Source: http://www.google.co.uk/patents/US8298291
Timestamp: 2017-12-16 09:26:14
Document Index: 691163331

Matched Legal Cases: ['Application No. 1750591', 'Application No. 1804680', 'Application No. 1804683', 'Application No. 1863389', 'Application No. 1901665', 'Application No. 2007511613']

Patent US8298291 - Methods and apparatus for securing and deploying tissue anchors - Google Patents
Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a...http://www.google.co.uk/patents/US8298291?utm_source=gb-gplus-sharePatent US8298291 - Methods and apparatus for securing and deploying tissue anchors
Publication number US8298291 B2
Application number US 11/412,261
Also published as US20060271074, WO2006127306A2, WO2006127306A3
Publication number 11412261, 412261, US 8298291 B2, US 8298291B2, US-B2-8298291, US8298291 B2, US8298291B2
Inventors Richard C. Ewers, Cang C. LAM
Patent Citations (603), Non-Patent Citations (58), Referenced by (26), Classifications (21), Legal Events (8)
US 8298291 B2
Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically by applying thermal energy through at least one suture cutting element disposed along the deployment assembly.
1. A tissue anchor deployment system, comprising:
an elongate flexible shaft having a proximal end attached to the housing and a distal end having a tissue piercing tip, and with a lumen extending through the elongate flexible shaft;
an elongate pusher slidable within the elongate shaft;
a release suture within the elongate shaft;
a stop fixed to a portion of the release suture, with the stop having a diameter sized to inhibit movement through at least part of the elongate pusher member;
a plug member slidably located along the release suture proximal to the stop;
a retraction control member attached to a proximal end of the release suture; and
an anchor assembly within the lumen of the elongate shaft at a position distal of the elongate pusher member, the anchor assembly comprising a distal anchor connected to a proximal anchor via a flexible connector;
wherein a distal end of the release suture is releasably engaged to the flexible connector of the anchor assembly.
2. The system of claim 1 further comprising a guide in the housing, with the guide including a channel.
3. The system of claim 2 wherein the guide further defines at least a first locking position along the housing.
4. The system of claim 3 wherein the guide further defines at least a second locking position along the housing.
5. The system of claim 2 further comprising an actuation member translatable along the guide and attached to a proximal end of the elongate pusher member.
6. The system of claim 5 wherein the actuation member comprises a carriage slidably positioned within the housing, the carriage defining a lumen through which the release wire is disposed.
7. The system of claim 1 wherein the elongate flexible shaft comprises a catheter shaft.
8. The system of claim 1 wherein the tissue piercing tip comprises a needle body having a lumen defined therethrough.
9. The system of claim 1 wherein the elongate pusher member further comprises a coiled body which is adapted to provide column support when pushed or pulled through the elongate flexible shaft.
10. The system of claim 1 wherein the plug member comprises one or more expandable arms projecting radially from a plug body in an expanded configuration and over or around the stop in a low-profile configuration.
11. The system of claim 10 wherein the one or more expandable arms are positionable around the stop such that distal ends of the one or more expandable arms are constrained within a proximal end of a carriage positioned within the housing.
12. The system of claim 1 wherein the retraction control member comprises a threaded attachment for connection to the housing.
13. The system of claim 1 wherein the release suture is within the pusher lumen extending through the elongate pusher.
14. The system of claim 13 wherein the release suture forms a loop within the pusher lumen.
15. The system of claim 1 wherein, the release suture forms a loop through the elongate shaft.
16. The system of claim 1 wherein a terminal end of the flexible connector is passed at least partially through or around the release suture within the elongate shaft.
17. The system of claim 1 further comprising a locking mechanism slidably positioned along the flexible connector between the tissue anchor assembly and the elongate pusher member.
18. The system of claim 1 further comprising a tissue grasping tool pivotably coupled to a distal end of an outer flexible shaft and adapted to be advanced endoluminally into a body lumen, wherein the elongate flexible shaft with the distal end having a tissue piercing tip is sized for advancement through the outer flexible shaft and through the tissue grasping tool.
19. The system of claim 18 wherein the tissue grasping tool comprises a first jaw member pivotably coupled to a distal end of the outer flexible shaft, a second jaw member pivotably coupled along the first jaw member, and a launch tube member adapted to urge the first and second jaw members between a low-profile delivery configuration and an expanded grasping configuration.
20. The system of claim 18 further comprising a tissue engagement device having a helical tissue engager adapted to reversibly engage tissue and further adapted to be positioned endoluminally within the body lumen adjacent to the tissue grasping tool.
21. The system of claim 18 further comprising an endoluminal elongate body adapted to transition between a flexible state, and a rigid state, wherein the tissue grasping tool and the elongate flexible shaft are removably advanceable therethrough.
22. The system of claim 1 with the release suture comprising a wire.
The present application is a continuation-in-part of U.S. patent application Ser. No. 11/238,543 filed Sep. 30, 2005, which is a continuation-in-part of U.S. patent application Ser. No. 11/139,920 filed May 26, 2005, each of which is incorporated herein by reference in its entirety.
The present invention relates to methods and apparatus for securing and deploying tissue anchors. More particularly, the present invention relates to methods and apparatus for endoluminally or laparoscopically securing and deploying anchors within or against tissue, for instance, to form and/or secure tissue folds or to approximate regions of tissue, etc.
A tissue manipulation assembly may be located at the distal end of the tubular body and is generally used to contact and form tissue folds, as mentioned above. The tissue manipulation assembly may be connected to the distal end of the tubular body via a pivotable coupling, and a lower jaw member may extend distally from the pivotable coupling with an upper jaw member, in this example, pivotably coupled to the lower jaw member via a jaw pivot. The location of the jaw pivot may be positioned at various locations along the lower jaw depending upon a number of factors, e.g., the desired size of the “bite” or opening for accepting tissue between the jaw members, the amount of closing force between the jaw members, etc. One or both jaw members may also have a number of protrusions, projections, grasping teeth, textured surfaces, etc., on the surface or surfaces of the jaw members to facilitate the adherence of tissue therebetween.
Once the one or more tissue anchors having been deployed, the tissue may be secured via an anchor deployment assembly, which may generally comprise an elongate member adapted for advancement within a body lumen of the patient and being further adapted to deploy at least one tissue anchor having a length of suture depending therefrom, wherein the elongate member comprises a suture cutting element disposed thereon which is adapted to sever a portion of the suture via thermal energy.
FIG. 12 illustrates yet another variation of the tissue manipulation assembly which may also utilize a pull wire connected directly to the launch tube.
FIG. 13 illustrates an exploded view of a variation of an anchor assembly and needle deployment assembly.
FIG. 14 illustrates an assembly view, partially in section, of the anchor assembly and needle deployment assembly variation of FIG. 13.
FIGS. 15A to 15F illustrate an exemplary method of using the anchor assembly and needle deployment assembly variation of FIGS. 13 and 14.
FIG. 16 illustrates a variation of the suture element for use with the anchor assembly and needle deployment assembly of FIGS. 13 to 15.
FIG. 17 illustrates a variation of the needle for use with the anchor assembly and needle deployment assembly variation of FIGS. 13 to 15.
FIG. 18 illustrates a variation of the control mechanisms for use with the needle deployment assemblies of FIGS. 13 to 17.
FIGS. 19A to 19C illustrate an exemplary method of using another variation of the anchor assembly and needle deployment assembly.
FIGS. 20A to 20C are schematic views illustrating another variation of the needle deployment assembly.
FIGS. 21A to 21C illustrate another variation of the needle deployment assembly utilizing a release suture or wire which may be routed through a looped terminal end of a suture element.
FIGS. 22A to 22C illustrate yet another variation of the needle deployment assembly utilizing a reconfigurable hook element which may configure itself from a hooked configuration to an open or straightened configuration.
FIGS. 23A to 23C illustrate yet another variation of the needle deployment assembly utilizing a release suture or wire with an obstructive element to be released from the release suture or wire.
FIGS. 24A to 24C illustrate yet another variation of the needle deployment assembly utilizing a suture cutting thermal element for releasing the suture and anchor assembly.
FIGS. 25A and 25B show partial cross-sectional side and assembly views, respectively, of the suture cutting thermal element assembly of FIGS. 24A to 24C.
FIGS. 26A and 26B show side and partial cross-sectional views, respectively, of another suture cutting thermal element.
FIGS. 27A and 27B show partial cross-sectional side and end views of yet another suture cutting thermal element.
FIG. 28 shows an example of a cyclical timing profile for heating the thermal element.
FIG. 29A shows another pusher variation having a circumferential cutting edge disposed at the distal end of the pusher.
FIG. 29B shows the instrument of FIG. 29A abutted against a locking mechanism for cinching of the tissue anchors against a tissue surface.
FIGS. 30A to 30C illustrate an alternative method for severing the suture utilizing the tissue manipulation assembly.
FIGS. 31A to 31E illustrate examples for incorporating a cutting blade or element along regions of the tissue manipulation assembly.
FIG. 32 illustrates another variation of a needle deployment assembly which may endoluminally deploy tissue anchors as well as cinch and release anchor assemblies.
FIG. 33A illustrates the variation of FIG. 32 having deployed a distal anchor into plicated tissue.
FIGS. 33B and 33C show partial cross-sectional views of the control or housing and the distal portion of the sheath of FIG. 33A illustrating advancement of the tissue anchors, respectively.
FIG. 34A illustrates the variation of FIG. 32 having deployed both tissue anchors into the plicated tissue prior to cinching of the anchors.
FIGS. 34B and 34C show partial cross-sectional views of the control or housing and the distal portion of the sheath of FIG. 34A illustrating advancement of both tissue anchors, respectively.
FIG. 35A illustrates the variation of FIG. 32 where the tissue anchors are cinched towards one another for securing the tissue.
FIGS. 35B and 35C show partial cross-sectional views of the control or housing and the distal portion of the sheath of FIG. 35A illustrating cinching of the tissue anchors, respectively.
FIG. 36A illustrates the variation of FIG. 32 where the cinched tissue anchors are released from the needle deployment assembly.
FIGS. 36B and 36C show partial cross-sectional views of the control or housing and the distal portion of the sheath of FIG. 36A illustrating release of the cinched tissue anchors, respectively.
Referring now to FIGS. 13 and 14, a variation of the anchor assembly and the needle deployment assembly is described. As with previously described needle deployment assembly 60, assembly 60′ comprises needle assembly control or housing 62, tubular sheath 64 and needle assembly 66 having needle body 72 with opening 74. Elongate pusher 76 is configured for translation within sheath 64 via actuation member 78. Pusher 76 illustratively comprises a hypotube having lumen 77 defined therethrough.
In the variation of FIGS. 13 and 14, locking mechanism 136 of anchor assembly 68′ is disposed proximal of proximal anchor 84, and the anchor assembly is positioned within the distal portion of tubular sheath 64, such that the distal region of pusher 76 abuts locking mechanism 136. Suture or flexible element 132′ comprising distal knot or protrusion 133 extends proximally from the knot in a manner that connects distal anchor 82, proximal anchor 84 and locking mechanism 136. Element 132′ then further extends through lumen 77 of pusher 76 to a proximal region of assembly 60′ such that element 132′ may be manipulated by a medical practitioner from outside a patient. The medical practitioner may, for example, engage previously described suture loop 134, or may engage some other control element 134′, such as a ring or handle, disposed at the proximal end of suture element 132′. As will be apparent, in another variation, element 132′ may extend to the proximal region of assembly 60′ alongside pusher 76 rather than within a lumen of the pusher.
With reference to FIG. 15, a method of using anchor assembly 68′ and needle deployment assembly 60′ is described. For the purposes of illustration, the assemblies are shown securing tissue without use of a tissue manipulation assembly. However, it should be understood that the assemblies alternatively may be used in combination with a tissue manipulation assembly, such as previously described tissue manipulation assembly 14 of assembly 10.
In FIG. 15A, needle deployment assembly 60′ has been positioned in proximity to approximated tissue T. The assembly is advanced such that needle assembly 66 pierces the tissue and is advanced through and across the tissue, as in FIG. 15B. Pusher 76 is advanced within the lumen of sheath 64 via actuation member 78, such that distal anchor 82 of anchor assembly 68′ is ejected through opening 74 of needle body 72 of needle assembly 66 on the distal side of approximated tissue T. Needle deployment assembly 60′ and pusher 76 then are retracted such that the pusher and needle assembly 66 again are disposed on the proximal side of the approximated tissue, as in FIG. 15C. Next, pusher 76 is distally advanced relative to sheath 64 to eject proximal anchor 84 from the sheath.
In FIG. 15D, with the proximal and distal anchors of anchor assembly 68′ disposed on either side of the approximated tissue, the anchor assembly is cinched by retracting control element 134′ relative to needle deployment assembly 60′. Pusher 76 abuts locking mechanism 136 and urges it distally during proximal retraction of element 134′, which shortens the length of suture element 132′ disposed between distal anchor 82 and proximal anchor 84, thereby cinching anchor assembly 68′. Locking mechanism 136 ensures that the anchors remain cinched by resisting distal passage of element 132′ through the mechanism, thereby resisting subsequent separation of the proximal and distal anchors.
With anchor assembly 68′ cinched, pusher 76 is retracted relative to sheath 64 such that needle assembly 66 engages suture element 132′, as in FIG. 15E. The needle assembly cuts the suture proximal of locking mechanism 136, as in FIG. 15F. The medical practitioner may facilitate cutting of the suture element by manipulating control element 134′ of anchor assembly 68′ and/or by manipulating needle assembly control 62 of needle deployment assembly 60′.
Referring now to FIG. 16, a variation of the suture element of anchor assembly 68′ is described. In FIG. 16, suture element 132″ comprises segment 135 of reduced integrity. The segment may for example, comprise fewer suture strands or may be reduced in integrity via chemical, electrical, thermal or physical processing, etc. Segment 135 may locally reduce the tensile strength of element 132″ to a desired threshold. When used to cinch anchor assembly 68′ in combination with anchor deployment assembly 60′, the segment may obviate a need to cut the suture with needle assembly 66 after cinching of the anchor assembly. Specifically, the anchor assembly may be cinched to a desired tension after which segment 135 plastically deforms and snaps, leaving the anchor assembly cinched and in place.
With reference to FIG. 17, a variation of the needle assembly of needle deployment assembly 60′ is described. Needle body 72′ of needle assembly 66′ may comprise one or more recessed cut-outs 73 having sharpened edges E for cutting the suture element. After cinching of anchor assembly 68′, the suture element may be snagged within a cut-out 73 and cut by the sharpened edge of the cut-out.
Referring now to FIG. 18, alternative control mechanisms for needle deployment assembly 60′ are described. Actuation member 78′ for controlling pusher 76 may be integrated with needle assembly control 62′, such that the actuation member is advanceable in controlled increments relative to the needle assembly control via detents 63 of the needle assembly control that coact with actuation member 78′.
With reference to FIG. 19, another variation of the anchor assembly and needle deployment assembly is shown. Control element 134′ of anchor assembly 68′ is coupled to or abuts needle assembly control 62′ of needle deployment assembly 60′. When distal anchor 82 of anchor assembly 68′ is disposed on the distal side of approximated tissue T, as in FIG. 19A, the proximal and distal ends of suture element 132′ are constrained. Thus, as seen in FIGS. 19A and 19B, advancement of pusher 76 via actuation member 78′ advances both proximal anchor 84 and locking mechanism 136 of anchor assembly 68′. This causes the anchor assembly to be progressively cinched as the proximal anchor is advanced. Once the anchor assembly has been ejected from sheath 64, as in FIG. 19B, and adequately cinched, as in FIG. 19C, suture element 132′ may be cut proximal of the locking mechanism, e.g., with needle assembly 66 as described previously.
Referring to FIG. 20, a variation of the needle deployment assembly is described. Pusher 76′ comprises suture ports 79 through which suture element 132 of anchor assembly 68′ is routed. As seen in FIG. 20A, with pusher 76′ disposed within tubular sheath 64 of needle deployment assembly 60′, suture element 132′ passes out of the pusher between the suture ports and is disposed between the pusher and the interior wall of the tubular sheath. As seen in FIG. 20B, when pusher 76′ is advanced through and distal of needle assembly 66, e.g., to eject proximal anchor 84 of anchor assembly 68′ from the needle deployment assembly and/or to cinch the anchor assembly, the section of suture element 132′ between the suture ports is exposed. Subsequent retraction of the pusher relative to the needle assembly causes the section of exposed suture to contact the sharpened edge of needle assembly 66, thereby severing suture element 132′ as in FIG. 20C.
Turning now to FIG. 21, another variation of the needle deployment assembly is shown. In this variation, suture element 132′″ may form a terminal loop 158 through which a release suture or wire 156 may be passed. Release suture or wire 156 may be routed through the length of the needle deployment assembly and through pusher 76, as described above, and both release suture or wire 156 and terminal loop 158 may both be situated within pusher 76, as shown in FIG. 21A. After deployment of the anchors into tissue and cinching of the assembly, as described above, one end of release suture or wire 76 may be pulled or tensioned proximally in the direction shown by arrow 162, as in FIG. 21B. This pulling may draw a terminal end of release suture or wire 156 through pusher 76 until terminal loop 158 of suture element 132′″ has been released therefrom, as shown in FIG. 21C.
In yet another variation shown in FIG. 22A, terminal loop 158 of suture element 132′″ may be seen restrained within pusher 76 via reconfigurable hook 164 of release wire 156′. Here, release wire 156′ may be fabricated from a shape memory or superelastic alloy material, such as Nitinol, which has been preformed to reconfigure its terminal end from a hook 164 configuration to a straightened or opened configuration once released from the constraints of pusher 76. Thus, after deployment and cinching of the anchor assembly, release wire 156′ may be advanced distally through pusher 76, as shown in FIG. 22B, until reconfigurable hook 164, which is retained in a hooked or obstructive configuration within the lumen of pusher 76, has been advanced out of pusher 76. Once free from the constraints of the lumen, hook 164 may reconfigure itself into an opened or straightened configuration to thereby release terminal loop 158 of suture element 132′″, as shown in FIG. 22C. Hook 164 having released terminal loop 158, may then be withdrawn proximally back into pusher 76 in its straightened configuration.
In another variation shown in FIG. 23A, a terminal end of suture element 132′″ may have an obstructive or enlarged element 160, e.g., a knot, formed thereon. The terminal end of suture element 132′″ with obstructive element 160 may be looped around release suture or wire 156 and retained within the lumen of pusher 76. After anchor deployment and cinching, release suture or wire 156 may be drawn distally with looped obstructive element 160 retained securely thereto, as shown in FIG. 23B, until obstructive element 160 and release suture or wire 156 have been advanced out of pusher 76. Once free from the constraints of the pusher lumen, obstructive element 160 may be released from release suture or wire 156, as shown in FIG. 23C, to thus release suture element 132′″.
Turning now to the alternative variation shown in FIGS. 24A to 24C, suture element 132′ may be passed through pusher 76″ having heating element assembly 170 disposed upon the distal end of pusher 76″. Heating element assembly 170 may generally comprise a heating element 172, e.g., a resistive metallic conductor such as nichrome, and an insulating element 174 disposed distally of heating element 172, as shown in FIG. 24A. In use, pusher 76″ may be urged distally from needle assembly 66 to cinch the anchors against the tissue surface, as described above. With heating element assembly 170 disposed externally or internally of needle assembly 66, heating element 172 may be powered such that its increase in temperature surpasses the melting point of the suture element 132′ passing therethrough, as shown in FIG. 24B. The melting point of the suture 132′ will vary depending upon the type of suture utilized.
Insulating element 174, which may be made from any number of electrically and thermally non-conductive insulating materials such as ceramics, polyimides, etc., may be disposed distal of heating element 172 to prevent inadvertent contact against the tissue by heating element 172 while it is heated although insulating element 174 may be omitted entirely from the assembly 170. As heating element 172 is heated, the portion of suture 132′ adjacent to element 172 will be melted and subsequently cut forming melted suture ends 176, 176′ on their respective terminal ends of suture element 132′ and the remaining suture length 178, as shown in FIG. 24C.
FIG. 25A shows a partial cross-sectional detail view of the heating element assembly 172 disposed upon the distal end of pusher 76″. As shown, heating element 172 and insulating element 174 may be positioned adjacent to one another. A covering, coating, or insulating layer 180 (e.g., heatshrink made from FEP, PEEK, Teflon, polyimide, etc.) may be disposed over the heating assembly 170 entirely or at least partially such that heating element 172 is completely encapsulated and insulated from surrounding tissue except for the inner exposed surface within lumen 188, where it may come in contact with or in proximity to the suture for severing the suture element 132′. Electrically conductive wires 182, which may be embedded along the length of pusher 76″, may be routed through heating element assembly 170 via wire contact lumens 184, 186 to not only provide power to heating element 172, but also to provide structural support in maintaining the position of heating element assembly 170 upon the distal end of pusher 76″. Alternatively, the elements 172, 174 of assembly 170 may be attached to one another utilizing any number of mechanical fasteners, e.g., adhesives, threaded connections, interference fitting, etc.
FIG. 25B shows a partial assembly of pusher 76″ and elements 172, 174 in an exploded view (cover 180 has been omitted for clarity). Wires 182 may pass through heating element assembly 170, along pusher 76″, and proximally into electrical contact with a controller and/or power supply 190 via a standard removable connector or through a direct electrical connection. Controller/power supply 190 may be located externally of the patient as a device separate from pusher 76″ and within or outside a sterile surgical field around the patient. Alternatively, the power supply 190 may be integrated with a proximal portion of the pusher 76″. An actuator 192, such as a foot-operated pedal or hand-operated switch, may be electrically connected via connector 194 to controller/power supply 190 for controlling the actuation of the heating element assembly 170.
An alternative heating assembly is shown in FIGS. 26A and 26B. FIG. 26A illustrates a partial side view of pusher 76′″ having a heating assembly 200 disposed upon the distal end of pusher 76′″ with suture element 132′ routed therethrough. Heating assembly 200 may generally comprise an insulative body 202 having a circumferentially-defined depression 204. One or more slots, grooves, or openings 206 extending radially through body 202 may be defined within the depression 204 such that an electrically resistive wire 208 which is coiled, wrapped, or otherwise wound around body 202 along depression 204 may effectively transfer heat generated by wire 208 through the one or more openings 206 to melt and separate the portion of suture element 132′ positioned within lumen 210 of body 202, as shown in FIG. 26B. A portion of coiled wire 208 may be optionally potted with an insulating material, such as epoxy, within depression 204 to retain the wire 208 in place as well as to insulate the wire 208 from surrounding tissue.
The heating assembly 200 may be positioned upon the distal end of pusher 76′″ utilizing any of the methods described above or generally known. Moreover, conductive wires 182 may be routed along or through pusher 76′″ and connected via, e.g., a connector, to controller and/or power supply 190, which may be connected to a foot pedal, hand switch, or other actuator 192, as described above.
Yet another variation is shown in the partial cross-sectional view of pusher 76″″ of FIG. 27A, which shows an alternative heating assembly 220 having a resistive wire or element 224 encased within a casing or housing 222 which forms a portion of the pusher wall. Although the housing 222 is shown near or at the distal end of pusher 76″″, housing 222 may also be located along the pusher wall proximal to the distal end. FIG. 27B shows a cross-section of a portion of pusher 76″″ and housing 222. As shown, resistive wire 224 may be positioned through housing 222 such that heat from the wire 224 may melt or sever the portion of suture 132′ adjacent to or in contact with housing 222. As above, wire 224 may be connected to a proximally located controller/power supply 190.
In the variations described above utilizing a heating element to sever the suture, the heating elements may be powered in a continuous manner until shut off by the user. Alternatively, the power may be configured to operate for a pre-determined period of time once turned on before automatically shutting off. In yet another alternative, the power may pulse in a cyclical manner such that the heating element is heated only for a specified period of time before automatically shutting off for a set period. This cycle may be repeated until the device is turned off. Such features may be incorporated as part of the instrument as a fail-safe feature, is so desired.
In one example of a cyclical timing profile shown in FIG. 28, once the actuator has been turned on to heat the heating element to sever the suture, the controller connected to the heating element may be configured to pulse the power 230 for a set period of time, Δt, e.g., 1 to 2 seconds. The power may then automatically shut off 234 for a set period of time, Δd, e.g., 1 to 5 seconds; then the power may be automatically turned on again 232 and then off again 236. This may occur for a set number of cycles or for a set period of time before the device is completely shut off or until the user completely shuts the power off upon suture separation.
In yet another variation for effecting suture separation, an alternative pusher 240 is shown in cross-section in FIG. 29A. Here, pusher 240 may have a needle body 242 with a circumferential cutting edge 244 defined at its distal end, similar to a coring needle, and a lumen 246 defined therethrough for passage of suture element 132′. Once the tissue anchors have been deployed into the tissue, cutting edge 244 may be used to cut or sever suture element 132′ passing through pusher 240 and needle body 242. During tissue anchor cinching of the locking mechanism 136 against the tissue anchor, as described above, cutting edge 244 may be optionally tapered to otherwise sized, without obstructing lumen 246, to allow cutting edge 244 to become seated within the locking mechanism 136. Thus, as pusher 240 and needle body 242 abuts against locking mechanism 136 to urge it distally along suture element 132′, cutting edge 244 may avoid direct contact against locking mechanism 136 so as to prevent dulling of cutting edge 244.
Alternatively or additionally, locking mechanism 136 itself may be coated or otherwise covered with a heatshrink material or other soft polymeric material, at least over a proximal portion, so as to present an atraumatic surface to cutting edge 244. In a further alternative, an intermediate element (not shown) made of a suitably soft material, e.g., polymers, may be disposed between needle body 242 and locking mechanism 136 to function as a temporary bumper.
In use, once the tissue anchors and locking mechanism 136 have been desirably deployed, pusher 240 and needle body 242 may be extended and the suture element 132′ passing through needle body 242 may be simply severed by pulling or urging suture element 132′ against cutting edge 244 until separation occurs. In another alternative method for separating suture element 132′, FIGS. 30A to 30C illustrate another method utilizing the tissue manipulation assembly described above. Once the tissue anchors and locking mechanism have been deployed from pusher 240 and launch tube 28, as shown in FIG. 30A, lower jaw 20 and upper jaw 22 of the tissue manipulation assembly may be actuated to clamp upon suture element 132′, as shown in FIG. 30B.
The suture element 132′ still disposed through pusher 240, which is positioned within the launch tube, may be tensioned at least partially, e.g., by pulling on a proximal end of suture element 132′. With suture element 132′ tightly secured between jaw members 20, 22, pusher 240 and needle body 242 may be urged distally through launch tube 28 until cutting edge 244 severs the portion of suture element 132′ held tightly by jaw members 20, 22, as shown in FIG. 30C. The tissue manipulation assembly may then be removed from the patient or manipulated to another portion of the body for treatment.
In yet another variation for suture separation, the tissue manipulation assembly may again be utilized by incorporating a suture cutting element along either or both jaw members 20, 22. For example, as shown in FIG. 31A, a cutting element, e.g., a blade, energizable wire, etc., may be positioned along an upper region 250 of upper jaw 22, or a cutting element may be positioned along a lower region 252 of lower jaw 20, or both may be utilized in combination with one another. FIGS. 31B and 31C show partial side views of upper jaw 22 and deployed launch tube 44 and pivot 30. A cutting blade, for instance, may be positioned adjacent to the launch tube 44 and angled at various directions relative to where the suture exits the launch tube such that the blade does not obstruct deployment of the tissue anchors or suture.
Placement of the cutting blade, however, is such that the upper jaw 22 may be manipulated to bring the suture element into contact with the blade for severing the suture. FIG. 31B shows blade 254 angled such that cutting edge 256 is directed away from the launch tube 44 opening. Alternatively, blade 154′, in FIG. 31C, shows another example where blade 254′ may be angled such that cutting edge 256′ is directed towards the launch tube 44 opening.
Rather than integrating a cutting blade along upper jaw 22, one or more cutting blades may instead be incorporated along lower jaw 20. As shown in the example of FIG. 31D, a partial top view of lower jaw 20 is shown with an optional cutting blade 258 with cutting edge 260 integrated near a proximal portion of needle assembly opening 50 defined in lower jaw member 20. Another alternative is shown in FIG. 31E where a cutting blade 258′ having a cutting edge 260′ may be integrated along a side portion of opening 50. These examples shown are intended to be illustrative and not limited and one or more cutting blades may be integrated along other surfaces of the tissue manipulation assembly as desired. Moreover, cutting blades may be integrated along the lower jaw, upper jaw, or both if so desired. Furthermore, the cutting blades may additionally be energized in further variations to facilitate severing the suture.
Turning now to FIG. 32, needle deployment assembly 270 is shown as a variation which is similar to that illustrated above in FIGS. 15 and 23. In this example, needle deployment assembly 270 is configured to endoluminally deploy tissue anchors as well as cinch and release anchor assemblies to secure one or more tissue folds. Assembly 270 generally comprises a needle assembly control or housing 272 which may be configured into an elongate shape having a guide track 274 defined therealong. A first locking position 276 may be defined at a proximal end of guide track 274 and a second locking position 278 may be defined at a distal end of guide track 274 where each locking position 276, 278 may be configured, e.g., as a cut-out or transverse section of guide track 274, within which a slidable actuation member 286 (described below) may be parked or locked temporarily.
Retraction control element 280 may be removably connected via a coupling mechanism such as a threaded connection 282 to the proximal end of control or housing 272 and tubular catheter or sheath 64 may be coupled via sheath attachment 284 at the distal end of control or housing 272. Needle assembly 66, including needle body 72 having needle opening 74, may be attached to the distal end sheath 64, as described above.
Needle deployment assembly 270 may operate in a similar manner as the variation described above where once needle body 72 has pierced through approximated tissue T, distal anchor 82 may be deployed through needle opening 74 on a distal side of tissue T, as shown in FIG. 33A. Suture element 132 may be seen connecting distal anchor 82 through the pierced tissue T and through needle opening 74. A terminal distal end of suture element 132 may define a distal knot or protrusion 133 to prevent distal anchor 82 from sliding off suture 132. Distal anchor 82, which is originally positioned within sheath 64 proximal or adjacent to needle body 72, may be urged distally through needle opening 74 by sliding actuation member 286 from its parked position in first locking position 276 distally along guide track 274 to a mid-point location. Actuation member 286 may be connected to slider carriage 290 translatably positioned within housing lumen 298 in control or housing 272, as shown in FIG. 33B.
Slider carriage 290 may be connected to pusher tube 294, which may comprise a hollow tubular member, such as a hypotube, extending at least partially through control or housing 272 and which may extend partly through sheath 64. A distal end of pusher tube 294 may in turn be connected via coil attachment 308 to pusher coil body 296 which may extend through sheath 64 proximal to an anchor assembly disposed within the distal portion of sheath 64. Pusher coil body 296 may be comprised of a tightly-wound coiled body which provides columnar support when pushed or pulled through sheath 64 and which is sufficiently flexible to enable pusher coil body 296 to conform to tortuous configurations. A wire lumen 292 may extend through carriage 290, pusher tube 294, and pusher coil body 296 within which a looped release suture or wire 156 may extend from retraction control member 280 to a cinchable anchor assembly positioned within a distal portion of sheath 64.
A stop 300 may be crimped or otherwise fixedly positioned along a length of release suture or wire 156 within housing or control 272 with a separate plug mechanism 302 slidably positioned along suture or wire 156 proximal to stop 300. Plug 302 may have a plug body 304 with one or more expandable arms 306 extending distally therefrom, the distal ends of which are temporarily locked within a proximal opening of lumen 292, as illustrated in FIG. 33B. With expandable arms 306 temporarily locked in carriage 290 and encompassing stop 300, when actuation member 286 is pushed distally along guide track 274, carriage 290 is forced distally to urge pusher tube 294 and pusher coil body 296 through sheath 64. Stop 300 is also urged distally along with carriage 290 by plug mechanism 302, which in turn enables the distal portion of looped suture or wire 156 to translate distally with pusher coil body 296 to push the distal anchor 82 from needle body 72, as shown in FIG. 33C. The proximal terminal end 310 of suture element 132 may be passed at least partially through looped suture or wire 156 within pusher coil body 296 such that when suture end 310 is withdrawn within pusher coil body 296 by suture or wire 156, suture end 310 is fixedly retained and prevented from inadvertently releasing or unwinding by the tortuous looped path to prevent the accidental release of one or more anchors 82, 84 from needle body 72.
Once the distal anchor 82 has been released on a distal side of tissue T, proximal anchor 84 may further be released on a proximal side of tissue T by further urging actuation member 286 distally along guide track 274 until actuation member 286 has reached the terminal end of track 274, where it may be locked into the second locking position 278. Pushing actuation member 286 along track 274 may urge the distal end of pusher coil body 296 distally until it is adjacent to or distal of needle body 72, thereby forcing proximal anchor 84 and locking mechanism 136 from needle opening 74, as illustrated in FIG. 34A. FIG. 34B illustrates the distal movement within control or housing 272 of stop 300 and plug body 304 attached to carriage 290 via expandable arms 306. FIG. 34C illustrates the corresponding distal translation of pusher coil body 296 and release suture or wire 156 through needle opening 74 to urge proximal anchor 84 and locking mechanism 132 therethrough. Terminal suture end 310 is still fixedly retained within pusher coil body 296 by release suture or wire 156.
To approximate the anchors 82, 84 towards one another and secure the plicated tissue T, retraction control element 280 may be de-coupled or unscrewed via attachment 282 from the proximal end of control or housing 272, as shown in FIG. 34A, and then pulled proximally or tensioned, as shown in FIG. 35A, to pull release suture or wire 156 proximally relative to carriage 290, pusher tube 294, pusher coil body 296, and housing 272. As release wire 156 is pulled, stop 300 is pulled proximally, which in turn may urge plug body 304 proximally relative to the stationary carriage 290. As the plug mechanism is forced proximally, expandable arms 306 may become released from the proximal end of carriage 290 to reconfigure themselves into an expanded configuration, as shown in FIG. 35B.
Moreover, as release wire 156 is tensioned, the terminal looped end 310 of suture 132, which is threaded at least partially through the looped distal end of release wire 156, may be pulled proximally further into pusher coil body 296, as shown in FIG. 35C, to force the distal knot or protrusion 133 against the distal anchor 82 to approximate anchor 82 towards proximal anchor 84 and locking mechanism 136, thereby securing the plicated tissue T between the collapsed tissue anchors 82, 84.
With plicated tissue T securely cinched between anchors 82, 84 and locking mechanism 136, actuation member 286 may be released from second locking position 278 and urged proximally along guide track 274, as illustrated in FIG. 36A The proximal translation of actuation mechanism 286 and carriage 290 may pull pusher tube 294 and pusher coil body 296 proximally relative to sheath 64. As carriage is translated through control or housing 272, stop 300 may pass freely into and through lumen 292 while the expandable arms 306 projecting from plug body 304 may inhibit or prevent the plug from re-entering carriage 290. Accordingly, plug body 304 may be forced to slide proximally along release suture or wire 156, as shown in FIG. 36B.
With stop 300 freely translating within lumen 292, the tension on release suture or wire 156 from suture element 132 and secured anchors 82, 84 may urge the distal looped end of wire 156 out of pusher coil body 296, thereby allowing suture element 132 to release itself from release suture or wire 156, as illustrated in FIG. 36C. However, stop 300 may be sized with a diameter which is larger than an inner diameter of pusher coil body 296 such that stop 300 is prevented from passing distally into pusher coil body 296. This feature may be utilized to limit the withdrawal of release suture or wire 156 and prevent it from being pulled entirely out of pusher coil body 296 when the anchors are released. Once suture element 132 has been released, needle deployment assembly 270 may be removed from the tissue manipulation assembly 14 or other instrument or from the patient body and another needle deployment assembly 270 may be reinserted to secure another region of tissue.
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U.S. Classification 623/23.72, 606/139
Cooperative Classification A61B2017/0496, A61B2017/06052, A61B17/0469, A61B2017/0464, A61B2017/0419, A61B2017/003, A61B2017/00349, A61B2017/2927, A61B17/0401, A61B2017/00867, A61B17/0482, A61B2017/0458, A61B17/0467, A61B17/29
European Classification A61B17/29, A61B17/04E, A61B17/04G, A61B17/04A
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EWERS, RICHARD C.;LAM, CANG C.;REEL/FRAME:017741/0598