Debrider with multiple flushing orifices

A surgical apparatus includes a debriding device, a hollow tube, and an irrigation assembly. The debriding device is fitted at a distal end of the surgical apparatus and is configured to debride tissue from a debriding site in a patient body. The hollow tube is configured to evacuate the debrided tissue away from the debriding site. The irrigation assembly is configured to apply irrigation fluid, via one or more orifices formed in the hollow tube, to the debrided tissue being evacuated.

FIELD OF THE INVENTION

The present invention relates generally to medical debriders, and particularly to methods and systems for irrigation in a debrider.

BACKGROUND OF THE INVENTION

Medical debriders are used in various procedures, such as in sinuplasty procedures carried out in a patient nose. Examples of prior art techniques for using debriders are provided below.

U.S. Pat. No. 6,371,934, whose disclosure is incorporated herein by reference, describes an irrigation system for removing arthritis-causing fragments from a joint in the body, the system includes a handpiece and a tip that is connectible to the handpiece. The tip includes a shaft that forms an irrigation lumen, and a debrider disposed along at least a part of the shaft. The debrider defines a substantially planar debriding surface for debriding the interior surfaces of the joint. The debrider may include a plurality of bristles extending from the shaft to the debriding surface.

U.S. Patent Application Publication 2014/0148835, issued as U.S. Pat. No. 9,814,484 on Nov. 14, 2017, whose disclosure is incorporated herein by reference, describes a bendable medical device that includes a distal housing, an outer support tube, an inner drive tube, a coupler and a commutator portion. The coupler and commutator portion serve to axially constrain a distal end of the inner drive tube during bending, and to supply fluid for lubricating, cooling and irrigating the distal end of the device.

U.S. Pat. No. 6,183,433, whose disclosure is incorporated herein by reference, describes a surgical suction cutting instrument with internal irrigation. The instrument includes a tubular outer member defining a cutting chamber with an opening, an inner member with a distal cutting edge movably received in the outer tubular member and a flushing mechanism for supplying fluid to the cutting chamber via an outlet communicating with the cutting chamber.

U.S. Patent Application Publication 2014/0148729, now abandoned, whose disclosure is incorporated herein by reference, describes a method for removing at least part of a brain tumor that may first involve contacting a forward-facing tissue cutter disposed at the distal end of a tissue removal device with the brain tumor. The tissue removal device may include a shaft having a diameter no greater than about 10 mm, and in some embodiments the tissue cutter does not extend laterally beyond the diameter of the shaft. The method may next involve cutting tissue from the brain tumor, using the tissue cutter. The method may then involve moving the cut tissue through a channel of the shaft in a direction from the distal end of the tissue removal device toward a proximal end of the device.

U.S. Pat. No. 6,293,957, whose disclosure is incorporated herein by reference, describes a method for performing sinus surgery that utilizes a sinus debrider instrument. The method includes the steps of positioning the distal end of the instrument at an operative site within the sinus, cutting tissue at the operative site within the sinus by rotating the tissue cutting surface, removing the cut tissue from the sinus through the suction passage and supplying fluid to the tissue cutting surface through the fluid passage to facilitate the removal of cut tissue without introducing fluid to the operative site.

SUMMARY OF THE INVENTION

An embodiment of the present invention that is described herein provides a surgical apparatus including a debriding device, a hollow tube, and an irrigation assembly. The debriding device is fitted at a distal end of the surgical apparatus and is configured to debride tissue from a debriding site in a patient body. The hollow tube is configured to evacuate the debrided tissue away from the debriding site. The irrigation assembly is configured to apply irrigation fluid, via one or more orifices formed in the hollow tube, to the debrided tissue being evacuated.

In some embodiments, each orifice is configured to regulate a selected irrigating pressure of the irrigation fluid delivered via the orifice. In other embodiments, the irrigation assembly is mounted inside the hollow tube. In yet other embodiments, the surgical apparatus includes a suction assembly, which is configured to assist in evacuating the debrided tissue by applying vacuum along the hollow tube.

In an embodiment, the surgical apparatus further includes a sleeve disposed around the hollow tube so as to form an intermediate lumen between the sleeve and an exterior of the hollow tube, and the irrigation assembly is configured to apply the irrigation fluid to the one or more irrigation orifices via the intermediate lumen. In another embodiment, the hollow tube is configured to rotate about its longitude axis so that at least a given orifice travels around an inner perimeter of the sleeve, such that the irrigation fluid is applied via the given orifice to multiple different locations distributed around the inner perimeter. In yet another embodiment, the sleeve includes an insertion tube for inserting the distal end into a patient body.

In some embodiments, the one or more orifices include multiple orifices that are distributed along the hollow tube. In other embodiments, the multiple orifices are configured to deliver the irrigation fluid at a same irrigation angle. In yet other embodiments, the multiple orifices include at least first and second orifices, such that the first orifice is located closer to the debriding device than the second orifice, and the irrigation assembly is configured to apply the irrigation via the second orifice to the debrided tissue that was previously irrigated via the first orifice.

In an embodiment, the irrigation assembly is configured to determine a distribution of irrigating pressures of the irrigation fluid along the hollow tube. In another embodiment, the multiple orifices include at least a first orifice, which is configured to apply the irrigation fluid at a first irrigation angle, and a second orifice, which is configured to apply the irrigation fluid at a second irrigation angle that is different from the first irrigation angle. In yet another embodiment, the hollow tube is perforated with one or more openings distributed along the hollow tube, and the irrigation assembly is coupled to an outer perimeter of the hollow tube so that each of the orifices is facing a respective one of the openings.

There is additionally provided, in accordance with an embodiment of the present invention, a surgical method including debriding tissue from a debriding site in a patient body. The debrided tissue is evacuated, through a hollow tube, away from the debriding site. Irrigation fluid is applied to the debrided tissue being evacuated via one or more orifices formed in the hollow tube.

There is additionally provided, in accordance with an embodiment of the present invention, a method for producing a surgical apparatus, the method includes fitting at a distal end of the surgical apparatus a debriding device, which is configured to debride tissue from a debriding site in a patient body. A hollow tube, which is configured to evacuate the debrided tissue away from the debriding site, is coupled to the debriding device. An irrigation assembly that is used for applying irrigation fluid to the debrided tissue being evacuated, via one or more orifices formed in the hollow tube, is fitted to the hollow tube.

DETAILED DESCRIPTION OF EMBODIMENTS

Overview

In various medical procedures, such as sinuplasty, a debriding catheter may be used for removing tissue from a human body. The catheter may comprise a cutter that removes the tissue and a hollow tube through which the debrided tissue is evacuated. In some cases, the debrided tissue may get stuck and clog the hollow tube during the evacuation, thus interrupting the medical procedure and possibly undesirably leaving at least some debrided tissue in the body.

It is possible in principle to apply irrigation at a single point close to the cutter, so as to wash out the debrided tissue during or shortly after cutting. Such irrigation, however, cannot prevent clogging of debrided tissue that may occur at points further along the hollow tube, especially in case of large or rough debrided tissue.

Embodiments of the present invention that are described hereinbelow provide improved techniques for evacuating debrided tissue away from the human body. In the disclosed techniques, tissue evacuation is carried out by applying irrigation fluid to the debrided tissue using an irrigation assembly that includes one or more irrigating orifices. In a typical embodiment, multiple irrigating orifices are distributed along the hollow tube. Since irrigation is applied at multiple points along the tube, the likelihood of clogging further away from the cutter is reduced considerably.

In some embodiments, the irrigation assembly may determine the angle of irrigation from each orifice. In addition, the irrigation assembly may control the pressure of irrigation as applied from every individual orifice, or a group of orifices, into the hollow tube. In other embodiments, the irrigation assembly may apply the fluid continuously into the hollow tube while the fluid and the debrided tissue are continuously evacuated away from the human body.

The disclosed irrigation assembly allows reliable evacuation of the debrided tissue along the tube using multiple distributed irrigating orifices. Furthermore, the disclosed techniques allow the removal of multiple selected pieces of tissue during a single procedure, therefore avoiding the need for retracting the catheter for cleaning after removing one or more pieces of debrided tissue.

System Description

FIG. 1is a schematic pictorial illustration of a sinuplasty procedure using a surgical system20, in accordance with an embodiment of the present invention. System20comprises a catheter28, which a physician24inserts into a nose26of a patient22so as to remove tissue, such as a nasal polyp45(shown in an inset40) at a debriding site. Catheter28comprises a proximal end30, configured to control a distal end38of the catheter.

System20further comprises a console33, which comprises a processor34, typically a general-purpose computer, with suitable front end and interface circuits for receiving signals from catheter28, via a cable32, and for controlling other components of system20described herein. Console33further comprises input devices48and a display36, which are configured to display data received from processor34and receive inputs inserted by a user (e.g., physician24).

Reference is now made to insets40and43, distal end38typically comprises a rigid hollow insertion tube58for insertion into the nose of patient22. Tube58is coaxially disposed around a rotating shaft56(shown in greater detail inFIG. 2). Shaft56may be driven using any suitable mechanism, such as a direct current (DC) motor that can rotate clockwise and counterclockwise depending on the polarity of the electrical current applied to the motor.

In some embodiments, tube58has an opening44. Shaft56comprises a debriding device such as a sinuplasty cutter46that is aligned with opening44in the insertion tube. Cutter46is configured to rotate together with the shaft so as to cut polyp45.

Reference is now made to inset40. During the sinuplasty procedure, physician24navigates catheter28so that opening44is facing the debriding site (e.g., polyp45). In other embodiments, catheter28may apply suction for pulling polyp45therein, and cutter46does not block opening44so that polyp45may be inserted through opening44into tube58. Once polyp45passes through opening44, physician24may use console33or proximal end30to rotate shaft56including cutter46so as to remove at least part of polyp45.

Catheter28evacuates the removed polyp into a drain (not shown) located, for example, in proximal end30. Sometimes, after being removed by cutter46, polyp45may get stuck and cause clogging at any point along tube58. In some embodiments, system20comprises an irrigation assembly42, mounted along an inner perimeter of tube58. Irrigation assembly42is configured to irrigate the removed polyp by applying fluid66via one or more orifices, e.g., multiple orifices distributed along cutter46and tube58so as to evacuate the debrided polyp and prevent clogging of tube58.

In another embodiment, catheter28may apply fluid suction, in conjunction with the irrigation, so as to improve the evacuation of fluid66together with the debrided polyp. The suction may be carried out using an internal vacuum pump (not shown) located at proximal end30or at console33. Assembly42is further described inFIG. 2below.

FIG. 1shows only elements related to the disclosed techniques, for the sake of simplicity and clarity. System20typically comprises additional modules and elements that are not directly related to the disclosed techniques, and thus, intentionally omitted fromFIG. 1and form the corresponding description.

Alternatively, some or all of the functions of processor34may be carried out by dedicated or programmable digital hardware components.

Irrigation of Sinuplasty Cutter

A sinuplasty procedure typically involves inserting catheter28, e.g., into the patient nose, navigating it to the location of polyp45(or any other tissue), and removing the polyp (or other tissue) using a debriding device such as cutter46. Sometimes, the removed polyp (or other tissue) may be large and/or have rough texture so that it may get stuck at any point along tube58, thus clogging the tube and interrupting the sinuplasty procedure.

In principle, it is possible to apply irrigation only close to cutter46during the cutting process, but such a solution may not prevent clogging at points further along tube58, even if irrigation was already applied upstream (e.g., close to cutter46). The disclosed techniques reduce or eliminate clogging of tube58, by applying pressurized irrigation fluid at one or more points in tube58, thereby securing the evacuation of the debrided tissue.

FIG. 2is a schematic side view of distal end38, in accordance with an embodiment of the present invention. Distal end38comprises cutter46and irrigation assembly42as described above. Irrigation assembly42comprises multiple irrigation orifices54,54A and54B located along assembly42. Orifices54A and54B are located in proximity to cutter46, and orifices54are grouped in a group60and located along distal end38, as shown inFIG. 2, and may continue along catheter28further away from cutter46.

Each orifice (e.g.,54A,54B and54) is configured to deliver pressurized fluid66into the internal lumen of tube58at a desired configurable delivery angle. In the example ofFIG. 2, orifices54are configured to deliver fluid66orthogonally to assembly42while orifices54A and54B are configured to deliver fluid66at a non-orthogonal angle. In alternative embodiments, all the orifices may deliver fluid at a substantially similar selected angle.

In the example ofFIG. 2, a debris50represents the removed portion of polyp45, or any other tissue being evacuated. In some embodiments, pressurized fluid66carries debris50(represented by arrows52) away from cutter46, along tube58, toward proximal end30. In other embodiments, system20may apply a suction force (e.g., using a vacuum pump) in catheter28so as to pull debris50and fluid66toward proximal end30. The suction force is typically moderate so as to prevent opening44from undesirably sticking to tissue because of the applied suction force.

In an embodiment, assembly42may control the delivery pressure or fluid66from each individual orifice. For example, orifice54A may deliver fluid66at a higher pressure level than orifice54B. In another embodiment, each orifice is configured to deliver fluid66at a predefined selected pressure. Thus, assembly42maintains sufficiently large internal pressure of fluid66so that all orifices, including the proximal (e.g., orifices54) and distal orifices (e.g.,54A,54B), deliver the fluid at a substantially uniform pressure.

In the example ofFIG. 2, irrigation assembly42is laid on the inside of tube58, along the length of the tube. In alternative embodiments, assembly42may have various other configurations and may be coupled to tube58in various other locations. For example, assembly42may by wrapped around the inner perimeter of tube58so that the orifices are mounted in a cascading arrangement around the inner perimeter of insertion tube58rather than arranged in line as depicted inFIG. 2. This arrangement may assist in decoupling portions of debris50that may undesirably adhere to specific locations along the inner perimeter of tube58.

In other embodiments, the wall of tube58may be perforated and assembly42may be coupled on an outer perimeter of tube58so that each orifice (e.g.,54,54A and54B) is arranged in front of a respective hole from which it delivers fluid66into the internal lumen of tube58.

FIG. 3is a schematic side view of a distal end39, in accordance with another embodiment of the present invention. Distal end39may be used, for example, to implement distal end38ofFIG. 1above. In some embodiments, the distal end comprises tube58that is coaxially disposed around a rotating shaft57, which is similar to shaft56ofFIG. 1above. Unlike shaft56, however, shaft57is perforated by multiple irrigation orifices70that may be located at any suitable location along shaft57. In an embodiment, shaft57is coupled to cutter46so that the shaft and cutter rotate together. Distal end39is configured to apply a suction force to draw fluid66that enters the shaft lumen via orifices70in the direction of arrows52, so as to evacuate debris50toward the proximal end, through the internal lumen of shaft57.

During operation, fluid66flows through a lumen that is formed between the inner surface of tube58and the outer surface of shaft57, in the direction from the proximal end to distal end39. Shaft57rotates about its longitude axis (i.e., in parallel to arrows52) so that each of orifices70rotates around the inner perimeter of tube58. For example, orifice70F rotates along a circle72F. Furthermore, each of orifices70is configured to deliver fluid66into the internal lumen of shaft57during the orifice travel along its circle at any desired delivery angle relative to the rotational axis.

The examples above refer to specific configurations of irrigation module42shown inFIGS. 1 and 2, and shaft57shown inFIG. 3, and are chosen purely for the sake of conceptual clarity. In alternative embodiments, any other suitable configuration can be used. For example, the debriding device need not necessarily comprise a rotating cutter, but may alternatively comprise a scissor-shaped surgical device. Further alternatively the debriding device may comprise a cutter that travels linearly toward the distal tip so as to cut polyp45, and retracted linearly toward the proximal end so as to allow insertion of a new object to be cut into opening44.

In alternative embodiments, the disclosed techniques can be used, mutatis mutandis, in various other types of surgical procedures in which tissue is cut and then evacuated using a suction catheter.

For example, debriding may be applied to some external surface of the patient body. The external debriding and irrigating to the surface tissue is carried out similarly to the procedures described above but without inserting tube58into the patient body.