Patent Application
20220202276
This application relates generally to endoscopes, particularly to endoscopes with vertebrae distal portion that deflects upon being pulled, and further to methods of the same for configuring and using the endoscopes.
Generally, the cost of medical procedures for minimally, invasively exploring and treating the body of a subject is significantly impacted by the cost of the endoscopes or scope used. Such scopes can be used, for example, for imaging and treating issues involving the kidney calyces, bladder, and ureter. In addition to the significant cost of such reusable scopes, which are on the order of about $25,000 each piece, they must be cleaned and sterilized after each procedure to prevent cross infection of patients. This process has been shown to take on the order of 4 hours with the cost of material or servicing the material being over $1000. For a high throughput endoscopy center, this means having to stock several scopes to do multiple procedures in a day as well as having to stock additional scopes to supplement the instrument due to breakage. It has been documented that these types of scopes need repair after 8-12 uses. In addition, for resterilization, there is clear evidence in recent years that many scopes are not as sterile as required after processing, such that cross infection still occurs. Resterilization in any form is a challenge in austere and cost sensitive environments, such as in the developing world.
The distal portion of endoscopes are required to be stiff enough to be pushed through cavities or conduits of organs, yet passively flexible to deflect when manipulated by the control attached to the handle. In existing practice, the distal portion of endoscopes are made of medical grade and expensive metal, such as steel, tungsten, platinum, or the like, in a shape of an elongated conduit. Metal mesh or metal tube with complicated perforation maybe applied. Further, in existing practice, internal working channels need to be built or placed into the metal conduit as an extra step. The cost of material and manufacturing process is high. In an economic sense, the existing type of distal portion of endoscopes does not allow it to be disposed after only one-time usage, and therefore does not allow the application of disposable or partially disposable endoscopes.
A traditional endoscope which is used for many times being sterilized between uses also has other significant disadvantages, including high sterilization cost and high risk of insufficient sterilization. In addition, clinicians have specific expectations as to how an ureteroscope should behave mechanically when they manipulate it. As a result, meeting the high quality of clinician expectations and while also achieving low cost to make single use economically possible are often the two conflicting factors not successfully reconciled in the existing practice. Therefore, producing high quality single use ureteroscope whose economics are compatible with typical hospital and outpatient clinics is highly desirable.
For these reasons, being able to eliminate the need for resterilization, while also reducing the cost of endoscopy use per procedure and meeting clinician quality expectations, can lead to improvements in both patient safety and hospital efficiency. Accordingly, herein disclosed methods and apparatus are directed to solve one or more problems set forth above and other problems.
In accordance with a first aspect of the present disclosure, there is set forth an endoscope that includes an elongated probe having a sensor at a distal end of the probe, and a vertebrae column immediately abutting the distal end. The endoscope further includes a handle abutting a proximal end of the probe and comprising an articulation lever.
The vertebrae column is configured to have at least two parallel groups of gaping slits, along an axial direction of the vertebrae column. Each two axially adjacent gaping slits come from the two groups of gaping slits respectively, are juxtaposed in circumferential positions in the respective circumferential planes. Furthermore, the articulation lever and the distal end are connected by pulling wires, and when the articulation lever is maneuvered, the distal end is pulled away from the axial direction, causing the vertebrae column to deflect.
The vertebrae column also envelopes working channel, pull wire channel and likely optical fiber cable. The vertebra column can be made of plastic molding or protrusion molding, with the working channel, pull wire channel and the optical fiber cable all formed or embedded at the same time when the vertebra column is formed during the plastic molding process. The vertebra gaping slits can be machined onto the vertebra column or directed molded together with the vertebra column.
In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the disclosed systems and methods and are not intended as limiting. For purposes of clarity, not every component may be labeled in every drawing. In the following description, various embodiments are described with reference to the following drawings.
Numerals corresponding to those shown in the drawings are listed in Table-1. Terms assigned to corresponding numerals are also given in Table-1.
The following description of the vertebra column of the endoscopes uses an ureteroscope as an example. It should be appreciated that the scope and spirit of this disclosure is not limited to this example. The example of using partially reusable endoscopes, entirely reusable, or entirely disposable endoscopes do not affect the scope of present disclosure. The term of endoscope or scope can be interchangeable used with many types of endoscopes, such as ureteroscope, cystoscope, bronchoscope, and laparoscope, etc.
Referring to
Reference is still made to
In various embodiments, part of the endoscope is disposable. For example, the coupling section 60 can be part of the handle and/or any part of the probe. All such variations are within the scope of the present disclosure. handle 48 is reusable, while probe 46 is detachable from the handle so that it may be of single use.
Optical, mechanical, and electrical transmissions are provided from distal tip 16 to probe handle 48. Detailed description regarding the transmission of optical, electrical, and mechanical functions between handle 48 and probe 46 is provided hereinafter.
Referring to
Each two axially adjacent gaping slits come from the two groups of gaping slits respectively, are juxtaposed in circumferential positions in the respective circumferential planes. That is to say, in any two adjacent circumferential cross-sections cut at the two respective vertebra slits, such as along cut lines 3A and 3B, the two vertebra slits 10A and 10B can be juxtaposed as shown in
Referring to
It can be appreciated that the juxtaposed positions in circumferential planes and interposed in axial direction of slit groups 10A and 10B provide the flexibilities at multiple circumferential directions, without harming the integrity of the vertebra column 12.
Reference now is made to
As shown in
Distal tip 16 includes a pull wire holder 38 configured to hold pull wire 14 threaded through pull wire channel 18. Pull wire holder 38 may be as simple as a holed short cylinder, allowing pull wire 14 to be threaded through, the size of which is configured to be smaller than a knot (not shown) tied by the end of pull wire 14. Alternatively, pull wire holder 38 may be a spring-loaded clamp that can be opened and closed to hold the end of pull wire 14. Further alternatively, pull wire 14 with one end having a crimp of a diameter larger than the hole of wire holder 38 can be threaded into the wire holder 38 from the other smaller end. All such alternations are within the scope of the present disclosure.
Further at distal tip 16, probe 46 also includes a bridge 34 connecting distal tip 16 with the main body of vertebra column 12.
Referring to
As can been seen in
Referring to
Pull wire 14 may also be a pair of pull wires 14 correspondingly attached to either side of the working pulley 54 and two opposite positions of wire holder 38 at the distal tip 16. More often, there may be two wire holders 38 positioned at circumferentially opposite sides, or circumferentially juxtaposed positions. In another word, working pulley 54 and the distal end 16 can be cabled by a pair of working pull wires 14 in such a way to translate the motion or displacement of working pulley 54, causing distal end of the probe to be pulled off center. Subsequently, vertebrae column 12 is deflected to either one of the directions. The structure of pull wire 14 and working pulley 54 is in the fashion of belt pulley but with only one pulley, which is the working pulley 54. The other end of working pull wire is fixed inside the distal tip 16 on wire holder 38.
Therefore, once assembled, articulation rudder 50 causes motion or displacement via working pulley 54, through pull wire 14, further causing vertebra column 12 to deflect accordingly.
The pull wires 14 are constructed in a manner that enables them to be sufficiently flexible, so they do not interfere with the flex of the passively flexible portion. The pull wires must also be sufficiently strong to apply enough force to the steerable distal portion 16 such that it can be deflected. In some embodiment, these pull wires may be made of braided stainless steel in a 7×7×7 pattern and are placed symmetrically along a vertical axis of the probe 12 and working channel 20. As explained above, the pull wire's movement is controlled by a rotational articulation rudder 50 on the most proximal portion of the handle 48. Accordingly, if both sides were pulled equally, the tip will not deflect and instead will become more rigid from co-contraction.
Probe 12, in many embodiments, are rigidly flexible and distal tip 16 is steerable. The two threads of the loop of working pull wire 14 loop between working pulley 54 and the end of distal tip 16, so that a pull of pull wire 14 in any direction caused by the rotation of working pulley 54, results in a deflection of the tip (up to 270° in either direction from pointing forward). Pull wire 14 is arranged in a pull-pull setup in the steerable distal portion 16 such that the tip deflects toward the side which is being pulled.
As shown in
Electric wire 32 may transmit data, such as image data via electric wire 32 to a processor (not shown) in handle 48. Alternatively, camera 30 may also directly transmit data via any forms of wireless communication to a processor as required by the procedure performed by endoscope 100.
Referring to
Camera 30 at the end of distal tip may be connected with the circuit board via electrical wire 32 which, together with optical fiber and working channel (which may pass fluids directly or with a conduit, working tool, etc.), goes through the flexible probe as well as vertebra column 12 to reach circuit board. Camera 30 may digitize optical data and transmits digitized data to circuit board 48 for processing. Further alternatively, camera 30 may be in direct wireless communication with a camera control unit (CCU) (not shown). All such variations are within the scope of the present disclosure.
Referring to
Working channel may be pre-installed in the probe, through probe conduit, continuing into vertebra column 12, with working channel 20 molded at the same time when vertebra column 12 is molded or made with plastic extrusion. In some embodiments, other kind of optical fibers may be introduced to the working channel 20 during a procedure to, for example, introduce laser energy for blasting a target area. Suitable tool(s) can also extend through the working channel 32a or through specific conduits other than the working channel to, for example, assist the fragmentation of kidney stones. Surgical tools such as collapsible basket for capturing kidney stones can also be threaded though working channel 32a.
As can be seen in
Referring to
One can see that the depth of the slit 10, (r+Le), includes a depth of imaginary lines extended from the physical cut of vertebrae slit 10.
Assuming a length of a flex section of the vertebrae column 12, is S, the total number of vertebrae slits in one group of the vertebrae slits 10, n, is given by:
Still referring to
Those skilled in the art should appreciate the advantage of one of the novel aspects to have at least two parallel groups of gaping slits aligned longitudinally along the vertebrae column, on the opposite side of each other. Each two adjacent vertebrae slits being arranged in a staggered fashion along the longitudinal (axial) direction of the vertebrae column allows a deeper cut of the gaping slits 10 without compromise the strength and the stiffness the vertebrae column. Subsequently it serves the purpose of providing easier bending and more agility of the surgical operation.
One can also see in
In some embodiment, a circumferential length of the gaping slits is preferably less than or equal to half of a circumference of the vertebra column, and larger than 1/16 of the circumference of the vertebra column.
In some embodiment, a depth of the gaping slits is less than half of a diameter of the vertebra column, and larger than 1/16 of the diameter of the vertebra column.
Additionally, it is contemplated that systems, devices, methods, and processes of the present application encompass variations and adaptations developed using information from the embodiments described in the following description. Adaptation or modification of the methods and processes described in this specification may be performed by those of ordinary skill in the relevant art.
Throughout the description, where compositions, compounds, or products are described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are articles, devices, and systems of the present application that consist essentially of, or consist of, the recited components, and that there are processes and methods according to the present application that consist essentially of, or consist of, the recited processing steps.
It should be understood that the order of steps or order for performing certain action is immaterial so long as the described method remains operable. Moreover, two or more steps or actions may be conducted simultaneously.
