Tissue surface penetration systems and methods

Abstract

A system comprising a needle guide defining a path of travel for a needle inserted through the guide, and a tissue manipulator configured to be proximate to tissue and the needle guide and to set a position of at least a portion of the tissue in the path of travel of the needle, and wherein the tissue manipulator and the needle guide are alignable such that the path of travel passes through a same surface of the tissue multiple times.

Description

[0001] Cross-referencing related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 982,440, filed February 27, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This technology generally relates to the field of tissue fixing and / or securing (e.g., tissue-pexy) systems and related methods. Background Technology

[0004] Needles used to pierce tissue, such as needles for introducing devices or substances into tissue, are typically positioned along the tissue using a needle guide. In some cases, the needle guide is a tube that includes an opening at its end and serves to guide the needle into that opening. In some embodiments, the opening of the needle guide is positioned near the tissue such that a needle traveling through the guide pierces the tissue.

[0005] Brief description of the attached figures

[0006] Referring to the following figures will provide a better understanding of many aspects of this technology. The components in the figures are not necessarily drawn to scale. Instead, the focus is on clearly illustrating the principles of this technology.

[0007] Figure 1A This is a perspective view of a tissue fixation system configured according to an embodiment of the present technology.

[0008] Figure 1B yes Figure 1A A partial schematic cross-sectional view of the tissue fixation system.

[0009] Figure 2 This is a perspective view of a needle guide configured according to an embodiment of the present technology.

[0010] Figure 3A and 3B These are perspective views and cross-sectional perspective views of a needle guide configured according to embodiments of the present technology.

[0011] Figure 4A 4B, 4C, 4D, 4E, and 4F are perspective views and corresponding cross-sectional views of the height variation of the travel path corresponding to tissue thickness according to some embodiments of the present technology.

[0012] Figure 5A 5B and 5C are perspective views of tissue manipulators configured according to some embodiments of the present technology.

[0013] Figure 6A and6B These are, respectively, a perspective view and a cross-sectional view of a probe configured according to an embodiment of the present technology.

[0014] Figure 7 This is a flowchart of a method for sew organization according to an embodiment of the present technology.

[0015] Figure 8A 8B and 8C are perspective views of a tissue fixation system configured according to another embodiment of the present technology.

[0016] Figure 9A and 9B This is a perspective view of a tissue fixation system configured according to a further embodiment of the present technology. Detailed Implementation

[0017] This technology relates to tissue fixation systems, apparatus, and methods for treating anatomical conditions. In some embodiments, the tissue fixation system may include a needle guide and a tissue manipulator. The needle guide may include an elongated structure or frame extending between a first end portion and a second end portion. The elongated structure has a path or cavity extending axially through it for receiving a needle and extending between the first end portion and the second end portion. The needle guide also includes a cavity, cut-out, or recess located in the elongated structure between the first end portion and the second end portion. The cavity bisects the longitudinal axis of the cavity such that when a needle advances through the cavity, the needle travels through a portion of the cavity. The tissue manipulator may include an elongated body configured to be placed within a hollow organ or other body cavity (e.g., the rectum). The tissue manipulator also includes one or more deployable probes or extension features that can be deployed from an external body portion to contact and guide tissue of the hollow organ or other body cavity in a specific direction or orientation.

[0018] In operation, the needle guide can be positioned adjacent to but external to a hollow organ or other body cavity, while the tissue manipulator can be positioned within the hollow organ or other body cavity. The needle guide and tissue manipulator can be positioned relative to each other such that the cavity of the needle guide is aligned with the deployment path of the probe on the tissue manipulator. Once aligned, the probe can be deployed from the tissue manipulator to guide a portion of patient tissue (e.g., the wall of a hollow organ) into the cavity of the needle guide (e.g., a portion of the patient tissue is "pinched" between the probe and the inner surface of the cavity). A needle connected to a suture can then be advanced through the cavity of the needle guide. As the needle advances, it traverses the cavity and thus pierces the tissue portion located within the cavity. The needle can be further advanced to pierce a second tissue different from the first tissue, and the suture can be used to secure the first tissue to the second tissue. It is worth noting that, in at least some embodiments, the aforementioned process can be used to suture tissue from a hollow organ or other cavity to another tissue without penetrating the inner surface of the hollow organ or other cavity, thus avoiding potential leakage from the hollow organ or other cavity. Therefore, an anticipated advantage of this technology is the ability to perform tissue fixation procedures (e.g., rectal fixation) without compromising the integrity of the target organ.

[0019] In some embodiments, for example, the tissue fixation system includes a needle guide that defines the path of travel of a needle inserted through the needle guide. The tissue fixation system is configured to attach a plurality of tissues to each other. In some embodiments, at least one of the tissues to be attached is at least a portion of a hollow organ, such as the wall of a hollow organ. The tissue fixation system is configured to attach a hollow organ to another tissue without interfering with the integrity of the cavity of the hollow organ.

[0020] In some embodiments, the system includes a tissue manipulator configured proximal to the tissue and the needle guide, such that at least a portion of the tissue located between the tissue manipulator and the needle is placed in the travel path of the needle. The tissue manipulator and the needle guide are alignable such that the tissue placed in the travel path of the needle is oriented relative to the needle guide such that the travel path passes through the same surface of the tissue multiple times without traversing the full thickness of the tissue.

[0021] In some embodiments, and as explained in more detail elsewhere herein, the needle guide includes one or more cavities along the longitudinal axis of the needle guide. The tissue manipulator is configured to be proximate to the needle guide and / or the cavities. In some embodiments, during operation of the system, the tissue manipulator is configured to be proximate to the needle guide and / or the one or more cavities, such that tissue is trapped between the tissue manipulator and the needle guide.

[0022] In some embodiments, the needle guide includes a self-held mechanism configured to be disposed on the tissue manipulator, such that the tissue layer therebetween remains intact. In some embodiments, the needle guide includes a self-held mechanism that independently maintains a fixed spatial orientation of the needle guide relative to the tissue manipulator, for example, without user intervention.

[0023] In some embodiments, the one or more cavities are configured to receive at least a portion of the tissue manipulator. In some embodiments, the tissue manipulator includes one or more probes extending from the body portion of the tissue manipulator to approach tissue and the needle guide and / or one or more cavities of the needle guide.

[0024] In some embodiments, the travel path of the needle passes through the tissue trapped between the tissue manipulator probe and the needle guide. In some embodiments, the geometry of at least one needle guide and the tissue manipulator is such that the travel path of the needle inserted along the needle guide passes through the same surface of the tissue multiple times without traversing the full thickness of the tissue.

[0025] Further embodiments of this technology relate to methods for performing rectal fixation to treat rectal conditions (e.g., rectal prolapse). Such methods may include, for example, performing a rectal examination and identifying the site of excessive / abnormal rectal mobility, determining the proximity of the identified site of excessive / abnormal rectal mobility in the rectum and / or pararectal tissues to the sacrospinous ligament, introducing anchors and sutures intra-abdominal and extra-rectal, and passing the anchors and sutures through at least a portion of the external rectal wall, and then: guiding the anchors and sutures into the sacrospinous ligament and anchoring the anchors and sutures at least partially within the sacrospinous ligament.

[0026] In some embodiments, the location of excessive / abnormal rectal activity is determined visually by palpation or via imaging (e.g., ultrasound). In some embodiments, passing the anchor and suture through at least a portion of the rectal wall includes passing the anchor and suture multiple times only through the outer surface of the rectum. In some embodiments, passing the anchor and suture through at least a portion of the rectal wall without traversing the full thickness of the rectal wall. In some embodiments, passing the anchor and suture through at least a portion of the rectal wall without compromising the integrity of the rectal lumen.

[0027] According to one aspect of some embodiments of the present technology, a method is provided for inserting a needle into a segment of tissue (e.g., a tissue wall) without traversing the full thickness of the wall. In some embodiments, the method includes positioning the tissue wall between a tissue manipulator and a needle guide. In some embodiments, the method includes positioning the needle guide along a first side of the tissue and positioning the tissue manipulator along a second side of the tissue. In some embodiments, the method includes bringing the tissue manipulator close to the needle guide such that at least a portion of the tissue is positioned within the path of travel of the needle. In some embodiments, the method includes driving the needle through the tissue such that the needle passes through the same surface of the tissue multiple times without traversing the full thickness of the tissue.

[0028] One anticipated advantage of the system and method described herein is that it prevents the needle's path of travel from passing through more than one surface of the tissue, i.e., the full thickness of the tissue. The tissue manipulator of the system can be used to suture the walls of hollow organs, for example, to repair tears or openings, and to suture the walls of hollow organs to other tissues (e.g., tissue fixation) without penetrating the tissue cavity.

[0029] For example, in some embodiments, the system is operated during rectal fixation, wherein the tissue manipulator is inserted into the subject's rectum and the needle is inserted inter-abdominally.

[0030] The potential advantage of this needle's path of travel not penetrating the tissue lumen is that the system allows suturing the tissue wall of a hollow organ (e.g., the bladder or digestive tract wall) without penetrating the lumen. For example, during rectal fixation, the rectal lumen remains intact. In other words, the rectal lumen remains unpierced by the needle. Therefore, during the manipulation of this system during rectal fixation, the needle's path of travel passes through the rectal tissue wall without penetrating the rectal lumen and does not compromise sterility.

[0031] The terminology used in the following description is intended to be interpreted in the broadest and most reasonable manner, even when used in conjunction with the detailed description of certain specific embodiments of the present technology. Although certain terms may even be emphasized below, any term intended to be interpreted in any limiting manner will be disclosed and explicitly defined in this Detailed Description section. Additionally, the present technology may include, but is not limited to, the examples provided. Figure 1A-9B Other embodiments described in detail.

[0032] Throughout this specification, the phrase "an embodiment" or "one embodiment" refers to a specific feature, structure, or characteristic described in connection with that embodiment, which is included in at least one embodiment of the present technology. Therefore, the phrases "in one embodiment" or "in one embodiment" appearing multiple times throughout this specification do not necessarily refer to the same embodiment. Furthermore, specific features or characteristics may be combined in any suitable manner in one or more embodiments.

[0033] Throughout this specification, terms such as “generally,” “approximately,” and “about” are used herein to indicate plus or minus 10% of the stated values.

[0034] The headings provided herein are for convenience only and do not explain the scope or meaning of the claimed technology.

[0035] Tissue fixation system and implementation method

[0036] Figure 1A This is a perspective view of a tissue fixation system 100 configured according to an embodiment of the present technology. Figure 1B yes Figure 1A A cross-sectional view of the tissue fixation system. (See also: [reference needed]) Figure 1A and 1B System 100 includes a needle guide 102 and a tissue manipulator 104. In some embodiments, system 100 is configured to suture a portion of a first tissue 150 with a needle 106 guided by the needle guide 102. In some embodiments, and as described in more detail elsewhere herein, the needle guide 102 is configured to couple and / or anchor to a second tissue 175. In some embodiments, and as described in more detail elsewhere herein, when coupled and / or anchored, the needle guide 102 remains in a stable state relative to the second tissue 175. System 100 allows coupling of the first tissue 150 to the second tissue 175 without penetrating the cavity of the first tissue 150.

[0037] The needle 106 moves along the travel path 135 along and / or within the cavity of the needle guide 102, traversing at least a portion of the cavity 214 in the needle guide 102. Figure 2 -described further below), and through the second opening 204 at the end of the needle guide 102 ( Figure 2 The needle 106, driven through the needle guide 102, penetrates the first tissue 150, exits the second opening 204, and penetrates the second tissue 175, thereby coupling at least a portion of the first tissue 150 and the second tissue 175. In some embodiments, the needle 106 is configured to guide the suture through the first tissue 150 and / or the second tissue 175. In some embodiments, the suture is released from the needle guide 102 through a groove 116 between the second opening 204 and one or more cavities 214.

[0038] In some embodiments, the needle 106 includes a coupling member, such as an anchor and / or a wire, for anchoring the first tissue 150 to the second tissue 175. In some embodiments, the needle guide 102 includes a handle 125.

[0039] In some embodiments, the tissue manipulator 104 is configured to be inserted into and within an organ cavity (e.g., the rectum of an object). In some embodiments, the tissue manipulator 104 is positioned relative to the needle guide 102 such that the first tissue 150 forms a barrier between the tissue manipulator 104 and the needle guide 102. In some embodiments, the tissue manipulator 104 is configured to pull a portion of the first tissue 150 toward the needle guide 102. For example, in some embodiments, and as described in more detail elsewhere herein, the tissue manipulator 104 includes one or more probes 508 configured to trap a portion of the first tissue 150 between the tissue manipulator 104 and the needle guide 102.

[0040] In some embodiments, one or more probes 508 (see below) Figures 5A-5C (Described in more detail) is configured to be close to the tissue and needle guide 102 while maintaining the thickness of the first tissue 150 between the probe tip 602 and the needle guide 102. In some embodiments, one or more probes 508 may be inserted into one or more cavities 214 in the needle guide 102.

[0041] In some embodiments, the proximity of one or more probes 508 to the cavity 214 and / or the inner wall 112 is automatic. For example, in some embodiments, the cavity 214 and / or the inner wall 112 and the one or more probes 508 include an attractive magnet configured to trap the thickness of the first tissue 150 along at least a portion of the travel path 135. In some embodiments, the needle guide 102 includes a suction mechanism configured to position the thickness of the first tissue 150 along at least a portion of the travel path 135.

[0042] In some embodiments, the cavity 214 and / or the needle guide 102 include a suction port, and the needle guide 102 is configured to apply suction through the suction port to facilitate the drawing of tissue (e.g., cavity wall) into the cavity 214. Reference Figure 1B This is a simplified illustration of a cross-sectional view of a system according to some embodiments of the present technology. In some embodiments, the tissue manipulator 104 is configured to introduce tissue (e.g., first tissue 150) into one or more cavities 214 of the needle guide 102, close to a portion of the tissue and the inner wall 112 of the needle guide 102, such that the tissue (e.g., at least a portion of the first tissue 150) is trapped between the inner wall 112 and the tissue manipulator 104 and is pushed against the inner wall 112.

[0043] For example, in some embodiments, the tissue manipulator 104 is inserted into the organ cavity 127 and the needle guide 102 is positioned near the outer surface 130 of the organ cavity 127, thereby operating the system 100.

[0044] In some embodiments, and as described in more detail elsewhere herein, the needle guide 102 includes a cavity 214 configured to receive at least a portion of the tissue manipulator 104 and / or a tissue layer or thickness and / or a tissue block.

[0045] In some embodiments, the tissue manipulator 104 is configured to be close to the tissue and needle guide 102 such that a tissue portion 156 of the first tissue 150 is pushed by the tissue manipulator 104 toward the needle guide 102 and into the cavity 214.

[0046] In some embodiments, the tissue portion 156 forms a barrier between the tissue manipulator 104 and the needle guide 102. In some embodiments, the geometry of the tissue contact surface 152 of the probe 602 conforms to the geometry of the inner wall 112 (e.g., a complementary geometry) such that when a portion of the first tissue 150 is trapped between the surface 152 and the inner wall 112 of the probe 602, only the thickness of the first tissue 150 is placed in the travel path 135 of the needle 106. In some embodiments, the travel path 135 is configured to pass through the same surface of the tissue portion 156 multiple times. In some embodiments, the travel path 135 is configured to pass through the outer surface 130 of the tissue portion 156 multiple times without penetrating or entering the organ lumen 127.

[0047] In some embodiments, the geometries of one or more of the tissue manipulator 104, cavity 214, and inner wall 112 are complementary. In some embodiments, the geometries of the tissue manipulator 104, cavity 214, and inner wall 112 are configured to hold the tissue layer in a fixed position relative to the travel path 135. For example, as described in more detail herein, in some embodiments, the inner wall 112 is generally, but not necessarily, parallel to the travel path 135.

[0048] A potential advantage of this configuration is that the needle 106 enters the first tissue 150 portion 156 at entry point 190-1 along the travel path 135, travels through the first tissue 150, and exits via exit point 190-2 without traversing the full thickness of the first tissue 150. In some embodiments, the first tissue 150 comprises the wall of a hollow organ, in which case the needle 106 traveling along the travel path 135 does not traverse the full thickness 192 of the wall of the hollow organ (first tissue 150) and does not disrupt the integrity of the cavity of the hollow organ. Maintaining the integrity of the cavity of the hollow organ, where the contents are not sterile (e.g., the rectum), helps maintain the sterility of the surgical site.

[0049] In some embodiments, at least one of the needle guide 102 and the tissue manipulator 104 includes one or more sensors for indicating the alignment of the tissue manipulator 104 with the needle guide 102. In some embodiments, the one or more sensors include one or more proximity sensors, optical sensors, pressure sensors, etc. In some embodiments, the positions of the one or more sensors are arranged along the needle guide 102 and / or the tissue manipulator 104. In some embodiments, the one or more sensors indicate to the user that at least a specific portion of the tissue manipulator 104 is accurately aligned with the cavity 214. In some embodiments, the tissue manipulator 104 and the needle guide 102 include an attraction magnet configured to align at least a specific portion of the tissue manipulator 104 with the cavity 214.

[0050] One or more needle guides

[0051] Figure 2 This is a perspective view of a needle guide 200 configured according to an embodiment of the present technology. In some embodiments, the needle guide 200 can be connected to the needle guide 102 of system 100. Figure 1A and 1B The needle guide 102 is identical or substantially identical to the needle guide 102, and therefore may be referred to as "needle guide 102", "needle guide 200", or "needle guide 102 / 200". In operation, the needle guide 102 is used to guide a needle inserted therethrough. For example, the needle guide 102 surrounds at least a portion of a needle inserted therethrough. In some embodiments, the needle guide 102 includes a needle guide body 202 having a tube or channel defining a path of travel for a needle 106 inserted into the needle guide 102.

[0052] In some embodiments, the needle guide 102 and / or the needle guide body 202 are configured to accommodate at least a portion of one or more tissues. For example, in some embodiments, at least a portion of the needle guide 102 includes recesses and / or protrusions or depressions. In some embodiments, the travel path 135 is coaxial with the needle guide 102.

[0053] In some embodiments, the diameter of the cross-section of the needle guide body 202 may vary. For example, in some embodiments, a portion of the needle guide body 202 is tapered.

[0054] In some embodiments, the needle guide body 202 includes a first end 212 configured to receive a needle and a second opposing end 210 including a second opening 204 configured to guide the needle 106 out of the needle guide 102. In some embodiments, the needle guide 102 / 200 includes a first end 212 and a second end 210, positioned such that, for example, the first end 212 includes a first opening 216 and the second end 210 includes a second opening 204.

[0055] In some embodiments and as disclosed elsewhere herein, the needle guide 102 includes one or more cavities 214 configured to receive a portion of tissue and / or a probe. In some embodiments, the one or more cavities 214 include one or more openings within the needle guide body 202. In some embodiments, the one or more cavities 214 are sized and / or configured to expose at least a portion of a travel path 135 within the needle guide 102.

[0056] In some embodiments, the travel path 135 exposed by one or more cavities 214 ensures that the location of tissue near the needle guide 200 can be positioned within one or more cavities 214 such that the travel path 135 traverses a portion of the tissue. In some embodiments, the cavity 214 is configured to receive the tissue of the object. In some embodiments, the location of the tissue of the object is positioned within the cavity 214 along the travel path 135. In some embodiments, and as described in more detail elsewhere herein, the tissue is trapped within the cavity 214 and between the needle guide 102 / 200 and the tissue manipulator.

[0057] In some embodiments, cavity 214 is configured to expose at least a portion of the inner wall 112 / 206 of needle guide 102. In some embodiments, needle guide body 202 includes inner wall 112 / 206 and cavity 228. In some embodiments, cavity 228 includes travel path 135. In some embodiments, needle guide 102 includes one or more cavities 214 configured to expose at least a portion of cavity 228 of needle guide body 202. In some embodiments, travel path 135 is oriented along longitudinal axis of cavity 228.

[0058] In some embodiments, one or more cavities 214 are defined by one or more transverse walls 224. In some embodiments, the one or more transverse walls 224 are configured to isolate exposed portions of cavities 228 (e.g., one or more cavities 214) from unexposed portions of cavities 228 located within the needle guide body 202. In some embodiments, the one or more transverse walls 224 are perpendicular to the travel path. In some embodiments, the one or more transverse walls 224 are permeable by a needle. In some embodiments, the one or more transverse walls 224 comprise a needle-permeable material such that a needle inserted along the needle guide 102 passes through the one or more transverse walls 224.

[0059] In some embodiments, one or more transverse walls 224 include one or more openings 222 configured to guide a travel path 135. In some embodiments, the one or more openings 222 are sized to accommodate a needle. In some embodiments, the one or more openings 222 are positioned along one or more transverse walls 224 to receive a needle traveling along the travel path 135.

[0060] In some embodiments, a first opening 216 at the first end 212 is configured to guide the needle into the cavity 228 of the needle guide 102. In some embodiments, a second opening 204 at the second end 210 is configured to guide the needle out of the needle guide 102. In some embodiments, the second opening 204 is configured to guide the needle out of its exit path 275 at a predetermined angle relative to the travel path 135.

[0061] In some embodiments, the needle guide 102 includes one or more slots 116 configured to release sutures guided by the needle 106 from a cavity 228 of the needle guide 102. In some embodiments, the slots 116 extend between one or more of the first opening 216 and the second opening 204 and one or more cavities 214. In some embodiments, the slots 116 extend through the thickness of the wall of the needle guide body 202. In some embodiments, the slots 116 extend substantially, but not necessarily, parallel to the travel path 135 along the needle guide, such that the sutures guided by the needle 106 can be released from the cavity 228 of the needle guide 102 through the slots 116 during and / or after the needle 106 is retracted. In some embodiments, the width of the slots 116 is sized to accommodate the sutures released from the needle 106.

[0062] In some embodiments, the needle guide 102 includes a magnetic portion 230. In some embodiments, the inner wall 112 / 206 includes a magnetic portion 230 configured to attract magnets on the tissue manipulator 104. In some embodiments, the magnetic portion 230 is disposed along and / or behind the inner wall 112 / 206. In some embodiments, the magnetic portion 230 is located around the travel path 135. For example, in some embodiments, the needle guide 102 includes a plurality of magnetic portions 230 disposed along the side of the travel path 135.

[0063] In some embodiments, the needle guide 102 / 200 is configured to be held by a user. For example, in some embodiments, the needle guide body 202 includes a rib-like portion 208 configured to increase traction between the needle guide and the user. In some embodiments, the rib-like portion 208 is positioned near a first end 212 of the needle guide 102.

[0064] In some embodiments, the needle guide body 202 may be anchored to the tissue of the object such that the tissue is positioned along the exit path 275. For example, in some embodiments, the needle guide 102 includes an insertion tip positioned near the second opening 204. In some embodiments, the needle guide 102 is configured to couple to the tissue of the object such that the second opening 204 is at least partially covered by tissue (e.g., the second tissue 175 as shown in FIG1).

[0065] In some exemplary embodiments of system 100, needle guide 102 is anchored to second tissue 175 such that first tissue 150, which is needle-stitched in one or more cavities 214, can be coupled to second tissue by threading at least a portion of the needle through second opening 204.

[0066] refer to Figure 3A and 3B This is a simplified illustration of a perspective view and a cross-sectional perspective view of a needle guide according to some embodiments of the present technology. In some embodiments, the needle guide 200 can be connected to the needle guide 102 of the system 100. Figure 1A and 1B The needle guide 102 / 300 is identical or substantially identical to the needle guide 102, and therefore may be referred to as "needle guide 102", "needle guide 300", or "needle guide 102 / 300". In some embodiments, the needle guide 102 / 300 is configured to engage with at least a portion of the tissue of an object, and / or with the tissue of an object being pulled above the tissue manipulator 104. In some embodiments, the needle guide 102 / 300 is configured to interlock and / or couple with a portion of the tissue covering the tissue manipulator 104. In some embodiments, the needle guide 300 is a self-coupling needle guide 300 that, once coupled to the tissue manipulator 104 covered by tissue, independently maintains its spatial orientation relative to the tissue manipulator 104.

[0067] For example, in some embodiments, the needle guide 102 / 300 is coupled to the tissue manipulator 104 such that the tissue covering the tissue manipulator 104 is stabilized within the cavity 314 of the needle guide 102 / 300.

[0068] In some embodiments, the needle guides 102 / 300 are configured such that in a predetermined position where the needle guides 102 / 300 are coupled to the tissue manipulator 104 covered by tissue, the travel path 310 of the needle 106 passes through the same surface of the tissue multiple times. In some embodiments, the self-coupling needle guide 300 is configured to remain coupled to a portion of the tissue covering the tissue manipulator 104, such that the travel path 310 is fixed relative to the tissue and / or the tissue manipulator 104.

[0069] The potential advantage of the needle guide 102 / 300 being self-coupled to a portion of the tissue covering the tissue manipulator 104 is that the needle guide 102 / 300 does not require the user to continuously hold and / or maintain the position of the travel path 310 at a specific location relative to the tissue and / or the tissue manipulator 104, thus freeing up the user's hands.

[0070] In some embodiments, such as Figure 2 Cavities 214 shown in 3A and 3B are structurally and / or functionally similar to cavity 314 as described elsewhere herein.

[0071] In some embodiments, the self-coupling needle guide 300 includes a clip 302 and a needle guide body 304. In some embodiments, the self-coupling needle guide 300 has no handle. In some embodiments, such as Figure 3B As shown, clip 302 is configured to hold a portion of the object’s tissue and / or tissue manipulator 104.

[0072] In some embodiments, the needle guide body 304 includes at least one of a first opening 306 and a second opening 308, configured to define a travel path 310 for insertion of a needle 106 into a self-coupled needle guide 300 through one or more of the first opening 306 and the second opening 308. In some embodiments, the needle guide body 304 includes a cavity 314 configured to assemble at least a portion of a tissue manipulator 104 therein. In some embodiments, the travel path 310 is defined to traverse at least a portion of the cavity 314. In some embodiments, the first opening 306 and the second opening 308 are on opposite sides of the cavity 314.

[0073] In some embodiments, the cavity 314 is defined by an inner wall 316 positioned opposite the opening 318 of the cavity 314. In some embodiments, the depth of the cavity 314 includes the distance between the defined travel path 310 and the inner wall 316. In some embodiments, the depth of the cavity 314 is configured to be associated with tissue thickness such that the travel path 310 traverses the same surface of the tissue multiple times.

[0074] In some embodiments, the clip 302 is coupled and / or detachably coupled to the needle guide body 304. In some embodiments, the clip 302 is coupled and / or detachably coupled to the needle guide 304 via a neck 312. In some embodiments, the neck 312 is configured to couple between the clip 302 and the needle guide body 304.

[0075] In some embodiments, the clamp 302 includes one or more arms 320 configured to hold tissue and / or tissue manipulator 104 therebetween. In some embodiments, the one or more arms 320 are rigid or semi-rigid. In some embodiments, the one or more arms 320 are resilient. In some embodiments, the one or more arms 320 are coupled to one or more of the needle guide body 304 and / or neck 312. In some embodiments, the one or more arms 320 are configured to guide tissue 350 of the tissue manipulator 104 and / or the object toward the needle guide body 304.

[0076] In some embodiments, the self-coupling needle guide 300 includes a band 322 configured to define a depth of a travel path 310 relative to the thickness of the tissue 350. In some embodiments, the band 322 is configured to define a travel path 310 relative to the tissue manipulator 104.

[0077] In some embodiments, the band 322 is integral with the needle guide 300 / 102. For example, in some embodiments, the band 322 is positioned adjacent to one or more openings 306 / 308. In some embodiments, the band 322 is configured to at least partially surround a portion of the tissue 350. In some embodiments, the band 322 is elastic or semi-rigid. In some embodiments, the band 322 is configured adjacent to a portion of the tissue manipulator 104 and / or the tissue in the insertion cavity 314. Reference Figure 4A 4B, 4C, 4D, 4E, and 4F are simplified illustrations of perspective and cross-sectional views of the height variation of the travel path corresponding to tissue thickness according to some embodiments of the present technology. Figure 4A 4B, 4C, 4D, 4E, and 4F depict the exemplary band 322 / 422 relative to the height of the tissue manipulator 104 and / or the thickness of the tissue 450-1 / 450-2 / 450-3 traversed by the travel path 310.

[0078] In some embodiments, the size and / or diameter of the band 322 / 422 is fixed and / or rigid. In some embodiments, the size and / or shape of the band 322 / 422 is configured according to the thickness of the tissue. For example, different tissues with different thickness ranges require a specific size of band 322 / 422.

[0079] In some embodiments, the position of the band 322 / 422 relative to the tissue manipulator 104 is associated with the thickness of the tissue located between the band 322 / 422 and the tissue manipulator 104. Figures 4A-4F In the process, tissues 450-1 / 450-2 / 450-3 each have different thicknesses, therefore the positions of strips 322 / 422 need to be set at different distances from the tissue manipulator 104.

[0080] For example, Figure 4A and 4B An exemplary embodiment is depicted, wherein the travel path 310 traverses tissue 450-1 such that the travel path 310 traverses the same surface of tissue 450-1 multiple times. For example, Figure 4C and 4D An exemplary embodiment is depicted in which the travel path 310 traverses more than one surface of the tissue 450-2. For example, Figure 4E and 4FAn exemplary embodiment is depicted in which the travel path 310 does not cross the surface of the tissue 450-3.

[0081] In some embodiments, the size of the band 322 / 422 is determined according to the thickness of the tissue, such that the position of the band 322 / 422 is set at a fixed position relative to the tissue manipulator 104, such that the travel path 310 passes through the same surface of the tissue multiple times.

[0082] In some embodiments, the size of the band 322 / 422 is determined according to the thickness of the tissue, such that the position of the band 322 / 422 is set at a fixed position relative to the tissue manipulator 104, so that the travel path 310 does not pass through the tissue manipulator.

[0083] One or more organizational manipulators

[0084] refer to Figure 5A Figures 5B and 5C are simplified perspective views of tissue manipulators according to some embodiments of the present technology. In some embodiments, the tissue manipulator 104 includes one or more probes 508 configured to manipulate a portion of tissue. In some embodiments, the probes 508 are configured to manipulate a portion of tissue, such as the wall of a hollow organ, from within an organ lumen (e.g., the rectum). In some embodiments, the one or more probes 508 are configured to adjust the position of tissue extending over or overlying the one or more probes 508 and / or the tissue manipulator 104.

[0085] In some embodiments, the tissue manipulator 104 includes a handle 504 configured to assist a user in manipulating the spatial orientation of the probe 508 relative to the needle guide 102. In some embodiments, the tissue manipulator 104 includes a housing or shaft 502 extending from the handle 504. In some embodiments, and as described in more detail elsewhere herein, the handle 504 includes a control lever 514 configured to control movement of the probe 508 relative to the handle 504 and / or the housing 502.

[0086] In some embodiments, the spatial orientation of one or more probes 508 relative to the handle 504 and / or the housing 502 is adjustable. In some embodiments, the spatial orientation of one or more probes 508 relative to the housing is fixed.

[0087] In some embodiments, the shell 502 includes a tube, channel, etc. In some embodiments, the shell 502 is cylindrical. In some embodiments, the shell 502 includes markings, such as a scale 530, positioned relative to the handle 504. In some embodiments, the markings are configured as depth gauges, enabling the surgeon to determine the insertion depth of the shell 502, for example, in an organ cavity.

[0088] In some embodiments, the housing 502 is configured to receive at least a portion of one or more probes 508. In some embodiments, with the probes 508 in at least a partially extended state, the one or more probes 508 extend radially outward through the housing 502. In some embodiments, with the one or more probes 508 in a fully retracted state, the probe 602 is flush with the surface of the housing 502.

[0089] In some embodiments, the housing 502 includes an eyelet 510 through which a probe can move relative to the housing 502 and / or the surface of the housing 502. In some embodiments, the eyelet 510 includes a groove or recess and extends through the thickness of the housing 502. In some embodiments, the eyelet 510 is circular. In some embodiments, the eyelet 510 is elongated and extends circumferentially and radially along the housing 502. In some embodiments, the eyelet 510 extends along the longitudinal axis 550 of the housing 502. In some embodiments, the eyelet 510 extends perpendicular to the longitudinal axis 550 of the housing 502.

[0090] In some embodiments, the aperture 510 is sized and positioned along the housing 502 to restrict the movement of one or more probes 508. In some embodiments, the aperture 510 is sized and positioned along the housing 502 such that the probe 508 is movable relative to the housing 502. In some embodiments, the aperture 510 is positioned along the distal end 532 of the tissue manipulator 104, or in other words, near the end of the tissue manipulator 104 opposite the handle 504. In some embodiments, the aperture 301 is positioned near the end 506 of the housing.

[0091] In some embodiments, the shell 502 includes a shell tip 506 at the distal end 532 of the tissue manipulator 104. In some embodiments, the shell tip 506 includes a circular portion for securely inserting the tissue manipulator 104 into a body cavity (e.g., rectum or vagina). In some embodiments, the shell tip 506 is flexible. In some embodiments, the shell tip 506 is flexible. In some embodiments, the shell tip 506 includes one or more proximity sensors, optical sensors, and pressure sensors for determining the position of the shell tip 506 within a tissue cavity of a subject.

[0092] In some embodiments, the handle 504 includes one or more control levers 514 configured to control one or more of the following: position, location, orientation, and extension length (L) of one or more probes 508 relative to the housing 502 and / or the handle 504. In some embodiments, each probe 508 is individually controlled by a corresponding one or more control levers 514.

[0093] In some embodiments, probe 508 can be adjusted to multiple positions relative to housing 502. For example, in the closed position of probe 508, such as... Figure 5B As shown, the probe 602 is flush with and / or housed inside the housing 502, with the aperture 510. For example, in the extended position, as... Figure 5C As shown, probe 508 extends from eyelet 510 by an extension length (L) as indicated by arrow 575. In some embodiments, the extension length (L) of one or more probes is controlled by one or more controls 514.

[0094] In some embodiments, one or more levers 514 include one or more buttons or slots. In some embodiments, the lever 514 is movable within one or more tracks 516 disposed along the handle 504. In some embodiments, the lever 514 is configured to be operated by a user within one or more tracks 516. In some embodiments, the lever 514 is slidable within one or more tracks 516. In some embodiments, the track 516 includes a slot along the handle 504, wherein one or more lever regions are slidable within the track 516.

[0095] In some embodiments, one or more dimensions of the track 516 correspond to one or more dimensions of the eyelet 510. For example, in some embodiments, the length of the eyelet 510 along the radius of the housing 502 is equal to the length of the track along the radius of the handle 504.

[0096] For example, in Figure 5B and 5C In the illustrated tissue manipulator 104, the position of the control lever 514 relative to the handle 504 determines the extension length of each probe 602 relative to the housing 502 and / or the orifice 510. In some embodiments, the distance by which the control lever 514 slides and / or rotates relative to the housing 502 corresponds to the extension length (L) of one or more probes 508 and / or the angle of the probe 602 relative to the orifice 510. In some embodiments, the extension length (L) of each probe 508 is individually controlled by one or more control levers 514.

[0097] In some embodiments, the angle of probe 602 relative to orifice 510 is individually controlled by one or more control levers 514. In some embodiments, one or more control levers 514 are coupled to one or more probes 508. In some embodiments, one or more control levers 514 are electronically coupled to one or more probes 508. In some embodiments, one or more probes 508 extend within housing 502 from orifice 510 toward handle 504 and are coupled to control levers 514 such that by positioning control levers 514 along track 516, control levers 514 can manipulate one or more of the following: length of probe 508, hinge angle, spatial orientation, and spatial orientation of probe 602.

[0098] In some embodiments, the housing 502 includes one or more magnets surrounding one or more apertures 510. In some embodiments, the magnets are configured to attract a portion of the needle guide 102. For example, in some embodiments, the needle guide 102 includes a magnet. For example, in some embodiments, the needle guide 102 includes a magnetic portion configured to attract one or more magnets of the housing 502, such that tissue located between the probe 508 and the needle guide 102 is tautly positioned along the travel path 135.

[0099] probe

[0100] refer to Figure 6A and 6B This is a simplified illustration of a perspective view and cross-sectional view of a probe according to some embodiments of the present technology. In some embodiments, one or more probes 508 include a rod-like member 504 and a probe 602. In some embodiments, the rod-like member 504 is within a housing 502 and extends from one or more apertures 510. In some embodiments, the probe 602 is positioned at the distal end 622 of the probe 508.

[0101] In some embodiments, the width of probe 602 is greater than the width of rod 504. In some embodiments, probe 602 is configured to be close to tissue and needle guide 102 and / or one or more cavities 214 of needle guide 102. In some embodiments, probe 602 is configured to be inserted into one or more cavities 214. In some embodiments, probe 602 is configured to support an extended tissue layer.

[0102] In some embodiments, the rod-like member 504 includes a rod-shaped component. In some embodiments, the spatial orientation of the rod-like member 504 is adjustable. In some embodiments, the spatial orientation of the rod-like member 504 can be adjusted via a control lever 514. In some embodiments, the spatial orientation of the probe 602 can be adjusted via adjustment of the rod-like member 504.

[0103] In some embodiments, the rod 504 is rotatable about its longitudinal axis. In some embodiments, the rod 504 is extendable. In some embodiments, the adjustment, rotation, and / or extension of the rod 504 may be controlled by one or more controls 514.

[0104] In some embodiments, the rod-like member 504 includes one or more hinges 606. In some embodiments, the hinges 606 are adjustable. In some embodiments, one or more angles of the hinges 606 can be adjusted via a control lever 514. In some embodiments, the hinges 606 include a range of free movement. In some embodiments, the hinges 606 include two to four degrees of freedom.

[0105] In some embodiments, the rod-shaped member 504 includes a plurality of hinges 606, such that the probe 602 includes up to six degrees of freedom. In some embodiments, the angles of the hinges 606 correspond to the length of the distance between the probe 602 and the housing 502.

[0106] In some embodiments, the hinge 606 is positioned flush with the surface of the housing 502 along the rod 504. In some embodiments, the hinge 606 extends beyond the housing 502 along the rod 504. In some embodiments, the position of the hinge 606 relative to the housing 502 is adjustable.

[0107] In some embodiments, the hinge 606 is disposed along the rod 504 between a first portion 610 and a second portion 612 of the rod 504. In some embodiments, the angle of the hinge 606, or in other words, the angle between the first portion 610 and the second portion 612, is adjustable. In some embodiments, once adjusted, the angle of the hinge 606 is fixed such that the position of the first portion 610 relative to the second portion 612 is fixed.

[0108] In some embodiments, one or more probes 602 include a tissue manipulation surface 650 having a geometry complementary to the inner walls 112 / 206 of the needle guide 102. For example, in some embodiments, the tissue manipulation surface 650 is generally flat, concave, and / or convex, one or more of these. In some embodiments, the edges of the tissue manipulation surface 650 are rounded to avoid tissue tearing that is pushed against the inner walls 112 / 206 and trapped between the probe 508 tissue manipulation surface 650 and the inner walls 112 / 206 of the needle guide 102.

[0109] The potential advantage of having at least a portion of the tissue manipulation surface 650 of probe 508 flat is that when a portion of tissue (e.g., first tissue 150) is pushed against the inner wall 112 / 206, the flat surface is configured to stretch the tissue and “ironout” wrinkles, and prevent the needle traveling along the path of travel 135 from traversing the full thickness of the tissue, as explained in more detail elsewhere herein, and in some configurations, to disrupt the integrity of the cavity of the hollow organ.

[0110] In some embodiments, the probe 602 includes a geometry complementary to the inner walls 112 / 206 of the needle guide body 202 and / or the needle guide 102. In some embodiments, a portion of the head 602 is rigid, semi-rigid, or flexible. In some embodiments, the probe 602 includes a geometry insertable and / or fixable within the cavity 214 of the needle guide 102.

[0111] In some embodiments, probe 508 and / or probe 602 include one or more light-emitting elements 614. For example, in some embodiments, such as Figure 6A and 6B As shown, probe 602 includes one or more LED circuits 618. In some embodiments, probe 602 includes an LED diffuser 616 for diffusing light emitted by LED emitting element 614.

[0112] The potential advantage of a probe 602 including one or more light-emitting elements 614 is that the orientation of the tissue manipulator 104, the shell 502, and / or one or more probes 508 can be visually monitored from outside the tissue cavity.

[0113] The potential advantage of visually monitoring the orientation of the tissue manipulator 104, shell 502, and / or one or more probes 508 from outside the tissue cavity is that when the tissue manipulator 104 is located within the tissue cavity, the tissue manipulator 104 and / or at least a portion thereof can be adjusted to a specific and / or desired position relative to the tissue cavity and / or other tissue of the object.

[0114] In some embodiments, one or more probes 508 include a magnet 620. In some embodiments, the magnet 620 is positioned along the probe 602. In some embodiments, the magnet is configured to attract a portion of the needle guide 102. For example, in some embodiments, the needle guide 102 includes a magnet. For example, in some embodiments, the inner wall 112 / 206 of the needle guide 102 includes a magnetic portion 230 configured to attract the magnet 620 of the probe 508. In some embodiments, the magnetic portion 230 of the needle guide 102 is positioned relative to a travel path 135 such that the tissue located between the magnet 620 and the magnetic portion 230 is positioned along the travel path 135.

[0115] The potential advantage of a probe 508 that includes a magnet 620 that attracts a portion of the needle guide 102 is that the attractive force between the probe 508 and the magnet of the needle guide 102 sets the position of the probe 508 at a predetermined position relative to the travel path 135.

[0116] The potential advantage of the probe 508, which includes a magnet 620 that attracts a portion of the needle guide 102, is that the attraction between the probe 508 and the magnet of the needle guide 102 automatically sets the position of the probe 508, so that the position of the tissue trapped between the magnets is set along the travel path 135.

[0117] The potential advantage of a probe 508 that includes a magnet 620 that attracts a portion of the needle guide 102 is that the attraction between the probe 508 and the magnet of the needle guide 102 pushes a portion of tissue (e.g., first tissue 150) against the inner wall 112 / 206, thereby trapping and flattening the portion of tissue without the assistance of a system operator.

[0118] In some embodiments, the magnet is positioned along the probe 508 and / or the needle guide 102 such that the travel path 135 is not interrupted by the magnet. For example, in some embodiments, the magnet is positioned along either side of the travel path 135.

[0119] method

[0120] This technology also includes methods for performing medical procedures using the tissue fixation systems and devices described herein. For example, Figure 7 This is a flowchart of a method for suturing tissue according to some embodiments of the present technology. In some embodiments, in step 702, the method includes positioning a first tissue at a location along the travel path of the needle in a needle guide, such that the travel path passes through the same surface of the first tissue multiple times. This may include, for example, (a) positioning the needle guide adjacent to the outer surface of the first tissue, and (b) positioning the tissue manipulator adjacent to the inner surface of the first tissue. Once the positions of the needle guide and the manipulator are set, a probe can be deployed from the tissue manipulator to position at least a portion of the first tissue within a cavity of the needle guide, which coincides with the travel path of the needle, as described above herein.

[0121] In some embodiments, at step 704, the method includes maintaining the position of the first tissue while inserting a needle along the path of travel through the needle guide, wherein the needle is coupled to a suture. Optionally, at step 706, the method includes inserting the needle into a second tissue such that the suture couples the first tissue to the second tissue. Optionally, at step 708, the method includes withdrawing the needle from the second tissue and / or from the suture such that the suture is removed from the needle.

[0122] In some embodiments, the method includes positioning a needle guide at a first side of the first tissue. In some embodiments, the method includes positioning a tissue manipulator at a second side of the same first tissue. In some embodiments, the method includes positioning the tissue manipulator close to the needle guide and positioning at least a portion of the first tissue in the path of a needle traveling through the needle guide, and inserting the needle into the needle guide such that the needle traverses the first tissue multiple times without penetrating the second side of the first tissue. The method includes inserting the needle into the needle guide, traversing the first tissue, exiting the needle guide, and inserting the needle into a second tissue.

[0123] In some embodiments, the suture is coupled to an anchor driven or carried by a needle 106, such that the suture is carried by the needle through one or more tissues, and once the anchor is embedded in the tissue, the needle 106 retracts from the one or more tissues, and the suture is separated from the needle guide 102. In some embodiments, the needle guide 102 includes a groove 116 at least between a cavity 214 and an opening 204 at the end of the needle guide 102. In some embodiments, the method includes allowing the suture to slide through the groove 116 of the needle guide 102. In some embodiments, the groove 116 allows the suture to disconnect from the needle guide 102 after the needle has penetrated through one or more tissues.

[0124] refer to Figure 8A 8B and 8C are simplified perspective illustrations of systems according to some embodiments of the present technology. In some embodiments, Figure 8A 8B and 8C depict some embodiments of the present technology with Figure 7 The steps of the described method correspond to the implementation of system 100.

[0125] refer to Figure 9A and 9B This is a simplified illustration of a three-dimensional view of a tissue fixation system according to some embodiments of the present technology. In some embodiments, Figure 9A and 9B Some embodiments of the present technology are depicted. Figure 7 The steps of the described method correspond to the implementation of system 100.

[0126] In some embodiments, the method includes positioning the needle guide 102 / 300 along a first side 830 of the first tissue 850 / 150 such that one or more cavities 214 face the first tissue 850 / 150.

[0127] In some embodiments, the method includes coupling the needle guide 102 to a second tissue 875 / 175. In some embodiments, for example, the second tissue 875 / 175 is a ligament, such as the supraspinous ligament. In some embodiments, the method includes anchoring a second opening 204 of the needle guide 102 / 300 to the second tissue 875 / 175.

[0128] In some embodiments, the method includes positioning the tissue manipulator 104 along a second side 835 of the first tissue 850 / 150 and adjusting one or more probes 508 via one or more levers 514.

[0129] In some embodiments, the method includes positioning needle guides 300 / 102 on a tissue manipulator 104 such that at least a portion of tissue 850 is located between the needle guides 300 / 102. In some embodiments, the method includes positioning needle guides 300 / 102 on a tissue-covered tissue manipulator 104 such that the needle guides independently maintain their position on the tissue covering the tissue manipulator 104. In some embodiments, the method includes positioning needle guides 300 / 102 on a tissue-covered tissue manipulator 104 such that the spatial orientation of the needle guides 300 / 102 is independently fixed relative to the tissue manipulator 104.

[0130] In some embodiments, the method includes one or more probes 508 extending the tissue manipulator 104. In some embodiments, the method includes rotating the one or more probes relative to the handle 504. In some embodiments, the method includes adjusting the angle of the hinge 606 of the head 602 of the one or more probes 508 such that the head 602 is aligned with the cavity 214 of the needle guide 102 / 300.

[0131] In some embodiments, the method includes extending a head 602 from the housing 502 and / or from the eyelet 510. In some embodiments, the method includes extending the head 602 such that the head 602 is aligned with the cavity 214 of the needle guide 102 / 300.

[0132] In some embodiments, the method includes activating the light-emitting element 614. In some embodiments, the method includes visually determining the position of the light-emitting element 614 located on the second side 835 of the first tissue 850 / 150 by observing light reaching the second side 835 of the first tissue 850 / 150. In some embodiments, the light emitted by the light-emitting element 614 is visible at least through the first tissue 850 / 150.

[0133] In some embodiments, the method includes using a light-emitting element 614 to align the probe head 602 with the needle guide 102 / 300 and / or cavity 214 to determine the position of the head 602. In some embodiments, the method includes positioning the needle guide 102 / 300 such that the cavity 214 is aligned with the head 602 of one or more probes 508.

[0134] In some embodiments, the method includes bringing the magnet 620 close to the magnetic portion 230 such that the probe 508 is automatically aligned with the cavity 214. In some embodiments, the method includes bringing the magnet 620 close to the magnetic portion 230 such that the probe 508 automatically extends into the cavity 214. In some embodiments, the method includes bringing the magnet 620 close to the magnetic portion 230 such that the probe 508 automatically extends toward the cavity 214.

[0135] In some embodiments, the method includes inserting a needle 106 along a travel path 135 and passing the needle 106 through a first tissue 850 / 150.

[0136] In some embodiments, the method includes passing the needle 106 through the first tissue 850 / 150 without entering the cavity of the tissue 850 / 150. In some embodiments, the method includes passing the needle 106 through the first tissue 850 / 150 by repeatedly inserting it into the surface of the first tissue 850 / 150 near the needle guide 102. In some embodiments, the method includes passing the needle 106 through the first tissue 850 / 150 without passing through the surface of the tissue 850 / 150 near the tissue manipulator 104.

[0137] Example

[0138] Several aspects of this technology are illustrated in the following examples:

[0139] 1. A tissue fixation system, comprising:

[0140] A needle guide having an elongated structure extending between a first end portion and a second end portion, the elongated structure having -

[0141] A cavity, located between the first end portion and the second end portion, wherein the cavity is configured to receive a portion of tissue, and

[0142] A cavity, configured to receive a needle, wherein the cavity includes a first cavity portion extending between a first end portion and the cavity, and a second cavity portion extending between a second end portion and the cavity; and

[0143] A tissue manipulator having one or more deployable probes configured to guide a portion of the tissue into the cavity.

[0144] The system is configured such that when the one or more deployable probes guide a portion of the tissue into the cavity and the needle advances through the cavity, the needle traverses the cavity and penetrates a portion of the tissue as it moves from the first cavity portion to the second cavity portion.

[0145] 2. The system according to Example 1, wherein a portion of the tissue has an outer surface and an inner surface, wherein the system is configured to penetrate the outer surface at at least two locations without penetrating the inner surface.

[0146] 3. The system according to Example 1 or 2, wherein the cavity has an inner surface, a first side surface, and a second side surface, and wherein -

[0147] The first side surface has a first opening in fluid communication with the first cavity portion, and

[0148] The second side surface has a second opening in fluid communication with a portion of the second cavity.

[0149] The first opening and the second opening are configured to receive the needle as it advances through the cavity from the first cavity portion to the second cavity portion.

[0150] 4. The system according to Example 3, wherein the system is configured such that the needle penetrates a portion of the tissue between the probe and the inner surface of the cavity as it advances from the first opening to the second opening.

[0151] 5. The system according to any one of Examples 1-4, wherein the geometry of the probe is complementary to the geometry of the cavity.

[0152] 6. The system according to any one of Examples 1-4, wherein the probe can switch between a low-profile delivery configuration and a deployment configuration.

[0153] 7. A system comprising:

[0154] A needle guide that defines the path of travel for a needle inserted through the guide; and

[0155] A tissue manipulator is configured to be close to the tissue and the needle guide, and to position at least a portion of the tissue within the path of travel of the needle; and

[0156] The tissue manipulator and the needle guide are aligned such that the travel path passes through the same surface of the tissue multiple times.

[0157] 8. The system according to Example 7, wherein the needle guide includes a cavity configured to receive at least a portion of the tissue manipulator.

[0158] 9. The system according to Example 8, wherein the travel path is exposed by the cavity.

[0159] 10. The system according to any one of Examples 7-9, wherein the tissue manipulator includes at least one probe.

[0160] 11. The system according to Example 10, wherein the probe includes a light-emitting element.

[0161] 12. The system according to any one of Examples 7-11, wherein the tissue manipulator includes a shell and at least one probe extending radially outward from the shell.

[0162] 13. The system according to any one of Examples 7-12, wherein the tissue manipulator includes a handle, and wherein one of the extension length, position, and spatial orientation of the probe is adjustable relative to the handle.

[0163] 14. The system according to any one of Examples 7-13, wherein the geometry of at least a portion of the guide and the geometry of at least a portion of the tissue manipulator are complementary.

[0164] 15. The system according to any one of Examples 7-14, wherein at least a portion of the tissue manipulator is flexible.

[0165] 16. The system according to any one of Examples 7-15, wherein the tissue manipulator includes at least one light-emitting diode.

[0166] 17. The system according to any one of Examples 7-16, wherein the tissue manipulator includes a first magnet and the needle guide includes a second magnet.

[0167] 18. The system according to any one of Examples 7-17, wherein the needle guide includes a second opening configured to guide the needle away from an exit path of the needle guide.

[0168] 19. The system according to Example 18, wherein the second opening of the needle guide is configured to couple to the tissue of the object.

[0169] 20. The system according to Example 18 or 19, wherein the needle guide includes a groove located between the cavity and the second opening and spanning the full thickness of the guide wall.

[0170] 21. The system according to any one of Examples 7-20, wherein the needle guide is a self-coupling needle guide.

[0171] 22. The system according to any one of Examples 7-21, wherein the needle guide includes a clip such that the spatial orientation of the needle guide is held fixed independently relative to the tissue manipulator, such that the travel path passes through the same surface of the tissue multiple times.

[0172] 23. A method for performing rectal fixation, comprising:

[0173] Perform a rectal examination and determine the location of excessive / abnormal rectal activity;

[0174] Identify the location of the identified excessive / abnormal rectal movement in the rectum and / or pararectal tissues, and its proximity to the sacrospinous ligament;

[0175] An anchor and suture are introduced intra-abdominally and extrarectally, passing through at least a portion of the external rectal wall; the anchor and suture are then guided into the sacrospinous ligament; and

[0176] The anchor and suture are at least partially anchored in the sacrospinous ligament.

[0177] 24. A method of suturing tissue, comprising:

[0178] The needle guide is positioned on the first side of the first tissue.

[0179] The position of the tissue manipulator is set on the second side of the same first tissue;

[0180] Bring the tissue manipulator close to the needle guide;

[0181] Positioning at least a portion of the first tissue within the travel path of the needle passing through the needle guide; and

[0182] The needle is inserted into the needle guide so that the needle passes through the first tissue multiple times without penetrating the second side of the first tissue.

[0183] 25. The method according to Example 24, comprising trapping the tissue between the needle guide and the tissue manipulator.

[0184] 26. The method according to Example 24 or 25 includes inserting the needle into the tissue such that the surface of the tissue near the tissue manipulator remains intact.

[0185] 27. The method according to any one of Examples 24-26, wherein the tissue manipulator and the needle guide are magnetically attracted.

[0186] 28. A method for coupling a first tissue to a second tissue, comprising:

[0187] The first tissue is positioned along the travel path of the needle in the needle guide, such that the travel path passes through the same surface of the first tissue multiple times;

[0188] While keeping the first tissue in a fixed position, a needle is inserted along the path of travel, wherein the needle is coupled to a suture; and

[0189] The needle is inserted into the second tissue, such that the suture couples the first tissue to the second tissue.

[0190] 29. The method according to Example 28, comprising retracting the needle from the second tissue and / or the suture, such that the suture is removed from the needle.

[0191] 30. The method according to Example 28 or 29, comprising positioning the first tissue using a tissue manipulator configured to be close to the first tissue and the needle guide, and positioning at least a portion of the tissue in the travel path of the needle.

[0192] 31. An apparatus comprising:

[0193] A shell, the shape of which is designed to define a blunt distal end and is configured to advance distally into the cavity of the object through an opening in the object;

[0194] A needle guide, configured to advance distally toward target tissue of the object, and shaped to define a cavity facing the side, the device being configured to facilitate pulling at least a portion of the cavity wall through the cavity and into the needle guide when the cavity faces the shell;

[0195] A suture spreading element, shaped to define the insertion end and configured to advance distally within the needle guide to:

[0196] A portion of the cavity wall is inserted when the portion is in the guide member;

[0197] At least partially penetrating the target tissue; and

[0198] The suture is passed through the insertion end to penetrate the suture within the target tissue to fix a portion of the cavity wall to the target tissue.

[0199] 32. The apparatus according to Example 31, wherein the cavity of the object comprises the rectum of the object, the orifice comprises the anus, and the target tissue comprises the sacrospinous ligament, and wherein:

[0200] The shell is configured to advance distally into the rectum through the anus;

[0201] The needle guide is configured to advance distally toward the sacrospinous ligament; and

[0202] The suture spreading element is configured as follows:

[0203] The portion of the tissue that pierces the rectal wall is located within the guiding member;

[0204] At least partially pierced the sacrospinous ligament; and

[0205] The suture is passed through the insertion end to unfold at least a portion of the suture within the sacrospinous ligament to fix the rectal wall to the sacrospinous ligament.

[0206] 33. The apparatus according to Example 30 or 31, wherein the shape of the longitudinal shell is further designed to define one or more probes protruding from the outer surface of the shell, such that a portion of the cavity wall is protruded by the protrusions, and wherein the protrusions are portions that are pulled into the cavity.

[0207] 34. The apparatus according to Example 33, wherein (a) the probe and the cavity each include a corresponding magnetic element configured to pull the portion of the cavity wall into the cavity.

[0208] 35. The device according to Example 33 or 34, wherein the housing includes a user-controllable slider or knob coupled to the probe, such that distal advance of the slider or rotation of the knob produces a protrusion that allows the probe to pass through the outer surface of the housing.

[0209] 36. The apparatus according to any one of Examples 31-35, wherein the cavity includes a suction port, and wherein the apparatus is configured to apply suction through the suction port to facilitate pulling the cavity wall into the cavity.

[0210] 37. The apparatus according to Example 36 further includes a suction source.

[0211] 38. The apparatus according to any one of Examples 31-35 further includes a reporting sensor configured to generate a reporting signal when the portion of the cavity wall is drawn into the needle guide cavity.

[0212] 39. The apparatus according to Example 38, wherein the reporting sensor includes a lighting source.

[0213] 40. The apparatus according to any one of Examples 31-35 further includes the suture.

[0214] 41. The apparatus according to any one of Examples 31-35, wherein the insertion tip is configured to insert into the wall of the cavity without penetrating the cavity.

[0215] 42. The device according to any one of Examples 31-35, wherein the device is configured to retract proximally after the portion of the suture has unfolded.

[0216] 43. The device according to any one of Examples 31-35, wherein the housing includes a user-controllable slider at a proximal portion of the housing, configured to control the housing to advance distally through the cavity.

[0217] 44. The apparatus according to any one of Examples 31-35, wherein the shape of the needle guide is designed to define a needle guide wall, at least a portion of which is transparent.

[0218] 45. The device according to any one of Examples 31-35, wherein at least a portion of the blunt distal end of the housing is domed.

[0219] in conclusion

[0220] The detailed description of the embodiments of this technology above is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments and examples of the technology have been described above for illustrative purposes, as those skilled in the art will recognize, various equivalent modifications can be made within the scope of this technology. For example, any feature of the intraocular shunt described herein may be combined with any feature of other intraocular shunts described herein, and vice versa. Furthermore, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0221] As will be understood from the foregoing, specific embodiments of the present technology have been described herein for illustrative purposes; however, to avoid unnecessarily obscuring the description of the embodiments of the present technology, well-known structures and functions associated with intraocular shunts have not been shown or described in detail. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0222] Unless the context explicitly requires otherwise, throughout this specification and examples, the terms “comprise,” “comprising,” etc., should be interpreted in an inclusive sense, rather than an exclusive or exhaustive sense; that is, in the sense of “including but not limited to.” As used herein, the terms “connected,” “coupled,” or any variation thereof refer to any direct or indirect connection or coupling between two or more elements; the coupling or connection between elements may be physical, logical, or a combination thereof. Additionally, the terms “this article,” “above,” “below,” and similar terms, when used in this application, should refer to the entire application and not any particular part of it. Where the context permits, the singular or plural terms used in the above detailed description may also include the plural or singular, respectively. As used herein, the phrase “and / or” in “A and / or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” throughout means including at least one or more of the stated features, such that no additional number of the same features and / or other types of features are excluded. It will also be understood that specific embodiments are described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit these advantages, and not all embodiments need to exhibit these advantages to fall within the scope of the present technology. Therefore, this disclosure and related technologies may include other embodiments not expressly shown or described herein.

Claims

1. A tissue fixation system, comprising: A needle guide having an elongated structure extending between a first end portion and a second end portion, the elongated structure having— A cavity, located between the first end portion and the second end portion, wherein the cavity is configured to receive a portion of tissue, and A cavity, configured to receive a needle, wherein the cavity includes a first cavity portion extending between a first end portion and the cavity, and a second cavity portion extending between a second end portion and the cavity; and A tissue manipulator having a body and one or more deployable probes configured to move relative to the body between a retracted first position and an deployed second position, wherein the one or more deployable probes are configured to guide a portion of the tissue into the cavity in the deployed second position. The system is configured such that when the one or more deployable probes guide a portion of the tissue into the cavity and the needle advances through the cavity, the needle traverses the cavity and penetrates a portion of the tissue as it moves from the first cavity portion to the second cavity portion.

2. The system according to claim 1, wherein, A portion of the tissue has an outer surface and an inner surface, wherein the system is configured to penetrate the outer surface at at least two locations without penetrating the inner surface.

3. The system according to claim 1, wherein, The cavity has an inner surface, a first side surface, and a second side surface, and wherein— The first side surface has a first opening in fluid communication with the first cavity portion, and The second side surface has a second opening in fluid communication with a portion of the second cavity. The first opening and the second opening are configured to receive the needle as it advances through the cavity from the first cavity portion to the second cavity portion.

4. The system according to claim 3, wherein, The system is configured such that the needle penetrates a portion of the tissue between one of the one or more deployable probes and the inner surface of the cavity as it advances from the first opening to the second opening.

5. The system according to claim 1, wherein, The geometry of the one or more deployable probes is complementary to the geometry of the cavity.

6. The system according to claim 1, wherein, The one or more deployable probes can switch between a low-profile delivery configuration and a deployment configuration.

7. A system comprising: A needle guide that defines the travel path of a needle inserted through the guide; and A tissue manipulator having one or more deployable probes, wherein the one or more deployable probes are configured to be close to tissue and the needle guide and to position at least a portion of the tissue within the needle's path of travel; and The tissue manipulator and the needle guide are aligned such that the travel path passes through the same surface of the tissue multiple times.

8. The system according to claim 7, wherein, The needle guide includes a cavity configured to receive at least a portion of the tissue manipulator.

9. The system according to claim 8, wherein, The travel path is exposed by the cavity.

10. The system according to claim 7, wherein, The one or more deployable probes include light-emitting elements.

11. The system according to claim 7, wherein, The one or more deployable probes extend radially outward from the tissue manipulator.

12. The system according to claim 7, wherein, The tissue manipulator includes a handle, and wherein one of the extension length, position, and spatial orientation of the one or more deployable probes is adjustable relative to the handle.

13. The system according to claim 7, wherein, The geometry of at least a portion of the guide and the geometry of at least a portion of the tissue manipulator are complementary.

14. The system according to claim 7, wherein, At least a portion of the tissue manipulator is flexible.

15. The system according to claim 7, wherein, The tissue manipulator includes at least one light-emitting diode.

16. The system according to claim 7, wherein, The tissue manipulator includes a first magnet, and the needle guide includes a second magnet.

17. The system according to claim 7, wherein, The needle guide includes a second opening configured to guide the needle away from the exit path of the needle guide.

18. The system according to claim 17, wherein, The second opening of the needle guide is configured to couple to the tissue of the object.

19. The system according to claim 17, wherein, The needle guide includes a groove located between the cavity and the second opening and spanning the full thickness of the guide wall.

20. The system according to claim 7, wherein, The needle guide is a self-coupling needle guide.

21. The system according to claim 7, wherein, The needle guide includes a clip that keeps the spatial orientation of the needle guide fixed independently relative to the tissue manipulator, such that the travel path passes through the same surface of the tissue multiple times.

22. An apparatus comprising: A tissue manipulator, shaped to define a blunt distal end and having one or more deployable probes, wherein the tissue manipulator is configured to advance distally into a cavity of the object through an orifice. A needle guide, configured to advance distally toward target tissue of the object, and shaped to define a side-facing cavity, wherein, when the cavity faces the tissue manipulator, the one or more deployable probes are configured to facilitate pulling at least a portion of the cavity wall through the cavity and into the needle guide; and A suture spreading element, shaped to define the insertion end and configured to advance distally within the needle guide to: When the portion is in the needle guide, it pierces a portion of the wall of the cavity; At least partially penetrating the target tissue; and The suture is passed through the insertion end to penetrate the suture within the target tissue to fix a portion of the cavity wall to the target tissue.

23. The apparatus according to claim 22, wherein, The cavity of the object includes the rectum of the object, the orifice includes the anus, and the target tissue includes the sacrospinous ligament, wherein: The tissue manipulator is configured to advance distally into the rectum through the anus; The needle guide is configured to advance distally toward the sacrospinous ligament; and The suture spreading element is configured as follows: The portion of the tissue that is inserted into the wall of the rectum, and the portion is located within the needle guide; At least partially pierced the sacrospinous ligament; and The suture is passed through the insertion end to unfold at least a portion of the suture within the sacrospinous ligament to secure the wall of the rectum to the sacrospinous ligament.

24. The apparatus according to claim 22, wherein, The one or more deployable probes protrude from the outer surface of the tissue manipulator such that a portion of the wall of the cavity protrudes through the protrusion, and wherein the protruding portion is the portion that is pulled into the cavity.

25. The apparatus of claim 24, wherein the one or more deployable probes and the cavity each include a corresponding magnetic element configured to pull the portion of the cavity wall into the cavity.

26. The apparatus according to claim 24, wherein, The tissue manipulator includes a user-controllable slider or knob coupled to the one or more deployable probes, such that forward movement of the distal side of the slider or rotation of the knob produces a protrusion that allows the one or more deployable probes to pass through the outer surface of the tissue manipulator.

27. The apparatus according to claim 22, wherein, The cavity includes a suction port, and the device is configured to apply suction through the suction port to help pull the walls of the cavity into the cavity.

28. The apparatus of claim 27 further includes a suction source.

29. The apparatus of claim 22 further includes a reporting sensor configured to generate a reporting signal when said portion of the wall of the cavity is drawn into the needle guide cavity.

30. The apparatus according to claim 29, wherein, The reporting sensor includes a lighting source.

31. The apparatus of claim 22, further comprising the suture.

32. The apparatus according to claim 22, wherein, The insertion tip is configured to pierce the wall of the cavity without penetrating the cavity.

33. The apparatus according to claim 22, wherein, The device is configured to retract proximally after the portion of the suture has unfolded.

34. The apparatus according to claim 22, wherein, The tissue manipulator includes a user-controllable slide bar located at the proximal portion of the tissue manipulator, configured to control the tissue manipulator to advance distally through the cavity.

35. The apparatus according to claim 22, wherein, The shape of the needle guide is designed to define a needle guide wall, at least a portion of which is transparent.

36. The apparatus according to claim 22, wherein, At least a portion of the blunt distal end of the tissue manipulator is dome-shaped.

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