hub and core member 2810 are axially movable relative to each other so that the treatment supply member 2800a can be deployed and / or folded. For example, the proximity end 2812 of the core member 2810 and the body member 2807 are displaced, for example, the core member 2810 in the first (proximity) direction 2814 and / or the body member 2807 in the second (distal) direction 2816. By manipulating to, the elongated member 2806 can be deployed within the capacity of the tooth cavity 2802 as shown in FIG. 28C. When fully deployed, the elongated member 2806 can contact the wall of the tooth cavity 2802 as shown in FIG. 28D and / or push into the tissue surrounding the wall of the tooth cavity 2802 as described below. ..

Figures 29A-29F show another embodiment of the brachytherapy device 2900 that can be deployed in the field. This device is similar in many respects to the device 2800 described above. For example, the device 2900 has a deployable cage portion of brachytherapy means, such as a flexible elongated member 2906. Each elongated member 2906 is connected to a hub 2909 at their distal end 2906b and to a body member 2907 at their near end 2906a. As shown in FIG. 29A, it is possible to provide the flange 2914 at the close end of the body member 2907. Similarly, the core member 2910 connected to the hub 2909 passes through the body member 2907 and extends beyond the flange 2914 to a button or another handle 2912.

The elongated members 2906 may be terminated within the body member 2907 at their close end 2906a. However, as will be described later, in other examples of the main body member, a passage may be provided for accessing the cavity formed in the elongated member 2906 from the proximity side of the flange 2914.

The device 2900 is the second because of its first folded shape, that is, the shape in which the elongated member 2906 is approximately linear and parallel to the central axis of the core member 2910 (see Figure 29B). The unfolded shape of, i.e., the elongated member 2906 is movable to a curved shape as shown in FIGS. 29A and 29C. For example, movement to the unfolded shape is obtained by moving the flange 2914 and the accompanying body member 2907 away from the button 2912 (ie, in the distal direction 2916). Similarly, the device 2900 can be folded by moving the flange 2914 towards the button 2912 (ie, towards the proximity 2918).

In addition to the flange 2914 and the button 2912, another operating means may be provided. For example, the core member 2910 and the main body member 2907 can be provided with screws (not shown) to be fitted, for example, on the inner surface of the main body member 2907 and the outer surface of the core member 2910 in the main body member 2907. Instead of moving the button 2912 axially, the body member 2907 is moved axially, i.e., distally beyond the core member 2910 by rotating the button 2912 in the first direction to move the elongated member 2906. Unfold to the unfolded shape. By rotating the button 2912 in the second opposite direction, the elongated member 2906 can be returned to the folded shape again.

Optionally, in these embodiments, the portion of the button and / or core member 2910 that exceeds the flange 2914 is made removable from the remaining core member 2910 (the portion of the body member 2907 that extends to the hub 2909). For example, it is possible to reduce the outer shape of the device 2900 after transplantation. For example, removable parts and other parts of the core member (not shown) can have male / female ends to fit, such as screws and other removable connectors (also not shown). .. Alternatively, by placing the barrel or other structure within the body member 2907 that is connected to the proximity end 2906a of the elongated member 2906, the axial movement of the barrel relative to the body member 2907 is the unfolding and folding of the elongated member 2906. It is also possible to cause an action.

In another option, the core member 2910 (and / or actuating means) has one or more stoppers (not shown) to limit the operation of the body member 2907, for example limiting the deployment of the elongated member 2906. It is possible. These stoppers may provide the maximum size of the unfolded shape or may provide various sizes in which the elongated member 2906 can be unfolded and fixed. For example, it is possible to move the body member 2907 by a latch or detent (not shown) while holding the body member 2907 in a moved position with respect to the core member 2910.

Figures 29B and 29C show the brachytherapy device 2900 after insertion through an incision in a body structure such as the breast 200. It is possible to place this device 2900 so that its distal end, such as the hub 2908, is located within the post-tumor cavity 2902. In the illustrated embodiment, the device 2900 is inserted through an existing incision. However, as mentioned above, the device 2900 may be provided with an element capable of forming its own incision (eg, a pointed distal tip). The pointed distal tip allows the tip of the device 2900 to be positioned beyond the edge of the tooth cavity, for example, to position the deployed element optimally within the tooth cavity.

In some embodiments, the device 2900 has a removable sheath (not shown) that can be covered by the elongated member 2906 during handling and / or implantation. After the device 2900 is positioned as shown in FIG. 29B, the sheath is removed (eg, using one or more attenuation seams or regions that extend along the strip and / or sheath placed outside the body. Exposing the elongated member 2906.

Once the device 2900 is in place, as shown, for example in FIG. 29B, the physician can displace the flange 2914 towards the body (distal to 2916). Similarly, the button 2912 can be displaced proximally away from the flange 2914. This action unfolds the elongated member 2906 within the capacity of the tooth cavity 2902 as shown in Figure 29C. Upon further deployment, the elongated member 2906 contacts the wall of the cavity and, when fully deployed, reshapes the cavity wall by press-fitting into the surrounding tissue so that the cavity walls fit together between the members 2906 ( For example, see Figures 32D to 32G below). This mating or invagination of the wall approximately secures the device 2900 to the tissue surrounding the tooth cavity 2902.

As used herein, the terms "invagination" and "fitting" move one or more parts or elements of device 2900 outward from the cavity 2902 into the tissue around the cavity 2902. Pressing allows the tissue adjacent to these elements to move freely, fold, and even extrude between the elongated members 2906. For example, this concept is shown in Figures 32D-32H. In addition to being substantially surrounded by the tissue, one or more elongated members 2906 penetrate into the surrounding tissue so that, for example, the elongated member 2906 is completely surrounded by the tissue, as will be described later.

FIG. 29D is a cross-sectional view of the device 2900 as viewed along lines 29D-29D in FIG. 29C. As shown in this figure, the elongated member 2906 may be a tubular member comprising one or more cavities, such as a first cavities 2918 and a second cavities 2920. The first lumen 2918 may have dimensions to accommodate brachytherapy means, such as means 102, 152, 402, 502 and 602 already described elsewhere herein, for example. On the other hand, the second lumen 2920 may have a shape that holds a reinforcing member (not shown). This reinforcing member can help maintain the correct orientation of the elongated member 2906, eg, the elongated member when the lumen 2918 (and thus the brachytherapy means) is sufficiently rigid to deploy to the surrounding tissue. It can help prevent bending and / or ensure that the elongated member 2906 deploys substantially in a predetermined shape.

Although the cross section is drawn round in FIG. 29D, one or both of the first and second cavities may have different shapes. For example, FIG. 29E shows a cross-section of the alternative member 2906', which is a round first lumen 2918'and a rectangular or other rectangular or other elongated cross-section second lumen 2920'. Has. A second lumen 2920'with a rectangular cross section is occupied by a correspondingly shaped reinforcing member (such as a nitinol wire or belt with a rectangular cross section) and the rotational displacement of the elongated member 2906 during deployment (eg, nitinol wire or belt with a rectangular cross section). And other deformation shapes) can be reduced. For example, because the moment around the smaller dimension 2920a'is smaller than the main dimension 2920b', the elongated member 2906'is laterally oriented in unfolding, eg, towards the adjacent elongated member, rather than outward. It tends to bend.

Although the member 2906 is depicted as a double cavity tube in FIGS. 29D and 29E, the elongated member 2906 may be a single cavity and may consist of, for example, a polymer or other flexible tube. The polymer tube may be flexible enough to be unfolded into a curved shape, yet rigid enough not to require a second reinforcing member. Such tubes are high durometer value polymers and can be made from, for example, nylon, polyetheretherketones, polyimides and the like. Although optional, the cross-sectional shape of the cross-section of the tube should be non-circular (eg trapezoidal, rectangular, etc.) to ensure proper bending direction when the means unfolds, as well as lateral stability of the element in the unfolded shape. It is also possible to improve. In addition, it is possible to obtain improved torsional and flexural rigidity by having the tube have a reinforcing element (not shown, for example, a flat wire braid) within the tube wall.

In another alternative, the elongated member 2906 may have another element to form an extending path between the near and distal ends 2906a, 2906b. For example, an elongated member can form a groove or orbit (not shown) to accommodate one or more (also not shown) radiation sources, as described below. These elements can be other interlocking elements that limit the movement of one or more radiation sources, such as axial movement along an elongated member. Thus, as used herein, a "path" is a cavity, orbit, provided in an elongated member that has a shape for guiding one or more sources of radiation along the elongated member. It includes rails or other elements.

FIG. 29F shows the proximity side of the flange 2914, as could be formed in one embodiment. The flange 2914 has a series of openings 2922 and 2924 that allow access to the cavities 2918 and 2920 of member 2906. For example, the opening 2922 is connected to the lumen 2918 (see FIG. 29D) in each elongated member 2906 through each lumen extending (not shown) through the body member 2907 to form the opening 2924. It is possible to connect to the lumen 2920. As a result, brachytherapy means (not shown) and stiffeners (not shown) before or after implantation of the device 2900 into the target location, as described elsewhere herein, in each lumen 2918 and It can be inserted inside the 2920. Optionally, the flange 2914 also has a locking member or ring (not shown) to secure one or both of the brachytherapy means and the reinforcing member to the flange 2914.

Although not shown, the flange 2914 has an index (eg, alphanumeric symbols such as consecutive numbers such as clocks), and it is possible to identify each opening 2922/2924 around the flange 2914. As a result, the physician / oncologist knows which opening 2922 should accommodate a particular brachytherapy instrument according to the desired dose regimen, eg, before or after introducing the device 2900 into the target location. It becomes possible. For example, in the dose planning, low-level means (means "1") shall be placed in the area close to the patient's skin. The corresponding opening 2922/2924 may have the same number (1) or may otherwise identify the correct opening 2922/2924 to accommodate a particular low level means. Therefore, in the state where the device 2900 is correctly positioned at the target position (for example, the low level path of the elongated member "1" faces the skin), the skin is injured by arranging the low level means along the low level path. Reduce risk. Therefore, higher levels of brachytherapy measures can be placed in other specific openings according to the desired dose regimen.

Dose planning can be performed using current imaging methods (eg CT, ultrasound, etc.) and dose planning software available for application to commercially available HDR or LDR. The timing and general scenarios of dose planning processing are at the discretion of the clinician / oncologist. However, in one such scenario, the device 2900 is placed in the target tissue area and the elongated member 2906 is moved into an unfolded shape. It is then possible to outline both the target tissue area and the location of the elongated member 2906 with reference to an image (such as CT). After that, the dose plan can be developed and changed as needed if the configurations of the device 2900 and the elongated member 2906 are adjusted.

Once the dose plan is optimized, the characteristics of the source (eg, brachytherapy measures) are selected (eg, LDR seed activity level, HDR retention location, etc.) and the device is through the access opening 2922/2924. Prepared for placement within the 2900. For example, in LDR brachytherapy, a tertiary of seed or radiation source that is held in place for an extended period of time by simultaneously or sequentially loading individual containers or other sources of radiation into each elongated member 2906. Configure the original array. These seeds may be spaced on each container or have different radioactivity intensity, depending on the dose plan. For example, seeds in different parts of the array can have different lengths and / or spacings along each elongated member 2906, so that the array is substantially radial to, for example, the central axis of device 2900. Alternatively, it can be axially asymmetric. Alternatively, in HDR brachytherapy, individual radiation sources are sequentially positioned along each path of the elongated member 2906 over a specific irradiation time. Alternatively, it is possible to guide one or more HDR radiation sources along the path at the same time.

Although described herein as using individual elements, in another embodiment of the device 2900, the elongated member 2906 may extend variously from the distal hub 2909 towards the flange 2914. Thus, each elongated member 2906 may define one or more lumens extending from the distal end 2906a to the flange 2914. The lumen may then contain brachytherapy means (not shown) that incorporate its own stiffeners (see, eg, means 1202 elsewhere described herein). .. Alternatively, a reinforcing member may be already contained in, for example, the lumen 2920, or otherwise fixed along the elongated member 2906 to the elongated member 2906.

Optionally, the stiffeners can have a shielding effect, similar to other embodiments described elsewhere herein. For example, in the case of an array or radiation source that is approximately spherical, the central region of the array is subject to greater radiation when compared to the peripheral regions of the array. Over-irradiation of the central region can be reduced by shielding provided along the inner region of the elongated member 2906. For example, in FIGS. 32F and 32G, reinforcing / damping members extending along the inner region of the elongated member 3106 are shown for this purpose.

Figures 30A-30C show the brachytherapy device 3000, which is similar in all respects to the device 2900 described above. However, the device 3000 differs in that it is designed to completely penetrate body or tissue structures, such as the breast (not shown). As a result, the distal end of device 3000 is deformed to some extent from the end of device 2900 to fit this application.

FIG. 30A shows a side view of the device 3000. Like device 2900, this device 3000 has an elongated member 3006 that is radioactive and flexible, and these members are relative to the body member 3007 at its proximity end 3006a and to the hub 3009 at its distal end 3006b. Be connected. A core member 3010 having a button 3012 at one end and a pointed distal end 3011 at the other end can extend through the body member 3007 and the hub 3009. The pointed distal end 3011 allows the device 3000 to penetrate tissue during implantation. Unlike device 2900, core member 3010 is not permanently fixed to hub 3009. Rather, the core member may be slidable with respect to the hub 3009 and the body member 3007. Although optional, the core member 3010, body member 3007 and / or hub 3009 have one or more connectors (not shown), and the core member 3010 is detachably fixed at the time of transplantation, for example, while the core is post-transplantation. Allow member 3010 to be removed.

FIG. 30B shows a cross-sectional view of the apparatus 3000 in the first folded shape. As shown in this figure, the elongated member 3006 comprises vessels 3018, 3020 (eg, similar to the cavities 2918 and 2920 shown in FIG. 29D), which extend through the body member 3007. Or communicate with separate cavities 3022 and 3024 that extend through the body member 3007. As a result, brachytherapy means such as means 102, 152, 402, 502 and 602 as described above can be passed through the elongated member 3006 before or after transplantation of the device 3000.

In FIG. 30C, a cross-sectional view of the device 3000 in the second unfolded shape is shown. This shape is obtained by, for example, using actuating means to displace the hub 3009 and the body member 3007 relative to each other, eg, as in the buttons 3012 and flange 3014 or other embodiments described herein.

In use, when in the folding shape shown in FIG. 30B, the device 3000 is inserted into the body, for example (not shown) breast or other tissue structure, and the elongated member 3006 is inserted into the body (also not shown) in the tooth cavity or. It should be placed at other target positions. Device 3000 is inserted until hub 3009 extends outward from the opposite (distal) side of the breast. The apex 3011 of the core member 3010 may be used to penetrate the tissue opposite the tooth cavity during implantation. Optionally, once the device 3000 has completely passed through the breast, the core member 3010 can be removed from the device 3000, for example by pulling the core member 3010 from the near end of the device 3000. At this point, the physician can grab the body member 3007 and the hub 3009 and push these elements 3007, 3009 toward each other. In this way, the elongated member 3006 extends radially outward to the cavity wall, for example to the unfolded shape shown in FIG. 30C.

When fully deployed, the body member 3007 and hub 3009 are secured to the body, such as the skin, with tape, sutures, or the like. Alternatively, a locking member (not shown) is inserted through the body member 3007 and / or hub 3009 to secure the elements to each other (not shown, for example, long plastic screw bolts and nuts). In yet another alternative, the operation of the body member 3007 and / or the hub 3009 can be restricted, for example, by using latches or detents (not shown) that secure the body member 3007 and the hub 3009 to each other. May be overcome to move the body member 3007 and / or the hub 3009, as described elsewhere herein.

The brachytherapy means (not shown) may be carried on the elongated member 3006 when the device 3000 is introduced, or the device 3000 may be introduced without the brachytherapy means. If the device 3000 does not contain brachytherapy measures at the time of implantation, a radiation oncologist or similar trained clinician may use the brachytherapy measures through a lumen 3022 or other route along the elongated member 3006. insert. Alternatively, an automated system may be used to supply one or more sources of radiation along the path. In another embodiment, the brachytherapy means is pre-mounted on the device 3000 prior to transplantation and is detachably or permanently supported by the elongated member 3006.

31A-31F are diagrams showing a brachytherapy treatment device 3100 that can be deployed in the field according to yet another embodiment. The device 3100 comprises a series of radioactive, elongated, flexible members 3106, the members of which are first (shown in FIG. 31A), eg, linear in shape to second (FIG. 31A). It can be developed into, for example, a curved shape (shown in 31B). In the folded shape, these members 3106 are collapsible with respect to the device 3100, eg, to minimize dimensions for transplantation (eg, approximately parallel to the longitudinal axis in the center of the device 3100). To). However, in the unfolded shape shown in FIG. 31B, at least a portion of the elongated member 3106 is further towards the outer wall of the body cavity, for example the post-tumor cavity (see FIGS. 32D-32G). Or it spreads radially inside it. As a result, the device 3100 is largely anchored within the tissue around the tooth cavity.

In the illustrated embodiment, the elongated member 3106 can be configured in two different groups, as is most commonly found in FIG. 31B. The first or outer group has an elongated member identified by reference numeral 3106a and forms an American football-shaped or watermelon-shaped boundary, as shown in FIG. 31B. The second or inner group has an elongated member identified by reference numeral 3106b, defining a similar but smaller watermelon shape. In the illustrated embodiment, the outer group has seven separate members 3106a and the inner group has three separate members 3106b. However, in another embodiment it is possible to change the number of elongated members 3106 in any group. The elongated members 3106a and 3106b can be collectively or collectively referred to as the elongated member 3106.

The elongated member 3106 is attached to the body member 3107 at the first (eg, proximity) end. However, the elongated member 3106a can be attached to the distal hub 3109, respectively, at the second (eg, distal) end, and the distal end of the member 3106b can be attached to another floating hub 3108.

The device 3100 further comprises a core member 3110 that is attached to the distal hub 3109 and extends outward from the proximity side of the body member 3107. Although the core member 3110 is fixed to the distal hub 3109, it may pass through openings in both the body member 3107 and the floating hub 3108 with a gap. As a result, the main body member 3107 and the floating hub 3108 can slide along the core member 3110 as described later. The core member 3110 can function as a pulling member. As a result, the core member may be generally rigid or may be a pull-only member, such as a cable or suture.

Each elongated member 3106 may have a reinforcing member, which in the illustrated embodiment is a flat wire 3112 having elasticity. The wire 3112 allows the elongated member 3106 to expand and contract in a desired direction (eg, without twisting). The wire 3112 further imparts some integrity to the elongated member 3106 so that, for example, the elongated member 3106 can be extended outward into the cavity wall with sufficient radial and lateral stability. To do. Although not desired to be tied to any particular material, in one embodiment these wires 3112 may be made of reinforced stainless steel or a shape memory alloy such as Nitinol. These materials allow the device 3100 to infiltrate the wall after tumor removal and / or maintain a substantially stable shape (see Figures 32D-32G) after the device 3100 has completed treatment. Can be folded into the shape before unfolding.

Individual tubes 3114 can be attached to each flat wire 3112. These tubes 3114 can be opened to accommodate brachytherapy means (not shown) similar to, for example, means 102, 152, 402, 502, etc., as described herein. .. Alternatively, the tube 3114 may be loaded onto the tube 3114 during or before treatment, as detailed elsewhere herein, with individual radiation sources such as seed 108 and spacers. It can be accommodated. Therefore, these tubes 3114 can form the outer surface of the actual brachytherapy means. These tubes 3114 can be made of any biocompatible material capable of retaining a radio source or pre-installed brachytherapy means, such as a fluoropolymer such as fluorinated ethylenepropylene (FEP), nylon. And can be manufactured from polyurethane and the like.

A side view of the device 3100 is shown in FIG. 31C, and an end view is shown in FIG. 31D. These two figures show a modified example of the main body member 3107 in which the flange 3111 is formed or attached. This optional flange 3111 is advantageous for physicians to perform transplantation and / or removal treatments because it provides a portion that can be grasped when arranging the core member 3110.

FIG. 31E is a vertical cross-sectional view showing the device 3100 in a folded shape in a twisted form (by twisting the cross-section, this figure is usually visible on a straight cross-section with two elongated members 3106a. The parts of the two elongated members 3106b are shown). In this figure, the attachment of the core member 3110 to the distal hub 3109 is clearly shown, and the fixation of the flat wire 3112 to the distal hub 3109, the floating hub 3108 and the body member 3107 is also shown.

In addition, FIG. 31E shows a pocket 3116 formed within the distal hub 3109. When the stopper surface is formed by the pocket 3116 and the device 3100 is in the deployed shape, the axial movement of the floating hub 3108 is restricted. Although illustrated as a pocket 3116, in other embodiments the floating hub 3108 may simply be in contact with the flat inner surface of the distal hub 3109.

FIG. 31F is a twisted longitudinal sectional view similar to FIG. 31E, with the device 3100 in an unfolded state. As shown in this figure, the unfolded shape is obtained by applying a tensile force to the tail of the core member 3110 while holding the body member 3107 in place. By applying such a tensile force, the distal hub 3109 moves toward the main body member 3107. When this movement occurs, the elongated member 3106a bends outward as shown. Once the floating hub 3108 comes into contact with the pocket 3116, these members 3106b also begin to flex outward. When the core member 3110 is pulled further, both the elongated members 3106a and 3106b begin to move outward. By changing the axial position of the core member 3110 with respect to the main body member 3107, it is possible to obtain a large number of unfolded diameters. Once the device 3100 has been deployed to the desired diameter, a clamp (not shown) or similar means can be crimped immediately next to the body member 3107 to prevent the core member 3110 from sliding against the body member 3107. It is possible.

Other methods for fixing the device 3100 to the desired diameter can use a threaded nut and bolt assembly (not shown). For example, the body member 3107 can be split and screwed to the outside like a conventional machinist collet (not shown). By screwing a nut (not shown) around the collet and tightening to hold the core member 3110, it is possible to hold the device 3100 to the desired degree of magnification. Alternatively, the core member 3110 can have a series of dense holes or pockets (not shown) provided along the region where the core member 3110 protrudes from the body member 3107. It is possible to place a cotter pin or the like (not shown) in the desired hole or pocket to hold the device 3100 at the desired magnification.

In FIGS. 32A-32F, a method for using the apparatus 3100 of FIGS. 31A-31F is illustrated. FIG. 32A is a perspective view showing a part of the body such as (eg, breast 200) in which a cavity formed by removing cancer tissue (eg, cavity 202 after tumor removal) is formed. .. Device 3100 is shown in the inserted and folded state. The device 3100 may be inserted through an existing incision, such as the incision used during tumor resection, or through a newly provided incision to supply the device 3100. 32B and 32C show the front and side views of the breast 200, showing the folded device 3100 in place within the tooth cavity 202.

Once the device 3100 is in the desired position, the core member 3110 is pulled by the physician while the body member 3107 is held against the incision in the breast. The length of the body member 3107 is sufficient to extend to the surface of the skin, regardless of the distance from the skin to the tooth cavity 202 after tumor removal. When the device 3100 is deployed, the device tends to reach a central position within the tooth cavity 202, for example, as shown in FIGS. 32D-32F.

Alternatively, it is possible for the device 3100 to move within the tooth cavity as the device 3100 deploys because the amount of elongated member penetrating into adjacent tissue is different. For example, as shown in FIG. 32H, the area adjacent to the skin is less likely to be penetrated by the elongated member 3106 compared to the tissue beneath the tooth cavity 202. As shown in FIG. 32H, the elongated member 3106 is small enough that at least some of the elongated members (eg, the elongated member 3106)._i、3106_iiEtc.) are cut, cleaved or otherwise penetrated into the tissue around the tooth cavity 202 to deliver radiation to deeper tissue than if the elongated member 3106 did not penetrate into the adjacent tissue. Will be. In this way, the elongate member 3106 can penetrate the tissue and, in some cases (eg, as shown in FIG. 32H), can be circumferentially surrounded by adjacent tissue so that the device 3100 is intra-tissue. It is possible to effectively arrange radionuclides in.

FIG. 32D is a perspective view showing the breast 200 and the tooth cavity 202, where the device 3100 is shown in a fully unfolded shape. As shown in this figure, the elongated member 3106a can be pressed beyond the wall of the tooth cavity 202, so that the tissue around the member 3106a is invaginated, for example, a part of the wall tissue 3120 is an elongated member. Flows between 3106a, extrudes or spreads inward, effectively surrounding the elongated member. In one embodiment, the wall structure 3120 may extend radially inward about 0.7 cm from the outermost elongated member 3106a. However, the actual indentation distance can vary based on multiple variable factors, such as the size and shape of the device, the size and shape of the tooth cavity and the tissue properties. The elongated member 3106b preferably stays within the diameter defined by the innermost portion of the extruded wall structure 3120. As can be seen from this figure, the invagination substantially anchors the device 3100 to the surrounding tissue and deforms the cavity until the cavity 202 roughly matches the shape of the device 3100.

In one embodiment, it is possible to connect a vacuum system (not shown) to device 3100. This vacuum system increases the degree of tissue invasion by applying vacuum pressure to the tooth cavity 202. Such a vacuum system may remain activated for all or part of the duration of the transplant, or may be disconnected immediately after treatment, for example in HDR treatment.

In yet another embodiment, the elongated member 3106a may be conductive or otherwise excited, for example by radio frequency (RF). By activating the elongated member 3106a after deployment in this way, the elongated member 3106a can bite into the wall of the tooth cavity, thereby allowing it to penetrate deeper into the surrounding tissue and further increase the degree of invagination. Can be done.

FIG. 32E shows a cross-sectional view of the implanted and fully deployed device 3100. The inwardly extending wall structure 3120 is clearly visible in this figure. FIG. 32F is a partial perspective cross-sectional view of the tooth cavity 202 showing the elongated member 3106 schematically shown in an unfolded shape.

FIG. 32G shows a cross-sectional view of the tooth cavity 202 when the device 3100 is in an unfolded shape (and some structures of the device 3100 are omitted for clarity). This figure further shows an exemplary dose cloud provided by the brachytherapy means contained within the elongated member 3106. For example, each elongated member 3106a results in a dose cloud commonly represented by the circle 3122, whereas each elongated member 3106b is simplified, commonly represented by the circle 3124. Can bring a dose cloud. These circles 3122 and 3124 represent a valid two-dimensional cloud boundary in a particular cross section, i.e. the dose cloud has two radiations, an outer layer around the elongated member 3106a and an inner layer around the elongated member 3106b. Form a layer. The actual cloud formed by each elongated member 3106 will have an approximately curved cylindrical shape.

The three-dimensional accumulation effect of all sources in each of the two layers of the elongated member 3106 is a therapeutic dose cloud shell that extends over the volume of tissue that directly surrounds the tooth cavity 202. With proper dose mapping and dose selection, this three-dimensional dose cloud shell typically delivers the right therapeutic dose to the right tissue area (eg 1 cm beyond the wall of the tooth cavity 202). Above etc.). Due to the interstitial nature of many radio sources, it is available when all radionuclide sources are located in or near the edges of the tooth cavity 202 (eg, as can occur with balloon applicators or intracavitary applicators). It is possible to deliver a therapeutic dose to the desired tissue area with less risk of such overdose effects.

Moreover, unlike balloon applicators, individual elongated members 3106 can locally apply individual radial forces to the surrounding tissue. Since the balloon applicator has a continuous surface, it applies a relatively continuous radial force to the adjacent cavity surface along that surface. On the other hand, since the elongated member 3106 is provided intermittently and has a space between them, each elongated member 3106 is an elongated member at the time of expansion by applying an extremely local radial force to the cavity surface. The organization will invade inside.

With reference to FIG. 32H, one or more elongated members 3106a, depending on the application._iv, 3106a_vIs placed in a relatively thin area of tissue area adjacent to the tooth cavity 202, for example adjacent to the patient's skin. If a container or other source of radiation with uniform radiation intensity is introduced into each elongated member 3106, there is a risk of over-irradiating or "burning" such thin tissue areas or the skin itself. Therefore, in the dose plan, the elongated member 3106a_iv, 3106a_vA source of radiation that has a relatively low radiation intensity within, or one or more "turned off" (ie, one or both elongated members 3106a)._iv, 3106a_vIt may be recommended to introduce seeds (with non-radioactive spacers between the sources along at least part of the).

Although optional, it may be recommended in dose planning to irradiate thin areas from the inner layer of the elongated member. For example, as shown in FIG. 32H, a single elongated member 3106b_iThe elongated member 3106a_iv, 3106a_vIt is possible to arrange the core member 3110 closer to the central axis of the core member 3110. This single elongated member 3106b_iIntroducing a radiation source inside the elongated member 3106a_iv, 3106a_vIrradiate into a thin tissue area beyond. Therefore, it is possible to provide an inner layer of the elongated member to further enhance the local radiation supply according to the desired dose plan.

In the embodiments shown in FIGS. 32D-32H, the elongated members 3106 are formed so as to have a maximum diameter of about 1 cm (which can be up to about 3 cm) with respect to each other (in a fully unfolded state). obtain. In addition, it is possible to obtain a therapeutic dose cloud (circles 3122 and 3124) of approximately 1 cm around the wire by a radiation source, such as the seed 108, as described elsewhere herein. As a result, the device 3100 is capable of irradiating all or substantially all the cavity walls and surrounding tissues as represented by the circles 3122 and 3124 in FIG. 32G. The radiation source used with the device 3100 can be a low dose rate source or a high dose rate source intermittently supplied (eg, iridium or ytterbium).

After the end of brachytherapy treatment, the device 3100 is returned to its collapsible shape and it is possible to remove the device 3100 from the breast 200 through an insertion incision.

Figures 33A-33G show the brachytherapy device 3600 according to yet another embodiment. The device 3600 comprises brachytherapy means 3602 having a treatment supply portion 3604 and an external portion such as a tail portion 3606.

As shown in FIG. 33A, this treatment supply portion 3604 can be formed by a deformable elongated radiation source, eg coil member 3608. The coil portion 3608, winding One around the elongate core member 3610 may form a vignetting helical coil. At least one end (eg, a close end) of the coil member 3608 is fixed to a mounting member (eg, sleeve 3612) that translates and / or rotates around the core member 3610. This configuration allows for thin means that can be inserted through a relatively small incision into a region of interest, such as a cavity after tumor removal (not shown). However, once in place, the coil member 3608 unfolds to form a spiral path within the tooth cavity as shown in FIG. 33B. To deploy Means 3602, a sleeve 3612, which may extend out of the body after transplantation, is rotated relative to the core member 3608. By rotating the sleeve relative to one direction, the coil member 3608 unfolds, or moves away, from the central core member 3610. By rotating the sleeve 3612 relative to each other, the coil member 3608 is similarly contracted around the core member 3610. The greater the diastolic rotation, the greater the radial force exerted on the cavity wall after tumor removal. As the force exerted on the cavity wall after tumor removal increases, the degree of invasion into the breast tissue increases due to the rotation of the deployed coil member 3608.

In addition to the rotational movement of the sleeves 3612, these sleeves can also translate axially with respect to the core member 3610. It is possible to adjust the length of the coil member 3608 in the unfolded shape by translating in the axial direction. The device 3600 provides a wide variety of post-tumor cavity sizes and shapes because the axial length and diameter of the coil member 3608 (and the concomitant deployment force with respect to the cavity wall) can be adjusted individually. Can be used to treat.

FIG. 33C shows an enlarged view of means 3602 in a partially unfolded position. FIG. 33D shows a cross-sectional view of the radioactive coil member 3608 viewed perpendicular to the central longitudinal axis of the coil member 3608 (eg, along line DD in FIG. 33C), whereas FIG. 33E shows the coil member. It shows the cross-sectional view seen from the longitudinal axis of 3608. As is clear from these figures, in one embodiment, the coil member 3608 is an elongated tube, the first cavity 3614 and the second cavity 3616 extending through the elongated tube between the sleeves 3612. Can have and. The first lumen 3614 may accommodate a radiation source, such as a series of radioactive seeds 108, offset from each other by any spacer 110 as shown in FIG. 33E. The second lumen 3616 may have a molding and / or reinforcing member, such as a molding wire 3618. The forming wire 3618 imparts rigidity and torsional resistance to the coil member 3608. In the illustrated embodiment, the forming wire 3618 (and the second cavity 3616 associated therewith) has a rectangular cross section as shown in FIG. 33D. This rectangular shape provides the desired torsional resistance to the deploying radiation source 3608, for example keeping the first lumen 3614 laterally positioned relative to the core member 3610 during deployment. However, it is natural that other shapes can be used without departing from the scope of the present invention.

The elongated tube forming the coil member 3608 can be made from a variety of materials. For example, in one embodiment, the elongated tube may consist of an extruded fluoropolymer or a thermoplastic similar to the material previously described in the context of member 2906.

The forming wire 3618 can be formed from any material capable of accommodating the spiral development without causing excessive twisting or permanent deformation. An exemplary material for the forming wire is, for example, a shape memory alloy such as nitinol.

In use, the means 3602 can be inserted through a tissue structure, such as the breast 200, with the treatment supply portion 3604, such as the coil member 3608, folded along the longitudinal axis of the device 3600. Insert the coil member until it is approximately centered within the cavity 3620 after tumor removal as shown in FIG. 33F. Means 3602 may be inserted through an existing incision (eg, an incision formed during tumor resection) or via a hollow needle (not shown) as described, for example, in the context of other embodiments. It may be arranged. Once the means 3602 is approximately in place as shown in Figure 33F, the physician will move the sleeve 3612, which is shaped to project from both sides of the breast 200 (eg, twist and / or move axially). Operate to deploy means 3602. FIG. 33G shows the shape of means 3602 when fully deployed within the tooth cavity 202. In an exemplary embodiment, the means 3602 is unfolded so that the spiral coil member 3608 is pushed into the cavity wall as described above (see, eg, FIGS. 32D-32G) and the device 3600 is peripherally tissued. Fixed to.

To secure the means 3602 in place, the physician folds the sleeves 3612 extending out of the body against the skin and secures these sleeves, for example with tape. Alternatively, the locking member 3622 can be slid over the end of the core member 3610. Each locking member 3622 can be frictionally engaged with its own sleeve 3612 along with the core member 3610. By fixing the sleeve 3612 to the core member 3610, it is possible to hold the means 3602 in a generally fixed position during the course of treatment.

Although described herein as using a proximity and / or distal sleeve that can project from outside the body during transplantation, another configuration with a non-protruding sleeve is also possible. In this case, a tool, such as a hollow needle (not shown), is inserted onto the core member and mechanically locked to the sleeve to provide these sleeves to the core member in the desired form (from outside the body). Can be operated.

FIG. 34 shows a modification of the single entry point in the brachytherapy means 3702, which is similar to the means 3602 shown in the previous figure. In this example, a brachytherapy means 3702 with a treatment supply portion 3704 and a single tail 3706 is provided. The treatment supply portion 3704 can be formed as a coil member 3708 as having substantially similar structure to the aforementioned coil member 3608 (eg, spirally wound around a core member 3710). The tail 3706 can also be formed as a sleeve 3712 that is in all respects similar to the sleeve 3612 described above. For example, the sleeve member 3712, which may be connected to the near end of the radiation source 3608, may be manipulated to slide around the core member 3710 and / or rotate further.

Unlike means 3602, the distal end of coil member 3708 was provided extracorporeally by being attached directly to or near the distal end of core member 3710 as shown in FIG. Manipulation of a portion of the core member 3710 results in the movement of the distal end of the radiation source.

In use, the means 3702 is inserted through the body (eg, breast 200) in a collapsible form to allow the treatment supply portion 3704 (eg, coil member 3708) to be positioned in the tooth cavity 3620 after tumor removal. Means 3702 may enter through an existing incision (eg, formed during tumor resection) or, for example, a needle (not shown) as detailed elsewhere in the context of another embodiment. It may be positioned through. Once the means 3702 is approximately in place as shown in FIG. 34, the physician can operate both the sleeve 3712 and the core member 3710, both of which project from the close side of the breast 200. That is, when the sleeve 3712 is moved axially toward the distal end of the core member 3710 while rotating the core member 3710 (fixed to the distal end of the coil member 3708), the center of the coil portion 3708. It is possible to unfold the portion away from the core member 3710 to form an unfolded shape (again, the means 3702 can be unfolded into the tissue as described herein. See 32D ~ 32F). The means 3702 can be fixed in the unfolded shape using, for example, a locking member 3622, in a manner similar to that previously described in the context of the means 3602.

It should be noted that just as device 3100 includes an inner array of element 3106b and an outer array of element 3106a, in an alternative embodiment of device 3600/3700, the inner coil (not shown) coincides with the outer coiled member 3608. It may have a coiled member. In either case, these bilayer means allow the supply of new radial layers of radiation. When combined with tissue invagination, these dual layers can provide multiple shells or layers of dose cloud to cover a significant thickness of curved breast tissue around the cavity after a given tumor resection. It becomes.

The devices described herein allow brachytherapy means (or other sources of radiation) to deliver radiation from a location within the tooth cavity to the tissue surrounding the tooth cavity through a single entry point. Is possible. In addition, the intracavitary devices, methods and systems described herein allow one or more sources of radiation to be substantially immobilized on the tissue of interest surrounding the tooth cavity. Peripheral tissue can be adequately anchored by sufficient invagination around the means, and / or the desired radiation dose to the tissue adjacent to the cavity after tumor removal over the entire transplant period. The approach is deep enough. As a result, it becomes possible to supply a desired dose to a specific tissue during the process of brachytherapy treatment. In addition, it is possible to minimize irradiation to unintended tissue (by moving the means to the surrounding tissue).

The brachytherapy measures described herein can be implanted intratumorally (and / or in the vicinity) prior to (neoadjuvant) surgical resection and subsequently before or during surgery. It can be taken out. Such treatment can also shrink or destroy the tumor. In another example, the devices and methods described herein are capable of providing brachytherapy after surgical removal of the tumor tissue and postoperatively treating the surrounding tissue (breast). After tumor removal). In some cases, the brachytherapy devices and methods illustrated herein complement the need for conventional treatment options such as tumor resection, total field radiation therapy (EBRT) and chemotherapy. It can be considered that it can be reduced or mitigated. Alternatively, the methods described herein can be performed in an adjunct manner in addition to or other therapies, such as chemotherapy or external beam radiotherapy.

With the treatment according to the present invention, in HDR treatment, for example, high radioactivity, irradiation of unintended tissues, sometimes bulky protruding catheters and / or the patient must be repeatedly visited for treatment, etc. It is possible to avoid that disadvantage. Alternatively, the devices and methods described herein can be used to perform HDR therapy, for example by supplying one or more HDR sources along the path of the means according to known HDR dose planning. Is possible. In yet another example, HDR radiation sources such as postload cables with iridium chips by Varian Medical Systems or small diameter X-ray sources as disclosed in US Patent Publication No. 2005/0061533A1 are described herein. It is possible to enter through any of the core members and allow expandable means to provide a more uniform supply of radiation to the tissues around the cavity by opening the cavity. Optionally, the core member shields the radiation source, allowing the radiation source to be directed at a desired portion of the surrounding tissue.

The brachytherapy measures described herein are substantially more flexible than conventional HDR catheters and can be arranged linearly or curvilinearly (eg, curved or spiral). This flexibility allows the implantation of radiation sources (such as seeds) in shapes and arrangements that would otherwise be inaccessible.

In addition, the devices and methods according to the invention make it possible to obtain the desired dose with a relatively small number of catheters. For example, the devices and methods described herein make it possible to obtain the desired dose delivery level with fewer subject-specific catheters than typically used in conventional HDR methods. However, the means described herein can be implanted using conventional imaging methods (eg, stereotactic fixed X-rays, ultrasound, CT, etc.).

The devices and methods of the present invention also provide additional benefits to the patient. For example, it is possible to reduce skin damage and discomfort by inserting a smaller and more flexible catheter. In addition, the small, flexible tail can be trimmed short once properly positioned, but unlike rigid HDR catheters, it can also be folded and taped to the skin. Therefore, it is possible to reduce patient discomfort over the course of treatment and obtain a potential improvement in postoperative rectification. In addition, the devices and techniques according to the invention, for example, potentially reduce side effects compared to other treatments such as EBRT and chemotherapy, for example, the number of visits in the course of the treatment regimen compared to current HDR brachytherapy, for example. May decrease.

In addition, the brachytherapy supply systems described herein are capable of providing standard dose irradiation based on lesion size. As a result, for some types of cancer (such as breast cancer), the need for large dose calculation and mapping systems can be reduced or omitted.

Further information on brachytherapy devices and methods is available in this co-pending application, Nos. 10 / 658,518, filed September 9, 2003, and Nos. 60 / 731,879 and 2005, filed October 31, 2005. It can be obtained from No. 60 / 735,532 filed on November 10, 2014.

Illustrative examples of the present invention have been described above. Those skilled in the art will recognize that many examples are conceivable within the scope of the present invention. Other variations, modifications and combinations of the various elements and methods described herein are, of course, within the scope of the present invention. For example, any of the therapeutic means described herein can be combined with the supply systems and methods described herein as well. Therefore, the present invention can be limited only by each of the claims described below and their equivalents.

<figref num="1">It is a figure which shows the example brachytherapy device or kit in one Example.</figref><figref num="2A">It is the schematic explaining the method for using the brachytherapy apparatus in FIG.</figref><figref num="2B">It is the schematic explaining the method for using the brachytherapy apparatus in FIG.</figref><figref num="2C">It is the schematic explaining the method for using the brachytherapy apparatus in FIG.</figref><figref num="2D">It is the schematic explaining the method for using the brachytherapy apparatus in FIG.</figref><figref num="2E">It is the schematic explaining the method for using the brachytherapy apparatus in FIG.</figref><figref num="2F">It is the schematic which shows the brachytherapy apparatus in another Example.</figref><figref num="3A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="3B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="4A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="4B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="5A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="5B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="5C">It is a figure of the means for brachytherapy in FIGS. 5A and 5B which illustrates the exemplary removal method.</figref><figref num="6">It is a development view of the device or kit for brachytherapy in still another example.</figref><figref num="7">It is a figure of the brachytherapy device in FIG. 6 which was partially assembled.</figref><figref num="8A">It is the schematic explaining the use method of the brachytherapy apparatus in FIGS. 6 and 7.</figref><figref num="8B">It is the schematic explaining the use method of the brachytherapy apparatus in FIGS. 6 and 7.</figref><figref num="8C">It is the schematic explaining the use method of the brachytherapy apparatus in FIGS. 6 and 7.</figref><figref num="8D">It is the schematic explaining the use method of the brachytherapy apparatus in FIGS. 6 and 7.</figref><figref num="8E">It is the schematic explaining the use method of the brachytherapy apparatus in FIGS. 6 and 7.</figref><figref num="9A">It is an enlarged partial view of the brachytherapy apparatus in another example.</figref><figref num="9B">It is an enlarged partial view of the brachytherapy apparatus in another example.</figref><figref num="10A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="10B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="11A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="11B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="12A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="12B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="13A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="13B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="14A">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="14B">It is an enlarged partial view of the means for brachytherapy in still another example.</figref><figref num="15">It is the schematic of the brachytherapy apparatus in another example.</figref><figref num="16A">It is a schematic diagram illustrating a non-linear brachytherapy device and method in various examples, showing a dual off-axis catheter assembly.</figref><figref num="16B">It is a schematic diagram illustrating a non-linear brachytherapy device and method in various examples, showing a dual off-axis catheter assembly.</figref><figref num="16C">It is a schematic diagram illustrating a non-linear brachytherapy device and method in various examples, showing a dual off-axis catheter assembly.</figref><figref num="16D">It is a schematic diagram illustrating a non-linear brachytherapy device and method in various examples, showing a dual off-axis catheter assembly.</figref><figref num="16E">It is a schematic diagram illustrating a non-linear brachytherapy device and method in various examples, showing a dual off-axis catheter assembly.</figref><figref num="16F">It is a schematic diagram explaining the device and method for brachytherapy which is non-linear in various examples, and shows the catheter which has a spiral shape.</figref><figref num="16G">It is a schematic diagram explaining the device and method for brachytherapy which is non-linear in various examples, and shows the catheter which has a spiral shape.</figref><figref num="17A">It is a figure which shows the brachytherapy apparatus in another example.</figref><figref num="17B">It is a figure which shows the brachytherapy apparatus in another example.</figref><figref num="18">It is a figure which shows the radiation attenuation garment such as a brassiere in one Example.</figref><figref num="19A">FIG. 5 is a schematic representation of a balloon catheter assembly, such as an HDR catheter, in one embodiment.</figref><figref num="19B">FIG. 5 is a schematic representation of a balloon catheter assembly, such as an HDR catheter, in one embodiment.</figref><figref num="19C">FIG. 5 is a schematic representation of a balloon catheter assembly, such as an HDR catheter, in one embodiment.</figref><figref num="20">Illustrative examples of supply or transplantation systems used with brachytherapy methods and devices described herein.</figref><figref num="21">FIG. 2 is a schematic representation of the supply system in FIG. 20 that can be used with the brachytherapy methods and devices described herein, such as the methods shown in FIGS. 2A-2F and 8A-8E.</figref><figref num="22">FIG. 2 is an enlarged view showing a template for guiding an exemplary catheter, such as a needle, used with the supply system of FIG.</figref><figref num="23">It is a schematic diagram showing another supply or transplantation system used with the brachytherapy methods and devices described herein.</figref><figref num="24">It is a development view which shows a part of the supply system in FIG. 23, for example, a cartridge.</figref><figref num="25A">FIG. 5 is a schematic illustrating a supply or porting system and method according to yet another embodiment.</figref><figref num="25B">FIG. 5 is a schematic illustrating a supply or porting system and method according to yet another embodiment.</figref><figref num="25C">FIG. 5 is a schematic illustrating a supply or porting system and method according to yet another embodiment.</figref><figref num="25D">FIG. 5 is a schematic illustrating a supply or porting system and method according to yet another embodiment.</figref><figref num="26">It is a figure which shows the part of the human body such as a woman's breast after the means for brachytherapy described in this specification is transplanted and fixed.</figref><figref num="27">It is a cross-sectional view which shows a part of the supply system in FIGS. 25A to 25D.</figref><figref num="28A">An intracavitary brachytherapy treatment device, FIG. 28A, is a diagram showing, for example, a linearly folded shape.</figref><figref num="28B">It is a figure which shows the brachytherapy treatment apparatus in a cavity which is partially expanded or expanded shape.</figref><figref num="28C">It is a figure which shows the brachytherapy treatment apparatus in a cavity which is partially expanded or expanded shape.</figref><figref num="28D">It is a figure which shows the brachytherapy treatment apparatus in the cavity which has a completely expanded shape.</figref><figref num="29A">FIG. 3 is a perspective view showing an intracavitary brachytherapy treatment device in an expanded or expanded shape, such as a curved line.</figref><figref num="29B">FIG. 5 is a cross-sectional view showing an intracavitary brachytherapy treatment device, for example, which is in a linearly folded shape and is installed in a cavity after tumor removal.</figref><figref num="29C">It is sectional drawing which shows the brachytherapy treatment apparatus in a cavity which is in a partially expanded shape in a cavity.</figref><figref num="29D">It shows the brachytherapy treatment apparatus in the cavity, and is the figure which shows the cross section along the line 29D-29D of FIG. 29C.</figref><figref num="29E">It shows an intracavitary brachytherapy treatment device and is another partial cross-sectional view showing a part of the device in FIG. 29D.</figref><figref num="29F">It is a perspective view which shows a part of the intracavitary brachytherapy treatment apparatus.</figref><figref num="30A">It is a side view which shows the brachytherapy treatment apparatus in the cavity in still another Example, and shows the device which is in an expanded or expanded shape, for example, a curve.</figref><figref num="30B">FIG. 5 is a cross-sectional view showing an intracavitary brachytherapy treatment device in still another embodiment, showing a folded shape such as a straight line.</figref><figref num="30C">FIG. 5 is a cross-sectional view showing an intracavitary brachytherapy therapy device in yet another embodiment, showing the device in an unfolded or unfolded shape.</figref><figref num="31A">FIG. 5 is a perspective view showing an intracavitary or curved brachytherapy treatment device according to still another embodiment, which is in a folded shape such as a straight line.</figref><figref num="31B">FIG. 5 is a perspective view showing an intracavitary or curved brachytherapy treatment device according to still another embodiment, which is in an expanded or expanded shape such as a curved line.</figref><figref num="31C">FIG. 5 is a side view showing an intracavitary or curved brachytherapy treatment device in yet another embodiment, which is in a folded shape.</figref><figref num="31D">FIG. 5 is an end view showing an intracavitary or curved brachytherapy treatment device in yet another embodiment, which is in a folded shape.</figref><figref num="31E">FIG. 5 is a cross-sectional view showing an intracavitary or curved brachytherapy treatment device in yet another embodiment, which is in a folded shape.</figref><figref num="31F">FIG. 5 is a cross-sectional view showing an intracavitary or curved brachytherapy treatment device in yet another embodiment, which is in an expanded shape.</figref><figref num="32A">It illustrates an exemplary method of using the device in FIGS. 31A-31F to supply brachytherapy to the tooth cavity in the human body, for example the tooth cavity after tumor removal in the breast, which was folded and transplanted. It is a perspective view which shows the apparatus.</figref><figref num="32B">It illustrates an exemplary method of using the device in FIGS. 31A-31F to supply brachytherapy to the tooth cavity in the human body, for example the tooth cavity after tumor removal in the breast, which was transplanted and folded. It is a front view which shows the apparatus.</figref><figref num="32C">It illustrates an exemplary method of using the device in FIGS. 31A-31F to supply brachytherapy to the tooth cavity in the human body, for example the tooth cavity after tumor removal in the breast, which was transplanted and folded. It is a side view which shows the apparatus.</figref><figref num="32D">It illustrates an exemplary method of using the device in FIGS. 31A-31F to supply brachytherapy to a tooth cavity in the human body, such as a tooth cavity after tumor removal in the breast, and is an expanded shaped device. It is a perspective sectional view of the breast including.</figref><figref num="32E">It illustrates an exemplary method of using the device in FIGS. 31A-31F to supply brachytherapy to a tooth cavity in the human body, such as a tooth cavity after tumor removal in the breast, and is an expanded shaped device. It is a cross-sectional view of the breast including.</figref><figref num="32F">It illustrates an exemplary method of using the devices in FIGS. 31A-31F to supply brachytherapy to the tooth cavities in the human body, such as the cavities after tumor removal in the breast, where the devices expand within the cavities. It is the schematic which shows the state which was done.</figref><figref num="32G">It illustrates an exemplary method of using the device in FIGS. 31A-31F to supply brachytherapy to a tooth cavity in the human body, such as a tooth cavity after tumor removal in the breast, provided by the device. It is a schematic cross-sectional view which shows a typical radiation covering area.</figref><figref num="32H">It is a cross-sectional view which shows the device expanded in the cavity after tumor excision in the tissue structure while showing the state which the elongated member of the device penetrates through the surrounding tissue.</figref><figref num="33A">FIG. 5 is a side view showing an intracavitary brachytherapy treatment device in yet another embodiment, which is in a folded shape.</figref><figref num="33B">FIG. 5 is a perspective view showing an intracavitary brachytherapy treatment device in still another embodiment, which is in an expanded shape.</figref><figref num="33C">FIG. 5 is a side view showing an intracavitary brachytherapy treatment device in still another embodiment, which is in an expanded shape.</figref><figref num="33D">It is an intracavitary brachytherapy treatment device in still another embodiment, and is a cross-sectional view taken along line 22D-22D of FIG. 33C.</figref><figref num="33E">It is another cross-sectional view of the brachytherapy treatment apparatus in the cavity in still another example.</figref><figref num="33F">It is a figure which shows the brachytherapy treatment apparatus in the cavity in still another Example, which was transplanted into the target tissue area and partially expanded.</figref><figref num="33G">It is a figure which shows the brachytherapy treatment apparatus in the cavity in still another Example, which is completely expanded in the target tissue area.</figref><figref num="34">It is a figure which shows the brachytherapy apparatus in still another Example which is in an expanded state in a target tissue area.</figref>