US20100057048A1 - Apparatus, System, and Method for Treating Atypical Headaches - Google Patents

Abstract

An apparatus, system, and method are disclosed for facilitating intranasal administration of a medication to a patient's sphenopalatine/pterygopalatine recess. The apparatus includes a catheter having a lumen disposed therethrough, the catheter comprising an insertion end and a manipulation end, the insertion end having an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane, wherein the catheter smoothly transitions between the first plane and the second plane, the intrinsic curvature conforming to a patients nasal anatomy such that the catheter may be inserted into a sphenopalatine/pterygopalatine recess. The apparatus also includes a straightening member configured to removably engage the catheter. The straightening member straightens the intrinsic curvature such that the first plane and the second plane are aligned when the catheter is engaged by the straightening member.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Patent Application No. 61/094,323 entitled “Apparatus, system and method for treating atypical headaches” and filed on Sep. 4, 2008 for Stephen Eldredge, which is incorporated herein by reference.
FIELD
• This invention relates to parasympathetic nerve blockade and more particularly relates to blockade of sphenopalatine/pterygopalatine ganglia.
BACKGROUNDDescription of the Related Art
• Sympathetic pain is a type of nerve pain that arises due to abnormalities in the function of the sympathetic nervous system. With sympathetic pain an abnormality in a group of nerves called a ganglion cause pain to an organ or body region. To treat sympathetic pain physicians can block a ganglion with the injection of medication into a specific area of the body. To therapeutically treat acute pain a physician injects a local anesthetic into the affected neuronal ganglion. This type of treatment may be referred to as a nerve block.
• The sphenopalatine/pterygopalatine ganglia is a neuronal structure located principally in the center of the head in the pterygopalatine fossa posterior to the middle turbinate. The sphenopalatine/pterygopalatine ganglia comprises the largest cluster of sympathetic neurons in the head outside of the brain. The sphenopalatine/pterygopalatine ganglia interfaces and directs nerve impulses to the majority of the head's autonomic or parasympathetic pathways. Therefore, any abnormality or injury to this structure may cause severe pain. A nerve block of the sphenopalatine/pterygopalatine ganglia is effective in relief in a variety of pain conditions ranging from headache to lower back pain. Additionally, other disease processes such as headache disorders and other neurological conditions can be arrested, or improved by local anesthetic blockade, and/or other pharmacological augmentation or mechanical alteration of the sphenopalatine/pterygopalatine ganglia and surrounding structures.
• Unfortunately, because of the anatomical position of the sphenopalatine/pterygopalatine ganglia, the structure is very difficult to block with a local anesthetic solution. The anatomical location of the sphenopalatine/pterygopalatine ganglia is dangerously close to many vital and delicate mid brain structures. Although direct needle placement can be employed under fluoroscopic guidance to administer anesthetic to the sphenopalatine/pterygopalatine ganglia, most practitioners will not attempt the procedure due to the technical difficulty and extreme dangers of an aberrant needle placement.
SUMMARY
• From the foregoing discussion, it should be apparent that a need exists for an apparatus, system, and method for treating parasympathetic nerve pain in the sphenopalatine/pterygopalatine ganglia. Beneficially, such an apparatus, system, and method would administer medication directly to the sphenopalatine/pterygopalatine ganglia.
• The present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available local anesthetic blockade methods, systems and apparatus for administering medication to a patient's sphenopalatine/pterygopalatine ganglia. Accordingly, the present invention has been developed to provide an apparatus, system, and method for performing a nerve block of the sphenopalatine/pterygopalatine ganglia that overcome many or all of the above-discussed shortcomings in the art.
• The apparatus, in one embodiment, includes a catheter, a straightening member, a spray orifice and a medication delivery port. In certain embodiments the catheter has a lumen disposed therethrough. The catheter includes an insertion end and a manipulation end. The insertion end of the catheter has an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane. The catheter smoothly transitions between the first plane and the second plane such that the intrinsic curvature is rounded and conforms to a patient's nasal anatomy. In certain embodiments the intrinsic curvature allows the catheter to be inserted into a sphenopalatine/pterygopalatine recess with minimum discomfort to the patient.
• In one embodiment the straightening member is configured to removably engage the catheter. The straightening member straightens the intrinsic curvature of the insertion end such that the first plane and the second plane are aligned when the catheter is engaged by the straightening member. Thus, with the intrinsic curvature of the catheter straightened, the catheter can easily be inserted into a patients nasal cavity.
• The spray orifice is located adjacent to the insertion end of the catheter. The spray orifice is in fluid communication with the lumen which is in communication with the medication delivery port. The medication delivery port is located adjacent to the manipulation end of the catheter and is configured to receive a medication and deliver the medication through the lumen to the spray orifice.
• The apparatus, in one embodiment, also includes a second lumen. The straightening member in certain embodiments includes a stylus configured to be received within the second lumen. In one embodiment the stylus is keyed to fit within the second lumen in one predefined orientation. In such an embodiment the stylus may identify a direction of the intrinsic curvature when the stylus is disposed within the second lumen. The stylus may also include a finger tab for manipulating the catheter.
• In another embodiment the straightening member may be a sleeve configured to receive the catheter. In such an embodiment the sleeve may be configured to straighten the intrinsic curvature of the catheter when the catheter is received within the sleeve.
• In one embodiment the apparatus may also include a rotational direction indicator that identifies a direction of the intrinsic curvature when the catheter is placed within the patient's nasal cavity. Thus, a physician may be able to identify the rotational direction of the spray orifice without being able to see the spray orifice or intrinsic curvature. Similarly, in certain embodiments the apparatus may include a depth indicator located on the catheter to identifying a defined depth. In one embodiment the defined depth is a depth equaling a distance between an entrance to a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril. In certain embodiments the apparatus includes a second depth indicator located on the catheter. The second depth indicator may identify a second defined depth. The second defined depth may be a depth equaling a distance between a location at a posterior position within a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril. In one embodiment the depth indicators are moveable on the catheter so that a physician can adjust a position of the depth indicator according to a patient's nasal anatomy. In another embodiment the depth indicators may be preposition to identify the typical distance between a patient's external opening of a nostril and the patient's sphenopalatine/pterygopalatine recess. The typical distance between a patient's external opening of a nostril and the patient's sphenopalatine/pterygopalatine recess may vary according to a patient's gender or age.
• A method of the present invention is also presented for treating migraines. The method in the disclosed embodiments substantially includes the steps necessary to carry out the functions presented above with respect to the operation of the described apparatus. In one embodiment, the method includes inserting a catheter and a straightening member into a nostril of a patient, advancing the catheter and the straightening member past a middle sinus turbinate in the nostril of the patient. The catheter includes an insertion end and a manipulation end. The insertion end has an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane. The catheter smoothly transitions between the first plane and the second plane with the intrinsic curvature conforming to a patient's nasal anatomy. This allows the catheter to easily be inserted into a sphenopalatine/pterygopalatine recess. The straightening member removably engages the catheter and straightens the intrinsic curvature of the insertion end such that the first plane and the second plane are aligned when the catheter is engaged by the straightening member.
• The method also may include removing the straightening member from the catheter such that the catheter bends in a direction towards a sphenopalatine/pterygopalatine recess of the patient and advancing the catheter into the sphenopalatine/pterygopalatine recess. In certain embodiments the method also includes dispensing a medication to a sphenopalatine/pterygopalatine ganglia disposed within the sphenopalatine/pterygopalatine recess of the patient.
• In a further embodiment, the method includes identifying a direction of the intrinsic curvature and aligning the intrinsic curvature of the catheter with the patient's sphenopalatine/pterygopalatine recess. In another embodiment the method includes identifying a defined depth of the catheter. In one embodiment the defined depth is a depth equaling a distance between an entrance to a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril.
• Reference throughout this specification to features, advantages, or similar language does not imply that all of the features and advantages that may be realized with the present invention should be or are in any single embodiment of the invention. Rather, language referring to the features and advantages is understood to mean that a specific feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, discussion of the features and advantages, and similar language, throughout this specification may, but do not necessarily, refer to the same embodiment.
BRIEF DESCRIPTION OF THE DRAWINGS
• In order that the advantages of the invention will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:
• FIG. 1 is a cutaway view illustrating one embodiment of the facial anatomy of a patient upon which the apparatus, system and method of the present invention may be employed;
• FIG. 2 is a cutaway view illustrating a prior art method of treating headaches;
• FIG. 3 is a cutaway view illustrating a prior art method of treating headaches;
• FIG. 4 is a side view illustrating one embodiment of a sphenocath apparatus for treating headaches in accordance with the present invention;
• FIG. 5A is a side view illustrating one embodiment of a sphenocath apparatus with a stylus inserted into a lumen to straighten the sphenocath in accordance with the present invention;
• FIG. 5B is a side view illustrating one embodiment of a sphenocath with a stylus partially removed from the lumen such that the sphenocath curves according to an intrinsic curvature in accordance with the present invention;
• FIG. 5C is a side view illustrating one embodiment of a sphenocath apparatus with a catheter having an intrinsic curvature received within a sleeve to straighten the intrinsic curvature in accordance with the present invention;
• FIG. 5D is a side view illustrating one embodiment of a sphenocath with a catheter having an intrinsic curvature partially removed from a sleeve such that the intrinsic curvature curves in accordance with the present invention;
• FIG. 6A is a cutaway view illustrating one embodiment of a catheter with a keyed lumen in accordance with the present invention;
• FIG. 6B is a cutaway view illustrating one embodiment of a catheter with three lumens in accordance with the present invention;
• FIG. 6C is a cutaway view illustrating one embodiment of a catheter with four lumens in accordance with the present invention;
• FIG. 7 is a cutaway view illustrating one embodiment of a sphenocath inserted within the nasal cavity of a patient in accordance with the present invention;
• FIG. 8 is a cutaway view illustrating one embodiment of a sphenocath advanced into the sphenopalatine/pterygopalatine recess of a patient in accordance with the present invention; and
• FIG. 9 is a side view illustrating one embodiment of a sphenocath apparatus for treating headaches in accordance with the present invention;
• FIG. 10 is a schematic block diagram illustrating one embodiment of a method for treating headaches in accordance with the present invention.
DETAILED DESCRIPTION
• Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
• Furthermore, the described features, structures, or characteristics of the invention may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to provide a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that the invention may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the invention.
• The schematic flow chart diagrams included herein are generally set forth as logical flow chart diagrams. As such, the depicted order and labeled steps are indicative of one embodiment of the presented method. Other steps and methods may be conceived that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the illustrated method. Additionally, the format and symbols employed are provided to explain the logical steps of the method and are understood not to limit the scope of the method. Although various arrow types and line types may be employed in the flow chart diagrams, they are understood not to limit the scope of the corresponding method. Indeed, some arrows or other connectors may be used to indicate only the logical flow of the method. For instance, an arrow may indicate a waiting or monitoring period of unspecified duration between enumerated steps of the depicted method. Additionally, the order in which a particular method occurs may or may not strictly adhere to the order of the corresponding steps shown.
• FIG. 1 is an illustration of the environment in which the present invention may be practiced. In particular,FIG. 1 depicts a cutaway view of the anatomical features of a typical human nasal cavity. One skilled in the art will recognize that certain anatomical features and structures of the human nasal cavity have been omitted to avoid obscuring the structures relevant to the practice of the current invention. To help orient the reader, themouth106 is illustrated withteeth108 andtongue110. The anatomical structures relevant to the practice of the current invention include thepalate100 which separates theoral cavity102 from thenasal cavity104, theinferior sinus turbinate112, themiddle sinus turbinate114 and thesuperior sinus turbinate116 as well as thenasal bone122. Themiddle sinus turbinate114 andsuperior sinus turbinate116 define the sphenopalatine/pterygopalatine recess118. Deep within the sphenopalatine/pterygopalatine recess118 at theposterior124 of the sphenopalatine/pterygopalatine recess118 lies the sphenopalatine/pterygopalatine ganglia120.
• One skilled in the art will recognize that the medical community is not uniform in the terminology with regard to the sphenopalatine or pterygopalatine ganglia. Certain practitioners use sphenopalatine while others use pterygopalatine. Therefore, the present description will refer to the ganglia labeled120 as the sphenopalatine/pterygopalatine ganglia120. Similarly, the recess labeled118 will be referred to as the sphenopalatine/pterygopalatine recess118. However, this terminology is in no way limiting on the structure for which the present invention is intended. Where practitioners or scientist differentiate between the sphenopalatine ganglia or the pterygopalatine ganglia, the present disclosure will be understood to apply to either structure.
• Sympathetic pain is a type of nerve pain that arises due to abnormalities in the function of the sympathetic nervous system. The majority of the “treatment resistant” headache population in the world suffers from what is now properly identified as “Sympathetic Mediated Cephalgia” a particular type of sympathetic pain. With sympathetic pain an abnormality in a group of nerves called a ganglion cause pain to an organ or body region. To treat sympathetic pain physicians can block a ganglion with the injection of medication into a specific area of the body. To therapeutically treat acute pain a physician injects a local anesthetic into the affected neuronal ganglion. This type of treatment may be referred to as a nerve block.
• The sphenopalatine/pterygopalatine ganglia120 is a neuronal structure located principally in the center of the head in the pterygopalatine fossa posterior to themiddle turbinate114. The sphenopalatine/pterygopalatine ganglia120 comprises the largest cluster of sympathetic neurons in the head outside of the brain. The sphenopalatine/pterygopalatine ganglia120 interfaces and directs nerve impulses to the majority of the head's autonomic or parasympathetic pathways. Therefore, any abnormality or injury to this structure may cause severe pain. A nerve block of the sphenopalatine/pterygopalatine ganglia120 is effective in relief in a variety of pain conditions ranging from headache to lower back pain. Additionally, other disease processes such as headache disorders and other neurological conditions can be arrested, or improved by local anesthetic blockade, and/or other pharmacological augmentation or mechanical alteration of the sphenopalatine/pterygopalatine ganglia120 and surrounding structures.
• Unfortunately, because of the anatomical position of the sphenopalatine/pterygopalatine ganglia120, the structure is very difficult to block with a local anesthetic solution. The anatomical location of the sphenopalatine/pterygopalatine ganglia120 is dangerously close to many vital and delicate mid brain structures. Although direct needle placement can be employed under fluoroscopic guidance to administer anesthetic to the sphenopalatine/pterygopalatine ganglia120, most practitioners will not attempt the procedure due to the technical difficulty and extreme dangers of an aberrant needle placement.
• As shown in the prior art illustration depicted inFIG. 2, the sphenopalatine/pterygopalatine ganglia120 lies deep within the sphenopalatine/pterygopalatine recess118. Conventional methods undertaken by pain specialists, neurologists, and neurosurgeons, include the use of an eight inch cotton-tippedapplicator200 saturated with a local anesthetic. Because a cotton-tippedapplicator200 is used, the procedure is referred to as the “Q-tip” procedure. The cotton-tippedapplicator200 is soaked in a vial of concentrated local anesthetic solution. In certain embodiments the anesthetic solution is lidocaine, cocaine, etidocaine or prilocaine, or other non-specified local anesthetic agents. The cotton-tippedapplicator200 is then advanced into thenostril202 and through thenasal cavity104. To reach the sphenopalatine/pterygopalatine ganglia120 in the sphenopalatine/pterygopalatine recess118, the cotton-tippedapplicator200 must be advanced into thenasal cavity104 past themiddle sinus turbinate114 and into the sphenopalatine/pterygopalatine recess118.
• FIG. 3 illustrates the tortuous path the cotton-tippedapplicator200 of the prior art must traverse to reach the sphenopalatine/pterygopalatine recess118. To perform the procedure the patient is placed in a supine position. The cotton-tippedapplicator200 is soaked in a vial of concentrated local anesthetic solution. The physician then inserts the cotton-tippedapplicator200 into the patients nostril202 and through thenasal cavity104. Advancing the straight, rigid cotton-tippedapplicator200 into the sphenopalatine/pterygopalatine recess118 can be difficult and painful for the patient as the cotton-tippedapplicator200 must be inserted almost parallel to the patient's face to clear theanterior ridge302 of themiddle sinus turbinate114. The cotton-tippedapplicator200 must then make an almost 90° bend to avoid theinferior surface304 of thenasal bone122 and access the sphenopalatine/pterygopalatine recess118. The cotton-tippedapplicator200 is left in the patient's sphenopalatine/pterygopalatine recess118 for approximately 20 minutes to allow diffusion of the local anesthetic through the sinus mucosa to depolarize the sphenopalatine/pterygopalatine ganglia120 to block nerve transmission.
• The use of a straight and rigid cotton-tippedapplicator200 that must make some fairly tortuous directional changes around some very sensitive, richly vascular, friable, highly innervated structures complicates the procedure to the point that many practitioners will not attempt it. Known complications include extreme patient discomfort, nosebleeds and the complications associated with nosebleeds including venous-irritating nuisances, arterial hemorrhaging, aspiration, hematochezia or even death. Other complications include local anesthetic toxicity, seizure, iatrogenic foreign bodies such as a broken cotton-tippedapplicator200, sinus mucosal tears and infection.
• Anesthetic blockade of any neuronal structure requires direct physical interaction between the anesthetic solution and the targeted tissue. Therefore, to work, the cotton-tippedapplicator200 must deliver the anesthetic solution directly to the sphenopalatine/pterygopalatine ganglion120. The correct placement of the cotton-tippedapplicator200 is technically challenging and many practitioners simply miss the desired structure, the sphenopalatine/pterygopalatine ganglion120 when attempting to perform the procedure. To help make the complicated bend required to reach the sphenopalatine/pterygopalatine recess118 many practitioners will soak the top 2 inches of the cotton-tippedapplicator200 and manipulate the stem to render it flexible so that the patient is less agitated and bleeding risks are lessened. Even with a flexible cotton-tippedapplicator200 the procedure is difficult. Common failure placements include theinferior surface304 of thenasal bone122 and theanterior ridge302 of themiddle sinus turbinate114. When the cotton-tippedapplicator200 is misplaced, a “wring-out” effect may occur wherein the anesthetic is wrung out of the cotton-tipped applicator before it is delivered to the sphenopalatine/pterygopalatine ganglion120 resulting in an ineffective procedure. Further, as discussed above, the rich vascular and neuronal structure of thenasal cavity104 makes any misplacement of the cotton-tippedapplicator200 both dangerous and painful.
• FIG. 4 illustrates asphenocath400 including acatheter402 having aninsertion end405 and amanipulation end407. In certain embodiments thecatheter402 includesmultiple lumens401 and403. Thecatheter402 has anintrinsic curvature404, aspray orifice406,depth indicators408, a straighteningmember409 such asstylus410 with apull tab412, amedication delivery port414, asyringe416, arotational direction indicator418 and arotation tab420.
• In certain embodiments thesphenocath400 comprises a soft sialasticdouble lumen catheter402 which is about 24 cm long. One of skill in the art will recognize that the length of thecatheter402 may be varied according to the anatomy of the patient. One of thelumens401 or403 is configured to deliver an anesthetic or medication to the sphenopalatine/pterygopalatine recess118. In certain embodiments theother lumen401 or403 is closed distally approximately 1.5 cm fromspay orifice406. For example, in certain embodiments lumen401 comprises a housing forstylus410 and is closed at its distal end near thespray orifice406. Thestylus410 is slideably received within thelumen401 and may be removed from within thelumen401 by pulling on thepull tab410.
• As discussed in further detail below with reference toFIGS. 7 and 8, thesphenocath400 is inserted into thenasal cavity104 of a patient lying in a supine position.Depth indicators408 identify when thesphenocath400 has been inserted into a patientsnasal cavity104 at a depth sufficient to pass themiddle sinus turbinate114. In certain embodiments additional depth indicators (not shown) may indicate a depth sufficient to identify when the tip of thesphenocath400 is within the sphenopalatine/pterygopalatine recess118. One skilled in the art will appreciate thatdepth indicators408 may vary depending on anatomical variables of the patient such as age and/or gender. Thedepth indicators408 may comprise a visual cue such as a line or other such indicator or thedepth indicators408 may comprise a physical structure configured to arrest further insertion of thesphenocath400. In certain embodiments thesphenocath400 may be individually sized to fit only one size of a patient. Thus, thesphenocath400, in certain embodiments, may comprise a large, medium or small size to be used with patients with large, medium or small anatomies. In another embodiment thedepth indicators408 are adjustable such that thedepth indicators408 can be slid along thesphenocath400 to a position which indicates a depth sufficient to identify when the tip of thesphenocath400 is within the sphenopalatine/pterygopalatine recess118 of a particular patient.
• Theintrinsic curvature404 of thecatheter402 causes thecatheter402 to bend such that theinsertion end405 of thecatheter402 lies in a first plane as indicated byline411 while themanipulation end407 of thecatheter402 lies in a second plane as indicated byline413. Thecatheter402 smoothly transitions between thefirst plane411 and thesecond plane413 such that theintrinsic curvature404 conforms to a patient's nasal anatomy. Theintrinsic curvature404 allows thecatheter402 to be inserted into a patient's sphenopalatine/pterygopalatine recess118 to direct a medication to the patient's sphenopalatine/pterygopalatine ganglia120.
• Rotational direction indicator418 identifies the rotational configuration of thesphenocath400. Because the end of thesphenocath400 has anintrinsic curvature404, it is beneficial for the physician to know which direction the curvature is pointing to manipulate thesphenocath400 into the sphenopalatine/pterygopalatine recess118. In certain embodiments therotational direction indicator418 is configured to signal the physician that theintrinsic curvature404 and thus thespray orifice406 is pointing in a downward angle when therotational direction indicator418 is pointing up. While the embodiment illustrated inFIG. 4 shows therotational direction indicator418 as a separate structure, one skilled in the art will recognize that the rotational direction may simply be a line on top of the sphenocath indicating which direction thespray orifice406 is pointing. In one embodiment, such as the embodiment shown inFIG. 4, therotational direction indicator418 may also comprise arotation tab420 to assist the physician in manipulating thesphenocath400 into the sphenopalatine/pterygopalatine recess118 by providing the physician a leverage point to rotate thesphenocath400 and align the spray orifice with the sphenopalatine/pterygopalatine recess118 or sphenopalatine/pterygopalatine ganglia120.
• Once thesphenocath400 is manipulated into the sphenopalatine/pterygopalatine recess118 thesyringe416 injects an antisthetic or medication into themedication delivery port414 and through one of thelumens401 or403. Thespray orifice406 is in fluid communication with the lumen (401 or403) that receives the medication, thus, as the physician injects or dispenses the medication into medication delivery port, the medication travels through the lumen (401 or403), through thespray orifice406, and into the sphenopalatine/pterygopalatine recess118. One skilled in the art will recognize that any metered medicinal or anesthetic delivery means may be substituted for thesyringe416 without departing from the scope of the present invention.
• Thespray orifice406 may be configured to deliver a stream of medication or anesthetic. In one embodiment thespray orifice406 may be configured to disperse the medication or anesthetic such that the area surrounding the sphenopalatine/pterygopalatine ganglia120 is completely saturated with anesthetic or medication. In certain embodiments thespray orifice406 may be configured to administer the medication or anesthetic in a controlled fine mist. Further, one of skill in the art will recognize that in certain embodiments thespray orifice606 may be adjustable such that the physician may dispense the medication in a broader or narrower pattern as dictated by the procedure and the patient's nasal anatomy.
• FIG. 5A illustrates one embodiment of thecatheter402 portion of thesphenocath400 with arigid member501 inserted into one of thelumens401 or403. Therigid member501 in the embodiments illustrated inFIGS. 5A and 5B is astylus410 inserted intolumen401 such that thesphenocath400 is forced straight by thestylus410. Thestylus410 comprises a rod, wire or other rigid device having sufficient strength to straighten theintrinsic curve404 of thecatheter402. With thesphenocath410 straightened thecatheter402 can be inserted into thenasal cavity104 until it reaches a point past theanterior ridge302 of themiddle sinus turbinate114.
• FIG. 5B illustrates an embodiment of thecatheter402 portion of thesphenocath400 with therigid member501, in this case thestylus410, partially removed fromlumen401. As thestylus410 is removed fromlumen401, thecatheter402 bends due to theintrinsic curvature404 of thecatheter402. Thus, once thesphenocath400 has been inserted deep enough into the patient'snasal cavity104 such that the tip has passed themiddle sinus turbinate114, thestylus410 is withdrawn fromlumen401 to allow the catheter to bend at theintrinsic curvature404. Thesphenocath400 may then be inserted all the way into the sphenopalatine/pterygopalatine recess118 to deliver the anesthetic or medication to the sphenopalatine/pterygopalatine ganglia120 or surrounding anatomical structure. In certain embodiments the radius of theintrinsic curvature404 is sufficient to allow thecatheter402 to bend within thenasal cavity104 to align thespray orifice406 with the sphenopalatine/pterygopalatine recess118. In one embodiment theintrinsic curvature404 may bend between about 45° and about 90° to allow thecatheter402 to be placed within the sphenopalatine/pterygopalatine recess118 without hitting theinferior surface304 of thenasal bone122 of the patient.
• FIG. 5C illustrates another embodiment of thecatheter402 portion of thesphenocath400 with arigid member501 which surrounds thecatheter402. In this embodiment, therigid member501 is asleeve504 surrounding thecatheter402. In certain embodiments thesleeve504 is sufficiently rigid to straighten theintrinsic curvature404 when thecatheter402 is received within thesleeve504. One of skill in the art will recognize that in certain embodiments, such as where asleeve504 is used in place of astylus410, thesphenocath400 may include asingle lumen catheter402 rather than themultiple lumen catheter402 illustrated inFIGS. 5A-5D. As discussed below with reference toFIGS. 6A-6C, in other embodiments, thecatheter402 may be configured with as many additional lumens as may be required for additional complex procedures such as fiber optics for visually guiding the catheter into the sphenopalatine/pterygopalatine recess118 or vacuum tubes configured to aspirate substances from within the sphenopalatine/pterygopalatine recess118.
• FIG. 5D illustrates an embodiment of thecatheter402 portion of thesphenocath400 with thesleeve504 partially withdrawn from thecatheter402 to expose theintrinsic curvature404 of thecatheter402. As thesleeve504 is removed fromcatheter402 in the direction ofarrow506 theintrinsic curvature404 of the catheter is no longer straightened by thesleeve504. Therefore, thecatheter402 bends at theintrinsic curvature404. Thus, once thesphenocath400, including thesleeve504, has been inserted deep enough into the patient'snasal cavity104 such that thespray orifice406 has passed themiddle sinus turbinate114, thesleeve504 is withdrawn fromcatheter402 to allow the catheter to bend at theintrinsic curvature404. Thesphenocath400 may then be inserted all the way into the sphenopalatine/pterygopalatine recess118 to deliver the anesthetic or medication to the sphenopalatine/pterygopalatine ganglia120 or surrounding anatomical structure.
• FIG. 6A throughFIG. 6C illustrate various embodiments of a cross section of thecatheter402 of thesphenocath400. In certain embodiments, such as the embodiment illustrated inFIG. 6A one of the lumens may be keyed to receive thestylus410 in only one direction such aslumen602. By keyinglumen602 to receive thestylus410 in only one configuration, the pull tab of thestylus410, such aspull tab502 ofFIGS. 5A and 5B, may be configured to indicate the rotational direction of thespray orifice406. Further, by keying one of the lumens to receive thestylus410 in only one direction theentire sphenocath400 may be rotated by thepull tab502. Thus, in certain embodiments therotational direction indicator418 and arotation tab420 may be omitted where one of the lumens is keyed to receive thestylus410 in only one direction. While thecatheter402 illustrated inFIG. 6acomprises a round structure with twolumens602 and604, one skilled in the art will recognize thecatheter402 structure may comprise any number of shapes such as the shapes illustrated inFIGS. 6B and 6C. One skilled in the art will recognize that the shape illustrated inFIG. 6A throughFIG. 6C are for illustrative purposes only and are in no way limiting of the shapes which may comprise thecatheter402 andlumens602,604,606,608,610,612,614,616,618 and620.
• In certain embodiments anadditional orientation identifier622 may be disposed on the top surface of thecatheter402. In one embodiment theorientation identifier622 serves as an additional visual cue to assists the physician in determining the rotational orientation of thesphenocath400 so that the physician will know which direction theintrinsic curvature404 will bend when thestylus410 is removed.
• In the embodiments illustrated inFIG. 6A thecatheter402 comprises twolumens602 and604. In the embodiment illustrated inFIG. 6B thecatheter402 comprises threelumens606,608 and610 and in the embodiment illustrated inFIG. 6C thecatheter402 comprises fourlumens612,614,618 and620. One skilled in the art will recognize that thecatheter402 may be configured with as many additional lumens as may be required for additional complex procedures such as fiber optics for visually guiding the catheter into the sphenopalatine/pterygopalatine recess118 or vacuum tubes configured to aspirate substances from within the sphenopalatine/pterygopalatine recess118.
• FIG. 7 illustrates one embodiment of the present invention wherein thesphenocath400 is inserted through thenostril202 into thenasal canal104 and past theanterior ridge302 of themiddle sinus turbinate114. To maintain astraight sphenocath400 thestylus410 is fully inserted into lumen401 (note that eitherlumen401 or403 may be configured to receive the stylus410).Depth indicator408 is configured to signal the physician when thespray orifice406 of thesphenocath400 is sufficiently deep enough within the patient'snasal cavity104 to clear theanterior ridge302 of themiddle sinus turbinate114.
• FIG. 8 illustrates one embodiment of the present invention whereinspray orifice406 of thesphenocath400 has passed themiddle sinus turbinate114 and thestylus410 has been partially withdrawn from withinlumen401. As the stylus is withdrawn fromlumen401 thecatheter402 bends due tointrinsic curvature404 of thecatheter402. Thesphenocath400 can then be further inserted into thenasal cavity104 deeper within the sphenopalatine/pterygopalatine recess118. In certain embodiments asecond depth indicator802 may be disposed on thesphenocath400 to identify the correct depth for administering the anesthetic or medication to the sphenopalatine/pterygopalatine ganglia120 or surrounding anatomical structure. Once thesphenocath400 is inserted to the correct depth thesyringe416 or other dispensing means delivers a desired amount of medication or anesthetic into themedication delivery port414, through thelumen403 to be dispersed at thespray orifice406 to the sphenopalatine/pterygopalatine ganglia120. Because the patient is in a supine position the medication or anesthetic pools in the sphenopalatine/pterygopalatine recess118.
• The schematic flow chart diagram that follows is generally set forth as a logical flow chart diagram. As such, the depicted order and labeled steps are indicative of one embodiment of the presented method. Other steps and methods may be conceived that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the illustrated method. Additionally, the format and symbols employed are provided to explain the logical steps of the method and are understood not to limit the scope of the method. Although various arrow types and line types may be employed in the flow chart diagrams, they are understood not to limit the scope of the corresponding method. Some arrows or other connectors may be used to indicate only the logical flow of the method. For instance, an arrow may indicate a waiting or monitoring period of unspecified duration between enumerated steps of the depicted method. Additionally, the order in which a particular method occurs may or may not strictly adhere to the order of the corresponding steps shown.
• FIG. 9 illustrates another embodiment of asphenocath900 having acatheter902 portion which includes anintrinsic curvature904 near aninsertion end906 and arotation tab908 near amanipulation end910. In certain embodiments thesphenocath900 also includes amedication delivery port912 located near themanipulation end910 and aspray orifice914 located at theinsertion end906.
• In the embodiment illustrated inFIG. 9, themedication delivery port912 includes a Luer fitting916 keyed to fit a syringe (not shown). Themedication delivery port912 is fluidly connected to thecatheter902 portion through astylet tube918. In certain embodiments thestylet tube918 is sufficiently rigid to straighten theintrinsic curvature904 in theinsertion end906 of thecatheter902 when thestylet tube918 is inserted into thecatheter902 in the direction ofarrow920. As thestylet tube918 is withdrawn from thecatheter902 in a direction oppositearrow920, past a point where thestylet tube918 support theintrinsic curvature904, thecatheter902 bends due to theintrinsic curvature904. For example, once thestylet tube918 is withdrawn from thecatheter902 past a certain point (such as point922) thecatheter902 bends in the direction shown due to theintrinsic curvature904. In certain embodiments thecatheter902 may begin to bend immediately as thestylet tube918 is withdrawn from thecatheter902. Inother embodiments catheter902 only bends once thestylet tube918 has been removed past apoint922 where theintrinsic curvature904 begins.
• In certain embodiments themanipulation end910 of thespenocath900 includes arotation tab908 for directing thespray orifice914 in the direction of the sphenopalatine/pterygopalatine recess118 when thespray orifice914 has passed themiddle sinus turbinate114. Therotation tab908 may be aligned with theintrinsic curvature904 in a predefined orientation to signal to the physician the direction of thespray orifice916 when thesphenocath900 is disposed within a patient'snasal cavity104. As discussed above, thesphenocath900 may includedepth indicators924 to signal a proper depth within thenasal cavity104 to insert thesphenocath900 into sphenopalatine/pterygopalatine recess118.
• FIG. 10 is a schematic flow chart diagram illustrating one embodiment of amethod1000 for treating sympathetic mediated cephalgia (headaches.) In one embodiment the method starts1002 and the patient is placed in a supine position. In certain embodiments, the patient may already be in the supine position. In other embodiments, the physician may wish to administer the treatment with the patient in a standing or seated position and thus, this step may be omitted.
• The physician inserts1006 a stylus, such asstylus410 into a lumen within a sphenocath such as thesphenocath400 ofFIG. 4. Thestylus410 may act to straighten thesphenocath400 to allow for easy insertion into a patientsnasal cavity104. In certain embodiments thestylus410 may already be inserted within the lumen and thus this step may be omitted.
• Thesphenocath400 is inserted1008 into the patient'snostril202 and advanced through thenasal cavity104 to a position wherein thespray orifice406 of thesphenocath400 has passed themiddle sinus turbinate114. Thestylus410 is withdrawn1010 from thesphenocath400 such that the sphenocath400 curves due to anintrinsic curvature404 of thecatheter402. Thesphenocath400 is advanced1012 into the sphenopalatine/pterygopalatine recess118. Anesthetic is dispensed1014 into the sphenopalatine/pterygopalatine recess118.
• The anesthetic may cause a temporary loss of sensation in the nasal cavity and may, in certain instances, drain into the patients throat causing a loss of sensation in the patients throat. Therefore, in certain embodiments the physician may monitor1016 the patient in the supine position for a period of time to make sure that the patient does not have any adverse reactions to the anesthetics. In one embodiment the patient may be observed1018 to determine the efficacy of the procedure and the method ends1020.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (20)

1. An apparatus facilitating intranasal administration of a medication to a patients sphenopalatine/pterygopalatine recess, the apparatus comprising:

a catheter having a lumen disposed therethrough, the catheter comprising an insertion end and a manipulation end, the insertion end having an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane, wherein the catheter smoothly transitions between the first plane and the second plane, the intrinsic curvature conforming to a patients nasal anatomy such that the catheter may be inserted into a sphenopalatine/pterygopalatine recess;

a straightening member configured to removably engage the catheter, wherein the straightening member straightens the intrinsic curvature of the insertion end such that the first plane and the second plane are aligned when the catheter is engaged by the straightening member;

2. The apparatus ofclaim 1, wherein the catheter further comprising a second lumen, wherein the straightening member comprises a stylus configured to be received within the second lumen.

3. The apparatus ofclaim 2, wherein the stylus is keyed to fit within the second lumen in one predefined orientation, the stylus identifying a direction of the intrinsic curvature when the stylus is disposed within the second lumen.

4. The apparatus ofclaim 1, further comprising a spray orifice and a medication delivery port, the spray orifice disposed adjacent to the insertion end of the catheter, the spray orifice in fluid communication with the lumen, the medication delivery port configured to receive a medication and deliver the medication through the lumen to the spray orifice.

5. The apparatus ofclaim 1, wherein the straightening member comprises a sleeve configured to receive the catheter, wherein the sleeve straightens the intrinsic curvature of the catheter when the catheter is received within the sleeve.

6. The apparatus ofclaim 1, further comprising a rotational direction indicator disposed on the catheter, the rotational direction indicator identifying a direction of the intrinsic curvature.

7. The apparatus ofclaim 1, further comprising a depth indicator disposed on the catheter, the depth indicator identifying a defined depth.

8. The apparatus ofclaim 7, wherein the defined depth comprises a depth equaling a distance between an entrance to a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril.

9. The apparatus ofclaim 7, further comprising a second depth indicator disposed on the catheter, the second depth indicator identifying a second defined depth, the second defined depth comprising a depth equaling a distance between a location at a posterior position within a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril.

10. The apparatus ofclaim 7, wherein the depth indicator is moveable on the catheter such that a physician can adjust a position of the depth indicator according to a patient's nasal anatomy.

11. The apparatus ofclaim 7, wherein the depth indicator identifies the typical distance between a patient's external opening of a nostril and the patient's sphenopalatine/pterygopalatine recess according to a criteria selected from a patient's gender and age.

12. An apparatus facilitating intranasal administration of a medication to a patients sphenopalatine/pterygopalatine recess, the apparatus comprising:

a catheter having a first lumen and a second lumen, the catheter comprising an insertion end and a manipulation end, the insertion end having an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane, wherein the catheter smoothly transitions between the first plane and the second plane, the intrinsic curvature conforming to a patients nasal anatomy such that the catheter may be inserted into a sphenopalatine/pterygopalatine recess;

a stylus configured to be removably received within one of the first lumen and the second lumen, wherein the stylus straightens the intrinsic curvature of the insertion end such that the first plane and the second plane are aligned when the stylus is received within one of the first lumen and the second lumen;

a spray orifice disposed adjacent to the insertion end of the catheter, the spray orifice in fluid communication with at least one of the first lumen and the second lumen; and

a medication delivery port disposed adjacent to the manipulation end of the catheter, the medication delivery port configured to receive a medication and deliver a medication through at least one of the first lumen and the second lumen to the spray orifice.

13. The apparatus ofclaim 12, wherein the stylus is keyed to fit within at least one of the first lumen and the second lumen in one predefined orientation, the stylus identifying a direction of the intrinsic curvature when the stylus is disposed within one of the first lumen and the second lumen.

14. The apparatus ofclaim 12, further comprising a rotational direction indicator disposed on the catheter, the rotational direction indicator identifying a direction of the intrinsic curvature.

15. The apparatus ofclaim 1, further comprising a depth indicator disposed on the catheter, the depth indicator identifying a defined depth, wherein the defined depth comprises a depth equaling a distance between an entrance to a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril.

16. The apparatus ofclaim 15, further comprising a second depth indicator disposed on the catheter, the second depth indicator identifying a second defined depth, the second defined depth comprising a depth equaling a distance between a location at a posterior position within a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril.

17. The apparatus ofclaim 15, wherein the depth indicator is moveable on the catheter such that a physician can adjust a position of the depth indicator according to a patient's nasal anatomy.

18. A method for treating migraines, the method comprising:

inserting a catheter and a straightening member into a nostril of a patient, the catheter comprising an insertion end and a manipulation end, the insertion end having an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane, wherein the catheter smoothly transitions between the first plane and the second plane, the intrinsic curvature conforming to a patients nasal anatomy such that the catheter may be inserted into a sphenopalatine/pterygopalatine recess, the straightening member removably engaging the catheter, wherein the straightening member straightens the intrinsic curvature of the insertion end such that the first plane and the second plane are aligned when the catheter is engaged by the straightening member;

advancing the catheter and the straightening member past a middle sinus turbinate in the nostril of the patient;

removing the straightening member from the catheter such that the catheter bends in a direction towards a sphenopalatine/pterygopalatine recess of the patient;

advancing the catheter into the sphenopalatine/pterygopalatine recess; and

dispensing a medication to a sphenopalatine/pterygopalatine ganglia disposed within the sphenopalatine/pterygopalatine recess of the patient.

19. The method ofclaim 18, further comprising identifying a direction of the intrinsic curvature and aligning the intrinsic curvature of the catheter with the patient's sphenopalatine/pterygopalatine recess.

20. The method ofclaim 18, further comprising identifying a defined depth of the catheter, the defined depth comprising a depth equaling a distance between an entrance to a patient's sphenopalatine/pterygopalatine recess and an external entrance to the patient's nostril.

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