Abstract:
A tissue penetrating device for endoscopy or endosonography-guided transluminal interventions using an automated spring-loaded mechanism is taught. Various modifications and uses including tissue anchoring, affixing, and creating an anastomosis are explained.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates to a tissue penetrating device for endoscopy or endosonography-guided transluminal interventions using an automated, for example, spring-loaded mechanism with various modifications and uses, including uses in surgical procedures and, in particular, tissue anchoring.  
       BACKGROUND OF THE INVENTION  
       [0002]     Endoscopy and endosonography-guided interventions have certain advantages over alternative surgical and percutaneous-guided procedures. Interventions that employ endoscopy or endosonography may avoid some of the harmful effects of alternative procedures.  
         [0003]     One technique that has been explained is a technique for endoscopy and endosonography-guided biopsy. Such a technique and associated devices are described, for example, in U.S. Pat. No. 6,228,039, which is hereby expressly incorporated by reference. A need exists, however, for other diagnostic and therapeutic interventional applications and related devices that may be performed in an endoscopy or endosonography-guided environment.  
         [0004]     In particular, a need exists for such devices and techniques that can traverse a first layer of tissue, such as the wall of the bowel, bladder, or other organ or structure that can be accessed endoscopically, and penetrate into or through another layer of tissue such as the wall of a hollow or solid organ, duct, vessel, or soft tissue structure, such as a muscle or ligament. In certain surgical operations, for example, a need exists to be able to connect and create an artificial lumen (anastomosis) between two neighboring luminal structures, such as, for example, two segments of bowel.  
         [0005]     Further, a need exists in certain surgical procedures to attach or affix two neighboring structures, such as the stomach to the diaphragm (gastropexy) or the bladder to the abdominal wall (cystopexy). Additionally, a need exists to be able to connect a first portion of the stomach with a second portion of the stomach (stomach stapling). A need also exists to be able to affix diagnostic and therapeutic devices to an organ or tissue. For example, a need exists to be able to implant a gastric pacemaker to treat gastroparesis. Furthermore, a need exists to perform the functions described above in a manner that is automated. For example, in circumstances in which it is desired that an operation take place from within a luminal structure, a surgeon may have limited ability to manipulate a needle, anchor, or other penetrating device to perform procedures such as those listed above, and in particular to position tissue or to create an artificial lumen. Thus, a need exists for an appropriate automatic tissue targeting device.  
       SUMMARY OF THE INVENTION  
       [0006]     The present invention may solve the needs in the art stated above and may provide certain advantages over the prior art. The present invention solves the need for the ability to perform additional techniques by providing an apparatus capable of use in such techniques.  
         [0007]     One embodiment of the present invention may be an apparatus including a roughly hollow cylindrical central member having a proximal end and a distal end; a leg member, attached to a distal end of the central member, wherein at least a portion of the leg member is adapted to permit production of an expanded distal radius in the apparatus; a tether attached to a proximal portion of the central member; an expander member, a distal portion of which is aligned co-axially through the central member; and a pusher member aligned co-axially around a proximal portion of the expander member and adapted to prevent the movement in a proximal direction of the central member.  
         [0008]     In an embodiment employing a cylindrical central member, there may be a number of leg members. These leg members may, for example, be segments of the cylinder. In an embodiment shown in  FIG. 4 , for example, the leg members are shown curled back, but it may be apparent from that figure that the four legs are each roughly a quarter of the circumference of the cylinder. Of course, there is no requirement that the legs be implemented in such a manner or comprise such a circumference of the cylinder. For example, a cylindrical member may be used. Such a cylindrical member may be adapted to transform from an approximately cylindrical shape to an approximately conical or pyramidal shape. Some examples include a “leg” deployed like the canopy of an umbrella, or a “leg” deployed by removing a sheath from an elastic (when reference is made to elastic, reference to superelastic is included) member shaped somewhat like a shuttlecock. Additionally, a multiplicity of legs, such as 2, 3, 4, or more legs may be used. Such legs may be malleable or elastic. An example material for use as an elastic material is a shape memory alloy such as Nitanol. Other structures that may be used as a leg include, for example, tines, fingers, or hooks. The deployment of legs may be described as an expanding process, or by other terms, such as an unfurling process.  
         [0009]     In an embodiment that may be employed in the lumen of a tissue or organ, the distal end may refer to the end most outwardly radial. In general, the distal end refers to the end closest to the first layer of tissue prior to normal use.  
         [0010]     Another embodiment of the present invention may be the apparatus described above, but further including a pre-biasing device adapted to selectively force at least a portion of the apparatus in a distal direction, and an outer sleeve surrounding the apparatus, wherein the outer sleeve is adapted to be fitted to an endoscope. The outer sleeve may be attached to the described apparatus directly or mediately, or may be slidably positioned relative to the apparatus. The outer sleeve may aid the operator in directing the application of the apparatus to target tissue.  
         [0011]     Another embodiment of the present invention may be the apparatus previously discussed in which the pre-biasing device includes a member such as compressed gas compartment, a coil spring, or a torsion spring. Of course, other pre-biasing devices such as electromagnetic devices (e.g., motors, stepper motors, rail guns, and the like), hydraulic devices, and chemical devices (e.g., a chemical explosive similar to that used in bullet cases or airbags) may be used. Additionally, the pre-biasing device may be located near the proximal or the distal end of the device, and may be activated directly or indirectly by, for example, an electronic switch or relay.  
         [0012]     Another embodiment of the present invention may be an apparatus including a roughly hollow cylindrical central member having a proximal end and a distal end; a leg member, attached to a distal end of the central member, wherein at least a portion of the leg member is adapted to permit production of an expanded distal radius in the apparatus; a suture attached to a proximal portion of the central member; an expander member, a distal portion of which is aligned co-axially through the central member; a pusher member aligned co-axially around a proximal portion of the expander member and adapted to prevent the movement in a proximal direction of the central member; and a tether connected to a proximal portion of the expander member.  
         [0013]     Another embodiment of the present invention may be an apparatus including a roughly hollow cylindrical central member having a proximal end and a distal end; a leg member, attached to a distal end of the central member, wherein at least a portion of the leg member is adapted to permit production of an expanded distal radius in the apparatus; and a shoulder member attached to a proximal end of the central member, the shoulder member being adapted to limit movement of the central member in a distal direction. The shoulder member may be collapsible to allow deployment and may be configured to automatically and/or manually deploy.  
         [0014]     Another embodiment of the present invention may be an apparatus including a roughly hollow cylindrical central member having a proximal end and a distal end, and a leg member, attached to a distal end of the central member, wherein at least a portion of the leg member is adapted to permit production of an expanded distal radius in the apparatus.  
         [0015]     Another embodiment of the present invention may be an apparatus including a roughly hollow cylindrical central member having a proximal end and a distal end; a leg member, attached to a distal end of the central member, wherein at least a portion of the leg member is adapted to permit production of an expanded distal radius in the apparatus; and a tether attached to a proximal portion of the central member.  
         [0016]     Another embodiment of the present invention may be methods of use, including anchoring a second tissue to a first luminal structure, wherein the second tissue is anchored by use of an expandable anchor that is adapted to perform the steps of penetrating through a first luminal structure, penetrating at least into a second tissue, and holding the second tissue in approximately constant position relative to at least a region of the first luminal structure. The step of holding the second tissue in approximately constant position relative to at least a region of the first luminal structure may be performed by an embodiment of the present invention including an anchor, without regard to the speed or precise manner by which the anchor is inserted.  
         [0017]     In such a method of use, the second tissue may be a luminal structure. Moreover, the first luminal structure may be a hollow organ such as a segment of the bowel (for example, esophagus, stomach, small intestine, and colon), bladder, gallbladder, uterus, or bronchotracheal tree. The first luminal structure may also be a ductal structure such as the bile duct, pancreatic duct, urethra, or ureter. The first luminal structure may also be a vascular structure such as an artery or a vein. The cylindrical central members described above may serve to create a conduit or anastomosis between two luminal structures.  
         [0018]     One embodiment of the present invention may be an apparatus including a substantially hollow central member adapted to permit the passage of a penetrating member adapted to penetrate tissue and a first leg member connected to a distal portion of the central member, wherein the first leg member may be adapted to produce an increase in a distal radius of the apparatus and wherein the increase may be adapted to restrain motion of the apparatus in a proximal direction.  
         [0019]     An embodiment may, for example, be adapted such that the first leg member employs a technique for producing an increased radius such as by being self-expanding or by being manually expandable. In a particular embodiment, the first leg member may be adapted to expand in radius in response to the proximal motion of the penetrating member.  
         [0020]     An embodiment may, for example, be fashioned with the first leg member including a shape memory alloy. Other parts of the embodiment may also include shape memory alloy, such as, for example, the hollow central member.  
         [0021]     In a particular embodiment, the first leg member may include a first end connected to a distal portion, and a second end that extends approximately proximally prior to increasing the radius of the apparatus. The first leg member may, for example, include a first end connected to a distal portion, and may also include a second end that extends approximately distally prior to increasing the radius of the apparatus.  
         [0022]     In an embodiment of the present invention, the first leg member may be adapted to expand in radius in response to the proximal motion of an encompassing sheath. Such a sheath may be particularly valuable in an embodiment in which shape memory or a self-expanding mechanism is used to increase a distal, mesial, or proximal radius of the device.  
         [0023]     In a further embodiment of the present invention, the apparatus may also include a second leg member connected to a proximal portion of the central member, wherein the second leg member is adapted to produce an increase in the proximal radius of the apparatus and wherein the increase is adapted to restrain motion of the apparatus in a distal direction. Such an embodiment may be designed such that the second leg member is adapted to expand in radius in response to the proximal motion of an encompassing sheath. In a particular embodiment, the second leg member may be adapted to expand in radius by means of one or more rubber bands.  
         [0024]     In a particular embodiment, the central member may be adapted to be a stent. Furthermore, the central member may be adapted to be expandable. Additionally, the central member may include a shape memory alloy mesh. Such a mesh may be an expandable mesh that is trained to an expanded diameter but restrained to a narrower diameter by a removable encompassing sheath.  
         [0025]     A further embodiment of the present invention may also include a tab connected to the central member and directed radially inward. The tab may be adapted to translate force in an axial proximal direction into force in a radially outward direction.  
         [0026]     It is understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. The accompanying drawings illustrating an embodiment of the invention and together with the description serve to explain the principles of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]      FIG. 1  is a drawing of an installation device for the anchors and other hardware of the present invention.  
         [0028]      FIG. 2  is a detail drawing of a relevant portion of  FIG. 1 .  
         [0029]      FIG. 3  is a sectional view of an embodiment of the present invention.  
         [0030]      FIG. 4  is a perspective view drawing of an embodiment of the present invention that may be an anchor and may be, as shown, in an expanded state with leg members deployed.  
         [0031]      FIG. 5  is another perspective view drawing of an embodiment of the present invention that may be an anchor and may be, as shown, in an unexpanded state.  
         [0032]      FIG. 6  is a four step side view partial cutaway drawing of an embodiment of the present invention in use.  
         [0033]      FIG. 7  is another four step side view partial cutaway drawing of an embodiment of the present invention in use.  
         [0034]      FIG. 8  is a drawing of an embodiment of the present invention including an anchor with an expander and a sensor or treatment delivery device attached to a tether.  
         [0035]      FIG. 9  is a drawing of an embodiment of the present invention including two anchors (with expanders) connected by two tethers.  
         [0036]      FIG. 10  is a drawing of an anchor with a shoulder.  
         [0037]      FIG. 11  is a cross-section drawing of an anchor with a shoulder that may serve as a stent.  
         [0038]      FIG. 12  is a drawing of an anchor with a separate shoulder.  
         [0039]      FIG. 13  is a drawing of an anchor with a separate shoulder installed on the anchor.  
         [0040]      FIG. 14  is a drawing of an alternative embodiment of the present invention including a release device.  
         [0041]      FIG. 15  is a drawing of an embodiment of the present invention including an anchor without an expander and further including a suture with a loop at the proximal end, with the loop optionally attached to a sensor or treatment delivery device.  
         [0042]      FIG. 16  is a drawing of an embodiment of the present invention including two anchors (without expanders) connected by two sutures.  
         [0043]      FIGS. 17A and 17B  is a drawing of an embodiment of an anchor with a collapsible shoulder.  
         [0044]      FIG. 18  is a two-step sectional view drawing of an embodiment of the collapsible shoulder anchor in use.  
         [0045]      FIG. 19  is a four-step sectional view of an embodiment of the invention with an anchor that may serve as an expandable stent.  
         [0046]      FIG. 20  is a perspective view drawing of an embodiment of the present invention with an anchor with a separate expandable shoulder.  
         [0047]      FIG. 21  is a sectional view drawing of an anchor (with an expandable shoulder) situated in a portion of bowel and securing another luminal tissue structure to the bowel.  
         [0048]     FIGS.  22 A-H are detailed depictions of detailed views of an expandable stent in combination with an anchor. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0049]     It is to be understood that the present invention is not limited to the particular methodology, compounds, materials, manufacturing techniques, uses, and applications, described herein, as these may vary. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include the plural reference unless the context clearly dictates otherwise. Thus, for example, a reference to “a suture” is a reference to one or more sutures and includes equivalents thereof known to those skilled in the art. The materials that may be used in conjunction with the present invention may include conventional materials such as stainless steel, other surgical alloys of steel, various biocompatible plastics and elastomers, and other conventional materials. In general it may be valuable to avoid using materials that are likely to cause allergic reactions or inflammation, unless such a result is desired.  
         [0050]     Reference herein to the term “endoscope” refers not only to conventional endoscopes, but also to any rigid, semi-rigid, or flexible optical instrument for use in visual examinations of the interior of the human body. Such examinations may include, for example, examinations of bodily canals or hollow organs such as stomachs, intestines, colons, or bladders. The term “endoscope” also includes echo-endoscopes, which may include an ultrasound transducer at, for example, the tip of the device.  
         [0051]     The present invention may be an embodiment that permits the automation of a tissue penetrating device by means of a pre-biasing device, which includes a member such as compressed gas compartment, a coil spring, or a torsion spring. In a specific embodiment, an integrated spring coil component, such as a compression spring component, may be used. Although a compression spring coil may be one component that may be used to forward-bias a portion of the device, other components may be used as well. For example, other types of elastically deformed mechanical spring elements, compressed air, chemical combustion, or magnetic repulsion (or attraction) may also be used a pre-biasing device.  
         [0052]     The compression spring, or other pre-biasing device, may be loaded. On release of the component, a tissue-penetrating component may shoot forward at high velocity. The velocity that may be desirable may depend on the tissue whose penetration is desired. A high velocity operation avoids striction effect and hence is more repeatable and accurate. Thus, the device may be able to penetrate in a more predictable and precisely calculable fashion. Further, the device may penetrate more than one tissue in a single forward movement or in more than one forward movement.  
         [0053]     Thus, the device may be used to penetrate through the wall of a luminal structure into and through a wall of an adjacent luminal structure. Thereafter, the adjacent tissue may be engaged by an anchoring or connecting member. Thus, the device may be able to create an anastomotic connection between two lumens.  
         [0054]     In certain embodiments, a device according to the present invention may be a tissue penetrating device that is inserted though the instrumentation channel of an endoscope, echo-endoscope, or the like. The handle of the device may be attached to the inlet port of the endoscope or echo-endoscope. Examples of such endoscopes are found, for example, in U.S. Pat. Nos. 6,638,213; 6,614,595; and 6,520,908. The tissue penetrating device may be manually advanced or retracted. Additionally, the forward-biasing device (for example, a compression spring) may be loaded and released. This may enable the tissue penetrating device to shoot forward with high velocity on the release of the device, which may occur via the release (or depression) of a trigger.  
         [0055]     The tissue penetrating device may, for example, take the form of a barbed needle. The needle may be housed in a protective outer sheath. The outer sheath may serve to protect the instrumentation channel in the endoscope from the needle, as well as to protect the needle. The outer sheath may be adapted to be separate from the tissue penetrating device. Thus, the outer sheath may be moved independently of the tissue penetrating device. The outer sheath may further serve as a guide for the tissue penetrating device. Finally, the outer sheath may also serve to dilate or enlarge a tissue penetration tract.  
         [0056]     The handle of the device may be screwed and thereby securely anchored into the inlet port of the instrumentation channel of the endoscope using a Luer lock mechanism. This may be useful to prevent the handle from back-firing after the forward-biasing device is activated.  
         [0057]     In the example of a spring-loaded embodiment, the distance of forward (or as it will be referred to herein, distal) movement of the tissue penetrating device may be controlled at the handle. For example, in one embodiment, the degree to which the spring is compressed or the degree to which the spring is permitted to travel may precisely control the distal movement of the tissue penetrating device. In an embodiment in which an anchor is to be inserted, the method of insertion is not essential to the operation of the anchor, although controlled, rapid insertion may accrue the benefits described.  
         [0058]      FIG. 1  depicts an installation device for the anchors and other hardware of the present invention, and may be an embodiment of the present invention.  FIG. 2  is a detailed depiction of a portion  2  of  FIG. 1 . This installation device may, for example, be attached to an endoscope or echoendoscope. An example of such an attachment may be found in U.S. Pat. No. 6,228,039, which is hereby incorporated in its entirety herein by reference.  
         [0059]     The embodiment depicted in  FIGS. 1 and 2  may be assembled as follows. The activation cable assembly (including outer sheath  40 , pusher  50 , tether  60 , and suture  20 ) may be threaded. The locknut  330  may be installed prior to threading. The locknut  330  may be used to assemble this embodiment together with an endoscope.  
         [0060]     Next the suture  20  may be pushed through an opening that may be provided in main cylinder  200  and outer sleeve  210 . Next, outer sleeve  210  may be attached to an endoscope via locknut  330  or via other appropriate attachment device. The outer sheath  40  may be attached onto the main cylinder  200  using an appropriate connection, such as a screw (not shown). Main cylinder  200  may be fastened to outer sleeve  210  by stop screw  220 . The stop screw  220  may permit setting the relative position of main cylinder  200  and outer sleeve  210 . One position that may be useful is one in which outer sheath  40  is consequently adjusted to an appropriate place within a patient.  
         [0061]     Sliding piston  230  may be tensioned and locked using pre-bias latch/release (not shown) as described in U.S. Pat. No. 6,228,039. It may be valuable to identify whether pusher  50  is in correct axial position along outer sheath  40 . If not, it may be valuable to adjust the position of pusher  50  accordingly. Stop screw  260  may be used to lock pusher  50  in an appropriate position once adjusted. Calibration cap  250  may be turned on mating threads on main cylinder  200  to adjust the amount of travel upon the release of the compression spring  240 .  
         [0062]     End cap  270  may be installed into the end of pusher  50 . The end cap  270  may be pushed down until the end of its axial travel has been reached. The end cap  270  may then be fastened in place with a locking screw  280 . This step of installation may be performed without clamp nut  290  or expansion nut  300  in place.  
         [0063]     Clamp nut  290  together with anti-rotation pin  320  and expansion nut  300  may be installed over the tether  60 . In this embodiment, expansion nut  300  may snap over clamp nut  290  to form a subassembly.  
         [0064]     Expansion nut  300  may be screwed down the threads of end cap  270  until the shoulders contact. It may be valuable to confirm that tether  60  is appropriately placed. The locking screw  310  may then be tightened.  
         [0065]     The device as described to this point may be used to deploy the anchor (not shown). After deploying the anchor, the expansion nut  300  may be rotated backwards until the proper expansion of the anchor (not shown) has been obtained. Expansion nut  300  may be connected to tether  60 . Tether  60  may be connected to an expander. Turning expansion nut  300  creates relative motion between tether  60  and pusher  50 .  
         [0066]      FIG. 3  depicts an embodiment of the present invention in a sectional view. This embodiment of the present invention may be inserted into tissue. This embodiment includes an expander  30  at a distal end of the apparatus, three anchors  10 , a pusher  50 , an outer sheath  40 , sutures  20 , and a tether  60 . In this example, the expander  30 , may be forced through a surface in a distal direction. The other elements depicted, except for the outer sheath, may also at least partially penetrate the surface. Thus, for example, one of the anchors  10  may partially penetrate the surface. A mechanism (not shown) may be used to retract the expander  30  in a proximal direction. The pusher  50  may prevent the anchor  10  from retracting in the proximal direction. As the expander  30  retracts, it may force the anchor  10  to expand. This expansion may result in anchor  10  having a greater diameter at its distal end. Thus the anchor  10  may be prevented from moving back through the surface in a proximal direction. However, a tether  60  may provide a tensile force in the proximal direction that may keep the anchor in contact with the penetrated surface. In certain circumstances, it may be advisable to apply an anchor  10  that has a suture  20  attached. Additionally, although this method may use motion of the expander, it may also use motion of the anchor relative to the expander.  
         [0067]      FIG. 4  depicts an embodiment of the present invention that may be an anchor. This embodiment includes an expanded-form anchor  10  at a distal end and a suture  20  at a proximal end. As shown here, an anchor  10  may be expanded (shown already expanded), creating a distal region with an effective diameter larger than the hole occupied by the more proximal region. A suture  20  may be attached to the expanded anchor  10 . The suture  20  may, in some embodiments be more easily attached prior to expansion of the anchor  10 . In particular, it may be desirable to attach the suture before penetrating a surface with the anchor.  
         [0068]      FIG. 5  depicts another embodiment of the present invention that may be an anchor. This embodiment includes an anchor  10  at a distal end and a suture  20  at a proximal end. As shown, the anchor  10  may be in a pre-expansion form. Such a form may be useful, for example, in aiding in the insertion of an anchor through a surface. As shown here, a suture  20  may be attached to the anchor  10  prior to expansion.  
         [0069]      FIG. 6  depicts the use of an embodiment of the present invention in four steps. In the first step (at top), the apparatus as a whole is shown as having been partially inserted through a first layer of tissue  80  (which may, for example be the bowel wall), and into a second layer of tissue  70  (which may, for example, be connective tissue outside the bowel wall). In the next three steps (proceeding downward), the expander  30  may be gradually retracted. This gradual retraction may force anchor  10  in its unexpanded state to partially expand. Eventually, the legs of anchor  10  may be fully expanded. In this instance, the anchor  10  may be retracted until it engages an outer surface of the first layer of tissue  80 . A suture  20  may remain attached and extend through the first layer of tissue  80 . The expander  30  and pusher  50  may be eventually completely withdrawn. In this instance the tether  60  may remain attached to the expander  30 .  
         [0070]     An alternative means of expanding the anchor  10  may be accomplished as follows. The anchor  10  may be constructed with legs made from a shape metal alloy, such as a nickel-titanium alloy. The legs may be pre-biased to assume an expanded state. However, the legs of the anchors may be maintained in an unexpanded state by means of a restraining sheath. Gradual retraction of the sheath may allow the legs to expand to their pre-biased expanded state. This mechanism may thus make use of the super-elastic properties of the shape-memory alloy. Alternatively, a temperature change memory effect of an alloy may also be used, by (for example) training the alloy into an expanded state, bending the legs into an unexpanded state, and then raising the temperature of the alloy above the necessary threshold to return it to the memorized expanded state. The temperature change may be accomplished by a variety of means such as the use of a heating element.  
         [0071]      FIG. 7  depicts another use of an embodiment of the present invention in four steps. In the first step (at top), the apparatus as a whole is shown as having been partially inserted through a first layer of tissue  80  (which may be, for example, the bowel wall), and into a second layer of tissue  70  (which may be, for example, a structure made of muscle tissue such as the diaphragm, and may, as shown here, be adjacent to the first layer of tissue  80 ). In the next three steps (proceeding downward), the pusher  50  may advance anchor  110  against expander  30 . This advancement may force anchor  110  in its unexpanded state to partially expand. Eventually, the anchor  110  may be fully expanded. As shown, the anchor  110  may be left completely within the second layer of tissue  70 . In this embodiment, the tether  60  and the expander  30  may remain partially within the second layer of tissue  70 . For example, the expander  3  may lie completely with the second layer of tissue  70 , and the tether  60  may remain attached and extend from the second layer of tissue  70 , through the first layer of tissue  80 . The pusher  50  may be withdrawn in a proximal direction. As previously discussed, the expansion may take place by any relative opposing motion of the expander and anchor. Additionally, an anchor may be deployed by prebiasing a leg to an expanded radius, constraining or constricting the leg to a narrower radius, and then removing the restraint. Such a technique may include the use of a superelastic leg constrained by a sheath. As the sheath is removed in, for example, a proximal direction, the leg may expand the distal radius of the anchor.  
         [0072]      FIG. 8  depicts an embodiment of the present invention including a sensor or treatment delivery device  120 . In this embodiment, the anchor  110  may lie within a second layer of tissue  70 . A tether  100 , may pass through a first layer of tissue  80 , and connect the anchor  110  with a sensor or treatment delivery device  120 . Example of sensors  120  include cameras, electromagnetic sensors, manometry sensors, pH probes, and probes for lumen content sampling. Example of treatment delivery devices  120  include pharmaceutical delivery devices; chemotherapy delivery devices; treatment activation devices (e.g,. photodynamic therapy devices); radioisotope containment or delivery devices; thermal or radiofrequency delivery devices; radioisotope containers; thermal, photochemical, and radio frequency delivery devices; and stimulating electrode devices, including pacemakers and nerve stimulators. Attachment of the sensor or treatment delivery device  120  to tether  100  may be accomplished by, for example, a nail, screw, bolt, clip, knot, loop, friction mount, or adhesive mechanism. A tether may be a suture, but it may also be a more rigid material, and may be an inflexible material. Example of materials that may serve as a tether include a wire.  
         [0073]      FIG. 9  depicts an embodiment of the present invention including two anchors  110  connected by two tethers  100 . In this example, the anchors and tethers may be inserted as previously described. However, the tethers  100  may further be connected by a lock ring  140 . Drawing the tethers together may allow the margins of the first layer of tissue  80  and the second layer of tissue  70  to approximate and close a tear or gap in tissue continuity  130 .  
         [0074]      FIG. 10  depicts an anchor  10  with a shoulder  150  In this embodiment of the present invention, an anchor  10  (shown expanded) may be provided with a shoulder  150 . This shoulder  150  may be adapted to prevent over penetration by providing significant resistance to further penetration.  
         [0075]      FIG. 11  depicts an anchor  10  with a shoulder  150  passing through a first layer of tissue  80  and a second layer of tissue  70 . In this example, the anchor  10  may be provided with a hollow center. Thus, when in place, as shown, the anchor  10  may serve as a stent. The stent may, for example, be self expanding or mechanically expandable. A balloon may be used to expand the stent, and this may permit the stent to acquire an increased diameter. Tabs may be provided directed radially inwardly to convert some of the force of an expander moving in an axial direction into a radially expansive force on the stent.  
         [0076]      FIG. 12  depicts an anchor  160  with a separate shoulder  170 . In this embodiment, the anchor  160  and the shoulder  170  are in two pieces. These pieces may be adapted to engage one another. This may be accomplished, for example, by providing the pieces with corresponding threadings, by arranging for a light frictional fit, or by tensioning tethers  180  while advancing rod  190 . One advantage of this design may be the ease of removal. In particular, the shoulder  170 , may be restrained from moving in a proximal direction, and tension may be applied in a proximal direction to the anchor  160 . This may force the anchor  160  through the shoulder  170  in a proximal direction, collapsing the anchor  160  in the process.  
         [0077]      FIG. 13  depicts an anchor  160  with a separate shoulder  170  as installed. This anchor  160  is otherwise the same as  FIG. 10 .  
         [0078]     It is an object of the invention to provide a device that efficiently and effectively penetrates tissue in a precisely targeted manner for a diagnostic or therapeutic endoscopy or endonography-guided transluminal procedures.  
         [0079]     The present invention may be a puncturing or penetrating member that includes or is provided with a tissue anchoring or engaging member. The puncturing member may be integral with the tissue anchoring member. For example, a barbed needle would integrate both a tissue penetrating and tissue anchoring member. In another embodiment the members be separate. For example, an anchor may be provided that may be fitted around a tissue penetrating member. The tissue penetrating member may also be adapted to be withdrawn in such a manner that it expands the distal radius of the anchor member. The anchoring member may involve such devices as crossbars, flanges, hooks, barbs, adhesive, or clips. The anchoring member may also be an gas or liquid inflatable element, such as a balloon. The puncturing member may be detachable by means of an elongate link such as a thread, wire, strand, or cord.  
         [0080]     Referring to  FIG. 14 , such an embodiment of the present invention may include a tissue penetrating device, an outer sleeve  210 , and a handle  1410 . The handle  1410  may include a main cylinder  200  that houses a sliding piston  230 , and a compression spring  240 . The upper (proximal) end of the outer piston may have a shoulder above which the compression spring  240  may be loaded.  
         [0081]     In a particular embodiment, when the outer piston is maximally advanced in the main cylinder  200 , the compression spring  240  may be relaxed (as opposed to tightly compressed) and handgrip may be in contact with the calibrating sleeve. The outer piston may be retracted by pulling back on the handgrip, thereby loading the compression spring  240  by compressing it.  
         [0082]     The main cylinder may be provided with a trigger that has a spring. Retraction of the outer piston may engage this spring in the groove, thereby locking the outer piston in the locked position. Pressing a button may release this lock, allowing the compression spring to uncoil (relax) and advance the outer piston distally at high velocity.  
         [0083]     The handgrip may be provided with a screw that secures the position of the inner piston  230  that contains the tissue penetrating device. The calibrating sleeve may be adjusted proximally to shorten the distance that the outer piston will progress after the spring is released. Thus, the distance of the tissue penetrating device may be precisely calibrated.  
         [0084]     An outer sleeve  210  may be connected and secured to the main cylinder  200  with a screw. The outer sleeve  210  may be screwed into the instrumentation channel inlet port of the endoscope or echo-endoscope by screw attachment. The outer sheath  40  may screw into the main cylinder. By loosening the screws, the position of the outer sleeve  210  may be adjusted relative to the main cylinder  200 . Such an adjustment may adjust the exposed length of the outer sheath  40 .  
         [0085]      FIG. 15  depicts an embodiment of the invention similar to that shown in  FIG. 8 . In this embodiment, the expander has been removed from the anchor  110 . The suture  105  may be attached to the anchor  110  in a non-coaxial position. The suture may have a loop or other member at the proximal end which may be used to attach a sensor or treatment delivery device. It may be advantageous to remove the expander from the anchor  110  because the expander may be used to expand anchors at other locations. Attachable devices may include, for example, treatment activation devices (e.g. photodynamic therapy devices), radioisotope containment devices, radioisotope delivery devices, thermal delivery devices, or radio frequency delivery devices. Although the invention is described in terms of an expander, the expander may also be used for non-expansion purposes (such as to aid in penetrating tissue) and may (in some instance) not be used for any expansion purpose. For example, if a leg (or a plurality of legs) of shape memory alloy is used, the deployment mechanism may be the withdrawal or rupture of an encompassing sheath.  
         [0086]      FIG. 16  depicts an embodiment of the invention similar to that shown in  FIG. 9 . In this embodiment, the expanders have been removed from the anchors  110 . The suture  106  may be attached to the anchor  110  in a non-coaxial position. It may be advantageous to remove the expander from the anchor  110  because the expander may be used to expand anchors at other locations. Sutures  106  may be connected by a lock ring  140 .  
         [0087]      FIGS. 17A and 17B  depict an anchor  1030  with a collapsible shoulder  1040 . Anchor assembly  1010  shows the distal legs of an anchor deployed with a collapsible shoulder mechanism at the proximal end of the anchor in its pre-deployed position. Shoulder tabs  1040  pivot on the anchor  1030  and may be connected to the anchor  1030  with elastic tension members  1050  such as silicone rubber bands. An encompassing sheath (not shown) may prevent the shoulder tabs  1040  from deploying until it the encompassing sheath  1065  retracted. Once the sheath  1065  is retracted, the shoulder tabs  1040  on anchor assembly  1020  may be forced by the elastic tension members  1050  to deploy and form a shoulder that may prevent the distal motion of the anchor  1030 . The distal legs (if more than one leg is used) may be implemented by a superelastic alloy. In such a configuration, the distal legs may be trained to produce an expanded distal radius, and may be constrained by the encompassing sheath  1065  to a narrower radius. Such an arrangement may require fewer discrete components.  
         [0088]      FIG. 18  depicts the use of the collapsible shoulder mechanism in two steps. In the first step (at top), the anchor  1030  is shown penetrating a first layer of tissue  1070  and a second layer of tissue  1080  with its legs already deployed. An encompassing sheath  1065  is shown in position restraining the opening of shoulder tabs  1040  against the applied force from the elastic tension member  1050 . The next step depicts the retraction of the expander  1055  and its associated tether  1060  and the encompassing sheath  1065 . These components may be retracted simultaneously or sequentially. The encompassing sheath  1065  may be removed first so that the expander  1055  and tether  1060  may stabilize the anchor  1030  prior to deployment of the collapsible shoulder. The encompassing sheath  1065  may be removed and the shoulder tabs  1040  may be forced into place against the second layer of tissue  1080  by the force supplied by elastic tension members  1050 . As described elsewhere, the encompassing sheath  1065  may also deploy legs by releasing a constraint on the legs. Additionally, the encompassing sheath  1065  may be releasably attached to a distal portion of the legs. The distal portion of the leg may be slightly spooned inward, so that its distal portion extends slightly radially outwardly. As the sheath is retracted, the ends of the legs may be pulled in a proximal direction. This may cause the legs to form an approximately U-shaped configuration which may have the effect of expanding a distal radius of the device. At a suitable time, the encompassing sheath may release the legs after they have formed such a shape. For such a deployment, as with deployment by an expander, it may be advantageous to use a leg formed of a malleable material.  
         [0089]      FIG. 19  depicts the use of an expandable stent in combination with an anchor. The figure shows a series of four steps of installing an anchor with an expandable stent. In the first step (at top), the combination anchor with expandable stent  1110  may be inserted through two layers of tissue  1170  and  1180 . An expander  1130  may be located coaxially within the anchor  1110 . The expander  1130  may be retracted proximally by, for example, a tether (not shown). A pusher  1150  may be slipped over the expander  1130  and positioned coaxially with the expander  1130 . The pusher  1150  may be used to counteract loads applied by the expander  1130  to the anchor  1110 . In the second step, the expander  1130  may cause the distal legs of the anchor to deploy. Simultaneously, the pusher  1150  may cause the proximal legs of the anchor to expand. The expander  1130  and pusher  1150  may then make contact with tabs in the anchor. This contact may prevent their further axial motion. Application of increased tensile force on the tether (not shown) connected to the expander  1130  and increased compression force on the pusher  1150  may load the anchor  1110  in compression.  
         [0090]     The compression loading of the anchor  1110  may yield the material and cause plastic deformation. The anchor body may be formed of an open mesh-like structure that expands in diameter as it yields and is forced into a shorter axial configuration. The third step in the figure illustrates an intermediate point of expansion of the diameter. Finally, the fourth step depicts the anchor fully expanded and the expander  1130  and pusher  1150  retracted from the anchor  1110 . It would also be possible to expand the stent portion of the anchor with an inflatable balloon. The expandable stent depicted in  FIG. 19  could be configured with a collapsible shoulder mechanism as illustrated in  FIGS. 17 and 18  if that proved useful. Such a stent may be made of a malleable material. Similarly, a stent may be made of a superelastic alloy. Such a stent may be constrained to a first diameter by an encompassing sheath (not shown) and may resume a larger diameter after the sheath is removed.  
         [0091]     FIGS.  22 A-H depicts detailed views of an expandable stent  2200  in combination with an anchor. Referring to  FIGS. 22A and 22E  ( FIG. 22E  is the sectional view A-A of  FIG. 22A ), the anchor may be delivered to the site with the legs  160  straight and the stent  2200  may initially be in an unexpanded state. Referring to  FIGS. 22B and 22F  ( FIG. 22F  is the sectional view B-B of  FIG. 22B ), the legs  160  may be deployed by means of the action of an expander device (not shown) moving coaxially through the anchor (from distal end towards proximal end). Referring to  FIGS. 22C and 22G  ( FIG. 22G  is the sectional view C-C of  FIG. 22C ), the stent  2200  diameter may be expanded. The expander that deployed the legs may also be used to expand the stent as well. Tabs  2210  may be formed on the stent  2200 . Such tabs  2210  may be bent radially inward. Such a bend may catch the expander as it is pulled toward the proximal end of the anchor. Continued pulling on the expander may cause the stent  2200  to plastically deform. The mesh-like walls of the stent  2200  may cause the stent diameter to increase as the stent length is reduced by the compressive force applied through the expander. A pusher device, not shown, may counteract the force applied by the expander and may thereby keep the anchor stationary. The stent  2200  may approximately double in diameter (compare  FIGS. 22A and 22D ). The reduction in length with increased diameter is also illustrated (compare  FIGS. 22E and 22H ). The coaxial expander may be used (if desired) to perform a part of the expansion (or none at all). Other ways to effectuate the expansion of the stent  2200  include using a shape-memory alloy such as Nitinol that may be pre-biased to the expanded state. The unexpanded stent  2200  may be constrained in a sheath that may be retracted once in the stent is in the proper position. Another way to expand the stent  2200  is to deform the stent  2200  into a larger diameter using an inflatable balloon.  
         [0092]      FIG. 20  depicts an anchor  1260  with a separate expandable shoulder  1270 . In this embodiment, the anchor  1260  and the shoulder  1270  are two separate pieces. The pieces may be adapted to engage each other. This may be accomplished as described above for the configuration shown in  FIG. 12 . Tethers  1280  and  1290  may be provided for applying tension to the anchor  1260  and compression to the expandable shoulder  1270 . The expandable shoulder  1270  may have its legs deployed in the same fashion as described earlier for deploying the legs of an anchor. An expander (not shown) may be forced between the legs of the expandable shoulder  1270  in a distal direction, and this forced movement may expand the legs.  FIG. 21  depicts the embodiment of the invention shown in  FIG. 20  installed between the stomach  1380  and section of bowel  1370  to create an anastomosis.  
         [0093]     Automatic operation of the penetrating device and pre-biasing the penetrating device may occur via use of, for example, a mechanical spring. Other pre-biasing devices may include, for example, compressed air or chemical explosion. In the example of a spring biasing device, as soon as the spring is released, the penetrating device may thrusts forward into a layer of tissue. By virtue of the greater inertia of the mass of the endoscope (if one is used in conjunction with the present invention), the penetrating device may experience all (or almost all) of the relative motion and may pass through even hardened tissue. The high velocity of the penetrating device may lessen the bending of the penetrating device and may help to overcome the striction effects.  
         [0094]     More specifically, according to the device of the present invention, the penetrating device pre-biased may rush forward after a release (or launch) device provided with the pre-biasing device is operated.  
         [0095]     Further, the use of the penetrating device of the invention may result in avoiding the potentially undesirable (in certain circumstances) repeated reciprocating motion that may be required by conventional techniques and devices.  
         [0096]     In this case, the penetrating device that may be located in the passage formed in the endoscope may be surrounded by a protecting sleeve. The sleeve may be made of an impenetrable material that may be moved independently of the penetrating device. The movable sleeve may protect and may reinforce the penetrating device and may position the penetrating device appropriately, even after the penetrating device has moved out of the passage provided in the endoscope.  
         [0097]     In order to reliably move the penetrating device forward and to prevent the pre-biasing device from projecting, the housing of the pre-biasing device may be set into screw engagement with the opening of the passage provided in the endoscope. Adjusting means (such as, for example, screws or slides) may precisely adjust the position of the penetrating device and the forward movement of the pre-biasing device.  
         [0098]     Referring to  FIG. 14 , the penetrating device may include an operating and pre-biasing device. The device may have a main cylinder  200  in which a sliding piston  230  may be provided. The sliding piston  230  may have a projection  1420  on its top end. To the projection  1420  there may be attached a spring  240  for pre-biasing the penetrating device. A release device  1430  having a spring  1440  may be provided on the main cylinder  200 . The spring  1440  may be set into a groove  1450  made in the slide piston, when the penetrating device or the slide piston  230  is biased. At the end of the slide piston  230 , which may be distant from the penetrating device, a grip  300  may be provided to move the piston  230 , thereby performing automatic penetration. On the grip  300  a stop pin  280  may be provided, by which the penetrating device may be secured. As long as the spring  240  is released, the grip  300  may remain in contact with a calibration cap  250 . The position of the calibration cap  250  may be changed to adjust the end position of the piston  230  and hence the penetration depth of the penetrating device.  
         [0099]     An outer sleeve  210  may be provided on the end of the main cylinder  200 , which may be near the penetrating device. This end of the cylinder  200  may hold the pre-biasing and control device in the penetrating device passage provided in the endoscope. The main cylinder  200  may be fastened to the outer sleeve  210  by means of a stop pin or screw  220 . The outer sleeve  210  may be fixed in the open end (inlet port) of the penetrating device passage of the echo-endoscope by means of a screw attachment  1460 .  
         [0100]     Standard endoscopes and “interventional” echo-endoscopes can be used. Using an interventional echo-endoscope, the angle of departure of the penetrating device may be adjusted at the echo-endoscope. The transducer at the end of the echo-endoscope may be surrounded by a latex balloon. The latex balloon can be filled with water during the use of the echo-endoscope. The water can serve as a medium between the detection probe and, for example, the intestinal wall.  
         [0101]     The penetrating device may extend through an outer sheath that may be made, for example, of a flexible metal weave or impenetrable plastic. The penetrating device may be inserted into the endoscope by the operating- and pre-biasing device until it projects, along with the sleeve, from the lower end of the endoscope. In certain eases, it may be desired that the penetrating device tip be beveled and that the distal end of the penetrating device be sand-blasted, pitted, or otherwise altered to improve the resolution of ultrasonic imaging.  
         [0102]     A dull stylette may be located in a hollow penetrating device (in some situations in which a hollow penetrating device is desired) and may be flush with or may project by approximately 2 mm from the open end of the penetrating device. The proximal end of the penetrating device, which may be ready for insertion into the operating and pre-biasing device may be set in screw engagement with the proximal end part of the operating and pre-biasing device.  
         [0103]     In the device according to the invention, the penetrating device can be manually moved back and forth by loosening the stop pin provided on the grip. The position of the penetrating device can therefore be manually adjusted.  
         [0104]     Referring to  FIG. 14 , the slide piston  230  may be drawn back greatly. If so, the groove  1450  may move toward the spring  1440 , compressing the coil spring  240 . When the spring  1440  comes into engagement with the groove  1450 , the penetrating device may be pre-biased and can be quickly moved forward by the release device  1430 . The calibrating sleeve  250  may adjust the depth of penetration of the penetrating device. A coarse adjustment may be possible in accordance with the depth of insertion of the main cylinder  200 . At this stage in the use of the device, the main cylinder  200  may be fixed in place by stop pin or screw  220 .  
         [0105]     A quick and accurate adjustment of the penetrating device may be performed by manipulation of the outer sleeve  210  provided at the end of the main cylinder  200 . Once the stop pin or screw  220  is loosened, while the stop pin  280  at the grip remains tightened, the protective sheath attached to the main cylinder  200  and the penetrating device secured to the slide piston may be inserted together into the outer sleeve  210  until they become visible by the endoscope. Thereafter, the stop pin or screw  220  may be tightened, whereby the calibrating sleeve  250  may adjust the depth of penetration with precision. The stylette (if one is used, a stylette is not required for the present invention) may be drawn a little from the hollow penetrating device, releasing the sharp end of the hollow penetrating device. The sharp end of the penetrating device first penetrates a first layer of tissue, such as the intestinal wall, and then comes close to a second layer of tissue that is to be punctured.  
         [0106]     As soon as the penetrating device reaches the tissue to be punctured, the stylette may be removed and may be replaced by any device or substance that may be set into contact with the other end of the hollow penetrating device.  
         [0107]     The stop pin  280  provided on the grip  300  may be loosened to insert the penetrating device into the tissue to be punctured. To accomplish manual puncture, the stop pin  280  may be loosened and the penetrating device may be moved back and forth with respect to the main cylinder  200 . When the manual puncture is difficult to achieve or when the tissue is hard to penetrate, the release device  1430  may release the elastic spring  240 . Thus, the penetrating device may project forward into the hardened tissue.  
         [0108]     Regarding one goal of this invention, the automation of the installation of anchors, one skilled in the art should recognize that it is possible to further automate the installation of anchors. As shown in  FIG. 3 , for example, it is possible to have multiple anchors staged near the distal end of the apparatus. The installation device may, thus, be readily modified to provide a cocking action that compresses the spring, retracts the pusher member through the next anchor and advances a next anchor and pusher member toward the expander.  
         [0109]     Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and the practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.