System for conforming a therapy applicator to a non-uniform surface

Abstract

Systems and methods for delivering therapy using an applicator guide and a plurality of catheters to deliver a therapy such as radiation, a drug, radiofrequency, laser, or ultrasound therapy. The applicator guide includes a through-hole passage through which the catheters can be introduced. The through-hole passage can be sized so that the plurality of catheters can freely and independently pass through the through-hole passage. By placing the applicator guide over a target area of a patient's skin, the catheters freely contact the patient's skin and conform to any contours of the patient's skin. The catheters can be microneedles that can be locked in a conformed orientation so that the microneedles can non-invasively penetrate the patient's skin to transdermally deliver the therapy. The applicator guide can be coupled with a backer, a reservoir, a pulse generator, and / or a power generator that is controlled by a healthcare provider through a computing device.

Description

[0001] Cross-reference of related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 937216, filed November 18, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to a system and method for improving the application of a therapeutic applicator to a non-uniform surface of a patient. Background Technology

[0004] Skin cancer is the most common type of cancer in the United States, with an annual incidence of over 5 million cases. Basal cell carcinoma (BCC) and squamous cell carcinoma (cSCC) account for more than 95% of all skin cancer diagnoses.

[0005] Currently, there are several treatment options available for skin cancer. Some of the most common treatments include surgical excision, cryotherapy, radiation therapy, and topical medications. Surgical excision is considered the "gold standard" for effectively treating BCC and cSCC. Although excision may be the preferred method, it is often painful and can lead to disfigurement. Cryotherapy and topical medications have limitations in their application and success rate.

[0006] Radiation therapy plays a crucial role in both decisive and adjuvant treatment of skin cancer. Brachytherapy is a form of radiation delivery that can be used to treat skin cancer. Brachytherapy typically involves placing radioactive material close to the treatment target using an applicator. Brachytherapy can include interstitial approaches, or it can be used to treat the surface of the patient's skin without penetrating the body.

[0007] Current surface brachytherapy systems are performed using prefabricated, shielded, fixed-geometric applicators or custom applicators made of thermoplastic materials. Current systems typically include multi-channel catheters parallel to the skin surface. Because the radioactive material must pass through these channels to reach the target tissue, the geometry of these channels is limited. Although channels can be formed to fit the patient's facial contours, this process is expensive and time-consuming.

[0008] In addition, other types of skin-based ailments can require drug delivery systems to effectively deliver drug therapy to a patient. For example, skin topical drug formulations such as foams, creams, lotions, gels, and the like are commonly used to address skin-based ailments. However, many drug molecules are too large or too hydrophobic to penetrate the stratum corneum (SC) barrier, the outermost layer of the skin. The hydrophobic lipids of the SC can prevent entry of most topical drugs. Thus, such drugs need to be delivered beyond the epidermis into the dermis or deeper.

[0009] Transdermal delivery systems (TDDSs) (using the skin as the primary pathway for drug delivery) have proven to have advantages over external and intravenous drug delivery pathways. In addition to being non-invasive and painless, TDDSs can facilitate effective drug delivery without the need for frequent dosing to maintain a constant drug delivery.

[0010] U.S. Patent Nos. 7658728, 7785301, 8414548 describe microneedle patches for transdermal drug delivery, such as Microneedle arrays (provided by nanoBios Sciences, Inc. of Sunnyvale, CA). These patches are static devices that create micro-holes in the outermost layer of the skin and thus do not conform to the uneven features of the skin. Even the application and delivery of these drugs can be critical to the effectiveness and satisfactory results of the treatment.

[0011] In view of the aforementioned shortcomings of previously known systems and methods for applying radiation therapy and other therapies (e.g., drugs, ultrasound, radiofrequency, laser, etc.) to contoured and uneven surfaces of a patient, it would be desirable to provide systems and methods for precisely applying therapy to uneven skin of a patient. It would also be desirable to provide systems and methods for applying therapy to a dynamic skin surface.

[0012] In addition, it would be desirable to provide systems and methods for transdermally applying therapy to a dynamic skin surface. SUMMARY

[0013] The present invention relates to a radiation therapy system having an applicator guide having a plurality of through-hole passages in which a plurality of catheters can be disposed. The catheters are free and independent to move within the through-hole passages and can conform to the skin of a patient when the applicator guide and catheters are disposed over uneven portions of the body of the patient. The catheters can be connected to a back-loader by a transfer tube, which sends a radiation source through the catheters. A healthcare provider using a computing device can control the back-loader.

[0014] In accordance with the principles of the present application, an example radiation treatment system can include an applicator guide having a plurality of through-hole channels extending from a first side of the guide structure to a second side of the guide structure. The plurality of through-hole channels can be formed in an array. A plurality of catheters configured to deliver radiation treatment can be disposed in respective through-hole channels in the applicator guide. The plurality of catheters can move independently and freely within the respective through-hole channels and in response to contact by distal ends of the plurality of catheters with an area of the patient's skin to cause the distal ends to move independently to conform to a contour of the area of the patient's skin and contact the area. The plurality of catheters can be configured to selectively deliver radiation treatment to a target area within the area of the patient's skin when the plurality of catheters are disposed in a conforming direction.

[0015] In accordance with the principles of the present application, an example method for delivering radiation treatment to a patient can include disposing an applicator guide over a target area of the patient and conforming a plurality of catheters to the target area of the patient. The applicator guide includes a plurality of through-hole channels respectively loaded with a catheter of the plurality of catheters. The plurality of catheters can move independently and freely within the respective through-holes of the plurality of through-holes and in response to contact by distal ends of the plurality of catheters with the target area of the patient to cause the distal ends to move independently to conform to a contour of the target area of the patient. The method can finally include delivering a radioactive substance to at least one of the plurality of catheters.

[0016] In accordance with the principles of the present application, an example system for delivering radiation treatment to a non-uniform portion of a patient's skin can include an applicator assembly, a backer connected to each of a plurality of catheters by a plurality of transfer tubes, and a computing device in communication with the backer and configured to instruct the backer to deliver a radioactive substance to the plurality of catheters.

[0017] The applicator assembly can include an applicator guide configured to hold a plurality of catheters in a vertical position and the plurality of catheters configured to deliver radiation treatment. Each of the plurality of catheters can move independently and freely relative to the applicator guide and to each other and in response to contact by distal ends of the plurality of catheters with an area of the patient's skin to cause the distal ends to move independently to conform to a contour of the area of the patient's skin and contact the area. Additionally, the plurality of catheters can be configured to selectively deliver radiation treatment to a target area within the area of the skin when the plurality of catheters are disposed in a conforming direction.

[0018] According to another aspect of the present application, another example treatment delivery system is provided. The system can include an applicator guide having a plurality of through-hole channels extending from a first side of the applicator guide to a second side of the applicator guide, the plurality of through-hole channels arranged in an array. The system can also include a plurality of conduits for delivering a treatment, each conduit of the plurality of conduits disposed in a respective through-hole channel of the plurality of through-hole channels in the applicator guide. The plurality of conduits can move independently and freely within the respective through-hole channel with at least one degree of freedom, such that the plurality of conduits can conform to a contour of a skin region of a patient and contact the region in a conforming direction. Accordingly, the plurality of conduits can deliver a treatment to at least a portion of the region of the patient's skin when the plurality of conduits are disposed in the conforming direction.

[0019] The plurality of conduits can include a plurality of microneedles sized and shaped to non-invasively penetrate a stratum corneum (SC) of the patient's skin, such that the plurality of microneedles can transdermally selectively deliver a treatment to the at least a portion of the region. For example, the applicator guide can include a plurality of locks, each of the plurality of locks operably coupled with a respective one of the plurality of microneedles to lock the respective one of the plurality of microneedles in the conforming direction. Accordingly, the plurality of microneedles can non-invasively penetrate the stratum corneum (SC) of the patient's skin in the conforming direction. The plurality of locks can be activated individually or collectively.

[0020] In some embodiments, the plurality of microneedles can transdermally selectively deliver a drug to the at least a portion of the region. For example, the plurality of microneedles can be coated with the drug. Additionally or alternatively, the plurality of microneedles can include lumens, such that the drug can be transdermally delivered to the at least a portion of the region through the lumens of the plurality of microneedles. Additionally or alternatively, the drug can be embedded within the plurality of microneedles, such that at least a portion of the plurality of microneedles can dissolve to transdermally deliver the drug to the at least a portion of the region.

[0021] In some embodiments, the plurality of conduits can be operably coupled with a pulse generator to selectively deliver radiofrequency energy to the at least a portion of the region. In some embodiments, the plurality of conduits can be operably coupled with an ultrasound transducer to selectively deliver ultrasound energy to the at least a portion of the region. In some embodiments, the plurality of conduits can be operably coupled with a carrier to selectively deliver a radiotherapy to the at least a portion of the region. For example, each of the plurality of conduits can be individually activated to deliver radiation. The carrier can be connected to each of the plurality of conduits through a plurality of delivery tubes. Accordingly, the system can also include a computing device in communication with the carrier, which can instruct the carrier to deliver a radioactive substance to the plurality of conduits. Further, one or more of the plurality of conduits can apply heat while delivering a treatment to the target region.

[0022] According to another aspect of this application, another example method for delivering treatment to a patient is provided. The method may include: positioning the applicator guide above a target region of the patient; loading a plurality of catheters into the through-channels of the plurality of through-channels, such that each of the plurality of through-channels contains a catheter of the plurality of catheters; aligning the plurality of catheters with the target region of the patient in a compliant direction; and delivering treatment to the target region of the patient through at least one of the plurality of catheters in the compliant direction.

[0023] The method may also include locking the microneedles along the compliant direction. Furthermore, the method may include penetrating the stratum corneum (SC) of the patient's skin with the plurality of microneedles along the compliant direction to deliver treatment to the target area of ​​the patient, including transdermal delivery of treatment to the target area of ​​the patient. Attached Figure Description

[0024] Figure 1A This displays a radiotherapy system including an afterload generator, an applicator guide, and a computing device that runs the afterload generator software.

[0025] Figure 1B This shows an example applicator guide set on a patient's face.

[0026] Figure 2 A schematic view showing example electronic and hardware components of the computing device.

[0027] Figures 3A-3C Displays a perspective view, a side sectional view, and a top view of the example applicator guide.

[0028] Figure 4A This is a perspective view of an example applicator guide loaded with a conduit.

[0029] Figure 4B This is a perspective view of an example applicator guide loaded with a conduit and a tungsten insert.

[0030] Figure 5 This is a cross-sectional view of an example applicator guide with a stop attached and disposed within the applicator guide.

[0031] Figure 6A and 6B Shows the side and top views of an example applicator guide with an example guide extension.

[0032] Figure 7 An example applicator guide with a guide extension is shown, which has a spring and is loaded with a conduit.

[0033] Figure 8An example applicator guide is shown having a guide extension with a sensor and loaded with a catheter.

[0034] Figure 9 An example applicator guide is shown coupled with a platform stand and disposed above a patient's face.

[0035] Figure 10 An example applicator guide is shown coupled with a head stand and disposed above a patient's face.

[0036] Figure 11 A cross-sectional view of an example catheter having a heater.

[0037] Figure 12 A perspective view of an example applicator guide loaded with microneedles.

[0038] Figure 13 A treatment system is shown including a drug reservoir, an applicator guide, and a computing device to deliver a drug transdermally.

[0039] Figure 14 A treatment system is shown including a pulse generator, an applicator guide, and a computing device to deliver radiofrequency energy.

[0040] Figure 15 A treatment system is shown including an ultrasound transducer, an applicator guide, and a computing device to deliver ultrasound energy.

[0041] Figure 16 A treatment system is shown including a laser energy source, an applicator guide, and a computing device to deliver laser energy.

[0042] The above-mentioned and other features of the present application will become more apparent and the application itself will be better understood by reference to the following description taken in conjunction with the accompanying drawings, wherein: DETAILED DESCRIPTION

[0043] Systems of the present application include systems and methods for delivering and guiding applicators (e.g., radiation therapy applicators or microneedles) to non-uniform surfaces to allow catheters to conform to curved surfaces, even to accommodate dynamic surfaces. The systems include applicator guides and further include a plurality of catheters, delivery tubes, afterloaders for delivering radioactive material, drug reservoirs for delivering drug therapy, or energy sources for delivering energy, and computing devices.

[0044] To deliver the radiation treatment to the skin target on the patient, the plurality of catheters can be disposed through the applicator guide and the computing device can control the afterloader to deliver the radioactive source through the delivery tube to a predetermined location (e.g., end) within the catheter. The end can be blunt and / or have a flat cap.

[0045] Referring now to Figure 1A which shows a radiation treatment system 10. The radiation treatment system 10 can include an applicator guide 11, a catheter 12, a delivery tube 13, an afterloader 14, and a computing device 15. As shown in Figure 1A the catheter 12 can be disposed completely through the applicator guide 11 via a through hole 18 and can be coupled at a connection interface 16 to the delivery tube 13. The delivery tube 13 can also be connected at the connection interface 16 to the afterloader 14. The computing device 15 can be a standalone computing device or can be incorporated into the afterloader 14. The computing device 15 can communicate with the afterloader 14 through any known wired or wireless connection (Blue Tooth, Wi-Fi Direct, etc.).

[0046] Referring now to Figure 1B which shows the applicator guide 11 disposed over a patient to deliver radiation treatment through the catheter 12. The catheter 12 will extend through the applicator guide 11 and rest on the surface of the patient. The catheter 12 is free to move within the applicator guide 11, so the catheter will conform to the contours and curves of the surface of the patient's body (e.g., face) and even will conform to changes in the surface. In particular, the catheter 12 will be oriented in a downward manner and will move downward due to gravity. When in contact with the patient, the catheter 12 will experience an opposing upward force, causing the catheter to conform to the surface of the patient.

[0047] After the catheter 12 has conformed to the surface of the patient's body and the applicator guide is secured in a repeatable position, a planned computed tomography (CT) scan will be performed through the applicator and the skin target to generate a CT data set. This CT data set will be used to generate a conformal radiation plan to treat the skin target. A radiation oncologist and medical physicist can utilize the computing device 15 to adjust the radiation dose and treatment time to control the afterloader 14 to deliver the appropriate amount of radiation treatment to the patient. The radiation plan can be approved by the radiation oncologist. The healthcare professional can activate the afterloader 14 through the computing device 15 to deliver the radioactive material through the delivery tube 13 to the location (e.g., end) within the catheter 12.

[0048] Referring now to Figure 2which shows example functional blocks representing hardware and software components of computing device 15. The hardware and software components of computing device 15 can include one or more processing units 21, memory 22, storage 27, communication units 23, and power supplies 26, input devices 24, and output devices 25. Computing device 15 can communicate with the Internet and / or other computing devices.

[0049] Processing unit 21 can be one or more processors configured to execute operating system 28 and / or one or more application programs 29. Application programs 29 running on processing unit 21 can control the operation of pod 14, and can otherwise implement the operations and actions of pod 14 as supervised by computing device 15. Application programs 29 can be stored in storage 27 and executed on processing unit 21. Application programs 29 can be software applications and / or software modules having one or more sets of instructions adapted to perform the operations of computing device 15 described herein.

[0050] Optionally, computing device 15 can execute operating system 28 stored in storage 27 and executed on processing unit 21. Operating system 28 can be adapted to control the general operation of computing device 15, and can work with application programs 29 to implement the functionality of computing device 15 described herein. Optionally, computing device 15 can also execute a graphics library, other operating systems, and / or any other application programs.

[0051] Memory 22 can include, but is not limited to, volatile (e.g., random access memory (RAM)), non-volatile (e.g., read-only memory (ROM)), flash memory, or any combination thereof. Communication units 23 can receive and / or transmit information from / to other computing devices and / or peripheral devices. Communication units 23 can be any well-known communication architecture facilitating communication over any known wired or wireless connection including over any known standard, such as any IEEE 802 standard. Power supplies 26 can be a battery or any other external power source. Storage 27 can include, but is not limited to, removable and / or non-removable storage such as magnetic, optical, or tape.

[0052] Input devices 24 can be one or more devices that are coupled to computing device 15 or included in computing device 15 for inputting data to computing device 15. For example, input devices 24 can include a keyboard, a mouse, a pen, a voice input device (e.g., a microphone), a touch input device (e.g., a touchpad or a touchscreen), and / or a camera. Output devices 25 can be any device (e.g., a display, a speaker, a printer, etc.) that is coupled to computing device 15 or included in computing device 15 for outputting or otherwise displaying data.

[0053] Of course, it should be understood that the above-described hardware and software components of computing device 15 are merely examples, and that computing device 15 can include different and / or other hardware and software components than those described above. Figure 2The computing device 15 can include additional or fewer components than those shown and can include more than one of each type of component. The computing device 15 can be a general purpose computer, a server computer, a handheld computer, a mobile telephone, a network appliance, a media player, a gaming console, a gaming machine, a personal digital assistant, a television, a television set top box, a medical device, a medical appliance, a financial appliance, a navigation appliance, or any other device that includes a processor and a memory.

[0054] Referring now to the drawings Figures 3A-3C , an applicator guide 11 is shown. The applicator guide 11 can be rectangular and have a plurality of through-holes 31 and through-hole passages 32 formed in an array that extend through the entire length of the applicator guide 11, as shown in Figure 3B . The applicator guide 11 can be hollow or can be solid with through-holes. The applicator guide 11 can have varying width W, length L, and height H dimensions and proportions than those shown in Figure 3A , but still perform the functions described herein. The applicator guide 11 has a height H that is large enough to hold the catheter 12 in a vertical orientation as shown in Figure 1B .

[0055] Although Figure 3A the applicator guide 11 is shown as having a rectangular shape, it should be understood that the applicator guide 11 can take any other shape, such as a circular or asymmetric shape. The through-holes 31 can have a circular cross-section with a constant radius. The radius can be sized to fit the catheter 12 within the through-hole passage 38 with enough clearance to move freely along the through-hole passage 38. The through-hole passage 38 can have a smooth surface to reduce friction and can even be lined along part or the entire length of the through-hole passage 38 with a different material than the applicator guide 11 to further reduce friction with the catheter 12. Alternatively, the through-hole passage 38 can vary in radius or even shape. For example, the through-hole passage 38 can have a conical shape that narrows at one end. Optionally, the applicator guide 11 can include a lock at one or more of the through-hole passages to lock the catheter in a particular position within the through-hole passage. For example, the lock can include a screw or other protrusion that extends into the through-hole passage and contacts the catheter to prevent the catheter from moving within the through-hole passage. The lock can be activated together or separately.

[0056] The arrangement of through-holes 31 extending through the applicator guide 11 can follow a generally uniform pattern as shown in the top view of the applicator guide 11 shown in Figure 3C . The through-holes can be closer or farther apart from each other than the through-holes shown in Figure 3C . Alternatively, the arrangement of through-holes 31 can take on a different pattern than that shown in Figure 3CThe patterns shown are different or non-uniform. Furthermore, the through-holes 31 can vary in diameter and even shape to accommodate different shapes and sizes of the conduit 12. For example, the through-holes 31 near the center of the applicator guide 11 can have a larger diameter than those near the edges of the applicator guide 11. In another alternative arrangement, the through-holes 31 can be closer together near the center of the applicator guide 11 and farther apart near the edges of the applicator guide 11.

[0057] Please refer to now. Figure 4A This shows the applicator guide 11 and the catheters 12 loaded in the through-holes 31 of the applicator guide 11. The combination of the applicator guide 11 and the catheters 12 is referred to herein as an applicator accessory. In this example, a triangular imprint is visible in the catheter. This shape may be due to the applicator guide 11 and catheters 12 being positioned above the patient's nose, as... Figure 1B As shown in the diagram. Since each conduit 12 can move independently and freely along each through-hole 31, each conduit can conform to the surface it contacts. When the applicator guide moves along... Figure 1B When arranged in the direction shown, the catheter will move freely along the through-hole channel and eventually conform to the patient's nose, thereby causing... Figure 4A The triangular mark 33 shown. Although Figure 4A The image shows a triangular shape, but the applicator guide 11 can conform to any other shape.

[0058] Please refer to now. Figure 4B It displays the applicator guide 11. (And...) Figure 4A Unlike other conduits, the conduit 12, which is connected to the afterload 14 and designed to receive a radiation source, may occupy only some of the through-holes 31. Figure 4B Other through-holes in the catheter 12 may be occupied by shielding inserts 34 having a similar shape to the catheter 12 but designed to move freely within the through-hole 31 channel. The catheter 12 will deliver a radiation source, thereby delivering radiotherapy to the patient. They can be inserted into specific through-hole 31 locations on the applicator guide 11. The position of the catheter 12 can be selected to deliver radiotherapy only to a localized area (target) of the patient's skin surface. The shielding inserts 34 may be made of a radiation-shielding material such as tungsten or any other material exhibiting similar characteristics. Therefore, the shielding inserts 34 may surround the catheter 12, such as... Figure 4B As shown, this is to block radiation scattering from outside the skin that is not involved in the radiation target.

[0059] Please refer to now. Figure 5 This shows a cross-sectional view of the applicator guide 11. The guide tube 12 extends through each through-hole channel 32. (Example...) Figure 5As shown, each conduit 12 may include a stop 35, which may be coupled to the outer surface of the conduit 12. The stop 35 may be a protrusion extending beyond the diameter of the conduit 12 and may extend 360° around the conduit 12 or only partially. By coupling with the stop 35, the conduit 12 will be prevented from extending downward beyond the stop 35 into the through-hole channel 32, since the stop 35 cannot be fitted inside the through-hole channel 32. This may be desirable for preventing the conduit 12 from falling completely through the applicator guide 11 and / or otherwise limiting the permissible movement of the conduit 12. It may also be desirable to include a second stop below the through-hole channel 32 to prevent the conduit 12 from exiting the applicator guide 11 from another direction, thereby further limiting the range of movement of the conduit 12.

[0060] like Figure 6A As shown, the applicator guide 11 may include a guide extension 36. The guide extension 36 may be removably coupled to the applicator guide 11 via a bracket 40 to provide increased stability to the conduit 12. The guide extension 36 may have a plurality of through holes 31 and corresponding through-hole channels 38 extending through the guide extension 36 and aligned with the through holes 31 and through-hole channels 32. Figure 6B This is an example top view of the guide extension 36 with a through-hole 31. Thus, the conduit 12 and / or shielding insert 34 can be disposed through the guide extension 36 and the applicator guide 11.

[0061] The guide extension 36 can be positioned at a specific height above the applicator guide 11 via the bracket 40. The distance between the guide extension 36 and the applicator guide 11 is adjustable. Figure 6A In the example shown, the guide extension 36 may include several screw holes 39 located in the bracket 40 through which a screw 41 can be inserted. The applicator guide 11 may include a threaded portion (not shown) into which the screw 41 can be screwed to secure the guide extension 36 in place. In this way, the distance between the guide extension 36 and the applicator guide 11 can be adjusted by placing the screw 41 in different screw holes 39. However, it should be understood that different adjustment structures can be used to adjust the height of the guide extension 36. For example, the guide extension 36 may be coupled to the applicator guide 11 via a guide rail system on which the guide extension 36 can slide up and down and (e.g., using screws or locking pins) lock in place. In another example, the guide structure may be permanently coupled to the applicator guide 11, or it may be formed from the same block.

[0062] Please refer to now. Figure 7which shows spring assembly 45. Spring assembly 45 includes applicator guide 11 and guide extension 36. In addition, spring assembly 45 can include springs 46 aligned with through-hole passageway 38, each spring 46 can have elastic properties such that when an axial compressive force is applied, it can compress to a length shorter than its neutral length, and when the force is removed, it can return to its neutral length. Each spring 46 can have an internal cavity sized such that catheter 12 and / or shield insert 34 can move freely within spring 46. For example, spring 46 can have the same internal diameter as through-hole passageway 38 and through-hole passageway 32.

[0063] Springs 46 can be coupled with guide extension 36 on the underside of guide extension 36. Alternatively, springs 46 can be sandwiched between guide extension 36 and lower protrusions 47. Lower protrusions 47 can extend from catheter 12 and can be sized and shaped such that they prevent springs 46 from extending beyond lower protrusions 47. As shown in Figure 7 Lower protrusions 47 can be triangular in shape, as shown in

[0064] Catheter 12 can also include upper protrusions 48. Upper protrusions 48 can extend from catheter 12 and can be sized and shaped such that they prevent catheter 12 from extending inside through-hole passageway 38. As shown in Figure 7 Upper protrusions 48 can have a triangular shape, as shown in

[0065] Spring assembly 45 can be used to limit the range of motion of catheter 12. Spring assembly 45 can be arranged to deliver therapy to a patient, similar to the direction shown in Figure 1B As described above with respect to Figure 1B Catheter 12 will be in contact with a surface of a patient (e.g., the patient's face). Thus, when in contact with the surface of the patient, catheter 12 will be subjected to an opposing upward force. This upward force will cause the catheter to move upward toward applicator guide 11 and guide extension 36.

[0066] As the catheter 12 is moved upward, the lower protrusion will also move upward toward the guide extension 36. As the guide extension 36 remains stationary, the upward movement of the lower protrusion 47 will compress the spring 46. At a certain point, the spring 46 will no longer be able to compress. Thus, the spring 46 will define the range of motion of the catheter 12, as the catheter 12 can be allowed to move upward a distance between the neutral length of the spring and the fully compressed length of the spring. The spring assembly 45 provides improved control over the movement of the catheter and, thus, the distribution of the radiation therapy.

[0067] Referring now to Figure 8 which shows a sensor assembly 50. The sensor assembly 50 includes at least the applicator guide 11 and the guide extension 36. The sensor assembly 50 can also include a reference identifier 51 and a sensor 52. The sensor 52 can be mounted on the guide extension 36 proximate the through hole 31. The sensor 52 senses the position of the reference identifier 51 and can determine whether the reference identifier 51 is more than a threshold distance from the sensor 52. The sensor 52 can communicate with and / or otherwise interface with the reference identifier 51 through a wired or wireless communication. For example, the sensor 52 can be an optical sensor. Alternatively, the sensor 52 can be any other well-known wired or wireless sensor designed to determine the position of the catheter 12 and / or the reference identifier 51.

[0068] The applicator guide 11 and / or the guide extension 36 can be coupled or otherwise house a power source, such as a battery, to power the sensor 52. The applicator guide 11 and / or the guide extension 36 can also include a transceiver to communicate with the sensor 52. Alternatively, the sensor 52 can include a transceiver, respectively. The sensor 52 can communicate with the computing device 15 through the transceiver through any well-known wireless connection (Blue Tooth, Wi-Fi, etc.). Alternatively, the sensor 52 can communicate with the computing device 15 through a wired connection.

[0069] The sensor 52 can determine the distance that the reference identifier 51 is from the sensor 52 or some other neutral position. The sensor 52 can then communicate this information to the computing device 15. Each sensor can correspond to a particular catheter. The computing device 15 can run the payload application 29, which can use this information to selectively deliver the radioactive material to a particular catheter.

[0070] In one example, the payload application 29 can analyze the data received from the sensor 52 and determine that a number of catheters have moved more than a particular threshold distance. For example, the sensor 52 can generate data to indicate that a number of catheters have moved a significant distance in response to contact with the patient's nose. The healthcare provider can target the nose or a portion thereof and, thus, can instruct the payload 14 to deliver the radioactive material only to the catheters that have moved a particular distance.

[0071] Referring now toFigure 9 The applicator guide 11, loaded with the catheter 20, can be positioned over the desired portion of the patient's body. Although the applicator guide 11 is shown in Figure 9 positioned over the patient's face, it should be understood that the applicator guide can be positioned over any other portion of the patient's body, such as the leg or arm. To secure the applicator guide 11 in place over the target body region, the applicator guide 11 can be secured to a platform stand 60 that rests on a platform 65.

[0072] To use the platform stand 60, the patient must be positioned on a platform, such as an operating table, or other generally flat surface, such as a bed. The platform stand 60 can include at least two stand arms 61 that are coupled with a stand stabilizer 64 that rests on the generally flat surface. The stand stabilizer 64 generally holds the platform stand 60, and thus the applicator guide 11, in a stable position, and can even be screwed or otherwise secured to the generally flat surface.

[0073] The stand arms can be coupled and secured to the stand stabilizer 64. The stand arms 61 can extend upwardly from the stand stabilizer and be coupled with the applicator guide 11. The stand arms 61 can include an arm extension 62 that is movably coupled with the stand arm 61. For example, as shown in Figure 10 each stand arm 61 can extend into a corresponding arm extension 62, and each arm extension 62 can include an engagement knob 63 to lock the stand arm 61 in a particular position along the arm extension 62. The engagement knob 63 can be a spring-loaded tab that extends into the stand arm 61 or otherwise locks the stand arm 61 in place. The engagement knob 63 can be used to extend the stand arm 61 to raise or lower the applicator guide 11.

[0074] The stand arms 61 can be removably coupled with the applicator guide 11 by any well-known coupling techniques. For example, the stand arms 61 can be coupled with the applicator guide 11 by threaded screws that are received by threaded receptacles located inside the applicator guide 11. In another example, the applicator guide 11 can be snapped into place. Alternatively, the platform stand 60 can be permanently coupled with the applicator guide 11. The platform stand 60 secures the applicator guide 11 so that the catheter 12 is oriented in a generally vertical position. In this orientation, the catheter 12 can be freely moved downwardly and through the through-hole passage 32.

[0075] Reference is now made to Figure 10The applicator guide 11, loaded with the catheter 20, can be positioned over a portion of the patient's head by the head support 70. For example, the applicator guide 11 can be positioned over a portion of the patient's face. In another example, the applicator guide 11 can be positioned over a different portion of the patient's head, such as an ear. To secure the applicator guide 11 in place over the target body region, the applicator guide 11 is secured to the head support 70, which is secured to the patient's head.

[0076] The head support 70 can include at least two support arms 71, each coupled with a respective head stabilizer 74, which is secured to the patient's head. The support arms 71 can extend upwardly from the head stabilizers 74 and are coupled with the applicator guide 11. The support arms 71 can include arm extensions 72, which are removably coupled with the support arms 71. For example, as shown in FIG. 6, each support arm 71 can extend into a respective arm extension 72, and each arm extension 72 can include an engagement knob 73 to lock the support arm 71 in a particular position along the arm extension 72. The engagement knob 73 can be a spring-loaded protrusion that extends into the support arm 71 or otherwise locks the support arm 71 in place. The engagement knob 73 can be used to raise or lower the support arm 71, and thus the applicator guide 11. Figure 10

[0077] The head stabilizers 74 can be secured to the patient's head by compressive pressure. The support arms 71 and / or the arm extensions 72 can be made of a resilient material and can stretch from a neutral position when secured to the patient's head, resulting in compressive forces. Alternatively or additionally, the head stabilizers 74 can be strapped to the patient's head by a strap, such as a Velcro strap, an elastic headband, or other well-known methods. The head stabilizers 74 can include a padded portion for contacting the patient's head.

[0078] The support arms 71 can be removably coupled with the applicator guide 11 by any well-known coupling techniques. For example, the support arms 71 can be coupled with the applicator guide 11 by threaded screws, which are received by threaded receptacles located inside the applicator guide 11. In another example, the applicator guide 11 can be snapped into place. Alternatively, the head support 70 can be permanently coupled with the applicator guide 11, or can be formed from the same piece of material.

[0079] The head support 70 secures the applicator guide 11 so that the catheter is oriented in the same position relative to the patient's head. The patient's head can be strapped down to the platform 65 so that the patient's head remains in a constant orientation. Preferably, the head support 70 is oriented toward the patient so that the catheter 12 is in a generally vertical position, and the catheter 12 can be freely moved downwardly and through the through-hole passage 32.

[0080] Referring now to FIG. 7, a method 700 for positioning a catheter 12 on a patient's head is shown. The method 700 can be performed by a medical practitioner, such as a physician, a nurse, or other medical professional. The method 700 can be performed using the catheter positioning system 10, as shown in FIGS. 1-6. Figure 11 ​which shows an optional hyperthermia catheter. Since it has been observed that radiation therapy combined with hyperthermia increases the rate of cancer cell killing and cure, it can be desirable to combine a conventional radiation therapy catheter with a hyperthermia needle. For example, hyperthermia catheter 80 can have similar functionality and structure as catheter 12, but can also include a heater 81 along at least a portion of catheter 80. As shown in FIG. 8A, heater 81 can be disposed in the wall 85 of the distal end 82 of catheter 80 to apply heat to the target tissue of the patient when the distal end 82 of catheter 80 is proximate the target tissue. Heater 81 can be electrically insulated from catheter 80. Figure 11

[0081] Heater 81 can be connected by electrical circuitry 83 to a power source (not shown) that can be in electrical communication with computing device 15. Computing device 15 can run afterloader application 29 or a separate application to selectively activate heater 81 to heat the target tissue. The electrical circuitry can be connected to a separate power source or can use the power source integrated in afterloader 14. A healthcare professional using computing device 15 can select all catheters or only specific catheters to apply heat. Alternatively, afterloader application 29 can automatically power up specific catheters based on data received from sensors and / or according to programmed instructions.

[0082] Although Figure 11 catheter 80 is shown with a heating coil, it should be understood that heater 81 can employ any other well-known heating technology. For example, heater 81 can be a radio frequency (RF) electrode. Alternatively, heater 81 can be one or more fluid channels located within the wall 85 of catheter 80 and heated fluid can be introduced into the one or more fluid channels to apply heat to the target tissue.

[0083] The systems and methods described herein for delivering and guiding applicators to uneven surfaces to allow catheters to conform to curved surfaces and even to dynamic surfaces can be used to transdermally apply a therapy to a dynamic skin surface. Please now refer to Figure 12 which provides an applicator guide 90 for transdermally applying a therapy. Applicator guide 90 can be similar in construction to applicator guide 11 of Figure 4A and 4B except that through-hole channel 91 of applicator guide 90 is sized and shaped to accommodate a microneedle 92 therethrough such that microneedle 92 fits within through-hole channel 91 with sufficient clearance to move freely along through-hole channel 91. Each microneedle 91 has a distal end configured to at least non-invasively penetrate the stratum corneum (SC) of a patient's skin. In addition, each microneedle 92 can be coupled with a delivery tube 93 extending from microneedle 92 to a therapy source (e.g., a drug reservoir, an ultrasound transducer, or a source of RF energy) such that the therapy can be applied to the patient through microneedle 92 and delivery tube 93. A computing device can be operably coupled with the therapy source to selectively administer the therapy. ​

[0084] The microneedle 92 moves freely within the applicator guide 90, thus adapting to the contours and curves of the patient's body surface, and even conforming to surface variations. The microneedle 92 can be oriented downwards and can move downwards due to gravity. Therefore, upon contact with the patient's skin surface, the microneedle 92 will experience an opposing upward force, causing it to conform to the patient's surface in a conforming direction. The microneedle 92 can also be oriented in other directions, so that when in contact with the patient's skin surface, the force applied to the applicator guide 90 towards the patient's skin will generate a reaction force on the microneedle 92.

[0085] The applicator guide 90 includes locking elements located at one or more through-hole channels 91 for securing the microneedle 92 to a specific position within the through-hole channel 91, for example, along the conforming direction. For example, the locking element may include a screw or other protrusion extending into the through-hole channel 91 and contacting the microneedle 92 to prevent movement of the microneedle 92 within the through-hole channel 91. The locking elements may be activated together or individually.

[0086] When the microneedle 92 is locked relative to the applicator guide 90 in a compliant direction, force can be applied to the applicator guide 90 toward the patient's skin, thereby allowing the microneedle 92 to penetrate the patient's skin non-invasively to a more uniform depth with uniform pressure, taking into account the contours and curves of the patient's body surface. Therefore, the microneedle 92 can deliver treatment to the patient transdermally.

[0087] In some embodiments, the microneedles 92 and the applicator guide 90 can be used to deliver drug therapy transdermally to a patient. For example, the microneedles 92 may be drug-coated to deliver the drug to the patient after the microneedles 92 penetrate the patient's skin. Alternatively, the microneedles 92 may be embedded with the drug and may be further soluble, for example, by actively applying heat to the microneedles 92 by the system or naturally by the patient's body. Thus, when the microneedles 92 are located within the patient's skin, the microneedles 92 can be dissolved to deliver the drug transdermally. In another embodiment, the microneedles 92 can be used to non-invasively penetrate the patient's skin and then be removed by the applicator guide 90, leaving a micro-incision within the patient's skin. A topical drug can then be administered to this micro-incision to allow the drug to penetrate the stratum corneum barrier and reach a target area within the patient's skin.

[0088] As an alternative or addition, the microneedle 92 may be hollow, for example, having an inner cavity extending through the distal end of the microneedle 92, which is in fluid communication with the delivery tube 93. Thus, as Figure 13 As shown, the delivery tube 93 can be coupled to the drug reservoir 102, for example, via the connection interface 16' and the delivery tube 13', so that the drug can be transdermally delivered from the drug reservoir 102 through the delivery tube 13' and the delivery tube 93 and through the distal end of the microneedle 92 to the target area in the patient's skin.

[0089] The computing device 15' may be a standalone computing device or may be included within the drug reservoir 102. The drug reservoir 102 may include a pump mechanism for delivering the drug to the reservoir 102 via the delivery tube 13'. The computing device 15' may communicate with the drug reservoir 102 via any well-known wired or wireless connection (Bluetooth, Wi-Fi Direct, etc.). Clinicians may use the computing device 15' to adjust the drug dosage and treatment time to control the delivery of the appropriate amount of drug to the patient by the drug reservoir 102.

[0090] In some embodiments, the applicator guide described herein can be used to deliver energy percutaneously and / or transdermally to a target area within a patient's skin via multiple delivery tubes, catheters, and / or microneedles. For example, the applicator guide can be used to deliver radiofrequency (RF) energy, ultrasound energy, or laser energy percutaneously and / or transdermally to a target area on / within a patient's skin.

[0091] like Figure 14 As shown, the distal end of the transmission tube 113 may be a needle electrode 112, which is electrically coupled to the pulse generator 114. The transmission tube 113 may be coupled to the pulse generator 114 via the transmission tube 13” and the connection interface 16”. The computing device 15” may be a separate computing device or may be included in the pulse generator 114. The pulse generator 114 may be programmed to deliver radiofrequency energy sufficient to ablate target tissue to a target area on / inside the patient's skin. For example, the needle electrode 112 may be guided by the applicator guide 110 to conform to the contour of the patient's skin at the target area, so that the radiofrequency energy can be uniformly delivered to the target tissue.

[0092] Alternatively, the pulse generator 114 can be programmed to deliver radiofrequency energy (e.g., sufficient for depigmentation, such as tattoo removal) to a target area within the patient's skin. Thus, the needle electrode 112 can be locked in place relative to the applicator guide 110 and can non-invasively penetrate the stratum corneum (SC) of the patient's skin to deliver radiofrequency energy within the target area of ​​the patient's skin. The computing device 15” can communicate with the pulse generator 114 via any well-known wired or wireless connection (Bluetooth, Wi-Fi Direct, etc.). Clinicians can use the computing device 15” to adjust the radiofrequency energy delivery and treatment timing to control the pulse generator 114 to deliver the appropriate amount of radiofrequency energy to the patient, for example, for ablation and / or depigmentation.

[0093] like Figure 15As shown, the distal end of the transmission tube 123 may include a piezoelectric element 122 operatively coupled to a power generator 124. The transmission tube 123 may be coupled to the power generator 124 via a transmission tube 13”' and a connection interface 16”'. The computing device 15”' may be a separate computing device or may be included in the power generator 124. The power generator 124 may be programmed to vibrate the piezoelectric element 122 and emit ultrasonic energy sufficient to ablate target tissue onto / within the patient's skin. For example, the piezoelectric element 122 may be guided by an applicator guide 120 to conform to the contours of the patient's skin at the target area, so that ultrasonic energy can be uniformly delivered to the target tissue. In some embodiments, the piezoelectric element 122 may be locked in place relative to the applicator guide 120 and may non-invasively penetrate the stratum corneum (SC) of the patient's skin to deliver ultrasonic energy within the patient's skin in the target area.

[0094] Alternatively, the power generator 124 can be programmed to deliver sufficient ultrasound energy to a target area on / within the patient's skin for ultrasound imaging, allowing one or more piezoelectric elements 122 to act as ultrasound imaging probes. The computing device 15” communicates with the power generator 124 via any well-known wired or wireless connection (Bluetooth, Wi-Fi Direct, etc.). Clinicians can use the computing device 15”' to adjust the ultrasound energy delivery and treatment timing to control the power generator 124 to deliver appropriate amounts of ultrasound energy to the patient, for example, for ablation and / or imaging.

[0095] like Figure 16 As shown, the distal end of the transmission tube 133 may have a laser emitter 132, which is operatively coupled to the energy source 134. The transmission tube 133 may be coupled to the energy source 134 via the transmission tube 13”” and the connection interface 16””. The computing device 15”” may be a separate computing device or may be included in the energy source 134. The energy source 134 may be programmed to cause the laser emitter 132 to emit laser energy sufficient to ablate target tissue onto / within the patient's skin. For example, the laser emitter 132 may be guided by the applicator guide 130 to conform to the contours of the patient's skin at the target area, so that the laser energy can be uniformly delivered to the target tissue.

[0096] Alternatively, the energy source 134 can be programmed to deliver laser energy (e.g., sufficient for depigmentation, such as tattoo removal) to a target area within the patient's skin. Thus, the laser emitter 132 can be locked in place relative to the applicator guide 130 and can non-invasively penetrate the stratum corneum (SC) of the patient's skin to deliver laser energy within the patient's skin in the target area.

[0097] While various example embodiments of the application have been described above, it should be understood that they have been presented by way of example only, and not limitation. Numerous changes to the disclosed embodiments can be made in accordance with the disclosure herein without departing from the true spirit and scope of the application. The appended claims do not intend to limit the application to the described embodiments, but intend to cover all modifications and variations of the described embodiments that fall within the true spirit and scope of the application.

Claims

1. A therapeutic delivery system, the system comprising: An applicator guide has a plurality of through-hole channels extending from a first side of the applicator guide to a second side of the applicator guide, the plurality of through-hole channels being arranged in an array; A platform support is configured to secure the applicator guide away from the patient's skin. as well as Multiple catheters, configured to deliver treatment, are disposed within corresponding through-channels of multiple through-channels in the applicator guide. Each catheter is capable of independent and free movement within its corresponding through-channel, thereby being configured to conform to the contours of a region of the patient's skin and to contact that region in a conforming direction. The plurality of catheters are configured to deliver treatment to at least a portion of the area of ​​the patient’s skin when the plurality of catheters are positioned along the compliant direction.

2. The system as claimed in claim 1, wherein, The multiple catheters include multiple microneedles configured to non-invasively penetrate the stratum corneum (SC) of the patient's skin, thereby selectively delivering treatment transdermally to at least a portion of the area.

3. The system as described in claim 2, wherein, The applicator guide includes a plurality of locking elements, each of which is operatively coupled to a corresponding one of the plurality of microneedles to lock the corresponding one of the plurality of microneedles in the compliant direction, thereby the plurality of microneedles being configured to non-invasively penetrate the stratum corneum (SC) of the patient's skin in the compliant direction.

4. The system as described in claim 3, wherein, These multiple locks are configured to be activated individually or together.

5. The system as described in claim 2, wherein, The multiple microneedles are configured to selectively deliver drugs transdermally to at least a portion of the area.

6. The system of claim 5, wherein, The multiple microneedles were coated with the drug.

7. The system as claimed in claim 5, wherein, The plurality of microneedles includes an inner lumen, so that the drug is configured to be transdermally delivered to at least a portion of the region through the inner lumen of the plurality of microneedles.

8. The system of claim 5, wherein, The drug is embedded within the plurality of microneedles, and at least a portion of the plurality of microneedles is configured to dissolve, thereby transdermally delivering the drug to at least a portion of the region.

9. The system of claim 1, wherein, The plurality of conduits are operatively coupled to a pulse generator and configured to selectively deliver radio frequency energy to at least a portion of the region.

10. The system of claim 1, wherein, The plurality of catheters are operatively coupled to an ultrasonic transducer and configured to selectively deliver ultrasonic energy to at least a portion of the region.

11. The system of claim 1, wherein, The plurality of catheters are operatively coupled to the afterload device and configured to selectively deliver radiotherapy to at least a portion of the region.

12. The system of claim 11, wherein, Each of the multiple catheters is configured to be activated individually to deliver radiation.

13. The system of claim 11, wherein, The loader is connected to each of the plurality of conduits via a plurality of delivery tubes. The system also includes a computing device that communicates with and is configured to instruct the loader to deliver radioactive material to the plurality of conduits.

14. The system of claim 1, wherein, One or more of the multiple catheters are configured to apply heat while delivering treatment to the area.

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