Patent Description:
During endoscopic urology procedures, an access sheath can be inserted into patient before inserting the endoscope. The sheath can help protect a patient's anatomy from the endoscope and from unwanted particles, such as kidney stones. The access sheath can be inserted into a patient's body until it reaches an internal surgical site, such as the ureter. The endoscope can then safely be inserted into and later withdrawn from the patient's body by passing through the interior of the access sheath. A guidewire can be used to help guide the access sheath to the internal surgical site. The guidewire can be inserted into a patient's bladder, can be passed through the ureter, and its distal portion can be inserted to enter a kidney. The access sheath can then be inserted over the guidewire to reach the kidney. <CIT> relates to a urological endoscopic device for the human body and more particularly to a ureteroscope for the operative management of the disease processes in the lower ureter under direct visual control.

Any methods disclosed hereinafter do not form part of the scope of the invention, and are mentioned for illustrative purposes only. Endoscopes can be used to visualize or extract calculi or other target masses from various regions of a patient's body such as the urinary system, gallbladder, nasal passages, gastrointestinal tract, stomach, or tonsils. During an endoscopic procedure, an access sheath can help protect a patient's internal anatomy from the endoscope, or other surgical instruments, such as during their insertion and withdrawal. During an endoscopic urology procedure, for example, the endoscope can be passed through an access sheath previously positioned within the ureter. The endoscope can then be advanced past a distal end of the access sheath, such as to perform certain aspects of the procedure.

An endoscope can include one or more features, such as a camera, a light, and one or more working channels (e.g., a suction channel, an irrigation channel, or both). A grasping tool, such as a basket or forceps, can be inserted through the working channel of the endoscope and advanced past the distal end of the access sheath such as to capture a target particle such as a kidneys stone (a "calculus"). The captured particle can then be drawn into the working channel of the endoscope. If the particle has a greater diameter than the working channel of the endoscope, the particle can instead be drawn into the access sheath by the grasping tool. Then, the endoscope, the access sheath, and the particle captured by the grasping tool within the access sheath can all be withdrawn together concurrently.

However, if the particle is larger than the inner diameter or similar inner lateral dimension of the access sheath, the particle may break free from the grasping tool, and the endoscope, securing device, or access sheath can be damaged if a physician attempts to pull the particle through the access sheath. Additionally, modern digital endoscopes may have a larger outer diameter than fiber optic endoscopes, requiring a correspondingly larger access sheath. A larger access sheath can distend a patient's ureter, increasing patient trauma and increasing the potential of insertion problems, such bunching or folding of the distal end of the access sheath during insertion. Additionally, distention of the ureter may also lead to undesirable postprocedural complications.

Also, hydrophilic properties of an access sheath may result in the access sheath unintentionally sliding within or out of a patient during a procedure. This can create a need for a physician to reposition, or re-insert, the access sheath, which may cause trauma to the patient and lengthen the procedure. Longer procedures can inhibit or prevent proper treatment (e.g., complete ablation of calculi) and expose the patient for longer than a shorter procedure.

This disclosure can help to address these issues, among others, such as by providing an endoscopic tip extender. The endoscopic tip extender can help avoid the need for an access sheath, fora grasping device, or both, in an endoscopic procedure. The tip extender can, in place of an access sheath, extend distally from a distal portion of the endoscope such as to help protect a patient's anatomy during the insertion or removal of the endoscope. The tip extender can be detachably coupled to, or integrally formed with, the distal portion of the endoscope. For example, during an endoscopic urology procedure, the tip extender can, in place of a grasping tool, receive and encompass both a distal portion of the endoscope and one or more particles for removal, such as one or more kidney calculi, such as to both help prevent damage to a patient's anatomy and to help prevent damage to the endoscope during removal of such particles.

Additionally, the tip extender can be configured to be used with suction. For example, the tip extender can be constructed such that when a physician introduces suction through the working channel of the endoscope, to draw a particle into the tip extender, the tip extender can roll or fold inwardly. This can help to trap a particle within the tip extender. The tip extender can also help to improve the navigation of difficult or tortuous anatomical paths, as can be of shorter length, relative to an access sheath (such as may otherwise extend along the length of ureter or the calices of the kidneys). The tip extender can help provide increased flexibility, increased visibility, or both. Further, the tip extender, in contrast to an access sheath, can also be manipulated using the endoscope, such as to help push or clear obstructive particles or other matter from the path of the endoscope.

Moreover, the tip extender can also help protect a patient's anatomy during a lithotripsy procedure. In laser lithotripsy procedures, particles of larger sizes can be ablated into smaller fragments using a laser. Laser exposure and stone fragmentation can affect surrounding tissues. The tip extender can encompass particles and absorb the laser's light emissions during ablation to help protect surrounding tissue from laser exposure or fragmentation impact.

The above overview is intended to provide an overview of subject matter of the present patent application. The description below is included to provide further information about the present patent application. While the following examples are discussed with a focus toward urology procedures, the endoscopic tip extender can also be used in various other endoscopic procedures.

<FIG> illustrates a cross-section of an example of an endoscopic tip extender coupled to an endoscope. <FIG> includes a dashed line corresponding to a central longitudinal axis A1 defined by the endoscope, and orientation indicators "Proximal" and "Distal". As illustrated in <FIG>, a tip extender <NUM> can be coupled to a distal portion of an endoscope <NUM>. The endoscope <NUM> can define the longitudinal axis A1. The endoscope <NUM> can be any of a variety of endoscopes, such as an ureteroscope. The endoscope <NUM> can be a fiber optic endoscope or a digital or other electronic endoscope. The endoscope <NUM> can be a disposable, or a single use, endoscope. The tip extender <NUM> can be configured to receive a distal portion <NUM> of the endoscope <NUM>, such as within a receptacle portion of the tip extender <NUM>. For example, the tip extender <NUM> can radially or otherwise laterally encompass the distal portion <NUM>. The distal portion <NUM> can include an objective head of the endoscope <NUM>. The distal portion <NUM> can include one or more features configured to engage the tip extender <NUM>, or vice-versa, such as further discussed below.

The distal portion <NUM> can include a notch <NUM>. The notch <NUM> can generally be a cutout or a recess formed in the distal portion <NUM> of the endoscope <NUM>. The notch <NUM> can extend longitudinally into the distal portion <NUM>. The notch <NUM> can extend at least partially around a circumference of the distal portion <NUM>. The tip extender <NUM> can include a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be generally cylindrical in shape. The distal portion <NUM> can be generally conical, frustoconical, or tapered, in shape. The tip extender <NUM> can taper inward toward the central longitudinal axis A1 between the proximal portion <NUM> and the distal portion <NUM>. The distal portion <NUM> of the tip extender <NUM> can include a bore <NUM>. The bore <NUM> can extend axially within the tip extender <NUM> between the proximal portion <NUM> and the distal portion <NUM>, along the longitudinal axis A1. The bore <NUM> can be configured to receive and engage the distal portion <NUM>. The bore <NUM> can be sized and shaped to create an interference fit with the distal portion <NUM>, such as to couple the endoscope <NUM> to the tip extender <NUM>. When coupled to the tip extender <NUM>, the distal portion <NUM> of the endoscope <NUM> can extend within the proximal portion <NUM> of the tip extender <NUM>, and the distal portion <NUM> of the tip extender <NUM> can extend axially and distally from the endoscope <NUM>.

The tip extender <NUM> can be configured to be disposable. The tip extender <NUM> and the endoscope <NUM> can be configured to be disposable. For example, the tip extender <NUM> and the endoscope <NUM> can be integrally formed. As such, both the tip extender <NUM> and the endoscope <NUM> can be disposed of together after an endoscopic procedure. The tip extender <NUM> can be configured to be reusable. For example, the tip extender <NUM> can be configured to be reprocessed, autoclaved, or otherwise sterilized for reuse in a subsequent procedure, after being detached from the endoscope <NUM> following a procedure. The endoscope <NUM> can be configured to be reprocessed or otherwise sterilized for reuse in a future procedure.

As such, the tip extender <NUM>, together with endoscope <NUM>, can provide a number of benefits to a patient and to a physician. The tip extender <NUM> can be atraumatic such via tapering, a decreased length, or increased flexibility, or a combination thereof, relative to an access sheath, such as to allow a physician to safely perform an endoscopic procedure without using an access sheath, which can distend a patient's ureter. The tip extender <NUM> can help to improve both the ease of insertion into a patient and navigation through tortuous anatomical paths. The tip extender <NUM> can also be used to encompass a particle such as kidney stone, such as to help allow a physician to remove one or more particles without using a grasping tool, reducing the potential of damage to both a patient's anatomy and to the endoscope <NUM>.

The tip extender <NUM> can be coupled to the distal portion <NUM> of the endoscope <NUM>, such that the tip extender extends distally from the endoscope <NUM>. For example, the distal portion <NUM> of the endoscope <NUM> can be inserted, into the proximal portion <NUM> of tip extender <NUM>, to couple the endoscope <NUM> to the tip extender <NUM>. The endoscope <NUM> can then be inserted into the patient. The tip extender <NUM> can protect a patient's anatomy from the generally blunt distal portion <NUM> of the endoscope <NUM>. The tip extender <NUM> can trap a particle, or a portion thereof. Suction or irrigation can be introduced through a working channel of the endoscope <NUM>. For example, the suction can draw the particle into the tip extender <NUM>, and can also cause a distal end of the tip extender <NUM> to fold inwardly, helping to retain the particle therein. The endoscope <NUM> can then be removed from the patient. The tip extender <NUM> can protect the patient's anatomy from any rough or sharp surfaces of the particle during removal. After the procedure, the tip extender <NUM> can be decoupled from the endoscope <NUM>. For example, the tip extender <NUM> can be pulled in a distal direction, while the endoscope <NUM> remains stationary, to remove the distal portion <NUM> of the endoscope <NUM> from the tip extender <NUM>. The tip extender <NUM> can be subsequently disposed of, or can be reprocessed or otherwise sterilized for reuse, along with the endoscope <NUM>.

<FIG> illustrates a cross-section of an example of the endoscopic tip extender <NUM> and a distal portion <NUM> of the endoscope <NUM>. Also shown in <FIG> is a central longitudinal axis A1, and orientation indicators Proximal and Distal. As illustrated in <FIG>, the tip extender <NUM> can include a lock groove <NUM>. The lock groove <NUM> can be a circumferentially or otherwise peripherally formed groove in the proximal potion <NUM> of the tip extender <NUM>. The lock groove <NUM> can be formed transversely to the longitudinal axis A1. The lock groove <NUM> can be laterally located at any of various locations along the proximal portion <NUM> of the tip extender <NUM>. The lock groove <NUM> can be configured to accept a lock ring <NUM>.

The lock ring <NUM> can generally be a semi-circular lock ring, or another type of lock collar. The lock ring <NUM> can be positioned over the proximal portion <NUM> of the tip extender <NUM>, within the lock groove <NUM>. When positioned within the lock groove <NUM>, the lock ring <NUM> can face inwardly to engage and squeeze the proximal portion <NUM> of the tip extender <NUM>. The lock groove <NUM> can laterally retain and positon the lock ring <NUM> on the proximal portion <NUM>. The lock ring <NUM> can be made from by swaging, molding, or machining from various materials, including, but not limited to stainless steel. As such, the lock ring <NUM>, together with the lock groove <NUM>, can help to securely couple the tip extender <NUM> to the endoscope <NUM>.

The distal portion <NUM> of the tip extender <NUM> can include a distal end <NUM>. The tip extender <NUM> can taper between the distal portion <NUM> and the distal end <NUM>. For example, the proximal portion <NUM> can have an outer diameter of about <NUM>-<NUM>, <NUM>- <NUM>, or <NUM>-<NUM>. The distal portion <NUM> portion can taper down, from the diameter of the proximal portion <NUM>, to an outer diameter of about <NUM>-<NUM>, <NUM>-<NUM>, or <NUM>-<NUM> at or near the distal end <NUM>. The distal portion <NUM> can also taper down over various longitudinal distances. For example, the distal portion <NUM> can taper down over a length of <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, or <NUM>-<NUM>. The distal end <NUM> can be angled orthogonally, relative to the longitudinal axis A1 and to the bore <NUM> of the tip extender <NUM>. The distal end <NUM> of the distal portion <NUM> can be angled obliquely, relative to the longitudinal axis A1 and to the bore <NUM> of the tip extender <NUM>. For example, the distal end <NUM> can be obliquely angled at, but not limited to, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> degrees relative to the longitudinal axis A1.

The bore <NUM> can include a first portion <NUM> and a second portion <NUM>. The first portion <NUM> and the second portion <NUM> of the bore <NUM> can generally define opposite proximal and distal portions of the bore <NUM>, respectively. The first portion <NUM> can extend axially within the proximal portion <NUM>. The first portion <NUM> can have a generally cylindrical shape. The first portion <NUM> can be configured to engage the distal portion <NUM> of the endoscope <NUM>. The first portion <NUM> can be sized and shaped to create an interference fit along a length of the distal portion <NUM> of the endoscope <NUM>. The first portion <NUM> can taper distally toward the second portion <NUM>. The first portion <NUM> can thereby limit distal translation of the distal portion <NUM> of the endoscope <NUM> within the bore <NUM>, to position the distal portion <NUM> within the proximal portion <NUM> of the tip extender <NUM>.

The first portion <NUM> can include a ridge <NUM>. The ridge <NUM> can be a protrusion or ridge extending radially into the first portion <NUM> of the bore <NUM>. The ridge <NUM> can extend at least partially around a circumference of the first portion <NUM>. The ridge <NUM> can also separate the first portion <NUM> from the second portion <NUM> of the bore <NUM>. The first portion <NUM> can thereby limit distal translation of the distal portion <NUM> of the endoscope <NUM> within the bore <NUM>, to position the distal portion <NUM> within the proximal portion <NUM> of the tip extender <NUM>. For example, the endoscope <NUM> can be inserted into the bore <NUM> until the distal portion <NUM> contacts the ridge <NUM>, preventing further distal translation of the endoscope <NUM> within the tip extender <NUM>.

The second portion <NUM> of the bore <NUM> can extend axially within distal portion <NUM>. The second portion <NUM> can have a generally cylindrical shape. The second portion <NUM> can be configured to accept, retain, or otherwise encompass a particle, or retain a portion thereof. The second portion <NUM> of the bore <NUM> can have a reduced diameter relative to the first portion <NUM>. The second portion <NUM> can be tapered toward the distal end <NUM> of the distal portion <NUM>. The second portion <NUM> of the bore <NUM> can include also be stepped. For example, the second portion <NUM> can include a first diameter <NUM> and a second diameter <NUM>. The first diameter <NUM> can extend distally from a distal end of the first portion <NUM>, to the second diameter <NUM>. The second diameter can <NUM> can extend distally from a distal end of the first diameter <NUM> to the distal end <NUM>. The second diameter <NUM> can have a reduced diameter, relative to the first diameter <NUM>.

The tip extender <NUM> can include a wall thickness <NUM>. The wall thickness <NUM> can be defined as the vertical distance between an outer surface <NUM> of the tip extender <NUM> and the bore <NUM>. For example, the wall thickness <NUM> can be about <NUM>-<NUM>, <NUM>-<NUM>, or <NUM>-<NUM>. The wall thickness <NUM> can taper, or decrease, between the proximal portion <NUM> and at the distal portion <NUM>. For example, the proximal portion <NUM> can have a wall thickness of about <NUM> and the distal portion can have a wall thickness of about <NUM>. A tapered wall thickness <NUM> can provide the benefit of allowing the tip extender <NUM> to securely engage the distal portion <NUM> of the endoscope <NUM>, while simultaneously allowing the distal portion <NUM> to have an increased flexibly relative to the proximal portion <NUM>.

The tip extender <NUM> can also form a fold-back <NUM>. The fold-back <NUM> can be defined as an orientation or a position of the distal end <NUM>. For example, the distal end <NUM> can roll or flex proximally and inwardly to form the fold-back <NUM>. The fold-back <NUM> can help to trap or retain a particle, such as a renal calculus (kidney stone), within the second portion <NUM> of the bore <NUM>. For example, a physician can introduce suction generated by an external device, though the endoscope <NUM>. The vacuum generated by the external device can draw the particle into the second portion <NUM> of the bore <NUM>. The vacuum can cause the distal end <NUM> to roll proximally and inwardly to form the fold-back <NUM>, to trap the particle within the tip extender <NUM>.

The tip extender <NUM> can be made by molding, swaging, extruding, or machining from any of a variety of materials, including but not limited to, rubber, plastic, silicone, or other polymers. The tip extender <NUM> can be made from a substantially softer or more flexible material, relative to the distal portion <NUM> of the endoscope <NUM>. For example, the tip extender <NUM> can be made from a material having a durometer of about, but not limited to, <NUM>-55a, 56a-60a, <NUM>-69a, or 70a-80a. The tip extender <NUM> can include materials of variable durometer hardness. For example, the proximal portion <NUM> can be made from a softer durometer and the distal portion <NUM> can be made from a firmer durometer. A softer durometer can increase the flexibility of the tip extender <NUM>, for example, to improve the ease of insertion through tortuous anatomical pathways and improve the ability of the tip extender <NUM> to flex, to accept a greater variety of particles. A firmer durometer can improve the ease of manipulation when clearing obstructions or other matter from the path of the endoscope <NUM>, and can help to improve engagement between the tip extender <NUM> and the endoscope <NUM>, to help to prevent the tip extender <NUM> from unintentionally releasing the endoscope <NUM>.

The tip extender <NUM> can also be made from a heat moldable material, such as a thermoset or thermoplastic elastomer, such as to allow a physician to manually shape the tip extender <NUM>. For example, the distal end <NUM> of the tip extender <NUM> can be rolled inwardly, by hand, and then heat-set form the fold-back <NUM> without the use of suction. The tip extender <NUM> could also be heated and manipulated into a curved shape, to aid in trapping a particle against, for example, a wall of patient's ureter or a wall of a calyx in a kidney.

<FIG> illustrates an exploded cross-section of an example of the endoscopic tip extender <NUM> and the endoscope <NUM>. Also shown in <FIG> is a longitudinal axis A1, and orientation indicators Proximal and Distal. As illustrated in <FIG>, the tip extender <NUM> can define a distal extension <NUM>. The distal extension <NUM> can be defined as the axial distance the tip extender <NUM> extends from the distal portion <NUM> when coupled to the endoscope <NUM>.

For example, the distal extension <NUM> can be <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, or <NUM>-<NUM>. The tip extender <NUM> can be configured to for a reduced distal extension <NUM>, such as <NUM>-<NUM>, to help to increase flexibility in reaching difficult to access locations, such as the calices of a patient's kidney, and field of view of for a camera positioned on the distal portion <NUM> of the endoscope <NUM>, thereby helping to improve intra-procedural visibility for a physician or user operating the endoscope <NUM>. The tip extender <NUM> can be configured to define a greater distal extension <NUM>, such as about <NUM>-<NUM> to accommodate or trap larger particles for within the tip extender <NUM>. Additionally, the tip extender <NUM> can also be made from a firmer material when configured to define a greater distal extension <NUM>, in order to increase the structural integrity of the tip extender <NUM>, to help in manipulating resistant particles or other matter, such as calculi or plasma, without folding inwardly or otherwise bending or deflecting.

The endoscope <NUM> can include an objective head <NUM>, an imaging device <NUM>, a working channel <NUM>, a string <NUM>, an adhesive <NUM>, shrink tubing <NUM>, and a deflection tube <NUM>. The objective head <NUM> and the imaging device <NUM>, along with the working channel <NUM>, the string <NUM>, the adhesive <NUM>, the shrink tubing <NUM>, and the deflection tube <NUM>, can be standard components of an endoscope. The distal portion <NUM> of the endoscope <NUM> can comprise, or include, the objective head <NUM>. The objective head <NUM> can be made from a variety of rigid or substantially rigid materials including, but not limited to, plastic, ceramic, or stainless steel. The objective head <NUM> can be made from a substantially harder, firmer, or otherwise less pliable material, relative to the tip extender <NUM>. The objective head <NUM> can include the imaging device <NUM>. The imaging device <NUM> can be located on a distal end of the objective head <NUM>, or distal portion <NUM>, and can include at least a camera and one or more lights. The imaging device <NUM> can also include electronics components or wiring extending axially within the endoscope <NUM>, in a proximal direction from the objective head <NUM> to a proximal end of the endoscope <NUM>.

The working channel <NUM> can be a bore extending along the longitudinal axis A1 within the endoscope <NUM>. The working channel <NUM> can be configured accept a surgical instrument <NUM>. The surgical instrument <NUM> can be a variety of surgical tools, such as an endoscopic forceps, a grasping tool, or a retaining basket. The working channel <NUM> can also be configured to withstand suction introduced by an external device or carry irrigation fluid axially through the endoscope <NUM>. The string <NUM> can couple the objective head <NUM> to external user controls, to allow a physician or user to manipulate the objective head <NUM> from a location external to a patient. The string <NUM> can be made from, but not limited to, cloth, twine, metals or other materials. The string <NUM> can be coupled to the objective head with an adhesive <NUM>.

The adhesive <NUM> can be an adhesive applied to the objective head <NUM>, the string <NUM>, and to the shrink tubing <NUM>. The adhesive <NUM> can form a protrusion extending radially outward and circumferentially around the objective head <NUM> and the shrink tubing <NUM>. The shrink tubing <NUM> can encompass the string <NUM> to protect the string <NUM>. The shrink tubing <NUM> can also form an outer surface of the endoscope <NUM>, proximal to the objective head <NUM>. The deflection tube <NUM> can generally form a core of the endoscope <NUM>, proximal to the objective head <NUM>. As such, the imaging device <NUM> and the working channel <NUM> can be formed in, and extend through, the deflection tube <NUM>.

The tip extender can include at least a first protrusion <NUM>. The first protrusion <NUM> can extend radially outwardly from the proximal portion <NUM> of the tip extender <NUM>. The first protrusion <NUM> can extend at least partially around a circumference of the proximal portion <NUM> of the tip extender <NUM>. The first protrusion <NUM> can have a generally triangular or wedge-shaped, but can also form other three-dimensional shapes such as ellipses, rectangles or cubes. The first protrusion <NUM> can be shaped to correspondingly engage a first recess <NUM>. The endoscope <NUM> can define a first recess <NUM>. The first recess <NUM> can be formed in an outer surface <NUM> of the distal portion <NUM> or the objective head <NUM>, of the endoscope <NUM>. The distal portion <NUM> of the endoscope <NUM> can define a second recess <NUM> in the outer surface <NUM>. The second recess <NUM> recess be axially spaced laterally, or longitudinally, apart from the first recess <NUM> along the longitudinal axis A1. As such, the second recess <NUM> can allow the distal extension <NUM> of the tip extender <NUM> to be selectively adjustable, based on whether a user chooses to engage the first <NUM> and second <NUM> recesses with the first protrusion <NUM>.

The tip extender <NUM> can also include a second protrusion <NUM>. When the tip extender <NUM> includes a second protrusion <NUM>, the second recess <NUM> (and the second protrusion <NUM>) can be circumferentially offset in the outer surface <NUM> of the distal portion <NUM>, relative to the first protrusion <NUM> and the first recess <NUM>. For example, the second recess <NUM> and the second protrusion <NUM> can be located at <NUM>-<NUM>, <NUM>-<NUM>, or <NUM>-<NUM> degrees, relative to the first protrusion <NUM> and to the first recess <NUM>.

In some examples, the tip extender <NUM> can further include additional protrusions and corresponding recesses. For example, the tip extender <NUM> can include a third and a fourth protrusion, and the distal portion <NUM> of the endoscope <NUM> can define a third and a fourth recess. The third protrusion can be axially aligned with, but laterally offset from, the first protrusion <NUM> and the first recess <NUM>; and the fourth protrusion can be axially aligned with, but laterally offset from, the second protrusion <NUM> and the second recess <NUM>. As such, this can allow the distal extension <NUM> of the tip extender <NUM> to be selectively adjustable while also strengthening the coupling between the tip extender <NUM> and the endoscope <NUM>.

In the operation of some examples, a user can couple the tip extender <NUM> to the endoscope <NUM> by translating the objective head <NUM> distally within the bore <NUM> of the tip extender <NUM>, until the first protrusion <NUM> and the second protrusion <NUM> engage the first recess <NUM> and the second recess <NUM>, respectively. The first protrusion <NUM> and the second protrusion <NUM> can slide along the outer surface <NUM> of the objective head, causing the tip extender <NUM> to flex outwardly. When the first protrusion <NUM> and the second protrusion <NUM> reach the first recess <NUM> and the second recess <NUM>, respectively, the tip extender <NUM> can flex inwardly as the first protrusion <NUM> enters the first recess <NUM> and the second protrusion <NUM> enters the second recess <NUM>, creating a snap fit between the tip extender <NUM> and the objective head <NUM> of the endoscope <NUM>.

The tip extender <NUM> can be transparent, translucent, or otherwise semitransparent to further increase visibility of internal anatomy over an access sheath. For example, the tip extender <NUM> can allow visible light, for example, light about <NUM>-<NUM> nanometers in wavelength, to pass through the outer surface <NUM> of the tip extender <NUM>, such as light provided by the objective head <NUM> or the imaging device <NUM>. In some examples, a transparent tip extender <NUM> can allow a user to view internal anatomy distinctly through the outer surface <NUM> of the tip extender <NUM>, for example, using the imaging device <NUM>. The tip extender <NUM> can be configured to absorb laser light during laser ablation of a calculus. The tip extender <NUM> can absorb, for example, light emitted from a <NUM> nanometer wavelength infrared laser. The tip extender <NUM> can help to keep obstructions away from the distal portion <NUM> of the endoscope <NUM>, which can often block imaging from the imaging device <NUM> and clog the working channel <NUM> of the endoscope <NUM>.

The tip extender <NUM> can provide a number of benefits to both a physician and a patient during an endoscopic procedure. The tip extender <NUM> can be atraumatic such via tapering, a decreased length, or increased flexibility, or a combination thereof, relative to an access sheath, and can receive and encompass both the objective head <NUM> of the endoscope <NUM>, and also particles to be removed, such as kidney stones, to eliminate the need for both an access sheath, and a grasping tool, during a urology procedure. The short length of the tip extender <NUM>, relative to a traditional access sheath, can also improve a user's intra-procedural view of a patient's internal anatomy at an anatomical site. Anatomical features, such as bends in the ureter, can be viewed directly through the distal end <NUM> of the tip extender <NUM>, instead of through a wall of an access sheath, thereby improving the ease of navigation through tortuous anatomical paths.

<FIG> illustrates a cross-section of an endoscope <NUM> and an endoscopic tip extender <NUM>. Also shown in <FIG> is a longitudinal axis A1, and orientation indicators Proximal and Distal. As illustrated in <FIG>, the outer surface <NUM> of the tip extender <NUM> can define one or more drainage or suction grooves <NUM>. The grooves <NUM> can be concave channels extending parallel to the longitudinal axis A1 between the proximal portion <NUM> and the distal portion <NUM>, of the tip extender <NUM>.

In the operation of some examples, the endoscope <NUM>, including the working channel <NUM>, can be configured to allow a user to actively introduce irrigation fluid into a patient's anatomy. Directional indicator D1 indicates the direction of irrigation fluid flow through the working channel <NUM>. The irrigation fluid can be, for example, a saline solution. In order to avoid over-pressurizing the anatomical site, such as a ureter, the irrigation fluid must be have access to an outlet. The grooves <NUM> can help to allow irrigation fluid to drain in a proximal direction around the tip extender <NUM>, between the outer surface <NUM> and an anatomical wall <NUM> of a patient. Directional indicator D2 indicates the direction of irrigation fluid drainage, through the grooves <NUM>. The anatomical wall <NUM>, for example, can be a wall of a ureter or a calyx of a kidney. The grooves <NUM> can used with both a passive drainage system (gravity); or active drainage system (suction).

If an active drainage system is to be used, the in situ pressure can be monitored, such as to ensure the pressure is within specified limits. Active introduction of irrigation fluid, or active suction for irrigation drainage, can result in respective positive or negative pressure changes in an anatomical site. Negative or positive pressure changes, if not properly controlled, may affect internal organs or other anatomy. The internal pressure can be monitored by various systems or methods. For example, one or more pressure sensors can be used in conjunction with a flow sensor and an external control module to monitor in situ pressure.

The in situ pressure can be monitored at various locations at or near the tip extender <NUM>. For example, pressure can be monitored with a first pressure sensor, such as a membrane sensor, at a first site <NUM>. The first site <NUM> can be a point located along the outer surface <NUM> of the proximal portion <NUM>, of the tip extender <NUM>. Pressure can also be monitored at second site <NUM>. The second point <NUM> can be a point located on the distal portion <NUM> of the endoscope <NUM>, within the bore <NUM> of the tip extender <NUM>. Both the first point <NUM> and the second point <NUM> can also be monitored concurrently, in a delayed, or in a time-interleaved fashion, to observe a pressure differential between the first site <NUM> and the second site <NUM>. Monitoring a differential pressure can help increase the accuracy of any pressure readings obtained from an anatomical site.

A flow sensor can be used to sense an irrigation fluid flow rate through the working channel <NUM> of the endoscope <NUM>. An external control module can be configured to detect the flow rate, which can indicate a presence or an absence of a clog in the working channel <NUM>. In response to the sensed fluid flow rate through the working channel <NUM>, the external control module can control one or more of an irrigation source or a suction source to provide suitable irrigation fluid flow, or suction pressure, through the working channel <NUM>. For example, the external control module can apply suction to unclog the working channel <NUM>. The external control module <NUM> can also automatically adjust one or more of the irrigation fluid flow rate, or a suction flow rate, through the working channel <NUM> to maintain the pressure of the anatomical site at substantially a desired pressure level (e.g., a predetermined or a user-specified pressure level).

The use of irrigation can provide numerous benefits to both an operating physician and to a patient. Irrigation can help to dislodge and facilitate the removal of particles such as calculi, tissue debris, stone fragments, or other unwanted matter through the working channel <NUM>. Irrigation fluid introduction can also help to maintain clear visibility of the anatomical site through the imaging <NUM>. Additionally, irrigation fluid flow can have a cooling effect on an endoscopic tissue removal device, and can also help to dissipate heat generated during laser ablation of calculi or other particles.

Additionally, the grooves <NUM> of the tip extender <NUM> can include one or more passages <NUM>. The passages <NUM> can be bores extending radially inwardly between the grooves <NUM> and the bore <NUM>. The passages <NUM> can be generally cylindrical in shape, but can also be other three-dimensional shapes such as rectangular, hexagonal, or trapezoidal prisms. When active drainage is used, the grooves <NUM>, together with the passages <NUM>, can help to prevent a reduction in suction through the working channel <NUM> of the tip extender <NUM>. For example, if a captured particle or other matter substantially or completely occludes the second portion <NUM> of the bore <NUM>; suction applied through the working channel <NUM> can alternatively reach the grooves <NUM> located along the outer surface <NUM> of the tip extender <NUM> via the passages <NUM>.

The grooves <NUM> can provide numerous benefits to both an operating physician and to a patient. The tip extender <NUM> can provide a secondary route for irrigation fluid drainage, helping increase the rate of irrigation fluid introduction without increasing the pressure on an anatomical site. For example, when an endoscope is used with an access sheath, bi-directional irrigation fluid flow is limited by combined introduction and drainage through one or more working channels <NUM> of the endoscope <NUM>. A slow or significantly limited irrigation flow rate can be less efficient in flushing out unwanted matter from the anatomical site, which can result in reduced visibility and can increase the likelihood of a clog in the working channel <NUM>. Reduced irrigation volume and flow rate may also limit cooling effects on surgical tools and increase the chance of undesirable heat accumulation at the anatomical site.

<FIG> illustrates an example of a method of extracting a mobile calculus from a patient. In this example, the method <NUM> includes operations such as attaching an endoscope to an endoscope tip extender at <NUM>, optionally positioning a lock ring over the tip extender at <NUM>, inserting the endoscope and the tip extender into a patient at <NUM>, and trapping a mobile calculus at <NUM>. In one or more examples, the method <NUM> can begin at step <NUM> with a user attaching an endoscope to an endoscope tip extender. For example, as shown in <FIG>, a user can insert the distal portion <NUM> of the endoscope <NUM> into the bore <NUM>, of the tip extender <NUM>.

In one or more examples, an optional second step <NUM> can be positioning a lock ring over the tip extender, to further secure the tip extender to the endoscope. For example, a user can position the lock ring <NUM> over the tip extender <NUM>; within the lock groove <NUM>. In one or more examples, a third step <NUM> can be inserting the endoscope and the tip extender into the patient. For example, a user can insert the tip extender <NUM> and the endoscope <NUM> through the bladder and into the ureter of a patient. In one or more examples, a fourth step can be trapping a mobile calculus with the tip extender. For example, a user can manipulate the distal portion <NUM> of the endoscope <NUM>, and also apply suction through the working channel <NUM>, to draw the mobile calculus into the tip extender <NUM> and trap the mobile calculus for safe removal. In some examples, the distal end <NUM> of the tip extender <NUM> can roll inwardly, in response to suction, to form the fold-back <NUM>, to further retain the mobile calculus within the tip extender <NUM>. Such a method can be repeated, as desired.

The steps or operations of the method <NUM> are illustrated in a particular order for convenience and clarity. The discussed operations can be performed in parallel or in a different sequence without materially impacting other operations. The method <NUM> as discussed includes operations that can be performed by multiple different actors, devices, and/or systems. It is understood that subsets of the operations discussed in the method <NUM> can be attributable to a single actor device, or system, and could be considered a separate standalone process or method.

The tip extender <NUM> of the present disclosure can help avoid the use of access sheath during an endoscopic procedure. Eliminating the use of an access sheath can help prevent undesirable dilation of the ureter, and access sheath movement or slippage within a patient, while protecting a patient's anatomy from a distal portion <NUM> of an endoscope during insertion and removal. The tip extender <NUM> can be easily manipulated by a user, and can used with or without a suction device to trap a calculus, without the use of a grasping tool. The tip extender <NUM> can help increase visibility of an anatomical site, relative to an access sheath, and can encompass a calculus during laser ablation to protect surrounding tissue from laser and heat exposure. Finally, the tip extender <NUM> can increase the flow rate of irrigation introduction and drainage from a patient's anatomy during an endoscopic procedure such as by providing a secondary drainage path.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure.

Claim 1:
An atraumatic endoscopic medical apparatus, comprising:
an endoscope;
an endoscope tip extender (<NUM>), configured to be attached to and extend longitudinally axially from a distal portion (<NUM>) of said endoscope (<NUM>), the tip extender defining a bore (<NUM>) extending longitudinally axially within the tip extender, the tip extender defining a tapered arrangement and configured to trap a mobile calculus within the bore of the tip extender, characterised by said tip extender including a material that is at least one of softer or more flexible than a material of the distal portion of the endoscope.