Systems, Instruments, and Methods for Treating Sinuses

Abstract

An instrument system for treating a sinus of a subject includes: an instrument including a base configured to be grasped by an operator; and an elongate probe including a proximal end of the probe coupled to the base and extending to a distal end of the probe. The probe includes a suction lumen terminating at an inlet port proximate the distal end of the probe and a delivery lumen terminating at an outlet port proximate the distal end of the probe. The instrument further includes a waveguide on the probe and having a light-emitting end proximate the distal end of the probe.

Description

[0001] Related Applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 662,565, filed on Apr. 25, 2018, the disclosure of which is incorporated herein by reference in its entirety. Background of the Invention

[0003] Referring to Figure 12A , a human nasal cavity is vertically separated by a cartilaginous wall called the nasal septum 201. On each side of the nasal septum are the nostrils 202 through which the nasal cavity is accessible. Opposite the septum, on each lateral side of the nasal cavity, is a series of nasal turbinates (also called conchae) that extend posteriorly through the nasal cavity from the nostrils toward the throat, including the inferior turbinate 203, the middle turbinate 204, and the superior turbinate (not shown in any figure). The turbinates are bony ridges that project into the nasal cavity.

[0004] Referring to Figure 13A , the paranasal sinuses are a combination of four pairs of inflatable cavities named after the facial bones in which they are located. The maxillary sinuses 205 are lateral to the nasal cavity in the cheek region, the frontal sinuses 206 are in the frontal region above the eyes, the ethmoid sinuses 207 are located between the two eyes, and the sphenoid sinuses 208 are in the skull base below the pituitary gland. The ethmoid sinuses 207 are separated into anterior ethmoid sinuses and posterior ethmoid sinuses by a structure called the basal lamella. The paranasal sinuses are lined with respiratory epithelium that secretes approximately one liter of sinus secretions per day, which drain from the sinus cavities through small orifices called ostia and through drainage pathways or outflow tracts leading to the nasal cavity. The drainage pathways include the ostia and transitional spaces called "recesses" in the ostia region. The transitional space near the frontal sinus is called the frontal recess 209, and the transitional space near the sphenoid sinus and posterior ethmoid sinuses is called the sphenoethmoidal recess (not shown in any figure), while the transitional space near the maxillary sinus is called the ethmoid infundibulum 210. The maxillary sinuses, anterior ethmoid sinuses, and frontal sinuses drain into the nasal cavity below the middle turbinate 204. The posterior ethmoid sinuses and sphenoid sinuses drain through an outflow tract called the sphenoethmoidal recess located behind the superior turbinate. Efficient and effective transport of the mucus-secreting is extremely important for the health of the respiratory epithelium lining the sinus cavities.

[0005] Inflammation of the mucosal lining of the sinus cavities is called sinusitis (or rhinosinusitis) and can be caused by a variety of factors such as anatomical abnormalities, allergies, bacteria, or viruses, which result in mild to severe symptomatic inflammation of the mucosal lining of one or more of the four pairs of sinus cavities (i.e., the maxillary sinuses, ethmoid sinuses, frontal sinuses, and sphenoid sinuses). This results in obstruction or impairment of the sinus or its drainage pathways. Symptoms of sinusitis may include nasal congestion, facial pressure / congestion / fullness, nasal discoloration, and loss of smell.

[0006] If the duration is less than four weeks, the sinusitis is classified as acute sinusitis; or if the duration exceeds 12 weeks, with or without acute exacerbation, the sinusitis is classified as chronic sinusitis. Acute sinusitis is typically treated with medications including oral antibiotics, oral antihistamines, topical or oral steroids. If unresponsive to medical management, chronic sinusitis may require surgical intervention.

[0007] Balloon dilation of the sinus ostium or balloon dilation and drainage pathways have been used to treat patients with chronic sinusitis. Balloon dilation generally includes an endoscope-based, catheter-mounted inflatable balloon located at the distal end of the catheter to expand the affected sinus ostium or drainage pathway. Generally, the inflatable balloon is inserted in a deflated state into the narrow ostium or drainage pathway. Once properly positioned and inflated, the balloon widens the wall of the sinus ostium or pathway without causing significant damage to the mucosa, resulting in reduced procedural morbidity and discomfort associated with the procedure for the patient.

[0008] For example, exemplary devices and methods particularly adapted to dilate anatomical structures associated with the maxillary and anterior ethmoid sinuses are disclosed in U.S. Patent No. 7,520,876 and U.S. Patent Application Publication No. 2008 / 0172033. Other systems for dilating the frontal sinus are also described. For example, U.S. Patent Application Publication No. 2008 / 0097295 discloses a frontal sinus guiding catheter ( Figure 6 B) and a method of treating the frontal sinus (e.g., Figure 8 B-8C). U.S. Patent Application Publication No. 2008 / 0125626 discloses another guiding device (e.g., Figure 10 C and Figure 10 C’) for transnasal access to the frontal sinus for treatment.

[0009] Existing balloon sinus dilation systems have several disadvantages. Some require multiple steps and multiple instruments. Some available sinus dilation systems require up to eighteen steps to complete the sinus dilation procedure. Some sinus dilation systems require connection to an external light source for transillumination, while other sinus dilation systems require connection to an image guidance system and thus require other systems to function. Summary of the Invention

[0010] According to some embodiments of the present invention, an instrument system for treating a subject's sinuses includes: an instrument including a base configured to be grasped by an operator; and an elongate probe including a proximal end of the probe coupled to the base and extending to a distal end of the probe. The probe includes a suction lumen terminating at an inlet port proximate the distal end of the probe and a delivery lumen terminating at an outlet port proximate the distal end of the probe. The instrument further includes a waveguide on the probe, and the waveguide has a light-emitting end proximate the distal end of the probe.

[0011] In some embodiments, the instrument system is configured to: perform a suction operation, wherein the instrument system sucks material through an inlet port into a suction lumen; perform a fluid delivery operation, wherein the instrument system causes fluid to flow through a delivery lumen and out through an outlet port; and perform an illumination operation, wherein the instrument system causes light to be transmitted through a waveguide and out through a light-emitting end.

[0012] According to some embodiments, the instrument system is configured to enable an operator to perform the suction operation, the fluid delivery operation, and the illumination operation simultaneously.

[0013] In some embodiments, the instrument system is configured to enable an operator to perform the suction operation and the fluid delivery operation simultaneously.

[0014] According to some embodiments, the instrument includes an expandable balloon mounted on the probe proximate to the distal end of the probe, and the instrument system is configured to perform an expansion operation in which the expandable balloon expands.

[0015] In some embodiments, the instrument system is configured to enable an operator to perform the expansion operation simultaneously with at least one of the suction operation and the fluid delivery operation.

[0016] According to some embodiments, the instrument system is configured to enable an operator to perform the expansion operation, the suction operation, and the fluid delivery operation simultaneously.

[0017] In some embodiments, the instrument system is configured such that: the probe defines a probe longitudinal axis extending from a proximal end of the probe to a distal end of the probe; the base includes a handle configured to be grasped by an operator's hand; and the handle has a handle axis extending at a transverse angle to the probe longitudinal axis.

[0018] According to other embodiments of the present invention, an instrument system for treating a subject's sinus includes: an instrument including a base configured to be grasped by an operator; and an elongate probe including a proximal end of the probe coupled to the base and extending to a distal end of the probe. The probe includes a suction lumen terminating at an inlet port proximate to the distal end of the probe and a delivery lumen terminating at an outlet port proximate to the distal end of the probe. The instrument further includes an expandable balloon mounted on the probe proximate to the distal end of the probe.

[0019] In some embodiments, the instrument system is configured to: perform a suction operation, wherein the instrument system sucks material through an inlet port into a suction lumen; perform a fluid delivery operation, wherein the instrument system causes fluid to flow through a delivery lumen and out through an outlet port; and perform an expansion operation, wherein the expandable balloon expands.

[0020] According to some embodiments, the instrument system is configured to enable an operator to perform the suction operation and the fluid delivery operation simultaneously.

[0021] In some embodiments, the instrument system is configured to enable an operator to perform a dilation operation simultaneously with at least one of a suction operation and a fluid delivery operation.

[0022] In some embodiments, the instrument system is configured to enable an operator to perform a dilation operation, a suction operation, and a fluid delivery operation simultaneously.

[0023] According to some embodiments, the instrument system includes: a rigid elongate shaft, wherein a suction lumen is defined in the shaft; and a delivery catheter extending through the suction lumen, wherein a delivery lumen is defined in the delivery catheter. A dilation balloon is mounted on the distal end of the shaft.

[0024] The instrument system may include a drug supply fluidly connected to the delivery catheter.

[0025] According to a method embodiment of the present invention, a method for treating a subject's sinus includes: providing an instrument including a base configured to be grasped by an operator; and an elongate probe including a proximal end of the probe coupled to the base and extending to a distal end of the probe. The probe includes a suction lumen terminating at an inlet port proximate to the distal end of the probe and a delivery lumen terminating at an outlet port proximate to the distal end of the probe. The instrument further includes a waveguide on the probe, and the waveguide has a light-emitting end proximate to the distal end of the probe. The method further includes: performing a suction operation, wherein the instrument system sucks material through the inlet port into the suction lumen; performing a fluid delivery operation, wherein the instrument system causes fluid to flow through the delivery lumen and out through the outlet port; and performing an illumination operation, wherein the instrument system causes light to be transmitted through the waveguide and out through the light-emitting end.

[0026] In some embodiments, the method includes performing the suction operation, the fluid delivery operation, and the illumination operation simultaneously.

[0027] According to a method embodiment of the present invention, a method for treating a subject's sinus includes: providing an instrument including a base configured to be grasped by an operator; and an elongate probe including a proximal end of the probe coupled to the base and extending to a distal end of the probe. The probe includes a suction lumen terminating at an inlet port proximate to the distal end of the probe and a delivery lumen terminating at an outlet port proximate to the distal end of the probe. The instrument further includes a dilation balloon mounted on the probe proximate to the distal end of the probe. The method further includes: performing a suction operation, wherein the instrument system sucks material through the inlet port into the suction lumen; performing a fluid delivery operation, wherein the instrument system causes fluid to flow through the delivery lumen and out through the outlet port; and performing a dilation operation, wherein the dilation balloon is inflated.

[0028] In some embodiments, the method includes performing the suction operation and the fluid delivery operation simultaneously.

[0029] According to some embodiments, the method includes performing a dilation operation simultaneously with at least one of a step of performing a suction operation and a step of performing a fluid delivery operation.

[0030] In some embodiments, the method includes performing a dilation operation, a suction operation, and a fluid delivery operation simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 is a front fluoroscopic view of a sinus treatment system according to some embodiments.

[0032] Figure 2 is a Figure 1 exploded rear perspective view of an instrument that is part of the sinus treatment system.

[0033] Figure 3 is a Figure 2 side view of the instrument.

[0034] Figure 4 is a Figure 2 partial side view of the instrument.

[0035] Figure 5 is a Figure 2 partial rear perspective view of the instrument.

[0036] Figure 6 is a Figure 2 distal view of the instrument with the balloon of the instrument in an inflated position.

[0037] Figure 7 is a Figure 2 distal view of the instrument with the balloon in a deflated position.

[0038] Figure 8 is a cross-sectional view of the Figure 6 instrument taken along line 8-8 of the Figure 2 instrument with the balloon in an inflated position.

[0039] Figure 9 is a cross-sectional view of the Figure 8 instrument taken along line 9-9 of the Figure 2 instrument with the balloon in an inflated position.

[0040] Figure 10 is a Figure 2 proximal view of a shaft that is part of the instrument.

[0041] Figure 11 is a Figure 2 rear perspective view of a fitting that is part of the instrument.

[0042] Figures 12A - 13F illustrates a method of using a Figure 1 sinus treatment system.

[0043] Figure 14 is a distal view of the shaft according to an alternative embodiment.

[0044] Figure 15 is a front perspective schematic view of a sinus treatment system according to another embodiment.

[0045] Figure 16 is formed Figure 15 exploded rear perspective view of an instrument that is part of a sinus treatment system.

[0046] Figure 17 is Figure 16 partial rear perspective view of the instrument.

[0047] Figure 18 is Figure 16 cross-sectional view of the instrument, in which a balloon forming part of the instrument is in an inflated position.

[0048] Figure 19 is Figure 16 distal view of the instrument.

[0049] Figure 20 is along Figure 18 line 20-20 of Figure 16 cross-sectional view of the instrument.

[0050] Figure 21 is formed Figure 16 partial rear perspective view of a balloon component that is part of the instrument. DETAILED DESCRIPTION

[0051] The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments of the invention are shown. In the figures, the relative sizes of regions or features may be enlarged for clarity. However, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0052] It will be understood that when an element is referred to as being "coupled" or "connected" to another element, it can be directly coupled or connected to the other element, or intervening elements may also be present. In contrast, when an element is referred to as being "directly coupled" or "directly connected" to another element, there are no intervening elements. Like numerals refer to like elements throughout.

[0053] In addition, spatial relative terms such as "below", "beneath", "lower", "above", "upper", etc. may be used in this document for convenience to describe the relationship of one element or feature shown in the figures to another element or feature. It will be understood that the spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, an element described as "below" or "beneath" another element or feature will then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an upper and a lower orientation. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatial relative descriptors used herein are to be interpreted accordingly.

[0054] Well-known functions or constructions may not be described in detail for the sake of brevity and / or clarity.

[0055] As used herein, the expression "and / or" includes any and all combinations of one or more of the associated listed items.

[0056] The terms described herein are for the purpose of describing particular embodiments only and are not intended to limit the invention. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof.

[0057] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will also be understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0058] As used herein, "treat", "treating", or "treatment of" (and their grammatical variants) refers to any type of treatment that is beneficial to a subject, and may mean a reduction in the severity of a disease, disorder, or condition of the subject, an improvement or alleviation at least in part, and / or the achievement of some alleviation of at least one clinical symptom associated with the disease, disorder, or condition, and / or a delay in symptom progression. In some embodiments, the severity of a disease, disorder, or condition associated with the sinuses in a subject may be reduced compared to the severity of the symptoms in the absence of the systems and / or methods of the present invention.

[0059] In some embodiments, a therapeutic agent as described herein may be administered in a therapeutically effective amount. As used herein, a "therapeutically effective amount" is an amount sufficient (as defined herein) to treat a subject. One of ordinary skill in the art will appreciate that the therapeutic effect need not be complete or curative, so long as some benefit is provided to the subject. In some embodiments, a therapeutically effective amount may be achieved by administering a drug as described herein to a subject using the systems and / or methods of the invention, optionally in the flushing fluid I, the supply section 114B of the drug N, and / or the inflation fluid E.

[0060] The terms "prevent", "preventing", and "prevention" (and their grammatical variations) refer to avoiding, reducing, and / or delaying the onset of symptoms associated with a disease, disorder, or condition, and / or reducing the severity of the onset of symptoms associated with a disease, disorder, or condition, compared to what would occur in the absence of the systems and / or methods of the invention. Prevention can be complete, e.g., no symptoms at all. Prevention can also be partial, such that the occurrence and / or severity of symptoms in the subject is less than what would occur in the absence of the systems and / or methods of the invention.

[0061] In some embodiments, a therapeutic agent as described herein may be administered in a prophylactically effective amount. As used herein, a "prophylactically effective amount" is an amount sufficient (as defined herein) to prevent a disease, disorder, or condition and / or symptoms thereof in a subject. One of ordinary skill in the art will appreciate that the degree of prevention need not be complete, so long as some benefit is provided to the subject. In some embodiments, a prophylactically effective amount may be achieved by administering a drug as described herein to a subject using the systems and / or methods of the invention, optionally in the flushing fluid I, the supply section 114B of the drug N, and / or the inflation fluid E.

[0062] The present invention can be used in both veterinary and medical applications. The term "subject" is used interchangeably herein with the term "patient". Suitable subjects of the present invention include, but are not limited to, mammals of all ages. As used herein, the term "mammal" includes, but is not limited to, primates (e.g., apes and humans), non-human primates (e.g., monkeys, baboons, chimpanzees, gorillas), cattle, sheep, goats, ungulates, pigs, horses, cats, dogs, rabbits, pinnipeds, rodents (e.g., rats, hamsters, and mice), etc. In some embodiments, the subject is a mammal, and in certain embodiments, the subject is a human. Human subjects include males and females, and subjects of all ages, including fetuses, neonates, infants, juveniles, adolescents, adults, and elderly subjects.

[0063] The systems and / or methods of the present invention can also be used and / or performed on animal subjects, particularly mammalian subjects such as mice, rats, dogs, cats, livestock, and horses for veterinary purposes and / or for drug screening and / or drug development purposes.

[0064] As used herein, "integral" means that an object is a single, unitary piece formed or composed of material without joints or seams. Alternatively, an integral object can be a composition composed of multiple parts or components fixed together at joints or seams.

[0065] Referring to Figures 1 - 13F , in which a sinus treatment system 10 according to an embodiment of the present invention is shown. The system 10 includes a sinus treatment instrument system 100 and an optional endoscope 20. The system 10 and the instrument system 100 can be used to perform procedures (e.g., surgical procedures) on the sinuses and / or treat the sinuses. In particular, the system 10 and the instrument system 100 can be used to perform surgical procedures and treatments on the paranasal sinuses of human patients (subjects). The system 10 and the instrument system 100 can be used to perform balloon angioplasty or balloon dilation of the patient's sinus ostia and drainage pathways. In some embodiments, the system 10 and the instrument system 100 can be used to administer one or more drugs to the patient, optionally into the patient's sinuses.

[0066] As described herein, the instrument system 100 can be used to perform a variety of different operations, namely: aspiration operations; fluid delivery operations (irrigation fluid and / or drugs); dilation operations; and illumination operations. Each of these operations can be performed simultaneously (i.e., at the same time) or independently using the instrument system 100 in any desired combination. "Independently" means that the operation can be selectively performed while selectively not performing another operation.

[0067] The instrument subsystem 100 includes a handheld instrument 120, an aspiration (negative pressure or vacuum) source 110, an irrigation fluid source 112, a drug source 114, and an inflation fluid source 116.

[0068] The suction source 110 can include a pump or compressor, such as an electric pump or compressor, a syringe, or any other suitable device for generating negative pressure (vacuum) to enable aspiration. In some embodiments, the suction source 110 generates and maintains a substantially constant negative pressure. The pressure level can be set by the operator.

[0069] The irrigation fluid source 112 can include a pump 112A and a supply 112B of irrigation fluid I ( Figure 12D ). The irrigation fluid I can be any suitable fluid, and in some embodiments, it is an irrigation solution. In some embodiments, the irrigation fluid I is water or saline. In some embodiments, the irrigation fluid source 112 is a syringe containing the irrigation fluid supply 112B. The irrigation syringe can be a manual syringe. In some embodiments, the irrigation fluid I includes a drug.

[0070] The drug source 114 may include a pump 114A and a supply section 114B of drug N ( Figure 12E ). The drug N can be any suitable flowable drug, and in some embodiments, it is a liquid. In some embodiments, the drug is a drug fluid. In some embodiments, the drug source 114 is a syringe containing the drug supply section 114B. The drug syringe can be a manual syringe.

[0071] The inflation fluid source 116 may include a pump 116A and a supply section 116B of inflation fluid E ( Figure 1 ). The inflation fluid can be any suitable fluid, and in some embodiments, it is an inflation liquid. In some embodiments, the inflation fluid E is water or saline. In some embodiments, the inflation fluid source 116 is a syringe containing the inflation fluid supply section 116B. The inflation syringe can be a manual syringe. In some embodiments, the inflation fluid E includes a drug.

[0072] As used herein, "drug" refers to a therapeutic agent and / or a diagnostic agent. One or more drugs (e.g., one or more therapeutic agents and / or one or more diagnostic agents) may be present in the flush fluid I, the supply section 114B, and / or the inflation fluid E. The drug can be in any suitable form. In some embodiments, the drug is present in a solution (e.g., an aqueous solution), a suspension, or an emulsion. In some embodiments, when no drug is needed or when drug administration is not required and / or when a drug is present in the flush fluid I and / or the inflation fluid E, there is no drug source 114. As used herein, "therapeutic agent" refers to any chemical and / or biological compound and / or agent that can be used to treat and / or prevent a disease, disorder, or condition and / or symptoms thereof in a subject. Therapeutic agents include, but are not limited to, antibiotics, antivirals, antiparasitics, antifungals, anti-inflammatories, decongestants, mucolytics, and / or steroids. As used herein, "diagnostic agent" refers to any substance that aids in the diagnosis of a disease, disorder, or condition in a subject and / or aids in the delivery of a therapeutic agent and / or a device or its components to the subject. Diagnostic agents include, but are not limited to, contrast agents and / or imaging agents. In some embodiments, the drug can be one or more diagnostic or therapeutic substances, such as those described in U.S. Patent No. 7,361,168, and optionally, the method of administering and / or delivering the drug to the subject can be as described in U.S. Patent No. 7,361,168, and for the relevant teachings of this paragraph, this U.S. patent is incorporated herein by reference.

[0073] Any means and / or method known to those skilled in the art can be used to administer and / or deliver a drug to a subject. In some embodiments, the drug can be administered and / or delivered to the subject via a fluid containing the drug (such as a solution (such as an aqueous solution), suspension, emulsion, etc.). The fluid can be the irrigation fluid I, the fluid provided in the supply unit 114B, and / or the inflation fluid E. In some embodiments, the inflation fluid E includes a drug, and the inflation fluid E is administered to the subject through balloons 174, 374 (discussed below). The balloons 174, 374 can include one or more pores, and the inflation fluid E containing at least one drug can flow out of one or more pores of the balloons 174, 374 and optionally into the sinus. In some embodiments, when the inflation fluid E fills and / or has filled the balloons 174, 374, one or more pores can open and / or expand, optionally to a given volume and / or pressure, and when opened and / or expanded, the inflation fluid E flows out, leaks, exudes, etc. from one or more pores. In some embodiments, the drug (such as, for example, in the form of a coating on the balloons 174, 374) is provided on the balloons 174, 374. The coating and / or the drug can be administered to the subject when in contact with the coating (such as, for example, when expanding on the balloons 174, 374 and / or contacting the tissue of the subject and / or the nasal and / or sinus surface). In some embodiments, the coating and / or the drug are administered to the subject when the balloons 174, 374 block and / or occlude the sinus tract of the subject. In some embodiments, the system 10 and the instrument 120 can administer and / or deliver an implant including a drug. The implant can be in the form of a coil, stent, staple, wire, mesh, patch, etc. The system 10 and the instrument 120 can attach the implant to the tissue of the subject and / or the nasal and / or sinus surface. In some embodiments, the system 10 and the instrument 120 can embed the implant into the tissue of the subject and / or the nasal and / or sinus surface. In some embodiments, when the balloons 174, 374 expand and / or contact the tissue of the subject and / or the nasal and / or sinus surface, optionally when the balloons 174, 374 block and / or occlude the sinus tract of the subject, the implant is attached and / or embedded. The implant can be bio-degradable and / or bio-absorbable. The implant can include a drug and an optional carrier material (such as a polymer). In some embodiments, the implant can be the implant described in U.S. Patent No. 7,361,168, and optionally can be delivered as described in U.S. Patent No. 7,361,168, the teachings of which are incorporated herein by reference for the relevant teachings related to this section.

[0074] The instrument 120 is a balloon dilation catheter device that includes functional features and mechanisms in addition to the dilation function. The instrument 120 includes a handheld unit or base 122, a probe (or guide member or extension assembly) 130, an illumination system 150, a suction system 160, a delivery system 165, a dilation system 170, and a connector fitting 178. The instrument 120 has a proximal end 120A and a distal end 120B that define a main axis or longitudinal axis L-L.

[0075] The base 122 has a main axis M-M that is substantially parallel to the longitudinal axis L-L of the instrument.

[0076] The base 122 includes a housing 124, and the housing includes opposing portions 124B that define an internal cavity 124A. As described herein, suitable features such as channels, cavities, posts, etc. may be provided in the base 122 and the cavity 124A to receive, position, and secure the various components housed in the base 122.

[0077] The housing 122 has a main section 126 that extends from a proximal end 126A to a distal end 126B parallel to the main axis M-M. A distal port 127 is defined in the distal end 126B.

[0078] The base 122 further includes a handle section 128 that defines a handle axis H-H that is transverse to the main axis M-M. The handle section 128 has an inner end 128B that merges with the main section 126 and an opposing outer end 128A. In some embodiments, the handle axis H-H forms an angle A1 ( Figure 3 ) within a range of about 50 degrees to 130 degrees with the main axis M-M, and in some embodiments, within a range of about 70 degrees to 110 degrees. In some embodiments, the handle axis H-H is substantially perpendicular to the main axis M-M and the longitudinal axis L-L of the instrument.

[0079] The base 122 is ergonomically shaped or contoured to have a rear handle face 129A, a top face 129B, an upper shoulder 129C, a lower front handle face 129D, an upper front handle face 129E, and an intermediate front handle face 129F. The face 129A is located behind the top face 129B and is connected to the top face by a rounded transition face or shoulder face 129C. The intermediate front handle face 129F projects forward beyond the lower front handle face 129D and the upper front handle face 129E.

[0080] The probe 130 includes an elongate shaft 132 that defines a longitudinal probe axis P-P that extends from a proximal end 132A to a distal end 132B. The probe axis P-P is substantially parallel to the instrument axis L-L and the main axis M-M. The shaft 132 includes a dilator section 136, an intermediate section 137, and a distal section 138. The distal section 138 terminates at a distal end 138A.

[0081] The shaft 132 has an outer surface 134A. In some embodiments, the outer surface 134A is substantially cylindrical. In some embodiments, the outer surface 134A is substantially conical or frustoconical. In some embodiments, the outer surface 134A is substantially elliptical in a transverse cross-section, and in some embodiments, is substantially circular in a transverse cross-section.

[0082] The shaft 132 can be formed of any suitable material. In some embodiments, the shaft 132 is formed of a stainless steel hypotube.

[0083] In some embodiments, the shaft 132 is integral. In some embodiments, the shaft 132 is integrally formed. In some embodiments, the shaft 132 is monolithic. The shaft 132 can be molded (e.g., injection molded) or extruded.

[0084] In some embodiments, the shaft 132 is formed of a rigid but malleable material. This allows the shaft 132 to be intentionally bent into a new shape or configuration in response to the application of a sufficient bending force, and to maintain the original or new shape or configuration when a lesser force is applied to the shaft 132. In some embodiments, the bending force required is greater than any force that the shaft 132 is expected or intended to experience in use during a surgical procedure (i.e., while navigating or using the probe 120 within a patient's anatomy). The malleability of the shaft 132 enables the user to bend the shaft 132 into a desired angle or curvature to achieve proper positioning of the balloon 174 and the distal tip 138A within a sinus ostium or sinus drainage pathway.

[0085] In some embodiments, the shaft 132 is preformed to have a curved distal portion (e.g., as Figures 12A - 12E shown). The curved distal portion can be configured to match the frontal sinus outflow tract or the frontal recess.

[0086] In some embodiments, the distal portion of the shaft 132 is formed on the right side of the distal end 132B and can have a radius of curvature in the range of about 0.25 inches to about 1.5 inches, and in some embodiments, in the range of about 0.75 inches to about 1.25 inches.

[0087] The shaft 132 extends from the base 122 to the distal end 132B a predetermined or specified distance or length L1 ( Figure 3 ). In some embodiments, the length L1 is in the range of about 4 to 12 inches, and in some embodiments, in the range of about 8 to 10 inches.

[0088] In some embodiments, the outer diameter D1 ( Figure 6 ) of the shaft 132 is in the range of about 1 to 5 mm, and in some embodiments, in the range of about 1.5 to 3.3 mm.

[0089] In some embodiments, the nominal wall thickness T1 (Figure 6 ) in the range of about 0.001 to 0.030 inches, and in some embodiments, in the range of about 0.005 to 0.020 inches.

[0090] In some embodiments, the outer diameter of the distal end 138A is in the range of about 0.5 to 5 mm, and in some embodiments, in the range of about 1 to 3.3 mm.

[0091] In some embodiments, the edge of the end 138A is rounded or smooth to prevent or reduce trauma to the sinus mucosa.

[0092] An illumination lumen 140, a suction lumen 142, and a delivery lumen 144 are defined in the shaft 132. Each lumen 140, 142, 144 is contained within or lies within the boundaries defined by the outer surface 134A of the shaft. The lumens 140, 142, 144 are elongated and extend radially or laterally side by side relative to each other along the axis P-P. In some embodiments, the lumens 140, 142, 144 extend substantially parallel to each other along the axis P-P.

[0093] The illumination lumen 140 terminates at a proximal opening 140A at the end 132A and at a distal opening 140B at the end 132B. The suction lumen 142 terminates at a proximal opening 142A at the end 132A and at a distal opening or suction inlet port 142B at the end 132B. The delivery lumen 144 terminates at a proximal opening 144A at the end 132A and at a distal opening or fluid delivery outlet port 144B at the end 132B. The distal openings 140B, 142B, 144B are formed in the end 138A.

[0094] In some embodiments, each lumen 140, 142, 144 is substantially uniform in size and cross-section throughout its length and includes its proximal and distal openings. In other embodiments, one or more of the lumens 140, 142, 144 may be non-uniform.

[0095] In some embodiments and as Figure 10 shown, one or more of the lumens 140, 142, 144 may have a cross-sectional shape and / or area different from that of another of the lumens 140, 142, 144. In some embodiments and as Figure 10 shown, one or more of the lumens 140, 142, 144 may have an irregular or asymmetric shape (e.g., non-elliptical and non-circular) that more closely optimizes the use of the available area within the shaft 132.

[0096] Referring to Figure 10, in some embodiments, the cross-sectional area of the aspiration lumen 142 is greater than the cross-sectional area of the delivery lumen 144. In some embodiments, the cross-sectional area of the aspiration lumen 142 is at least 1.5 times the cross-sectional area of the delivery lumen 144. In some embodiments, the cross-sectional area of the aspiration lumen 142 ranges from about 2 to 4 times the cross-sectional area of the delivery lumen 144.

[0097] In some embodiments, the cross-sectional area of the aspiration lumen 142 is greater than the cross-sectional area of the illumination lumen 140. In some embodiments, the cross-sectional area of the aspiration lumen 142 is at least 15 times the cross-sectional area of the illumination lumen 140. In some embodiments, the cross-sectional area of the aspiration lumen 142 ranges from about 8 to 40 times the cross-sectional area of the illumination lumen 140.

[0098] In some embodiments, the cross-sectional area of the delivery lumen 144 is greater than the cross-sectional area of the illumination lumen 140. In some embodiments, the cross-sectional area of the delivery lumen 144 is at least 8 times the cross-sectional area of the illumination lumen 140. In some embodiments, the cross-sectional area of the delivery lumen 144 ranges from about 4 to 10 times the cross-sectional area of the illumination lumen 140.

[0099] In some embodiments, the cross-sectional area of the aspiration lumen 142 ranges from about 0.28 to 1.76 mm 2 within the range.

[0100] In some embodiments, the cross-sectional area of the delivery lumen 144 ranges from about 0.07 to 0.8 mm 2 within the range.

[0101] In some embodiments, the cross-sectional area of the illumination lumen 140 ranges from about 0.007 to 0.2 mm 2 within the range. In some embodiments, the cross-sectional area of the illumination lumen 140 is substantially the same as the outer diameter of the waveguide 154 (including the sheath).

[0102] In some embodiments, the cross-sectional area of the through-passage or lumen of the inflation catheter 172 is less than the cross-sectional area of the aspiration lumen 142, and in some embodiments, less than the cross-sectional areas of the delivery lumen 144 and the illumination lumen 140.

[0103] Connector fitting 178( Figure 2 , Figure 5 and Figure 11)It includes a suction channel 178A and a delivery channel 178B that respectively extend completely therethrough. The distal end of the fitting 178 mates with and is fixed to the proximal end 132A of the shaft 132 such that the distal opening of the suction channel 178A is fluidly connected to the suction lumen 142 and the distal opening of the delivery channel 178B is fluidly connected to the delivery lumen 144. The fitting 178 can be formed of any suitable material (e.g., metal) and can be fixed to the proximal end of the shaft 132 by any suitable technique (e.g., welding or an adhesive).

[0104] The integrated lighting system 150 includes a light source 151, an internal battery 152, and a waveguide 154. In some embodiments, the light source 151, the battery 152, and the battery contact spring are mounted in the cavity 124A of the base 122. In some embodiments, the light source 151 includes a light emitting diode (LED) and may include an associated printed circuit board (PCB).

[0105] In some embodiments, the waveguide 154 is an optical fiber (e.g., a polymer or glass optical fiber). The waveguide 154 can be an optical fiber including a core and a surrounding cladding and can be provided to provide total internal reflection. The waveguide 154 can be surrounded by a sheath to protect the waveguide and prevent light loss. A light emitting filament such as that disclosed in U.S. Patent Application Publication No. 2007 / 0249896 can be used as the waveguide 154, which U.S. Patent Application is incorporated herein by reference.

[0106] The waveguide 154 extends from a proximal end 154A in the base 122 and approaches the light source 151, passes through the opening 140A, passes through the illumination lumen 140, and reaches a distal end 154B adjacent to the distal end 132B. The waveguide 154 has an end face 154C at the distal end 154B from which light is emitted. The end face 154C can be polished. In some embodiments, the distal end 154B of the waveguide is positioned substantially flush with the distal end 132B. In other embodiments, the distal end 154B of the waveguide extends outwardly beyond the distal end 132B by a distance in the range of about 1 to 5 cm.

[0107] As Figures 1 to 4 shown, the electrically insulated switch tab 151A electrically disconnects the terminals of the battery 152 from the lighting circuit until it is desired to operate the light source 151. In use, the operator removes the tab 151A, thereby actuating the light source 151 to produce light that is transmitted through the waveguide 154 and emitted from the distal end 154B. Alternatively, the lighting system 150 can include a lamp switch for turning the light source on and off.

[0108] In some embodiments, instead of or in addition to the battery 152, the instrument 120 can include an external power source (e.g., connected to the instrument 120 by wires).

[0109] The aspiration system 160 includes a catheter 162, an aspiration port 160P, and an aspiration controller 164. The aspiration port 160P is disposed at the outer end of the handle 128. The catheter 162 extends through the handle 128. The proximal end of the catheter 162 is fluidly connected to the aspiration port 160P. The distal end of the catheter 162 is fluidly coupled to the aspiration channel 178A of the connector fitting 178 and is thus fluidly connected to the proximal opening 142A of the aspiration lumen 142. A suction source 110 is fluidly connected to the aspiration port 160P by a conduit 160T. The aspiration port 160P may be provided with a connector or coupler (such as a luer lock) to fluidly connect the conduit 160T from the suction source 110 to the port 160P.

[0110] The aspiration controller 164 includes a valve 164A in the base 122, an integral trigger 164B attached to the base 122, and a return spring 164C. The trigger 164B is operable to selectively permit and block the flow of fluid through the catheter 162 between the lumen 142 and the suction source 110.

[0111] In some embodiments and as shown, the valve 164A is a pinch valve. The trigger 164B is positioned near the handle 128 such that the trigger 164B can be conveniently pulled using the operator's finger. A portion 164D of the trigger 164B serves as a pinch feature that compresses and closes the catheter 162 when the trigger 164B is not depressed. When the trigger 164B is depressed, the catheter 162 is opened. Upon release, the trigger 164B is pushed back to the closed position by the spring 164C. The trigger 164B thus operates as a manual valve 164A that the user can selectively operate to open and close the fluid path between the suction source 110 and the lumen 142.

[0112] In an alternative embodiment, the trigger 164B is configured such that its operation is reversed. In this case, the catheter 162 is open by default. When the trigger 164B is depressed, the catheter 162 is closed. Upon release, the trigger 164B is pushed back to the open position by the spring 164C.

[0113] The delivery system 165 includes a catheter 166, a delivery port 165P, and a delivery controller 168 (for flushing fluid) or a delivery controller 169 (for drugs). The outlet port 165P is provided at the outer end of the handle 128. The catheter 166 extends through the handle 128. The proximal end of the catheter 166 is fluidly connected to the delivery port 165P. The distal end of the catheter 166 is fluidly coupled to the delivery channel 178B of the connector fitting 178 and is thereby fluidly connected to the proximal opening 144A of the delivery lumen 144. The delivery source 112 is fluidly connected to the delivery port 165P by the catheter 165T. The delivery port 165P may be provided with a connector or coupler (such as a Luer lock) to fluidly connect the catheter 165T from the flushing fluid source 112 to the port 165P.

[0114] The delivery controller 168 is operable to control the actuation of the delivery source 112 and / or selectively allow and block fluid flow through the catheters 166, 165T to the delivery lumen 144. In some embodiments, the controller 168 is outside the instrument 120. In some embodiments, the delivery source 112 is embodied in a syringe that includes a reservoir (supply section 112B) and a pump mechanism (pump 112A and controller 168). In some embodiments, the syringe is a manual syringe. The drug delivery controller 169 may be similarly constructed and operated to control drug delivery from the source 114.

[0115] The dilation system 170 includes a dilator mechanism 171 (in the form of a balloon 174), a catheter 172, an inflation port 170P, and a dilation controller 176. The balloon 174 is mounted near the distal end 132B of the shaft 132. The dilation system 170 is configured to selectively inflate and deflate the balloon 174 according to the needs of the operator.

[0116] The inflation port 170P is provided at the outer end of the handle 128. The catheter 172 extends through the handle 128. The proximal end of the catheter 172 is fluidly connected to the inflation port 170P. The inflation source 116 is fluidly connected to the inflation port 170P by the catheter 170T. The inflation port 170P may be provided with a connector or coupler (such as a Luer lock) to fluidly connect the catheter 170T from the inflation source 116 to the port 170P.

[0117] The connecting section of the catheter 172 extends from the handle 128 along the outer surface 134A of the shaft 132 to the balloon 174. The distal end of the catheter 172 extends into the balloon 174 through a port 175 defined between the outer diameter of the balloon 174 and the shaft 132. The connecting section may be fixed to the shaft 132 by a band, adhesive, welding, or any other suitable method.

[0118] The balloon 174 includes a sealed end 174B, a main section 174A therebetween, and an outer surface 174C. In some embodiments, the balloon 174 is directly mounted on the shaft 132 to form a fluid seal between the two components. The balloon 174 can be bonded to the shaft 132 using welding, adhesives, etc. Alternatively, a mechanical connection can be used to secure the balloon 174 to the shaft 132. The balloon 174 and the shaft 132 define a sealed balloon inflation chamber 177 therebetween.

[0119] The balloon 174 is flexible and expandable when inflated. The dilation system 170 is operable to alternately place the balloon 174 in at least a first relatively radially non-expanded configuration (herein, non-expanded position) and a second radially expanded configuration (herein, expanded configuration). In the expanded configuration, the outer diameter D2 ( Figure 8 ) of the balloon 174 is larger than in the deflated configuration.

[0120] In some embodiments, and as will be appreciated from the description herein, the dilation system 170 is operable to place the balloon 174 within a range of different expanded configurations. That is, the balloon 174 can be forced to assume one of a plurality of different expanded configurations each having a different outer diameter D2.

[0121] In some embodiments, and as will be appreciated from the description herein, the non-expanded configuration of the balloon 174 may not be a completely non-expanded or deflated configuration. That is, the outer diameter of the balloon 174 can be greater than the smallest possible diameter in the non-expanded configuration.

[0122] In some embodiments, when the balloon 174 is substantially fully inflated, the main section 174A assumes a cylindrical shape (e.g., as shown in Figure 6 , Figure 8 and Figure 9 ). In some embodiments, when the balloon 174 is substantially fully inflated, the end section 174B assumes a frustoconical shape. However, depending on the target anatomy, other shapes can be used.

[0123] In some embodiments, the balloon 174 has an outer diameter D2 in the range of about 3 mm to about 9 mm when fully inflated.

[0124] In some embodiments, the balloon 174 has a fully inflated length L2 in the range of about 10 mm to 25 mm when fully inflated.

[0125] The balloon 174 can be formed from any suitable material. In some embodiments, the balloon 174 is formed from a high-strength but flexible polymeric material such as polyamide (e.g., nylon), PEBAX, etc. The balloon 174 can be "blow molded" to a relatively thin wall thickness and is capable of maintaining a relatively high inflation pressure from about 6 atmospheres to about 28 atmospheres.

[0126] The dilation controller 176 is operable to control the actuation of the inflation fluid source 116 to selectively force inflation fluid E through conduits 172, 170T to the balloon 174 to inflate the balloon 174, and alternatively, to allow (or force the withdrawal of) fluid flow from the balloon 174 through conduits 172, 170T to deflate the balloon 174.

[0127] In some embodiments, the dilation controller 176 is outside the instrument 120. In some embodiments, the inflation fluid source 116 is embodied in a syringe including a reservoir (supply section 116B) and a pump mechanism (pump 116A and dilation controller 176). In some embodiments, the syringe is a manual syringe. In some embodiments, the dilation controller 176 includes a closed-loop fluid pump system. An exemplary inflation device that can be used to selectively inflate the balloon 174 is described in U.S. Published Patent Application No. 2010 / 0211007, which is hereby incorporated by reference in its entirety as set forth. Other inflation devices can also be used.

[0128] According to the method of the present invention, the sinus treatment system 10 and the instrument 120 can be used as follows.

[0129] The system 10 can be established by connecting the conduits 160T, 165T, 170T to the ports 160P, 165P, 170P, respectively. The ports 160P, 165P, 170P can include disconnectable connectors. If an endoscope is to be used, the endoscope 20 can be set as needed. If a flushing step is to be performed, the conduit 165T is connected to the flushing fluid source 112. If a drug delivery step is to be performed, the conduit 165T is connected to the drug source 114.

[0130] Generally, the illumination system 150 is activated by removing the tab 151A (or operating the light-actuated switch on the instrument 120, if any), thereby allowing the battery 152 to power the LED 151. The light emitted by the LED 151 propagates through the waveguide 154 and exits the waveguide 154 through the end face 154C. Thus, the illumination function of the instrument system 100 can be selected and actuated, and can be used to perform an illumination operation (e.g., transmitted illumination) that emits light from the waveguide end face 154C.

[0131] As described above, the aspiration system 160 is actuated and deactivated using the trigger 164B. When the trigger 164B is pressed, the suction source 110 will create a negative pressure (vacuum) in the aspiration lumen 142 and at the opening 142B. The negative pressure will direct the aspiration flow through the inlet port 142B into the aspiration lumen 142 and out of the instrument 120 through the conduits 162, 160T. Thus, the aspiration function of the instrument system 100 is selected and actuated, and can be used to perform an aspiration operation. When the trigger 164B is released, the negative pressure and the aspiration flow terminate.

[0132] Using either the flush controller 168 or the drug delivery controller 169 connected to port 165P, the delivery system 165 is actuated and deactivated. Thereby, the fluid delivery function of the instrument system 100 is selected and actuated, and it can be used to perform fluid delivery options. The fluid delivery operation can be a flush fluid delivery operation and / or a drug delivery operation.

[0133] If the flush system 112 is connected, the flush controller 168 is actuated to force the flow of flush fluid I through the catheter 166, 165T, and the delivery lumen 144, and out of the probe 130 through the outlet port 144A.

[0134] If the drug delivery system 114 is connected, the drug delivery controller 169 is actuated to force the drug N to flow through the catheter 166, 165T, and the delivery lumen 144, and out of the probe 130 through the outlet port 144A.

[0135] The dilation controller 176 is used to actuate and deactivate the dilation system 170. During the inflation operation or step, the dilation controller 176 operates to force the inflation fluid E to flow through the catheter 172, 170T and into the balloon lumen 177, pressurize the inflation fluid E in the balloon lumen 177, and maintain the pressure of the inflation fluid E in the balloon lumen 177.

[0136] During the deflation operation or step, the dilation controller 176 operates to withdraw the flow of the inflation fluid E from the balloon lumen 177 through the catheter 172, 170T. Thus, the balloon 174 is depressurized and deflated.

[0137] Referring to Figure 1 and Figure 3 and, the handle 128 and the faces 129A - F provide an ergonomic shape that can be grasped by an operator (e.g., a doctor) with one hand H, like a pistol grip, to position and navigate the probe 130 into, through, and within the patient's anatomy. In use, the operator grasps the handle 128 such that the operator's palm P receives and rests on the rear face 129A, while one or more of the operator's fingers F are positioned opposite the palm P and against the front faces 129D - F. Additionally, the operator can wrap his or her thumb T around or beside the handle 128, or can place the thumb T above the shoulder 129C and on the top face 129B. One or more of the operator's fingers F can grasp the upper front face 129D, while one or more other (lower) fingers F of the operator can grasp the lower front face 129E. As discussed below, one or more of the operator's fingers F can operate the trigger 164B.

[0138] The ergonomic shape of the base 122 allows the handle to sit between the palm muscles and the opposing fingers, thereby providing an ergonomic solution for the operator to hold the handle. The device is further stabilized by positioning the thumb on top of the handle. The ergonomic shape of the base 122 can thus provide improved flexibility, balance, and stability for the operator. The ergonomic shape of the base 122 enables the operator to hold the instrument 120 with one hand to effectively manipulate, position, and operate the instrument 120.

[0139] As discussed herein, the ergonomic shape also enables the operator to conveniently control aspiration through the instrument 120 using the trigger. The trigger 164B is ergonomically positioned for actuation using the index finger and / or middle finger.

[0140] In some embodiments, one or more control mechanisms (e.g., buttons or switches) may be provided on the shoulder 129C or the top surface 129B. The design of the base 122 also enables the operator to conveniently and effectively access and actuate these mechanisms with the thumb of the hand that holds the base 122.

[0141] Typically, the probe 120 will be inserted into the patient through the nostril and guided to the target area of the patient's anatomy with the balloon 174 in its deflated configuration. Typically, during these steps, the light source 151 is activated to provide light to observe the surgical area through the endoscope 20 and / or to provide transillumination through the patient's tissue. The operator can monitor the transillumination light from outside the patient to identify the position of the probe tip 138A relative to known anatomical features of the patient.

[0142] Before inserting the probe 120 into the patient, the probe 120 can be bent as described above.

[0143] The irrigation system 165 can be used to flow or spray irrigation fluid onto the endoscope 20 to clean the lens 22 of the endoscope. Advantageously, the instrument 120 can be used in this manner to clean the endoscope 20 without the need to remove the endoscope or the instrument 120 from the patient.

[0144] According to the method of the present invention, the sinus treatment system 10 and the instrument 120 can be used to perform surgical and therapeutic procedures (e.g., balloon sinuplasty) using one or more of the operations or steps and functions described above. That is, for a given procedure, the operator can use the instrument 120 to aspirate, irrigate, deliver drugs, dilate, and / or illuminate as described. Each of these operations or steps can be performed in a selected combination of operations or steps.

[0145] The aspiration, delivery, dilation, and / or illumination functions and operations can be employed and performed independently of each other. Thus, for a given procedure, one or more of these operations can be omitted (i.e., the function is not used). One or more operations can be performed simultaneously. One or more operations can be performed sequentially.

[0146] Each of the aspiration, delivery, dilation, and illumination operations can be performed without removing the probe 130 from the patient between different functions and without replacing components within or on the probe. For example, it is not necessary to remove and reconfigure the probe 130 between the irrigation and aspiration steps. However, it may be necessary or desirable to remove the probe 130 from the patient in order to reconfigure the instrument 120 between the irrigation fluid delivery and drug delivery operations.

[0147] The illumination function of the instrument 120 can be used in combination with any of the functions or methods described below.

[0148] The aspiration function and operation can be used to aspirate fluid and / or debris from the surgical site (e.g., the paranasal sinuses). The fluid can include fluid that has been introduced into the surgical site by the operator (e.g., irrigation fluid and / or drugs) or fluid or debris originating from the patient (e.g., mucus or blood). In this way, the aspiration function can be used to remove undesirable materials (e.g., infectious or obstructive materials) and clear the field of view for visualization. For example, during this procedure, the aspiration function and operation can be used to remove bleeding caused by mucosal trauma or mouth dilation, which otherwise could obscure the surgeon's endoscopic view and thus impede the procedure.

[0149] In some procedures, the system 10 and instrument 120 are used to dilate a portion of the patient's anatomy using balloon dilation as follows. The balloon 174 is held in or placed in a non-inflated configuration using the inflation controller 176. With the balloon 174 deflated, the probe 130 is navigated to a location within the patient's anatomy (e.g., the paranasal sinuses). Then, when in the selected location, the balloon 174 is inflated to an inflated configuration using the inflation controller 176. Thus, the patient's anatomy is dilated and treated by the inflation of the balloon 174. Thereafter, the balloon 174 is deflated to a non-inflated configuration using the inflation controller 176 and removed from the patient. This dilation procedure can be supplemented with aspiration, delivery (irrigation fluid and / or drugs), and illumination steps that are performed simultaneously with or in any selected order with respect to the dilation step.

[0150] In some procedures, the system 10 and instrument 120 are used only to aspirate using the aspiration function.

[0151] In some procedures, the system 10 and the instrument 120 are used to occlude or block the passage of a patient's anatomical structure with an inflated balloon 174 and then use a suction function to aspirate a region (the "occluded region") that is partially or completely sealed by the occluded passage. In some procedures, the occluded passage is the ostium or frontal recess, and the occluded region is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0152] In some procedures, the system 10 and the instrument 120 are used to inflate the balloon 174 in a region of the patient's anatomical structure while aspirating using the suction function.

[0153] In some procedures, the system 10 and the instrument 120 are only used to irrigate using an irrigation delivery function.

[0154] In some procedures, the system 10 and the instrument 120 are used to occlude or block the passage of a patient's anatomical structure with an inflated balloon 174 and then use an irrigation delivery function to irrigate a region (the "occluded region") that is partially or completely sealed by the occluded passage. In some procedures, the occluded passage is the ostium or frontal recess, and the occluded region is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0155] In some procedures, the system 10 and the instrument 120 are used to inflate the balloon 174 in a region of the patient's anatomical structure while irrigating using the irrigation function.

[0156] In some procedures, the system 10 and the instrument 120 are only used to deliver a drug using a drug delivery function.

[0157] In some procedures, the system 10 and the instrument 120 are used to occlude or block the passage of a patient's anatomical structure with an inflated balloon 174 and then use a drug delivery function to deliver a drug to a region (the "occluded region") that is partially or completely sealed by the occluded passage. In some procedures, the occluded passage is the ostium or frontal recess, and the occluded region is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0158] In some procedures, the system 10 and the instrument 120 are used to inflate the balloon 174 in a region of the patient's anatomical structure while delivering a drug using the irrigation function.

[0159] In some procedures, the system 10 and the instrument 120 are used to irrigate using the irrigation delivery function and then aspirate using the suction function.

[0160] In some procedures, the system 10 and the instrument 120 are used to occlude or block the passage of a patient's anatomical structure with an inflated balloon 174, and then using a flushing delivery function, flush the area that is partially or completely sealed by the blocked passage ("occluded area") and then aspirate the occluded area using an aspiration function. Aspiration can remove the flushing fluid from the occluded area. In some procedures, the blocked passage is the ostium or frontal recess, and the occluded area is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0161] In some procedures, the system 10 and the instrument 120 are used to aspirate the area that is partially or completely sealed by the blocked passage ("occluded area") using an aspiration function and then flush the occluded area using a flushing delivery function after occluding or blocking the passage of a patient's anatomical structure with an inflated balloon 174. The procedure may also include aspirating the occluded area again using the aspiration function to remove the flushing fluid. In some procedures, the blocked passage is the ostium or frontal recess, and the occluded area is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0162] In some procedures, the system 10 and the instrument 120 are used simultaneously to aspirate using the aspiration function and flush using the flushing delivery function.

[0163] In some procedures, the system 10 and the instrument 120 are used to plug an area of a patient's anatomical structure with an inflated balloon 174 and then simultaneously aspirate and flush the occluded area.

[0164] In some procedures, the system 10 and the instrument 120 are used to occlude or block the passage of a patient's anatomical structure by an inflated balloon 174 and then use the aspiration and flushing functions to simultaneously aspirate and flush the area that is partially or completely sealed by the occlusion of the passage ("occluded area"). In some procedures, the blocked passage is the ostium or frontal recess, and the occluded area is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0165] In some procedures, the system 10 and the instrument 120 are used to deliver a drug using a drug delivery function and then aspirate using the aspiration function.

[0166] In some procedures, the system 10 and the instrument 120 are used to occlude or block the passage of a patient's anatomical structure with an inflated balloon 174 and then use a delivery function to deliver a drug to the area that is partially or completely sealed by the blocked passage ("occluded area") and then aspirate the occluded area. Using the aspiration function, aspiration can remove the excess drug from the occluded area. In some procedures, the blocked passage is the ostium or frontal recess, and the occluded area is the sinus adjacent to and in fluid communication with the ostium or frontal recess.

[0167] In some procedures, the system 10 and the instrument 120 are used to aspirate using an aspiration function and then to deliver a drug using a drug delivery function. The procedure may also include aspirating a blocked area again using the aspiration function to remove an excess of the drug.

[0168] In some procedures, the system 10 and the instrument 120 are used to occlude or block a passageway of a patient's anatomy with an inflated balloon 174, and then to aspirate a region (a "blocked region") that is partially or completely sealed by the blocked passageway using an aspiration function and then to deliver a drug to the blocked region using an irrigation delivery function. The procedure may also include aspirating the blocked region again using the aspiration function to remove an excess of the drug. In some procedures, the blocked passageway is the ostium or the frontal recess, and the blocked region is a sinus that is adjacent to and in fluid communication with the ostium or the frontal recess.

[0169] In some procedures, the system 10 and the instrument 120 are used to aspirate using an aspiration function and simultaneously to deliver a drug using a drug delivery function.

[0170] In some procedures, the system 10 and the instrument 120 are used to occlude or block a passageway of a patient's anatomy with an inflated balloon 174, and then to aspirate and deliver a drug to a region (a "blocked region") that is partially or completely sealed by the blockage of the passageway using an aspiration and delivery function. In some procedures, the blocked passageway is the ostium or the frontal recess, and the blocked region is a sinus that is adjacent to and in fluid communication with the ostium or the frontal recess.

[0171] Each of the foregoing procedures may also be modified to include inflating the balloon 174 simultaneously with one or more of the aspiration and fluid delivery steps. The step of inserting or modifying the patient's anatomy by inflating the balloon may be performed simultaneously with or independently of other steps or functions (i.e., aspiration, fluid delivery, and illumination) performed using the instrument 120.

[0172] Now will refer to Figures 12A - 12F Describe an exemplary method of use in accordance with some embodiments.

[0173] The system 10 and the balloon dilation catheter instrument 120 may be particularly adapted for the treatment of the sinus outflow tract.

[0174] Figure 12A A cross-sectional (coronal) view of the maxillary sinus and other associated anatomy of a subject (i.e., a patient undergoing treatment) is shown.

[0175] Figure 12A A cross-sectional (coronal) view of the maxillary sinus of a subject is shown, wherein the probe 130 (balloon dilation catheter) of the instrument 120 is advanced in the nasal cavity of the subject toward the treatment target region.

[0176] Figure 12BA cross-sectional (coronal) view of a subject's maxillary sinus is shown, where the balloon 174 of the instrument 120 is in a deflated or non-inflated state and is located in the ostium of the subject's maxillary sinus.

[0177] Figure 12C A cross-sectional (coronal) view of a subject's maxillary sinus is shown, where the balloon 174 of the instrument 120 is in an inflated or expanded state at the ostium of the subject's maxillary sinus. The balloon 174 has been inflated using the dilation system 170.

[0178] Figure 12D A cross-sectional (coronal) view of a subject's maxillary sinus is shown, where the balloon 174 of the instrument 120 is in an inflated or expanded state in the ostium of the subject's maxillary sinus, and the maxillary sinus is being irrigated and aspirated simultaneously using the aspiration system 160 and the delivery system 165. By keeping the balloon 174 inflated during this process, little fluid flows out of the ostium of the maxillary sinus and into the nasal cavity and nasopharynx. This allows substantially all of the irrigation fluid to be withdrawn from the maxillary sinus.

[0179] Figure 12E A cross-sectional (coronal) view of a subject's maxillary sinus is shown, where the balloon 174 of the instrument 120 is in an inflated or expanded state in the ostium of the subject's maxillary sinus, and a drug is being applied to the maxillary sinus using the delivery system 165. By keeping the balloon 174 inflated during this process, little drug moves out of the maxillary sinus.

[0180] Figure 12F A cross-sectional (coronal) view of the dilated ostium of the maxillary sinus of a subject is shown after a balloon dilation procedure using the balloon 174.

[0181] Figure 13A A cross-sectional (sagittal) view of the frontal sinus and other associated anatomical structures of a subject (i.e., the patient undergoing treatment) is shown.

[0182] Figure 13A A cross-sectional (sagittal) view of the frontal sinus of a subject is shown, where the probe 130 of the instrument 120 is advanced anteriorly in the nasal cavity of the subject towards the frontal recess.

[0183] Figure 13B A cross-sectional (sagittal) view of the frontal sinus of a subject is shown, where the balloon 174 of the instrument 120 is in a deflated or non-inflated state and is located at the frontal recess of the subject.

[0184] Figure 13C A cross-sectional (sagittal) view of the frontal sinus of a subject is shown, where the balloon 174 of the instrument 120 is in an inflated or expanded state at the frontal recess of the subject.

[0185] Figure 13DA cross-sectional (sagittal) view of a subject's maxillary sinus is shown, where the balloon 174 of the instrument 120 is in an inflated or expanded state at the subject's frontal recess, and the frontal sinus is flushed and aspirated simultaneously using the aspiration system 160 and the delivery system 165. During this procedure, by keeping the balloon inflated, little fluid flows out of the frontal recess and into the nasal cavity and nasopharynx. This allows all the flushing fluid to be aspirated from the frontal sinus.

[0186] Figure 13E A cross-sectional (sagittal) view of a subject's frontal sinus is shown, where the balloon 174 of the instrument 120 is in an inflated or expanded state at the subject's frontal recess, and a drug is administered to the frontal sinus using the delivery system 165. By keeping the balloon inflated during this procedure, little drug moves out of the frontal sinus.

[0187] Figure 13F A cross-sectional (sagittal) view of the expanded frontal recess is shown after a balloon dilation procedure using the balloon 174.

[0188] During use, the probe 130 is maneuvered and advanced through or into the relevant anatomical space. As shown in Figure 12A 、 Figure 12B 、 Figure 13A and Figure 13B the balloon 174 is typically in a deflated state during the movement or navigation of the probe 130 to the appropriate position and when the instrument 120 is used in steps that do not require an inflated balloon 174. After the probe 130 is correctly positioned in the sinus ostium or sinus outflow pathway, the balloon 174 is inflated.

[0189] During this procedure, any bleeding caused by mucosal trauma or ostium dilation may obscure the surgeon's endoscopic view, thus hindering the procedure. The system 100, instrument 120 and method of the present invention provide a mechanism for aspirating mucus present in the sinus and a mechanism for flushing the diseased sinus, as well as the ability to perform the two activities simultaneously or independently as needed.

[0190] Unlike known devices that are held between the thumb and index finger of the operating surgeon like a design imaging pen, with the device placed in the interdigital space between the thumb and index finger, the instrument 120 has a more ergonomic design. The ergonomic design of the instrument 120 aligns the main load of the instrument with the weight-bearing muscles of the operator's arm. Compared with the "pen"-type device, this reduces the inappropriate weight pressure on the surgeon's forearm and wrist, which can reduce or prevent wrist cramps. Additionally, the ergonomic design of the instrument 120 expands the operator's range of motion.

[0191] In most, if not all, cases, the use of the probe 130 made of a rigid but malleable material enables the balloon dilation catheter 120 to be positioned without the need for a separate guiding catheter or guide wire.

[0192] The inhalation or aspiration function allows for the removal of blood and other secretions, which makes it easier to visualize the placement of the balloon dilation catheter 120 during the procedure using the endoscope.

[0193] The inhalation or aspiration system 160 can be used to inhale or aspirate blood or other secretions. The delivery system 165 can be used to deliver fluids and / or medications to the nasal cavity. By providing separate, coexisting catheters for aspiration and delivery in the instrument 120 and the probe 130 respectively, the instrument enables simultaneous aspiration and irrigation. This prevents the irrigation fluid from flooding the operative area. Additionally, thick secretions can be diluted by irrigation and diluted to a degree sufficient to be inhaled / aspirated in the aspiration catheter. This can keep the endoscope line of sight in the operative area clear and the anatomical structures visible.

[0194] The different shapes of the probe 130 can be formed into a specific shape at the factory and provided as different models when fully assembled. Alternatively, the probe 130 can be one of a set of replaceable, interchangeable, or modular elements that can be installed within the handle 128 using a sliding and press-fit seal arrangement. In yet another alternative, the shape of the probe 130 can represent a desired shape that the user can form with a deployable inner guiding member to better fit a specific application or the anatomy of the subject.

[0195] The light emitted from the distal end of the waveguide 154 at the distal end of the probe 130 can be used to guide the correct placement of the probe 130. In particular, the light can provide transmitted illumination through the patient's tissue, which the surgeon can observe and use to determine the position of the tip 138A relative to the patient's anatomy. Moreover, the light emitted from the distal end of the waveguide 154 can help illuminate the surgical area for viewing through the endoscope 20.

[0196] In other embodiments, the shaft 132 can include aspiration lumens, delivery lumens, and waveguide lumens with cross-sectional shapes different from the cross-sectional shapes shown for the lumens 140, 142, 144. For example, Figure 14 An alternative shaft 132' is shown, which includes a waveguide lumen 140', an aspiration lumen 142, and an irrigation lumen 144.

[0197] In other embodiments, the inflation catheter 172 can be replaced with a tubular sheath that wraps around the shaft 132 and forms an inflation channel in the space between the outer diameter of the sheath and the shaft 132. In this case, the sheath can be substantially non-expandable or relatively non-expandable compared to the balloon 174.

[0198] In a further embodiment, the inflation catheter 172 and the balloon 174 can be replaced with a self-sealing balloon component as described below with respect to the balloon component 373.

[0199] Refer toFigures 15 - 21 , which shows a sinus treatment system 30 according to another embodiment of the present invention. The system 30 includes a sinus treatment instrument system 300 and an optional endoscope 20. The system 30 and the instrument system 300 can be used in the same manner as the system 10 and the instrument system 100. However, the structure of the instrument system 300 is different from that of the instrument system 100.

[0200] The instrument subsystem 300 includes a hand-held instrument 120, a suction (negative pressure or vacuum) source 110, a flushing fluid source 112, a drug source 114, and an inflation fluid source 116.

[0201] The instrument 320 is a balloon dilation catheter device, which includes the same functional features and mechanisms in addition to the dilation function described for the instrument 100. The instrument 120 includes a hand-held unit or base 322, a probe (or guiding member or extension assembly) 330, a lighting system 350, a suction system 360, a delivery system 365, and a dilation system 370, which are constructed and operated in the same manner as the base 122, the probe 130, the lighting system 150, the suction system 160, the delivery system 165, and the dilation system 170, except as discussed below. The instrument 320 has a proximal end 320A and a distal end 320B that define a main axis or longitudinal axis LL.

[0202] The probe 130 includes an elongated tubular shaft 332, which defines a longitudinal probe axis P-P extending from a proximal end 332A to a distal end 332B. The probe axis P-P is substantially parallel to the instrument axis L-L. The shaft 332 includes a dilator section 336, an intermediate section 337, and a distal section 338. The distal section 338 terminates at a distal end 338A.

[0203] The shaft 332 has an outer surface 334A and an inner surface 334B. In some embodiments, the outer surface 334A and the inner surface 334B are substantially cylindrical. The inner surface 334B defines an axially extending shaft passage or lumen 333. The shaft lumen 333 extends completely from a proximal opening 333A in the end 332A to a distal opening 333B in the end 332B.

[0204] The shaft 332 can be formed of any suitable material. In some embodiments, the shaft 332 is formed of a stainless steel hypotube.

[0205] In some embodiments, the shaft 332 is integral. In some embodiments, the shaft 332 is integrally formed. In some embodiments, the shaft 332 is monolithic. The shaft 332 can be molded (e.g., injection molded) or extruded.

[0206] In some embodiments, the shaft 332 is formed of a rigid but malleable material. This allows the shaft 332 to be intentionally bent into a new shape or configuration in response to the application of sufficient bending force and to maintain the original or new shape or configuration when a lesser force is applied to the shaft 332. In some embodiments, the bending force required is greater than any force that the shaft 332 is expected or intended to experience during use during a surgical procedure, i.e., while navigating or using the probe 320 within a patient's anatomy. The malleability of the shaft 332 enables the user to bend the shaft 332 into a desired angle or curvature to achieve proper positioning of the balloon 374 and the distal tip 338A within the sinus ostium or sinus drainage pathway.

[0207] In some embodiments, the shaft 332 is preformed to have a curved distal portion. The curved distal portion may be configured to match the frontal sinus outflow tract or the frontal recess.

[0208] In some embodiments, the distal portion of the shaft 332 is formed on the right side of the distal end 332B and may have a radius of curvature in the range of about 0.25 inches to about 1.5 inches, and in some embodiments, in the range of about 0.75 inches to about 1.25 inches.

[0209] The shaft 332 extends from the base 322 to the distal end 332B a predetermined or specified distance or length L3( Figure 15 ). In some embodiments, the length L3 is in the range of about 3 to 10 inches, and in some embodiments, in the range of about 5 to 7 inches.

[0210] In some embodiments, the outer diameter of the probe 330 is in the range of about 1 to 5 mm, and in some embodiments, in the range of about 3 to 7 mm.

[0211] In some embodiments, the nominal wall thickness T3( Figure 19 ) of the shaft 332 is in the range of about 0.1 to 0.3 mm, and in some embodiments, in the range of about 0.2 to 0.5 mm.

[0212] In some embodiments, the outer diameter of the distal tip 338A is in the range of about 1 to 3 mm, and in some embodiments, in the range of about 2 to 5 mm.

[0213] In some embodiments, the edge of the tip 338A is rounded or smooth to prevent or reduce trauma to the sinus mucosa.

[0214] The aspiration system 360 includes an aspiration catheter 362 that replaces catheter 162. The catheter 362 extends through the handle 328. The proximal end of the catheter 362 is fluidly connected to the inhalation port 360P. The distal end of the catheter 362 is fluidly coupled to the proximal opening 333A of the shaft lumen 333 and is thus coupled to the annular aspiration lumen 363, as discussed below. The catheter 362 also includes an integral tubular faucet or receiver leg 362A. A receiver port 362B is defined in the leg 362A and is also fluidly connected to the proximal opening 333A.

[0215] The aspiration catheter 362 can be formed from any suitable material. In some embodiments, the catheter 362 is formed from an elastomeric material. In some embodiments, the catheter 362 is formed from a flexible material. Suitable materials for the catheter 362 can include, for example, silicone.

[0216] The delivery system 365 includes a catheter 366. The catheter 366 defines a longitudinally extending delivery lumen 367 that terminates at a distal opening 367B.

[0217] The delivery catheter 366 extends from the delivery port 365P, through the handle 328, through the receiver port 362B, through the distal portion of the catheter 362, through the shaft lumen 333, and the distal end 332B. In some embodiments, the end opening of the delivery catheter 366 and the distal opening 367B are substantially located at the distal opening 333B.

[0218] In some embodiments, a fluid-impermeable seal is provided between the catheter 366 at the port 366B and the catheter 362.

[0219] The delivery catheter 366 can be formed from any suitable material. In some embodiments, the catheter 366 is formed from an elastomeric material. In some embodiments, the catheter 366 is formed from a flexible material. Suitable materials for the catheter 366 can include, for example, silicone.

[0220] The dilation system 370 includes a balloon component 373 that replaces catheter 172 and balloon 174. The balloon component 373 is a self-sealing balloon unit. The balloon component 373 includes a catheter 372, an integral dilation section 374, and an integral non-dilation section 375.

[0221] The dilation section 374 is a balloon. The balloon 174 is doughnut-shaped and includes a tubular inner wall 374A and a tubular outer wall 374B that radially define a closed annular balloon chamber 374C therebetween.

[0222] The non-dilation section 375 includes a tubular inner wall 375A and a tubular outer wall 375B that radially define a closed annular inflation passage 375C therebetween. The passage 375C fluidly connects the catheter 372 to the balloon chamber 374C.

[0223] The balloon 374 is installed near the distal end 332B. The balloon member 373 can be coupled to the shaft 332 using welding, adhesives, etc. Alternatively, the balloon 374 can be fixed to the shaft 332 using a mechanical connection.

[0224] The dilation system 370 is configured to selectively inflate and deflate the balloon 374 according to the needs of the operator (as described above for the balloon 174). The balloon 374 is flexible and expandable when inflated. The dilation system 170 is operable to alternately place the balloon 374 in at least a first relatively radially non-expanded configuration (herein, the non-expanded position) and a second radially expanded configuration (herein, the expanded configuration). In the expanded configuration, the outer diameter D4 of the balloon 374 ( Figure 18 ) is larger than in the deflated configuration.

[0225] The non-dilation section 375 is non-expandable or expands less than the balloon 374 such that when the balloon 374 is inflated and expanded, the non-dilation section 375 will not expand radially or will expand to a substantially lesser extent than the balloon 374.

[0226] In some embodiments, and as will be appreciated from the description herein, the dilation system 370 is operable to place the balloon 374 within a range of different expanded configurations. That is, the balloon 374 can be forced to assume one of a plurality of different expanded configurations each having a different outer diameter D4.

[0227] In some embodiments, and as will be appreciated from the description herein, the non-expanded configuration of the balloon 374 may not be a completely non-expanded or deflated configuration. That is, the outer diameter of the balloon 374 can be greater than the smallest possible diameter in the non-expanded configuration.

[0228] In some embodiments, when the balloon 374 is substantially fully inflated, the main section 374A has a frustoconical shape.

[0229] In some embodiments, the balloon 374 has the size as described above for the balloon 174.

[0230] The balloon 374 can be formed of any suitable material. In some embodiments, the balloon 374 is formed of the materials as described above for the balloon 174 and / or using the techniques as described above for the balloon 174.

[0231] As Figure 18 and Figure 19 shown, a longitudinally extending space 353 is defined between the outer surface 334A of the shaft 332 and the inner wall 374A of the balloon member 373.

[0232] The integrated illumination system 350 includes a waveguide 354 constructed and operating in the same manner as waveguide 154. In some embodiments, the waveguide 354 is an optical fiber (e.g., a polymer or glass optical fiber) and may include a sheath to protect the waveguide and prevent light loss. The waveguide 354 extends from a light source 351 and longitudinally through a space 353 to a waveguide distal end 354B adjacent to the distal end 332B of the shaft. The waveguide 354 has an end face 354C at the distal end 354B from which light is emitted. In some embodiments, the waveguide distal end 354B is positioned substantially flush with the distal end 332B. In other embodiments, the waveguide distal end 354B extends outwardly beyond the distal end 332B by a distance in the range of about 1 to 5 cm.

[0233] As can be seen in Figure 19 the shaft 332 and the delivery catheter 366 nested therein define generally concentric aspiration and delivery lumens. In particular, the delivery catheter 366 defines an internal or generally central delivery lumen 367. The shaft 332 and the delivery catheter 366 define an annular aspiration lumen that radially surrounds but is fluidly separated or isolated from the delivery lumen 367.

[0234] In some embodiments and as shown in Figure 19 the lumens 363 and 367 may have different cross-sectional areas from each other. In some embodiments, the cross-sectional area of the aspiration lumen 363 is greater than the cross-sectional area of the delivery lumen 367. In some embodiments, the cross-sectional area of the aspiration lumen 363 is at least 1.5 times the cross-sectional area of the delivery lumen 367. In some embodiments, the cross-sectional area of the aspiration lumen 363 is in the range of about 2 to 4 times the cross-sectional area of the delivery lumen 367.

[0235] In some embodiments, the cross-sectional area of the aspiration lumen 363 is in the range of about 0.28 to 1.75 mm 2 2.

[0236] In some embodiments, the cross-sectional area of the delivery lumen 367 is in the range of about 0.07 to 0.8 mm 2 2.

[0237] In an alternative embodiment, the instrument 320 is modified such that the internal lumen 367 is used for aspiration and the external lumen 363 is used for delivering fluid (e.g., irrigation fluid and / or drug).

[0238] A balloon inflation device and method according to embodiments of the present invention can be used to treat diseased paranasal sinuses. More particularly, embodiments can provide a minimally invasive balloon-based system and method for dilating the ostia or drainage pathways of the human paranasal sinuses in the treatment of chronic sinusitis and other related diseases.

[0239] In some embodiments, the balloon dilation device includes a handle shaped like a pistol grip, a rigid shaft coupled to an inflatable balloon, the rigid shaft having a plumbing system for simultaneously aspirating, irrigating, and / or delivering a drug by positioning the balloon at the ostium and drainage pathway of the sinus to surgically dilate an anatomical constriction of the paranasal sinuses (i.e., the maxillary, frontal, and sphenoid sinuses). The balloon is inflated to expand or reshape the drainage pathway.

[0240] In some embodiments, there is provided a device for balloon dilation of an anatomical constriction of a human paranasal sinus, for delivering a drug to the paranasal sinus, and for collecting fluid or tissue samples from the paranasal sinus for diagnostic purposes. A device for dilating an ostium of a paranasal sinus may include: a handle shaped to be stabilized using the palm and juxtaposed fingers; an elongate shaft that is easily molded, having a proximal end coupled to the handle and extending to a distal end; and a dilator balloon mounted on the shaft and having a non-inflated configuration and an inflated configuration.

[0241] In some embodiments, a device includes: an ergonomically designed handle piece; a rigid probe coupled to an inflatable balloon on an outer surface of the probe; and a tube system on an inner side of the probe to carry an optical fiber from a light source housed in the handle piece; and a system of conduits and valves that allows simultaneous aspiration and irrigation, independent of the inflation state of the balloon. The handle piece may be configured to be held by an operating surgeon in his palm such that the handle is positioned between the muscles of the palm and opposite the four fingers, with the index finger controlling an inhalation trigger. The handle piece is further secured from the top by the thumb. This results in a weight distribution of the system that is aligned with the muscle axis of the arm. The rigid probe may be bent at various angles to navigate the sinus passageway and assist in positioning the balloon in the correct location. The curvature and longitudinal position of the bent section are configured by the operating surgeon.

[0242] In some embodiments, the balloon 174 is coated with one or more drugs at one or more predetermined locations along the length of the balloon 174. This enables delivery of the drug to the area or sinus dilated by the balloon 174.

[0243] Because the size of the sinus ostium and the depth of the sinus are different for the maxillary / frontal / sphenoid sinuses, resulting in different portions of the balloon 174 contacting the maxillary, frontal, and sphenoid sinuses respectively, the balloon 174 may be coated with drugs at three different locations on the balloon 174, and these drugs may be transferred to the corresponding sinus ostia.

[0244] It will be appreciated that the system 10 may include some components, such as a vacuum pump, reservoirs for dispensing and collecting fluids, a power source, pumps, hydraulic cylinders, pressure sensors, flow control valves, and / or electronic controls, as components or supplements to the suction source 110, irrigation fluid source 112, drug source 114, aspiration system 160, delivery system 165, and dilation system 170.

[0245] In some embodiments, the luer lock connectors of ports 160P, 165P, 170P are recessed into the profile of the handle 128.

[0246] According to additional embodiments, the dilation system may include a trigger or other control mechanism integral with and on the handle 128 and operable selectively to inflate and deflate the balloons 174, 374. In some embodiments, an inflation mechanism (e.g., a pump or syringe) and / or an inflation fluid reservoir is integrated into the handle 128.

[0247] According to additional embodiments, the delivery system may include a trigger or other control mechanism integral with and on the handle 128 and operable selectively to control the delivery of fluid (e.g., flush fluid and / or drug) through the delivery lumens 144, 367. In some embodiments, a delivery mechanism (e.g., a pump or syringe) and / or a fluid reservoir (e.g., containing flush fluid and / or drug) is integrated into the handle 128.

[0248] In some embodiments, the instruments 120, 320 may include one or more interchangeable or replaceable modular components. For example, the instrument 120 may be configured such that the probe 130 is releasably coupled to the base 122. After the instrument 120 has been used to perform a procedure, e.g., the probe 130 may be removed and discarded, recycled, cleaned, or sterilized. A new probe 130 may then be mounted on and coupled to the base 122, and the base 122 may be reused with the new probe 130 for another procedure. Thus, an instrument according to some embodiments (e.g., instrument 120 or instrument 320) may include a combination of reusable and disposable components.

[0249] According to some embodiments, the balloons 174, 374 of each instrument 120, 320 are substantially non-compliant. That is, the ability of the balloon material to stretch beyond a specified inflated size as pressure increases and thus further expands the balloon size is very small. The balloon may be crimped and wrapped around the shafts 132, 332 in its deflated position to provide a small initial deflated balloon profile. When the balloon is inflated, it will unwind to its initial fully inflated balloon diameter. Then, within a very small range of plastic deformation, the balloon may be further inflated under additional pressure (via pressurized fluid). The nominal diameter of the balloon (i.e., the nominal diameter of the inflated balloon measured at a specified pressure) may be set at a pressure between the pressure required to fully inflate and unwind the crimps of the balloon and the pressure that causes the balloon to burst (“rated burst pressure”). Relatively high balloon inflation pressures may be required as described herein to provide sufficient force against the sinus anatomy and in particular to push tissue posteriorly and disrupt small bones in the sinus.

[0250] In some embodiments, during a procedure on a patient, balloons 174, 374 are inflated multiple times to perform multiple dilation procedures as described herein. These multiple balloon dilations can be applied to the same anatomical structure or different locations within a sinus.

[0251] In some embodiments, instruments 120, 320 are configured and used to deliver a drug (e.g., a pharmaceutical formulation in solution, suspension, or emulsion) through balloons 174, 374. In this case, the drug can be contained within the inflation fluid. When the balloon is pressurized and inflated, a portion of the inflation fluid will exude or clear from the balloon (e.g., through micropores) and flow onto the surrounding anatomical structure. In this case, a portion of the balloon wall can be formed by a microporous membrane through which the drug can pass.

[0252] Aspects of some embodiments include:

[0253] Aspect 1. A device for dilating paranasal sinus ostia and sinus outflow pathways, comprising: a rigid and extensible guiding member having a proximal end and a distal end; a guiding member connected to a balloon on its outer surface, the lumen of the guiding member having an inner cannula for aspiration / suction, fluid, or drug delivery, and an optical fiber connected to a light source, and a pistol-grip shaped handle disposed along the proximal portion of the guiding member, the handle comprising a housing for the light source and an interface for the light source to the optical fiber line, a closed fluid delivery system that terminates distally at the proximal end of the guiding member and proximally at three separate conduits that can be operated independently and simultaneously without the operation of one affecting the other.

[0254] Aspect 2. The device of Aspect 1, wherein the rigid guiding member includes a lumen along its length.

[0255] Aspect 3. The device of Aspect 2, further comprising an inner cannula system within the length of the lumen of the rigid guiding member. The inner cannula performs independent and simultaneous functions of aspiration / suction, fluid, or drug delivery and provides a pathway for the optical fiber line that carries light from a light source housed in the handle of the device of Claim 1 and terminates distally at the distal end of the rigid guiding member.

[0256] Aspect 4. The device of Aspect 1, wherein the distal end of the substantially rigid guiding member is extensible enough to bend at various angles and shapes according to the anatomical structure and the operator's preference.

[0257] Aspect 5. The device of Aspect 4, wherein the distal end of the rigid member terminates in a hollow spherical tip to allow not only a non-invasive procedure but also independent and simultaneous functions of aspiration / suction, fluid, or drug delivery according to the operator's needs.

[0258] Aspect 8. The device of Aspect 1, wherein the inflation lumen of the balloon is coupled to the surface of the guiding member.

[0259] Aspect 9. The apparatus of aspect 1, wherein the inflation lumen of the balloon is fluidly connected to the interior of the balloon at its distal end and to an inflation port proximally.

[0260] Without departing from the spirit and scope of the present invention, many changes and modifications may be made by those of ordinary skill in the art given the benefits of this disclosure. Accordingly, it must be understood that the illustrated embodiments are set forth by way of example only and should not be regarded as a limitation of the present invention as defined by the appended claims. Thus, the appended claims are to be understood to include not only combinations of elements literally set forth, but also all equivalent elements for performing substantially the same function in substantially the same way to obtain substantially the same result. Accordingly, the claims are to be understood to include what is specifically shown and described above, what is conceptually equivalent, and also what incorporates the basic idea of the present invention.

Claims

1. An instrument system for treating a subject's sinus, the instrument system comprising: an instrument, the instrument comprising: a base configured to be grasped by an operator; an elongate probe, the elongate probe including a proximal end of the probe coupled to the base and extending to a distal end of the probe, the probe including: a suction lumen that terminates at an inlet port proximate the distal end of the probe; and a delivery lumen that terminates at an outlet port proximate the distal end of the probe; and an expandable balloon mounted on the probe proximate the distal end of the probe, wherein the expandable balloon is inflatable to an inflated configuration to perform an expansion operation; and a waveguide on the probe and having a light-emitting end proximate the distal end of the probe; wherein: the probe includes a rigid elongate shaft; the suction lumen and the delivery lumen extend through the shaft; the expandable balloon is mounted on the distal end of the shaft; the expandable balloon surrounds a distal portion of the shaft; and a longitudinally extending space is defined between an outer surface of the shaft and an inner wall of the expandable balloon, and the waveguide extends from a light source and longitudinally through the space to a distal end of the waveguide adjacent the distal end of the shaft.

2. The instrument system according to claim 1, wherein, the instrument comprises: an integrated illumination system, the integrated illumination system comprising: the light source; a battery that powers the light source; and the waveguide, wherein the waveguide is configured to transmit light from the light source to the light-emitting end.

3. The instrument system according to claim 2, wherein, the light source and the battery are mounted in the base.

4. The instrument system according to claim 2, wherein: the probe defines a longitudinal axis of the probe from the proximal end of the probe to the distal end of the probe; the base includes a handle configured to be grasped by the hand of the operator; and the handle has a handle axis that extends at a transverse angle to the longitudinal axis of the probe.

5. The instrument system according to claim 4, wherein, the light source and the battery are mounted in the handle.

6. The instrument system according to claim 2, wherein, the light source includes a light-emitting diode (LED).

7. The instrument system according to claim 1, wherein: the suction lumen has a first cross-sectional area; the delivery lumen has a second cross-sectional area; and the first cross-sectional area is at least 1.5 times the second cross-sectional area.

8. The instrument system according to claim 1, wherein, the instrument system comprises: a suction source fluidly connected to the suction lumen and operable to create a negative pressure in the suction lumen to perform a suction operation, wherein the instrument system sucks material through the inlet port into the suction lumen; and a flush fluid source fluidly connected to the delivery lumen and operable to perform a fluid delivery operation, wherein the instrument system causes fluid to flow through the delivery lumen and out through the outlet port.

9. The instrument system according to claim 8, wherein, The instrument system includes a suction controller that is operable to selectively control the fluid flow between the suction source and the suction lumen, wherein the suction controller is mounted on the base.

10. The instrument system according to claim 9, wherein: the probe defines a probe longitudinal axis extending from a proximal end of the probe to a distal end of the probe; the base includes a handle configured to be grasped by the operator's hand; the handle has a handle axis extending at a transverse angle to the probe longitudinal axis; and the suction controller includes a trigger that is mounted on the handle and is operable by the operator to selectively control the fluid flow between the suction source and the suction lumen.

11. The instrument system according to claim 8, wherein: the instrument system includes a suction controller that is operable to selectively control the fluid flow between the suction source and the suction lumen; the instrument system includes a delivery controller that is operable to selectively control the fluid flow between the flush fluid source and the delivery lumen; and the instrument system is operable by the operator to simultaneously perform the suction operation, the fluid delivery operation, and the illumination operation.

12. The instrument system according to claim 11, wherein: the instrument system includes a dilation controller that is operable to selectively inflate and deflate the dilation balloon; and the suction controller and the delivery controller are operable by the operator to simultaneously perform the suction operation and the fluid delivery operation when the dilation balloon is in its inflated configuration.

13. The instrument system according to claim 1, wherein: the suction lumen is defined in the shaft; the instrument includes a delivery catheter that extends through the suction lumen; and the delivery lumen is defined in the delivery catheter.

14. The instrument system according to claim 1, wherein, the shaft is extensible.

15. The instrument system according to claim 1, wherein, the instrument system further includes an endoscope.

16. The instrument system according to claim 8, wherein: the instrument system includes a suction controller that is operable to selectively control the fluid flow between the suction source and the suction lumen; the instrument system includes a delivery controller that is operable to selectively control the fluid flow between the flush fluid source and the delivery lumen; and the suction controller and the delivery controller are operable by the operator to simultaneously perform the suction operation and the fluid delivery operation.

17. The instrument system according to claim 8, wherein, the instrument system is configured to enable the operator to simultaneously perform the suction operation, the fluid delivery operation, and the illumination operation.

18. The instrument system according to claim 8, wherein, the instrument system is configured to enable the operator to perform the dilation operation simultaneously with at least one of the suction operation and the fluid delivery operation.

19. The instrument system according to claim 18, wherein, the instrument system is configured to enable the operator to simultaneously perform the dilation operation, the aspiration operation, and the fluid delivery operation.

20. The instrument system according to claim 1, wherein: the probe defines a probe longitudinal axis from a proximal end of the probe to a distal end of the probe; the base includes a handle configured to be grasped by the operator's hand; and the handle has a handle axis extending at a transverse angle to the probe longitudinal axis.

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