CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit and priority pursuant to 35 U.S.C. § .5 1 (e) from U.S. .Provisional Patent Application Serial No. 61/541 ,715 filed on September 30, 201 L the content of which is hereby incorporated by reference.

FIELD OF THE DISCLOSURE

[0002] Exemplary embodiments of the present disclosure relate to apparatus and methods for treating internal tissue disorders, and more particularly, to apparatus and methods for the treatment of such disorders by direct application of radiation and or pharmacological therapy to areas within a patient's body.

BACKGROUND INFORM ATION

1 _. 0003] Internal tissue disorders (e.g., cancer) can be a result of genetic-malformations or can arise from sickness or trauma. Such disorders can typically be treated, for example, with, the application of pharmaceuticals (e.g., directly or syste icaily), by the application of tissue altering forces (e.g., radiotherapy), or by surgical intervetttioa. fO00 j In certain instances, the choice and application of treatments can be distinctly separate, and can be performed in a prescribed order sod fashion. However,, it can be beneficial to provide an optimal combination of treatments directly to the site of the disorder within the same procedure. Such treatment options, however, are generally _, not easily achievable.

[0005] Thus, it may be beneilcral to provide a treatment option directly to the site of the disorder that can be combined with other treatment options. Accordingly, it is the object(s) of the present disclosure include addressing ami/or overcoming at least some of the deficiencies described herein above.

SUMMARY OF EXEMPLARY EMBODIMENTS

[0006} These and other objects of the exemplary disclosure can be achieved by provision of a treatment apparatus and method for using the treatment apparatus in at least one tissue ofa patient. For example, the treatment apparatus can. comprise a first structural arrangement configured to expand a first portion of a distal end of the apparatus, a second structural arrangement configured to expand a second portion of the distal, end and. at ieaaf. one lamea associated with at least one of the first structural arrangement or the second structural, arrangement. The first stractoral arrangement and/or the second, structural arrangement can be configured to position the at least one I amen at a particular position with, respect to the tissue. A tip at the distal end can be configured to aid in the insertion, of the apparatus into the Ussae(s). The iumen(s) can. be located between the first structural arrangement and the second structural arrangement. The second structural arrangement can be configured to expand the tissue(s), and the first structural arrangement can be configured, to positions the !urnen(s) at a particular position with respect to the (issue(s).

( _. 0007] In certain exemplary embodiments, ihe lumen(s) can comprise ai least 8 lumens, e.g, equally spaced circamferentially around the distal end. One of the lumens can be labeled to provide a reference point for all of the lumens. One of the lumens can configured to receive a ^• treatment ^' option, which can be a radiation source or a pharmacological agent, A second lumen can be located substantially in the center of the apparatus. The apparatus can he configured i be guided into the tubular structure using a guide, which can be an endoscope, a cable or a wire, A proximal end of the apparatus can ha ve distance markers spaced equally apart, which can be detected by an imaging arrangement which can aid in the insertion of the apparatus. The firs! structural arrangement and/or the second structural arrangement can be a baffle. The first structural arrangement and/or the second structural, can be filled with sterile water or air. A single baffle source can inflate the first structural arrangement and the second structural arrangement, or two ^' baffles sources can be included, one each for filling the first structural arrangement and the second structural arrangement. The apparatus can be an anorectal applicator, an esophageal applicator, a sigmoid applicator, and/or a colon applicator.

|0Θ68 ^' ] These and other objects, features and advantages of the present disclosure will become apparent upon reading the following detailed description of exemplary embodiments of ^' the present ^' disclosure, when taken in conjunction with the appended drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Further objects, features and advantages of the present disclosure will become apparent .from the ioS Sowing detailed description, taken in conjunction with the accompanying drawings showing illustrative embodiments of the present disclosure, in which: [0010] Figure 1 is a side view of the exemplary applicator according to an exemplary embodiment of the present, disclosure;

10011 j Figure 2 is s cross-section of the exemplary applicator of Figure 1 according to an exemplary embodiment of the present disclosure;

[0012] Figure 3 is a partial cross-section of the exemplary applicator from Fig. 1 according to art exemplary embodiment of the present disclosure;

[0013] Figures 4A and 4B are cross-sectional views of the exemplary applicator irom Figure i according to an exemplary embodiment of the present disclosure; 1 _. 0014} Figure 5 is a side view of the xemplary applicator from Figure ! according to an exemplar embodiment of the present disclosure;

1 _. 0015] FIGS 6A-6D are side views of the exemplary applicator of Figure I at different inflation points according to an exemplary embodiment of the present disclosure; and

1 _. 0016] Fi ure 7 is a method for treating a patient using the exem lary applicator of Figure 3 according to an. exemplary embodiment of the presen t disclosure.

I ^' OOl?] Throughout tiie figures, the s ne reference numerals and characters, if any and unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the subject disclosure will now he described ia detail with reference to the figures, it is done so in connection with the illustrative embodiments, it is intended thai changes and modifications can be made to the described exemplary embodiments without departing from the true scope and spirit of the subject disclosure.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

1 _. 0038] Exemplary embodiments of the present disclosure may be further understood with reference to the following description and tire related appended drawings. The exemplary embodiments of ihe present disclosure relate to an applicator that can be used to treat miemal tissue disorders by targeting multiple treatments directly to the internal tissue disorder. For ^' example, the exemplary applicator can use a plurality oflitmeas to provide the treatment directly to the disorder de ending on where M the tabular ^' structure the disorder is located. Those having ordinar skill in the art will understand that the exemplary embodiments of the present disclos ure can be implemented i any tubular structure in the body of a patient (e.g . _; the rectum, the nose, the lungs, the Gl track, etc) [00191 Figure 1 shows a side view of an exemplary applicator/arrangement apparatus 1 (^according to an exemplary embodiment of the present disclosure in an inflated form, for delivering treatment to an internal tissue disorder. Exemplary applicator 100 can have a distal or treatment, end 105 that can be inserted into the tubular structure and a proximal end. 125 (e.g.., a handle or handle extension). Distal end 105 cm include a tip 140 which can be configured to aid in the .insertion of exemplary applicator 100 into the tubular structure. For example, tip 140 can be smaller than the width of distal end 105, and can increase in size towards distal end 105. With the aid of a lubricant (e.g., liquid, gel or the like), exemplary applicator 100 can be inserted into a tubular structure by inserting tip 140 into the tubular structure until the desired location is reached.

[0020] Distal end 105 can include an outer baffle 1 10, an inner bailie .! 15, and a plurality of source lumens 120 which can be located circaraferentially around distal end 105 in one or both of outer baffle .1 10 and inner baffle 1 15 or separately therefrom. Additionally, a single center source lumen 145 can be provided which can exetnd substantially through the center of distal end 105. iimer baffle 1 10 and outer baffle 1 15 can inflate d istal end 105 in order to move source lumens 120 closer to the targeted treatment area. Exemplary applicator 100 can. be fitted upon a guide 150 (e.g., an endoscope, a cable, a guide wire, or the like). A center channel i 55 can be used to glide the apparatus over guide 150, for example, from a proximal to a distal location after guide 150 is placed. Accordingly, exemplary applicator 100 can be positioned, e.g., via cable and/or wire 150, at the location of the treatment Site, and can be held stationary or otherwise maintained at the location of treatment Alternately or in addition, exemplary applicator 100 can be fixed to the endoscope, cable, or guide wire, and can be introduced simultaneously with the endoscope, cable or guide wire placement at the treatment site. I fMi 21 J Source lumens 120 can provide radial access to an intended treatment site for the placement of therapeutic agents, such as, e.g., high dose radiation, chemotherapy, etc.

Further, there can be additional tabes along the axis that are connected to outer baffle i 10 and inner baffle 1 .15. As can be seen in Figure 2, inner baffle 1 1.5 can be located between the center core opening and source lumens .120, facilitating the expansion and separation, of source lumens 120 or it can be located outsi de o f source lumens ! 20 when viewed, from the front. Inner baffle 1 i 5 can be composed of a compliaiit or non-compliant material,, and can be configured or structured to position, the tabes at a predetermined position. Outer baffle i 10 cart be disposed over the outside of the treatment tubes thus facilitating an expansion in order to fixate and align the treatment area of the device relative to the wall of the intended treatment site. Outer baffle 110 can be composed of a compliant or non-compliant material (e.g., an elastomer material), and can position the treatment delivery tabes at one or more positions and/or locations relative to the treatment site.

[ ^' 0O22 ^; j Outer baffle I. ! 0 can be configured to ex and the tabular structure exem la )? applicator 100 has been inserted into. Inner baffle i 15 can then be used to expand source lumens 120 to be in close proximity of the wall of the tabular structure.

[0023] Outer baffle 1.1.0 can include a restrictor arrangement which can be configured and/or structured to contour outer baffle 110 in order to better position and target the treatment to the treatment site. The exemplary restrictor.arrangemetu can include various t ng , bands, sleeves, tongues, etc. that can facilitate Control over the shape and contour the baffle for the proper position and targeting of the treatment of the anatomical structure . According to certain exemplary embodiments of the present disclosure, the restrictor arrangement can be slidable to position the restrictor over exemplary applicator 100, Alternatively or in addition, the shape and contour of outer baffle 1 1 can be facilitated through the use of multiple baffles , in certain exemplary embodiments of the presen disclosure, outer baffle 110 and/or inner baffle 1 15 can be filled with sterile water and have a drain mechanism for easier device removal. In addition to utilization of a low coefficient of friction material for the inner channel, the outer most .material can. also have a kbricious characteristic. [0024 j inner baffle 115 can be configured to open to a predetermined diameter, and set the array of source lumens 120 equidistant from one another. Outer baffle 1 1 can be con figured to provide a determinable water layer between the radiation sourcefs) and the treatment site, facilitating a dosimetric optimisation. Source kmem 120 can be provided or sandwiched between, inner baffle .1 1 and outer baffle i 20, and can therefore be provided in a straight and/or parallel · configuration with, respect to the treatment site thus providing a definitive "Effective Treatment. Zone*. Radiopaque ^' markers at the proximal and distal ends of the Effective Treatment Zone, as well as along the axis of the tubes, can be used to facilitate an accurate placement confirmation with standard imaging techniques. One or more additional tubes (e.g., center source lumen 145} along the center axis of the. device can provide another mechanism, of administering an optimized treatment dose such as a pharmacological agent. The center tube can also accept a removable stiffening mandrel providing added rigidity during device insertion.

[00251 Figure 3 shows a partial cross-section of exemplary applicator 100. Exemplary applicator 100 can have any suitable number of source lumens (e.g., 8 as shown in. Figure 3). Source lumens 120 can be labeled by number <e.g„ _. 1, 2, 3.. .} or by letter (e.g., a, i¾ c.. .). Alternatively, a combination of letters and numbers- such as the letter and the numbers 2-8 can be used. The use of the Setter can facilitate the user of exemplary applicator 100 to main tain: a relative direction of exemplary applicator 100, f0¾2f»j Figures 4A and 4B show cross-sections of exemplary applicator 100. Exemplary applicator 1.00 can have a single inflation lumen configured to inflate both outer baffle 1 .10 and inner baffle 115 at the same time, or the single lumen can be configured to separately inflate outer baffle 11.0 and inner baffle 11.5, Alternatively, exemplary applicator .100 can have an outer baffle inflation lumen configured to only inflate outer baffle i 10, and one or more inner baffle inflation lumens configured to inflate inner baffl 115 (e.g., outer baffle infusion port 1.30 inflates outer baffle 110 and inner baffle infusion port 135 inflates inner baffle 1.15). As shown, exemplary applicator 100 can. have 8 sosrce lumens 120, which can be equally spaced circumferentially, such that a 45 angle is formed by an angle composed of a line connecting the center of exemplary applicator 100 to a first lumen and a line connecting the center of exemplary applicator 100 to a second lumen adjacent to the first lumen. Alternatively, more or less than 8 source lumens can be used, and source lumens 120 can be spaced unequally apart.

| ^' 0027j The deployed diameter of outer baffle J 10 can be any suitable size (e.g., ό

centimeters), although not limited thereto. Additionally, die deployed, diameter of inner baffle 115 can be of any suitable size (e.g., 4 centimeters), although not limited thereto.

[00281 Exemplary applicator 100 can have a sliding iockahle anal positioning fiatige 505 to provide both secure placement of the apparatus and relief of pressure or discomfort should the applicator be pressing against the distal sigmoid wall. Lockable ana! positioning flange 505 can include a proximal base plate which can. have, for example, a device orientation arrangement and tube numbering on its face, which can facilitate the user knowing which direction corresponds to the marker for one of the source lumens as described above. This exemplary configuration can facilitate the user being able to determine the approximate position of each source lumen 120 inside exemplary applicator 1 0, facilitating the user to choose the best, -source lumen. 120, Exemplary applica tor i 00 can also have a plurality of distance marker 5 0 which can facilitate the user knowing the approximate distance exemplary applicator 100 has been inserted into the tubular structure. This can benefit, the user arid the patient ^' when exemplary applicator .100 is being inserted into as the nser can. mark the distance of the first insertion, and the same distance can be used in subsequent insertions, limiting any discomfort.

[0029] The inner surface of source lumens 120 and the ouler surface of exemplary applicator 1.00 can. include a luhrfcioas quality for ease of both, of either patient and/or source insertion. Additional exemplary modifications can include hemispherical baffles, external dreg elution ports, etc.

[0030] In an exemplary embodiment of the present disclosure, the overall length of exemplar ' applicator 100 can be approximately 28.54 centimeters. The over length of distal end 105 can be approximately 16.3 centimeters. The overall length from tip 1.40 of exemplar}' applica tor 100 to the end of source lumens 120 can be approximately 3.3 centimeters, it should be noted thai the above exemplary lengths are for illustrative purposes only, and other lengths, greater or les than the above, can be used depending on the size of the tubular structure to be entered and the s se of the patient.

[0031] Exemplary applicator 100 can be configured to be- uniform in s ze prior to being inflated, as seen in Figure 6A. After exemplary applicator 1.00 has been inserted to the desired location, the baffles can be expanded, inflating exemplary applicator 100 to its desired inflation size, as seen. in. Figures 6B-D.

[0032] According io certain exemplary embodiments of the present disclosure, exemplary applicator 100 can he used as an esophageal applicator and can be a "Rail Guided" arrangement. Exemplary applicator .109 can have a iri-iumen inner tube surrounded by a single baffle. One of the lumens (e.g., three lumens) can include a through-hole or bore for facilitating device to fit over a guide wire iaciiitatitig placement. The second lumen can be provided for filling the haffle(s). The third im can be closed at the end of the Effective Treatment Zone, and can be the conduit for the high dose radiation (H.DR) wire, The outer diameter of the esophageal applicator arrangement: can preferably be less than, approximately 8 millimeters for insertion. When in place, thebaffle(s) can foe inflatable up to, for example, approximately 2 centimeters in diameter or extension. ^' Exemplary applicator 100

arrangement can also include a slidable locking base plate which can include a moethpiece and the length can be adjustable up to, for example, approximately 130 centimeters (e.g., markings on the proximal handle). The exemplary Effective Treatment Zone can be, for example, approximately 1.5 centimeters with parallel orientation to the treatmen site.

[0033J According to another embodiment of the present disclosure, exemplary applicator 1 0 can be or include a sigmoid applicator arrangement and a colon applicator arrangement, or exemplary applicator 100 can be a hybrid of an anorectal applicator and an esophageal applicator arrangement. For example, exemplary applicator 100 can apply the working mechanisms of the anorectal applicator with the "Rail Guided" exemplary feature of the esophageal applicator. Because of the path of the sigmoid and the colon, exemplary applicator 100 can be longitudinally flexible in order to make the various turns, while preferably also being axially stiff enough to be pushed to the treatment site. Accordingly, this can be where the " ail Guidance" configuration can be employed.

[0034] Exemplary applicator 100 can be designed such that any radiation source can be inserted into source lumens .120, including multiple radiations sources at a time. The radiation source can be positioned in the source lumen nearest to the interaal tissue disorder

- 1.0 - di thai a radiation does can be maximal applied, to the internal tissue disorder, and yet minimally applied io the surrounding area, thus limiting the patient's exposure to the radiation, and any possible side effects.

[0035] Exemplary applicator 1 0 can be used in conjunction with an imaging apparatus (e.g., X-ray, MR! etc.) to aid in the positioning of exemplary apparatus 100 nearest to the internal tissue disorder. This can greatly -reduce the setup and treatment time. Markers on exempiary applicator 100 can he made from "exotic' ¹ materials to easily be seen, on imaging apparatuses.

(0036 j Figure 7 shows an exeiaplary method for treating a patient using exemplary applicator

1 0, After the location of an internal tissue disorder has been determined, the method begins at procedure 700. At procedure 705, guide wire 150 can be inserted i to the patient to the desired site of the internal tissue disorder. At procedure 710, exemplary applicator 100 can be inserted into the patient to the desired site using guide wire 150 and exemplary applicator {00 can be inflated to the desired size. At procedure 715, a radiation source can be inserted into one of source lumens 120 that, corresponds to the location closest to the internal tissue disorder. At procedure 720, .radiatio can be applied to the internal tissue disorder. At procedure 725, the radiation source can be prilled back, and an additional radiation does can be applied at procedure 730. At procedure 735, the process of pulling back the radiation source and applying the radiation source can be .repeated, if preferred or as necessary. At procedure 740, most or all of the equi ment, ihcluding.exempiaiy applicator 100, can be removed .from, the patient. At procedure 745, a further procedure of applying a radiation source using exemplary applicator 100 can be re e ted and at. procedure 750, the method of treating the patient can end.

( _. 0037] The foregoing merely illustrates the principles of the disclosure. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachin s herein. It wiii thus be appreciated thai those skilled in the art will be able to devise numerous systems, arrangements, and procedures which, although not explicitly shown or described herein, embody the principles of the disclosure and can be thus within, the spirit and scope of the disclosure, in addition, ail. publications and references referred to above can be incorporated herein by reference in. their entireties. In addition, certain terms used in the present disclosure, including the specification, drawings and claims thereof, can be used synonymously in certain instances, it should be understood that, while these words, and/or other words that can be synonymous to one another, cart be used synonymously herein, that there can be instances when such words can be intended, to not be used synonymously. Further, to the extent that the prior art knowledge has not been explicitly incorporated by reference herein above, it can be explicitly incorporated herein in its entirety.

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