Method and system for in situ replacement

Abstract

To provide a method and a system for suitable in-situ replacement.SOLUTION: The imaging component comprises a shaft and a cavity extending across the shaft from a proximal end thereof toward a distal end thereof. The cavity removably receives at least one of a plurality of different instruments. The wall of the cavity includes an elongated opening at least partially along the shaft and in communication with the exterior of the shaft. An imaging transducer is coupled to the distal end of the shaft. The imaging component is advanced to the target site alone or with a first instrument coupled thereto. A therapeutic or diagnostic procedure is performed with the first instrument. The first instrument is then retracted and removed from the imaging component while the imaging component remains at the target site. A second instrument is then coupled to the imaging component and advanced to the target site to perform a further therapeutic or diagnostic procedure.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 674,479, filed May 21, 2018, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medical systems, devices, and methods, and more particularly, to imaging components for use with therapeutic and diagnostic instruments. [Background technology]

[0003] Current systems, devices, and methods for imaging may be sub-ideal in at least some respects. For example, many current devices may have limited flexibility for use with various diagnostic and therapeutic procedures. For example, many current devices may not interface well with other therapeutic or diagnostic instruments. For example, many current devices may be expensive and / or difficult to clean. For example, many current devices may pose a risk of patient injury during insertion and / or removal.

[0004] Additionally, or alternatively, current systems, devices, and methods for diagnosing and providing therapy may be sub-ideal in at least some other respects. For example, in procedures that may require more than one instrument, multiple instruments may need to be inserted or removed from the patient lumen, and these additional steps of insertion and removal may increase the risk of injury to the patient. Additionally, or alternatively, many current methods may require the removal of imaging components multiple times during a single procedure, which may limit the ability to continuously and consistently view the surgical field during the procedure.

[0005] In light of the above, improved systems, devices, and methods for imaging surgical fields are desirable that would address at least some of the above-mentioned shortcomings and would, for example, be less expensive, easier to clean, and / or capable of being used for a wider variety of therapeutic and diagnostic procedures. Summary of the Invention [Means for solving the problem]

[0006] The present disclosure relates to imaging components for use with therapeutic and diagnostic instruments. In particular, the imaging components disclosed herein can be positioned in situ to capture images of a surgical field while various therapeutic and / or diagnostic instruments can be exchanged at least partially through the imaging component. The imaging components disclosed herein can be used alone, with only one instrument, or in combination with multiple instruments. An exemplary imaging component can include a shaft and a cavity extending across the shaft from its proximal end to its distal end. The cavity can removably receive at least one of a plurality of different instruments. The walls of the cavity can include an elongated opening at least partially along the shaft and communicating with the exterior of the shaft. An imaging transducer can be coupled to the distal end of the shaft to continuously image the surgical field when the imaging component is positioned in situ. The imaging component can be advanced to a target site for imaging alone or with a first instrument coupled thereto. The first instrument can be inserted into the shaft of the in situ imaging component. A therapeutic or diagnostic procedure can be performed using the first instrument. The first instrument may then be retracted and removed from the imaging component. The imaging component may continuously and steadily capture images of the surgical field before, during, and after retraction and removal of the first or other instrument. A second instrument may then be coupled to the imaging component and advanced to the target site to perform additional therapeutic or diagnostic procedures without interrupting imaging of the surgical field. The first instrument may be a diagnostic instrument for performing a diagnostic procedure, and the second instrument may be a therapeutic instrument for performing a therapeutic procedure as informed by the diagnostic procedure (or vice versa, or both the first and second instruments may be diagnostic instruments, or both the first and second instruments may be therapeutic instruments). Additional instruments may be coupled to the imaging transducer after removal and retraction of the second instrument. For example, the diagnostic procedure may be repeated to review therapeutic effectiveness. In some cases, the imaging transducer may be used alone.In some cases, one or more disposable tubes may be coupled to the cavity to serve as sterile, optionally disposable adapters for different instruments to be coupled to and advanced along the imaging component.

[0007] Aspects of the present disclosure provide an imaging component. An exemplary imaging component may include a shaft having a proximal end, a distal end, and a cavity extending across the shaft from the proximal end to the distal end. The cavity may be configured to removably receive at least one of a plurality of different instruments. A wall of the cavity may include an elongated opening at least partially along the shaft and communicating with an exterior of the shaft. The exemplary imaging component may further include an imaging transducer coupled to the distal end of the shaft.

[0008] The cavity may be defined by an exterior surface of the shaft. The exterior surface of the shaft may include only atraumatic edges. The edges of the elongated opening may be curved toward the interior of the cavity. The cavity may be configured to slidably receive an instrument. A distal portion of the cavity may be angled axially relative to the shaft. The distal portion of the cavity may be angled axially relative to the shaft at approximately 3 to 45 degrees.

[0009] At least one of the multiple instruments may comprise a tube. The tube may be aligned to be parallel to the shaft of the imaging component. The tube may be rotatable relative to the shaft while the shaft remains stationary. The tube may comprise a lumen configured to slidably receive a second instrument of the multiple instruments. The tube may be configured to slidably receive a second instrument after the second instrument is aligned to be parallel to the shaft of the imaging component. The second instrument may be rotatable relative to the shaft while the shaft remains stationary. The tube may be disposable. The second instrument may comprise a tissue collector. The tissue collector may comprise a biopsy needle. The second instrument may comprise a tissue ablation element. The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The second instrument may comprise an excision tool. The second instrument may comprise instrumentation for implantation of a device such as a radiopaque marker, a drug-eluting wireform, a sterility / contraception treatment, an anchoring system, a hernia mesh, a stent, or other device. The second instrument may comprise instrumentation for providing detailed mapping of the anatomy such as a laser, x-ray, secondary ultrasound, or other device. The first and second instruments may be any diagnostic or therapeutic device or may be tubes for receiving additional instruments.

[0010] At least one of the plurality of different instruments comprises a therapeutic or diagnostic instrument. The therapeutic or diagnostic instrument may comprise a tissue collector, a biopsy needle, a tissue ablation element, an optical scope, an implanted device, and / or a therapeutic electrode. The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element.

[0011] The shaft may be flexible and may be controllably deflected along its longitudinal axis via a deflection mechanism.

[0012] The imaging transducer may comprise an ultrasound transducer, a light emitting diode (LED), or a camera.

[0013] The cavity may define a circular cross-sectional area. The cavity may have a substantially uniform cross-sectional area along the shaft. The cavity may have an asymmetric cross-sectional area. The cavity may extend across the shaft from the proximal end to the distal end.

[0014] Aspects of the present disclosure may provide an imaging system. An exemplary imaging system may include any of the imaging components described herein and a disposable tube slidably received within a cavity of the imaging component. The system may further include a second instrument removably received within the lumen of the disposable tube. The second instrument may be a diagnostic or therapeutic instrument, a tissue collector, a biopsy needle, an optical scope, an implantable device, and / or a tissue ablation element. The tissue ablation element may include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, or the like.

[0015] Aspects of the present disclosure may provide a method for performing therapy or diagnosis at a target site. In an exemplary method, any of the imaging components described herein may be inserted into a subject. With the imaging component in situ, at least one of a plurality of instruments may be inserted into a cavity toward the target site, therapy or diagnosis may be performed at the target site using the instrument, and the instrument may then be removed from the cavity.

[0016] At least one of the plurality of instruments comprises a tissue collector, a biopsy needle, and / or a tissue ablation element. The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The instrument may comprise a therapeutic or diagnostic instrument, such as an optical scope, an implantable device, or a therapeutic electrode.

[0017] An exemplary method may include inserting a second instrument into the cavity toward a target site, performing therapy or diagnosis at the target site using the second instrument, and removing the second instrument from the cavity. The second instrument may be different from at least one of the multiple instruments. The method may be performed laparoscopically, non-invasively, and / or minimally invasively.

[0018] The second instrument may comprise a tissue collector, a biopsy needle, and / or a tissue ablation element. The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The second instrument may comprise a therapeutic or diagnostic instrument, such as an optical scope, an implanted device, or a therapeutic electrode.

[0019] Aspects of the present disclosure may provide a method for performing image-guided ablation therapy. In an exemplary method, any of the imaging components described herein may be inserted into a subject. With the imaging component in situ, a biopsy needle may be inserted into the cavity, a pathology sample may be collected using the biopsy needle, the biopsy needle may be removed from the cavity, a radiofrequency (RF) ablation element may be inserted into the cavity, tissue may be ablated using the RF ablation element, the RF ablation element may be removed from the cavity, an optical scope may be inserted into the cavity, completion of the image-guided ablation therapy may be confirmed using the optical scope, and the optical scope may be removed from the cavity. The method may be performed laparoscopically, non-invasively, and / or minimally invasively.

[0020] Aspects of the present disclosure may provide a method of coupling instruments. An imaging component may be advanced into a surgical space. The imaging component may include a shaft having a proximal end and a distal end. A first instrument may be coupled to the imaging component for use within the surgical space. The first instrument may be a therapeutic or diagnostic instrument. The first instrument may be decoupled from the imaging component while the imaging component remains within the surgical space. A second instrument may be coupled to the imaging component for use within the surgical space while the imaging component remains within the surgical space. The second instrument may be a therapeutic or diagnostic instrument different from the first instrument. The imaging component may include an imaging transducer that includes an ultrasound transducer. The method may be performed in laparoscopic, non-invasive, and / or minimally invasive surgery.

[0021] Coupling the first instrument can occur while the imaging component remains within the surgical space. Alternatively, or in combination, coupling the first instrument can occur while the imaging component is outside the surgical space.

[0022] The method may further include collecting a tissue sample from the surgical space with the first instrument and / or ablating an area within the surgical space with the second instrument.

[0023] The method may further include performing a therapy or diagnosis using the first instrument. The second instrument may be selected based on data collected from performing the therapy or diagnosis using the first instrument. Parameters of the therapy or diagnosis performed using the second instrument may be adjusted based on data collected from performing the therapy or diagnosis using the first instrument. The collected data may comprise image data, and the parameters may be adjusted by adjusting an ablation zone for the second instrument.

[0024] The imaging component may further include a cavity extending across the shaft from the proximal end to the distal end. The wall of the cavity may include an elongated opening at least partially along the shaft and in communication with the exterior of the shaft. The cavity may be defined by the exterior surface of the shaft. The exterior surface of the shaft may include only an atraumatic edge. The edge of the elongated opening may be curved toward the interior of the cavity. The cavity may be configured to slidably receive a first instrument or a second instrument. A distal portion of the cavity may be axially angled relative to the shaft. The distal portion of the cavity may be axially angled at approximately 3 to 45 degrees relative to the shaft. A tube may be advanced into the cavity. The tube may be aligned so as to be parallel to the shaft of the imaging component. The tube may be rotatable relative to the shaft while the shaft remains stationary. The tube may include a lumen configured to slidably receive a first instrument or a second instrument. The tube can be configured to slidably receive the first or second instrument after the first or second instrument is aligned so that it is parallel to the shaft of the imaging component. The first or second instrument can be rotatable relative to the shaft while the shaft remains stationary. The tube can be disposable.

[0025] The first or second instruments may comprise a tissue collector, a biopsy needle, a tissue ablation element, an optical scope, an implanted device, and / or a therapy electrode. The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element.

[0026] The shaft may be flexible and may be controllably deflected along its longitudinal axis via a deflection mechanism.

[0027] The imaging component may include an imaging transducer comprising a light emitting diode (LED) or a camera. The cavity may define a circular cross-sectional area. The cavity may have a substantially uniform cross-sectional area along the shaft. The cavity may have an asymmetric cross-sectional area. The cavity may extend across the shaft from the proximal end to the distal end.

[0028] 1) the imaging component and 2) the first or second instrument may be coupled axially; 1) the imaging component and 2) the first or second instrument may be coupled laterally; 1) the imaging component and 2) the first or second instrument may be coupled with the aid of magnets or indentations.

[0029] Aspects of the present disclosure provide a system for performing therapy and / or diagnosis at a target site within a patient. An exemplary system may include a first therapy or diagnostic instrument, a second therapy or diagnostic instrument different from the first therapy or diagnostic instrument, and an imaging component configured to be removably coupled to both the first and second therapy or diagnostic instruments, either simultaneously or separately. The imaging component may be configured to be deliverable to a target site within a patient both (i) separately from the first and second therapy or diagnostic instruments and (ii) coupled to the first and / or second therapy or diagnostic instruments. The imaging component may be configured to be removably coupled to both the first and second therapy or diagnostic instruments, either simultaneously or separately, after the imaging component has been delivered to the target site within the patient. The imaging device may be used alone, with only one instrument, or in combination with multiple instruments.

[0030] The first and second therapeutic or diagnostic instruments may comprise two of the following: a tissue collector, a tissue ablation element, an optical scope, or a therapy electrode. The tissue collector may comprise a biopsy needle. The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element.

[0031] The imaging component may include a shaft having a proximal end, a distal end, and a cavity extending across the shaft from the proximal end to the distal end. The wall of the cavity may include an elongated opening communicating at least partially along the shaft with the exterior of the shaft. The cavity may be defined by an exterior surface of the shaft. The exterior surface of the shaft may include only atraumatic edges. The edges of the elongated opening may be curved toward the interior of the cavity. The cavity may be configured to slidably receive an instrument. A distal portion of the cavity may be axially angled relative to the shaft. The distal portion of the cavity may be axially angled at approximately 3 to 45 degrees relative to the shaft.

[0032] The system may further include a tube. The tube may be aligned to be parallel to the shaft of the imaging component. The tube may be rotatable relative to the shaft while the shaft remains stationary. The tube may include a lumen configured to slidably receive a first instrument or a second instrument. The tube may be configured to slidably receive a first instrument or a second instrument after the first or second instrument is aligned to be parallel to the shaft of the imaging component. The first or second instrument may be rotatable relative to the shaft while the shaft remains stationary. The tube may be disposable.

[0033] The shaft of the imaging component can be flexible and can be controllably deflected along its longitudinal axis via a deflection mechanism.

[0034] The imaging component may include an imaging transducer comprising a light emitting diode (LED) or a camera. The cavity may define a circular cross-sectional area. The cavity may have a substantially uniform cross-sectional area along the shaft. The cavity may have an asymmetric cross-sectional area. The cavity may extend across the shaft from the proximal end to the distal end. The imaging transducer may include an ultrasound transducer.

[0035] Aspects of the present disclosure provide a method for performing therapy or diagnosis at a target site. An imaging component can be advanced to the target site. The imaging component can include: 1) a shaft having a proximal end, a distal end, and a cavity extending across the shaft from the proximal end to the distal end, the wall of the cavity including an elongated opening communicating with the exterior of the shaft at least partially along the shaft; and 2) an imaging transducer coupled to the distal end of the shaft. The therapy or diagnosis can be performed using a first instrument inserted into the cavity and advanced to the target site.

[0036] The method may further include inserting a first instrument into the cavity before advancing the imaging component to the target site. The first instrument may be inserted after advancing the imaging component to the target site. The first instrument may be removed from the cavity while the imaging component remains at the target site. A second instrument may be inserted into the cavity, and the second instrument may be advanced to the target site. Therapy or diagnosis may be performed using the second instrument.

[0037] The cavity of the imaging component can be defined by an exterior surface of the shaft. The exterior surface of the shaft can include only atraumatic edges. The edges of the elongated opening can be curved toward the interior of the cavity. The cavity can be configured to slidably receive an instrument.

[0038] The distal portion of the cavity may be angled axially relative to the shaft. The distal portion of the cavity may be angled axially relative to the shaft at about 3 to 45 degrees.

[0039] The imaging component may further include a tube. The tube may be aligned to be parallel to the shaft of the imaging component. The tube may be rotatable relative to the shaft while the shaft remains stationary. The tube may include a lumen configured to slidably receive a first instrument. The tube may be configured to slidably receive a first instrument after a second instrument is aligned to be parallel to the shaft of the imaging component. The first instrument may be rotatable relative to the shaft while the shaft remains stationary. The tube may be disposable.

[0040] The first instrument may include a tissue collector. The tissue collector may include a biopsy needle. Alternatively, or in combination, the first instrument may include a tissue ablation element. The tissue ablation element may include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The instrument may include an optical scope. The instrument may include a therapy electrode.

[0041] The shaft of the imaging component can be flexible and can be controllably deflected along its longitudinal axis via a deflection mechanism.

[0042] The imaging transducer may comprise a light emitting diode (LED) or a camera.

[0043] The cavity may define a circular cross-sectional area. The cavity may comprise a substantially uniform cross-sectional area along the shaft. The cavity may comprise an asymmetric cross-sectional area. The cavity may extend across the shaft from the proximal end to the distal end. The imaging transducer may comprise an ultrasound transducer.

[0044] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the present disclosure have been shown and described. As will be recognized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive. The present invention provides, for example, the following. (Item 1) An imaging component, the imaging component comprising: a shaft having a proximal end, a distal end, and a cavity, the cavity extending across the shaft from the proximal end toward the distal end; the cavity is configured to removably receive at least one of a plurality of different instruments; a shaft, the wall of the cavity having an elongated opening at least partially along the shaft and communicating with the exterior of the shaft; an imaging transducer coupled to a distal end of the shaft; an imaging component comprising: (Item 2) Item 2. The component of item 1, wherein the cavity is defined by an outer surface of the shaft. (Item 3) Item 3. The component of item 2, wherein the exterior surface of the shaft comprises only atraumatic edges. (Item 4) Item 3. The component of item 2, wherein the edges of the elongated opening are curved toward the interior of the cavity. (Item 5) Item 1, wherein the cavity is configured to slidably receive the instrument. (Item 6) Item 1, wherein the distal portion of the cavity is axially angled relative to the shaft. (Item 7) 7. The component of claim 6, wherein the distal portion of the cavity is angled axially relative to the shaft at about 3 to 45 degrees. (Item 8) Item 1, wherein at least one of the plurality of instruments comprises a tube. (Item 9) Item 9. The component of item 8, wherein the tube is aligned to be parallel to the shaft of the imaging component. (Item 10) 10. The component of claim 9, wherein the tube is rotatable relative to the shaft while the shaft remains stationary. (Item 11) Item 9. The component of item 8, wherein the tube comprises a lumen configured to slidably receive a second instrument of the plurality of instruments. (Item 12) Item 12. The component of item 11, wherein the tube is configured to slidably receive the second instrument after the second instrument is aligned so that it is parallel to the shaft of the imaging component. (Item 13) Item 13. The component of item 12, wherein the second instrument is rotatable relative to the shaft while the shaft remains stationary. (Item 14) Item 1, wherein the tube is disposable. (Item 15) Item 1, wherein the second instrument comprises a tissue collector. (Item 16) Item 16. The component of item 15, wherein the tissue collector comprises a biopsy needle. (Item 17) Item 1, wherein the second instrument comprises a tissue ablation element. (Item 18) Item 18. The component of item 17, wherein the tissue ablation element comprises one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 19) Item 1, wherein the at least one of the plurality of different devices comprises a therapeutic or diagnostic device. (Item 20) 20. The component of item 19, wherein the therapeutic or diagnostic instrument comprises a tissue collector. (Item 21) 21. The component of item 20, wherein the therapeutic or diagnostic tool comprises a biopsy needle. (Item 22) 20. The component of item 19, wherein the therapeutic or diagnostic tool comprises a tissue ablation element. (Item 23) 23. The component of claim 22, wherein the tissue ablation element comprises one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 24) 20. The component of item 19, wherein the therapeutic or diagnostic instrument comprises an optical scope. (Item 25) 20. The component of claim 19, wherein the therapeutic or diagnostic device comprises a therapeutic electrode. (Item 26) 20. The component of item 19, wherein the therapeutic or diagnostic instrument comprises an implanted device. (Item 27) 20. The component of item 19, wherein the therapeutic or diagnostic instrument comprises instrumentation for providing detailed mapping of anatomy. (Item 28) 28. The component of item 27, wherein the anatomical structure to be mapped is a uterus. (Item 29) Item 1, wherein the shaft is flexible. (Item 30) 30. The component of claim 29, wherein the shaft is controllably flexed along its longitudinal axis via a flexing mechanism. (Item 31) Item 1, wherein the imaging transducer comprises an ultrasound transducer. (Item 32) Item 1, wherein the imaging transducer comprises a light emitting diode (LED) or a camera. (Item 33) Item 1, wherein the cavity defines a circular cross-sectional area. (Item 34) Item 10. The component of item 1, wherein the cavity has a substantially uniform cross-sectional area along the shaft. (Item 35) Item 1, wherein the cavity has an asymmetric cross-sectional area. (Item 36) Item 2. The component of item 1, wherein the cavity extends across the shaft from the proximal end to the distal end. (Item 37) 1. An imaging system, comprising: Item 1-36. An imaging component according to any one of items 1-36; a disposable tube slidably received within the cavity of the imaging component; An imaging system comprising: (Item 38) Item 38. The imaging system of item 37, further comprising a second instrument removably received within the lumen of the disposable tube. (Item 39) Item 39. The imaging system of item 38, wherein the second instrument is a diagnostic or therapeutic instrument. (Item 40) Item 39. The imaging system of item 38, wherein the second instrument is a tissue collector. (Item 41) Item 39. The imaging system of item 38, wherein the second instrument is a biopsy needle. (Item 42) Item 39. The imaging system of item 38, wherein the second instrument is an optical scope. (Item 43) Item 39. The imaging system of item 38, wherein the second instrument is an implantable device. (Item 44) Item 39. The imaging system of item 38, wherein the second instrument comprises instrumentation for providing detailed mapping of anatomy. (Item 45) Item 45. The imaging system of item 44, wherein the anatomical structure being mapped is a uterus. (Item 46) Item 39. The imaging system of item 38, wherein the second instrument comprises a tissue ablation element. (Item 47) Item 47. The imaging system of item 46, wherein the tissue ablation element comprises one or more of a radio frequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 48) 1. A method for performing therapy or diagnosis at a target site, the method comprising: Inserting the imaging component of any one of items 1-36 into a subject; With the imaging component in place, inserting the at least one of the plurality of instruments into the cavity toward the target site; performing therapy or diagnosis at the target site using the at least one of the plurality of instruments; removing the at least one of the plurality of instruments from the cavity; and A method comprising: (Item 49) Item 49. The method of item 48, wherein the at least one of the plurality of instruments comprises a tissue collector. (Item 50) 50. The method of claim 49, wherein the tissue collector comprises a biopsy needle. (Item 51) Item 49. The method of item 48, wherein the at least one of the plurality of instruments comprises a tissue ablation element. (Item 52) Item 49. The method of item 48, wherein the tissue ablation element comprises one or more of a radio frequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 53) Item 49. The method of item 48, wherein the at least one of the plurality of different devices comprises a therapeutic or diagnostic device. (Item 54) 49. The method of claim 48, wherein the therapeutic or diagnostic instrument comprises an optical scope. (Item 55) Item 49. The method of item 48, wherein the therapeutic or diagnostic instrument comprises an implanted device. (Item 56) 49. The method of claim 48, wherein the therapeutic or diagnostic instrument comprises instrumentation for providing detailed mapping of anatomy. (Item 57) 57. The method of claim 56, wherein the anatomical structure being mapped is the uterus. (Item 58) Item 49. The method of item 48, wherein the therapeutic or diagnostic device comprises a therapeutic electrode. (Item 59) inserting a second instrument into the cavity toward the target site; performing therapy or diagnosis at the target site using the second instrument; and removing the second instrument from the cavity; and further comprising Item 49. The method of item 48, wherein the second instrument is different from the at least one of the plurality of instruments. (Item 60) 49. The method of claim 48, wherein the method is performed laparoscopically. (Item 61) 49. The method of claim 48, wherein the method is performed non-invasively. (Item 62) 49. The method according to item 48, wherein the method is performed by minimally invasive surgery. (Item 63) Item 49. The method of item 48, wherein the second instrument comprises a tissue collector. (Item 64) Item 64. The method of item 63, wherein the tissue collector comprises a biopsy needle. (Item 65) Item 49. The method of item 48, wherein the second instrument comprises a tissue ablation element. (Item 66) Item 66. The method of item 65, wherein the tissue ablation element comprises one or more of a radio frequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 67) Item 49. The method of item 48, wherein the second instrument comprises an optical scope. (Item 68) Item 49. The method of item 48, wherein the second instrument comprises an implantation device. (Item 69) Item 49. The method of item 48, wherein the second instrument comprises instrumentation for providing detailed mapping of anatomy. (Item 70) 70. The method of claim 69, wherein the anatomical structure to be mapped is the uterus. (Item 71) Item 49. The method of item 48, wherein the second device comprises a therapy electrode. (Item 72) 1. A method of performing image-guided ablation therapy, the method comprising: Inserting the imaging component of any one of items 1-36 into a subject; With the imaging component in place, inserting a biopsy needle into the cavity; collecting a pathology sample using said biopsy needle; removing the biopsy needle from the cavity; inserting a radio frequency (RF) ablation element into the cavity; ablating tissue using the RF ablation element; removing the RF ablation element from the cavity; inserting an optical scope into the cavity; confirming completion of the image-guided ablation therapy using the optical scope; and removing the optical scope from the cavity; and A method comprising: (Item 73) 73. The method of claim 72, wherein the method is performed laparoscopically. (Item 74) 73. The method of claim 72, wherein the method is performed non-invasively. (Item 75) 73. The method of claim 72, wherein the method is performed by minimally invasive surgery. (Item 76) 1. A method of joining devices, the method comprising: advancing an imaging component into a surgical space, the imaging component comprising a shaft having a proximal end and a distal end; coupling a first instrument to the imaging component for use within the surgical space, the first instrument being a therapeutic or diagnostic instrument; decoupling the first instrument from the imaging component while the imaging component remains within the surgical space; coupling a second instrument to the imaging component for use within the surgical space while the imaging component remains within the surgical space; Including, The method wherein the second device is a different therapeutic or diagnostic device than the first device. (Item 77) Item 77. The method of item 76, wherein the imaging component comprises an imaging transducer comprising an ultrasound transducer. (Item 78) 77. The method of claim 76, wherein the method is performed by laparoscopic surgery. (Item 79) 77. The method of claim 76, wherein the method is performed non-invasively. (Item 80) 77. The method of claim 76, wherein the method is performed by minimally invasive surgery. (Item 81) Item 77. The method of item 76, wherein coupling the first instrument occurs while the imaging component remains within the surgical space. (Item 82) Item 77. The method of item 76, wherein coupling the first instrument occurs while the imaging component is outside the surgical space. (Item 83) 77. The method of claim 76, further comprising collecting a tissue sample from the surgical space with the first instrument. (Item 84) Item 77. The method of item 76, further comprising ablating an area within the surgical space with the second instrument. (Item 85) 77. The method of claim 76, further comprising performing therapy or diagnosis using the first instrument. (Item 86) Item 86. The method of item 85, further comprising selecting the second instrument based on data collected from performing the therapy or diagnosis using the first instrument. (Item 87) Item 86. The method of item 85, further comprising adjusting parameters of a therapy or diagnosis performed using the second instrument based on data collected from performing the therapy or diagnosis using the first instrument. (Item 88) Item 88. The method of item 87, wherein the collected data comprises image data and adjusting the parameters includes adjusting an ablation zone for the second instrument. (Item 89) Item 77. The method of item 76, wherein the imaging component further comprises a cavity extending across the shaft from the proximal end toward the distal end, the wall of the cavity comprising an elongated opening at least partially along the shaft and in communication with the exterior of the shaft. (Item 90) Item 90. The method of item 89, wherein the cavity is defined by an exterior surface of the shaft. (Item 91) Item 91. The method of item 90, wherein the exterior surface of the shaft comprises only atraumatic edges. (Item 92) Item 90. The method of item 89, wherein the edges of the elongated opening are curved toward the interior of the cavity. (Item 93) Item 90. The method of item 89, wherein the cavity is configured to slidably receive the first instrument or the second instrument. (Item 94) Item 90. The method of item 89, wherein the distal portion of the cavity is axially angled relative to the shaft. (Item 95) Item 95. The method of item 94, wherein the distal portion of the cavity is angled axially relative to the shaft at about 3 to 45 degrees. (Item 96) Item 90. The method of item 89, further comprising advancing a tube into the cavity. (Item 97) Item 97. The method of item 96, wherein the tube is aligned to be parallel to the shaft of the imaging component. (Item 98) Item 97. The method of item 96, wherein the tube is rotatable relative to the shaft while the shaft remains stationary. (Item 99) Item 97. The method of item 96, wherein the tube comprises a lumen configured to slidably receive the first instrument or the second instrument. (Item 100) Item 99. The method of item 99, wherein the tube is configured to slidably receive the first instrument or the second instrument after the first or second instrument is aligned so that it is parallel to the shaft of the imaging component. (Item 101) Item 100. The method of item 99, wherein the first or second instrument is rotatable relative to the shaft while the shaft remains stationary. (Item 102) Item 97. The method of item 96, wherein the tube is disposable. (Item 103) Item 77. The method of item 76, wherein the first or second instrument comprises a tissue collector. (Item 104) Item 104. The method of item 103, wherein the tissue collector comprises a biopsy needle. (Item 105) Item 77. The method of item 76, wherein the first or second instrument comprises a tissue ablation element. (Item 106) Item 106. The method of item 105, wherein the tissue ablation element comprises one or more of a radio frequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 107) Item 77. The method of item 76, wherein the first or second instrument comprises an optical scope. (Item 108) Item 77. The method of item 76, wherein the first or second instrument comprises an implantation device. (Item 109) Item 77. The method of item 76, wherein the first or second instrument comprises instrumentation for providing detailed mapping of anatomy. (Item 110) 110. The method of claim 109, wherein the anatomical structure to be mapped is the uterus. (Item 111) Item 77. The method of item 76, wherein the first or second device comprises a therapeutic electrode. (Item 112) Item 77. The method of item 76, wherein the shaft is flexible. (Item 113) Item 113. The method of item 112, wherein the shaft is controllably deflected along its longitudinal axis via a deflection mechanism. (Item 114) Item 77. The method of item 76, wherein the imaging component comprises an imaging transducer comprising a light emitting diode (LED) or a camera. (Item 115) Item 90. The method of item 89, wherein the cavity defines a circular cross-sectional area. (Item 116) Item 90. The method of item 89, wherein the cavity has a substantially uniform cross-sectional area along the shaft. (Item 117) Item 90. The method of item 89, wherein the cavity has an asymmetric cross-sectional area. (Item 118) Item 90. The method of item 89, wherein the cavity extends across the shaft from the proximal end to the distal end. (Item 119) Item 77. The method of item 76, wherein 1) the imaging component and 2) the first instrument or the second instrument are axially coupled. (Item 120) Item 77. The method of item 76, wherein 1) the imaging component and 2) the first instrument or the second instrument are laterally coupled. (Item 121) Item 77. The method of item 76, wherein 1) the imaging component and 2) the first instrument or the second instrument are coupled with the aid of a magnet or an indentation. (Item 122) 1. A system for performing therapy and / or diagnosis at a target site within a patient, the system comprising: a first therapeutic or diagnostic device; a second therapeutic or diagnostic device different from the first therapeutic or diagnostic device; an imaging component configured to be removably coupled to both the first and second therapeutic or diagnostic instruments, either simultaneously or separately; Equipped with the imaging component is configured to be deliverable to the target site within the patient (i) separately from the first and second therapeutic or diagnostic devices, or (ii) in combination with the first and / or second therapeutic or diagnostic devices; The system, wherein the imaging component is configured to be removably coupled to both the first and second therapeutic or diagnostic instruments, either simultaneously or separately, after the imaging component is delivered to the target site within the patient. (Item 123) Item 123. The system of item 122, wherein the first and second therapeutic or diagnostic instruments comprise two of the following: a tissue collector, a tissue ablation element, an optical scope, or a therapy electrode. (Item 124) Item 124. The system of item 123, wherein the tissue collector comprises a biopsy needle. (Item 125) Item 124. The system of item 123, wherein the tissue ablation element comprises one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 126) Item 123. The system of item 122, wherein the imaging component comprises a shaft having a proximal end, a distal end, and a cavity, the cavity extending across the shaft from the proximal end toward the distal end, and a wall of the cavity comprising an elongated opening communicating with the exterior of the shaft at least partially along the shaft. (Item 127) Item 127. The system of item 126, wherein the cavity is defined by an exterior surface of the shaft. (Item 128) Item 128. The system of item 127, wherein the exterior surface of the shaft comprises only atraumatic edges. (Item 129) Item 127. The system of item 126, wherein the edges of the elongated opening are curved toward the interior of the cavity. (Item 130) Item 127. The system of item 126, wherein the cavity is configured to slidably receive the instrument. (Item 131) Item 127. The system of item 126, wherein the distal portion of the cavity is axially angled relative to the shaft. (Item 132) Item 132. The system of item 131, wherein the distal portion of the cavity is angled axially relative to the shaft at approximately 3 to 45 degrees. (Item 133) Item 133. The system of item 132, further comprising a tube. (Item 134) Item 134. The system of item 133, wherein the tube is aligned to be parallel to the shaft of the imaging component. (Item 135) Item 135. The system of item 134, wherein the tube is rotatable relative to the shaft while the shaft remains stationary. (Item 136) Item 134. The system of item 133, wherein the tube comprises a lumen configured to slidably receive the first or second instrument. (Item 137) Item 137. The system of item 136, wherein the tube is configured to slidably receive the first or second instrument after the first or second instrument is aligned so that it is parallel to the shaft of the imaging component. (Item 138) Item 138. The system of item 137, wherein the first or second instrument is rotatable relative to the shaft while the shaft remains stationary. (Item 139) Item 134. The system of item 133, wherein the tube is disposable. (Item 140) Item 127. The system of item 126, wherein the shaft is flexible. (Item 141) Item 141. The system of item 140, wherein the shaft is controllably flexed along its longitudinal axis via a flexing mechanism. (Item 142) Item 123. The system of item 122, wherein the imaging component comprises an imaging transducer comprising a light emitting diode (LED) or a camera. (Item 143) Item 127. The system of item 126, wherein the cavity defines a circular cross-sectional area. (Item 144) Item 127. The system of item 126, wherein the cavity has a substantially uniform cross-sectional area along the shaft. (Item 145) Item 127. The system of item 126, wherein the cavity has an asymmetric cross-sectional area. (Item 146) Item 127. The system of item 126, wherein the cavity extends across the shaft from the proximal end to the distal end. (Item 147) Item 127. The system of item 126, wherein the imaging transducer comprises an ultrasound transducer. (Item 148) 1. A method for performing therapy or diagnosis at a target site, the method comprising: advancing an imaging component to the target site, the imaging component comprising: a shaft having a proximal end, a distal end, and a cavity, the cavity extending across the shaft from the proximal end toward the distal end; a shaft, the wall of the cavity having an elongated opening at least partially along the shaft and communicating with the exterior of the shaft; an imaging transducer coupled to a distal end of the shaft; and performing therapy or diagnosis using a first instrument inserted into the cavity and advanced to the target site; A method comprising: (Item 149) Item 149. The method of item 148, comprising inserting the first instrument into the cavity before advancing the imaging component to the target site. (Item 150) Item 149. The method of item 148, comprising inserting the first instrument into the cavity after advancing the imaging component to the target site. (Item 151) Item 149. The method of item 148, further comprising removing the first instrument from the cavity while the imaging component remains at the target site. (Item 152) Item 152. The method of item 151, further comprising inserting a second instrument into the cavity and advancing the second instrument to the target site. (Item 153) Item 153. The method of item 152, further comprising using the second instrument to perform therapy or diagnosis. (Item 154) Item 152. The method of item 151, wherein the cavity is defined by an outer surface of the shaft. (Item 155) Item 155. The method of item 154, wherein the exterior surface of the shaft comprises only atraumatic edges. (Item 156) Item 155. The method of item 154, wherein the edges of the elongated opening are curved toward the interior of the cavity. (Item 157) Item 149. The method of item 148, wherein the cavity is configured to slidably receive the instrument. (Item 158) Item 149. The method of item 148, wherein the distal portion of the cavity is axially angled relative to the shaft. (Item 159) Item 159. The method of item 158, wherein the distal portion of the cavity is angled axially relative to the shaft at about 3 to 45 degrees. (Item 160) Item 149. The method of item 148, wherein the imaging component further comprises a tube. (Item 161) Item 161. The method of item 160, wherein the tube is aligned to be parallel to the shaft of the imaging component. (Item 162) Item 162. The method of item 161, wherein the tube is rotatable relative to the shaft while the shaft remains stationary. (Item 163) Item 161. The method of item 160, wherein the tube comprises a lumen configured to slidably receive the first instrument. (Item 164) Item 164. The method of item 163, wherein the tube is configured to slidably receive the first instrument after the second instrument is aligned so that it is parallel to the shaft of the imaging component. (Item 165) Item 165. The method of item 164, wherein the first instrument is rotatable relative to the shaft while the shaft remains stationary. (Item 166) Item 161. The method of item 160, wherein the tube is disposable. (Item 167) Item 149. The method of item 148, wherein the first instrument comprises a tissue collector. (Item 168) Item 168. The method of item 167, wherein the tissue collector comprises a biopsy needle. (Item 169) Item 149. The method of item 148, wherein the first instrument comprises a tissue ablation element. (Item 170) Item 169. The method of item 169, wherein the tissue ablation element comprises one or more of a radio frequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. (Item 171) Item 149. The method of item 148, wherein the instrument comprises an optical scope. (Item 172) Item 149. The method of item 148, wherein the device comprises a therapeutic electrode. (Item 173) Item 149. The method of item 148, wherein the shaft is flexible. (Item 174) Item 174. The method of item 173, wherein the shaft is controllably deflected along its longitudinal axis via a deflection mechanism. (Item 175) Item 149. The method of item 148, wherein the imaging transducer comprises a light emitting diode (LED) or a camera. (Item 176) Item 149. The method of item 148, wherein the cavity defines a circular cross-sectional area. (Item 177) Item 149. The method of item 148, wherein the cavity has a substantially uniform cross-sectional area along the shaft. (Item 178) Item 149. The method of item 148, wherein the cavity has an asymmetric cross-sectional area. (Item 179) Item 149. The method of item 148, wherein the cavity extends across the shaft from the proximal end to the distal end. (Item 180) Item 149. The method of item 148, wherein the imaging transducer comprises an ultrasound transducer.

[0045] (Incorporated by reference) All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief explanation of the drawings]

[0046] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description and accompanying drawings that set forth illustrative embodiments, in which the principles of the disclosure are utilized.

[0047] [Figure 1A] FIG. 1A shows a perspective view of an imaging component, according to some embodiments.

[0048] [Figure 1B] FIG. 1B shows a side cross-sectional view of the imaging component of FIG. 1A, according to some embodiments.

[0049] [Figure 1C] FIG. 1C shows an enlarged perspective view of the distal end of the imaging component of FIG. 1A including a cavity, according to some embodiments.

[0050] [Figure 2A] FIG. 2A shows an enlarged perspective view of the distal end of the imaging component of FIG. 1A with a tissue collector instrument disposed within the shaft of the imaging component, according to some embodiments.

[0051] [Figure 2B] FIG. 2B shows a side cross-sectional view of the imaging component of FIG. 1A with a biopsy instrument disposed within the shaft of the imaging component, according to some embodiments.

[0052] [Figure 2C]FIG. 2C shows an enlarged perspective view of the distal end of the imaging component of FIG. 1A with a radio frequency ablation instrument disposed within the shaft of the imaging component, according to some embodiments.

[0053] [Figure 2D] FIG. 2D shows a top view of the imaging component of FIG. 1A with a drug delivery device disposed within the shaft of the imaging component, according to some embodiments.

[0054] [Figure 2E] FIG. 2E shows a side cross-sectional view of the imaging component of FIG. 1A with a needle positioned within the shaft of the imaging component, according to some embodiments.

[0055] [Figure 3A] FIG. 3A shows an assembly diagram of an imaging system including the imaging components of FIG. 1A and an optical scope instrument, according to some embodiments.

[0056] [Figure 3B] FIG. 3B shows an assembly view of the imaging system of FIG. 3A illustrating the mounting mechanism of the system, according to some embodiments.

[0057] [Figure 4] FIG. 4 shows an enlarged perspective view of the shaft of the imaging component of FIG. 1A, in which the shaft of the imaging component is flexible, according to some embodiments.

[0058] [Figure 5A] 5A illustrates a perspective view of a system for diagnosing and / or providing therapy that includes an imaging component configured to be removably coupled to multiple therapy and / or diagnostic instruments, according to some embodiments. FIG. 5A shows the imaging component and the therapy and / or diagnostic instruments separated.

[0059] [Figure 5B]FIG. 5B illustrates a perspective view of the system of FIG. 5A with a therapeutic and / or diagnostic instrument in a ready position to be removably coupled to the imaging component, according to some embodiments.

[0060] [Figure 5C] FIG. 5C illustrates a perspective view of the system of FIG. 5A with a therapeutic and / or diagnostic instrument removably coupled to the imaging component, according to some embodiments.

[0061] [Figure 6] FIG. 6 shows a schematic diagram of an imaging system including a digital processing device and a display visible to a user, according to some embodiments.

[0062] [Figure 7A] FIG. 7A shows a schematic diagram of the imaging components of FIG. 1A positioned within the uterus to image the tissue therein, according to some embodiments.

[0063] [Figure 7B] FIG. 7B shows a surgical field image captured as in FIG. 7A as it would be visible on a display, showing safety and treatment boundaries, according to some embodiments.

[0064] [Figure 7C] FIG. 7C shows a surgical field image that combines both a virtual image showing safety and treatment boundaries and the physical presence of a treatment needle, according to some embodiments.

[0065] [Figure 7D] FIG. 7D shows a surgical field image that combines both a virtual image showing safety and treatment boundaries and the physical presence of treatment needles and tines, according to some embodiments.

[0066] [Figure 8] FIG. 8 is a flowchart illustrating an exemplary method for performing therapy or diagnosis at a target site, according to some embodiments.

[0067] [Figure 9] FIG. 9 is a flowchart illustrating an exemplary method of performing image-guided ablation therapy, according to some embodiments.

[0068] [Figure 10] FIG. 10 illustrates a schematic diagram of an exemplary digital processing device programmed or otherwise configured with imaging components, according to some embodiments.

[0069] [Figure 11A] FIG. 11A shows a side cross-sectional view of an imaging component having a shaft with a circular cross-section, according to some embodiments.

[0070] [Figure 11B] FIG. 11B shows a side cross-sectional view of an imaging component with edges bent inward toward the interior of the cavity, according to some embodiments.

[0071] [Figure 12A] 12A illustrates a system for diagnosing and / or providing therapy that includes an imaging component configured to be removably coupled to a plurality of therapy and / or diagnostic instruments in situ, according to some embodiments. FIG. 12A shows the imaging component in use separate from the therapy and / or diagnostic instruments.

[0072] [Figure 12B] FIG. 12B illustrates the system of FIG. 12A with a therapeutic and / or diagnostic instrument in a ready position to be removably coupled to the imaging component in situ, according to some embodiments.

[0073] [Figure 12C]FIG. 12C illustrates the system of FIG. 12A with therapeutic and / or diagnostic instruments and imaging components removably coupled to each other in situ so that therapeutic and / or diagnostic procedures can be performed in situ, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0074] Embodiments of the present disclosure provide imaging components including a cavity extending across (e.g., along) the length of the shaft, which may be configured to removably receive at least one of a plurality of different instruments. In some embodiments, the cavity of the imaging component may be partially open to the exterior of the shaft. The imaging component may include an imaging transducer at the distal end of the shaft. In addition, the shaft of the imaging component may be configured so that additional therapeutic and / or diagnostic instruments / attachments may be removed and / or received and / or inserted during a medical procedure without interfering with the imaging component. Additionally, or alternatively, the imaging component may remain in situ while the therapeutic and / or diagnostic instruments are received and / or removed. In some embodiments, the imaging component may be used without additional therapeutic and / or diagnostic instruments coupled thereto. In some embodiments, the imaging component may be inserted into and / or removed from a patient lumen without the presence of therapeutic and / or diagnostic instruments. Such imaging components may be used, for example, during medical procedures such as non-invasive, minimally invasive, and / or laparoscopic surgery.

[0075] Embodiments of the present disclosure may improve upon existing methods for imaging and treating lesions within tissue tracts for procedures in which multiple instruments may be required to diagnose and / or provide therapy during a single procedure. For example, an imaging component may be used for diagnosis, then a biopsy attachment may be inserted for pathology samples, then an ablation attachment may be inserted to ablate any lesions, and then additional attachments or instruments may be inserted to perform additional procedures, such as delivery of drugs, implants, and / or therapeutic and / or diagnostic agents. The imaging component of the present disclosure may facilitate the insertion and removal of medical instruments by providing a shaft with atraumatic edges and a cavity configured to receive multiple different instruments. Additionally or alternatively, the imaging component may be used independently of additional instruments or attachments. In such embodiments, the edges of the cavity may be smooth or rounded so that the edges may not catch on patient tissue when used alone.

[0076] The imaging component cavity may improve existing methods for imaging and treatment by providing an imaging component cavity that may be easier to clean than a component with a closed cavity or lumen. The imaging component cavity may improve existing methods for imaging and treatment by facilitating manufacturing of the imaging component. Embodiments of the present disclosure may reduce treatment costs by providing an imaging component with a disposable tube. Embodiments of the present disclosure may reduce treatment costs by providing a reusable imaging component with a cavity into which a disposable instrument can be inserted. Embodiments of the imaging component may provide a shaft that keeps the instrument aligned with the ultrasound image. Embodiments of the present disclosure may accommodate a variety of instruments with different sizes and shapes. Embodiments of the present disclosure may provide scale or position information to aid in instrument insertion.

[0077] The systems and methods of the present disclosure may be particularly useful in treating fibroids within a patient's uterus. The imaging component may be deployed transvaginally and transcervically into the uterus or other organs or tissue tracts, or in other cases, laparoscopically through their exterior. The imaging component may be used in conjunction with additional instruments, such as biopsy needles, tissue ablation elements, such as radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, and / or other instruments suitable for placement within the cavity of the imaging component. Additionally or alternatively, additional instruments may be used to deliver drugs, implants, or other therapeutic agents to the tissue to be treated. Additionally or alternatively, the tissue ablation elements may comprise embodiments or variations of the needle / tine assemblies of commonly assigned U.S. Patent Nos. 8,206,300, 8,262,574, and 8,992,427, the contents of which are incorporated herein by reference.

[0078] Embodiments of the present disclosure may improve upon at least some of the systems and methods of commonly-assigned references by providing an imaging component shaft with an atraumatic edge, enabling the use of the imaging component alone. In some embodiments, embodiments of the present disclosure may improve the ability to remove and / or receive additional instruments by providing an imaging system without an attachment mechanism located within at least a portion of the system to be positioned in situ. In such embodiments, the imaging component shaft may be non-cylindrically symmetric (e.g., oval or rectangular in cross section) to indicate the rotation of the additional instrument relative to the imaging component shaft. In some embodiments, the present disclosure may additionally or alternatively provide an imaging component shaft with a small angled portion to minimize the risk of instrument damage to the imaging transducer surface. Additionally or alternatively, the imaging component may include a disposable tube inserted into the cavity to provide a working channel for inserting additional instruments with different diameters and making the system easier to clean, among many other possible purposes.

[0079] The imaging components described herein can be used in surgical procedures to provide real-time images of target structures to be treated, including projecting safety and treatment boundaries as described in commonly owned U.S. Patent Nos. 8,088,072 and 8,262,577, the contents of which are incorporated by reference. The imaging components described herein can be useful for both imaging and treating uterine fibroids as described in commonly owned U.S. Patent No. 7,918,795, the contents of which are incorporated by reference. Other commonly owned patents and published applications describing probes useful for treating uterine fibroids that can be used with the imaging components described herein include U.S. Patent Nos. 7,815,571, 7,874,986, 8,506,485, 9,357,977, and 9,517,047, the contents of which are incorporated by reference. Additional commonly owned patent applications describing systems for establishing and adjusting displayed safety and treatment zone boundaries that may be used in conjunction with the imaging components described herein include U.S. Patent Publication No. 2014 / 0073910, U.S. Patent No. 8,992,427, U.S. Patent Application No. 15 / 811,520, and PCT Application No. US2017 / 060674, each of which is incorporated herein by reference. A commonly owned patent application, PCT Application No. PCT / US2017 / 060674, describing a mapping and planning system that may be used in conjunction with the imaging components described herein is also incorporated herein by reference.

[0080] In some embodiments, the systems and methods of the present disclosure may provide imaging components to be used in various diagnostic and therapeutic procedures. Some embodiments may provide methods and systems for performing therapy or diagnosis on a volume of tissue. The volume of tissue may include a patient organ. The patient organ or body cavity may include, for example, muscles, tendons, mouth, tongue, pharynx, esophagus, stomach, intestines, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lungs, kidneys, bladder, urethra, uterus, vagina, ovaries, testes, prostate, heart, arteries, veins, spleen, glands, brain, spinal cord, nerves, etc. Some embodiments provide systems and methods suitable for laparoscopic surgery. Some embodiments provide systems and methods suitable for non-invasive surgery. Some embodiments provide systems and methods suitable for minimally invasive surgery. Some embodiments provide systems and methods suitable for robotic or robot-assisted surgery.

[0081] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the invention and the described embodiments. However, the invention may optionally be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0082] The terms “first,” “second,” etc. are used herein arbitrarily to describe various elements, but it should be understood that these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, a first instrument may be referred to as an instrument sensor, and similarly, a second instrument may be referred to as a first instrument, without changing the meaning of the description, so long as all occurrences of “first instrument” are consistently renamed and all occurrences of second instrument are consistently renamed. Although a first instrument and a second instrument are both instruments, they are not the same instrument.

[0083] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the claims. As used in the description of the embodiments and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term "and / or," as used herein, refers to and encompasses any and all possible combinations of one or more of the associated listed items. Furthermore, it should be understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0084] As used herein, the term "if" is interpreted to mean "when," or "upon," or "in response to determining," or "in accordance with a determination," or "in response to detecting," depending on the context, as the case may be. Similarly, the phrases "if it is determined that the stated condition precedent is true," or "if the stated condition precedent is true," or "when the stated condition precedent is true" are interpreted to mean "in response to determining," or "in response to determining," or "in accordance with a determination," or "in response to detecting," or "in response to detecting," depending on the context, as the case may be.

[0085] For ease of explanation, the following figures and corresponding descriptions may be specifically described below with reference to uterine imaging in conjunction with the diagnosis and ablation and / or treatment of uterine fibroids. However, those skilled in the art will recognize that similar imaging components may be used with similar instruments in other therapeutic applications, such as instruments for tissue biopsy, drug delivery, fluid injection and / or aspiration within any suitable body lumen, and treatment of cancer, tumors, fibroids, and other malignant or benign tumors.

[0086] FIG. 1A shows an illustration of an imaging component 100, according to some embodiments. The imaging component 100 may include a handle portion 101 connected to an imaging shaft 103. An imaging transducer 107 may be coupled to the distal end of the imaging shaft 103. The imaging shaft may include a proximal end and a distal end, with a cavity 105 extending across the length of the shaft from the proximal end to the distal end. The cavity 105 may be partially open to the exterior of the shaft. For example, a side or wall of the cavity may include an elongated opening that communicates with the exterior of the shaft. The elongated opening may communicate with the exterior of the shaft at least partially along its length. In some embodiments, the edges of the elongated opening may be curved toward the interior of the cavity of the shaft (e.g., see FIG. 11B , described further below). The length of the shaft may be long enough to fully access the patient's uterus while the handle portion 101 remains outside the patient. Additionally or alternatively, the shaft may have a length significantly longer than sufficient to fully access the patient's uterus. The side openings may be open along the entire length of the shaft or only partially along the length of the shaft. The side openings may be open, for example, over more than three-quarters of the length of the shaft, over more than half of the length of the shaft, or over more than one-quarter of the length of the shaft. Cavity 105 may be configured to receive at least one of a plurality of different additional instruments or attachments such that a first instrument can be received by the cavity, the first instrument can be removed from the cavity, and a second instrument can be received by the cavity.

[0087] The handle portion 101 may be one part of a two-piece handle so that when a first or second instrument is received, the two handle portions can combine to form a single handle. The interior of the handle portion 109 may include an alignment element 111 so that the first and second parts can be reproducibly aligned relative to one another after exchanging instruments. The alignment element may be configured so that the first and second parts can be sufficiently secured relative to one another for use as a single handle. In some embodiments, the alignment element may include a magnet. In other embodiments, the alignment element may include, for example, a latch, a hook, or any other mechanism suitable for removably combining a two-piece handle. The handle portion may additionally include a positioning element 113, such as a slot for accommodating a complementary protrusion or other element on the opposing handle portion to provide a more reliable reference between the parts of the two-piece handle. The positioning element may include a mechanical feature for securing the instrument relative to the imaging component by limiting translation of the instrument on the axis of the imaging component's shaft.

[0088] In other embodiments, imaging component 100 may be configured to be used with an instrument that does not have a handle portion. In such embodiments, handle portion 101 of imaging component 100 is sufficient to be used alone to guide the imaging component during a procedure. In some embodiments, imaging component 100 may have scales or guides inside handle portion 109 to gauge the insertion depth of an instrument. In other embodiments, the imaging component may be used without an instrument. In some embodiments, the scales may facilitate embodiments in which the instrument does not have a handle. In other embodiments, the scales may facilitate insertion of an instrument component in embodiments in which the instrument has a handle.

[0089] FIG. 1B shows a cross-sectional view of the imaging component 100, according to some embodiments. The shaft body may include an internal structure for carrying electronics or other associated components for controlling the imaging transducer. The shaft may also include a wire system or other bending mechanism to allow the shaft to controllably bend, flex, or deflect the distal end of the shaft. The shaft may include a channel or duct for directing fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The imaging shaft 103 may be shaped with rounded or sufficiently softened cross-sections, chamfered, rounded, or beveled edges so that the edges can be atraumatic to the patient orifice during insertion or removal of the imaging component, with or without an instrument. The shaft 103 may additionally include a smooth exterior surface. The shaft 103 may be made of a material whose surface may be deformable to allow the shaft to bend or conform to the shape of a body lumen.

[0090] The cavity 105 of the imaging shaft 103 may be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the cavity may be defined by the exterior surface of the shaft. In some embodiments, the cavity may be partially open along a wall such that the cavity is in communication with the exterior of the shaft. The opening may be sufficiently closed to provide structural support when the imaging component may be inserted into a patient's body lumen so that the opening of the lumen is not significantly obstructed by the insertion or removal of the instrument. Optionally, the exterior surface of the shaft may include only an atraumatic edge. The cavity 105 of the imaging shaft 103 may be sufficiently open so that the cavity may allow some distortion of the cavity opening when instruments of different sizes may be received or inserted therein. The cavity may facilitate cleaning of the imaging component.

[0091] FIG. 11A shows a cross-sectional view of an imaging component having a shaft with a circular cross-section, according to some embodiments. The imaging component of FIG. 11A may be sufficiently circular in cross-section so that the imaging component can be rotated without obstructing the patient lumen. FIG. 11B shows a cross-sectional view of an imaging component with an inwardly bent edge toward the interior of a cavity, according to some embodiments. The inwardly bent edge 1111 of the cavity may serve to support the opening of the body lumen so that the shaft, with or without an instrument, can be atraumatically inserted into or removed from the body lumen.

[0092] While the shaft cavity in the illustrated example may define a circular cross-sectional area, in other embodiments, the cavity may be oval or any other geometric shape with sufficiently softened, rounded, or beveled edges and corners so that insertion or removal of the shaft may not damage the patient's body lumen. In some embodiments, the cavity may be non-cylindrically symmetric. In some embodiments, the cavity may be asymmetric so as to provide an axis for alignment of an internal instrument. The cavity may be open in cross section over less than three-quarters of its circumference; additionally, or alternatively, the cavity may be open over less than half of its circumference, less than one-quarter of its circumference, and less than one-eighth of its circumference. In other embodiments, the imaging component shaft cavity may be closed to the exterior of the shaft, and an instrument may be slidably inserted completely within the imaging component shaft.

[0093] In some embodiments, the cavity may have a substantially uniform cross-sectional area along the shaft. In other embodiments, a portion of the length of the shaft may have a different cross-section than another portion of the length of the shaft. In certain instances, the proximal portion of the shaft may be asymmetric to provide an axis for alignment of the instrument, and the distal portion of the shaft may have a circular cross-sectional area. In another embodiment, the cavity tapers toward the end of the shaft. In such instances, the taper may facilitate delivery of the instrument into the cavity. In some embodiments, the cross-sectional area of ​​the cavity may be narrower in diameter to allow for more flexibility at the distal end of the shaft.

[0094] In some embodiments, the imaging shaft 103 may additionally include a tube 115 to be positioned in the cavity 105 of the imaging shaft 103. The tube 115 may include a lumen. The lumen of the tube 115 may be configured to slidably receive one or more of the multiple instruments. The tube 115 may be aligned parallel to the shaft of the imaging component so that additional instruments / attachments may be slidably received by the tube. Subsequently, the tube 115 may slidably receive additional instruments / attachments after being aligned parallel to the shaft of the imaging component. In some embodiments, the tube 115 may be disposable. In some embodiments, the tube 115 may be reusable by being detached from the imaging shaft 103, cleaned, autoclaved, etc. The tube 115 may have an exterior surface that substantially contacts the interior wall of the cavity 105. The tube 115 may have an interior surface of a different geometry relative to the exterior surface that is configured to receive one or more of the multiple instruments. In some embodiments, a second tube may be removably inserted into the first tube, the second tube having a different inner lumen geometry than the first tube, thereby aiding in the insertion of one or more of the instruments. In some embodiments, the tube 115 may be rotated relative to the imaging component. In some embodiments, the tube 115 may be fully rotated relative to the imaging component in either direction within the shaft of the imaging component under user control. In some embodiments, the tube 115 may be smoothed internally or externally to facilitate the insertion or removal of instruments.

[0095] The tube 115 may be inserted into the body lumen in situ without the imaging component having been advanced therein. Additionally or alternatively, the tube 115 may be inserted into the shaft of the imaging component prior to insertion of the imaging component into the body lumen. The tube 115 may have sufficient structural integrity to support the body lumen during insertion of the imaging component without an instrument. Disturbance to the body lumen may be minimized when additional instruments are inserted into the tube 115 or when the tube 115 is inserted into the imaging component in situ. The tube 115 may be made from a material that can be sterilized. The tube 115 may be made from a material that can be low enough in cost to be discarded after a single use. Exemplary materials for disposable tubes may include polyimide, PTFE, urethane, and thermoplastics such as Pebax or nylon. The tube 115 may be made from a material that has sufficient elasticity to accommodate instruments slightly larger or smaller than the circumference of the tube. In embodiments where the cavity is not circular, the tube may take the shape of the cavity or may take another shape.

[0096] The tube 115 may reduce the cost of treatment by facilitating the insertion and / or removal of additional instruments into the cavity of the imaging component 100, thereby preventing damage to the surface of the cavity 105 of the imaging component 100. The tube 115 may reduce costs by facilitating cleaning of the cavity 105 of the imaging component 100. The tube 115 may reduce the cost of treatment by providing an inexpensive component that can serve as an adapter for a variety of different therapeutic and / or diagnostic instruments / attachments, such as by being provided with a variety of different interior geometries suitable for different instruments / attachments, but having a uniform exterior geometry to be removably coupled to the same single imaging component 100. For example, a disposable tube with a smaller inner diameter may facilitate the insertion and control of a needle with an outer diameter smaller than the inner diameter of the shaft of the imaging component.

[0097] 1C shows a close-up view of the distal end of an imaging component including a cavity, according to some embodiments. The distal end of the imaging component may include an imaging transducer 107. The imaging transducer may include an ultrasound transducer and / or multiple ultrasound transducers. The ultrasound transducer may operate at a frequency of 500 kHz, 1 MHz, 5 MHz, 10 MHz, 20 MHz, 100 MHz, or a range defined by any two of the preceding values. Some embodiments of the ultrasound transducer may include specifications for other transducers from commonly-assigned references incorporated herein.

[0098] In some embodiments, the distal end of the imaging transducer 117 may additionally include a light emitting diode and / or a camera to provide an image to a user. In such embodiments, the imaging component may serve as an optical scope and an ultrasound imaging platform. The distal end of the imaging transducer may include optical components such as optical fibers, relay lenses, objective lenses, etc.

[0099] The imaging transducer 107 may be configured to be deflectable. The imaging transducer may be configured to deflect relative to the longitudinal axis of the imaging component shaft. In some embodiments, the distal end of the imaging component includes a hinge to facilitate deflection of the imaging transducer. Deflection of the imaging transducer may be controlled by a deflection lever 119 on the handle portion 101 of the imaging component. One or more imaging transducers may be oriented by deflection of the imaging transducer. One or more imaging transducers may be oriented by deflection of the imaging transducer to facilitate maintaining an image field of view during treatment. Additionally or alternatively, the ultrasound transducer may be aligned radially and / or axially to simultaneously image multiple fields of view. Deflection of the imaging transducer may be induced to avoid instrument obstruction. Additionally or alternatively, deflection of the imaging transducer may be used to deflect a flexible instrument within a cavity. The distal end of the shaft may include an interlock system similar to those in the incorporated references to prevent the imaging transducer from interfering with the instrument or being damaged by sharp edges of the instrument. Actuation of the deflection lever may function in a manner similar to that described in U.S. Pat. No. 8,992,427 (incorporated herein by reference). The deflection lever 119 may deflect the imaging transducer by less than 45 degrees, additionally or alternatively by, for example, less than 120 degrees, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0100] The distal end of the imaging component may include an atraumatic edge to facilitate insertion of the imaging component with or without an instrument in the cavity. The distal end of the imaging component cavity may additionally or alternatively include a portion that is axially angled relative to the shaft so that the distal end of an instrument may be deflected upward as it is pushed out of the distal end of the cavity. The distal end of the imaging component cavity may include an angled portion with an angle of 3 to 45 degrees. The distal end of the imaging component cavity may additionally or alternatively include an angled portion with an angle of less than 45 degrees, for example, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0101] The cavity of the imaging component may be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the imaging component may be configured to receive one or more therapeutic or diagnostic instruments. In some embodiments, at least one of the plurality of different instruments may be a therapeutic or diagnostic instrument. In some embodiments, the instrument may comprise an instrument such as a biopsy needle, an optical scope, an implanted device, a therapy electrode, a tissue ablation element such as a radiofrequency ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, and / or other instrument suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver drugs or other therapeutic agents to the tissue to be treated. Figures 2A-2E illustrate instruments that may be slidably received by the imaging component. Those skilled in the art will recognize that many instruments, including those disclosed in the following figures, may be used with the imaging components disclosed herein.

[0102] 2A shows a close-up view of the distal end of the imaging component 100 with a tissue collector instrument 210 disposed within the shaft 105 of the imaging component, according to some embodiments. The tissue collector instrument may be used to extract tissue and / or cytopathology samples for examination by a medical professional to determine the extent of disease. In some embodiments, the tissue collector may comprise a biopsy needle. The tissue collector 210 may comprise a tissue collector shaft 211 having a distal end and a proximal end. The tissue collector shaft 211 may be configured to be detached from the handle component of the instrument or may be configured to be used without the handle component such that the tissue collector 210 may be disposable.

[0103] The tissue collector shaft 211 may be made of a soft and / or flexible material so that it can be deflected by the imaging transducer and / or angled portion within the shaft cavity. In the illustrated example, the distal end of the tissue collector shaft is deflected upward by the angled portion within the shaft cavity. The distal end of the tissue collector shaft may be deflected upward to avoid damage to the imaging transducer, among other possible purposes. The distal end of the imaging component cavity may include a portion that is axially angled relative to the shaft so that the distal end of the instrument may be deflected upward as it is pushed out of the distal end of the cavity. The distal end of the imaging component cavity may include an angled portion that is angled at less than 45 degrees, additionally or alternatively at less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees, for example.

[0104] Additionally or alternatively, the shaft of the imaging collector may include a wire system or other means for deflecting the distal end of the tissue collector so that it does not damage the imaging transducer. The distal end of the tissue collector instrument may include a slot or opening 213 through which tissue may be collected. In some embodiments, the tissue collector may rotate relative to the shaft. In some embodiments, the tissue collector may be fully rotated relative to the shaft in either direction under user control within the shaft of the imaging component while the shaft remains stationary so that the slot 213 may scrape, scoop, or otherwise collect tissue.

[0105] The shaft of the tissue collector can be longer than the shaft of the imaging transducer so that the slot or opening can collect tissue from deep inside the uterus or other body cavity. In some embodiments, the shaft of the tissue collector can be 2 inches longer than the shaft of the imaging transducer. Additionally or alternatively, for example, the shafts can be 6 inches longer, 4 inches longer, 2 inches longer, the same length, or within a range of any two of the preceding values.

[0106] FIG. 2B shows a cross-sectional view of an imaging component with a tissue collector instrument 211 disposed within the shaft of the imaging component, according to some embodiments. The tissue collector 211 may be disposed within a tube 115 disposed within the cavity 105 of the imaging component. Additionally, or alternatively, the tissue collector 211 may be disposed within the cavity of the imaging component without the use of a tube. While the shaft of the collector instrument in the illustrated example may be circular, in other embodiments, the shaft of the collector instrument may be oval or any other geometric shape so that the shaft can be inserted into or removed from the cavity of the imaging component. In some embodiments, the collector shaft may be asymmetric to provide an axis for alignment of the instrument within the cavity of the imaging component. In some embodiments, the cavity comprises a substantially uniform cross-sectional area along the length of the shaft. In other embodiments, the change in cross-sectional area along the length of the shaft, such as the proximal end of the shaft, may be asymmetric to provide an axis for alignment, while the distal end of the shaft may be circular.

[0107] 2C shows a close-up view of the distal end of the imaging component with an ablation instrument 230 disposed within the shaft of the imaging component, according to some embodiments. The ablation instrument 230 may include a needle assembly comprising a needle 235 and, optionally, tines 233. The ablation instrument shaft 231 may be deployed from the shaft of the imaging component 103. Additionally or alternatively, the needle may be deployed from the lumen of the tube 115. The ablation instrument may comprise, for example, one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, a cryo-ablation element, and any other type of ablation element known to those skilled in the art.

[0108] The ablation instrument 230 may be disposed within a tube 115 that is disposed within the cavity 105 of the imaging component. Additionally or alternatively, the ablation instrument 230 may be disposed within the cavity of the imaging component without the use of a tube. While the shaft 231 of the ablation instrument in the illustrated example may be circular, in other embodiments, the shaft of the ablation instrument may be oval or any other geometric shape such that the shaft can be inserted into or removed from the cavity of the imaging component. In some embodiments, the shaft of the ablation instrument may be asymmetric to provide an axis for alignment of the instrument within the cavity of the imaging component.

[0109] The ablation instrument shaft 231 may be made of a soft and / or flexible material so that it can be deflected by the imaging transducer and / or angled portion within the shaft cavity. Additionally or alternatively, the ablation instrument shaft may include a wire system or other means for deflecting the distal end of the ablation instrument so that it does not damage the imaging transducer. In some embodiments, the ablation element may rotate relative to the imaging component. In some embodiments, the ablation instrument may be fully rotated relative to the imaging component in either direction under user control within the imaging component shaft while the shaft remains stationary so that the tines can be optimally aligned.

[0110] The needle assembly may be constructed and controlled by a user, for example, as described above in commonly assigned U.S. Patent Nos. 8,206,300, 8,262,574, and 8,992,427 (the entire disclosures of which are incorporated herein by reference). The needle assembly may be integrated into an instrument handle so that the position and deployment of the needle and tines may be controlled by a user. The handle may be constructed, for example, as described above in commonly assigned U.S. Patent No. 8,992,427 (the entire disclosures of which are incorporated herein by reference). The needle assembly may be compatible with systems and methods for improved safety and treatment boundaries during the treatment of uterine fibroids, for example, as described in the incorporated references.

[0111] FIG. 2D shows a diagram of the imaging component 100 with a drug delivery device 240 disposed within the shaft 105 of the imaging component, according to some embodiments. The drug delivery device can serve as a platform for injecting a therapeutic agent into a patient's tissue. Exemplary therapeutic agents can include analgesics, anesthetics, hemostatic agents, antibiotics, steroids, anticoagulants, anti-inflammatory agents, etc. Additionally or alternatively, the drug delivery device can be configured to deliver one or more drug-eluting, drug-releasing, or otherwise therapeutic and / or diagnostic seeds, pellets, or other implants to the target tissue. The drug delivery device can include a needle 243 disposed within the distal end of the drug delivery device shaft 241. The drug delivery device shaft 241 can include a distal end and a proximal end. The drug delivery device shaft can be longer than the imaging transducer shaft so that the needle can inject an agent deep inside the uterus. In some embodiments, the drug delivery device shaft can be 2 inches longer than the imaging transducer shaft. Additionally or alternatively, for example, the shaft may be 6 inches longer, 4 inches longer, 2 inches longer, the same length, or within a range of any two of the preceding values.

[0112] The drug delivery instrument shaft 241 may be made of a soft and / or flexible material so that it can be deflected by the imaging transducer and / or angled portion within the shaft cavity. Additionally or alternatively, the drug delivery instrument shaft may include a wire system or other means for deflecting the distal end of the drug delivery instrument so that it does not damage the imaging transducer. In some embodiments, the drug delivery instrument may rotate relative to the imaging component. In some embodiments, the drug delivery instrument may be fully rotated relative to the imaging component in either direction under user control within the imaging component shaft while the shaft remains stationary.

[0113] The shaft of the drug delivery device may be detachable from the handle component of the device, or may be constructed without a handle component so that the drug delivery device may be disposable. In the illustrated embodiment, the drug delivery device 240 does not have a handle portion. In such an embodiment, the handle portion 101 of the imaging component 100 may be used to guide the drug delivery device during the procedure. The imaging component 100 shown in FIG. 2D may have scales, guides, or other markings 245 on the inner surface of the handle portion 109 to measure the insertion depth of the needle 243 of the drug delivery device 240.

[0114] FIG. 2E shows a cross-sectional view of an imaging component 103 with a needle disposed within the shaft thereof, according to some embodiments. A drug delivery instrument shaft 241 equipped with a needle 243 may be disposed within a tube 115 disposed within the cavity 105 of the imaging component. Additionally, or alternatively, the drug delivery instrument shaft 241 may be disposed within the cavity of the imaging component without the use of a tube. While the drug delivery instrument shaft in the illustrated example may be circular, in other embodiments, the drug delivery instrument shaft may be oval or any other geometric shape such that the shaft can be inserted into or removed from the cavity of the imaging component. In some embodiments, the drug delivery instrument shaft may be asymmetric to provide an axis for alignment of the instrument within the cavity of the imaging component. In some embodiments, the drug delivery instrument may rotate relative to the imaging component. In some embodiments, the drug delivery instrument may be fully rotated relative to the imaging component in either direction under user control within the tube of the imaging component shaft while the shaft remains stationary.

[0115] 2A-2E illustrate exemplary instruments that may be disposed within the shaft of the imaging component, examples of which are not intended to be limiting. Other examples may include fluid injection and / or suction instruments. The fluid injection and / or suction instruments may comprise instruments with a shaft having a lumen therein configured to conduct fluid to the patient's tissue. The fluid injection and / or suction instruments may deliver fluids for cooling tissue. Additionally or alternatively, the fluid injection and / or suction instruments may deliver fluids for clearing tissue. Additionally or alternatively, the fluid injection and / or suction instruments may deliver fluids for distending a body cavity. The fluid injection and / or suction instruments may deliver solutions and / or suspensions of therapeutic agents, such as antiseptics, anesthetics, pain relievers, antibiotics, steroids, etc. Fluid injection and / or suction elements may be integrated into any of the instruments described herein. Alternatively, the fluid injection and / or suction elements may comprise instruments to be inserted and retracted as steps in a multi-instrument procedure.

[0116] FIG. 3A shows an assembly diagram of an imaging system including an imaging component 100 and an optical scope instrument 300, according to some embodiments. While an optical scope element may be shown in the illustrated embodiment, the optical scope instrument 300 may be any other suitable instrument, such as any of the instruments disclosed herein. The imaging system illustrated in FIG. 3A may slidably receive a disposable tube 115 within a cavity 105 of the imaging component. In some embodiments, the imaging system may include a disposable tube slidably received within the cavity of the imaging component. In such embodiments, an instrument may be removably received within the lumen of the disposable tube. Additionally or alternatively, the cavity of the imaging component may be configured to slidably receive one or more of a plurality of instruments, which may include various therapeutic and / or diagnostic instruments.

[0117] In illustrative examples, the imaging component may removably receive an instrument such as a biopsy needle, a tissue collector instrument, an optical scope, an implanted device, a therapy electrode, a tissue ablation element such as a radiofrequency ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, and / or other instrument suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver a drug or other therapeutic agent to the tissue to be treated. Additionally or alternatively, with or without the use of a disposable tube, the imaging component may removably receive any of the instruments illustrated in FIGS. 2A-2E.

[0118] In the illustrated embodiment, the distal end 305 of the optical scoping instrument may include a light emitting diode and / or a camera to provide an image to a user. In such an embodiment, the optical scoping instrument may function as an endoscope. The distal end 305 of the optical scoping element may include optical components such as optical fibers, relay lenses, objective lenses, etc. The optical scoping instrument 300 may include an optical scoping instrument shaft 303 having a distal end and a proximal end. The optical scoping instrument shaft 303 may be configured to be detached from a handle component of the instrument or may be configured to be used without a handle component such that the optical scoping instrument 300 may be disposable.

[0119] The optical scoping instrument shaft 303 may be made of a soft and / or flexible material so that it can be deflected by the imaging transducer and / or angled portion within the shaft cavity. Additionally or alternatively, the optical scoping instrument shaft may include a wire system or other means for deflecting (e.g., pushing, pulling, and / or rotating / torque) the distal end of the optical scoping instrument. Deflection of the distal end of the optical scoping instrument may serve to prevent damage to the imaging transducer and / or allow multiple image angles to be collected. In some embodiments, the optical scoping element may rotate relative to the imaging component. In some embodiments, the optical scoping element may be fully rotated relative to the imaging component in either direction under user control within the imaging component shaft while the shaft remains stationary so that multiple image angles can be collected.

[0120] The shaft of the optical scope instrument can be longer than the shaft of the imaging transducer so that images can be collected from deep inside the uterus. In some embodiments, the shaft of the optical scope instrument can be 2 inches longer than the shaft of the imaging transducer. Additionally or alternatively, for example, the shafts can be 6 inches longer, 4 inches longer, 2 inches longer, the same length, or within a range of any two of the preceding values.

[0121] In the illustrated embodiment, the optical scope instrument includes a handle portion 301. While the handle portion 301 may be shown connected to an optical scope in the illustrated example, a similar handle portion may be connected to any suitable instrument, such as those disclosed herein. The handle portion 301 may be the second part of a two-piece handle such that when the optical scope instrument may be slidably inserted into the imaging component, the two handle portions may combine to form a single handle. The handle portion may additionally include a positioning element 313 to provide a more reliable reference between the parts of the two-piece handle. The positioning element 313 may mate with the slot 113. In such an embodiment, the handle portion may include a release control 321 that may be actuated by a user to retract the positioning element into the handle and allow the two-piece handle to be separated.

[0122] The handle portion may additionally include one or more control elements 319. The control elements 319 may enable a medical professional to control the distal end of the instrument. In one example, the control elements control a wire system that can reproducibly deflect or steer the distal end of the instrument. Additionally or alternatively, the control elements may rotate the shaft of the instrument within a cavity of an imaging component or within a disposable tube. In another example, the control elements scoop tissue with a tissue collector instrument. In another example, the control elements deploy a needle assembly with optional tines within an ablation instrument. Additionally or alternatively, the control elements initiate an ablation procedure. In another example, the control elements apply pressure and inject chemicals through a drug delivery instrument. In another example, the control elements start and stop image acquisition with an optical scope instrument.

[0123] FIG. 3B shows an assembly diagram of the imaging system illustrating the system's attachment mechanism, according to some embodiments. The inside of the handle portion 309 may include an alignment element 311. The alignment element 311 may be configured so that an optical scope instrument can be reproducibly aligned with the imaging component after changing instruments. Additionally, or alternatively, the alignment element may sufficiently secure the instrument and imaging component relative to one another to use the two handle portions as a single handle. In some embodiments, the alignment element may include a magnet. In other embodiments, the alignment element may include, for example, a latch, a hook, or any other mechanism suitable for removably combining a two-piece handle. The inside of the handle portion 309 may additionally include a positioning element 313 to provide a more reliable reference between the parts of the two-piece handle. In such an embodiment, the handle portion may include a release control 321 that can be actuated by the user to retract the positioning element into the handle, allowing the two-piece handle to be separated.

[0124] In some embodiments, a method for detecting or sensing the identity of a removable instrument is provided upon coupling of the imaging component with the removable instrument. The imaging component may include software for recognizing the removable instrument and managing the interconnection between the imaging component and the removable instrument. The sensor or mechanism may be, by way of non-limiting example, optical, RF, magnetic, biometric, electronic, and mechanical ID and reader. The method will ensure that only qualified removable devices are received on the imaging device and that only compatible devices can be used with the imaging component.

[0125] FIG. 4 illustrates a shaft of an imaging component, according to some embodiments, where the shaft of the imaging component can be flexible. In the illustrated embodiment, the shaft of the imaging component can comprise a flexible shaft portion 403. The body of the flexible portion of the shaft can comprise internal structure to carry electronics or other associated components for controlling the imaging transducer. The imaging transducer can comprise channels or ducts for directing fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The flexible portion can comprise a portion of the length of the imaging component shaft. In some embodiments, the flexible portion comprises less than three-quarters of the length of the shaft. Additionally or alternatively, the flexible portion can comprise less than one-quarter of the length of the shaft, less than one-eighth of the length of the shaft, and the entire length of the shaft.

[0126] The cross section of the flexible portion of the shaft may continue the geometry of the shaft so that no gaps or traumatic edges are created between the flexible portion of the shaft and the shaft. The flexible portion may be rounded in cross section or shaped with sufficiently softened, chamfered, rounded, or beveled edges so that the edges may be atraumatic to the patient orifice during insertion or removal of the imaging component, with or without an instrument. The flexible portion may additionally include a smooth outer surface. The flexible portion may be made from a material whose surface may be deformable to allow the flexible portion to bend or conform to the shape of a body lumen.

[0127] The cavity of the flexible portion can be configured to slidably receive one or more of the instruments. The cavity of the flexible shaft portion can be configured to continue the shape of the cavity of the shaft so that no gaps or traumatic edges are created between the flexible portion and the shaft. In some embodiments, the cavity of the flexible portion can be partially open along its wall so that the lumen of the cavity of the flexible portion can communicate with the exterior of the shaft. The opening of the flexible portion can be sufficiently closed to provide structural support so that when the imaging component can be inserted into the patient's body lumen, the opening of the lumen is not significantly obstructed by the insertion or removal of an instrument. In some embodiments, the edges of the cavity of the flexible portion can be curved inward toward the interior of the cavity, as in the embodiment illustrated in FIG. 11B. The inwardly curved edges of the cavity of the flexible portion can serve to support the opening of the body lumen so that the shaft, with or without an instrument, can be atraumatically inserted or removed from the body lumen. The cavity of the flexible portion may be sufficiently open so that some distortion of the cavity opening can occur when instruments of different sizes can be received or inserted into the cavity. The cavity may facilitate cleaning of the imaging component by providing access to the interior of the cavity from its exterior.

[0128] While the flexible segment cavity in the illustrated example defines a circular cross-sectional area, in other embodiments, the flexible segment cavity can be oval or any other geometric shape with sufficiently softened, rounded, or beveled edges and corners so that insertion or removal of the flexible segment shaft does not damage the patient's body lumen. In some embodiments, the flexible segment cavity can be asymmetric so as to provide an axis for alignment of an internal instrument. The flexible segment cavity can be open in cross section over less than three-quarters of its circumference; additionally, or alternatively, the cavity can be open over less than half of its circumference, less than one-quarter of its circumference, and less than one-eighth of its circumference. In other embodiments, the flexible segment cavity can be closed to the exterior of the flexible segment shaft, allowing an instrument to be slidably inserted completely within the interior of the flexible segment shaft.

[0129] In some embodiments, the flexible shaft portion may be constructed from a soft and / or flexible material so that it can be flexed within a patient's body lumen. In some embodiments, the shaft may be controllably flexed along its longitudinal axis via a flexing mechanism. Additionally or alternatively, the flexible portion of the shaft may include a wire system or other flexing mechanism to enable the flexible portion to controllably bend, flex, or deflect the distal end of the flexible portion. The flexing mechanism may be controlled by a control element on the handle portion of the imaging component.

[0130] In the illustrated example, the flexible segment can be axially flexed to an angle of about 90 degrees relative to the handle. Additionally or alternatively, the flexible segment can be axially flexed, for example, by less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, or less than 1 degree. Additionally or alternatively, the flexible segment can be flexed in the anterior-posterior axis relative to the handle of the imaging component. In some embodiments, the flexible segment can be flexed in the anterior-posterior axis, for example, by less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, or less than 1 degree. Additionally or alternatively, the flexible segment can be flexed in the medial-lateral axis relative to the handle of the imaging component. In some embodiments, the flexible segment can be flexed in the medial-lateral axis, for example, by less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, or less than 1 degree.

[0131] FIG. 5A illustrates a system for diagnosing and / or providing therapy that can be removably coupled to multiple therapeutic and / or diagnostic instruments, according to some embodiments. The system for performing therapy and / or diagnosis may include a therapeutic or diagnostic instrument 510 and an imaging component 520. The instrument 510 of the system for performing therapy and / or diagnosis may include a therapeutic or diagnostic instrument, such as any of the therapeutic or diagnostic instruments described herein. In some embodiments, the imaging component may be used in conjunction with instruments such as biopsy needles, tissue collectors, optical scopes, implanted devices, therapy electrodes, tissue ablation elements, such as radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, and / or any other instrument suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver drugs or other therapeutic agents to the tissue to be treated. FIGS. 2A-2E show exemplary instruments that can be slidably received by the imaging component. In some embodiments, the system may include first and second therapeutic or diagnostic instruments. Imaging component 520 may comprise an imaging component such as, for example, examples, embodiments, and variations based on the imaging components described herein.

[0132] 5B illustrates a system for diagnosing and / or providing therapy with a therapeutic and / or diagnostic instrument removably coupled to an imaging component, according to some embodiments. As shown, instrument 510 can be axially aligned with respect to imaging component 520. In addition, the distal end of instrument shaft 513 can be delivered into the proximal end of imaging component cavity 525. The instrument can then be advanced toward the imaging component such that the instrument shaft is slidably received by the imaging component cavity. The instrument can be slidably removed from the imaging component by a similar procedure.

[0133] FIG. 5C illustrates a system for diagnosing and / or providing therapy with a therapeutic and / or diagnostic instrument removably coupled to an imaging component, according to some embodiments. The system for diagnosing therapy may include a retention element, such as a hook, latch, or mechanical feature described herein, to secure the instrument 510 to the imaging component 520. The system for diagnosing and / or providing therapy may be configured to couple to multiple instruments. For example, a first instrument may be coupled to the imaging component, followed by a second instrument. The imaging component may be configured to couple to both the first and second therapeutic and / or diagnostic instruments simultaneously or separately. For example, if the first instrument is a disposable tube, the second instrument may be slidably inserted into the first instrument. In some embodiments, the imaging component may be configured to be pre-coupled with the first and / or second therapeutic or diagnostic instruments outside the target site and deliverable to the target site within the patient. Additionally or alternatively, the imaging component may be configured to be removably coupled to both the first and second therapeutic or diagnostic instruments, either simultaneously or separately, after the imaging component has been delivered to the target site within the patient (e.g., the instruments may be coupled in situ).

[0134] FIG. 12A illustrates a system for diagnosing and / or providing therapy that can be configured to be removably coupled to multiple therapeutic and / or diagnostic instruments in situ, according to some embodiments. FIG. 12A shows an imaging component in use separate from the therapeutic and / or diagnostic instruments, according to some embodiments. The system for performing therapy and / or diagnosis may include a therapeutic or diagnostic instrument 1210 and an imaging component 1220. The instrument 1210 of the system for performing therapy and / or diagnosis may include a therapeutic or diagnostic instrument, such as any of the therapeutic or diagnostic instruments described herein. In some embodiments, the imaging component may be used in conjunction with an instrument such as a biopsy needle, a tissue collector, an optical scope, an implanted device, a therapy electrode, a tissue ablation element, such as a radiofrequency ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, and / or any other instrument suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver a drug or other therapeutic agent to the tissue to be treated. 2A-2E show example instruments that may be slidably received by the imaging component. In some embodiments, the system may include first and second therapeutic or diagnostic instruments. The imaging component 1220 may include an imaging component, such as examples, embodiments, and variations based on the imaging components described herein. As shown in the illustrated embodiment, the imaging component 1220 may be positioned within the patient's body lumen L without additional therapeutic and / or diagnostic instruments positioned within the shaft of the imaging component. In some examples, the imaging component 1220 may be used without therapeutic and / or diagnostic instruments.

[0135] FIG. 12B illustrates a system for diagnosing and / or providing therapy with a therapeutic and / or diagnostic instrument removably coupled to the imaging component in situ, according to some embodiments. As shown, the instrument 1210 can be axially aligned with the imaging component 1220 while the imaging component is positioned within a patient lumen. In addition, the distal end of the instrument 1213 shaft can be delivered into the proximal end of the imaging component cavity 1225 while the imaging component remains in situ. The instrument can then be advanced toward the imaging component such that the instrument shaft is slidably received by the imaging component cavity in situ. The instrument can be slidably removed from the imaging component by a similar procedure. The instrument 1210 can be slidably inserted without displacing the distal end of the imaging component. The instrument 1210 can be slidably inserted without interrupting or interfering with the imaging functionality of the imaging component 1220.

[0136] 12C illustrates a system for diagnosing and / or providing therapy with a therapeutic and / or diagnostic instrument removably coupled to the imaging component in situ, according to some embodiments. The system for diagnosing therapy may include a retention element, such as a hook, latch, or mechanical feature described herein, to secure the instrument 1210 to the imaging component 1220. The system for diagnosing and / or providing therapy may be configured to couple to multiple instruments. For example, a first instrument may be coupled to the imaging component, followed by a second instrument. The imaging component may be configured to couple to both the first and second therapeutic and / or diagnostic instruments simultaneously or individually. For example, if the first instrument is a disposable tube, the second instrument may be slidably inserted into the first instrument.

[0137] FIG. 6 shows an imaging system 600 including a digital processing device 612 and a display 614 visible to a user, according to some embodiments. As illustrated in FIG. 6 , the imaging system 600 may additionally include the imaging component 100 and the instrument 300. The digital processing device 612 may include one or more processors configured with instructions for setting and recording both treatment parameters and imaging parameters. The display 614 may be contained within a common enclosure 618; however, in other embodiments, the display 614 may be remote from the digital processing device and / or the imaging component 100. The imaging component 100 may be connected to the digital processing device 612 by an imaging cord 624 to provide captured images to the digital processing device 612 to be displayed by the display 614; however, additionally or alternatively, the imaging component may communicate with the digital processing device wirelessly. The instrument 300 may be connected to the digital processing device 612 by an instrument cord 622; however, in addition or alternatively, the instrument may communicate with the digital processing device wirelessly. In embodiments in which the imaging component and the instrument are connected by a cord, the digital processing device may provide power to both components.

[0138] Instrument 300 may include a handle portion 301 having a control element 319 slidably mounted on its upper surface. In some embodiments, control element 319 may control the position of an internal stop within the handle, the position of which may be monitored by processor 612 to calculate the size and position of the boundary of the target area and / or safety area shown on display 614. In embodiments in which instrument 300 is an ablation element, the stop may also serve to physically limit the deployment of the needles and, optionally, the tines.

[0139] Some embodiments of the presently disclosed methods and systems may be integrated with systems and methods for establishing and adjusting displayed safety and treatment zone boundaries. Such embodiments may include the systems and methods of the incorporated references, including U.S. Patent Publication No. 2014 / 0073910, U.S. Patent No. 8,992,427, U.S. Patent Application No. 15 / 811,520, and PCT Application No. US2017 / 060674, the contents of which are incorporated herein by reference. Some embodiments of the presently disclosed methods and systems may be integrated with systems and methods for mapping and planning systems. Such embodiments may include the systems and methods of the incorporated references, including PCT Application No. PCT / US2017 / 060674.

[0140] 7A illustrates an imaging component that may be used to treat a fibroid F located within the myometrium M within the uterus U beneath the uterine wall UW (endometrium) and surrounded by a serosal wall SW. The imaging component 100 may be introduced transvaginally and transcervically (or alternatively, laparoscopically) into the uterus, and the imaging transducer 107 may be deployed to image the fibroid within the field of view indicated by the dashed line.

[0141] FIG. 7B shows an image that may be visible on the display showing the safety and treatment boundaries, according to some embodiments. In some embodiments, once the fibroid is positioned on the display 614, controls on the handle can be used to position and size both the treatment boundary TB and the safety boundary SB. In some embodiments, the virtual borders TB and SB are not initially positioned over the fibroid or properly sized to treat it. Prior to initiating therapy, the physician may want to both position and size the boundaries TB and SB for proper treatment. Because the imaging transducer 107 may already be positioned relative to the uterine wall UW, the only way to advance the treatment and safety boundaries may be to move the boundaries forward by actuating the control element 319. In some embodiments, this may move the treatment and safety boundaries TB and SB forward along the axis AL, thereby translating the area to be treated. This may move the virtual boundary on the real-time image display 614 over the image of the fibroid. Additionally or alternatively, the size of the treatment boundary TB may be increased or decreased to reduce the risk of affecting healthy and / or more sensitive tissue surrounding the area of ​​treatment.

[0142] In embodiments where the instrument is a tissue ablation element, while holding the imaging component 100 steady, the physician may then advance the needle slide to extend the needle 235 into the fibroid F, as shown in FIG. 7C. The illustration in FIG. 7C includes a representation of the imaging component 100, which corresponds to the physical probe present in the patient. The remainder of FIG. 7C corresponds to the image present on the target display 614.

[0143] After the needle 235 is fully deployed as defined by an optional physical or virtual needle stop housing within the instrument handle 301, the tines 233 may be deployed by engagement of the tine slide with an optional tine stop or by advancing the tine slide, which reaches a target level of tine deployment, as visually indicated on the display. Optionally, the imaging component 100 may be rotated about a central axis (typically aligned with the axis of the needle 235) to confirm treatment and safety boundaries in all planes of view centered on the fibroid. The display 614 will show the location of the treatment and safety boundaries in real time relative to the target fibroid and serosa. The tines may then be configured as shown in FIG. 7D, and power may be supplied to the tines (and optionally the needles) to achieve treatment within the boundaries delineated by the virtual treatment boundary TB. Again, FIG. 7D blends both the virtual image that would be present on the display 614 and the physical presence of the imaging component 100.

[0144]

[0041] Embodiments of the present disclosure may provide a method for performing therapy or diagnosis at a target site. FIG. 8 shows an exemplary method 800 for performing therapy or diagnosis at a target site, according to some embodiments. In step 810, an imaging component may be inserted into a subject. In step 820, an instrument may be inserted into a cavity toward the target site. Alternatively, the imaging component may be inserted into the cavity with additional therapeutic and / or diagnostic instruments previously inserted into the cavity of the imaging component. In step 830, therapy or diagnosis may be performed at the target site using the instrument. In step 840, the instrument may be removed from the cavity.

[0145] In some embodiments, method 800 may additionally include at least steps 850, 860, and 870. In step 850, the method may include inserting a second instrument into the cavity toward the target site. During step 850, the imaging component may remain in situ. In step 860, therapy or diagnosis may be performed at the target site using the second instrument. In step 870, the second instrument may be removed from the cavity, and the second instrument may be different from the first instrument. In some embodiments, steps 850, 860, and 870 may be repeated using a third, fourth, or more instruments.

[0146] Method 800 may represent a general method of use of imaging components for which one skilled in the art would recognize many variations and adaptations.

[0147] In some embodiments, the present disclosure may additionally provide a method for performing image-guided ablation therapy. FIG. 9 shows an exemplary method 900 for performing image-guided ablation therapy, according to some embodiments. In step 905, an imaging component may be inserted into a subject, with the imaging component in situ. In step 910, a biopsy needle may be inserted into the cavity. In step 915, a pathology sample may be collected using the biopsy needle. In step 920, the biopsy needle may be removed from the cavity. Test results obtained from the biopsy sample may be used to inform subsequent steps of the method for performing image-guided ablation therapy. For example, one or more biopsies and / or additional imaging may inform a surgeon whether and / or where tissue needs to be removed and / or ablated, where therapeutic and / or diagnostic agents should be delivered, and / or where additional imaging should be performed. In step 925, a radiofrequency (RF) ablation element may be inserted into the cavity. In step 930, the lesion may be ablated using the RF ablation element. In step 935, the RF ablation element may be removed from the cavity. In step 940, an optical scope may be inserted into the cavity. In step 945, completion of image-guided ablation therapy may be confirmed using the optical scope. In step 950, the optical scope may be removed from the cavity. Alternatively, or in addition to confirming ablation with the optical scope, the RF ablation element may be replaced with a drug delivery device to deliver painkillers, hemostatic agents, and / or other therapeutic agents after tissue ablation or other therapeutic and / or diagnostic steps.

[0148] Other exemplary methods may include a method of coupling instruments including: advancing an imaging component into a surgical space, the imaging component having a shaft with a proximal end and a distal end; coupling a first instrument to the imaging component for use within the surgical space, the first instrument may be a therapeutic or diagnostic instrument; decoupling the first instrument from the imaging component while the imaging component remains within the surgical space; and coupling a second instrument to the imaging component for use within the surgical space while the imaging component remains within the surgical space, the second instrument may be a therapeutic or diagnostic instrument different from the first instrument.

[0149] In some embodiments, the method of coupling instruments additionally includes coupling the first instrument while the imaging component remains within the surgical space. In some embodiments, the method of coupling instruments additionally includes coupling the first instrument while the imaging component is outside the surgical space. In some embodiments, the method of coupling instruments additionally includes collecting a tissue sample from the surgical space using the first instrument. In some embodiments, the method of coupling instruments additionally includes ablating an area within the surgical space using the second instrument. In some embodiments, the method of coupling instruments additionally includes performing a therapy or diagnosis using the first instrument. In some embodiments, the method of coupling instruments additionally includes selecting a second instrument based on data collected from performing a therapy or diagnosis using the first instrument. In some embodiments, the method of coupling instruments additionally includes adjusting parameters of a therapy or diagnosis performed using the second instrument based on data collected from performing a therapy or diagnosis using the first instrument. In such embodiments, the collected data may comprise image data, and adjusting the parameters may include adjusting an ablation zone for the second instrument.

[0150] In another exemplary method, embodiments of the present disclosure may provide a method of performing therapy or diagnosis at a target site. The method of performing therapy may include advancing an imaging component to the target site. The method of performing therapy may include an imaging component including a shaft having a proximal end, a distal end, and a cavity extending across the shaft from the proximal end to the distal end, the wall of the cavity including an elongated opening at least partially along the shaft and communicating with the exterior of the shaft. The method of performing therapy may include an imaging transducer coupled to the distal end of the shaft. The method of performing therapy may include performing therapy or diagnosis using an instrument inserted into the cavity and advanced to the target site.

[0151] In some embodiments, the method of performing therapy may additionally include inserting a first instrument into the cavity before advancing the imaging component to the target site. In some embodiments, the method of performing therapy may additionally include inserting a first instrument into the cavity after advancing the imaging component to the target site. In some embodiments, the method of performing therapy may additionally include removing the first instrument from the cavity while the imaging component remains at the target site. In some embodiments, the method of performing therapy may additionally include inserting a second instrument into the cavity and advancing the second instrument to the target site. In some embodiments, the method of performing therapy may additionally include performing therapy or diagnosis using the second instrument.

[0152] The methods described herein may function to perform therapy or diagnosis on a volume of tissue (e.g., a patient's uterus, another organ). In some embodiments, the methods described herein may be performed via laparoscopic surgery. In such embodiments, the methods described herein may additionally include the insertion of a trocar into a patient's body lumen. During laparoscopic surgery, an imaging component may be inserted into the cannula of the trocar to perform the surgical procedure. In some embodiments, the methods may be performed non-invasively. In such embodiments, the imaging component may be inserted into a pre-existing or naturally formed patient body lumen. Additionally, or alternatively, the methods may be performed via minimally invasive surgery. In such embodiments, a lumen may be formed in the patient, which may be of a minimal size to accelerate healing time and minimize surgical trauma.

[0153] The methods described herein may be implemented, at least in part, by the imaging component 100 described herein, in addition to or as an alternative to the instrument embodiments, variations, and / or examples. Additionally or alternatively, the methods described herein may be implemented using any other suitable imaging component and / or instrument and as facilitated by any of the computing and / or processing components described further below. The methods described herein may be implemented by systems 500 and / or 1200. The imaging component may be used in conjunction with instruments such as biopsy needles, optical scopes, implanted devices, therapy electrodes, tissue ablation elements such as radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, and / or other instruments suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver drugs or other therapeutic agents or implants to the tissue to be treated. Figures 2A-2E show exemplary instruments that may be slidably received by the imaging component.

[0154] Those skilled in the art will recognize many adaptations and variations to the methods described herein. Furthermore, one or more steps described with respect to the methods herein may be deleted or repeated, additional steps may be added, and steps may be performed in any order. Steps described with respect to one method may be added or combined with another. For example, steps of method 900 may be added to method 800.

[0155] In some embodiments, the imaging components, systems, and methods described herein include a digital processing device or the use of the same. In further embodiments, the digital processing device includes one or more hardware central processing units (CPUs), general-purpose graphics processing units (GPGPUs), or field-programmable gate arrays (FPGAs) that perform the functions of the device. In still further embodiments, the digital processing device further comprises an operating system configured to execute the executable instructions. In some embodiments, the digital processing device may optionally be connected to a computer network. In further embodiments, the digital processing device is optionally connected to the Internet to access the World Wide Web. In still further embodiments, the digital processing device is optionally connected to a cloud computing infrastructure. In other embodiments, the digital processing device is optionally connected to an intranet. In other embodiments, the digital processing device is optionally connected to a data storage device.

[0156] In accordance with the description herein, suitable digital processing devices include, by way of non-limiting example, server computers, desktop computers, laptop computers, notebook computers, subnotebook computers, netbook computers, netpad computers, set-top computers, media streaming devices, handheld computers, Internet appliances, mobile smartphones, tablet computers, personal digital assistants, video game consoles, and vehicles. Those skilled in the art will recognize that many smartphones are suitable for use with the systems described herein. Those skilled in the art will also recognize that optional televisions, video players, and digital music players with optional computer network connectivity are suitable for use with the systems described herein. Suitable tablet computers include those with booklet, slate, and convertible configurations known to those skilled in the art.

[0157] In some embodiments, the digital processing device includes an operating system configured to execute executable instructions. An operating system is software including programs and data that, for example, manages the device's hardware and provides services for the execution of applications. Those skilled in the art will recognize that suitable server operating systems include, by way of non-limiting example, FreeBSD, OpenBSD, NetBSD®, Linux®, Apple® Mac OS X Server®, Oracle® Solaris®, Windows® Server®, and Novell® NetWare®. Those skilled in the art will recognize that suitable personal computer operating systems include, by way of non-limiting example, UNIX®-like operating systems such as Microsoft® Windows®, Apple® Mac OS X®, UNIX®, and GNU / Linux®. In some embodiments, the operating system is provided by cloud computing. Those skilled in the art will also recognize that suitable mobile smartphone operating systems include, by way of non-limiting example, Nokia® Symbian® OS, Apple® iOS®, Research In Motion® BlackBerry OS®, Google® Android®, Microsoft® Windows® Phone® OS, Microsoft® Windows® Mobile® OS, Linux®, and Palm® WebOS®.Those skilled in the art will also recognize that suitable media streaming device operating systems include, by way of non-limiting example, Apple TV®, Roku®, Boxee®, Google TV®, Google Chromecast®, Amazon Fire®, and Samsung® HomeSync®. Those skilled in the art will also recognize that suitable video game console operating systems include, by way of non-limiting example, Sony® PS3®, Sony® PS4®, Microsoft® Xbox 360®, Microsoft Xbox One, Nintendo® Wii®, Nintendo® Wii U®, and Ouya®.

[0158] In some embodiments, the device comprises a storage and / or memory device. A storage and / or memory device is one or more physical devices used to temporarily or permanently store data or programs. In some embodiments, the device is volatile memory and requires power to maintain stored information. In some embodiments, the device is nonvolatile memory and retains stored information when the digital processing device is not powered. In further embodiments, the nonvolatile memory comprises flash memory. In some embodiments, the nonvolatile memory comprises dynamic random access memory (DRAM). In some embodiments, the nonvolatile memory comprises ferroelectric random access memory (FRAM). In some embodiments, the nonvolatile memory comprises phase change random access memory (PRAM). In other embodiments, the device is a storage device, including, by way of non-limiting example, a CD-ROM, a DVD, a flash memory device, a magnetic disk drive, a magnetic tape disk, an optical disk drive, and a cloud computing-based storage device. In further embodiments, the storage and / or memory device is a combination of devices such as those disclosed herein.

[0159] In some embodiments, the digital processing device includes a display for transmitting visual information to a user. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In further embodiments, the display is a thin film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light emitting diode (OLED) display. In various further embodiments, the OLED display is a passive matrix OLED (PMOLED) or an active matrix OLED (AMOLED) display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0160] In some embodiments, the digital processing device includes an input device for receiving information from a user. In some embodiments, the input device is a keyboard. In some embodiments, the input device is a pointing device, including, by way of non-limiting example, a mouse, trackball, trackpad, joystick, game controller, or stylus. In some embodiments, the input device is a touchscreen or multi-touchscreen. In other embodiments, the input device is a microphone for capturing voice or other audio input. In other embodiments, the input device is a video camera or other sensor for capturing motion or visual input. In further embodiments, the input device is a Kinect, Leap Motion, or the like. In still further embodiments, the input device is a combination of devices such as those disclosed herein.

[0161] 10 , in certain embodiments, an exemplary digital processing device 612 is programmed or otherwise configured to control imaging components and / or instruments as described herein. The device 612 may coordinate various aspects of the imaging components and / or instruments of the present disclosure, such as, for example, performing processing steps. In this embodiment, the digital processing device 612 includes a central processing unit (CPU, also referred to herein as “processor” and “computer processor”) 1005, which may be a single-core or multi-core processor, or multiple processors for parallel processing. The digital processing device 612 also includes memory or memory locations 1010 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1015 (e.g., a hard disk), a communication interface 1020 (e.g., a network adapter) for communicating with one or more other systems, and peripheral devices 1025, such as cache, other memory, data storage, and / or electronic display adapters. The memory 1010, storage unit 1015, interface 1020, and peripheral devices 1025 communicate with the CPU 1005 through a communication bus (solid lines) such as a motherboard. The storage unit 1015 may be a data storage unit (or data repository) for storing data. The digital processing device 612 can be operatively coupled to a computer network (“network”) 1030 with the aid of the communication interface 1020. The network 1030 may be the Internet, an Internet and / or extranet, or an intranet and / or extranet communicating with the Internet. The network 1030, in some cases, is a telecommunications and / or data network. The network 1030 may include one or more computer servers, which may enable distributed computing such as cloud computing. The network 1030, in some cases, may implement a peer-to-peer network with the aid of the device 612, which may enable devices coupled to the device 612 to act as clients or servers.

[0162] Continuing to refer to FIG. 10, CPU 1005 can execute a series of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as memory 1010. The instructions may be directed to CPU 1005, which may then program or otherwise configure CPU 1005 to implement the methods of the present disclosure. Examples of operations performed by CPU 1005 include fetch, decode, execute, and writeback. CPU 1005 may be part of a circuit, such as an integrated circuit. One or more other components of device 612 may be included in the circuit. In some cases, the circuit is an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA).

[0163] Continuing to refer to FIG. 10 , the storage unit 1015 can store files such as drivers, libraries, and saved programs. The storage unit 1015 can store user data, such as user preferences and user programs. The digital processing device 612 can include one or more additional data storage units that are external, in some cases, such as located on a remote server communicating through an intranet or the Internet. The digital processing device 612 can communicate with one or more remote computer systems through the network 1030. For example, the device 612 can communicate with a user's remote computer system.

[0164] Examples of remote computer systems include a personal computer (e.g., a portable PC), a slate or tablet PC (e.g., an Apple® iPad®, a Samsung® Galaxy Tab), a telephone, a smartphone (e.g., an Apple® iPhone®, an Android-enabled device, a Blackberry®), or a personal digital assistant.

[0165] Methods as described herein may be implemented via machine (e.g., computer processor) executable code stored on electronic storage locations of the digital processing device 612, such as on the memory 1010 or electronic storage unit 1015. The machine-executable or machine-readable code may be provided in the form of software. In use, the code may be executed by the processor 1005. In some cases, the code may be read from the storage unit 1015 and stored on the memory 1010 for easy access by the processor 1005. In some situations, the electronic storage unit 1015 may be omitted and the machine-executable instructions may be stored on the memory 1010.

[0166] The digital processing device 612 may include or communicate with an electronic display 614 having a user interface (UI) 1040. Examples of a UI include, but are not limited to, a graphical user interface (GUI) and a web-based user interface. In some cases, the electronic display 614 may be connected to the computer system 612 via a network, for example, via network 1030.

[0167] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitory computer-readable storage media encoded with a program including instructions executable by an operating system of an optionally networked digital processing device. In further embodiments, the computer-readable storage medium is a tangible component of the digital processing device. In yet further embodiments, the computer-readable storage medium is optionally removable from the digital processing device. In some embodiments, computer-readable storage media include, by way of non-limiting example, CD-ROMs, DVDs, flash memory devices, solid-state memory, magnetic disk drives, magnetic tape drives, optical disk drives, cloud computing systems and services, and the like. In some cases, the programs and instructions are encoded on the medium permanently, substantially permanently, semi-permanently, or non-transitoryly.

[0168] In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program or the use of the same. A computer program includes a sequence of instructions executable in a CPU of a digital processing device that is written to perform a specified task. The computer-readable instructions may be implemented as program modules, such as functions, objects, application programming interfaces (APIs), data structures, etc., that perform particular tasks or implement particular abstract data types. Given the disclosure provided herein, those skilled in the art will recognize that computer programs can be written in a variety of languages ​​and versions.

[0169] The functionality of the computer-readable instructions may be combined or distributed as desired in various environments. In some embodiments, a computer program comprises a single sequence of instructions. In some embodiments, a computer program comprises multiple sequences of instructions. In some embodiments, a computer program is provided from a single location. In other embodiments, a computer program is provided from multiple locations. In various embodiments, a computer program comprises one or more software modules. In various embodiments, a computer program comprises, in part or in whole, one or more web applications, one or more mobile applications, one or more standalone applications, one or more web browser plug-ins, extensions, add-ins, or add-ons, or a combination thereof.

[0170] In some embodiments, the computer program comprises a web application. Given the disclosure provided herein, those skilled in the art will recognize that web applications, in various embodiments, utilize one or more software frameworks and one or more database systems. In some embodiments, the web application is created on a software framework such as Microsoft® .NET or Ruby on Rails (RoR). In some embodiments, the web application utilizes one or more database systems, including, by way of non-limiting example, relational, non-relational, object-oriented, associative, and XML database systems. In further embodiments, suitable relational database systems are, by way of non-limiting example, Microsoft® SQL Server, mySQL TM, and Oracle®. Those skilled in the art will also recognize that web applications, in various embodiments, are written in one or more versions of one or more languages. Web applications may be written in one or more markup languages, presentation definition languages, client-side scripting languages, server-side coding languages, database query languages, or combinations thereof. In some embodiments, web applications are written to some extent in a markup language such as Hypertext Markup Language (HTML), Extensible Hypertext Markup Language (XHTML), or Extensible Markup Language (XML). In some embodiments, web applications are written to some extent in a presentation definition language such as Cascading Style Sheets (CSS). In some embodiments, web applications are written to some extent in a client-side scripting language such as Asynchronous JavaScript and XML (AJAX), Flash Actionscript, JavaScript, or Silverlight®. In some embodiments, the web application may be implemented in any language, including, to some extent, Active Server Pages (ASP), ColdFusion®, Perl, Java®, Java Server Pages (JSP), Hypertext Preprocessor (PHP), Python TM , Ruby, Tcl, Smalltalk, WebDNA®, or Groovy. In some embodiments, the web application is written, in part, in a database query language such as Structured Query Language (SQL). In some embodiments, the web application is written in a server-side coding language such as IBM® Integrates with enterprise server products such as Lotus Domino®. In some embodiments, the web application includes a media player element. In various further embodiments, the media player element utilizes one or more of many suitable multimedia technologies, including, by way of non-limiting example, Adobe® Flash®, HTML 5, Apple® QuickTime®, Microsoft® Silverlight®, Java®, and Unity®.

[0171] In some embodiments, the computer program comprises a mobile application that is provided to the mobile digital processing device. In some embodiments, the mobile application is provided to the mobile digital processing device when the mobile digital processing device is manufactured. In other embodiments, the mobile application is provided to the mobile digital processing device via a computer network as described herein.

[0172] In light of the disclosure provided herein, mobile applications are created using hardware, languages, and development environments known in the art and by techniques known to those skilled in the art. Those skilled in the art will recognize that mobile applications are written in a number of languages. Suitable programming languages ​​include, by way of non-limiting example, C, C++, C#, Objective-C, Java, Javascript, Pascal, Object Pascal, and Python. TM , Ruby, VB.NET, WML, and XHTML / HTML with or without CSS, or a combination thereof.

[0173] Suitable mobile application development environments are available from several sources. Commercially available development environments include, by way of non-limiting example, Airplay SDK, alcheMo, Appcelerator®, Celsius, Bedrock, FlashLite, .NET Compact Framework, Rhomobile, and WorkLight Mobile Platform. Other development environments are available at no cost, including, by way of non-limiting example, Lazarus, MobiFlex, MoSync, and Phonegap. Additionally, mobile device manufacturers provide SDKs for the iPhone® and iPad® (iOS), Android, and iOS devices, by way of non-limiting example. TM The Company distributes software developer kits, including the SDK, BlackBerry® SDK, BREW SDK, Palm® OS SDK, Symbian SDK, webOS SDK, and Windows® Mobile SDK.

[0174] Those skilled in the art will recognize that several commercial forums are available for the distribution of mobile applications, including, by way of non-limiting example, the Apple® App Store, Google® Play, Chrome WebStore, BlackBerry® App World, the App Store for Palm devices, the App Catalog for webOS, the Windows® Marketplace for Mobile, the OviStore for Nokia® devices, Samsung® Apps, and the Nintendo® DSiShop.

[0175] In some embodiments, the computer program includes a standalone application, which is a program that is launched as an independent computer process rather than an add-on to an existing process, e.g., a plug-in. Those skilled in the art will recognize that standalone applications are often compiled. A compiler is a computer program that converts source code written in a programming language into binary object code, such as assembly language or machine code. Suitable compiled programming languages ​​include, by way of non-limiting example, C, C++, Objective-C, COBOL, Delphi, Eiffel, Java, Lisp, and Python. TM , Visual Basic, and VB.NET, or a combination thereof. Compilation is often performed to create, at least in part, an executable program. In some embodiments, a computer program includes one or more executable compiled applications.

[0176] In some embodiments, the computer program includes a web browser plug-in (e.g., an extension). In computing, a plug-in is one or more software components that add specific functionality to a larger software application. Software application manufacturers support plug-ins to allow third-party developers to create the ability to extend the application, facilitate the easy addition of new features, and reduce the size of the application. When supported, plug-ins allow customization of the software application's functionality. For example, plug-ins are commonly used in web browsers to play video, generate interactivity, scan for viruses, and display specific file types. Those skilled in the art will be familiar with several web browser plug-ins, including Adobe® Flash® Player, Microsoft® Silverlight®, and Apple® QuickTime®. In some embodiments, the toolbar comprises one or more web browser extensions, add-ins, or add-ons. In some embodiments, the toolbar comprises one or more explorer bars, tool bands, or desk bands.

[0177] In light of the disclosure provided herein, one of ordinary skill in the art would be able to implement a number of programming languages, including, by way of non-limiting example, C++, Delphi, Java, PHP, Python, TM , and VB.NET, or a combination thereof.

[0178] A web browser (also called an internet browser) is a software application designed for use with network-connected digital processing devices to retrieve, present, and traverse information resources on the World Wide Web. Suitable web browsers include, by way of non-limiting example, Microsoft® Internet Explorer®, Mozilla® Firefox®, Google® Chrome, Apple® Examples of suitable web browsers include Safari®, Opera Software® Opera®, and KDE Konqueror. In some embodiments, the web browser is a mobile web browser. Mobile web browsers (also called microbrowsers, minibrowsers, and wireless browsers) are designed for use on mobile digital processing devices, including, by way of non-limiting example, handheld computers, tablet computers, netbook computers, subnotebook computers, smartphones, music players, personal digital assistants (PDAs), and handheld video game systems. Suitable mobile web browsers include, by way of non-limiting example, the Google® Android® browser, the RIM BlackBerry® browser, the Apple® Safari®, the Palm® Blazer, the Palm® WebOS® browser, Mozilla® Firefox® for Mobile, the Microsoft® Internet Explorer® Mobile, the Amazon® Kindle® Basic Web, the Nokia® browser, the Opera Software® Opera® Mobile, and the Sony® PSP. TM Including the browser.

[0179] (Software Module) In some embodiments, the platforms, systems, media, and methods disclosed herein involve the use of software, server, and / or database modules, or portions thereof. In light of the disclosure provided herein, software modules are created by techniques known to those skilled in the art using machines, software, and languages ​​known in the art. The software modules disclosed herein are implemented in numerous ways. In various embodiments, a software module comprises a file, a section of code, a programming object, a programming structure, or a combination thereof. In further various embodiments, a software module comprises multiple files, multiple sections of code, multiple programming objects, multiple programming structures, or a combination thereof. In various embodiments, one or more software modules comprise, by way of non-limiting examples, a web application, a mobile application, and a standalone application. In some embodiments, a software module is within one computer program or application. In other embodiments, a software module is within two or more computer programs or applications. In some embodiments, a software module is hosted on one machine. In other embodiments, a software module is hosted on two or more machines. In further embodiments, a software module is hosted on a cloud computing platform. In some embodiments, the software modules are hosted on one or more machines in one location. In other embodiments, the software modules are hosted on one or more machines in two or more locations.

[0180] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more databases or the use of such databases. In light of the disclosure provided herein, those skilled in the art will recognize that many databases are suitable for storing and retrieving information. In various embodiments, suitable databases include, by way of non-limiting example, relational databases, non-relational databases, object-oriented databases, object databases, entity-relationship model databases, associative databases, and XML databases. Further non-limiting examples include SQL, PostgreSQL, MySQL, Oracle, DB2, and Sybase. In some embodiments, the database is internet-based. In further embodiments, the database is web-based. In yet further embodiments, the database is cloud computing-based. In other embodiments, the database is based on one or more local computer storage devices.

[0181] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

[Claim 1] The invention described in this specification.

Images