Adapter for Attaching Devices to Endoscopes
20200289103 ยท 2020-09-17
Assignee
Inventors
Cpc classification
A61B17/0644
HUMAN NECESSITIES
A61B2017/0641
HUMAN NECESSITIES
A61B17/068
HUMAN NECESSITIES
A61B17/0057
HUMAN NECESSITIES
A61B1/00142
HUMAN NECESSITIES
A61B1/0014
HUMAN NECESSITIES
International classification
A61B1/00
HUMAN NECESSITIES
A61B17/068
HUMAN NECESSITIES
Abstract
An improved system for attaching devices to the distal end of endoscopic instruments is described. An attachment adapter comprises a distal stop, such as a complete or partial loop or cylinder, which limits the penetration of an endoscope into the adapter. The adapter has at least one flange protruding proximally along the endoscope. The adapter is secured on the endoscope by a securing means, which compresses the flange or flanges sufficiently to provide a friction fit. The flexibility of the inventive adapter system allows the adapter to work reliably with endoscopes that are used, damaged or repaired. The adapter may further provide a slit or window allowing viewing of the vessel wall by a lens on an endoscope, thereby improving the operator's ability to understand the location of the endoscope during operation. The adapter may carry any of a variety of devices, including devices for closing a surgical incision, or treating or manipulating tissue. Improvements are described in a number of areas to allow more flexible pairing of particular endoscopes or endoscopic instruments with devices to be carried on their exteriors, while maintaining a tightly locked position of the external device on the carrier.
Claims
1. An adapter for attaching devices to the distal end of an endoscopic instrument, the adapter comprising distal stop means to limit the penetration of said endoscopic instrument into said adapter; wherein the adapter is constructed so that the central axis of said adapter and the center axis of said endoscopic instrument are not concentric when said adapter is mounted on said instrument.
2. The adapter of claim 1, wherein the distal stop means has a closed perimeter.
3. The adapter of claim 1 having at least one flange projecting from said distal stop means, wherein said flange comprises a securing means to secure said flange to said endoscopic instrument to prevent motion of said flange with respect to said instrument.
4. The adapter of claim 3 wherein the flange is comprised of a material flexible enough to at least partially encircle an endoscopic instrument circumference, said encirclement being sufficient to allow the securing of the adapter to the distal end of endoscopic instruments having a range of diameters and shapes at their distal tips.
5. The adapter of claim 3, wherein the flange has a non-closed perimeter.
6. The adapter of claim 3, wherein the flange has a perimeter with at least one opening, and the distal stop has a perimeter with at least one opening.
7. The adapter of claim 3, wherein the projecting flange perimeter openings and the distal stop perimeters openings are aligned.
8. The adapter of claim 1, wherein the adapter is constructed so that the central axis of said adapter and the center axis of said endoscopic instrument are substantially parallel when said adapter is mounted on said instrument.
9. The adapter of claim 3, wherein said securing means is constructed and arranged to provide a force that is sufficient to impede movement of said adapter with respect to said endoscope, when said adapter is placed on said endoscope and said securing means is engaged with said adapter.
10. The adapter of claim 3, wherein said securing means may be one or more of an o-ring, a wrap around, an overlapping wrap around, a hook-loop closure, at least one hook or snap closure, an elastomeric material, a thermoplastic material, a thermoset material, a spring material, a super-elastic material, a metallic material, an adhesive material, an inflatable element, a collapsible shrink wrap, a welded in place securing means, a cut or sever to remove securing means, or any combination thereof.
11. The adapter of claim 3, wherein said at least one flange, after it is secured to the endoscopic instrument, defines at least one region which is open or sufficiently transparent to allow visualization of tissues surrounding said endoscopic instrument by visualization means mounted on said endoscopic instrument.
12. The adapter of claim 1, further comprising a sheath covering said adapter.
13. The adapter of claim 12 further comprising a sheath or membrane covering the adapter proximally of the distal end of the adapter, which may be deployed before or during a medical procedure.
14. The adapter of claim 13 wherein the sheath is optically clear at least in part.
15. The adapter of claim 14 wherein the sheath is extendable to enclose the full length of the endoscopic instrument.
16. The adapter of claim 1, wherein said adapter is used to attach one or more devices to an endoscopic instrument to allow specific functions to be performed at a tissue site located remotely in the body.
17. The adapter of claim 16 wherein the attached device comprises one or more of a tissue fastener, or a dispenser therefor; additional lumens for access to the operative site; functional means to dynamically resize or reconfigure the attached device portion; drug delivery or medicament dispensing means; energy delivery means; sensor or measurement devices; visualization means; and markers to assist in determination of the location of the endoscope tip.
18. The adapter of claim 16 wherein said at least one device is connected to said adapter by connecting means, wherein said connecting means include without limitation one or more of co-fabrication, mechanical assembly of discrete function components and sub assemblies, bonded assembly of discrete function components and sub assemblies, fused assembly of discrete function components and sub assemblies.
19. The adapter of claim 3, wherein the adapter can accommodate endoscopes varying in diameter over a range wherein the largest diameter of endoscope that can be accommodated by the adapter is at least 150% of the smallest diameter of endoscope onto which the adapter can reliably stabilized.
20. The adapter of claim 3, wherein said flange is arranged to have a highly expandable portion to accommodate the insertion of an endoscopic device having a diameter greater than that of said distal stop.
21. The adapter of claim 20, wherein after the binding of said flange to said endoscope, a sealing property is created between said adapter and said endoscope sufficient to allow suction to occur at the distal end of said endoscope upon provision of a vacuum to said endoscope at its proximal end.
22. The adapter of claim 20, wherein said flange is arranged to have a highly expandable portion which is visually clear.
23. The adapter of claim 20, wherein said flange is arranged to have a highly expandable portion which overlaps an expandable flange portion.
24. The adapter of claim 20, wherein said flange has at least one slit.
25. The adapter of claim 1 further comprising at least one delivery channel attached to said adaptor, said channel suitable for the conveyance of at least one of a fluid or an instrument from outside of the body to an interior site.
26. The adapter of claim 25 in which said channel can be changed in functional cross section by one or more of mechanical manipulation and inflation by gas or liquid.
27. The adapter of claim 1, wherein said adapter is used to attach one or more devices to an endoscopic instrument to allow specific functions to be performed at a tissue site located remotely in the body said adaptor comprising: at least one flange projecting from said distal stop means, a securing means to secure said flange to said endoscopic instrument, a means for attaching a device to said adapter, and a means for discharging said device from said adapter.
28. An adapter for attaching devices to the distal end of an endoscopic instrument, the adapter comprising: a distal stop means to limit the penetration of said endoscopic instrument into said adapter; at least one flange projecting axially from said distal stop means; and a securing means for locking said adapter on to said endoscope; wherein said flange comprises a non closed cross-section portion of a generally hollow cylinder.
29. An adapter for attaching devices to the distal end of an endoscopic instrument, the adapter comprising: a distal stop means to limit the penetration of said endoscopic instrument into said adapter; at least one flange projecting axially from said distal stop means; a securing means for locking said adapter on to said endoscope; and an attachment means for engaging the securing means, said attachment means located proximal from said distal stop means.
30. A method of conveying a device to a remote location in the body using an endoscopic device, the method comprising: providing an adapter for attaching a device to be transported to an endoscope, said adapter consisting essentially of a terminal stop, a flange, means for attaching a device to said adapter, a means for discharging said device from said adapter and means for attaching said adapter to an endoscope; attaching a device to be transported to said adapter; attaching said adapter to said endoscopic instrument; and delivering said device to said remote location using said endoscope.
31. The method of claim 30 wherein the means for attaching said flange to said endoscope are selected from mechanical assembly of discrete function components and sub assemblies, bonded assembly of discrete function components and sub assemblies, fused assembly of discrete function components and sub assemblies or any combinations thereof.
32. The method of claim 30 wherein the adapter provides means for lateral visualization of tissue through the side of said flange, through one or more of an opening or window, and an optically transparent material.
33. The method of claim 30 wherein the adapter is constructed so that the central axis of said adapter and the center axis of said endoscopic instrument are not aligned when said adapter is mounted on said instrument.
34. A method of manufacturing an adapter, said adapter consisting essentially of a terminal stop, a flange, means for attaching a device to said adapter, and means for attaching said adapter to an endoscopic instrument; the method of manufacturing selected from one or more of injection molding, insert molding, multi-material molding, casting, mechanical assembly of discrete function components and sub assemblies, bonded assembly of discrete function components and sub assemblies, fused assembly of discrete function components and sub assemblies or any combinations thereof.
35. The method of manufacturing of claim 34, wherein the adapter is constructed so that the central axis of said adapter will be essentially parallel to the center axis of said endoscopic instrument when said adapter is mounted on said instrument.
36. The method of claim 35 wherein the manufacturing method ensures that the parallel axes of said adapter and said instrument will not be concentric.
37. The adapter of claim 3 wherein the endoscope is selected to be larger in diameter than the distal stop effective diameter and wherein said flange, when in contact with said endoscopic instrument prevents movement of the endoscope with respect to the flange.
38. The adapter of claim 3 wherein the endoscope is selected to be larger in diameter than the distal stop effective diameter and wherein said flange, once in contact with said endoscopic instrument along at least a portion of its length and secured on said instrument by said securing means, prevents proximal movement of the endoscope with respect to the flange.
39. The adapter of claim 3 wherein the endoscope is selected to be no larger in diameter than the distal stop, and wherein the flange, once in contact with said endoscopic instrument and secured on said instrument by the securing means, prevents both proximal and distal movement of the endoscope with respect to the flange.
40. The adapter of claim 3 wherein said flange covers more than 180 degrees of the circumference of said endoscopic instrument.
41. The adapter of claim 3, wherein at least a portion of the flange is optically transparent.
42. The adapter of claim 1 wherein said adapter consists essentially of a single device having at least a distal stop and attaching means for attaching said device to an endoscopic instrument.
43. An adapter for attaching devices for dispensing tissue fasteners to the distal end of an endoscopic instrument, the adapter comprising: a distal stop means to limit the penetration of said endoscopic instrument into said adapter; at least one flange projecting axially from said distal stop means; a securing means for locking said adapter on to said endoscope; and wherein said adapter carries a deployment assembly activated by actuating means operated from outside the patient by a wire sheath connected to a pusher, wherein said pushing said pusher into said deployment assembly pushes a tissue-affixing clip out of said assembly.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0076] Particular embodiments of the invention are described in detail to enable the reader to understand the invention. In
[0077] In
[0078]
[0079] In
[0080] In
[0081] A raised area 141, located on the inner surface of the flange 230, provides part of the distal stop function by limiting the distal movement of distal end 137 of endoscopic device 135. Additionally, depending on the size of the endoscopic instrument, the endoscope position distal stop function may otherwise be provided by the connecting ring 119 feature in this embodiment, or may be a separate element with the stop feature placed some distance along feature 141 at a distance proximal to connecting ring 119.
[0082] With the elastomeric connector 300 in place, the flange 230 of the adjustable fitting is pressed tightly against the endoscope 135, thereby preventing any motion of the fastener deployment assembly 101 with respect to the endoscopic device 135, aside from ejection of the fastener 30.
[0083] As can best be seen in
[0084] The endoscopic instrument shown in
[0085] The opening 235 may contain no material, or may be arranged to have an optically clear material covering it to prevent passage of fluids through the opening. The additional off axis peripheral viewing capability takes advantage of the wide angle view characteristics of state of the art endoscopic instruments. This expanded view is extremely helpful to the endoscopist in finding the target area and achieving the proper distance from the operative site.
[0086] The distal position of the endoscopic instrument relative to the adapter's most distal end may vary as a function of instrument size and by design may be intentionally controlled within a singular attachment adaptor embodiment by the definition and location of features 141 and 119. Such capability is highly desirable and provides a universal attachment adaptor, fitting numerous instruments with optimal functional location of operating features. This function may also be obtained, for endoscopic instruments significantly larger in diameter than the distal stop, by the flexibility of the flange 230. Depending on the elasticity and thickness of the material of the flange, the penetration distance of the endoscope into the flange towards the distal stop is limited. There will be little variation in the final position of the lens 139 with respect to the wall 119 or other limiting feature of the distal stop, and so both functional optical viewing and well-controlled deployment of a device, such as tissue fastener 30, are possible without requiring complete reproducibility of instrument location within the attachment 320.
[0087] Any securing embodiment that enables and/or assists the flange means in gripping and attaching to the endoscope may be utilized in the design of the adapter. The securing embodiment alone in some constructs may be insufficient by itself to provide the required gripping and stiction forces to prevent an inadvertent disassembly or disengagement. However, when such a securing embodiment is used in conjunction with the highly compliant and adaptable flange embodiment geometry as described above, as a preferred embodiment of the present invention, then the combination of these features, their placement and performance provide a unique, superior and much more reliable endoscopic attachment means. It is preferred that the material or surface of the flange or flanges, and the force applied to the flange by the securing means, must be coordinated to provide sufficient resistance to movement (as stiction or other measure) to prevent excessive movement of the attachment with respect to the endoscopic instrument. Such attachment means are thereby made more widely applicable to the numerous sizes of endoscopic surgical instruments known in the art. Moreover, in some embodiments the flange 230 may have sufficient adherence to the surface of endoscope 135 to prevent easy removal of the adapter 320, without requiring a separate force applicator such as securing loop 300 or an equivalent.
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[0089] In an alternative construction, assembly and user preparation method, said scope penetration limit 141 may be a separate non-integral component, loaded in at the time of use to space the scope distally of distal stop 120. Such a component is inserted by the user to reside in front of the distal end of the endoscopic instrument, to specifically rest against distal stop feature 120, and be captured within the confines of adapter 320. Such an embodiment is intended, like the integral form of feature 141 previously described, to limit the depth of endoscope penetration by providing a robust hard stop property to feature 141; and in this embodiment, may be inserted by the user before the endoscopic instrument is loaded.
[0090] As shown in
[0091]
[0092] When mounted on the same adapter, the amount of axial offset between the instrument centerline and the embodiment centerline can be clearly seen. Furthermore, the visual lens already displaced axially within the instrument design is further displaced peripherally in the embodiment virtually into an open slit which has now assumed a more tapered like feature. These figures describe and illustrate the flexible flaring adaptable properties of flange feature 230, and the enhanced peripheral vision capability.
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[0094] The adapter 320 again comprises distal stop features 120 (ring) and 141 (internal protrusion or wedge) to limit the penetration of the dual channel endoscopic instrument 135 into the adapter 320. The adapter 320 also has at least one flange 230 projecting proximally from said distal stop 120, said flange comprising at least one attachment point 322 and/or 323 for securing means 300. Dual instrument channels 138 in the endoscope 135 are shown; they are typically associated with instruments of this size, and it can be seen in this Figure that the instrument channels 138 are easily positioned in the adapter, such that instruments delivered from within them would pass through terminal ring 120 and thus a more or less along the centerline axis of the attached adapter.
[0095] In
[0096] In other embodiments of the attachment adapter 320, the distal stop 120, which has a closed perimeter here, may have a non closed perimeter and also an internal limiter 141 limiting endoscope penetration. In other embodiments the securing means 300 are not elastomeric, or do not comprise loops. Securing means 300 may instead or in addition include springs, coils, wire or hinged integral and locking features attached to flange portion 230. Any embodiment which represents a non closed cross-sectional geometry, or a loop or closed perimeter geometry which can be configured to be attached and detached to the distal features 321,322 and 323 (in the preferred embodiment) or their functional equivalent, can provide the required radial forces to lock the endoscopic instrument with respect to the adapter.
[0097] Moreover, this can be done without requiring a rotational motion or movement of the adapter embodiment in relation to the endoscope to be used, either to apply or to remove the adapter from the instrument. Furthermore, this does not require an axial motion or movement to insert or withdraw said endoscopic instrument from said securing means.
[0098] Preferably, the at least one flange 230 defines a slit or window opening 235 allowing visualization of the surroundings through said opening by 139 endoscope vision lens, or equivalent, located on said endoscopic instrument 135.
[0099]
[0100] As shown in detail in
[0101] The embodiment described in
[0102]
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[0104] Other such constructs which may replace feature 400 may be singular or multiple instrument channels of numerous sizes which can be expanded and contracted in diameter to change directions or provide a wider tissue manipulating platform by using mechanical manipulation and/or inflatable or hydraulic mounting schemes. This allows the tube profile to be in a minimum profile state for passage to a tissue site, after which the tube size is expanded to a maximum condition once through the natural constrictions of the body orifices. For example, and without limitation, the extra channels 400 could be made of a tough but flexible fabric or membrane, to allow passage of devices or fluids.
[0105] These examples are but some of the types of controls, instruments and medical device embodiments which may be controlled and manipulated with confidence due to the secure attachment function of the present invention. The securing function may be performed by any mechanism suitable for reversibly attaching an adapter to an endoscopic device, including but not limited to springs, clamps, clips, wire, wire-ties, ratchets, adhesives, Velcro hook-loop fasteners, or tapes. Securing means will typically be constructed from medical grade plastic, fabric or metal, optionally including coatings or other surface treatments to achieve surface properties suitable for obtaining the desired functional properties. For example, a prototype flange, found to be suitable, was made from an injection molded polypropylene thermoplastic material approximately 1 mm in thickness. This flange was secured using an elastomeric O-ring, approximately 1.5 mm in thickness and with a diameter about the same as, or slightly less than, the diameter of the endoscope.
[0106] The securing means 300 is portrayed herein as a rubber band, but is not so limited in the invention. The securing means can be any material or device that is constructed and arranged to provide a force that is sufficient to impede movement of said adapter with respect to said endoscope when said adapter is placed on said endoscope and said securing means is engaged with said adapter. The securing means 300 may for example be one or more of, but not limited to, an o-ring or elastic band, a wrap around material, optionally overlapping, including hook/loop material (e.g. Velcro fabric), or equivalent. A cuff, preferably somewhat elastic, can be slid over the adapter, including optionally the flange, to bind it to the endoscope with sufficient firmness. Attachment means can also be one or more snaps, hooks or other simple connectors. It may be an elastomeric material, a thermoplastic material, a thermosetting material, a super-elastic material, or a metallic material. It can be an adhesive material, an inflatable or hydraulic actuated inflatable device, a collapsible shrink wrap, a welded in place connector, a cloth or fiber or strand which is cut or severed to remove it, or any combination thereof. Adhesive, preferably reversible, can be used to enhance adherence of the flange to the endoscope.
[0107] In a preferred embodiment, an adapter for attaching devices for dispensing tissue fasteners to the distal end of an endoscopic instrument can comprise at least:
[0108] a distal stop means to limit the penetration of said endoscopic instrument into said adapter;
[0109] at least one flange projecting axially from said distal stop means;
[0110] a securing means for locking said adapter on to said endoscope; and
[0111] characterized in that said adapter carries a deployment assembly activated by actuating means operated from outside the patient by a wire sheath connected to a pusher, wherein said pushing said pusher into said deployment assembly pushes a tissue-affixing clip out of said assembly.
[0112] The method of manufacturing the adapter of the invention, its use, and the composition thereof, is not limited except for suitability for use in medical or veterinary procedures. A method of manufacturing an adapter of the invention may be selected from, but is not limited to, one or more of injection molding, insert molding, multi-material molding, casting, mechanical assembly of discrete function components and sub assemblies, bonded assembly of discrete function components and sub assemblies, fused assembly of discrete function components and sub assemblies or any combinations thereof.
[0113] Having described the invention in particular embodiments to allow it to be understood by a person of normal in the art, additional embodiments will occur to such a person. The scope of the invention is not limited to the embodiments described, but is limited only by the scope of the claims.