Abstract
A brachytherapy source delivery device includes a first tissue-piercing leg having proximal and distal ends, a second tissue-piercing leg having proximal and distal ends, wherein the proximal ends of the first and second tissue-piercing legs are joined at a span section in a first angular orientation with respect to each other, and a carrier element formed at, or attached to, the span section, the carrier element configured to support a radioactive brachytherapy source. The distal ends of the first and second legs can be curved inward toward each other to pierce a tissue when engaged toward each other into a closed position. The first and second tissue-piercing legs can be formed of a wire having a circular cross-sectional or non-circular cross-sectional shape. The carrier element can be tangentially attached to the span section. Each of the legs have a length that is greater than the length of the span section.
Claims
1. A brachytherapy source delivery device comprising: a first tissue-piercing leg having proximal and distal ends; a second tissue-piercing leg having proximal and distal ends, wherein the proximal ends of the first and second tissue-piercing legs are joined at a span section in a first angular orientation with respect to each other; and a carrier element formed at, or attached to, the span section, the carrier element configured to support a radioactive brachytherapy source; each of said first and second tissue-piercing legs comprising a straight and longitudinally extending leg each having at the distal end thereof a barb, and wherein the respective barbs extend in a direction toward each other; said span section comprising only an arcuate span section having respective ends that are contiguous with the respective proximal ends of the first and second tissue-piercing legs; wherein each of the first and second tissue-piercing legs have a like straight length that is greater than an arcuate length of the arcuate span section.
2. The brachytherapy source delivery device of claim 1, wherein the distal ends of the first and second legs are curved inward toward each other and configured to pierce a tissue when engaged toward each other into a closed position.
3. The brachytherapy source delivery device of claim 1, wherein the first and second tissue-piercing legs are formed of a wire having a circular cross-sectional shape.
4. The brachytherapy source delivery device of claim 1, wherein the first and second tissue-piercing legs are formed of a wire having a non-circular cross-sectional shape.
5. The brachytherapy source delivery device of claim 1, wherein the carrier element is formed as part of a unitary structure with the first and second tissue-piercing legs.
6. The brachytherapy source delivery device of claim 1, wherein the carrier element comprises a tube having a circular or non-circular cross-sectional shape.
7. The brachytherapy source delivery device of claim 1, wherein the carrier element extends along a full length of the radioactive brachytherapy source.
8. The brachytherapy source delivery device of claim 1, wherein the carrier element has an opening at a top portion of the carrier element.
9. The brachytherapy source delivery device of claim 1, further comprising a radiation shield disposed on the carrier element.
10. The brachytherapy source delivery device of claim 1, wherein the carrier element is tangentially attached to the span section.
11. The brachytherapy source delivery device of claim 1, wherein the length of each of the first and second tissue-piercing legs is at least two times the arcuate length of the arcuate span section.
12. The brachytherapy source delivery device of claim 1, wherein the span section defines a first curved exterior surface having an angle of approximately 90 degrees, wherein the distal end of the first leg forms a second curved exterior surface having a second angle of approximately 90 degrees, and wherein the distal end of the second leg forms a third curved exterior surface having a third angle of approximately 90 degrees.
13. The brachytherapy source delivery device of claim 1, wherein the legs are configured to be brought into a closed position from an open position in a single step.
14. A brachytherapy source delivery device that is comprised of a one piece wire member that extends in a substantial single plane, said wire member including a pair of longitudinally extending legs that each have a tissue piercing distal end, and an interconnecting span section that connects proximal ends of the respective pair of longitudinally extending legs, and a carrier element that is attached to the span section and that is configured to receive a radioactive brachytherapy source, each of said pair of longitudinally extending legs comprising a straight leg each having at the distal end thereof a barb, said span section having a semi-circular are having respective ends that are contiguous with respective proximal ends of the pair of longitudinally extending legs; said wire member constructed and arranged having an open position in which the barbs are separated so that the barbs can circumvent a tissue site and a closed position in which the barbs engage the tissue site.
15. The brachytherapy source delivery device of claim 14 wherein, in the open position, the pair of longitudinally extending legs are disposed at an acute angle to each other, and, in the closed position, the pair of longitudinally extending legs are disposed substantially in parallel to each other.
16. The brachytherapy source delivery device of claim 15 wherein, in the closed position, the pair of longitudinally extending legs are disposed so that the respective barbs overlap each other.
17. The brachytherapy source delivery device of claim 16 wherein the carrier is a tubular member, and the tubular member extends longitudinally along a longitudinal axis that is disposed at an angle to the single plane of the wire member.
18. The brachytherapy source delivery device of claim 17 wherein the span section is arcuate and configured to continuously connect with the respective longitudinally extending legs that are of equal length so as to form a symmetric wire member.
19. The brachytherapy source delivery device of claim 18 wherein the longitudinal axis of the tubular member is disposed at substantially at a right angle to the single plane of the wire member.
20. The brachytherapy source delivery device of claim 18 wherein the longitudinal axis of the tubular member is disposed within the single plane of the wire member.
21. The brachytherapy source delivery device of claim 17 wherein, in the open position the barbs are configured to be separated so that the barbs can circumvent a tissue site and in a closed position the barbs are configured to engage and overlap at the tissue site.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) It should be understood that the drawings are provided for the purpose of illustration only and are not intended to define the limits of the disclosure. In the drawings depicting the present invention, all dimensions are to scale. The foregoing and other objects and advantages of the embodiments described herein will become apparent with reference to the following detailed description when taken in conjunction with the accompanying drawings in which:
(2) FIG. 1A is a perspective view of a brachytherapy source delivery device having tissue-piercing legs and a carrier element;
(3) FIG. 1B is a front view of the brachytherapy source delivery device of FIG. 1A;
(4) FIG. 1C is a side view of the brachytherapy source delivery device of FIG. 1A;
(5) FIG. 1D is a cross-sectional view as taken through line 1D-1D of FIG. 1B;
(6) FIG. 1E is a cross-sectional view as taken through line 1E-1E of FIG. 1C;
(7) FIG. 1F is a front view of the device of FIG. 1A;
(8) FIG. 1G is a top view of the device of FIG. 1A;
(9) FIG. 1H is a bottom view of the device of FIG. 1A;
(10) FIG. 2A is a perspective view of a brachytherapy source delivery device with the source prior to installment into the carrier element;
(11) FIG. 2B is a perspective view of the brachytherapy source delivery device with the source partially installed in the carrier element;
(12) FIG. 2C is a perspective view of the source fully installed within the carrier element of the brachytherapy delivery device
(13) FIG. 3A is a perspective view of the brachytherapy source delivery device shown in the closed position;
(14) FIG. 3B is a front view of the device shown in the closed position with the legs piercing a desired tissue site;
(15) FIG. 3C is a side view of the device shown in the closed position with the legs piercing a desired tissue site;
(16) FIG. 4A shows a perspective view of the carrier tube with radiation shield;
(17) FIG. 4B is a front view of the carrier tube and radiation shield tangentially attached to the proximal ends of the legs;
(18) FIG. 4C is a side view of the carrier tube and radiation shield tangentially attached to the proximal ends of the legs.
(19) FIG. 5A is a perspective view of the shorter tube supporting the source;
(20) FIG. 5B is a front view of the device of FIG. 5A;
(21) FIG. 5C is a side view of the device of FIG. 5A;
(22) FIG. 6A is a perspective view of the device with a non-circular shaped element encircling brachytherapy radiation source;
(23) FIG. 6B is a front view of the device of FIG. 6A;
(24) FIG. 6C is a side view of the device of FIG. 6A;
(25) FIG. 7A is a perspective view of the device with an open carrier element that supports the brachytherapy radiation source at the joined proximal ends of the legs;
(26) FIG. 7B is a front view of the device of FIG. 7A;
(27) FIG. 7C is a side view of the device of FIG. 7A;
(28) FIG. 8A is a perspective view of the device having a brachytherapy source attached directly to the span section of the legs;
(29) FIG. 8B is a front view of the device of FIG. 8A;
(30) FIG. 8C illustrates a side view of the device of FIG. 8A;
(31) FIG. 9A is a perspective view of the carrier element and brachytherapy source approximately parallel to the plane of the wire form;
(32) FIG. 9B is a front view of the device of FIG. 9A;
(33) FIG. 9C is a side view of the device of FIG. 9A;
(34) FIG. 10A is a perspective view of an axis of the carrier element and source at a predetermined angle with respect to the plane of the wire form;
(35) FIG. 10B is a front view of the device of FIG. 10A;
(36) FIG. 10C is a side view of the device of FIG. 10A;
(37) FIG. 11A is a perspective view of the device with a carrier element supporting a source tangentially with respect to the proximal ends of the legs;
(38) FIG. 11B is a front view of the device of FIG. 11A;
(39) FIG. 11C is a side view of the device of FIG. 11A;
(40) FIG. 12A shows a perspective view of the carrier element supporting the source at a point proximate the end of the source;
(41) FIG. 12B shows a front view of the device of FIG. 12A;
(42) FIG. 12C shows a side view of the device of FIG. 12A;
(43) FIG. 13A shows a perspective view of a device having a generally rectangular cross-sectional shape;
(44) FIG. 13B shows a front view of the device of FIG. 13A;
(45) FIG. 13C shows a side view of the device of FIG. 13A;
(46) FIG. 13D shows a top view of the device of FIG. 13A;
(47) FIG. 13E shows a bottom view of the device of FIG. 13A;
(48) FIG. 14 illustrates a perspective view of the rectangular cross-sectional device with the source prior to being supported by the ears of the device;
(49) FIG. 15A illustrates a perspective view of another embodiment where the carrier element is formed integral as part of the wire form, either by machining or bending, according to a rectangular cross-sectional shape of the wire form;
(50) FIG. 15B illustrates a front view of the device 300;
(51) FIG. 15C illustrates a side view of the device 300;
(52) FIG. 15D illustrates a top view of the device 300;
(53) FIG. 15E illustrates a bottom view of the device 300;
(54) FIG. 16A is a perspective view of a device having first and second tissue-piercing legs in a generally circular cross-sectional wire form shape, with the proximal ends of the legs joined together at a span section;
(55) FIG. 16B is a side view of the device of FIG. 16A;
(56) FIG. 16C is a front view of the device of FIG. 16A without the course attached;
(57) FIG. 16D is a top view of the device of FIG. 16A;
(58) FIG. 16E is a bottom view of the device of FIG. 16A;
(59) FIG. 16F is a side view of the device of FIG. 16A;
(60) FIGS. 17A-17D illustrate various shapes for the tissue-piercing end of the legs;
(61) FIG. 18 illustrates a stack of the devices according to an embodiment;
(62) FIG. 19 illustrates a stack of the devices according to an embodiment;
(63) FIG. 20 illustrates a stack of the devices according to an embodiment;
(64) FIG. 21 illustrates a stack of the devices according to an embodiment;
(65) FIG. 22A illustrates a perspective view of a brachytherapy source delivery device having tissue-piercing legs with a brachytherapy source incorporated into the legs;
(66) FIG. 22B illustrates a front view of the device of FIG. 22A;
(67) FIG. 22C illustrates a side view of the device of FIG. 22A;
(68) FIG. 22D illustrates a side view of the device of FIG. 22A;
(69) FIG. 22E illustrates a bottom view of the device of FIG. 22A;
(70) FIG. 22F illustrates a cross-sectional view as taken along line 22F-22F of FIG. 22D;
(71) FIG. 23A illustrates a perspective view of a brachytherapy source delivery device having tissue-piercing legs with a brachytherapy source incorporated into the legs;
(72) FIG. 23B illustrates a front view of the device of FIG. 23A;
(73) FIG. 23C illustrates a side view of the device of FIG. 23A;
(74) FIG. 23D illustrates a top view of the device of FIG. 23A; and
(75) FIG. 23E illustrates a bottom view of the device of FIG. 23A.
DETAILED DESCRIPTION
(76) The present invention provides a means for achieving greater ability to attach and firmly affix a brachytherapy source to a desired tissue site. The desired tissue site refers to the tissue that is intended to receive a brachytherapy treatment by a brachytherapy radiation source. The device is a formed wire used to support a radioactive brachytherapy source and to be deployed by pressing the legs of the device toward each other, piercing the tissue between them and securing the device to the tissue in a single, continuous motion which may be referred to herein as a “single step”.
(77) In an example embodiment shown in FIGS. 1A-1E, the device 100 is a wire formed to include first and second tissue-piercing legs 101a, 101b with a carrier tube 102 attached to the formed wire. The first and second tissue-piercing legs 101a, 101b may be more generally referred to as a “wire form” or “formed wire” herein. In use, the carrier tube 102, which may be referred to as a “carrier element” is configured to hold a radioactive brachytherapy source (i.e., source 103 shown in FIGS. 2A-2C for example). The legs 101a, 101b are formed of a wire having a circular cross-sectional shape in this embodiment. Other non-circular cross-sectional shapes (such as rectangular, square, or hexagonal) can be implemented within ordinary skill. Refer, for example, to FIGS. 13a-15 for various cross-sectional shapes.
(78) FIG. 1A is a perspective view of the device 100 including tissue-piercing legs 101a, 101b and carrier element 102. As shown in FIG. 1A, the brachytherapy source delivery device 100 includes a first tissue-piercing leg 101a having proximal and distal ends, and a second tissue-piercing leg 101b likewise having proximal and distal ends. An arm 110 extends from the distal end of the second tissue-piercing leg 101b and an arm 112 extends from the distal end of the first tissue-piercing leg 101a. Each arm 110, 112 has a respective barb 110a, 112a extending therefrom and the barbs 110a, 112a are in an orientation such that the ends of the barbs 110a, 112a are facing each other.
(79) The carrier tube 102 is attached to the proximal ends of the first and second tissue-piercing legs 101a, 101b. The carrier tube 102 can be welded to the wire form. Other attachment mans can be implemented, such as adhesives (e.g., cyanoacrylate, glue, or epoxy), especially with polymers, welded polymers, or biocompatible soldering techniques.
(80) FIG. 1B is a front view of the device 100. As shown in FIG. 1B, the proximal ends of the first and second legs 101a, 101b are joined at a span section 121 in a first angular orientation with respect to each other. The span section can be arcuate and configured to continuously connect with the respective longitudinally extending legs that are of equal length so as to form a symmetric wire member. The span section 121 is generally denoted by the dotted-line section 121 indicating the curved portion where the proximal ends of the legs 101a, 101b are joined. This angular orientation is shown by angle θ.sub.1 which may be approximately 15-90 degrees. In an alternate embodiment of the invention this angle may be on the order of 15-120 degrees. This angle needs to be sufficient to “open” the barbs to allow them to extend beyond a resting open position (as shown in FIG. 1B) and go around the desired tissue site, yet not too large so that the force in deploying the brachytherapy source delivery device 100 is able to overcome the force provided by the angular orientation of the first and second tissue-piercing legs 101a, 101b.
(81) Each tissue-piercing leg 101a, 101b has a respective arm 112, 110 extending from a distal end of the leg 101a, 101b, which may be joined at a respective curved section 124, 122. The curved section 122 may have an angle θ.sub.2 of approximately 60-90 degrees. Likewise, the curved section 124 may have an angle θ.sub.3 of approximately 60-90 degrees. The angle is preferably approximately 90-degrees to facilitate the piercing of the tissue to which the formed wire is to be applied. An angle less than 90-degrees would also work but likely not as effectively at piercing tissue. In some embodiments θ.sub.1, θ.sub.2, and θ.sub.3 can all have the same value of approximately 90-degrees.
(82) Although the arms 110, 112 are shown as being substantially straight, there may be a bend along this segment to further assist in securing the device 100 to an underlying tissue site. Likewise, the ends of the barbs 110a, 112a may have varying shapes, for example as shown in FIGS. 17A-17D herein.
(83) The carrier tube 102 is attached tangentially with respect to the span section 121 of the joined tissue-piercing legs 101a, 101b. By tangentially, it is intended to mean herein that the carrier tube 102 is an approximately straight line or plane that touches a curve or curved surface (the span section) at a point. Note that by tangentially securing the carrier tube to the tissue-piercing legs, this can also reduce or even eliminate attenuation that could result if the carrier tube were placed along the length of a metal leg. A metallic wire that is, for example, placed along the entire length of the radioactive source attenuates the radiation from the entire length of the source. Thus, a tangentially connected source, such as that disclosed according to the present disclosure, does not have the attenuation along the entire length of the source, given that there is only contact at most at one point along the curve.
(84) The length of each of the legs 101a, 101b is longer than a length of the span section 121 such that a sufficient force applied to the legs causes the tissue to be pierced while providing the sufficient pivot by the span section. For example, the length of the legs 101a, 101b can be at least two times the length of the span section, as shown in FIG. 1B. Other ratios and variations in the length of the legs with respect to the span section will be apparent in light of the present disclosure.
(85) FIG. 1C is a side view of the brachytherapy source delivery device 100, showing the carrier element 102 tangentially attached to the tissue-piercing legs 101a, 101b. Note that there is an offset in the distal ends of the legs 101a, 101b so that they are next to each other (i.e., side-by-side) as shown in FIG. 1C. However, in some embodiments, it will be appreciated that there can be no offset such that the legs 101a, 101b are along a same plane. This depends upon the desired tissue-piercing effect, whereas an offset is provided when desired to have the barbs of the legs next to each other (side-by-side) when in the closed position, and no offset is provided so that the barbs face each other (along a same plane) when in the closed position.
(86) FIG. 1D is a cross-sectional view as taken through line 1D-1D of FIG. 1B. As shown, there is an offset in that the legs 101a, 101b are at a slight angle with respect to the perpendicular axis of the carrier element 102. Thus, when pierced through a tissue, the barbs at the distal ends of the legs 101a, 101b will be side-by-side, for example as shown in FIG. 3C. The carrier element 102 is shown in semi-circular cross-sectional shape in this view.
(87) FIG. 1E is a cross-sectional view as taken through line 1E-1E of FIG. 1C. The carrier element 102 is shown tangentially attached to the proximal ends of the legs 101a, 101b.
(88) FIG. 1F is a front view of the device of FIG. 1A. FIG. 1G is a top view of the device of FIG. 1A. FIG. 1H is a bottom view of the device of FIG. 1A.
(89) Reference is now made to FIGS. 2A-2C, showing the source at various positions with respect to the carrier element. In use, a brachytherapy source 103 would be installed within the carrier tube 102 prior to deployment of the device 100. The source 103 is shown exterior of the carrier tube 102 in FIG. 2A, prior to installment of the source within the tube. FIG. 2B illustrates the source 103 partially installed within the carrier element 102, as being slid or otherwise placed within the tube. FIG. 2C illustrates the source 103 fully installed within the carrier element 102. As shown in FIG. 2C, the carrier element 102 extends along a full length of the radioactive brachytherapy source 103.
(90) As shown, the carrier element 102 could remain open on both ends. The source 103 can be secured within the carrier element with an adhesive (such as cyanoacrylate). The source can be secured by deforming the carrier element 102 (e.g., forming a dent in the tube prior to inserting the source provides sufficient friction) or a dent after inserting likewise provides the requisite friction. Both ends of the carrier element 102 can be crimped to secure the source in place. The carrier element could be partially or completely sealed to leave the opening smaller than the source preventing its release.
(91) As shown in FIGS. 3A-3C, at deployment, the legs of the wire form are placed over a segment of tissue and the legs are pressed together, causing the ends to pierce the tissue (not shown) and to secure the device 100 in place. FIG. 3A is a perspective view of the device 100 shown in the closed position. Although the desired tissue site is not shown, in the closed position the barbs pierce the underlying tissue. The barbs are shown side-by-side in the closed orientation; however, it will be appreciated that the barbs can face each other in the closed orientation. FIG. 3B is a front view of the device 100 shown in the closed position with the legs 101a, 101b piercing a desired tissue site. FIG. 3C is a side view of the device 100 shown in the closed position with the legs 101a, 101b piercing a desired tissue site.
(92) In some embodiments, as shown in FIGS. 4A-4C, a thin radiation shield 104 can be attached to a section of the outer surface of the carrier tube 102 to reduce the radiation exposure in unwanted directions. FIG. 4A shows a perspective view of the carrier tube 102 with radiation shield 104. FIG. 4B is a front view of the carrier tube 102 and radiation shield 104 tangentially attached to the proximal ends of the legs 101a, 101b. FIG. 4C is a side view of the carrier tube 102 and radiation shield 104 tangentially attached to the proximal ends of the legs 101a, 101b. The radiation shield 104 can be any high-density biocompatible metal, such as gold, platinum, iridium, silver, or tungsten. The radiation shield 104 could also be a high-density metal such as lead if encapsulated in a biocompatible covering or coating.
(93) In another embodiment, the carrier tube does not need to encompass the entire length of the brachytherapy source. As shown in FIGS. 5A-5C, a shorter tube 105 could be used to carry the brachytherapy source 103. FIG. 5A is a perspective view of the shorter tube 105 supporting the source 103. FIG. 5B is a front view of the shorter tube 105 supporting the source 103, with the tube 105 tangentially attached to the proximal ends of the legs 101a, 101b via attachment member 120. FIG. 5C is a side view of the shorter tube 105 supporting the source 103, with the tube 105 tangentially attached to the proximal ends of the legs 101a, 101b.
(94) In another embodiment, the carrier element can be another non-circular shape that encircles the entire brachytherapy source can be used as shown in FIGS. 6A-6C. FIG. 6A is a perspective view of the device 100 with a non-circular shaped element 106 encircling brachytherapy radiation source 103. FIG. 6B is a front view of the element 106 encircling the source 103 at the proximal ends of the legs 101a, 101b. As shown, the element 106 has an approximate cross-sectional D-shape, with the flattened portion of the tube 106 tangentially attached to the span section connected at the proximal ends of the legs 101a, 101b. FIG. 6C is a side view of the tube 106 encircling the source 103 at proximal ends of the legs 101a, 101b.
(95) In another embodiment, the carrier element does not need to encircle the entire brachytherapy source. “Open” carrier elements that encircle at least more than 180 degrees of the circumference of the brachytherapy source can be used as shown in FIGS. 7A-7C. FIG. 7A is a perspective view of the device 100 with an open carrier element 107 that supports the brachytherapy radiation source 103 at the joined proximal ends of the legs 101a, 101b. FIG. 7B is a front view of the device 100 with the open carrier element 107 that supports the brachytherapy radiation source 103. The carrier element 107 includes an opening 107a. The opening 170a provides flexibility for the insertion of the source 103 into the carrier element 107. The carrier element 107 is tangentially attached to the span section connected at the proximal ends of the legs 101a, 101b. FIG. 7C is a side view of the carrier element 107 attached to the span section connected at the proximal ends of the legs 101a, 101b.
(96) In some embodiments, the carrier element may be omitted, and the source may be attached directly to the joined proximal ends of the legs. The brachytherapy source 103 can be attached directly to the wire form as shown in FIGS. 8A-8C. FIG. 8A is a perspective view of the device having a brachytherapy source 103 attached directly to the span section of the legs 101a, 101b. The source 103 can be attached tangentially to the joined proximal ends of the legs 101a, 101b as shown in FIG. 8B, illustrating a front view of the device with the source 103 directly attached to the tissue-piercing legs 101a, 101b. FIG. 8C illustrates a side view of the device with the source directly attached to the tissue-piercing legs.
(97) The source 103 is shown attached to the wire form, however it will be appreciated that the source is separable from the attachment device (e.g., attachment member 120 shown in FIG. 1B). The source can be joined to the attachment device (or another part of the brachytherapy source delivery device such as the carrier tube) in the clinic or other medical environment performing the brachytherapy treatment at the time of the device deployment. Clinics or other facilities can maintain an inventory of attachment devices and sources, which can be used for other procedures. This provides an advantage over permanently affixed sources, which require the requisite number of devices to be specifically ordered for a procedure. After a relatively short period of time, these sources decay and cannot be used. Thus, attachment at time of treatment has significant advantages. The source can be attached via welding or other adhesive or can be formed by stamping and/or bending a strip of material, by machining or by casting and/or molding.
(98) In the aforementioned embodiments, the axis of the brachytherapy source has been shown to be approximately perpendicular to the plane of the wire form. However, in these aforementioned or other embodiments, the brachytherapy source can be positioned parallel to the plane of the wire form, or at any angle between perpendicular and parallel, as shown on FIGS. 9A-9C. As shown in FIGS. 9A-9C, the axis of the brachytherapy source is approximately parallel to the plane of the wire form. FIG. 9A is a perspective view of the carrier element 105 and brachytherapy source 103 approximately parallel to the plane of the wire form. FIG. 9B is a front view of the carrier element 105 and brachytherapy source 103. FIG. 9C is a side view of the carrier element 105 and brachytherapy source 103 approximately parallel to the plane of the wire form.
(99) Although shortened tube 105 is shown, any of the carrier elements disclosed herein may be implemented at the approximately parallel configuration.
(100) In the aforementioned embodiments, the brachytherapy source has been shown to be centered on the plane of the wire form. However, in other embodiments, wire form can be positioned centered on the plane of the brachytherapy source wire form, at the extreme end of the brachytherapy source or at any position between, as shown on FIGS. 10A-10C. In this embodiment, the carrier element 105 and source 103 are shown positioned at an angle of approximately 45-degrees with respect to the plane of the wire form. Any other value for the angle can be implemented, as will be appreciated. FIG. 10A is a perspective view of an axis of the carrier element 105 and source 103 at a predetermined angle with respect to the plane of the wire form. FIG. 10B is a front view of an axis of the carrier element 105 and source 103 positioned at a predetermined angle with respect to the plane of the wire form. FIG. 10C is a side view of the axis of the carrier element 105 and source 103 positioned at a predetermined angle with respect to the plane of the wire form.
(101) In some embodiments, it may be desirable for the source to be positioned so that it is not central within the carrier element 105, however rather extends from the carrier element 105 so that the majority of the source 103 is on one side of the element 105. FIG. 11A is a perspective view of the device 100 with a carrier element 105 supporting a source 103 tangentially with respect to the proximal ends of the legs 101a, 101b. FIG. 11B is a front view of the device with the carrier element supporting a source 103 on its end, and tangentially with respect to the proximal end of the legs 101a, 101b. FIG. 11C is a side view of the device with the carrier element 105 supporting a source 103 on its end, and tangentially with respect to the proximal end of the legs 101a, 101b.
(102) In some embodiments, it may be desirable for the source to be positioned so that a certain predetermined amount of the source is extending from one side of the carrier element 105, and another amount of the source is extending out from the other side of the carrier element 105, as shown in FIGS. 12A-12C. FIG. 12A shows a perspective view of the carrier element 105 supporting the source 103 at a point proximate the end of the source, however not at the extreme end of the source, so as to allow for an amount of the source to extend from each side of the carrier element, whilst not being in the direct center of the carrier element. FIG. 12B shows a front view of the carrier element 105 supporting the source 103 at the end of the source. FIG. 12C shows a side view of the carrier element 105 supporting the source 103 at the end of the source.
(103) In the aforementioned embodiments, the wire form has been shown to have a generally round cross-sectional shape. However, in other embodiments, the wire form can have rectangular, or other shape, cross sections. Also, the legs of the wire form do not necessarily need to be positioned straight from the point of connection with the carrier. Other shapes can be used, as shown in FIGS. 13A-13C. FIG. 13A shows a perspective view of a device 200 having a generally rectangular cross-sectional shape. The device 200 includes first and second tissue-piercing legs 201a. 201b which are joined together at a proximal end, and have barbs formed at a distal end of each tissue-piercing leg. The proximal ends of the legs 201a, 201b are joined together at a span section 215. The span section 215 has a first ear 211a and a second ear 211b extending therefrom, which together support the brachytherapy radioactive source 103. FIG. 13B is a front view of the device showing the first and second tissue-piercing legs 201a, 201b, having ears 211a, 211b extending from the proximal ends of the legs 201a, 20b where they are joined together. FIG. 13C is a side view of the device showing the first tissue-piercing leg 201a with ear 211a extending from the distal end of the leg 201a, which supports the source 103.
(104) In the aforementioned embodiments, the carrier has been attached to the wire form. However, in other embodiments, it is possible to have the carrier be part of the wire form, either by machining or bending, as shown on FIGS. 13A-14. FIG. 14 illustrates a perspective view of the rectangular cross-sectional device 200 with the source 103 prior to being supported by the ears 211a, 211b of the device 200. The ears 211a, 211b may be considered the “carrier element” according to the present disclosure and are formed as an integral piece with the tissue-piercing legs 210a, 201b to provide a unitary structure (without the source, or with the source when attached).
(105) FIG. 15A illustrates a perspective view of another embodiment where the carrier element is formed integral as part of the wire form, either by machining or bending, according to a rectangular cross-sectional shape of the wire form. The brachytherapy source delivery device 300 includes a first tissue-piercing leg 301a and a second tissue piercing leg 301b joined together at a span section 321. A carrier element 331 is formed in the span section 321 and has an opening 311. The source (e.g., source 103 shown herein) can be supported by the carrier element 331. In this embodiment, the legs 301a, 301b extend in an approximately straight orientation from the span section 321, and the legs 301a, 301b have barbs 325a, 325b, respectively extending therefrom. FIG. 15B illustrates a front view of the device 300. FIG. 15C illustrates a side view of the device 300. FIG. 15D illustrates a top view of the device 300. FIG. 15E illustrates a bottom view of the device 300.
(106) Although a rectangular cross-sectional shape for the wire form is shown in FIG. 15 it will be appreciated that a likewise structure can be implemented having another cross-sectional shape, such as circular or square, or other non-circular shape.
(107) In the aforementioned embodiments, the carrier has been positioned on the “outside” of the wire form. Meaning, the wire form has an exterior surface that has supported the source and an interior surface toward which the barbs are oriented. However, in other embodiments, it is possible to have the carrier be positioned “inside” the wire form and in same general orientation inward toward the barbs, as shown in FIGS. 16A-16B.
(108) FIG. 16A is a perspective view of a device 500 having first and second tissue-piercing legs 501a, 501b in a generally circular cross-sectional wire form shape, with the proximal ends of the legs joined together at a span section 505. The span section supports the carrier element 102 on an interior surface thereof as shown. The source 103 is supported by the carrier element 102.
(109) FIG. 16B is a side view of the device 500 having first and second tissue-piercing legs 501a, 501b joined together at a span section 505 at proximal ends of the legs 501a, 501b. The device 500 includes the upper span section 505 having a first convex curved surface 505a, which is joined to two concave curved surfaces 505b, 505c. The concave curved surface 505c is joined to another convex curved surface 510b, which is connected to the leg portion 501b, secured to another concave curved surface 522, and to a barb 521. The concave curved surface 505b is joined to another convex curved surface 510a, which is connected to the leg portion 510a, secured to another concave curved surface 524, and to a barb 511.
(110) FIG. 16C is a front view of the device 500 without the course attached. FIG. 16D is a top view of the device 500. FIG. 16E is a bottom view of the device 500. FIG. 16F is a side view of the device 500.
(111) In the aforementioned embodiments, the ends of the wire form that pierce the tissue have been shown to have a wedge-shaped end for the distal end of the legs where the barbs are formed. However, it is possible for the tissue-piercing end to be conical, barbed, or, because of the small size of the wire, even flat, as shown in FIGS. 17A-17D.
(112) FIG. 17A illustrates a tissue-piercing end 601 that has a wedged surface as a shape. FIG. 17B illustrates a tissue-piercing end 602 that is conical in shape. FIG. 17C illustrates a tissue-piercing end 603 that is barbed in shape at the distal end. FIG. 17D illustrates a tissue-piercing end 604 that is flat at the distal end.
(113) FIG. 18 illustrates a stack 180 of the devices according to an embodiment, with the source perpendicular to the plane of the wire, for example as shown in FIG. 1A. The stack 180 comprises a plurality of devices that are arranged together as they would appear in a delivery applicator.
(114) FIG. 19 illustrates a stack 190 of the devices according to an embodiment, with the source perpendicular to the plane of the wire, for example as shown in FIG. 3A in the closed position. The stack 190 illustrates how the devices would appear when positioned within a patient.
(115) FIG. 20 illustrates a stack of the devices according to an embodiment, with the source parallel to the plane of the wire, for example as shown in FIG. 9A. FIG. 20 illustrates the stack 2000 as it would appear in a delivery applicator.
(116) FIG. 21 illustrates a stack of the devices according to an embodiment with the source parallel to the plane of the wire, for example as shown in FIG. 9A. FIG. 21 illustrates the stack 2100 as it would appear when positioned in the patient.
(117) FIG. 22A illustrates a perspective view of a brachytherapy source delivery device 2200 having tissue-piercing legs 2201a, 2201b with a brachytherapy source incorporated into the legs. Refer to FIG. 22F showing the sources incorporated into the legs. In this embodiment, there are six individual sources incorporated into the legs, with three sources in each leg, however any number of sources may be implemented.
(118) FIG. 22B illustrates a front view of the device 2200 of FIG. 22A. The device 2200 includes first and second tissue-piercing legs 2201a, 2201b. The length of the leg 2201b can be a distance D22 of approximately 4.8 centimeters (cm), and generally has the length of 2.4-4.8 cm; however any length can be implemented depending upon the particular application and/or patient involved. The angle θ22 is approximately 60-degrees, and can be in the range of 60-120 degrees.
(119) FIG. 22C illustrates a side view of the device 2200 of FIG. 22A. FIG. 22D illustrates a side view of the device 2200 of FIG. 22A. FIG. 22E illustrates a bottom view of the device 2200 of FIG. 22A.
(120) FIG. 22F illustrates a cross-sectional view as taken along line 22F-22F of FIG. 22D. As shown, there are six radioactive sources 2210, 2212, 2214, 2216, 2218, and 2219, with three radioactive sources 2210, 2212 and 2214 in the tissue-piercing leg 2210b, and sources 2216, 2218, and 2219 in the tissue-piercing leg 2210a. It will be appreciated that the position and placement of the sources within the legs can be variable depending upon the particular application and/or patient and/or tissue site
(121) FIG. 23A illustrates a perspective view of a brachytherapy source delivery device 2300 having tissue-piercing legs 2301a, 2301b with a brachytherapy source (not shown in FIG. 23A) incorporated into the legs. The legs can have a length D23 that is approximately 2.4 cm, however this can be approximately 2.4-4.8 cm. The angle θ23 can be approximately 120-degrees, or can be in the range of 60-120 degrees.
(122) FIG. 23B illustrates a front view of the device 2300 of FIG. 23A. FIG. 23C illustrates a side view of the device 2300 of FIG. 23A. FIG. 23D illustrates a top view of the device 2300 of FIG. 23A. FIG. 23E illustrates a bottom view of the device 2300 of FIG. 23A.
(123) Various embodiments discussed herein may be combined with each other in appropriate combinations in connection with the system described herein.
(124) Other embodiments of the invention will be apparent to those skilled in the art from a consideration of the specification or practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.
