Photodynamic therapy device and method of use

Abstract

The present invention relates to a treatment device comprising a shaft extending between a proximal portion and a distal portion, a surgical instrument located at the distal portion, a handpiece located at the proximal portion, a treatment end located at a distal end of the surgical instrument, the treatment end being capable of applying photodynamic therapy (PDT). The treatment end comprises an applicator for applying a photosensitizing agent to a surface of a target tissue and a light emitter capable of emitting generated light therapy light to activate the photosensitizing agent to ablate the target tissue. A method for providing PDT to a target tissue, the method comprising: inserting the treatment device into a patient; applying a photosensitizing agent and light therapy light to a surface of the target tissue; and removing the device from the patient.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent No. 62 / 951,447, filed December 20, 2019, entitled “PHOTODYNAMIC THERAPY DEVICE AND METHODS OF USE,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This document generally covers, but is not limited to, surgical instruments and methods that can be used to apply photodynamic therapy to treat target tissues. Background Technology

[0004] Many surgical procedures involve treating or removing target tissues, such as diseased or unwanted tissues, located within a patient's body. Thus, these procedures require access to the patient's internal anatomy via open surgery or, in minimally invasive surgery, through small incisions.

[0005] Women suffer from various uterine abnormalities that can cause a range of problems. Endometriosis is the growth of endometrial tissue, which normally lines the inside of the uterus, on the outside. Endometriosis can cause severe, persistent, chronic pain. Endometriosis typically occurs in and around the pelvic cavity, such as near the ovaries, fallopian tubes, and other tissues that line the pelvis. In rare cases, endometrial tissue can spread outside the pelvic organs. Endometriosis can include superficial endometrial tissue growth in and around these areas, deep endometrial tissue growth, or both.

[0006] Another abnormality is menorrhagia, which is defined as menstrual bleeding lasting more than seven days and often includes heavy bleeding. Melatonin affects more than ten million American women each year, meaning that one in five women in the country suffers from menorrhagia. Untreated menorrhagia can cause anemia, a common blood problem where patients lack enough healthy red blood cells to carry sufficient oxygen throughout the body.

[0007] Heavy menstrual bleeding can be caused by uterine problems, hormonal problems, or other diseases. Some specific causes can include, but are not limited to, growths or tumors in the uterus, uterine or cervical cancer, problems related to pregnancy such as miscarriage or ectopic pregnancy, bleeding disorders, some types of birth control, kidney, thyroid, or liver disease, infections of the female reproductive organs such as pelvic inflammatory disease, menopause, childbirth, fibroids or polyps in the lining or muscle of the uterus, taking certain medications such as aspirin, or combinations thereof. SUMMARY

[0008] Various approaches can be employed to treat uterine abnormalities including endometriosis, heavy menstrual bleeding, polyps, and fibroids. For example, ablation therapy can be provided to treat various uterine abnormality cases. In an example of treating endometriosis, targeted ablation such as radiofrequency (RF) ablation can be used to provide electromagnetic energy for resection of tissue or can provide a blade-like device for physically ablating tissue. In an example of treating heavy menstrual bleeding, endometrial tissue in the uterus can be treated by ablation therapy such that the tissue does not continue to bleed heavily during the menstrual cycle. This treatment of the uterus can be referred to as global endometrial ablation (GEA). GEA approaches can use various ablation techniques to ablate the endometrium and prevent heavy menstrual bleeding. Some of these approaches can include radiofrequency (RF) energy ablation techniques, microwave energy ablation techniques, cryogenic ablation techniques, thermal energy ablation techniques, steam ablation techniques, and plasma ablation techniques. Devices and methods for implementing these approaches can be large and cause pain or discomfort to the patient when used.

[0009] To help improve efficacy and reduce complications, the present disclosure describes, among other things, improved treatment modalities for treating various uterine abnormalities using photodynamic therapy.

[0010] Photodynamic therapy (PDT) uses a photosensitizing chemical and light to treat diseased tissue, often hyperproliferative tissue. For example, PDT involves two nontoxic components that combine at the treatment site to induce cellular and tissue damage in an oxygen-dependent manner. A nontoxic photosensitizer drug and innocuous light of matching wavelength are delivered to the treatment site. Photosensitization of the drug causes energy or electron transfer to molecular oxygen, resulting in transient, local production of cytotoxic reactive oxygen species (ROS). Depending on the drug and treatment protocol, phototoxicity can be directed toward target tissue. These radicals have very short half-lives in the biological environment, thereby localizing damage to the illuminated area. Compared to surgical tissue resection and ablation therapy, PDT is a highly controllable, minimally invasive local treatment that can be effective for treating uterine abnormalities such as endometriosis, heavy menstrual bleeding, and polyps, among other uterine abnormalities.

[0011] Examples of previous PDT procedures include treatment of tumors. Typically, a photosensitizer is delivered, usually by intravenous injection, and then a period of time is allowed for the photosensitizer to accumulate in the target tissue while most non-target tissue eliminates the photosensitizer. The therapeutic response of PDT includes both cellular and vascular effects. Current treatment protocols for PDT require a procedure step that allows a period of time to elapse after the photosensitizer is injected into the bloodstream to allow the photosensitizer to accumulate sufficiently in the target tissue, sometimes referred to as the "drug and light" time. The elapsed time required for accumulation prior to the administration of phototherapeutic light is counted down, i.e., begins when the photodynamically active photosensitizer is introduced into the patient's circulatory system. Over time, the photosensitizer is absorbed and bound to tissues and tissue components. While the utilization of this preferential, differentially selected photosensitizer absorption / retention by the hyperproliferative tissue is effective for various photosensitizers and target tissues, the delay time required to accumulate a therapeutically effective concentration of photosensitizer in the tissue is often necessitated by absorption throughout the body and elimination, often requiring the use of relatively high photosensitizer doses. This high level of drug in turn leads to problems such as systemic and local toxic reactions and prolonged cutaneous photosensitivity. In addition, this approach does not specifically target the vasculature but rather focuses on the selectability of the target tissue (the tissue to be treated by PDT) to absorb and retain the photosensitizer from the blood. In addition, by injecting the photosensitizer into the patient's circulatory system and waiting until a sufficient amount of photosensitizer is retained in the target tissue, a critical window of opportunity is provided that requires irradiation to occur for effective treatment of the target tissue.

[0012] The present disclosure describes devices and methods that can selectively deliver targeted PDT treatment to treat various conditions and eliminate the need for the previous approach of waiting between injection of the photosensitizer and irradiation. In addition, the devices and methods disclosed herein can provide for targeted PDT treatment of specific target tissues (e.g., endometriosis or polyps) or can provide for whole PDT treatment of the interior uterine wall that can be used to treat, for example, menorrhagia.

[0013] In particular, the devices and methods disclosed herein provide for the delivery of a photosensitizer and illumination to the surface of a target tissue. In examples, the photosensitizer and illumination occur substantially simultaneously. In this way, a precise targeted PDT treatment can be delivered to the target tissue. Such an approach can include providing or using a PDT treatment device for generating an intrauterine tissue effect for menorrhagia and a targeted tissue effect for endometriosis and uterine polyps. The treatment device can include a portion that can be sized and shaped for at least partial insertion into a patient. The device can have a shaft that includes a proximal portion and a distal portion. The device can also include a treatment end that includes a therapeutic light emitter and an applicator that can deliver a photosensitizer to a particular tissue or region (target tissue) in a desired manner. The photosensitizer and therapeutic light can be delivered to the tissue or region simultaneously or substantially simultaneously so that the tissue or region can be effectively treated. Moreover, because the photosensitizer is applied to the surface of the tissue, the amount of photosensitizer used and absorbed by the human body can be reduced and the uncertain waiting period in previous approaches to allow a sufficient amount of photosensitizer to concentrate in a particular tissue is eliminated.

[0014] This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the application. The detailed description is included to provide further information about the present patent application. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 is a schematic illustration of a treatment device including a surgical device having a treatment end that can provide PDT to a target tissue according to one example of the present disclosure.

[0016] Figure 2 is a schematic illustration of a treatment device providing PDT to a patient having menorrhagia according to one example of the present disclosure.

[0017] Figure 3 is a schematic illustration of a treatment device including a phototherapeutic light retaining device and a distending member that can provide PDT according to one example of the present disclosure.

[0018] Figure 4 is Figure 3 is a close-up view of a distal portion of the treatment device shown in

[0019] Figure 5A is a schematic perspective view of a phototherapeutic light retaining device according to one example of the present disclosure.

[0020] Figure 5B is Figure 5A is a schematic end view of the phototherapeutic light retaining device shown in

[0021] Figure 6 FIG. 1 is a schematic illustration of a laparoscopic surgical procedure to provide PDT to a patient with endometriosis, according to one example of the present disclosure.

[0022] Figure 7 FIG. 2 is a schematic cross-sectional view of another example of a treatment device that can provide PDT to target tissue, according to one example of the present disclosure.

[0023] Figure 8 FIG. 3 is a schematic cross-sectional view of another example of a treatment device that can provide PDT to target tissue, according to one example of the present disclosure.

[0024] Figure 9 FIG. 4 is a schematic cross-sectional view of another example of a treatment device that can provide PDT to target tissue, according to one example of the present disclosure.

[0025] Figure 10 FIG. 5 is a schematic line frame diagram illustrating a method for providing PDT to target tissue, according to one example of the present disclosure.

[0026] Figure 11 FIG. 6 is a schematic line frame diagram illustrating a method for providing PDT to target tissue, according to one example of the present disclosure.

[0027] Figure 12 FIG. 7 is a schematic line frame diagram illustrating a method for providing PDT to target tissue, according to one example of the present disclosure.

[0028] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, various embodiments discussed in the present document. DETAILED DESCRIPTION

[0029] The present disclosure describes, among other things, devices and methods that can be used to treat a patient, such as for the local treatment of target tissue, including but not limited to endometriosis, heavy menstrual bleeding, and uterine growths such as polyps. As defined herein, "target tissue" refers to any biological tissue or portion of a biological tissue, including blood and / or blood vessels, that is the target of focused tissue ablation and includes, for example, a cellular group, a tissue, a body part, or an organ.

[0030] The device can include an outer shaft that can be inserted into a patient. A surgical instrument having a treatment end portion can be translated within the outer shaft to extend from the outer shaft and deliver PDT treatment to the patient. The treatment end portion can include a light emitter and an applicator tip portion in a configuration such that photosensitizer and light illumination provided by the light emitter can be applied to a surface of the target tissue. As discussed herein, the photosensitizer and illumination can be provided simultaneously, i.e., synchronously, during a procedure that provides PDT. In one example, the photosensitizer can be applied alone initially, but after a certain time limit, the light illumination can be delivered while the photosensitizer continues to be applied. In some examples, the photosensitizer can be applied to the surface of the target tissue and the illumination can be provided substantially simultaneously or subsequently. In this case, the illumination can be provided subsequently after the photosensitizer is applied. For example, the illumination can be provided within 10 minutes, such as about 9 minutes, 8 minutes, 7 minutes, 6 minutes, 5 minutes, 4 minutes, 3 minutes, 2 minutes, and 1 minute, after the photosensitizer is applied. In one example, the illumination occurs within less than 1 minute, such as within 40 seconds, 30 seconds, 20 seconds, 10 seconds, 5 seconds, and 3 seconds. Further, as discussed further herein, a combination of simultaneous application of illumination and photosensitizer and spaced-apart (or subsequent) illumination application can be used during a procedure. Whether the photosensitizer and illumination are provided simultaneously, substantially simultaneously, or subsequently can depend on various factors such as the target tissue, the particular photosensitizer, and the desired treatment outcome.

[0031] Figure 1 is a schematic view of a treatment device 10 (also referred to herein as "device 10") that can apply PDT to a target tissue. The treatment device 10 can include a handle or handpiece 20, an outer shaft 12, and a surgical instrument 23. The surgical instrument 23 can deliver PDT by applying a photosensitizer and light illumination to a target tissue, such as a surface of the target tissue. The surgical instrument 23 can provide the photosensitizer via an applicator system 29 and can provide the illumination via a light illumination system 21. The applicator system 29 can include an applicator shaft 28 and an applicator tip portion 26. The light illumination system 21 can include a light source 38, a light delivery shaft 33, a light conductor 32, and a light emitter 24. The applicator tip portion 26 and the light emitter 24 can form a treatment end portion 22 of the surgical instrument 23 that delivers PDT to the target tissue.

[0032] The outer shaft 12 can include an elongate member extending from a proximal end portion 14 to a distal end portion 16. The outer shaft 12 defines a lumen 19 extending from the proximal end portion 14 to the distal end portion 16, the lumen 19 including a distal end opening 18. The handpiece 20 can be mounted or connected to the proximal end portion 14 of the outer shaft 12, and a portion of the applicator system 29 and a portion of the light illumination system 21 can be within or along the outer shaft 12, such as extending from the proximal end portion 14 to the distal end portion 16.

[0033] In the example, the outer shaft 16 can be sized, shaped, or arranged for use in conjunction with laparoscopy to perform laparoscopic surgery and cervical surgery. Thus, the shaft 16 can be inserted into an incision in the patient's skin, through the patient's body cavity, and into organs or through the cervix into the uterus. Therefore, it is desirable that the diameter or cross-sectional shape of the shaft 16 be as small as possible to facilitate minimally invasive surgery and minimal cervical dilation. The outer shaft 12 can be rigid and formed of metallic or plastic materials. In the example, the outer shaft 12 can have a diameter of less than about 6 mm. The proximal portion 14 can be close to the operator when the device 10 is in use.

[0034] The drug delivery conduit 30 may be defined by the application shaft 28. A drug source 46 may be connected to the drug delivery conduit 30 at its proximal end 14 to deliver a photosensitizer to the applicator tip 26. The applicator tip 26 is configured to apply the photosensitizer to the target tissue in a manner specific to the treatment type and the anatomy to be treated. The treatment device 10 may also include a power source or generator 48, which may be coupled to the drug source 46 via a link 50 and to the treatment device 10 via a link 44. The drug source 46 may be removable (or refillable), thereby allowing different photosensitizers to be attached or used during treatment.

[0035] The handheld component 20 may include any suitable means to facilitate the manipulation and operation of the treatment device 10. The handheld component 20 may be located at another suitable position along axis 12 at the proximal portion 14. In examples, the handheld component 20 may include a grip, knob, hand-held handle, etc. An actuation device 42 may be attached to the handheld component 20 to operate links 44, 50. The actuation device 42 may include one or more of a button, trigger, lever, knob, dial, etc. Links 44, 50 may include any suitable means for allowing operation of the treatment device 10 from the handheld component 20. In examples, links 44, 50 may be mechanical links, electronic links, electrical links, fluid links, or acoustic links.

[0036] The light guide 32 can include a medium for transmitting light from the light source 38 to the light emitter 24. The light guide 32 can be positioned within the optical axis 33 to extend from the proximal portion 14 to the light emitter 24 at the distal portion 16. The light guide 32 can include a material suitable for transmitting waves of electromagnetic radiation of various wavelengths. The light guide 32 can be coupled to the light source 38 via the cable 36 and the connector 34. The cable 36 can include an extension of the light guide 32 and can be made of the same material as the light guide 32. In an example, the light guide 32 and the cable 36 can include an optical fiber cable. In an example, the optical fiber cable can include glass and plastic fibers encased in one or more protective coatings. The light emitter 24 can be located at or near the distal end of the light guide 32. The light emitter 24 can be coupled to the light guide 32 by any suitable means. In an example, the light emitter 24 can include a lens for focusing or a diffuser for spreading the light waves from the light guide 32. The light emitter 24 can be unidirectional or omnidirectional. The light emitter 24 can include a glass or plastic body of transparent material. However, in additional examples, a separate light emitter is not used and the light guide 32 can include an end-emitting fiber such that the distal or terminal end of the light emitter 32 can include the light emitter 32.

[0037] In an example, the light emitter 24 and the applicator tip 26 are coupled such that the light emitter 24 and the applicator tip 26 cannot move relative to each other. That is, the light emitter 24 and the applicator tip 26 can be linearly locked together such that the light emitter 24 and the applicator tip 26 move together relative to the outer shaft 12. The light emitter 24 and the applicator tip 26 can be located at the end of a single shaft or at the ends of two respective shafts (the optical axis 33 and the applicator axis 28), which can be coupled together. In another example, the light emitter 23 and the applicator tip 26 are not linearly locked and can move relative to each other and relative to the outer shaft 12.

[0038] The light source 38 can be any suitable light source that emits a light beam having a wavelength that matches one of the absorption peaks of the photosensitizer drug. That is, the light source 38 should emit photosensitizer-activating light (also referred to herein as “phototherapeutic light” or “treatment light”), and the light source 38 is emitting the photosensitizer-activating light based on the type of photosensitizer drug used.

[0039] As mentioned, the light source 38 can be coupled to the light conductor 32 via a cable 36. The connector 34 can include any suitable means for joining the light conductor 32 and the cable 36 such that the fibers disposed in the light conductor 32 and the cable 36 can abut end-to-end. As such, the light source 38 can be positioned away from the treatment device 10. In an example, the light source 38 can include a separate module that can be coupled to the treatment device 10 via the cable 36. In an additional example, the light source 38 can be directly attached to the exterior of the handpiece 20 via the connector 34 without the need to use the cable 36. As such, the light source 38 can be removable, thereby allowing attachment of a light generator that produces different intensities or wavelengths that can allow for activation of different types of photosensitizer drugs as described below. In an additional example, the light source 38 can be incorporated into the handpiece 20 such that the connector 34 is not used. In an additional example, the light source 38 can be incorporated into the generator 48 and the cable 36 and the cable 44 can be contained in a common cable bundle. In an additional example, the light source 38 can be disposed at the distal end of the optical shaft 33 such that the light source 38 is coupled to the power source and produces light at the distal end of the optical shaft 33 rather than using the light conductor 32 to produce and transmit light to the light emitter 24.

[0040] Light from the light source 38 can be transmitted through the optical shaft 33 using the light conductor 32 to provide photosensitizer activation light (illumination) with or without the aid of a separate light emitter device such as the light emitter 24. As mentioned, a removable light generator can facilitate the production of different wavelengths of light such that the activation wavelength can be matched to the particular photosensitizer drug being used. This is beneficial because the particular photosensitizer drug being used can depend on the type of target tissue surrounding the tissue / anatomy being treated and the intensity needed to treat the target tissue. As discussed herein, one or more photosensitizers can be applied to the target tissue during treatment of the target tissue to vary the intensity of the PDT. In an example, the drug source 46 and the light source 38 can be varied such that the wavelength of light from the light source 38 matches the new photosensitizer such that a different photosensitizer can be used. For example, different photosensitizers can be used during a single PDT treatment depending on the target tissue and the intensity of treatment needed.

[0041] The actuation device 40 can be attached to the handpiece 20 to operate the linkage 36. The actuation device 40 can include one or more of a button, trigger, lever, knob, dial, etc. The linkage 36 can include any suitable means for allowing one or more features of the illumination system 21 to be operated from the handpiece 20. In an example, the linkage 36 can be a mechanical linkage, an electronic linkage, an electrical linkage, a fluidic linkage, or an acoustic linkage.

[0042] As discussed herein, the wavelength emitted from the light source 38 matches one of the absorption peaks of the selected photosensitizer. The estimated light intensity to be delivered depends on the illumination system 21, the illumination mode used, the properties of the target tissue, and the purpose of the treatment.

[0043] The drug source 46 can control the selection of the photosensitizer. As discussed herein, since the photosensitizer is typically applied to the target tissue, a smaller amount of photosensitizer can be used, and since the photosensitizer is not intravenously injected or taken orally, less of the photosensitizer is absorbed into the body. Additionally, because the photosensitizer and the light illumination are provided substantially simultaneously and to the surface of the target tissue, there is no critical window of opportunity for the user to provide the illumination to provide an effective and efficient PDT to the patient.

[0044] The photosensitizer can be selected from any suitable photosensitizer. An exemplary list of photosensitizers includes, but is not limited to, porphyrins, 5-aminolevulinic acid (ALA), chlorins, pyrrole-derived macrocycles, porphyrins, chlorins, bacteriochlorins, isobacteriochlorins, phthalocyanines, naphthalocyanines, porphyrinoid compounds, porphycenes, pentaphyrins, sapphyrins, deuteroporphyrins, phenoxazines, phenothiazines, chaloorganapyrylium dyes, triarylmethanes, rhodamines, fluoresceins, azapophyrins, benzochlorins, purpurins, chlorophylls, verdins, and derivatives thereof.

[0045] The manner in which the photosensitizer is applied to the target tissue via the applicator tip 26 can depend on the location and type of the target tissue. For example, the photosensitizer can be applied in a stream at high or low pressure, such as a spray, such as an atomized spray (thin mist or fog), or as a paste.

[0046] As discussed herein, the photosensitization of the drug causes energy transfer and can ablate the target tissue. The ablation can include, for example, removing or destroying the target tissue by applying the PDT. In some cases, the ablation can cause the tissue to necrose. In an example, the target tissue can scar in response to the ablation, thereby preventing the target tissue from bleeding profusely and creating a menorrhagia effect.

[0047] Furthermore, although not shown in Figure 1 , a gas conduit can be provided in the treatment device 10 to provide a flow of oxygen to the target tissue. The concentration of oxygen at the target tissue can alter the results from the PDT. For example, a low oxygen content can reduce the phototoxicity, thereby preventing the PDT from achieving the full therapeutic potential of the PDT. Accordingly, any of the treatment devices disclosed herein can be configured to supply oxygen to the target tissue to increase the oxygen at the target tissue and maximize the therapeutic potential of the PDT.

[0048] Figure 2 is a schematic of a treatment device 10 providing PDT to a patient with menorrhagia according to one example of the present disclosure. The outer shaft 12 has been inserted into a body lumen (uterus 66) and the surgical instrument 23 is advanced from the outer shaft 12 such that the treatment end 22 is at a desired location. In this example, since the treatment device 10 is treating menorrhagia, the photosensitizer 61 can be applied from the applicator tip 26 in a mist form such that there is the most efficient contact with the surface of the uterine wall 70. However, any method of application of the photosensitizer is contemplated.

[0049] The phototherapeutic light 63 (photosensitizer activating light) is delivered to irradiate the uterine wall 70. The phototherapeutic light 63 can be applied simultaneously or substantially simultaneously with the photosensitizer 61. The treatment device 10 allows for selective destruction of the uterine wall 70 because the light is delivered during the maximum photosensitizer concentration at the surface of the target tissue. That is, the light is delivered while the photosensitizer is continuously applied to the surface of the target tissue. The dosage, amount, and type of photosensitizer and the length of irradiation can depend on the particular patient and the desired tissue result. Thus, in one example, a protocol for PDT can include simultaneous application of photosensitizer / light over a period of time.

[0050] As discussed herein, the type of abnormality being treated can determine the protocol used during PDT. For example, in other examples, the protocol can include switching between applying PDT (photosensitizer / light) and not applying PDT. For example, a duty cycle of applying PDT can be applied while treating a patient. The type of photosensitizer can also determine the type of protocol used. In examples, some photosensitizers can act immediately and the therapeutic effect of the some photosensitizers is complete while other photosensitizers can have a longer effective period. Thus, an operator can apply PDT such as applying photosensitizer / light and then diagnose the target tissue after a period of time to determine if additional segments of PDT are needed.

[0051] In one example, a coaxial optical fiber can be used and includes visible light that can be connected to a camera and treatment light to apply a wavelength that matches the photosensitizer used. The operator can then switch between applying PDT and diagnosis until the target tissue is sufficiently treated. In one example, diagnosis can occur simultaneously with the application of PDT. However, in other examples, diagnosis can occur after PDT (photosensitizer / light) has stopped and the effective period of the photosensitizer has ended. An optical system and / or imaging system can be used to identify the target tissue, to detect the treated target tissue in real time to determine if more treatment is needed and to determine if the procedure is complete. One example of such an optical system is disclosed in U.S. Provisional Patent Application 62 / 940,328, filed November 26, 2019, entitled “Surgical devices with Integrated Lighting Systems,” which is incorporated by reference herein in its entirety.

[0052] In another example, the same effect can be achieved by applying photosensitizer 61, stopping the application of photosensitizer 61, and irradiating the target tissue within a time limit after the application of photosensitizer 61 has stopped. This sequence can be repeated multiple times until the desired tissue result is achieved. Thus, in one example, a protocol for delivering PDT can be: apply photosensitizer-irradiate-apply photosensitizer-irradiate-apply photosensitizer-irradiate, etc. The time limit can vary and be less than 5 minutes, such as, but not limited to, less than 1 minute and less than 10 seconds.

[0053] Optionally, treatment device 10 can include fallopian tube blockers 60A, 60B that can extend from outer shaft 12. Fallopian tube blockers 60A, 60B include elongate members 62A, 62B having blocking portions 64A, 64B configured to block fallopian tubes 71 to minimize the entry of photosensitizer 61 and phototherapeutic light 63 into fallopian tubes 71 and ablate undesired target tissue.

[0054] As Figure 2As shown in FIG. 1 1, the treatment device 10 is applying overall application of PDT to treat menorrhagia, where the fallopian tubes are the tissue intended not to be treated. However, there can be other cases where a large area of tissue is the target tissue, but there can be other areas other than the fallopian tubes that are not intended to be treated. Optionally, a pre-treatment can be performed on the areas around the target tissue that are not intended to be treated. The pre-treatment can include applying a barrier coating to the tissue that is not intended to be treated with PDT. The barrier coating can prevent the photosensitizer from contacting / absorbing into the tissue and / or block the wavelengths from the light source 38. In an example, the treatment device 10 or a separate device can be used to apply the barrier coating to the surface of the tissue that is not intended to be treated with PDT. Examples of the barrier coating can include, but are not limited to, a hydrophobic coating, beeswax, and mucoadhesive, etc., that has properties that prevent the photosensitizer from attaching / contacting with the tissue or blocking the wavelengths produced by the light source 38.

[0055] As discussed herein, the light emitter 24 and the applicator tip 26 can be linearly locked together. In an example, during treatment of the uterine wall 70, the light emitter 24 and the applicator tip 26 can be moved together along the longitudinal axis within the uterus 66 to treat the target tissue while the PDT is being delivered. Alternatively, the light emitter 24 and the applicator tip 26 can be moved independently of each other, such that one can remain in a stationary position while the other can be linearly moved. Further, both the light emitter 24 and the applicator tip 26 can be simultaneously moved relative to each other in different directions or at different speeds. In one example, the position of the applicator tip 26 remains constant while the photosensitizer 61 is being applied, and the light emitter 24 is moved back and forth along the longitudinal axis to effectively apply and fully irradiate the uterine wall 70. Further, the surgical device 23 can be rotated about the longitudinal axis to improve the efficiency of the PDT.

[0056] Figure 3 is a schematic view of the treatment device 10 including the dilation member 74 and the phototherapeutic light retaining device 72. Figure 4 is Figure 3 is a close-up view of the distal portion of the treatment device shown in FIG. 1 1 applying PDT to a patient having an intramural polyp. The dilation member 74 and the phototherapeutic light retaining device 72 are optional and can be used in certain cases to improve the efficiency of applying the PDT. Figure 3 and Figure 4 will be discussed together.

[0057] The dilation member 74 is translatable within the outer shaft 12 and is configured to dilate the patient's uterus. The dilation member 74 can also be used to Figure 2The expansion member 74 can have a non-expanded position and an expanded position. For example, the expansion member 74 can be in the non-expanded position (compressed state) while positioned within the outer shaft 12, and as the expansion member 74 is advanced from the outer shaft 12, the expansion member 74 transitions from the non-expanded position to the expanded position (uncompressed state) to expand a body cavity such as the uterus. Although any expansion structure is contemplated in one example, the expansion member 74 includes two or more elongated legs. The expansion member 74 can be formed from, but is not limited to, silicone, PET, polyurethane, rubber, etc.

[0058] The phototherapy light retaining device 72 can be used to retain light exposure to a particular area. For targeted PDT such as applying PDT to a polyp (as shown in Figure 4 ) or endometriosis (as shown in Figure 6 ), it can be easier to retain light than to apply a photosensitizer to a particular location. In some cases, the properties of the photosensitizer such as viscosity can be altered to allow the photosensitizer to stay in a particular location for an extended period of time. For example, the photosensitizer can be applied in liquid, gel, or paste form depending on the location and characteristics of the treatment device 10.

[0059] Similar to the expansion member 74, the phototherapy light retaining device 72 can have a non-expanded position and an expanded position. For example, the phototherapy light retaining device 72 can be in the non-expanded position (compressed state) while positioned within the outer shaft 12, and as the phototherapy light retaining device 72 is advanced from the outer shaft 12, the phototherapy light retaining device 72 transitions from the non-expanded position to the expanded position (uncompressed state) and can be advanced so that the distal end of the phototherapy light retaining device 72 contacts the area around the target tissue 76 (uterine polyp). The phototherapy light retaining device 72 surrounds the treatment end 22 of the surgical instrument 23 to retain the phototherapy light 63 to the desired location while the photosensitizer 61 is being delivered. To retain the phototherapy light 63, the phototherapy light retaining device 72 is formed from a material that does not transmit the phototherapy light.

[0060] The treatment device 10 can also include a gas conduit 78, for example, located in the wall of the outer shaft 12 to deliver a gas. The gas can help to expand a body cavity but can also be used to increase the reactivity of the photosensitizer when the gas is oxygen. Although shown fed in the wall of the outer shaft 12, the oxygen gas flow can be fed in various ways. In one example, the oxygen gas flow can be fed through the phototherapy light retaining device 72. However, other configurations are contemplated.

[0061] Figure 5A is a schematic perspective view of the phototherapy light retaining device 72, and Figure 5B is a schematic end view of the phototherapy light retaining device 72. Figure 5AA light therapy light retaining device 72 in an inflated state is illustrated. The light therapy light retaining device 72 can include an elongated body 80 and a plurality of flexible members 82 connected by a flexible material 84. The area defined by the distal end of the light therapy light retaining device 72 can vary and depend on how far the light therapy light retaining device 72 protrudes from the outer shaft 12. The light therapy light retaining device 72 can define a lumen 86 that can receive a surgical instrument 23 and / or provide an oxygen gas flow.

[0062] Figure 6 is a schematic illustration of a laparoscopic surgical procedure to provide PDT to a patient having endometriosis. The surgical procedure can include an open surgery or a laparoscopic surgery. Figure 6 is a schematic illustration of a laparoscopic surgical procedure performed without the dilation member 74 using the treatment device 10 shown in Figure 4 is a schematic illustration of a laparoscopic surgical procedure performed without the dilation member 74 using the treatment device 10 shown in Figure 6 is a schematic illustration of a surgical procedure being performed to remove endometrial tissue that has grown outside of the uterus U from the cavity of the abdomen A. Figure 9 is a schematic illustration of a surgical room environment with a laparoscope 90 coupled to a camera 92 and a display 94.

[0063] The treatment device 10 can be inserted into a channel 96 of the laparoscope 90. As shown, the distal portion 16 of the outer shaft 12 protrudes from the channel 96 and is located inside the abdomen A. The treatment end 22 of the surgical instrument 23 can be advanced from the outer shaft 12 and positioned to deliver PDT. As Figure 6 is a schematic illustration of a laparoscopic surgical procedure performed without the dilation member 74 using the treatment device 10 shown in

[0064] Figure 7 and Figure 8 is a schematic illustration of a portion of other examples of treatment devices 100, 200 such as for one or more uterine tissue effects. Figure 7 is a schematic illustration of a treatment device 100 including a treatment end 22. The treatment end 22 includes a light illumination system 21 as disclosed herein and an applicator system 103. The applicator system 103 includes an inflatable medium 102 including a layer 104 of photosensitizer on an outer surface 109 of the inflatable medium 102. Inflation of the inflatable medium 120 is configured to apply the photosensitizer to a target tissue. The light illumination system 21 can include a light emitter 24, a light axis 33, and a light conductor 32. However, as Figure 7The light shaft 33 shown in FIG. 1 can include a media delivery conduit 106 in fluid communication with the interior 105 of the inflatable medium 102. The media delivery conduit 130 can run within or along the light shaft 33. A media source, such as a gas or a liquid, can be connected to the media delivery conduit 106 at a proximal end of the light shaft 12. The inflatable medium 102, for example, can be elastic and inflatable, such as using a balloon-type material, and transmissive to wavelengths generated by the light source.

[0065] The applicator system 103 includes a layer 104 of photosensitizer on an outer surface 109 of the inflatable medium 103. In one example, the layer 104 can be a composite material that includes the photosensitizer.

[0066] The inflatable medium 102 can have both a lower profile state and a relatively higher profile state. In the lower profile state, the inflatable medium 102, for example, can collapse over the light shaft 33. In the lower profile state, the inflatable medium 102, for example, can be more narrow in profile, such as to be more easily inserted into a patient. In the lower profile state, the inflatable medium 102 can have a lateral profile outer dimension, such as a diameter, of less than about 6 mm, such as to be more easily inserted trans-cervically into a patient.

[0067] In the higher profile state, the inflatable medium 102 can expand to a larger dimension, such as a larger diameter, cross-section, or volume, while located within the uterus, for example. When in the relatively higher profile state, the inflatable medium 102 can have a lateral profile outer dimension, such as a diameter, of about 3 cm to about 4 cm.

[0068] The inflatable medium 102, for example, can include a polyurethane material. In some cases, the inflatable medium 102 can include more than one layer of material, as discussed below with reference to Figure 8

[0069] The media delivery conduit 106 can deliver media to the inflatable medium 102 at or via an outlet 107. When deployed, the inflatable medium 102 can cover or surround the outlet 107, such that fluid can be delivered directly into the inflatable medium 102. The fluid, for example, can include water, saline, oxygen, carbon dioxide, or other suitable liquid or gas.

[0070] In some cases, the outlet 107 can include a valve in fluid communication with the media delivery conduit 106. The valve can be configured to be triggered by a user to allow or prevent or otherwise control the delivery of media via the valve toward the inflatable medium 102. The operator, for example, can trigger the valve through a button or trigger on a handpiece. In some cases, the operator can trigger the valve through a foot pedal or other actuator coupled to the device 100.

[0071] ​The medium can be provided to the expandable medium 102 from a medium source via the fluid delivery conduit 106. In examples, the medium source can include a pre-filled syringe, which can be integrated with or attached to the handpiece, for example. The syringe can have a plunger, which can be actuated by a coil spring, for example, or can be manually actuated by an operator, for example. The fluid source can include a tube, a hose, a pump, or a combination thereof, for example, to connect the device to a larger tank, a container, a faucet, or other reservoir containing the fluid.

[0072] In some cases, the operator can use the device 100 by inserting the distal portion 16 through the cervix into the uterus of the patient with the expandable medium 102 in a low profile state (e.g., a compressed state), for example. In some cases, the operator can determine the correct placement of the device 100 in the patient by visual confirmation with the aid of a scope (such as an endoscope) or camera integrated into the device. In some cases, the operator can use other imaging techniques such as ultrasound. In other examples, the operator can physically detect when the device 100 touches the uterine wall in cases where the operator intends for the expandable medium 103 to touch, extend, or expand the uterine wall. The applicator system 103 includes a layer 104 of photosensitizer on the outer surface 109 of the expandable medium 103.

[0073] After insertion, the operator can actuate the medium source so that the medium can be delivered down the medium delivery conduit 106 and instilled, sprayed, or poured into the expandable medium 102, causing the expandable medium 102 to distend from the low profile state (e.g., a compressed state) to a higher profile state (e.g., an expanded state) with the medium and partially or fully filled with fluid. In the higher profile state, the layer 104 of photosensitizer can contact the inner wall of the uterus. Subsequently or concurrently, the user can activate the light so that the light emitter 24 can emit the phototherapeutic light to irradiate the uterus and activate the photosensitizer.

[0074] The generated energy can ablate the endometrium. The ablation can include removing or destroying the target tissue, for example. In some cases, the ablation can cause the tissue to necrose. The target tissue can scar in response to the ablation, preventing the target tissue from bleeding profusely and creating a menorrhagia effect.

[0075] Figure 8A treatment device 200 for providing PDT is illustrated. The device 200 can include an outer shaft 12, a surgical device 23 including a light application system 21, and an applicator system 111. The applicator system 111 includes an inflatable medium 110 including a first layer 112 and a second layer 114. As discussed herein, inflation of the inflatable medium 110 is to distend the uterus and apply a photosensitizer to a surface of the target tissue. The light application system 21 can have a light emitter 24, a light axis 33, and a light conductor 32. However, as shown in Figure 8 the light axis 33 includes a medium delivery conduit 106 in fluid communication with an interior 113 of the inflatable medium 110. The medium delivery conduit 106 can transition the inflatable medium 110 from a low profile state to a higher profile state, as described in Figure 7

[0076] In the device 200, the inflatable medium 110 can include a second layer 114 for delivering a photosensitizer. The device 200 includes a drug delivery conduit 108, for example, within the light axis 33. The drug delivery conduit 108 can extend along a length of the light axis 33 to an outlet 115. In an example, the outlet 115 is completely surrounded by the first layer 112 and the second layer 114.

[0077] The second layer 114 is porous and includes pores 116 in fluid communication with the drug delivery conduit 108. The second layer 114 can be made of a material that interacts well with the target tissue without causing damage to the target tissue. In some cases, the second layer 114 can touch or directly interact with the target tissue when the inflatable medium 110 is in the higher profile state. In some cases, the inflatable medium can extend or distend the uterine wall with the second layer 114 touching the target tissue.

[0078] The medium delivery conduit 106 can deliver a medium to the inflatable medium 110. For example, the medium can be provided to the interior 114 of the first layer 112 of the inflatable medium 110 to transition the inflatable medium 110 to a higher profile state. Once in the higher profile state, the drug delivery conduit 108 can deliver a photosensitizer at or via the outlet 115 to the inflatable medium 110. The photosensitizer can flow from the drug delivery conduit 108 into a space 121 between the first layer 112 and the second layer 114 of the inflatable medium 110 and out of the pores 116 of the second layer 114 and contact the inner wall of the uterus.

[0079] ​In some cases, the outlet 115 can include a valve in fluid communication with the drug delivery conduit 108. The valve can be configured to be triggered by a user to allow or prevent or otherwise control the delivery of photosensitizing agent to the inflatable medium 110 via the valve. The operator can trigger the valve, for example, by a button or trigger on the handpiece. In some cases, the operator can trigger the valve by a foot pedal or other actuator coupled to the device 100. Photosensitizing agent can be provided from a photosensitizing agent source to the inflatable medium 110 via the drug delivery conduit 108.

[0080] In some cases, the operator can use the device 200, for example, by inserting the distal portion 16 of the inflatable medium 110 with the inflatable medium 110 in a lower profile state (e.g., a compressed state) through the cervix into the uterus of a patient. The operator can in some cases determine proper placement of the device 100 in the patient by visual confirmation with the aid of a vision scope (such as an endoscope) or camera integrated into the device. In some cases, the operator can use other imaging techniques such as ultrasound. In other examples, where the operator intends for the inflatable medium 110 to touch, extend, or expand against the uterine wall, the operator can physically detect when the device 200 touches the uterine wall. The applicator system 111 includes the inflatable medium 110 having a first layer 112 and a second layer 114 (a porous layer).

[0081] After insertion, the operator can actuate the medium source so that the medium can be delivered down the medium delivery conduit 106 and instilled, sprayed, or poured into the inflatable medium 110, causing the inflatable medium 110 to swell from a lower profile state (e.g., a compressed state) to a higher profile state (e.g., an expanded state) and be partially or fully filled with fluid. In the higher profile state, the second layer 114 can contact the inner wall of the uterus. Once in the higher profile state, the operator can actuate the photosensitizing agent source so that the photosensitizing agent can be delivered along the drug delivery conduit 108 and instilled, sprayed, or poured into the space 121 between the first layer 112 and the second layer 114 so that the photosensitizing agent flows through the pores 116 and contacts the target tissue. Subsequently or concurrently, the user can activate the light so that the light emitter 24 can emit the phototherapeutic light to irradiate the uterus and cause activation of the photosensitizing agent. Although shown with one drug delivery conduit 108, one or more drug delivery conduits can be employed.

[0082] Figure 8 The embodiment shown in FIG. 1 includes a two-layer balloon configuration. However, the second porous layer can also be a sponge that can receive photosensitizing agent from the drug delivery conduit 108 and deliver the photosensitizing agent to the target tissue.

[0083] The generated energy can ablate the endometrium. Ablation can include, for example, removing or destroying the target tissue. In some cases, ablation can cause necrosis of the tissue. The target tissue can scar in response to the ablation, thereby preventing the target tissue from bleeding profusely and creating a menorrhagia effect.

[0084] Figure 9 A therapeutic device 300 for providing targeted PDT is illustrated. The device 300 can include an outer shaft 12, a surgical device 23 including a light illumination system 21, and an applicator system 130. The light illumination system 21 can have a light emitter 24, a light shaft 33, and a light conductor 32. The applicator system 130 includes an applicator shaft 132 defining a lumen 134 that can receive a portion of the light illumination system 21. For example, the light emitter 24, the light shaft 33, and the light conductor 32 can extend within the lumen 124. The applicator shaft 132 includes a cover 136, such as a lens, at a distal end. The cover 136 is a phototherapeutic light transparent lens such that phototherapeutic light generated from the light source can be transmitted through the cover 136. The cover 136 includes a photosensitizer layer 138.

[0085] In some cases, an operator can use the device 300, for example, by inserting the distal portion 16 into a patient through the cervix or through an incision during a laparoscopic procedure. The operator can determine the location of the target tissue by visual confirmation with the aid of a vision scope, such as an endoscope, or a camera integrated into the device. In some cases, the operator can use other imaging techniques, such as ultrasound. The operator can direct the surgical instrument 23 such that the photosensitizer material layer 138 contacts the surface of the target tissue. While in contact with the target tissue or shortly thereafter, the operator can activate the light source such that the generated phototherapeutic light can be delivered to the target tissue via the light emitter 24.

[0086] The generated energy can ablate the target tissue. Ablation can include, for example, removing or destroying the target tissue. In some cases, ablation can cause necrosis of the tissue. The target tissue can scar in response to the ablation, thereby preventing the target tissue from bleeding profusely and creating a menorrhagia effect.

[0087] Figure 10is a line diagram illustrating a method 1000 for performing a surgical procedure in accordance with the present disclosure. The method 100 can include providing PDT to a target tissue within a patient. The method 1000 can include inserting a device at step 1002. That is, the distal portion 16 of the outer shaft 12 can be inserted into the patient. At step 1004, the method 100 can include applying a photosensitizer and a phototherapeutic light to a surface of the target tissue. As described herein, the photosensitizer and the phototherapeutic light can be applied simultaneously, substantially simultaneously (within seconds / minutes), or in a combination of the two, depending on the target tissue, the purpose of the treatment, the type of therapeutic device and photosensitizer used. Additionally, the treatment can include applying one or more photosensitizers to the target tissue. Furthermore, a regimen for PDT treatment can include a duty cycle of applying PDT. That is, the photosensitizer / light can be applied intermittently until the operator is satisfied with the tissue effects produced by the PDT. After applying the PDT treatment, at step 1006, the therapeutic device can be removed from the patient.

[0088] Figure 11 is a line diagram illustrating a more detailed method 1100 for performing PDT in accordance with the present disclosure. The method 1100 can include providing PDT to a target tissue within a patient. The method 1100 can include inserting a device at step 1102. That is, the distal portion 16 of the outer shaft 12 can be inserted into the patient. At optional step 1104, the method 1100 includes dilating the body cavity. For example, as shown in Figure 4 , the dilation member 74 can be deployed to dilate the uterus. Dilating the uterus can or can not be required and can be at the discretion of the operator.

[0089] At optional step 1104, the method 1100 can include blocking non-treatment areas. In one example, step 1106 can include blocking the fallopian tubes. For example, as shown in Figure 2 , the fallopian tube blockers 60A, 60B can be deployed from the outer shaft 12 to block the fallopian tubes 71 to prevent the photosensitizer and / or light from entering the fallopian tubes, which in some cases can be considered non-target tissue. In another example, a pre-treatment can be performed, such as applying a blocking coating to the non-treatment areas, which will prevent the photosensitizer from contacting and / or being absorbed into the tissue and / or prevent wavelengths from the light source from penetrating the blocking coating.

[0090] At step 1108, the treatment end is advanced to a desired position relative to the target tissue. At optional step 1110, the phototherapeutic light holding device can be advanced around the treatment end. For example, as shown in Figure 3 and Figure 4As shown, the phototherapy light holding device 72 can be deployed from the outer axis 12 to maintain the exposure of the generated phototherapy light, so that the PDT targets specific target tissues that may be adjacent to non-target tissues. At step 1112, method 1100 may include applying a photosensitizer and phototherapy light to the surface of the target tissue, as described herein.

[0091] At step 1114, method 1110 may include examining other target tissues of the patient. That is, the operator may examine the patient to determine whether further PDT needs to be applied to previously treated tissues, or whether there are other untreated target tissue areas requiring PDT. If other target tissues are identified, or if a portion of previously treated tissue requires additional treatment, then at step 1116, the operator may return to step 1112 and apply PDT again until the user is satisfied that the target tissues have been adequately treated or that all target tissues have been identified and adequately treated. At step 1118, method 1100 includes removing the device from the patient.

[0092] Figure 9 It is based on Figure 6 A schematic diagram of a laparoscopic surgical procedure performed using method 1200. For illustrative purposes, Figure 6 The components were not drawn to scale. Also, regarding... Figure 6 and Figure 9 To elaborate.

[0093] Surgical procedures can include open surgery or laparoscopic surgery. Figure 6 The diagram illustrates the process of... Figure 3 and Figure 4 The treatment device 10 shown performs laparoscopic surgery without the dilation member 74. Surgical procedures can be performed to remove or otherwise reduce diseased or invasive target tissue. Figure 6 The illustration depicts a surgical procedure performed to remove endometrial tissue that has grown outside the uterus U from a cavity in the abdomen A. However, the instruments and methods of this application can be used to perform other procedures. The surgery can be performed in the operating room of a hospital or outpatient facility. Figure 6 The illustration shows an operating room environment where a laparoscope 90 is connected to a camera 92 and a monitor 94. The patient can be appropriately anesthetized.

[0094] At step 1202, an incision 91 may be made in the patient's abdomen A. Incision 91 may be an incision of sufficient length to form an entry point for performing open surgery. Incision 91 may also be a minimally invasive incision, such as... Figure 6 The structure shown is configured to receive the incision of the laparoscopy 90.

[0095] At step 1204, a laparoscope 90 can be inserted into the incision 91. The laparoscope 90 can be coupled to a camera 92 for viewing tissue within the patient's abdomen A inside the incision 91. The laparoscope 90 can include a channel 96 that extends through the incision 91 to allow access to the patient's internal tissue from outside the patient's body.

[0096] At step 1206, a treatment device, such as the treatment device 10 having a surgical instrument 23 with a light emitter 24 and an applicator 26, can be inserted into the incision 91. For example, the surgical instrument 23 can be inserted into the channel 96 of the laparoscope 90. In particular, the shaft 12 of the treatment device 10 can be inserted through the channel 96 so that the distal end 16 protrudes from the channel 67 and is positioned inside the abdomen A. At step 1208, the treatment end 22 including the light emitter 24 and the applicator 26 can be advanced from the outer shaft 12 and positioned within the abdomen A. Figure 4

[0097] At step 1210, optionally, a phototherapy light holding device can be advanced around the treatment end 22. For example, the phototherapy light holding device 72 can be advanced until the distal end of the phototherapy light holding device contacts the uterine surface near, for example, the target tissue 93, such as endometriosis.

[0098] At step 1212, PDT can be delivered by applying a photosensitizer and phototherapy light to the surface of the target tissue 93. For example, the phototherapy light can be generated by a light source to emit toward the target tissue 93 and held by the phototherapy light holding device. The light source can be attached to the surgical instrument. The light can also be light of a wavelength sufficient to activate the photosensitizer. The light from the light source can pass through the treatment device including the surgical instrument. For example, the light can be emitted from the light source 38( Figure 1 ), pass through the light conductor 72( Figure 1 ), and into the light emitter 24( Figure 1 ) of the treatment end 22.

[0099] At step 1214, the target tissue can be examined to determine if more PDT needs to be applied to the target tissue, or other target tissue of the patient can be examined for treatment. In particular, the treatment device 10 can be moved around the abdomen A to view different tissue. Steps 1212 and 1214 can be repeated as necessary with step 1216 to ensure that all target tissue has been removed from the patient. After determining that there is no other tissue to be removed, the patient can be prepared for the end of the procedure and the incision 91 can be closed.

[0100] At step 1218, all instruments can be removed from the patient. For example, the treatment device 10 can be removed from the laparoscope 90 and the laparoscope 90 can be removed from the incision 91.

[0101] ​At step 1220, the incision can be closed. For example, the incision 91 can be sutured or closed with any suitable method.

[0102] Benefits of the systems and methods of the present disclosure can take the form of, for example: 1) combining a photosensitizer and a phototherapeutic light at a tool end of a surgical instrument to provide PDT capability at the tool end of the surgical instrument; 2) eliminating the need to wait between administering a photosensitizer and applying a phototherapeutic light; 3) elucidating the need to infer when a sufficient concentration of photosensitizer is present at a desired target tissue; 3) providing targeted surface PDT treatment; 4) reducing the time to perform a surgical procedure; and 5) reducing the need for post-surgical pathological testing.

[0103] Various notes and examples

[0104] Each of these non-limiting examples can exist independently or can be combined in various permutations or in combination with one or more of the other examples.

[0105] Example 1 provides a treatment device for providing photodynamic therapy to a target tissue, the treatment device comprising: an outer shaft extending from a proximal end portion to a distal end portion; a surgical instrument translatable within the outer shaft, the surgical instrument comprising: a treatment end portion at the distal end portion, the treatment end portion configured to apply a photosensitizer to the target tissue and to deliver a phototherapeutic light to the target tissue.

[0106] In Example 2, the subject matter of Example 1 optionally includes wherein the photosensitizer and the phototherapeutic light are applied to a surface of the target tissue simultaneously.

[0107] In Example 3, the subject matter of Examples 1-2 optionally includes wherein the surgical instrument comprises an illumination system to provide the phototherapeutic light and an applicator system to deliver the photosensitizer.

[0108] In Example 4, the subject matter of Example 3 optionally includes wherein the illumination system comprises a light source sufficient to produce a wavelength that matches an absorption peak of the photosensitizer.

[0109] In Example 5, the subject matter of Example 4 optionally includes wherein the illumination system further comprises a light conductor coupled to the light source, the light conductor extending from the proximal end portion to a light emitter at the distal end portion.

[0110] In Example 6, the subject matter of Example 5 optionally includes wherein the light emitter is connected to the light conductor to emit light from the light conductor toward the target tissue.

[0111] In Example 7, the subject matter of Example 6 optionally includes wherein the light source comprises an optical fiber and the light emitter comprises an end surface of the optical fiber.

[0112] In Example 8, the subject matter of Example 3 optionally includes wherein the applicator system includes an applicator shaft extending from the proximal portion to an applicator tip at the distal portion, the applicator shaft defining a media conduit configured to transport the photosensitizing agent from the media source to the applicator tip.

[0113] In Example 9, the subject matter of Example 8 optionally includes wherein the applicator system provides the photosensitizing agent to the target tissue in a predetermined form selected from one of: a stream, a spray, a paste, a mist.

[0114] In Example 10, the subject matter of Example 9 optionally includes a generator coupled to the media source and the media conduit to transport the photosensitizing agent from the media source through the media conduit and out of the applicator tip in the desired form.

[0115] In Example 11, the subject matter of Example 10 optionally includes wherein the generator is a nebulizer.

[0116] In Example 12, the subject matter of Examples 1-11 optionally includes a dilation device configured to extend from the outer shaft and dilate the body lumen.

[0117] In Example 13, the subject matter of Examples 1-12 optionally includes a phototherapy light retaining device translatable within the outer shaft, the phototherapy light retaining device configured to retain phototherapy light to a specific location defined by the phototherapy light retaining device.

[0118] In Example 14, the subject matter of Example 13 optionally includes wherein the phototherapy light retaining device is formed of a material that is opaque to the phototherapy light.

[0119] In Example 15, the subject matter of Example 14 optionally includes wherein the phototherapy light retaining device is configured to surround a treatment end of the surgical device when deployed from the outer shaft.

[0120] Example 16 provides a treatment device for providing photodynamic therapy to a target tissue, the treatment device comprising: a handle; a shaft extending from the handle at a proximal end to a distal end; a light illumination system configured to apply phototherapy light to the target tissue; and an applicator system configured to apply a photosensitizing agent to the target tissue.

[0121] In Example 17, the subject matter of Example 16 optionally includes wherein the light illumination system includes: a light conductor extending from the handle and into the shaft; and a light emitter connected to the light conductor and configured to protrude from the distal end to illuminate the target tissue.

[0122] In Example 18, the subject matter of Examples 16-17 optionally include wherein the application system includes an application shaft extending from the handle and into the shaft, the application shaft defining a conduit, and an application tip end defining an outlet configured to deliver the photosensitizing agent to the target tissue.

[0123] In Example 19, the subject matter of Examples 16-18 optionally include wherein the shaft includes a tubular body having a wall defining a working lumen, the wall defining a gas conduit configured to deliver oxygen to the target site.

[0124] In Example 20, the subject matter of Examples 16-19 optionally include a dilation device configured to extend from the outer shaft and dilate the body lumen.

[0125] In Example 21, the subject matter of Examples 16-20 optionally include a phototherapy light holding device translatable within the outer shaft, the phototherapy light holding device configured to hold phototherapy light to a specific location defined by the phototherapy light holding device.

[0126] In Example 22, the subject matter of Examples 16-21 optionally include a fallopian tube blocker configured to extend from the outer shaft and block an opening in a fallopian tube.

[0127] Example 23 provides a method for providing photodynamic therapy to a target tissue, the method comprising: delivering a photosensitizing agent and phototherapy light to a surface of the target tissue to provide photodynamic therapy to treat the target tissue.

[0128] In Example 24, the subject matter of Example 23 optionally include wherein delivering the photosensitizing agent and the phototherapy light includes applying the photosensitizing agent and the phototherapy light to the surface of the target tissue simultaneously.

[0129] In Example 25, the subject matter of Examples 23-24 optionally include wherein delivering the photosensitizing agent and the phototherapy light includes applying the photosensitizing agent to the surface of the target tissue and, after a period of time, applying the phototherapy light to the target tissue.

[0130] In Example 26, the subject matter of Example 25 optionally include wherein the period of time is less than 5 minutes.

[0131] In Example 27, the subject matter of Example 25 optionally include wherein the period of time is less than 1 minute.

[0132] In Example 28, the subject matter of Example 25 optionally include wherein the period of time is less than 5 seconds.

[0133] In Example 29, the subject matter of Examples 23-28 optionally include inserting the treatment device into the patient, the treatment device including an outer shaft extending from a proximal portion to a distal portion and a surgical instrument translatable within the outer shaft and configured to provide PDT.

[0134] In Example 30, the subject matter of Example 29 optionally include wherein the surgical instrument includes an illumination system to provide phototherapeutic light and an applicator system to deliver photosensitizer.

[0135] In Example 31, the subject matter of Example 30 optionally include wherein the applicator includes an applicator shaft extending from a proximal portion to an applicator tip at a distal portion, the applicator shaft defining a media conduit configured to deliver photosensitizer from a media source to the applicator tip.

[0136] Example 32 provides a treatment device for providing photodynamic therapy to a target tissue, the treatment device including a shaft having a proximal portion and a distal portion, a surgical instrument translatable within the outer shaft, the surgical instrument including an illumination system configured to apply phototherapeutic light to the target tissue and an applicator system configured to apply photosensitizer to the target tissue.

[0137] In Example 33, the subject matter of Example 32 optionally include wherein the applicator system includes an expandable media proximate the distal portion of the shaft, a media delivery conduit extending between the proximal portion and the distal portion of the shaft, the media delivery conduit including an outlet proximate the distal portion of the shaft for delivering media toward the expandable media, and a photosensitizer layer deposited onto an outer surface of the expandable media.

[0138] In Example 34, the subject matter of Example 32 optionally include wherein the applicator system includes an expandable media proximate the distal portion of the shaft, the expandable media including a first layer and a second layer, the second layer including pores, a media delivery conduit extending between the proximal portion and the distal portion of the shaft, the media delivery conduit including a first outlet proximate the distal portion of the shaft for delivering media toward the expandable media, and a drug delivery conduit extending between the proximal portion and the distal portion of the shaft, the drug delivery conduit including a second outlet proximate the distal portion of the shaft for delivering photosensitizer between the first layer and the second porous layer to deliver photosensitizer to the target tissue.

[0139] In Example 35, the subject matter of Example 32 optionally includes wherein the applicator system includes: an applicator shaft extending between a proximal end portion and a distal end portion of the shaft, wherein the light emitter, the light axis, and the light conductor of the light illumination system are positioned within the applicator shaft; a cover positioned at the distal end of the applicator shaft, the cover being transparent to the light therapy light emitted by the light emitter; and a coating of a photosensitizing agent on an outer surface of the cover.

[0140] In Example 36, a combination comprising any of Examples 1-35.

[0141] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the application can be practiced. These embodiments are also referred to as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0142] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “comprising” are used as the plain-English equivalents of the respective terms “including” and “comprising.” Additionally, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0143] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used as well, which can become apparent upon reading the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b) requiring an abstract that will allow the reader to quickly ascertain the nature of the technical disclosure. It is not intended that the Abstract be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This should not be interpreted as intending that the claimed subject matter requires more features than are expressly identified in the claims. Rather, the inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the application should be determined, not by the Abstract, but by the appended claims and their full scope of equivalents.

Claims

1. A treatment device for providing photodynamic therapy to a target tissue, the treatment device comprising: an outer shaft extending from a proximal end portion to a distal end portion; and a surgical instrument translatable within the outer shaft, the surgical instrument comprising: a treatment end portion at the distal end portion, the treatment end portion configured to advance from the outer shaft and to apply a photosensitizing agent to the target tissue and to deliver a phototherapeutic light to the target tissue, the treatment end portion comprising: a phototherapeutic light holding device surrounding the treatment end portion of the surgical instrument in an expanded configuration and configured to hold a phototherapeutic light within a treatment region, the treatment region comprising the target tissue, wherein the phototherapeutic light holding device is configured to advance from the outer shaft and a distal end portion of the phototherapeutic light holding device is configured to contact at least a portion of the treatment region surrounding; and a dilation device translatable within the outer shaft and configured to expand around the phototherapeutic light holding device.

2. The treatment device of claim 1, wherein, the surgical instrument includes an illumination system to provide the phototherapeutic light and an applicator system to deliver the photosensitizing agent.

3. The treatment device of claim 2, wherein, the illumination system includes a light source sufficient to produce a wavelength matching an absorption peak of the photosensitizing agent.

4. The treatment device of claim 2, wherein, the applicator system includes: an applicator shaft extending from the proximal end portion to an applicator tip end portion at the distal end portion, the applicator shaft defining a media conduit configured to deliver the photosensitizing agent from a media source to the applicator tip end portion.

5. The treatment device of claim 4, further comprising: a generator coupled to the media source and the media conduit to deliver the photosensitizing agent from the media source through the media conduit and out of the applicator tip end portion in a predetermined form.

6. The treatment device of claim 5, wherein, the generator is a nebulizer.

7. The treatment device of any one of claims 1 to 6, wherein, the dilation device is configured to extend from the outer shaft and to dilate a body lumen.

8. The treatment device of any one of claims 1 to 6, wherein, the phototherapeutic light holding device is formed of a material that is opaque to the phototherapeutic light.

9. A treatment device for providing photodynamic therapy to a target tissue, the treatment device comprising: a handle; a shaft extending from the handle at a proximal end to a distal end; an illumination system configured to apply a phototherapeutic light to a target tissue; an applicator system configured to apply a photosensitizing agent to the target tissue; a dilation device configured to dilate a uterus; and a phototherapeutic light holding device configured to advance from within the shaft, wherein the phototherapeutic light holding device expands within the expanded dilation device when advanced from within the shaft, the phototherapeutic light holding device surrounds the illumination system and the applicator system, and a distal end of the phototherapeutic light holding device contacts a treatment region, the treatment region comprising the target tissue; wherein at least one of the application of the phototherapeutic light or the application of the photosensitizing agent occurs within the treatment region. the illumination system includes:

10. The treatment device of claim 9, wherein, a light conductor extending from the handle and into the shaft; and a light source coupled to the light conductor. a light emitter connected to the light conductor and configured to protrude from the distal end of the shaft to irradiate the target tissue.

11. The treatment device of claim 9 or 10, wherein, The application system includes: an application shaft extending from the handle and into the shaft, the application shaft defining a conduit; and an application tip end defining an outlet configured to deliver the photosensitizer to the target tissue.

12. The treatment device of claim 9 or 10, wherein, The dilation device is configured to extend from the shaft and dilate a body lumen.

13. The treatment device of claim 9 or 10, wherein, The phototherapy light-retaining device is formed of a material that is opaque to the phototherapy light.

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