Tissue Surface Puncture System
The tissue fixation system addresses the issue of organ integrity disruption by using a needle guide and manipulator to traverse tissue surfaces multiple times, ensuring secure fixation without penetrating the organ's lumen, thus maintaining sterility and functionality.
Patent Information
- Application Number
- JP2022551719
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-02-27
- Filing Date
- 2021-02-27
- Publication Date
- 2025-11-25
- Estimated Expiration
- 2041-02-27
AI Technical Summary
Existing needle-based tissue puncture systems often disrupt the integrity of hollow organs by penetrating their lumens during procedures like rectopexy, leading to potential leaks and loss of sterility.
A tissue fixation system comprising a needle guide and a tissue manipulator that allows the needle to traverse the tissue surface multiple times without penetrating the entire thickness, using a cavity within the needle guide and deployable probes to secure tissues without disrupting the organ's lumen.
Enables secure tissue fixation procedures like rectopexy without compromising the integrity or sterility of hollow organs, maintaining the organ's functionality and preventing leaks.
Smart Images

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Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 982,440, filed February 27, 2020, which is incorporated by reference herein in its entirety.
[0002] TECHNICAL FIELD The present technology relates generally to the field of tissue fixation and / or anchoring (e.g., tissue fixation) systems and associated methods. [Background technology]
[0003] Needles used to puncture tissue, for example to introduce a device or substance into the tissue, are often positioned along the tissue using a needle guide. In some cases, the needle guide is a tube with an opening at its end that is used to direct the needle into the opening. In some embodiments, the opening in the needle guide is positioned proximal to the tissue so that a needle advancing through the guide will puncture the tissue. [Brief explanation of the drawings]
[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present technology.
[0005] [Figure 1A] FIG. 1A is a perspective view of a tissue fixation system configured in accordance with an embodiment of the present technology.
[0006] [Figure 1B] FIG. 1B is a partially schematic cross-sectional view of the tissue fixation system of FIG. 1A.
[0007] [Figure 2] FIG. 2 is a perspective view of a needle guide configured in accordance with an embodiment of the present technology.
[0008] [Figure 3A] 3A and 3B are a perspective view and a cross-sectional perspective view, respectively, of a needle guide configured in accordance with an embodiment of the present technology. [Figure 3B] 3A and 3B are a perspective view and a cross-sectional perspective view, respectively, of a needle guide configured in accordance with an embodiment of the present technology.
[0009] [Figure 4-1] 4A, 4B, 4C, 4D, 4E, and 4F are perspective views and corresponding cross-sectional views of variations in the height of a travel path corresponding to tissue thickness, in accordance with some embodiments of the present technology. [Figure 4-2] 4A, 4B, 4C, 4D, 4E, and 4F are perspective views and corresponding cross-sectional views of variations in the height of a travel path corresponding to tissue thickness, in accordance with some embodiments of the present technology.
[0010] [Figure 5A] 5A, 5B, and 5C are perspective views of tissue manipulators configured in accordance with certain embodiments of the present technology. [Figure 5B] 5A, 5B, and 5C are perspective views of tissue manipulators configured in accordance with certain embodiments of the present technology. [Figure 5C] 5A, 5B, and 5C are perspective views of tissue manipulators configured in accordance with certain embodiments of the present technology.
[0011] [Figure 6] 6A and 6B are perspective and cross-sectional views, respectively, of a probe configured in accordance with an embodiment of the present technology.
[0012] [Figure 7] FIG. 7 is a flowchart of a method for threading tissue in accordance with an embodiment of the present technology.
[0013] [Figure 8A]8A, 8B, and 8C are perspective views of a tissue fixation system configured in accordance with another embodiment of the present technology. [Figure 8B] 8A, 8B, and 8C are perspective views of a tissue fixation system configured in accordance with another embodiment of the present technology. [Figure 8C] 8A, 8B, and 8C are perspective views of a tissue fixation system configured in accordance with another embodiment of the present technology.
[0014] [Figure 9A] 9A and 9B are perspective views of a tissue fixation system configured in accordance with a further embodiment of the present technology. [Figure 9B] 9A and 9B are perspective views of a tissue fixation system configured in accordance with a further embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION
[0015] The present technology is directed to tissue fixation systems, devices, and methods for treating anatomical disorders. In some embodiments, the tissue fixation system can include a needle guide and a tissue manipulator. The needle guide can include an elongated structure or frame extending between a first end portion and a second end portion. The elongated structure has a passageway or lumen extending axially therethrough for receiving a needle and extending between the first end portion and the second end portion. The needle guide further includes a cavity, cutout, or recess within the elongated structure positioned between the first end portion and the second end portion. The cavity bisects the longitudinal axis of the lumen such that, when the needle is advanced through the lumen, the needle travels through a portion of the cavity. The tissue manipulator can include an elongated body configured for placement within a hollow organ or other body lumen (e.g., the rectum). The tissue manipulator further includes one or more deployable probes or extension features that can be deployed from other body parts to contact tissue in a hollow organ or other body lumen and direct it in a particular direction or orientation.
[0016] During surgery, the needle guide can be positioned adjacent to but outside of a hollow organ or other body lumen, while the tissue manipulator can be positioned within the hollow organ or other body lumen. The needle guide and tissue manipulator can be positioned relative to one another so 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 and directed against a portion of the patient's tissue (e.g., the wall of the hollow organ) into the cavity of the needle guide (e.g., the portion of the patient's tissue is "sandwiched" between the probe and the inner surface of the cavity). A needle connected to a suture can then be advanced through the lumen of the needle guide. As the needle is advanced, it traverses the cavity, thus piercing the portion of the tissue positioned 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. In particular, in at least some embodiments, the aforementioned procedures can be used to suture tissue of a hollow organ or other lumen to another tissue without penetrating the inner surface of the hollow organ or other lumen, and therefore without creating a possible leak from the hollow organ or other lumen. Thus, one anticipated advantage of the present technology is the ability to perform tissue fixation procedures (e.g., rectopexy) without affecting the integrity of the target organ.
[0017] In some embodiments, for example, the tissue fixation system includes a needle guide that defines a path of travel for a needle inserted through the needle guide. The tissue fixation system is configured to attach multiple tissues to one another. In some embodiments, at least one of the tissues to be attached is at least a portion of a hollow organ, e.g., a wall of the hollow organ. The tissue fixation system is configured to attach the hollow organ to another tissue without disturbing the integrity of the lumen of the hollow organ.
[0018] In some embodiments, the system includes a tissue manipulator configured to approximate the tissue and the needle guide, wherein at least a portion of the tissue positioned between the tissue manipulator and the needle is located within the path of travel of the needle, and the tissue manipulator and the needle guide are alignable such that the tissue located within the path of travel of the needle is oriented relative to the needle guide such that the path of travel crosses the same surface of the tissue multiple times without traversing the entire thickness of the tissue.
[0019] In some embodiments, as described in more detail elsewhere herein, the needle guide comprises one or more cavities along its longitudinal axis. The tissue manipulator is configured to approximate the needle guide and / or the cavities. In some embodiments, during implementation of the system, the tissue manipulator is configured to approximate the needle guide and / or the one or more cavities, and tissue is captured between the tissue manipulator and the needle guide.
[0020] In some embodiments, the needle guide comprises a self-retaining mechanism configured to secure onto the tissue manipulator, such that the tissue layer positioned therebetween remains intact. In some embodiments, the needle guide comprises a self-retaining mechanism that independently maintains the spatial orientation of the needle guide fixed relative to the tissue manipulator, e.g., without user intervention.
[0021] In some embodiments, the one or more cavities are configured to accommodate at least a portion of a tissue manipulator, hi some embodiments, the tissue manipulator comprises one or more probes extending from a body portion of the tissue manipulator for approximating the tissue and the needle guide and / or one or more cavities of the needle guide.
[0022] In some embodiments, the needle travel path crosses tissue captured between the probe of the tissue manipulator and the needle guide, hi some embodiments, the geometry of at least one needle guide and tissue manipulator is such that the travel path of a needle inserted along the needle guide crosses the same surface of the tissue multiple times without traversing the entire thickness of the tissue.
[0023] Further embodiments of the present technology are directed to methods for performing a rectopexy to treat rectal disorders, such as rectal prolapse. Such methods may include, for example, performing a rectal examination to identify an area of excessive / abnormal rectal mobility, identifying the proximity of the identified area of excessive / abnormal rectal mobility of the rectum and / or pararectal tissues to the sacrospinous ligament, introducing anchors and sutures into the abdomen and outside the rectum, passing the anchors and sutures through at least a portion of the outer rectal wall, and then guiding the anchors and sutures into the sacrospinous ligament, and anchoring the anchors and sutures at least partially to the sacrospinous ligament.
[0024] In some embodiments, identifying the site of excessive / abnormal rectal mobility is performed by palpation, visually, or via imaging (e.g., ultrasound). In some embodiments, passing the anchors and sutures through at least a portion of the outer rectal wall comprises passing the anchors and sutures multiple times only through the outer surface of the rectum. In some embodiments, passing the anchors and sutures through at least a portion of the outer rectal wall without traversing the entire thickness of the rectal wall. In some embodiments, passing the anchors and sutures through at least a portion of the outer rectal wall without disrupting the integrity of the lumen of the rectum.
[0025] According to an aspect of some embodiments of the present technology, a method is provided for puncturing a section of tissue, e.g., a tissue wall, without traversing the entire 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 approximating the tissue manipulator relative to the needle guide, where at least a portion of the tissue is located within a path of travel of the needle. In some embodiments, the method includes driving a needle through the tissue, where the needle crosses the same surface of the tissue multiple times without traversing the entire thickness of the tissue.
[0026] One anticipated advantage of the systems and methods described herein is that the needle's path of travel is prevented from crossing more than one surface of the tissue, i.e., the entire thickness of the tissue, and the tissue manipulator of the system can be employed to suture hollow organ walls without penetrating the tissue lumen, e.g., not only to repair tears or openings, but also to suture the walls of hollow organs to other tissues (e.g., tissue fixation).
[0027] For example, in some embodiments, the system is implemented in a rectopexy procedure, where a tissue manipulator is inserted into the subject's rectum and a needle is inserted into the abdomen.
[0028] A potential advantage of a needle path that does not cross the tissue lumen is that the system allows threading through the tissue wall of a hollow organ (e.g., the bladder or gastrointestinal wall) without penetrating the lumen. For example, in a rectopexy procedure, the rectal lumen is maintained intact. In other words, the rectal lumen remains unpenetrated by the needle. Thus, during implementation within the system in a rectopexy procedure, the needle path crosses the tissue wall of the rectum but does not penetrate the rectal lumen or disrupt sterility.
[0029] The terminology used in the description provided below is intended to be interpreted in its broadest reasonable manner, even when used in conjunction with a detailed description of a specific embodiment of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restrictive manner will be overly and specifically defined as such in this "Detailed Description of the Invention" section. Additionally, the present technology can include other embodiments within the scope of the examples that are not described in detail with respect to Figures 1A-9B.
[0030] Throughout this specification, references to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the technology. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.
[0031] Throughout this specification, references to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean plus or minus 10% of the stated value.
[0032] The headings provided herein are for convenience only and do not describe the scope or meaning of the claimed technology. Tissue fixation system and implementation
[0033] FIG. 1A is a perspective view of a tissue fixation system 100 configured in accordance with an embodiment of the present technology, and FIG. 1B is a cross-sectional view of the tissue fixation system of FIG. 1A. Referring to both FIGS. 1A and 1B, system 100 includes a needle guide 102 and a tissue manipulator 104. In some embodiments, system 100 is configured to thread a portion of a first tissue 150 with a needle 106 directed by needle guide 102. In some embodiments, needle guide 102 is configured to couple and / or anchor to a second tissue 175, as described in more detail elsewhere herein. In some embodiments, when coupled and / or anchored, needle guide 102 is maintained stationary relative to second tissue 175, as described in more detail elsewhere herein. System 100 allows for coupling of first tissue 150 to second tissue 175 without penetrating a lumen of first tissue 150.
[0034] The needle 106 advances along the travel path 135, along and / or within the lumen of the needle guide 102, traverses at least a portion of a cavity 214 ( FIG. 2 ) within the needle guide 102, and exits the needle guide 102 through a second opening 204 ( FIG. 2 ) at the tip of the needle guide 102. Thus, during operation, the needle guide opening 204 is placed against the surface of the second tissue 175, and at least a portion of the first tissue 150 is urged into the cavity 214, for example, against the inner wall 112 of the needle guide 102. The needle 106, driven through the needle guide 102, penetrates the first tissue 150, exits the needle guide second opening 204, and penetrates the second tissue 175, thus joining at least a portion of the first tissue 150 with 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 between the second opening 204 and the one or more cavities 214 through the slot 116.
[0035] In some embodiments, the needle 106 comprises a connecting member, for example, an anchor and / or thread, that anchors the first tissue 150 to the second tissue 175. In some embodiments, the needle guide 102 comprises a handle 125.
[0036] In some embodiments, the tissue manipulator 104 is configured for insertion into and within a lumen of an organ, for example, the rectum of a subject. In some embodiments, the tissue manipulator 104 is positioned relative to the needle guide 102, and 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 retract a portion of the first tissue 150 toward the needle guide 102. For example, in some embodiments, the tissue manipulator 104 includes one or more probes 508 configured to capture a portion of the first tissue 150 between the tissue manipulator 104 and the needle guide 102, as described in more detail elsewhere herein.
[0037] In some embodiments, one or more probes 508 (described in more detail below with reference to FIGS. 5A-5C ) are configured to approximate the tissue and needle guide 102 while maintaining a thickness of first tissue 150 between the probe tip 602 and the needle guide 102. In some embodiments, the one or more probes 508 are insertable into one or more cavities 214 in the needle guide 102.
[0038] In some embodiments, the approximation of the one or more probes 508 and the cavity 214 and / or inner wall 112 is automatic. For example, in some embodiments, the cavity 214 and / or inner wall 112 and the one or more probes 508 comprise attractive magnets configured to capture the thickness of the first tissue 150 along at least a portion of the path of travel 135. In some embodiments, the needle guide 102 comprises a suction mechanism configured to position the thickness of the first tissue 150 along at least a portion of the path of travel 135.
[0039] In some embodiments, the cavity 214 and / or the needle guide 102 include a suction port, and the needle guide 102 is configured to facilitate the retraction of tissue, e.g., a lumen wall, into the cavity 214 by application of suction through the suction port. Reference is made to FIG. 1B, which is a cross-sectional simplified diagram of a system in accordance with some embodiments of the present technology. In some embodiments, the tissue manipulator 104 is configured to introduce tissue (e.g., a first tissue 150) into one or more cavities 214 of the needle guide 102 to approximate a portion of the tissue and an inner wall 112 of the needle guide 102, such that the tissue (e.g., at least a portion of the first tissue 150) is captured between the inner wall 112 and the tissue manipulator 104 and urged against the inner wall 112.
[0040] For example, in some embodiments, the system 100 is implemented by inserting the tissue manipulator 104 into the organ lumen 127 and positioning the needle guide 102 proximal to the outer surface 130 of the organ lumen 127.
[0041] In some embodiments, as described in more detail elsewhere herein, the needle guide 102 comprises a cavity 214 configured to accommodate at least a portion of the tissue manipulator 104 and / or a tissue layer or thickness and / or tissue mass.
[0042] In some embodiments, the tissue manipulator 104 is configured to approximate the tissue and the needle guide 102, and the 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.
[0043] 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 contacting surface 152 of the probe head 602 conforms to (e.g., is a complementary geometry with) the geometry of the inner wall 112, such that when a portion of the first tissue 150 is captured between the probe head 602 and the surface 152 of the inner wall 112, only a certain thickness of the first tissue 150 is located within the travel path 135 of the needle 106. In some embodiments, the travel path 135 is configured to cross the same surface of the tissue portion 156 multiple times. In some embodiments, the travel path 135 is configured to cross the outer surface 130 of the tissue portion 156 multiple times without penetrating or entering the organ lumen 127.
[0044] 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 maintain the tissue layer in a fixed position relative to the path of travel 135. For example, as described in more detail herein, in some embodiments, the inner wall 112 is generally, although not necessarily, parallel to the path of travel 135.
[0045] A potential advantage of this configuration is that needle 106, following travel path 135, enters portion 156 of first tissue 150 at entry point 190-1, travels through first tissue 150, and exits via exit point 190-2 without traversing the entire thickness of first tissue 150. In some embodiments, first tissue 150 comprises the wall of a hollow organ, in which case needle 106 traveling along travel path 135 does not traverse the entire thickness 192 of the wall of the hollow organ (first tissue 150) and does not disrupt the integrity of the lumen of the hollow organ. If the contents of the hollow organ are non-sterile, e.g., the rectum, maintaining the integrity of the lumen of the hollow organ maintains the sterility of the surgical site.
[0046] In some embodiments, at least one of the needle guide 102 and the tissue manipulator 104 comprises one or more sensors for indicating alignment of the tissue manipulator 104 with the needle guide 102. In some embodiments, the one or more sensors comprise one or more of a proximity sensor, an optical sensor, a pressure sensor, and the like. In some embodiments, the one or more sensors are positioned along the needle guide 102 and / or the tissue manipulator 104. In some embodiments, the one or more sensors indicate to a user the correct alignment of at least a specific portion of the tissue manipulator 104 with the cavity 214. In some embodiments, the tissue manipulator 104 and the needle guide 102 comprise an attractive magnet configured to align at least a specific portion of the tissue manipulator 104 with the cavity 214. Needle guide
[0047] 2 is a perspective view of a needle guide 200 configured in accordance with embodiments of the present technology. In some embodiments, needle guide 200 may be identical or substantially identical to needle guide 102 of system 100 (FIGS. 1A and 1B) and, therefore, may be referred to as "needle guide 102," "needle guide 200," or "needle guide 102 / 200." During surgery, needle guide 102 is used to direct a needle inserted therethrough. For example, needle guide 102 surrounds at least a portion of a needle inserted therethrough. In some embodiments, needle guide 102 includes a needle guide body 202 having a tube or channel that defines a travel path for needle 106 inserted within needle guide 102.
[0048] 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 comprises a concave and / or convex portion or recess. In some embodiments, the travel path 135 is coaxial with the needle guide 102.
[0049] In some embodiments, the cross-sectional diameter of the needle guide body 202 varies. For example, in some embodiments, a portion of the needle guide body 202 is gradually tapered.
[0050] In some embodiments, the needle guide body 202 comprises a first end 212 configured to receive a needle and a second, opposite end 210 comprising a second opening 204 configured to guide the needle 106 out of the needle guide 102. In some embodiments, the needle guide 102 / 200 comprises a first end 212 and a second end 210 positioned such that the first end 212 comprises a first opening 216 and the second end 210 comprises a second opening 204.
[0051] In some embodiments, the needle guide 102 comprises one or more cavities 214 configured to accommodate a portion of tissue and / or a probe, as disclosed elsewhere herein. In some embodiments, the one or more cavities 214 comprise one or more openings in 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 the travel path 135 within the needle guide 102.
[0052] In some embodiments, exposure of the travel path 135 through one or more cavities 214 ensures that tissue approaching the needle guide 200 can be positioned within one or more of the cavities 214, with the travel path 135 traversing a portion of the tissue. In some embodiments, the cavities 214 are configured to contain the tissue of interest. In some embodiments, the tissue of interest is positioned within the cavity 214 along the travel path 135. In some embodiments, the tissue is captured within the cavity 214 between the needle guide 102 / 200 and a tissue manipulator, as described in more detail elsewhere herein.
[0053] In some embodiments, the cavity 214 is configured to expose at least a portion of the inner wall 112 / 206 of the needle guide 102. In some embodiments, the needle guide body 202 comprises an inner wall 112 / 206 and a lumen 228. In some embodiments, the lumen 228 comprises an advancement path 135. In some embodiments, the needle guide 102 comprises one or more cavities 214 configured to expose at least a portion of the lumen 228 of the needle guide body 202. In some embodiments, the advancement path 135 is oriented along the longitudinal axis of the lumen 228.
[0054] In some embodiments, the 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 separate an exposed portion of the lumen 228 (e.g., one or more cavities 214) from an unexposed portion of the lumen 228 positioned within the needle guide body 202. In some embodiments, the one or more transverse walls 224 are perpendicular to the path of travel. In some embodiments, the one or more transverse walls 224 are penetrable by a needle. In some embodiments, the one or more transverse walls 224 are made of a material that is pierceable by a needle, and a needle inserted along the needle guide 102 crosses the one or more transverse walls 224.
[0055] In some embodiments, one or more transverse walls 224 include one or more openings 222 configured to direct the travel path 135. In some embodiments, the one or more openings 222 are sized to mate with a needle. In some embodiments, the one or more openings 222 are positioned along the one or more transverse walls 224 to receive a needle traveling along the travel path 135.
[0056] In some embodiments, the first opening 216 at the first end 212 is configured to direct the needle into the lumen 228 of the needle guide 102. In some embodiments, the second opening 204 at the second end 210 is configured to direct the needle as it exits the needle guide 102. In some embodiments, the second opening 204 is configured to direct the needle exit path 275 at a predetermined angle relative to the travel path 135.
[0057] In some embodiments, the needle guide 102 is configured to release a suture guided by the needle 106 from the lumen 228 of the needle guide 102. The needle guide 102 includes one or more slots 116. In some embodiments, the slots 116 extend between one or more of the first opening 216 and the second opening 204 and the one or more cavities 214. In some embodiments, the slots 116 extend through a wall of a certain thickness of the needle guide body 202. In some embodiments, the slots 116 extend substantially along the needle guide, but not necessarily parallel to the travel path 135, such that the suture guided by the needle 106 can be released from the lumen 228 of the needle guide 102 through the slots 116 during and / or after retraction of the needle 106. In some embodiments, the width of the slots 116 is sized to accommodate the suture being released from the needle 106.
[0058] In some embodiments, the needle guide 102 comprises a magnet portion 230. In some embodiments, the inner wall 112 / 206 comprises a magnet portion 230 configured to be attracted to a magnet on the tissue manipulator 104. In some embodiments, the magnet portion 230 is positioned along and / or rearward of the inner wall 112 / 206. In some embodiments, the magnet portion 230 is located around the periphery of the travel path 135. For example, in some embodiments, the needle guide 102 comprises multiple magnet portions 230 positioned along the sides of the travel path 135.
[0059] 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 ribbed portion 208 configured to increase traction between the needle guide and the user. In some embodiments, the ribbed portion 208 is positioned proximal to the first end 212 of the needle guide 102.
[0060] In some embodiments, the needle guide body 202 is anchorable to tissue of a subject, the tissue being positioned along the exit path 275. For example, in some embodiments, the needle guide 102 comprises a piercing tip positioned proximal to the second opening 204. In some embodiments, the needle guide 102 is configured to couple to tissue of a subject, the second opening 204 being at least partially covered by tissue (e.g., the second tissue 175 as depicted in FIG. 1 ).
[0061] In some exemplary implementations of the system 100, the needle guide 102 is anchored to the second tissue 175, and in one or more cavities 214, the first tissue 150 threaded by the needle is coupled to the second tissue by threading at least a portion of the needle through the second opening 204.
[0062] Reference is made to Figures 3A and 3B, which are perspective and cross-sectional perspective simplified illustrations of a needle guide, according to some embodiments of the present technology. In some embodiments, needle guide 200 may be identical or substantially identical to needle guide 102 of system 100 (Figures 1A and 1B), and thus may be referred to as "needle guide 102," "needle guide 300," or "needle guide 102 / 300." In some embodiments, needle guide 102 / 300 is configured to engage at least a portion of a tissue of interest and / or engage against tissue of interest drawn over tissue manipulator 104. In some embodiments, needle guide 102 / 300 is configured to interface with and / or couple to a portion of tissue covering tissue manipulator 104. In some embodiments, needle guide 300 is a self-binding needle guide 300, which independently maintains its spatial orientation relative to tissue manipulator 104 once tissue is coupled to the covered tissue manipulator 104.
[0063] For example, in some embodiments, the needle guide 102 / 300 couples to the tissue manipulator 104, and the tissue covering the tissue manipulator 104 rests within the cavity 314 of the needle guide 102 / 300.
[0064] In some embodiments, the needle guide 102 / 300 is configured such that in a set position, the needle guide 102 / 300 is coupled to a tissue manipulator 104 that is covered by tissue and the travel path 310 of the needle 106 crosses the same surface of the tissue multiple times. In some embodiments, the self-binding needle guide 300 is configured to remain coupled to a portion of the tissue that is covering the tissue manipulator 104 and the travel path 310 is fixed relative to the tissue and / or tissue manipulator 104.
[0065] A possible advantage of the needle guide 102 / 300 being self-attached to a portion of the tissue covering the tissue manipulator 104 is that the needle guide 102 / 300 does not require the user to continually hold and / or maintain the position of the travel path 310 in a specific position relative to the tissue and / or tissue manipulator 104, freeing one of the user's hands.
[0066] In some embodiments, the cavity 214 depicted in Figures 2, 3A, and 3B is structurally and / or functionally similar to the cavity 314 as described elsewhere herein.
[0067] In some embodiments, the self-binding needle guide 300 comprises a clip 302 and a needle guide body 304. In some embodiments, the self-binding needle guide 300 is handleless. In some embodiments, the clip 302 is configured to securely hold a portion of tissue of interest and / or the tissue manipulator 104, as depicted in FIG.
[0068] In some embodiments, the needle guide body 304 comprises at least one of a first opening 306 and a second opening 308 and is configured to define a travel path 310 for a needle 106 inserted into the self-binding 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 comprises a cavity 314 configured to fit at least a portion of the 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.
[0069] In some embodiments, the cavity 314 is defined by an inner wall 316 positioned opposite an opening 318 of the cavity 314. In some embodiments, the depth of the cavity 314 comprises 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 correlate with the thickness of the tissue, such that the travel path 310 crosses the same surface of the tissue multiple times.
[0070] In some embodiments, the clip 302 is coupled and / or removably coupled to the needle guide body 304. In some embodiments, the clip 302 is coupled and / or removably coupled to the needle guide 304 through a constriction 312. In some embodiments, the constriction 312 is configured to couple between the clip 302 and the needle guide body 304.
[0071] In some embodiments, the clip 302 comprises one or more arms 320 configured to capture tissue and / or the 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 the needle guide body 304 and / or one or more of the constrictions 312. In some embodiments, the one or more arms 320 are configured to direct the tissue manipulator 104 and / or the tissue 350 of interest toward the needle guide body 304.
[0072] In some embodiments, the self-binding needle guide 300 comprises a band 322 configured to define the depth of the travel path 310 in relation to the thickness of the tissue 350. In some embodiments, the band 322 is configured to define the travel path 310 in relation to the tissue manipulator 104.
[0073] In some embodiments, the band 322 is integral with the needle guide 300 / 102. For example, in some embodiments, the band 322 is positioned proximate one or more of the openings 306 / 308. In some embodiments, the band 322 is configured to at least partially circumferentially fit around 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 to abut the tissue manipulator 104 and / or the portion of the tissue inserted into the cavity 314. Reference is made to Figures 4A, 4B, 4C, 4D, 4E, and 4F, which are perspective and cross-sectional simplified illustrations of variations in the height of the travel path corresponding to tissue thickness, according to some embodiments of the present technology. 4A, 4B, 4C, 4D, 4E, and 4F depict the height of example bands 322 / 422 in relation to the thickness of tissue 450-1 / 450-2 / 450-3 through which tissue manipulator 104 and / or travel path 310 traverse.
[0074] In some embodiments, the size and / or diameter of band 322 / 422 is fixed and / or rigid. In some embodiments, the size and / or shape of band 322 / 422 is configured to conform to tissue thickness. For example, different tissues having different ranges of thickness require specifically sized bands 322 / 422.
[0075] In some embodiments, the position of band 322 / 422 relative to tissue manipulator 104 correlates to the thickness of the tissue positioned between band 322 / 422 and tissue manipulator 104. In Figures 4A-4F, tissues 450-1 / 450-2 / 450-3 each have a different thickness, thereby requiring band 322 / 422 to be positioned at different distances from tissue manipulator 104.
[0076] For example, Figures 4A and 4B depict exemplary embodiments in which travel path 310 crosses tissue 450-1 and in which travel path 310 crosses the same surface of tissue 450-1 multiple times. For example, Figures 4C and 4D depict exemplary embodiments in which travel path 310 crosses more than one surface of tissue 450-2. For example, Figures 4E and 4F depict exemplary embodiments in which travel path 310 does not cross the surface of tissue 450-3.
[0077] In some embodiments, the band 322 / 422 is sized according to the thickness of the tissue so that the travel path 310 crosses the same surface of the tissue multiple times to position the band 322 / 422 at a fixed location relative to the tissue manipulator 104.
[0078] In some embodiments, the band 322 / 422 is sized according to the thickness of the tissue so as to position the band 322 / 422 in a fixed location relative to the tissue manipulator 104 and so that the travel path 310 does not cross the tissue manipulator. Tissue Manipulator
[0079] 5A, 5B, and 5C, which are perspective simplified diagrams of tissue manipulators, in accordance with 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 probe 508 is configured to manipulate a portion of tissue, e.g., a wall of a hollow organ, from within the lumen of the organ, e.g., from within the lumen of the rectum. In some embodiments, the one or more probes 508 are configured to adjust the position of tissue extending or spread across the one or more probes 508 and / or the tissue manipulator 104.
[0080] In some embodiments, the tissue manipulator 104 comprises 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 comprises a shell or pivot 502 extending from the handle 504. In some embodiments, the handle 504 comprises a control lever 514 configured to control the movement of the probe 508 relative to the handle 504 and / or shell 502, as described in more detail elsewhere herein.
[0081] In some embodiments, the spatial orientation of one or more probes 508 relative to the handle 504 and / or the outer shell 502 is adjustable. In some embodiments, the spatial orientation of one or more probes 508 relative to the outer shell is fixable.
[0082] In some embodiments, the outer shell 502 comprises a tube, channel, or the like. In some embodiments, the outer shell 502 comprises a cylindrical shape. In some embodiments, the outer shell 502 comprises markings, such as a scale 530, positioned relative to the handle 504. In some embodiments, the markings are configured to be a depth gauge that allows the surgeon to know the insertion depth of the outer shell 502, for example, in the lumen of an organ.
[0083] In some embodiments, the outer shell 502 is configured to store at least a portion of the one or more probes 508. In some embodiments, when the probes 508 are at least partially extended, the one or more probes 508 extend radially outward through the outer shell 502. In some embodiments, when the one or more probes 508 are fully retracted, the probe head 602 is flush with the surface of the outer shell 502.
[0084] In some embodiments, the outer shell 502 includes an eyelet 510 through which the probe is movable relative to and / or the surface of the outer shell 502. In some embodiments, the eyelet 510 includes a slot or recess and extends through a thickness of the outer shell 502. In some embodiments, the eyelet 510 is circular. In some embodiments, the eyelet 510 is elongated and extends circumferentially and radially along the outer shell 502. In some embodiments, the eyelet 510 extends along the longitudinal axis 550 of the outer shell 502. In some embodiments, the eyelet 510 extends perpendicular to the longitudinal axis 550 of the outer shell 502.
[0085] In some embodiments, the eyelets 510 are sized and positioned along the shell 502 to limit the movement of one or more probes 508. In some embodiments, the eyelets 510 are sized and positioned along the shell 502 so that the probes 508 are movable relative to the shell 502. In some embodiments, the eyelets 510 are 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 eyelets 301 are positioned proximal to the shell tip 506.
[0086] In some embodiments, the shell 502 comprises a shell tip 506 at the distal end 532 of the tissue manipulator 104. In some embodiments, the shell tip 506 comprises a rounded portion for safe insertion of the tissue manipulator 104 into a body cavity, for example, the rectum or vagina. In some embodiments, the shell tip 506 is soft. In some embodiments, the shell tip 506 is flexible. In some embodiments, the shell tip 506 comprises one or more proximity sensors, optical sensors, and pressure sensors for determining the location of the shell tip 506 within the tissue lumen of interest.
[0087] In some embodiments, the handle 504 comprises one or more control levers 514 configured to control one or more of the position, location, orientation, and length of the extension (L) of one or more probes 508 in relation to the shell 502 and / or the handle 504. In some embodiments, each probe 508 is independently controlled by a corresponding one or more control levers 514.
[0088] In some embodiments, the probe 508 is maneuverable to multiple positions relative to the outer shell 502. For example, in a closed position of the probe 508, the probe head 602 is flush with the eyelet 510 and / or positioned inside the outer shell 502, as depicted by FIG. 5B. In an extended position, for example, as depicted by FIG. 5C, the probe 508 extends from the eyelet 510 in a length of extension (L), depicted by arrow 575. In some embodiments, the length of the extension (L) of one or more probes is controlled by one or more controllers 514.
[0089] In some embodiments, the one or more control levers 514 comprise one or more of a button or a notch. In some embodiments, the control lever 514 is movable within one or more tracks 516 positioned along the handle 504. In some embodiments, the control lever 514 is configured to be operated by a user within the one or more tracks 516. In some embodiments, the control lever 514 is slidable within the one or more tracks 516. In some embodiments, the track 516 comprises a slot along the handle 504, and the one or more control levers are slidable within the track 516.
[0090] In some embodiments, one or more of the dimensions of track 516 match one or more dimensions of eyelet 510. For example, in some embodiments, the length of eyelet 510 along the radius of shell 502 is equal to the length of the track along the radius of handle 504.
[0091] 5B and 5C , the position of the control lever 514 relative to the handle 504 determines the length of extension of each probe head 602 relative to the shell 502 and / or the eyelet 510. In some embodiments, the distance that the control lever 514 slides and / or rotates relative to the shell 502 corresponds to the length of extension (L) of one or more probes 508 and / or the angle of the probe head 602 relative to the eyelet 510. In some embodiments, the length of extension (L) of each probe 508 is independently controlled by one or more control levers 514.
[0092] In some embodiments, the angle of the probe head 602 relative to the eyelet 510 is independently controlled by one or more control levers 514. In some embodiments, the one or more control levers 514 are coupled to one or more probes 508. In some embodiments, the one or more control levers 514 are electronically coupled to the one or more probes 508. In some embodiments, the one or more probes 508 extend from the eyelet 510 into the shell 502 toward the handle 504 and are coupled to the control lever 514, which manipulates one or more of the length, articulation angle, spatial orientation of the probe 508, and the spatial orientation of the probe head 602 by positioning the control lever 514 along a track 516.
[0093] In some embodiments, the outer shell 502 comprises one or more magnets around one or more eyelets 510. In some embodiments, the magnets are configured to be attracted to a portion of the needle guide 102. For example, in some embodiments, the needle guide 102 comprises a magnet. For example, in some embodiments, the needle guide 102 comprises a magnetic portion configured to attract the one or more magnets of the outer shell 502, such that tissue positioned between the probe 508 and the needle guide 102 is positioned taut along the path of travel 135. probe
[0094] 6A and 6B, which are perspective and cross-sectional simplified diagrams of a probe, in accordance with some embodiments of the present technology. In some embodiments, one or more probes 508 comprise a handle 504 and a probe head 602. In some embodiments, the handle 504 extends from one of one or more eyelets 510 within the shell 502. In some embodiments, the probe head 602 is positioned at a distal end 622 of the probe 508.
[0095] In some embodiments, the width of the probe head 602 is greater than the width of the handle 504. In some embodiments, the probe head 602 is configured to access tissue and the needle guide 102 and / or one or more cavities 214 of the needle guide 102. In some embodiments, the probe head 602 is configured to be inserted into the one or more cavities 214. In some embodiments, the probe head 602 is configured to support an extended tissue layer.
[0096] In some embodiments, the handle 504 comprises a rod-shaped member. In some embodiments, the spatial orientation of the handle 504 is adjustable. In some embodiments, the spatial orientation of the handle 504 is adjustable via a control lever 514. In some embodiments, the spatial orientation of the probe head 602 is adjustable via an adjustment device on the handle 504.
[0097] In some embodiments, the handle 504 is rotatable about a longitudinal axis of the handle 504. In some embodiments, the handle 504 is extendable. In some embodiments, the adjustment, rotation, and / or extension of the handle 504 is controllable by one or more controllers 514.
[0098] In some embodiments, the handle 504 comprises one or more joints 606. In some embodiments, the joints 606 are adjustable. In some embodiments, one or more angles of the joints 606 are adjustable via a control lever 514. In some embodiments, the joints 606 comprise a free range of movement. In some embodiments, the joints 606 comprise two to four degrees of freedom.
[0099] In some embodiments, the handle 504 includes multiple joints 606, and the probe head 602 includes up to six degrees of freedom. In some embodiments, the angle of the joints 606 corresponds to the length of the distance between the probe head 602 and the outer shell 502.
[0100] In some embodiments, the position of the joint 606 along the handle 504 is flush with the surface of the shell 502. In some embodiments, the position of the joint 606 along the handle 504 extends outside of the shell 502. In some embodiments, the position of the joint 606 is adjustable relative to the shell 502.
[0101] In some embodiments, the joint 606 is positioned along the handle 504 between a first portion 610 and a second portion 612 of the handle 504. In some embodiments, the angle of the joint 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 joint 606 is fixable, and the position of the first portion 610 is fixed in relation to the second portion 612.
[0102] In some embodiments, the one or more probe heads 602 comprise a tissue manipulation surface 650 having a complementary geometry to the inner wall 112 / 206 of the needle guide 102. For example, in some embodiments, the tissue manipulation surface 650 is one or more of substantially flat, concave, and / or convex. In some embodiments, the edges of the tissue manipulation surface 650 are rounded and press against the inner wall 112 / 206 to avoid tearing of tissue caught between the tissue manipulation surface 650 of the probe 508 and the inner wall 112 / 206 of the needle guide 102.
[0103] A possible advantage of at least a portion of the tissue manipulation surface 650 of the probe 508 being flat is that when a portion of the tissue, e.g., the first tissue 150, is pressed against the inner wall 112 / 206, the flat surface is configured to stretch the tissue and "smooth out" wrinkles, which, as described in more detail elsewhere herein, in some embodiments, prevents the needle from progressing along the progression path 135, traversing the full thickness of the tissue and disrupting the integrity of the lumen of the hollow organ.
[0104] In some embodiments, the probe head 602 comprises a geometry that is complementary to the needle guide body 202 and / or the inner wall 112 / 206 of the needle guide 102. In some embodiments, a portion of the head 602 is rigid, semi-rigid, or flexible. In some embodiments, the probe head 602 comprises a geometry that allows it to be inserted into and / or secured within the cavity 214 of the needle guide 102.
[0105] In some embodiments, the probe 508 and / or the probe head 602 include one or more light-emitting elements 614. For example, in some embodiments, as depicted by Figures 6A and 6B, the probe head 602 includes one or more LED circuits 618. In some embodiments, the probe head 602 includes an LED diffuser 616 for diffusing the light emitted by the LED light-emitting elements 614.
[0106] A possible advantage of the probe head 602 having one or more light-emitting elements 614 is that the orientation of the tissue manipulator 104, outer shell 502, and / or one or more probes 508 can be visually monitored from outside the tissue lumen.
[0107] A possible advantage of being able to visually monitor the orientation of the tissue manipulator 104, outer shell 502, and / or one or more probes 508 from outside the tissue lumen is that while the tissue manipulator 104 is positioned within the tissue lumen, the tissue manipulator 104 and / or at least a portion of the tissue manipulator 104 can be adjusted to a specific and / or desired position relative to the tissue lumen and / or other tissue of interest.
[0108] In some embodiments, one or more probes 508 include a magnet 620. In some embodiments, the magnet 620 is positioned along the probe head 602. In some embodiments, the magnet is configured to be attracted to 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 magnet portion 230 configured to attract the magnet 620 of the probe 508. In some embodiments, the magnet portion 230 of the needle guide 102 is positioned relative to the path of travel 135, and tissue positioned between the magnet 620 and the magnet portion 230 is positioned along the path of travel 135.
[0109] A possible advantage of the probe 508 having a magnet 620 that is attracted to a portion of the needle guide 102 is that the attraction of the magnets of the probe 508 and needle guide 102 positions the probe 508 in a predetermined position relative to the path of travel 135.
[0110] A possible advantage of the probe 508 having a magnet 620 attracted to a portion of the needle guide 102 is that the attraction of the magnets of the probe 508 and needle guide 102 automatically positions the probe 508 so that the tissue captured between the magnets is positioned along the path of travel 135.
[0111] A possible advantage of the probe 508 having a magnet 620 that is attracted to a portion of the needle guide 102 is that the attraction of the magnet of the probe 508 and the needle guide 102 presses a portion of the tissue, for example the first tissue 15, against the inner wall 112 / 206, capturing and leveling that portion of the tissue without assistance from the operator of the system.
[0112] In some embodiments, magnets are positioned along the probe 508 and / or needle guide 102 such that the path of travel 135 is not interrupted by the magnets. For example, in some embodiments, magnets are positioned on either side of the path of travel 135. method
[0113] The present technology further includes methods of performing medical procedures using the tissue fixation systems and devices described herein. For example, FIG. 7 is a flowchart of a method for threading tissue according to some embodiments of the present technology. In some embodiments, in step 702, the method includes positioning a first tissue along a needle travel path within the needle guide such that the travel path crosses the same surface of the first tissue multiple times. This may include, for example, (a) positioning the needle guide proximate an outer surface of the first tissue and (b) positioning a tissue manipulator proximate an inner surface of the first tissue. Once the needle guide and manipulator are positioned, 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, i.e., a cavity aligned with the needle travel path, as described herein above.
[0114] In some embodiments, in step 704, the method includes maintaining a fixed position of the first tissue while inserting a needle through the needle guide along the travel path, the needle being coupled to a suture. Optionally, in step 706, the method includes piercing the second tissue with the needle such that the suture couples the first tissue to the second tissue. Optionally, in step 708, the method includes retracting the needle from the second tissue and / or from the suture such that the suture is removed from the needle.
[0115] In some embodiments, the method includes positioning a needle guide on a first side of a first tissue. In some embodiments, the method includes positioning a tissue manipulator on a second side of the same first tissue. In some embodiments, the method includes approximating the tissue manipulator relative to the needle guide, positioning at least a portion of the first tissue in a path of travel of the needle traveling through the needle guide, and inserting the needle into the needle guide such that the needle advances through the first tissue multiple times without crossing the second side of the first tissue. The method includes inserting the needle into the needle guide, crossing the first tissue, and exiting the needle guide, and inserting the needle into the second tissue.
[0116] In some embodiments, the suture is coupled to an anchor driven or carried by the needle 106, the suture is carried by the needle through one or more tissues, and is detached from the needle guide 102 once the anchor is embedded in the tissue and the needle 106 is retracted from the one or more tissues. In some embodiments, the needle guide 102 comprises a slot 116 at the tip of the needle guide 102, disposed at least between the cavity 214 and the opening 204. In some embodiments, the method includes sliding the suture through the slot 116 of the needle guide 102. In some embodiments, the slot 116 allows the suture to disconnect from the needle guide 102 after the needle has penetrated through one or more tissues.
[0117] Reference is made to Figures 8A, 8B, and 8C, which are simplified perspective illustrations of a system according to some embodiments of the present technology. In some embodiments, Figures 8A, 8B, and 8C depict implementations of system 100 according to some embodiments of the present technology, consistent with the steps of the method depicted in Figure 7.
[0118] 9A and 9B, which are perspective simplified illustrations of a tissue fixation system in accordance with some embodiments of the present technology. In some embodiments, Figures 9A and 9B depict implementations of system 100 in accordance with some embodiments of the present technology, consistent with the steps of the method depicted in Figure 7.
[0119] In some embodiments, the method includes positioning the needle guide 102 / 300 along a first side 830 of the first tissue 850 / 150 so that one or more cavities 214 face the first tissue 850 / 150.
[0120] In some embodiments, the method includes coupling the needle guide 102 to the 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 the second opening 204 of the needle guide 102 / 300 to the second tissue 875 / 175.
[0121] In some embodiments, the method includes positioning the tissue manipulator 104 along the second side 835 of the first tissue 850 / 150 and adjusting one or more probes 508 via one or more control levers 514.
[0122] In some embodiments, the method includes anchoring the needle guide 300 / 102 onto the tissue manipulator 104 such that at least a portion of the tissue 850 is positioned between the needle guides 300 / 102. In some embodiments, the method includes anchoring the needle guide 300 / 102 onto the tissue-covered tissue manipulator 104 such that the needle guide independently remains positioned over the tissue covering the tissue manipulator 104. In some embodiments, the method includes anchoring the needle guide 300 / 102 onto the tissue-covered tissue manipulator 104 such that a spatial orientation of the needle guide 300 / 102 independently remains fixed relative to the tissue manipulator 104.
[0123] In some embodiments, the method includes extending one or more probes 508 of 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 a joint 606 of a 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.
[0124] In some embodiments, the method includes extending the head 602 from the outer shell 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.
[0125] In some embodiments, the method includes switching on the light-emitting element 614. In some embodiments, the method includes visually locating the light-emitting element 614 positioned on the second side 835 of the first tissue 850 / 150 by observing the 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 through at least the first tissue 850 / 150.
[0126] In some embodiments, the method includes aligning the head 602 of the probe with the needle guide 102 / 300 and / or the cavity 214 using a light-emitting element 614 to locate 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.
[0127] In some embodiments, the method includes bringing magnet 620 close to magnet portion 230 such that probe 508 is automatically aligned with cavity 214. In some embodiments, the method includes bringing magnet 620 close to magnet portion 230 such that probe 508 is automatically deployed within cavity 214. In some embodiments, the method includes bringing magnet 620 close to magnet portion 230 such that probe 508 is automatically extended toward cavity 214.
[0128] In some embodiments, the method includes inserting a needle 106 along the path of travel 135 and threading the needle 106 through the first tissue 850 / 150.
[0129] In some embodiments, the method includes threading the needle 106 through the first tissue 850 / 150 without entering a lumen of the tissue 850 / 150. In some embodiments, the method includes threading the needle 106 through the first tissue 850 / 150 by puncturing a surface of the first tissue 850 / 150 proximal to the needle guide 102 multiple times. In some embodiments, the method includes threading the needle 106 through the first tissue 850 / 150 without crossing a surface of the tissue 850 / 150 proximal to the tissue manipulator 104. (Example)
[0130] Several aspects of the present technology are described in the following examples. Example 1 1. A tissue fixation system comprising: 1. A needle guide having an elongated structure extending between a first end portion and a second end portion, the elongated structure comprising: a cavity between the first end portion and the second end portion, the cavity configured to receive a portion of tissue; a lumen configured to receive a needle, the lumen including a first lumen portion extending between the first end portion and the cavity and a second lumen portion extending between the second end portion and the cavity; a needle guide having a tissue manipulator having one or more deployable probes configured to direct the portion of the tissue into the cavity; Equipped with the one or more deployable probes are configured to direct the portion of the tissue within the cavity, and when a needle is advanced through the lumen, the needle traverses the cavity and pierces the portion of the tissue as it moves from the first lumen portion to the second lumen portion; Tissue fixation system. Example 2 The system of example 1, wherein the portion of tissue has an outer surface and an inner surface, and the system is configured to puncture the outer surface in at least two locations without puncturing the inner surface. Example 3 the cavity having an inner surface, a first outer surface, and a second outer surface; the first exterior surface has a first opening in fluid communication with the first lumen portion; the second exterior surface has a second opening in fluid communication with the second lumen portion; 3. The system of claim 1 or 2, wherein the first opening and the second opening are configured to receive the needle when the needle is advanced through the lumen from the first lumen portion to the second lumen portion. Example 4 The system of Example 3, wherein the needle is configured to penetrate a portion of the tissue between the probe and the inner surface of the cavity when the needle is advanced from the first opening to the second opening. Example 5 5. The system of any of Examples 1-4, wherein the geometry of the probe is complementary to the geometry of the cavity. Example 6 The system of any of Examples 1-4, wherein the probe is capable of transitioning between a low-profile delivery configuration and a deployed configuration. Example 7 1. A system comprising: a needle guide defining a path of travel for a needle inserted through said guide; a tissue manipulator configured to approximate tissue and the needle guide and position at least a portion of the tissue in the path of travel of the needle; Equipped with the tissue manipulator and the needle guide are alignable so that the path of travel crosses the same surface of the tissue multiple times; system. Example 8 The system of Example 7, wherein the needle guide comprises a cavity configured to accommodate at least a portion of the tissue manipulator. Example 9 9. The system of example 8, wherein the travel path is exposed by the cavity. Example 10 A system described in any of Examples 7-9, wherein the tissue manipulator comprises at least one probe. Example 11 The system of example 10, wherein the probe comprises a light-emitting element. Example 12 A system described in any of Examples 7-11, wherein the tissue manipulator comprises an outer shell and at least one probe extends radially outward from the outer shell. Example 13 A system described in any of Examples 7-12, wherein the tissue manipulator has a handle, and one of the length, position, and spatial orientation of the extension portion of the probe is adjustable relative to the handle. Example 14 A system described in any of Examples 7-13, wherein the geometric shapes of at least a portion of the guide and at least a portion of the tissue manipulator are complementary. Example 15 A system described in any of Examples 7-14, wherein at least a portion of the tissue manipulator is flexible. Example 16 A system described in any of Examples 7-15, wherein the tissue manipulator comprises at least one light-emitting diode. Example 17 A system described in any of Examples 7-16, wherein the tissue manipulator comprises a first magnet and the needle guide comprises a second magnet. Example 18 A system described in any of Examples 7-17, wherein the needle guide has a second opening configured to direct the needle's exit path out of the needle guide. Example 19 The system of Example 18, wherein the second opening of the needle guide is configured to couple to tissue of a target. Example 20 The system of Example 18 or 19, wherein the needle guide has a slot between the hollow lumen and the second opening, spanning the entire thickness of the wall of the guide. Example 21 A system described in any of Examples 7-20, wherein the needle guide is a self-binding needle guide. Example 22 A system described in any of Examples 7-21, wherein the needle guide is provided with a clip, the spatial orientation of the needle guide remains independently fixed relative to the tissue manipulator, and the travel path crosses the same surface of the tissue multiple times. Example 23 1. A method for performing a rectopexy procedure, comprising: performing a rectal examination to identify areas of excessive / abnormal rectal mobility; identifying the proximity of the identified area of excessive / abnormal rectal mobility of the rectum and / or pararectal tissue to the sacrospinous ligament; introducing an anchor and suture into the abdomen and outside the rectum, passing the anchor and suture through at least a portion of the outer rectal wall, and then guiding the anchor and suture into the sacrospinous ligament; anchoring the anchor and suture at least partially to the sacrospinous ligament; A method comprising: Example 24 A method for threading tissue, comprising: positioning a needle guide on a first side of a first tissue; positioning a tissue manipulator on a second side of the same first tissue; approximating the tissue manipulator relative to the needle guide; positioning at least a portion of the first tissue in a path of advancement of a needle through the needle guide; inserting a needle into the needle guide such that the needle advances through the first tissue a plurality of times without crossing the second side of the first tissue; A method comprising: Example 25 25. The method of example 24, comprising capturing the tissue between the needle guide and the tissue manipulator. Example 26 26. The method of claim 24 or 25, comprising puncturing the tissue so that the surface of the tissue proximal to the tissue manipulator remains undamaged. Example 27 The method described in any of Examples 24-26, wherein the tissue manipulator and the needle guide are attracted by magnetic force. Example 28 1. A method of joining a first tissue to a second tissue, comprising: positioning a first tissue at a location along a needle travel path of the needle guide such that the travel path crosses the same surface of the first tissue multiple times; maintaining the position of the first tissue fixed while inserting a needle along the travel path, the needle being coupled to a suture; puncturing a second tissue with the needle such that the suture joins the first tissue to the second tissue; A method comprising: Example 29 29. The method of Example 28, comprising retracting the needle from the second tissue and / or from the suture such that the suture is removed from the needle. Example 30 The method described in Example 28 or 29, comprising a step of positioning the first tissue using a tissue manipulator configured to approximate the first tissue and the needle guide and position at least a portion of the tissue in the path of travel of the needle. Example 31 1. An apparatus comprising: an outer shell shaped to define a blunt distal end and configured to be advanced distally through an orifice of a subject and into a lumen of the subject; a needle guide configured to be advanced distally toward a target tissue of the subject and shaped to define a laterally facing cavity, the device being configured to facilitate retraction of at least a portion of a wall of the lumen through the cavity and into the needle guide when the cavity is opposed to the outer shell; a suture deployment element shaped to define a piercing tip and configured to be advanced distally within the needle guide, puncturing the portion of the lumen wall while the portion is within the guide member; at least partially puncturing the target tissue; passing a suture through the piercing tip and penetrating the suture into the target tissue; and securing the portion of the lumen wall relative to the target tissue. a suture deployment element; and 1. An apparatus comprising: Example 32 the lumen of the subject comprises the rectum of the subject, the orifice comprises the anus, and the target tissue comprises the sacrospinous ligament; the shell is configured to be advanced distally through the anus and into the rectum; the needle guide is configured to be advanced distally toward the sacrospinous ligament; The suture deployment element includes: puncturing the portion of the tissue of the rectal wall while the portion is within the guide member; at least partially puncturing the sacrospinous ligament; passing a suture through the puncture tip and deploying at least a portion of the suture within the sacrospinous ligament to secure the rectal wall to the sacrospinous ligament; 32. The device of Example 31, configured to: Example 33 The device described in Example 30 or 31, wherein the longitudinal shell is further shaped to define one or more probes protruding from the outer surface of the shell, a portion of the lumen wall being protruded by the protrusion, the protruded portion being a portion that is retracted into the cavity. Example 34 (a) The device described in Example 33, wherein the probe and the cavity each comprise a separate magnetic element, the magnetic element configured to draw the portion of the wall lumen into the cavity. Example 35 The device described in Example 33 or 34, wherein the outer shell comprises a user-controllable slide bar or knob coupled to the probe, and distal advancement of the slide bar or rotation of the knob produces protrusion of the probe through the outer surface of the outer shell. Example 36 A device described in any of Examples 31-35, wherein the cavity is provided with a suction port and the device is configured to promote retraction of the lumen wall into the cavity by application of suction through the suction port. Example 37 Example 36. The device of Example 36, further comprising the suction source. Example 38 An apparatus described in any of Examples 31-35, further comprising a reporting sensor configured to generate a reporting signal when the portion of the lumen wall is retracted into the cavity of the needle guide. Example 39 The device of Example 38, wherein the reporting sensor comprises an illumination source. Example 40 The device described in any of Examples 31-35, further comprising the suture. Example 41 A device described in any of Examples 31-35, wherein the puncture tip is configured to puncture the wall of the lumen without passing through the lumen. Example 42 A device described in any of Examples 31-35, wherein the device is configured to be retracted proximally following deployment of the portion of the suture. Example 43 A device described in any of Examples 31-35, wherein the outer shell comprises a user-controllable slide bar at a proximal portion of the outer shell configured to control distal advancement of the outer shell through the lumen. Example 44 An apparatus described in any of Examples 31-35, wherein the needle guide is shaped to define a needle guide wall, at least a portion of which is transparent. Example 45 A device described in any of Examples 31-35, wherein at least a portion of the blunt distal end of the outer shell is dome-shaped. conclusion
[0131] The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Specific embodiments of the present technology and examples therefor are described above for illustrative purposes, but various equivalent modifications are possible within the scope of the present technology as those skilled in the art will recognize. For example, any of the features of the intraocular shunts described herein may be combined with any of the features of the other intraocular shunts described herein, and vice versa. Furthermore, while 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.
[0132] From the foregoing, it will be understood that specific embodiments of the present technology have been described herein for purposes of illustration, although well-known structures and features associated with intraocular shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.
[0133] Unless the context clearly requires otherwise, throughout the description and examples, the words "comprise," "comprising," and equivalents should be construed in an inclusive sense, i.e., "including, but not limited to," as opposed to an exclusive or exhaustive sense. As used herein, the terms "connected," "coupled," or variants thereof, mean any connection or coupling, either direct or indirect, between two or more elements, and the coupling between the elements may be physical, logical, or a combination thereof. Additionally, the words "herein," "above," "below," and words of similar import, when used herein, refer to this specification as a whole and not to any particular portions of this specification. Where the context permits, words in the above Detailed Description using the singular or plural may also include the plural or singular, respectively. As used herein, the phrase "and / or," such as "A and / or B," refers to A only, B only, and A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited features, so as not to exclude any greater number of the same features and / or other features of additional types. Specific embodiments have been described herein for illustrative purposes, but it will also be understood that various modifications can be made without departing from the technology. Furthermore, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not necessarily all embodiments to be within the scope of the technology. Thus, the present disclosure and related technology may contain other embodiments not explicitly shown or described herein. The present invention provides, for example, the following. (Item 1) 1. A tissue fixation system comprising: 1. A needle guide having an elongated structure extending between a first end portion and a second end portion, the elongated structure comprising: a cavity between the first end portion and the second end portion, the cavity configured to receive a portion of tissue; and a lumen configured to receive a needle, the lumen including a first lumen portion extending between the first end portion and the cavity and a second lumen portion extending between the second end portion and the cavity; a needle guide having a tissue manipulator having one or more deployable probes configured to direct the portion of the tissue into the cavity; Equipped with the system is configured such that the one or more deployable probes direct the portion of the tissue within the cavity, and when a needle is advanced through the lumen, the needle traverses the cavity and punctures the portion of the tissue as it moves from the first lumen portion to the second lumen portion; Tissue fixation system. (Item 2) Item 10. The system of item 1, wherein the portion of tissue has an outer surface and an inner surface, and the system is configured to puncture the outer surface in at least two locations without puncturing the inner surface. (Item 3) the cavity having an inner surface, a first outer surface, and a second outer surface; the first exterior surface has a first opening in fluid communication with the first lumen portion; the second exterior surface has a second opening in fluid communication with the second lumen portion; Item 1, wherein the first opening and the second opening are configured to receive the needle when the needle is advanced through the lumen from the first lumen portion to the second lumen portion. (Item 4) 4. The system of claim 3, wherein the needle is configured to penetrate a portion of the tissue between the probe and the interior surface of the cavity when the needle is advanced from the first opening to the second opening. (Item 5) Item 10. The system of item 1, wherein the geometry of the probe is complementary to the geometry of the cavity. (Item 6) Item 10. The system of item 1, wherein the probe is transitionable between a low-profile delivery configuration and a deployed configuration. (Item 7) 1. A system comprising: a needle guide defining a path of travel for a needle inserted therethrough; a tissue manipulator configured to approximate tissue and the needle guide and position at least a portion of the tissue in the path of travel of the needle; Equipped with the tissue manipulator and the needle guide are alignable so that the path of travel crosses the same surface of the tissue multiple times; system. (Item 8) 8. The system of claim 7, wherein the needle guide comprises a cavity configured to accommodate at least a portion of the tissue manipulator. (Item 9) Item 9. The system of item 8, wherein the travel path is exposed by the cavity. (Item 10) Item 8. The system of item 7, wherein the tissue manipulator comprises at least one probe. (Item 11) Item 11. The system of item 10, wherein the probe comprises a light-emitting element. (Item 12) 8. The system of claim 7, wherein the tissue manipulator comprises an outer shell and at least one probe extends radially outward from the outer shell. (Item 13) 8. The system of claim 7, wherein the tissue manipulator comprises a handle, and one of the length, position, and spatial orientation of the extension of the probe is adjustable relative to the handle. (Item 14) Item 8. The system of item 7, wherein the geometric shapes of at least a portion of the guide and at least a portion of the tissue manipulator are complementary. (Item 15) Item 8. The system of item 7, wherein at least a portion of the tissue manipulator is flexible. (Item 16) Item 8. The system of item 7, wherein the tissue manipulator comprises at least one light-emitting diode. (Item 17) Item 8. The system of item 7, wherein the tissue manipulator comprises a first magnet and the needle guide comprises a second magnet. (Item 18) Item 8. The system of item 7, wherein the needle guide comprises a second opening configured to direct an exit path of the needle out of the needle guide. (Item 19) Item 19. The system of item 18, wherein the second opening of the needle guide is configured to couple to tissue of a target. (Item 20) Item 19. The system of item 18, wherein the needle guide comprises a slot between the hollow lumen and the second opening, spanning the entire thickness of the wall of the guide. (Item 21) Item 8. The system of item 7, wherein the needle guide is a self-binding needle guide. (Item 22) Item 8. The system of item 7, wherein the needle guide comprises a clip, the spatial orientation of the needle guide remains independently fixed relative to the tissue manipulator, and the path of travel crosses the same surface of the tissue multiple times. (Item 23) 1. A method for performing a rectopexy procedure, comprising: Perform a rectal examination to identify areas of excessive / abnormal rectal mobility; Identifying the proximity of the identified area of excessive / abnormal rectal mobility of the rectum and / or pararectal tissue to the sacrospinous ligament; introducing an anchor and suture into the abdomen and outside the rectum, passing the anchor and suture through at least a portion of the outer rectal wall, and then guiding the anchor and suture into the sacrospinous ligament; anchoring the anchor and suture at least partially to the sacrospinous ligament; A method comprising: (Item 24) A method for threading tissue, comprising: Positioning a needle guide on a first side of a first tissue; positioning a tissue manipulator on a second side of the same first tissue; approaching the tissue manipulator relative to the needle guide; Positioning at least a portion of the first tissue in a path of travel of a needle traveling through the needle guide; inserting a needle into the needle guide such that the needle advances through the first tissue a plurality of times without crossing the second side of the first tissue; A method comprising: (Item 25) 25. The method of claim 24, comprising capturing the tissue between the needle guide and the tissue manipulator. (Item 26) 25. The method of claim 24, comprising piercing the tissue such that the surface of the tissue proximal to the tissue manipulator remains intact. (Item 27) 25. The method of claim 24, wherein the tissue manipulator and the needle guide are attracted by magnetic force. (Item 28) 1. A method of joining a first tissue to a second tissue, comprising: positioning a first tissue at a location along a needle travel path of the needle guide such that the travel path crosses the same surface of the first tissue multiple times; maintaining the position of the first tissue fixed while inserting a needle along the travel path, the needle being coupled to a suture; and puncturing a second tissue with the needle so that the suture joins the first tissue to the second tissue; A method comprising: (Item 29) 29. The method of claim 28, comprising retracting the needle from the second tissue and / or from the suture such that the suture is removed from the needle. (Item 30) 29. The method of claim 28, comprising positioning the first tissue using a tissue manipulator configured to approximate the first tissue and the needle guide and position at least a portion of the tissue in the path of travel of the needle. (Item 31) 1. An apparatus comprising: an outer shell shaped to define a blunt distal end and configured to be advanced distally through an orifice of a subject and into a lumen of the subject; a needle guide configured to be advanced distally toward a target tissue of the subject and shaped to define a laterally facing cavity, the device configured to facilitate retraction of at least a portion of a wall of the lumen through the cavity and into the needle guide when the cavity is opposed to the outer shell; a suture deployment element shaped to define a piercing tip and configured to be advanced distally within the needle guide; puncturing the portion of the lumen wall while the portion is within the guide member; at least partially puncturing the target tissue; passing a suture through the puncture tip, penetrating the suture into the target tissue, and securing the portion of the lumen wall relative to the target tissue; a suture deployment element; 1. An apparatus comprising: (Item 32) the lumen of the subject comprises the rectum of the subject, the orifice comprises the anus, and the target tissue comprises the sacrospinous ligament; the shell is configured to be advanced distally through the anus and into the rectum; the needle guide is configured to be advanced distally toward the sacrospinous ligament; The suture deployment element includes: puncturing the portion of the tissue of the rectal wall while the portion is within the guide member; at least partially puncturing the sacrospinous ligament; passing a suture through the puncture tip and deploying at least a portion of the suture within the sacrospinous ligament to secure the rectal wall to the sacrospinous ligament; Item 32. The apparatus of item 31, configured to perform the following: (Item 33) Item 31. The device of item 30, wherein the longitudinal shell is further shaped to define one or more probes protruding from an outer surface of the shell, a portion of the lumen wall being protruded by the protrusion, the protruded portion being a portion that is retracted into the cavity. (Item 34) 34. The apparatus of claim 33, wherein (a) the probe and the cavity each comprise a separate magnetic element, the magnetic element configured to draw the portion of the wall lumen into the cavity. (Item 35) Item 34. The device of item 33, wherein the outer shell comprises a user-controllable slide bar or knob coupled to the probe, wherein distal advancement of the slide bar or rotation of the knob produces protrusion of the probe through the outer surface of the outer shell. (Item 36) 32. The device of claim 31, wherein the cavity comprises a suction port, and the device is configured to facilitate retraction of the lumen wall into the cavity by application of suction through the suction port. (Item 37) 37. The apparatus of claim 36, further comprising the suction source. (Item 38) Item 32. The apparatus of item 31, further comprising a reporting sensor configured to generate a reporting signal when the portion of the lumen wall is retracted into the cavity of the needle guide. (Item 39) Item 39. The apparatus of item 38, wherein the reporting sensor comprises an illumination source. (Item 40) 32. The apparatus of claim 31, further comprising the suture. (Item 41) 32. The device of claim 31, wherein the puncture tip is configured to puncture the wall of the lumen without passing through the lumen. (Item 42) 32. The device of claim 31, wherein the device is configured to be retracted proximally following deployment of the portion of the suture. (Item 43) 32. The device of claim 31, wherein the outer shell comprises a user-controllable slide bar at a proximal portion of the outer shell configured to control distal advancement of the outer shell through the lumen. (Item 44) 32. The device of claim 31, wherein the needle guide is shaped to define a needle guide wall, at least a portion of which is transparent. (Item 45) Item 32. The device of item 31, wherein at least a portion of the blunt distal end of the outer shell is dome-shaped.
Claims
1. 1. A tissue fixation system, comprising:
1. A needle guide having an elongated structure extending between a first end portion and a second end portion, the elongated structure comprising: a cavity between the first end portion and the second end portion, the cavity configured to receive a portion of tissue; and a lumen configured to receive a needle connected to a suture, the lumen including a first lumen portion extending between the first end portion and the cavity and a second lumen portion extending between the second end portion and the cavity; a needle guide having a tissue manipulator having one or more deployable probes configured to direct the portion of the tissue into the cavity; Equipped with The tissue fixation system is configured such that the one or more deployable probes direct the portion of the tissue into the cavity and, when the needle is advanced through the lumen, the needle traverses the cavity and punctures the portion of the tissue as the needle moves from the first lumen portion to the second lumen portion.
2. 10. The tissue fixation system of claim 1, wherein the portion of tissue has an outer surface and an inner surface, and the tissue fixation system is configured to pierce the outer surface in at least two locations without piercing the inner surface.
3. the cavity having an inner surface, a first outer surface, and a second outer surface; the first exterior surface has a first opening in fluid communication with the first lumen portion; the second exterior surface has a second opening in fluid communication with the second lumen portion; 2. The tissue fixation system of claim 1, wherein the first opening and the second opening are configured to receive the needle when the needle is advanced through the lumen from the first lumen portion to the second lumen portion.
4. 4. The tissue fixation system of claim 3, wherein the tissue fixation system is configured such that when the needle is advanced from the first opening to the second opening, the needle penetrates a portion of the tissue between the one or more deployable probes and the interior surface of the cavity.
5. The tissue fixation system of claim 1 , wherein the geometry of the one or more deployable probes is complementary to the geometry of the cavity.
6. The tissue fixation system of claim 1 , wherein the one or more deployable probes are transitionable between a low-profile delivery configuration and a deployed configuration.
7. 1. A system comprising: a needle guide defining a path of travel for a needle inserted therethrough, the needle being connected to a suture; a tissue manipulator having one or more deployable probes configured to approximate tissue and the needle guide and position at least a portion of the tissue in the path of travel of the needle; Equipped with The system wherein the tissue manipulator and the needle guide are alignable so that the path of travel crosses the same surface of the tissue multiple times.
8. The system of claim 7 , wherein the needle guide comprises a cavity configured to accommodate at least a portion of the tissue manipulator.
9. The system of claim 8 , wherein the travel path is exposed by the cavity.
10. The system of claim 7 , wherein the one or more deployable probes comprise a light-emitting element.
11. The system of claim 7 , wherein the tissue manipulator comprises an outer shell, and at least one of the one or more deployable probes extends radially outward from the outer shell.
12. The system of claim 11, wherein the tissue manipulator comprises a handle, and one of a length, a position, and a spatial orientation of an extension of the at least one of the one or more deployable probes is adjustable relative to the handle.
13. The system of claim 7 , wherein the geometry of at least a portion of the needle guide and the geometry of at least a portion of the tissue manipulator are complementary.
14. The system of claim 7 , wherein at least a portion of the tissue manipulator is flexible.
15. 8. The system of claim 7, wherein the tissue manipulator comprises a first magnet and the needle guide comprises a second magnet, the first magnet configured to be attached to the second magnet, and the second magnet configured to be attached to the first magnet.
16. The system of claim 8 , wherein the needle guide comprises a second opening configured to direct an exit path of the needle out of the needle guide.
17. The system of claim 16 , wherein the second opening of the needle guide is configured to couple to tissue of a target.
18. 17. The system of claim 16, wherein the needle guide further comprises a slot between the cavity and the second opening, the slot spanning the entire thickness of the needle guide wall, the slot configured to allow the suture to be released from the needle guide.
19. 8. The system of claim 7, wherein the needle guide is configured to couple to a tissue-covered tissue manipulator and to independently maintain its spatial orientation relative to the tissue-covered tissue manipulator.
20. 8. The system of claim 7, wherein the needle guide comprises a clip, the spatial orientation of the needle guide is independently maintained fixed relative to the tissue manipulator, and the path of travel crosses the same surface of the tissue multiple times.
21. 1. An apparatus comprising: a tissue manipulator shaped to define a blunt distal end, the tissue manipulator having one or more deployable probes, the tissue manipulator configured to be advanced distally through an orifice of a subject and into a lumen of the subject; a needle guide configured to be advanced distally toward a target tissue of the subject, the needle guide shaped to define a side-facing cavity, the one or more deployable probes configured to facilitate retraction of at least a portion of a wall of the lumen through the side-facing cavity and into the needle guide when the side-facing cavity faces the tissue manipulator; a suture deployment element shaped to define a piercing tip, the suture deployment element configured to be advanced distally within the needle guide; The suture deployment element includes: puncturing the portion of the wall while the portion is within the needle guide; at least partially puncturing the target tissue; passing a suture through the piercing tip and penetrating the suture into the target tissue to secure the portion of the wall relative to the target tissue; a suture deployment element configured to An apparatus comprising:
22. the lumen of the subject comprises the rectum of the subject, the orifice comprises the anus, and the target tissue comprises the sacrospinous ligament; the tissue manipulator is configured to be advanced distally through the anus and into the rectum; the needle guide is configured to be advanced distally toward the sacrospinous ligament; The suture deployment element includes: puncturing the portion of the wall while the portion is within the needle guide; at least partially puncturing the sacrospinous ligament; passing the suture through the puncture tip and deploying at least a portion of the suture within the sacrospinous ligament to secure the rectum against the sacrospinous ligament; 22. The apparatus of claim 21 configured to:
23. 23. The device of claim 21 or claim 22, wherein the tissue manipulator further comprises a longitudinal shell, the one or more deployable probes are configured to protrude from an outer surface of the longitudinal shell, and a portion of the wall is protruded by the one or more deployable probes, the protruding portion being a portion that retracts into the laterally facing cavity.
24. 24. The device of claim 23, wherein each of the one or more deployable probes and the laterally-facing cavity comprises a respective magnetic element, the magnetic element configured to draw the portion of the wall into the laterally-facing cavity.
25. 24. The device of claim 23, wherein the tissue manipulator comprises a user-controllable slide bar or knob coupled to the one or more deployable probes, wherein distal advancement of the slide bar or rotation of the knob generates protrusion of the one or more deployable probes through the outer surface of the longitudinal shell.
26. 22. The device of claim 21, wherein the laterally facing cavity comprises a suction port, the device being configured to facilitate retraction of the wall into the laterally facing cavity by application of suction through the suction port.
27. 27. The device of claim 26, wherein the device further comprises a suction source.
28. 22. The device of claim 21, further comprising a reporting sensor configured to generate a reporting signal when the portion of the wall is retracted into the needle guide cavity.
29. 30. The apparatus of claim 28, wherein the reporting sensor comprises an illumination source.
30. 22. The device of claim 21, wherein the device further comprises the suture.
31. 22. The device of claim 21, wherein the puncture tip is configured to puncture the wall of the lumen without passing through the lumen.
32. 22. The device of claim 21, wherein the device is configured to be proximally retracted following deployment of the suture portions.
33. 22. The apparatus of claim 21, wherein the tissue manipulator comprises a user-controllable slide bar at a proximal portion thereof configured to control distal advancement of the tissue manipulator through the lumen.
34. 22. The device of claim 21, wherein the needle guide is shaped to define a needle guide wall, at least a portion of which is transparent.
35. 22. The device of claim 21, wherein at least a portion of the blunt distal end of the tissue manipulator is dome-shaped.
Citation Information
Patent Citations
JP1977052389U
Suture device
JP1998500318A
Treatment tool for fluorescent observation endoscope
JP2004024618A
Suture instrument for endoscope
JP2010036024A