Patent Application
20060287666
The present invention relates to apparatus and methods for endoluminal advancement through a hollow body organ. More particularly, the present invention relates to apparatus and methods for achieving endoluminal access via anatomical pleating of tissue.
A physician performing a gastrointestinal examination or treatment commonly advances an endoscope through a patient's anus into the patient's colon. In order to permit full examination of the colon, the endoscope must be advanced up to the cecum. Advancement may be directed via a steerable distal end portion of the endoscope. However, at bends in the colon, e.g., at the sigmoid and especially at the two colonic flexures, advancement problems regularly occur, including a risk of injury, pain to the patient, cramp-like contractions of the colon, and even an inability to further advance the colonoscope. Much of these problems occur because the colon is comprised of soft tissue which is weakly adhered to the abdomen.
After a first deflection of the endoscope, a principal direction of force by which the endoscope is advanced no longer points towards the distal end of the endoscope, but rather points towards the readily yielding wall of the colon. Because of the severe bends typically found in the colon, as well as in the small intestines, and further because of the looping which may occur in the colon and small intestines, pleating or “accordionizing” of the tissue may be performed to facilitate advancement of the endoscope is generally along the length of the scope. This is most likely to occur if the scope is repeatedly advanced and withdrawn.
Pleating of the tissue typically enables examination of the greatest length of colon with the least amount of scope. In contrast to techniques where the scope is advanced up into the colon, accordionization typically brings the colon down over the scope. Accordionization of the tissue requires significant skill and experience on the part of the physician in order to be successful. Furthermore, many variables must be taken into account in order to properly pleat the colon, including cyclic rhythm, amount of torque, degree of tip deflection, and shaft advancement distance.
Moreover, even when the tissue has been pleated over the scope, further advancement of the scope relative to the pleated tissue may inadvertently unravel at least some of the pleating. The unraveled tissue may thereby require repeated pleating over the endoscope thereby increasing the time required for examination and also increasing the skill level necessary to complete advancement of the endoscope within the patient.
In view of the aforementioned limitations, it would be desirable to provide methods and apparatus for pleating hollow body organs, such as the colon and small intestines, that require less skill and experience on the part of the physician. It also would be desirable to provide apparatus and methods that simplify and expedite pleating of tissue.
An example of shapelock anchoring assembly may generally comprise an elongate body which defines at least one lumen therethrough for advancement of an endoscope or other endoscopic instruments therethrough. An anchoring assembly may be positioned at or proximal to a distal tip of the elongate body and the handle assembly may be coupled to a proximal end of the elongate body. The handle assembly may be comprised generally of a handle body and locking handle which may be configured to actuate one or more cables routed throughout the elongate body such that a plurality of nested links comprising body are compressed against one another to transition the elongate body from a flexible state to a rigid shape-locked state.
Once in its shape-locked condition, the elongate body maintains any configuration in a rigid manner. Release of the locking handle relative to handle body releases the elongate body to transition back into a flexible body to conform into another configuration. An endoscope or any number of endoscopic instruments may be advanced into and through an entry lumen and elongate body to effect treatment. Further details and examples of shape-locking elongate bodies are disclosed in U.S. patent application Ser. No. 10/281,462 filed Oct. 25, 2002 (U.S. Pat. Pub. 2003/0233066 A1), which is incorporated herein by reference in its entirety.
In addition to the shape-locking features of the elongate body, the anchoring assembly may comprise, in one variation, an expandable or projected anchoring feature which may be utilized to contact and anchor or retain tissue relative to the elongate body such that the anchored tissue is temporarily immobile relative to the elongate body. In one variation, the anchoring assembly comprises an anchoring member attached at its proximal end to the elongate body via a proximal band. The distal portion of a mesh member may be attached to a distal band which may be movable relative to the elongate body. The mesh member may be reconfigurable from a low-profile configuration for advancement within the patient body to a radially expanded anchoring configuration. The mesh member may be expanded in this variation by urging the distal band relatively towards the proximal band to compress the mesh member therebetween and to thereby radially expand the member. In alternative variations, the proximal band may be advanced distally towards a static distal band or both bands may be translated towards one another simultaneously to effect an anchoring configuration.
The anchoring assembly may likewise be actuatable such that actuation of the mechanism for the shape-locking feature of the elongate body simultaneously actuates expansion of, in this variation, the mesh member. Alternatively, the anchoring assembly may be actuated via a separate mechanism such that shape-lock actuation of the elongate body and anchor actuation remain independent from one another.
One variation for simultaneous shape-lock and anchor actuation may comprise at least one or more actuation wires attached to the distal band at attachment points and routed beneath or through a liner within respective lumens along elongate body and attached at corresponding attachment points located on a shape-locking actuation shaft extending from the handle. At least one actuation wire is used and several wires uniformly positioned about a circumference of distal band may also be utilized. Upon depressing the locking handle to shape-lock elongate body, the attachment points may be pulled proximally towards the handle body such that actuation wires likewise pull the distal band proximally relative to the proximal band, which is statically attached to the elongate body. The approximation of the proximal and distal bands towards one another compresses the anchoring member such that the mesh member is forced to radially expand and come into contact with the tissue to be temporarily anchored. Upon releasing the locking handle, the actuation wires may slacken to allow for the mesh member to reconfigure itself back into its original low-profile shape.
Additional methods and mechanisms which may be utilized in combination with a shape-lockable elongate body may be seen in further detail in U.S. patent application Ser. No. 10/746,286 filed Dec. 23, 2003 (U.S. Pat. Pub. 2004/0186349 A1), which is incorporated herein by reference in its entirety. Any of the tissue anchoring variations may be actuated via a mechanism common to the shape-locking feature and anchoring feature such that a single operation may actuate both shape-locking and tissue anchoring features simultaneously. Alternatively, the anchoring feature may also be actuated independently of the shape-locking feature, if so desired by the user.
Additional tissue anchoring mechanisms and methods may include one or more expandable balloons disposed near or at the distal end of the elongate body and expandable into a variety of configurations, expandable balloon members having a covering or coating disposed over the outer surface of the balloon, as well as one or more expandable balloon members which are configured to expand into an eccentric shape relative to a longitudinal axis of the elongate. Other tissue anchoring variations may include pivoting members which lie against the elongate body in a low-profile configuration and rotates from a proximal-to-distal or distal-to-proximal pivoting manner like a clamshell into its anchoring configuration, malecot-type anchoring assemblies, distensible sheaths or membranes supported via one or several radially extending support members, compliant sleeves or portions having a plurality of projections which may extend from a low-profile shape to an extended configuration, as well as portions of the elongate body having a compressible element, such as a compressible spring elements, having an expandable covering or coating, e.g., mesh covering.
In an example of use for pleating and/or anchoring tissue, one method may include advancing a conventional endoscope into a colon of a patient body along with an elongate body of the shape-lockable device in its flexible state and having an expandable anchor disposed thereon. Once the shape-lockable elongate body has been desirably advanced over the endoscope body, the steerable distal section of the endoscope may be steered into a hooked configuration to engage the colon tissue. The hooked and engaged tissue may be actively pulled proximal relative to the elongate body such that a portion of the colon is shortened by the engaged tissue being drawn and pleated over the elongate body. Once the endoscope is to be further advanced through the colon, the anchor member on the elongate body may be actuated to expand and thereby capture the pleated tissue along elongate body, prior to advancement of the endoscope or shortly after advancement of the endoscope relative to the elongate. The elongate body may also be optionally actuated to shape-lock its configuration simultaneously with anchor expansion or sequential to anchor expansion.
With the pleated tissue captured and inhibited from unraveling by the anchoring member, and with the elongate body optionally shape-locked (if so desired), the steerable distal portion of the endoscope may be straightened from its hooked configuration and the endoscope body may be advanced further into the colon relative to the captured pleated tissue. Upon further advancing the endoscope, the steerable distal portion may again be formed into a hooked configuration for hooking and pulling the tissue engaged thereby. Again, tissue engaged by the steerable distal portion of the endoscope may be drawn proximally towards the elongate body and the anchoring member, which may be reconfigured into its low-profile to allow for distal advancement of elongate body. If the elongate body were optionally shape-locked, it may be transitioned into its flexible configuration as well.
Once the anchoring member has been released from tissue engagement, further pleating of colon tissue around the elongate body may be accomplished. With the elongate body advanced distally further into the colon and colon tissue further pleated about the elongate body, the anchoring member may be actuated again to capture the additional pleated tissue and prevent its unraveling as the endoscope steerable distal portion and endoscope body are again advanced distally further through the colon. This process may be repeated as many times as desired or necessary to shorten the colon as well as to remove any tortuous looping of portions of the colon and to facilitate advancement of an endoscope or endoscopic instruments therethrough.
In another method for endoscope advancement and tissue pleating, a shape-lockable elongate body may additionally comprise a shape-lockable distal steerable portion. In use, a steerable endoscope and shape-lockable elongate body may be advanced into a patient's colon, as described above. The steerable distal portion of the endoscope may be steered into a hooking configuration to engage a portion of the colon which may then be pulled proximally to pleat the tissue about the elongate body in a hook-and-pull maneuver. To prevent the pleated tissue from unraveling, the steerable portion of the elongate body may be urged into an angled, arcuate, or curved configuration such that steerable portion is curved relative to a longitudinal axis of a proximal portion of the elongate body. The steerable portion may be simply angled or curved such that the steerable portion rests against a portion of the colon along a tissue contact region. Thus, the tissue contact region between the curved distal portion and the colon may be sufficient to anchor the pleated tissue and prevent unraveling as the steerable distal portion of the endoscope is straightened and endoscope body is further advanced into the colon.
Generally in use, an endoscope may be advanced into a patient's body lumen, such as the lower gastro-intestinal tract via the anus or the upper gastro-intestinal tract via the patient's mouth. However, the tissue of the colon and small intestines are typically unsupported and advancement through these body lumens is difficult. Furthermore, looping of the tissue and unraveling of pleated tissue relative to the endoscope makes endoscopic advancement particularly difficult. Accordingly, secured or temporarily anchored accordionization or pleating of the tissue around the endoscope may facilitate advancement of the endoscope and examination of the tissue.
An example of a device is shown in shapelock anchoring assembly 10 in
Handle assembly 20 may be comprised generally of handle body 22 and locking handle 24 which may be configured to actuate one or more cables routed throughout elongate body 12 such that a plurality of nested links comprising body 12 are compressed against one another to transition elongate body 12 from a flexible state, shown in
Locking handle 24 may be rotatably coupled to handle body 22 via pivot 26 such that rotation of locking handle 24 in the direction shown in
In addition to the shape-locking features of elongate body 12, anchoring assembly 14 may comprise, in one variation, an expandable or projected anchoring feature which may be utilized to contact and anchor or retain tissue relative to elongate body 12 such that the anchored tissue is temporarily immobile relative to elongate body 12. In the variation shown in
Mesh member 30 may be reconfigurable from a low-profile configuration, shown in
Anchoring assembly 14 may likewise be actuatable via handle assembly 20 such that actuation of the mechanism for the shape-locking feature of elongate body 12 simultaneously actuates expansion of, in this variation, mesh member 30. Alternatively, anchoring assembly 14 may be actuated via a separate mechanism, e.g., control wheel or slider mechanism, such that shape-lock actuation of elongate body 12 and anchor actuation remain independent from one another.
One variation for simultaneous shape-lock and anchor actuation is shown in the side views of
Anchoring assembly 14 may be comprised of a number of different anchoring configurations and mechanisms. Mesh member 30 is shown as an example of one type of tissue anchoring variation. Additional methods and mechanisms which may be utilized in combination with a shape-lockable elongate body 12 may be seen in further detail in U.S. patent application Ser. No. 10/746,286 filed Dec. 23, 2003 (U.S. Pat. Pub. 2004/0186349 A1), which is incorporated herein by reference in its entirety.
Any of the tissue anchoring variations described herein as well as in U.S. patent application Ser. No. 10/746,286 may be actuated via a mechanism common to the shape-locking feature and anchoring feature such that a single operation, such as depressing locking handle 24, may actuate both shape-locking and tissue anchoring features simultaneously. Alternatively, the anchoring feature may also be actuated independently of the shape-locking feature, if so desired by the user.
Turning to
In yet another variation, elongate body 12 may utilize a pivoting anchoring assembly 60 generally comprising a first and a second pivoting member 62, 64, respectively, which lie against elongate body in a low-profile configuration, as shown in
The variation of pivoting anchor assembly 70 shown in the side and end views of
In another variation, malecot anchoring assembly 80 shown in
In yet another variation, expandable anchor assembly 90 may generally comprise a distensible sheath or membrane 96 which may be supported via one or several radially extending support members 94. Each of the support members 94, as well as the sheath or membrane 96, may be secured at their distal ends to elongate body 12 along a distal anchoring portion 92. In use, support members 94 may be extended radially, as shown in the respective side and end views of
In another variation shown in
In yet another variation, elongate body 12 may comprise one or more expandable balloon members, as shown in
In another variation, a helical balloon assembly 120 may generally comprise an expandable balloon configured to maintain a low-profile shape, as in
Angled projections 134, as well as sleeve 132, may be fabricated from a distensible material such that projections 134 lie flat relative to elongate body 12 but distend when inflated or expanded, e.g., via saline, water, nitrogen, carbon dioxide, etc. Alternatively, projections 134 may be configured to bias to form an inverted configuration within sleeve 132 to provide for a low-profile during advancement of elongate body 12. When inflated or expanded, the inverted angled projections 134 may evert to extend into its expanded, angled configuration. Moreover, any number of projections 134 may be utilized in a number of configurations. They may be uniformly positioned about sleeve 132, as shown in the figures, or they may alternatively be positioned in single or multiple circumferential patterns; alternatively, projections 134 may be positioned in one or more linear or non-linear pattern along the length of sleeve 132.
In yet another variation, a spring body assembly 140 may be utilized to expanded or project an anchoring mechanism. As shown in
When in its non-compressed state, spring element 142 may stretch the mesh covering 144 into a low-profile configuration. However, when a distal portion of spring element 142 is drawn proximally towards elongate body 12, e.g., by actuation wires attached to a distal portion of spring 142 or to a distal tip of elongate body 12 being tensioned from their proximal ends outside the patient, spring element 142 may become compressed and expand the mesh covering 144 into its expanded anchoring profile, as shown in the respective side and end views of
As mentioned above, any of the tissue anchoring variations described herein may be actuated via a mechanism common to the shape-locking feature and anchoring feature such that a single operation actuates both shape-locking and tissue anchoring features simultaneously. Alternatively, the anchoring feature may also be actuated independently of the shape-locking feature.
Although the tissue anchoring system disclosed may be used as a single shape-lockable elongate body 12 with an endoscope or other endoscopic instruments, multiple elongate devices which are also optionally shape-lockable may be used in combination with one another. One example is shown in the assembly of
In use, second elongate body 152 may be advanced relative to first elongate body 12 in an alternating manner while both bodies 12, 152 are in a relaxed, non-rigid state, as shown in
After pleating the tissue, anchoring member 30 may be maintained in its expanded configuration and optionally first elongate body 12 may also be maintained in a shape-locked configuration while anchoring member 154 may be reconfigured into a low-profile and second elongate body 152 may be advanced distally relative to any pleated tissue and relative to first elongate body 12, as shown in
Once second elongate body 152 has been desirably advanced within the patient, anchoring member 154 may be expanded to engage the distally located tissue and second elongate body 152 may optionally be shape-locked, if so desired. Anchoring member 30 may be reconfigured into its low-profile shape and then advanced over or along second elongate body 152, which may or may not be shape-locked. If first elongate body 12 were shape-locked, it is preferably transitioned into a its flexible state prior to advancement over second elongate body 152. Once first elongate body 12 has been desirably advanced, anchoring member 30 may then be expanded and elongate body 12 may be optionally shape-locked and the process repeated for further advancement within the patient. The process may be reversed for withdrawal from the patient; alternatively, both anchoring members 30, 154 may be configured into their low-profiles and both elongate bodies 12, 152 may be transitioned into their flexible shapes for withdrawal from the patient.
In an example of use for pleating and/or anchoring tissue,
Once endoscope 160 has been desirably positioned, elongate body 12 in its flexible state and having expandable anchor 30 disposed thereon, may be advanced into the colon C over or along endoscope body 162. Once shape-lockable elongate body 12 has been desirably advanced over endoscope body 162, endoscope 160 may be advanced further into colon C relative to elongate body 12, as shown in
Once endoscope 160 has been advanced to a desirable position, the steerable distal section 164 may be steered into a hooked configuration to engage the tissue of colon C to endoscope 160, as shown in
As seen in
Again, tissue engaged by steerable distal portion 164 may be drawn proximally towards elongate body 12 and anchoring member 30, which may be reconfigured into its low-profile to allow for distal advancement of elongate body 12. If elongate body 12 were optionally shape-locked, it may be transitioned into its flexible configuration as well. Once anchoring member 30 has been released from tissue engagement, further pleating of colon tissue around elongate body 12 may be accomplished, as shown in
In another method for endoscope advancement and tissue pleating, a shape-lockable elongate body 12 may additionally comprise a shape-lockable distal steerable portion 170. In use, a steerable endoscope 160 and shape-lockable elongate body 12 may be advanced into a patient's colon C, as shown in
To prevent the pleated tissue PL from unraveling, the steerable portion 170 of elongate body 12 may be urged into an angled, arcuate, or curved configuration, as shown in
Optionally, during this hook-and-pull procedure, when steerable portion 170 is curved into its anchoring configuration, elongate body 12 may be configured to shape-lock into its rigid state simultaneously with the actuation of steerable portion 170 into its curved configuration, as seen in
Although various illustrative embodiments are described above, it will be evident to one skilled in the art that a variety of combinations of aspects of different variations, changes, and modifications are within the scope of the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
