Source: http://www.google.com/patents/US20060009789?dq=5639005
Timestamp: 2018-01-20 22:07:40
Document Index: 183731098

Matched Legal Cases: ['Application No. 60', 'art 460', 'art 460', 'arts 460', 'arts 460', 'arts 460', 'arts 460', 'art 460', 'art 460', 'arts 460', 'arts 460', 'art 460', 'arts 460', 'arts 460']

Patent US20060009789 - Tissue capturing devices - Google Patents
The present invention provides tissue capture devices configured to hold tissue in a distorted configuration. The devices may hold precaptured tissue in a distorted configuration or it may change their shape to cause the tissue to become deformed. Some embodiments of the device alter the configuration...http://www.google.com/patents/US20060009789?utm_source=gb-gplus-sharePatent US20060009789 - Tissue capturing devices
Publication number US20060009789 A1
Application number US 11/199,955
Also published as EP1542598A2, EP1542598A4, US20040138704, US20110092990, WO2004021872A2, WO2004021872A3, WO2004021872A9
Publication number 11199955, 199955, US 2006/0009789 A1, US 2006/009789 A1, US 20060009789 A1, US 20060009789A1, US 2006009789 A1, US 2006009789A1, US-A1-20060009789, US-A1-2006009789, US2006/0009789A1, US2006/009789A1, US20060009789 A1, US20060009789A1, US2006009789 A1, US2006009789A1
Inventors Richard Gambale, Michael Weiser
Patent Citations (99), Referenced by (226), Classifications (28)
US 20060009789 A1
10. A tissue capturing element comprising:
an internal tissue contacting portion;
an external tissue portion;
a tissue contacting anchor for engaging tissue; and
a securement mechanism that when engaged causes the tissue engaged by the tissue contacting anchor to be retained in distorted form.
11. A tissue capturing element comprising:
one or more tissue contacting anchors for engaging tissue, where each tissue contacting anchor is attached to an internal tissue contacting portion, and where each internal tissue contacting portion is connected to a securement portion, and where the securement portion holds the tissue in distorted form when the securement portion is engaged.
12. A method of capturing tissue in a distorted form comprising:
providing a tissue capturing element having an exterior tissue portion, an interior tissue contacting portion, a tissue contacting anchor for engaging tissue, and a securement mechanism;
engaging the tissue capturing element with tissue so that the interior tissue contacting portion and tissue contacting anchor are contained within the subject tissue;
engaging the securement mechanism so that the tissue engaged by the tissue contacting anchor is captured in distorted form.
13. A method of capturing tissue in a distorted form, comprising:
providing a tissue contacting element comprising one or more tissue contacting anchors for engaging tissue, where each tissue contacting anchor is attached to an internal tissue contacting portion, and where each internal tissue contacting portion is connected to a securement portion, and where the securement portion holds the tissue in distorted form when the securement portion is engaged;
engaging the tissue capturing element with tissue so that the interior tissue contacting portion and tissue contacting anchor are contained within the subject tissue; and
This application is a divisional of U.S. application Ser. No. 10/658,619, filed Sep. 8, 2003, now abandoned, which claimed benefit of U.S. Provisional Application No. 60/408,554, filed on Sep. 6, 2002. The entire teachings of the above applications are incorporated herein by reference. The subject matter of the present application is also related to the disclosure document filed at the U.S. Patent and Trademark Office on Sep. 7, 2000, and assigned Disclosure Document No. 479569.
FIG. 16A-16B are side sectional views of a tissue capture device placed through tissue and experiencing a removal of a coating to expose a roughened surface that captures the tissue;
FIG. 22 shows a side sectional view of a tissue implant device comprising a reverse wound spring;
FIG. 25 is a side sectional view of the tissue capture device configured as a dart with flexible tether implanted in tissue and secured;
Independent vacuum supply to the air passages of each chamber not only helps to ensure adequate vacuum pressure to each chamber, but also permits sequential suctioning of tissue into the chambers. When tissue is collected into both chambers simultaneously, the distal chamber is blocked from the viewing lens 48 on the distal face 46 of the endoscope 1, as shown in FIG. 5. Therefore, the physician is unable to visually determine whether tissue has been adequately collected into the vacuum chamber so that the needle 80 can be safely advanced through. By applying vacuum first to the distal chamber, tissue collection into that chamber can be visually verified before the view is blocked by tissue entering the proximal chamber. Next, vacuum can be applied to the proximal chamber to capture tissue so that tissue is collected in both chambers simultaneously and held in readiness for penetration by the suture needle (or staple) through both tissue portions with one-stroke. However, even with independent vacuum lines, it is possible, and may be desirable to apply a vacuum to all chambers simultaneously.
FIG. 6C shows another embodiment of the multiple port tissue apposition device in which the suction ports are arranged side-by-side rather than longitudinally in line as were the above-described embodiments. The suturing capsule 200 has a tissue capture mechanism comprising two or more suction ports 202 that arranged side-by-side, angularly offset but substantially aligned with each other longitudinally (referring to the longitudinal axis of the capsule and endoscope). The suction ports 202 define openings into the capsule 200 and are separated by partition 204. As with the previous embodiments, suction ports 202 open to a vacuum chamber 206 defined by sidewalls 208 inside the capsule 200. As with the above embodiments, vacuum is created in the vacuum chambers through negative pressure introduced by air passages 88 (not shown) to cause tissue to be drawn into the vacuum chambers through suction ports 202. The air passages are in communication with vacuum channel 234 formed through the capsule body and joinable to a vacuum channel 4 of the endoscope or an independent vacuum line.
FIG. 8A shows a nitinol capture device 302 having a V-shape with two prongs 304 each inserted into the top of a separate tissue mound 306 that had been previously manipulated into the mound shape by separate means such as one of the devices discussed above. As shown in FIG. 8B, the nitinol capture device is preformed so that upon exposure to the elevated temperature of surrounding body tissue, the prongs 306 that extend into the tissue undergo a configuration change due to the shape memory effect of the nitinol. In this example, the nitinol is preconditioned to form zigzags 308 through each prong 304 extending through a tissue mound 306. Transformation to a sinusoidal or zigzag shape as shown by 308 in FIG. 8B serves to hold each prong 304 in the tissue bound 306 so that it is not easily removed through the mound. The V-shape of the capture device 302 is maintained, despite the shape memory change of the nitinol material in order to maintain the captured tissue mounds 306 held together in close proximity as is shown in the figures. It is contemplated that the capture device could be delivered endoscopically in a multiple suction port tissue apposition device such as that shown in FIG. 6. The tissue capture mechanism could be arranged in the suction port such that each of the prongs 304 upwardly and outwardly in each of the ports so as tissue is sucked into the port, the prongs will be driven into each tissue mound that is formed and captured by the device.
FIG. 11A shows another capture device, similar to the embodiments of FIGS. 8B and 9B, but incorporating an umbrella anchor 324 at the free end of each prong 322. The capture device is inserted into the pre-formed tissue mounds 306 with the prongs 322 in a straight configuration as shown in FIG. 11A. After implantation, the prongs 322 have expanded at their free ends. Small umbrella anchors 324 to hold the device in the tissue. The mechanism for expansion of the umbrella anchors may be shape memory effect if the device is formed from nitinol or may be resilient expansion if the device is formed from stainless steel. If formed from stainless steel, it is expected that a confining sheath will be placed over the umbrella anchors 324 during insertion into the tissue to maintain them in a low profile. After implantation, the sheath may be removed from the device to permit resilient expansion of the anchors. The device may be delivered to the captured tissue mounds 306 by a multiple chamber suction device such as shown in FIG. 6, each prong of the device may be delivered separately by an axially oriented suction device such as the ligator device shown in FIGS. 7A-7C.
The device 340 may be placed in a single mound 306 of pre-captured tissue, as is shown in FIG. 12A. To pre-capture the mount of tissue 306, an endoscopic ligator device 112 such as that discussed above in connection with FIG. 7A-7C may be employed. As shown in FIG. 12A, an endoscope 118 carrying a ligator 112 is navigated to a tissue location and a mount of tissue 306 aspirated into the suction chamber of the ligator. A ligating band 134 is advanced distally from the device to surround the aspirated tissue mound 306 as described above in the operation of the device. Next, the device 340 may be advanced distally into the top of the tissue mound 306. The device may be advanced by a slidable pusher 346 extending through the working channel of the endoscope 118 and having an device engaging member 348 at its distal end. The device is advanced so that the prongs 342 become embedded into the tissue. The cross member 344 becomes flush with the top of the tissue mound where it becomes slightly embedded when the device is fully seated (FIG. 12B).
FIG. 13D shows another shape memory transformation possibility where the free ends of the device 350 are configured to undergo a shape change transformation in which they wrap around a side of each mound 306 and become engaged with each other in a twisted form 356.
FIGS. 14A and 14B show another embodiment of a tissue capture device 360 that operates to bring a plurality of tissue mounds together by a shape transformation in areas of the device that remain external to the tissue after implantation. The tissue capture device 360 comprises two or more prongs 366 joined by a deformable bridge 364 to define a generally U-shaped implant. Prior to and during implantation, the bridge 364 is maintained in a relatively straight configuration by a removable brace 362 so that the prongs 366 remain spaced apart in a U-shaped configuration that is easy to insert into pre-captured tissue mounds 306 (FIG. 14A). The bridge 364 is preferably formed from a different material from that of the prongs 366 and has a predefined and unrestrained configuration that is more compact so as to draw the ends of the prongs 366 closer together to draw captured tissue portions together after release of the device. As shown in FIG. 14B, the bridge 364 may transform into a loop or coil to reduce the length of the bridge and draw the prongs 366 closer. The inherent predefined shape of the bridge may be caused by resilient spring tension in the case of the stainless steel bridge member or may be a preformed shape memory configuration if formed from nitinol. To temporarily hold the bridge in a straight configuration during implantation, the bridge is held in a straight form and has molded around it a biodegradable polymer of sufficient strength to maintain the bridge in the straight configuration. After some exposure to the interior of the human body, the brace 362 degrades and ultimately releases the bridge section to reform into its unrestrained configuration as shown in FIG. 14B.
FIGS. 15A and 15B show another tissue capture device 370 implantable into a plurality of tissue mounds 306 and deformable on its external surfaces to bring the tissue mounds in close proximity. The device comprises a pair of tissue prongs 372 arranged substantially parallel to each other and linked together at their proximal ends by an adjuster 374. The adjuster 374 is slidable along both of the prongs such that sliding in the distal directions serves to bring the prongs together to a fixed distance that is in close proximity to one another. In use, the device 370 is delivered to a tissue location in which two tissue mounds of pre-captured to delivery by a device such as that shown in FIG. 6. The device 370 is inserted such that each of the prongs 372 is inserted into the top of a tissue mound 306, as shown in FIG. 15A. After implantation, the adjuster 374 is advanced distally over the ends of the prongs 372 so that the prongs are brought together along with the tissue portions 306 into which they are then inserted, as shown in FIG. 15B.
FIGS. 17A and 17B show another embodiment of a tissue capture device 390 that is inserted into captured tissue mounds 306 into separate components that are later joined together and after insertion to pull the tissue mounds 306 in close proximity. The device 390 may comprise a helical spring that is implanted into the tissue by rotating such that the helical winding is screwed into the tissue. The individual coils 392 serve to capture the device 390 and the tissue mound 306. As mentioned above, a second coil device 390 is placed in an adjacent tissue mound during the insertion process. The implantation process may be carried out using a device similar to that shown in FIG. 6 in which two tissue mounds 306 are captured simultaneously. The coil spring may then be delivered longitudinally through the mounds along the longitudinal axis of the device, such as through the working channel of an endoscope. A rotational element can be introduced into the working channel to rotate the springs through the tissue. Use of such a device capable of capturing both tissue mounds simultaneously, will ensure proper spacing between the tissue mounds that are to be joined together. However, the spring devices 390 may be introduced individually through tissue mounds that are captured separately.
FIG. 18 shows an alternate delivery method for a spring coil type tissue capture device 400. In the delivery method, the spring coil 400 is delivered through the lumen of a catheter or a working channel of an endoscope 402 with the spring in a straightened, uncoiled configuration, shown in FIG. 18A. As the spring coil is pushed through the lumen distally, it emerges through the side port 404 and resumes its coiled configuration forming coils 406 at a right angle to the linear advancement of the straightened portion of the device. As the coils 406 reform, they rotate about an axis that is perpendicular to the linear motion of the straightened portion of the device. The rotating coils penetrate the captured tissue mounds 306 so that the device becomes implanted to capture both mounds in close proximity as shown in FIG. 18B. After the coil 400 has been fully advanced by a longitudinal pusher 408 extending through the lumen of the catheter or endoscope, the device 400 will be shaped entirely of coils 406 to secure the tissue mounds 306 together.
FIGS. 19A-19C show additional tissue capture device embodiments 410, 418 and 424 that are implantable directly into captured tissue mounds and have barbs 412 to prevent the device from becoming withdrawn from the captured tissue portions after implantation. In FIG. 19A the device 410 is provided with multiple barbs 412 spaced along each prong 414 provided for insertion into each captured tissue mound 306. In FIG. 19B a single barb 412 is provided on each prong 420. In FIG. 19C the tissue capture device 424 is provided with a single barb 412 on each prong 422 as with the embodiment described above in connection with FIG. 19B. However, the device 424 further includes a tab 426 serving as a junction for the ends of each prong 412. The tab 426 provides a convenient means for varying the number of prongs 412 that can extend from a given device. In other words, two, three or more tissue mounds could be captured with a single device by providing the necessary number of prongs and joining them together at the tab 426. Additionally, the tab is beneficial in stabilizing the device during implantation. It is noted that each of the embodiments shown in FIGS. 19A-19C may be formed from flexible stainless steel that is resiliently bendable. The devices maintain their shape (generally U-shaped) but may be deflected as required during insertion into the tissue mounds 306. It is noted that the barbs 412 may be deflected to a low profile configuration during insertion into the tissue, but if provided with an arrow shape, they will become anchored within the tissue upon application of a withdrawal force on the device.
FIG. 20 shows a tissue capture device 430 that may be molded as a single element having a linear interior tissue portion 432 that is inserted through pre-captured tissue mounds 306. The device 430 further comprises an external portion 434 configured to loop around the captured tissue mounds 306 and engage the linear interior tissue portion 432 at contact points 436 that remain exterior to the tissue to lock the device 430 in place. The exterior portion 434 may be flexible or semi-rigid and may hook onto the straight portion such as a safety pin may be flexed into a catch to be placed in a locked position at contact points 436.
FIG. 21 shows another embodiment of the tissue capture device that may be inserted through pre-captured tissue portions 306 and lock the portions together without undergoing a configuration change in areas that remain inside the tissue. The device 440 may comprise a single linear element of sufficient length to extend through a desired number of adjacent tissue portions 306. The interior tissue portions 444 remain unchanged after implantation. However, the device 440 is locked in position within the tissue by locking discs 442 applied at the proximal and distal ends of the device where it protrudes from the tissue portions. The device may be applied by a tissue apposition device as shown in FIG. 6, with the linear device being inserted along the longitudinal axis of the device, through the working channel of the endoscope, when the tissue mounds 306 are collected in the suction ports. The proximal blocking disc 442 may be in place already while the linear device is advanced distally such that it is inserted through the distal locking disc 442. The locking disc may comprise a commonly available locking washer having a small center cut out consisting of a hole with several radial slots extending therefrom that serves to lock around a cylinder to prevent sliding motion of the disc relative to the cylinder by virtue of the slotted surfaces of the disc biting into the surface of the cylinder when relative motion is applied. The device in FIG. 20 may also be delivered through the tissue apposition device of FIG. 6 with the external portion 434 disengaged from contact points 436 so that the linear interior portion 432 can be inserted through the captured tissue mounds 306 from the working channel of the endoscope. By secondary device, the external portion 434 may be latched onto the contact points 436 of the device such as an endoscopic forceps device. To facilitate the positioning of the exterior portion 434, it may be pre-attached to the proximal contact point 436 of the device that need not be inserted through a tissue portion.
FIG. 22 shows another embodiment of a tissue capture device delivered into pre-captured tissue mounds that does not require a shape change after delivery to attain the tissue mounds in close proximity to each other. The device 450 comprises a helical coil spring that is wound in two opposing helical directions. A proximal portion of the spring 452 is wound in a first helical direction while the distal portion 454 of the spring is wound in the opposite helical direction so that once implanted in the tissue, each end of the spring will restrain the other end from unwinding out of the tissue. The spring is preferably wound from a flat metal ribbon to provide a greater contact area with the tissue. The ribbon may be canted so that the cross section of each coil 456 presents an angle that is acute to the longitudinal axis of the spring coil 450. To deliver the device, the tissue apposition device as shown in FIG. 6 may be used to pre-capture the multiple tissue mounds 306. The device 450 may be delivered longitudinally through the tissue mounds in a hypotube or hypodermic needle then pushed out of the tubing while placed within the tissue to avoid interference of the reverse wound coils of the device with the tissue during insertion.
FIG. 23 shows another embodiment of the tissue capture device employing a rigid device configured as a dart for penetrating and becoming retained in an area of tissue. The dart 460 is configured to have a penetrating distal tip 462, possibly with an arrowhead shape to resist migration from the tissue after implantation. Extending proximally from the arrowhead 462 is a straight stem portion 464 that terminates in a tether receptacle portion 468 having a tether hole 466 for receiving a tether 470 to join the dart 460 to other darts 460 placed in adjacent tissue areas as shown in FIG. 23B. FIG. 23B shows in diagrammatic fashion the placement of several tissue capture darts 460 in adjacent areas of tissue. The multiple darts are joined together by a tether 470, which when pulled tightly through the several darts, gathers the darts together and serves to pull the penetrated tissue areas into mounds 306.
A device for delivering multiple darts to a plurality of tissue areas is shown in FIGS. 24A-24G. The dart delivery device 472 may be similar to the prior art band ligator device shown in FIGS. 7A-7C. The delivery device 472 is configured to be mounted at the distal end of an endoscope 118 as shown in FIG. 24A and comprises a slender pole suction chamber 474 with a supple distal tip 476 for engaging tissue areas and for creating a relatively vacuum tight seal such that when suction is applied to the chamber 474, a tissue mound 306 is drawn into the chamber. The suction chamber also supports along the center of its longitudinal axis a rotatable auger spring 478 for driving the darts distally into the captured tissue mound 306. The spring 478 rotates under motion from torque cable 480 that extends through the working channel of the endoscope 118 and joins the spring in the suction chamber 474. Multiple darts 460 reside between the coils 482 of the spring such that coils fit closely against the stem portion 464 of the dart and abut the enlarged penetrating tip 462 and tether receptacle 468. In this engagement, when the spring rotates, the darts 460 will be advanced as a ride between the individual coils 478. As shown in FIG. 24B, continued rotation of the auger spring 478 serves to drive the first distal dart 460 into the captured tissue mound 306. The darts are pre-loaded with a tether 470 that is not yet tightened so that the darts can be aligned longitudinally in the auger spring for sequential delivery. FIG. 24C shows a dart fully seeded into a tissue mound 306 such that the penetrating tip 462 and stem 464 are embedded in the tissue mound and the tether receptacle 468. After implantation of the first dart, the vacuum is released and the delivery device 472 moved to a new tissue location. As shown in FIG. 24D, a new tissue mound is aspirated into the suction chamber 474 and as shown in FIG. 24E, the auger spring 478 is rotated to advance the second dart 460 into the second tissue mound 306. Tether 470 remains joined to both the first and second darts 460 throughout the delivery process. After delivery of the second dart, the vacuum may be released, leaving the implanted darts 460 in tissue that has returned to its natural configuration. Tether key 482, which has also been advanced in line behind the darts by the rotation of the auger spring 478, receives the free end of the tether 470. After delivery of the second dart 460, the auger spring 478 is rotated and reversed to draw the tether key 482 proximally in order to tighten the tether 470 between the two implanted darts 460 as is shown in FIG. 24F. The tether hole 466 of the tether receptacle 468 of each dart may be configured to receive the tether 470 in a ratcheted fashion such that the tether passes freely in one direction (i.e., the direction of tightening) but is locked and prevented from sliding in the opposite direction (i.e., the direction that loosens the tether between the two darts). Such a ratcheting configuration may be similar to that of the locking disc described in the embodiments of FIG. 21. As shown in FIG. 25, after the tether 470 has been pulled to draw the two implanted darts 460 together, the tissue into which they are implanted again form defined mounds 306 with perhaps some additional folds 484 present between the captured mounds. After the tether has been tightened sufficiently, the tether key 482 can be triggered to release the free end of the tether so that the delivery device 472 can be removed from the tissue location.
FIG. 26A shows an embodiment of the invention employing a tissue apposition device configured as a band ligator such as that shown in FIG. 7A-7C discussed above. The band ligator is advanced to adjacent tissue portions, tissue mound 306 aspirated in bands 134 released on the tissue mounds and endoscopic band ligator instrument removed, shown in FIG. 26B. Next, a separate tissue capture delivery device 474 is advanced to the adjacent tissue mounds 306, now defined by ligating bands 134, temporarily placed around them. A tissue capture device 476 comprising a length of filament material and having arrow shaped barbs at each end is then advanced from the delivery device 474 directly into one of the tissue mounds 306 with continued advancement by pusher 478 so that at least one of the barbs 480 from the tissue capture device reaches the adjacent tissue mound 306 as shown in FIG. 26C. With each tissue mound 306 receiving an opposite facing barb 480, the mounds will be held in close proximity. After delivery of the tissue capture device 476, the bands either may be cut away from the tissue portions or may be made of a dissolvable material so that the tissue mounds 306 are left with only the capture device 476 placed to hold them together as shown in FIG. 26D.
FIGS. 27A-27D show another embodiment of the tissue capture device that may be implanted into tissue that is not pre-deformed by aspiration or a ligating band. The tissue capture device 482 comprises a nitinol substrate base 490 from which projects a plurality of tissue piercing prongs 492 having barbs 494 at their ends. The capture device may be delivered through a catheter or endoscope 486, advanced by a pusher 496 while being arranged laterally to its axis of penetration shown by arrow 498. (See FIG. 27A). The pusher 496 has a swivel connection 488 with the device 482 that permits the advancement through the catheter 486 in the lateral orientation. Once the device 482 is advanced distally past the end of the shaft 486, the swivel point 488 is spring loaded to rotate the device 900 so that its axis of penetration 498 is in alignment with the longitudinal access of the catheter 486 and pusher 496 so that further distal advancement of the pusher will result in penetration of the barbs 492 into the tissue 484 as shown in FIGS. 27B and 27C. After exposure to the warm internal body temperature, the nitinol base 490 having a shape memory configuration that is non-linear and compacted such as a sinusoidal shape shown in FIG. 27D transforms to its stored shape. The new shape of the base 490 causes the tissue captured by prongs 492 to become distorted and follow the shape of the base 490 as shown in FIG. 27D.
Another embodiment of the tissue capture device is shown in FIGS. 28A-28D. FIG. 28A shows a tissue capture device 500 comprising two coil spring segments 502 joined by a nitinol super elastic hypo tube 504. The super elastic hypo tube permits the device to be folded in half and advance through a catheter or endoscope 506, as shown in FIG. 28B, with the spring portions 502 leading distally-and in parallel through the scope 506. The hypo tube, positioned proximally within the lumen on the endoscope 506 is engaged by a rotational pusher 508 that engages the hypo tube 504 and uses it as a universal joint to in part rotation to both coil spring as segments 502. As the rotational pusher 508 advances distally, it imparts a rotation to the continuously bending hypo tube 504. The axis of rotation of the hypo tube 504 is parallel to the drawing page. The resulting spinning motion of the coils 502 permits them to drive into the tissue 510 as two cork screws as shown in FIG. 28C once the coil springs have fully embedded in the tissue 510, the pusher 508 may be disengaged from the hypo tube 504 and the endoscope 506 removed, when the capture devise is released, it will resiliently return to a relatively straight shape as shown in FIG. 28D. The resulting deformation of the tissue causes two distinct mounds as shown in FIG. 28D.
US5735793 * Jul 11, 1996 Apr 7, 1998 Olympus Optical Co., Ltd. Endoscope
DE102014004772A1 * Apr 1, 2014 Oct 1, 2015 Ruprecht-Karls-Universität Heidelberg Chirurgische Vorrichtung, Verfahren zum Verwenden der chirurgischen Vorrichtung und Nahtmaterial
International Classification A61B17/08, A61B17/10, A61B, A61B17/04, A61B17/00, A61B17/30, A61B17/11, A61B17/06
Cooperative Classification A61B2017/1103, A61B2017/0414, A61B17/0487, A61B2017/0458, A61B2017/0443, A61B17/0469, A61B2017/00827, A61B2017/0409, A61B2017/06171, A61B17/1114, A61B2017/0649, A61B2017/1142, A61B2017/00867, A61B2017/0464, A61B2017/308, A61B2017/00349, A61B2017/0417