The present disclosure is generally related to an optical trocar. More particularly, the present disclosure is related to a bendable optical trocar.
The technology disclosed herein generally relates to an assembly having a handle and a tunneling shaft coupled to the handle. The tunneling shaft extends from the handle to a distal end, where at least a portion of the tunneling shaft extends in a curved orientation between the handle and the distal end. An optical window is disposed at the distal end of the tunneling shaft. An insertion pathway extends through the handle and the tunneling shaft to the optical window. A constriction mechanism is coupled to the handle and defines a portion of the insertion pathway. The constriction mechanism is configured to selectively constrict the insertion pathway. An endoscope is configured to be inserted in the handle to the optical window along the insertion pathway.
In some such embodiments, the constriction mechanism has an inner diaphragm defining the portion of the insertion pathway. Additionally or alternatively, the constriction mechanism has a manually engageable knob. Additionally or alternatively, the constriction mechanism is configured for selective disengagement and reengagement of the endoscope. Additionally or alternatively, the assembly has an optical material disposed in the insertion pathway, where the optical material is in contact with the optical window. Additionally or alternatively, the assembly has an orientation indicator on the optical window. Additionally or alternatively, the constriction mechanism has a pressure limiter that is configured to limit constriction of the insertion pathway. Additionally or alternatively, the magnitude of constriction of the constriction mechanism is adjustable by a user. Additionally or alternatively, the tunneling shaft is bendable.
Some embodiments of the current technology relate to a method. An endoscope is inserted through an insertion pathway of a trocar assembly from a proximal end to an optical window disposed on a distal end of the trocar assembly. A constriction mechanism is engaged that is positioned towards the proximal end of the trocar assembly to secure the endoscope relative to the insertion pathway. A tunneling shaft of the trocar assembly is bent. The constriction mechanism is disengaged. The endoscope is repositioned within the insertion pathway. The constriction mechanism is re-engaged to secure the endoscope relative to the insertion pathway.
In some such embodiments, the constriction mechanism is engaged by pivoting a lever. Additionally or alternatively, the constriction mechanism is engaged by turning a knob. Additionally or alternatively, optical material is disposed within the insertion pathway. Additionally or alternatively, inserting the endoscope includes translating the endoscope through an optical material disposed in the insertion pathway. Additionally or alternatively, the constriction mechanism is configured to limit pressure on the endoscope. Additionally or alternatively, the optical window has an orientation indicator. Additionally or alternatively, the magnitude of the constriction is adjusted. Additionally or alternatively, adjusting the magnitude of the constriction includes adjusting an inner diaphragm. Additionally or alternatively, the distal end is inserted through an incision in a patient. Additionally or alternatively, cutting blades coupled to the distal end are deployed.
The above summary is not intended to describe each embodiment or every implementation. Rather, a more complete understanding of illustrative embodiments will become apparent and appreciated by reference to the following Detailed Description of Exemplary Embodiments and claims in view of the accompanying figures of the drawing.
The present technology may be more completely understood and appreciated in consideration of the following detailed description of various embodiments in connection with the accompanying drawings.
The figures are rendered primarily for clarity and, as a result, are not necessarily drawn to scale. Moreover, various structure/components, including but not limited to fasteners, electrical components (wiring, cables, etc.), and the like, may be shown diagrammatically or removed from some or all of the views to better illustrate aspects of the depicted embodiments, or where inclusion of such structure/components is not necessary to an understanding of the various exemplary embodiments described herein. The lack of illustration/description of such structure/components in a particular figure is, however, not to be interpreted as limiting the scope of the various embodiments in any way.
The technology disclosed herein generally relates to an optical trocar assembly, an example of which is depicted in
The tunneling shaft 110 is generally configured to be inserted into and translated through the body tissue of a patient. The tunneling shaft 110 has a first end 111, which can be considered a proximal end 111, and a second or distal end 113. The tunneling shaft 110 is coupled to the handle 120 at the first end 111. The tunneling shaft 110 extends from the handle 120 to the distal end 113.
In various embodiments at least a portion of the tunneling shaft 110 extends in a curved orientation between the handle 120 and the distal end 113. For example, the tunneling shaft 110 may define a curve relative to axis 40, where axis 40 is straight line. The curved orientation of tunneling shaft 110 results in offset 115 between distal end 38 and axis 40 shown in
In some examples, tunneling shaft 110 is curved about the entire length from proximal end 111 to distal end 113 or may include one or more sections that are substantially straight with one or more other sections that are curved. For example, a proximate portion of the tunneling shaft 110 extending directly from handle 120 may be approximately straight for some of the length of tunneling shaft 110 and then transition to a more distal portion of tunneling shaft 110 that is curved. In some examples, the curved portion of tunneling shaft exhibits a radius of curvature of about 15 inches to about 40 inches. In various embodiments the tunneling shaft 110 is bendable. As such, the curve of the tunneling shaft 110 can be adjusted by a user. Such a configuration may advantageously allow a user to modify the curvature of the tunneling shaft 110 to accommodate the anatomy of a particular patient and/or operating environment within which the tunneling shaft 110 is being used.
The tunneling shaft 110 can be constructed of a variety of types of material and combinations of materials. The tunneling shaft 110 can be constructed of metals (stainless steel, coated steel, titanium alloys, aluminum alloys and others) and plastics. Suitable plastic materials include but are not limited to acetal copolymer, polytetrafluoroethylene (PTFE) (e.g., TEFLON), polyether ether ketone (PEEK), polyphenylsulfone (PPSU) (e.g., RADEL), and polycarbonate. In some examples, the tunneling shaft 110 may be constructed of a material that allows for all or at least a portion of tunneling shaft 110 to be transparent along the length of shaft 110. The tunneling shaft 110 may be substantially rigid so a user can accurately control the position of the tip in relation to vital organs under visualization afforded by fluoroscopy or other techniques. In some examples, the distal end 113 of the tunneling shaft 110 has at least some metal components (like a metal blade) which will allow visualization using suitable medical imaging technology.
In some examples, the bendability and rigidity of the tunneling shaft 110 may be described in the context of possible forces that may act of shaft 110, e.g., before or during an implant procedure. In various embodiments, the tunneling shaft 110 is sufficiently rigid to maintain its shape during a tunneling operation where the tunneling shaft 110 is being inserted into and through the tissue of a patient. However, in many such embodiments, the tunneling shaft 110 is bendable by a user's hands absent the use of additional tools. In many such embodiments, the tunneling shaft 110 is configured to bend without collapse of the inner lumen 112. In some examples, tunneling shaft 110 exhibits substantially no flex when greater than about 5 pounds of force is applied to the distal end 113 from a direction perpendicular to the linear extension of the distal end 113. In some examples, tunneling shaft 110 does not “jam up” (e.g. can still deploy a cutting tool and/or allow for visualization via an optical window) when greater than about 5 pounds of force is applied to the distal end 113 from a direction perpendicular to the linear extension of the distal end 113.
The tunneling shaft 110 may exhibit any suitable shape and dimensions. In some embodiments the tunneling shaft 110 has a substantially circular cross-section perpendicular to the extension of the tunneling shaft 110, however other example cross-section shapes are contemplated. In some examples, the tunneling shaft 110 has an oval cross-section. The maximum cross-dimension (such as a diameter or diagonal dimension) of the tunneling shaft 110 can range from about 3 millimeters (mm) to about 15 mm, although other examples are contemplated. The length of tunneling shaft 110 from the proximal end 111 directly adjacent the handle 120 to the distal end 113 may range from about 4 inches to about 12 inches, although other examples are contemplated.
In various embodiments, the tunneling shaft 110 is tubular. The tunneling shaft 110 has an inner lumen 112 that extends from the proximal end 111 towards the distal end 113. The inner lumen 112 is a portion of an insertion pathway 130 that extends through the handle 120 and the tunneling shaft 110 to the optical window 150. The optical window 150 extends across the inner lumen 112 to seal the inner lumen 112 from the external environment on the distal end 113 of the tunneling shaft 110.
The distal end 113 of the tunneling shaft 110 has an optical window 150 that is constructed of a transparent or at least semi-transparent material to facilitate light ray transmission.
In some embodiments, the optical window 150 is shaped to facilitate blunt dissection when tunneled through tissue of patient. In some other embodiments, including the one depicted, the optical window 150 is configured to dissect between tissue planes without cutting or incising tissue. In some such embodiments the optical window 150 is considered to have a ‘dolphin-nose” or “parabolic” type shape. Other shapes are certainly contemplated. More particularly, the optical window 150 has a leading face that is an atraumatic guiding nub 152, a proximal section 154, and a central section 156. The optical window 150 generally has a hollow interior. The proximal section 154 has a pair of diametrically opposed convex surfaces 155. The central section 156 includes a pair of diametrically opposed concave surfaces 153. The atraumatic guiding nub 152 extends distally from the central section 156. The atraumatic guiding nub 152 is a cylindrical protrusion that has a rounded distal end 151. The rounded distal end 151 defines a radius of curvature dimensioned to be atraumatic to tissue. The atraumatic guiding nub 152 can generally have a circular profile in a direction perpendicular to the longitudinal extension of the optical window 150. The central section 156 can have an ovular profile in a direction perpendicular to the longitudinal extension of the optical window 150. The proximal section 154 can have a circular profile in a direction perpendicular to the longitudinal extension of the optical window 150.
The proximal section 154 of the optical window 150 further includes a pair of diametrically opposed outer surfaces 157 which are generally linear and/or convex (where only one outer surface 157 is visible in
The atraumatic guiding nub 152 permits initial insertion within a pre-formed opening, e.g., a pre-cut scalpel incision, in the tissue and facilitates the advancement of the optical window 150 between the tissue layers to gently dissect tissue, without any cutting or incising of the tissue. After initial insertion and continued distal insertion, the central section 156 and the proximal section 154 continue to gently enlarge the opening in tissue by further dissecting the tissue planes, e.g. by the rounded outer surfaces of optical window separating the tissue planes during a clocking, twisting, or rocking motion thereof.
Referring back to
In some embodiments, an air gap is formed between the distal end 142 of the endoscope 140 and the optical window 150. In some embodiments, an optical material 116 can be disposed in the insertion pathway 130 between the endoscope 140 and the optical window 150. The optical material 116 can generally be configured to facilitate visualization of the surrounding environment by the endoscope 140 through the optical window 150. The optical material 116 may advantageously eliminate glare in some implementations. In some implementations, the optical material 116 may advantageously mitigate condensation on the optical window 150. In some implementations, the optical material 116 is an optically clear substance that facilitates transmission of optical signals. In various embodiments the optical material 116 is in contact with the optical window 150. The optical material 116 can be a liquid, but in other embodiments the optical material can be a solid. In some embodiments the optical material 116 is a saline solution. In some embodiments the optical material 116 is water. In some embodiments the optical material 116 is an optical silicone. In various embodiments the optical material 116 is a compressible material that allows linear translation of the endoscope 140 along the insertion pathway 130. In some embodiments the optical material 116 extends along most of the length of the insertion pathway 130. In some embodiments the optical material 116 is disposed towards a portion of the insertion pathway 130 such as towards the distal end 113 of the tunneling shaft 110.
In some embodiments the assembly consistent with the technology disclosed herein has an orientation indicator 159 disposed on the optical window, an example of which is depicted in
Returning to
In various embodiments, the constriction mechanism 160 is configured to selectively frictionally engage at least a portion of a perimeter region of the endoscope 140 within the insertion pathway 130. In various embodiments the constriction mechanism 160 is configured to be selectively disengaged from the endoscope and then selectively reengaged such that the endoscope can be repositioned relative to the insertion pathway 130. The constriction mechanism 160 can be adjustable in a variety of embodiments to selectively frictionally engage endoscopes having varying cross-sectional cross-dimensions (such as a diameter). In some embodiments, the magnitude of the constriction (such as the pressure) of the constriction mechanism 160 is adjustable by a user. In various embodiments, the constriction mechanism 160 has a pressure limiter that is configured to limit the pressure exerted on the endoscope 140 by the constriction mechanism 160. The pressure limiter can be configured to limit constriction of the insertion pathway 130. Such a configuration may advantageously avoid over compression of the endoscope's electrical wiring.
In various embodiments, the constriction mechanism 160 has a manually engageable knob 162. The manually engageable knob 162 is configured to be rotated by a user around a knob central axis to selectively constrict or expand the portion of the insertion pathway 130 defined by the constriction mechanism 160. In some embodiments the manually engageable knob 162 is in operative communication with radial protrusions that are configured to advance radially into the insertion pathway 130 when the manually engageable knob 162 is rotated in one direction and the radial protrusions are configured to advance radially outward from the insertion pathway 130 when the manually engageable knob 162 is rotated in an opposite direction. In another embodiment the manually engageable knob 162 can be a rotatable pin such as a pin vice or set screw that is advanced into the insertion pathway 130 to fix the endoscope 140 relative to the insertion pathway 130 and is advanced outward from the insertion pathway 130 to unfix the endoscope 140 relative to the insertion pathway 130.
In the current example, the constriction mechanism 160 has an inner diaphragm 164 that defines a portion of the insertion pathway 130. Upon rotation of the manually engageable knob in a first direction, the diaphragm 164 advances radially inward towards the endoscope 140. Upon rotation of the manually engageable knob 162 in a second direction, the diaphragm 164 advances radially outward from the endoscope 140.
While in the current example the constriction mechanism 160 has a manually engageable knob 162, in some other embodiments the constriction mechanism 160 has a lever that is pivotably coupled to the optical trocar in communication with the insertion pathway.
The components depicted in the current figure are generally consistent with the descriptions of components discussed above with reference to
It is noted that the example optical trocar assembly 100 of
In the example optical trocar assembly 100 of
The cutting tool 390 can take the form of a knife blade, scalpel blade, or other tool with a sharp edge 392 that is configured to cut through tissue, such as, scar tissue, of patient while the tunneling shaft 310 is tunneled in the tissue of a patient to a target location. The cutting tool 390 can be configured to be selectively actuated by a surgeon or other user from a recessed position (not currently depicted) to a deployed position (as shown in
Any suitable mechanism may be used to transition the cutting tool 390 between a recessed position and deployed position (
In some examples, the engagement (such the depressing) the trigger (122,
Technology consistent with the present disclosure may advantageously allow re-use of an endoscope with different optical trocar tools. In some embodiments, the optical trocar tools are generally configured for a single-use and are disposable. In some implementations, the endoscopes are configured for multiple uses and are generally not considered disposable after a single use. Referring to
The isolation sheath 590 is generally a tubular structure that is configured to receive a portion of the length of the endoscope 540 extending beyond the proximal end of the handle 520. The isolation sheath 590 generally forms an outer circumferential barrier between the outside environment and a length of an outer surface of the endoscope 540 extending beyond the optical trocar. In some embodiments the isolation sheath 590 is a nonbreathable material. In some embodiments the isolation sheath 590 obstructs liquid flow therethrough. In some embodiments the isolation sheath 590 is configured to be sterile. The isolation sheath 590 can be constructed of a polymeric material such as polyethylene.
The isolation sheath 590 can have a first end 591 that is configured to be sealed about a proximal end 531 of the insertion pathway (not currently visible but shown as element 130 in
In the current example, the constriction mechanism 560 includes a manually engageable knob 562 rotatably coupled to the proximal end of the handle 520. The manually engageable knob 562 is a ring defining a central opening that defines the proximal end 531 of the insertion pathway. The central opening of the manually engageable knob 562 is configured to receive the endoscope 540 and frictionally engage the outer surface of the endoscope 540 upon engagement such as by manually rotating the knob 562 around its central opening. In this example, the first end 591 of the isolation sheath 590 is sealed to the constriction mechanism 560, such as the manually engageable knob 562, around the proximal end 531 of the insertion pathway.
The isolation sheath 590 can be constructed of a thin, flexible material that is configured to be manually extended along the length of the endoscope 540 from the handle 520. Prior to engagement, the isolation sheath 590 can have a first, un-extended length. Upon insertion of the endoscope into the proximal end 531 of the insertion pathway and in preparation for or during a procedure, the isolation sheath 590 can be manually extended along the length of the endoscope 540 to prevent contamination of the length of the endoscope 540 beyond the handle. The isolation sheath 590 can have an extended length that is greater than the un-extended length.
The endoscope is generally inserted 610 through an insertion pathway of a trocar assembly. The endoscope is inserted 610 from a proximal end to an optical window disposed on a distal end of the trocar assembly. In some embodiments where optical fluid is disposed in the insertion pathway, inserting the endoscope 610 includes translating the endoscope through the optical material disposed in the insertion pathway. In some embodiments, optical fluid is disposed in the insertion pathway as part of the method described herein. The optical fluid can be disposed in the insertion pathway prior to insertion of the endoscope through the insertion pathway. In some other embodiments, however, the optical fluid can be disposed in the insertion pathway after insertion of the endoscope through the insertion pathway 610.
The constriction mechanism is engaged 620 to secure the endoscope relative to the insertion pathway. The constriction mechanism is generally positioned towards the proximal end of the trocar assembly. In some embodiments where the constriction mechanism has a lever, engaging the constriction mechanism includes pivoting the lever to an engaged position. In some embodiments where the constriction mechanism has a rotatable knob, engaging the constriction mechanism includes turning the knob to an engaged position. In some embodiments the magnitude of the constriction can be manually adjusted. In some such embodiments where an inner diaphragm forms a portion of the constriction mechanism, adjusting the magnitude of the constriction includes adjusting the inner diaphragm. In various embodiments the constriction mechanism is configured to limit pressure on the endoscope.
Bending the tunneling shaft 630 of the trocar assembly can include, for example, manually grasping the tunneling shaft 630 by a user and applying a bending force to the tunneling shaft that is sufficient to overcome the stiffness of the tunneling shaft 630. In some embodiments, the tunneling shaft is bent 630 to accommodate the present operating environment, such as the anatomy of the particular patient on which the procedure is performed.
In various embodiments, bending the tunneling shaft 630 while the constriction mechanism is engaged will translate the distal end of the endoscope relative to the optical window due to the differences in the radius of curvature forming the bend between the tunneling shaft and the endoscope. As such, before or after bending the tunneling shaft 630, the constriction mechanism can be disengaged 640 to unfix the endoscope relative to the insertion pathway. The endoscope can then be repositioned within the insertion pathway 650 such as by manually translating the endoscope along the insertion pathway so that the distal end of the endoscope is positioned desirably relative to the optical window. When the desired position to attained, the constriction mechanism can be re-engaged to again secure the endoscope relative to the insertion pathway 660.
In various embodiments, the procedure can include inserting the distal end of the trocar assembly through an incision in a patient. Any one of the steps discussed above can occur before, after, or during insertion of the distal end of the trocar assembly through the incision in the patient. In some embodiments that have been discussed above, the optical window has an orientation indicator. In such embodiments the user can consult the orientation indicator, such as during insertion of assembly through the incision in the patient to orient the device in a desirable orientation. In come embodiments where the optical trocar assembly incorporates a deployable cutting blade coupled to the distal end of the optical trocar, the cutting blades can be deployed by the user.
It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed to perform a particular task or adopt a particular configuration. The word “configured” can be used interchangeably with similar words such as “arranged”, “constructed”, “manufactured”, and the like.
All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this technology pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference. In the event that any inconsistency exists between the disclosure of the present application and the disclosure(s) of any document incorporated herein by reference, the disclosure of the present application shall govern.
This application is intended to cover adaptations or variations of the present subject matter. It is to be understood that the above description is intended to be illustrative, and not restrictive, and the claims are not limited to the illustrative embodiments as set forth herein.
The following examples are a non-limiting list of clauses in accordance with one or more techniques of this disclosure.
Example 1. An assembly comprising: a handle; a tunneling shaft coupled to the handle, the tunneling shaft extending from the handle to a distal end, wherein at least a portion of the tunneling shaft extends in a curved orientation between the handle and the distal end; an optical window disposed at the distal end of the tunneling shaft; an insertion pathway extending through the handle and the tunneling shaft to the optical window; a constriction mechanism coupled to the handle defining a portion of the insertion pathway, wherein the constriction mechanism is configured to selectively constrict the insertion pathway; and an endoscope configured to be inserted in the handle to the optical window along the insertion pathway.
Example 2. The assembly of Example 1, wherein the constriction mechanism comprises an inner diaphragm defining the portion of the insertion pathway.
Example 3. The assembly of any one of Examples 1 or 2, wherein the constriction mechanism comprises a manually engageable knob.
Example 4. The assembly of any one of Examples 1-3, wherein the constriction mechanism is configured for selective disengagement and reengagement of the endoscope.
Example 5. The assembly of any one of Examples 1-4, further comprising optical material disposed in the insertion pathway, wherein the optical material is in contact with the optical window.
Example 6. The assembly of any one of Examples 1-5, further comprising an orientation indicator on the optical window.
Example 7. The assembly of any one of Examples 1-6, wherein the constriction mechanism has a pressure limiter that is configured to limit constriction of the insertion pathway.
Example 8. The assembly of any one of Examples 1-7, wherein the magnitude of constriction of the constriction mechanism is adjustable by a user.
Example 9. The assembly of any one of Examples 1-8, wherein the tunneling shaft is bendable.
Example 10. A method comprising: inserting an endoscope through an insertion pathway of a trocar assembly from a proximal end to an optical window disposed on a distal end of the trocar assembly; engaging a constriction mechanism that is positioned towards the proximal end of the trocar assembly to secure the endoscope relative to the insertion pathway; bending a tunneling shaft of the trocar assembly; disengaging the constriction mechanism; repositioning the endoscope within the insertion pathway; and re-engaging the constriction mechanism to secure the endoscope relative to the insertion pathway.
Example 11. The method of Example 10, wherein engaging the constriction mechanism comprises pivoting a lever.
Example 12. The method of any one of Examples 10 or 11, wherein engaging the constriction mechanism comprises turning a knob.
Example 13. The method of any one of Examples 1-12, further comprising disposing optical material within the insertion pathway.
Example 14. The method of any one of Examples 1-13, wherein inserting the endoscope further comprises translating the endoscope through an optical material disposed in the insertion pathway.
Example 15. The method of any one of Examples 1-14, wherein the constriction mechanism is configured to limit pressure on the endoscope.
Example 16. The method of any one of Examples 1-15, wherein the optical window comprises an orientation indicator.
Example 17. The method of any one of Examples 1-16, further comprising adjusting the magnitude of the constriction.
Example 18. The method of example 17, wherein adjusting the magnitude of the constriction comprises adjusting an inner diaphragm.
Example 19. The method of any one of Examples 1-18, further comprising inserting the distal end through an incision in a patient.
Example 20. The method of any one of Examples 1-19, further comprising deploying cutting blades coupled to the distal end.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2023/053258 | 3/31/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63330072 | Apr 2022 | US |