Patent Document

RELATED APPLICATION 
       [0001]    This patent application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 62/190,175, entitled “Turbinate Compressor,” filed on 8 Jul. 2015 (Attorney Docket No. ENTL-027), which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND 
       [0002]    Surgical procedures are commonly performed within the nasal anatomy of humans. Balloon sinuplasty, for example, has become an important method of treating sinusitis in recent years. A balloon is advanced into a drainage pathway of a nasal sinus cavity and inflated. The inflated balloon expands the drainage pathway, thereby providing for improved drainage of the sinus cavity. 
         [0003]    It is often challenging to maneuver surgical instruments within the nasal anatomy. The mucosal tissue lining the nasal anatomy is often diseased and inflamed. Further, anatomical structures (e.g., nasal conchae or turbinates) may obstruct access to desired locations within the nasal and sinus systems. 
       OVERVIEW 
       [0004]    Balloon sinuplasty procedures, as well as other surgical procedures performed in the nasal or sinus anatomy, can often be complicated by anatomical features. The features may make it difficult or impossible for a surgeon to access a desired anatomical location. 
         [0005]    The present inventors have recognized, among other things, that a problem to be solved can include improving access to the nasal and sinus anatomy. The present subject matter can help provide a solution to this problem, such as by compressing or reducing the size of a turbinate. 
         [0006]    In some embodiments, the present invention is directed towards a surgical forceps for use in the nasal anatomy of a human. The surgical forceps can include a proximal portion and a distal portion. The proximal portion can include a first handle portion and a second handle portion, where the first handle portion and the second handle portion are configured to be grasped by a hand of a practitioner. The distal portion can be sized or configured to pass through a human nostril and into a nasal passageway, wherein the distal portion includes a jaw portion having a first paddle and a second paddle. The first paddle and the second paddle can be configured to actuate between a fully closed position and an open position when the practitioner moves the first handle portion relative to the second handle portion, wherein the first paddle defines a first flat inner clamping face and the second paddle defines a second flat inner clamping face. A proximal portion of the first flat inner clamping face may not contact the second paddle when the first paddle and the second paddle are in the fully closed position. 
         [0007]    The present invention, in some embodiments, also includes methods of compressing a nasal turbinate. The methods may include grasping a surgical forceps with a hand of a practitioner (e.g., a surgical forceps of the present invention) and directing a distal portion of the surgical forceps through a human nostril and into a nasal passageway, wherein the distal portion includes a jaw portion having a first paddle and a second paddle, and wherein the first paddle and the second paddle are configured to actuate between a fully closed position and an open position when the practitioner moves the first handle portion relative to the second handle portion, and wherein the first paddle defines a first flat inner clamping face and the second paddle defines a second flat inner clamping face. The method may further include positioning the jaw portion proximate the nasal turbinate, wherein the first flat inner clamping face is positioned one a first side of the nasal turbinate and the second flat inner clamping face is positioned on a second side of the nasal turbinate opposite the first side. The method may further include compressing the nasal turbinate with the surgical forceps by pressing the first flat inner clamping face against the first side of the nasal turbinate while simultaneously pressing the second flat inner clamping face against the second side of the nasal turbinate. 
         [0008]    This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. 
           [0010]      FIGS. 1A and 1B  illustrate side views of one embodiment of a surgical forceps of the invention. 
           [0011]      FIG. 1C  illustrates a top-down view of the forceps shown in  FIGS. 1A and 1B . 
           [0012]      FIG. 1D  illustrates a close-up side view of a jaw portion of the forceps shown in  FIGS. 1A-1C . 
           [0013]      FIGS. 2A-2D  illustrate various views of a paddle portion of a forceps of the present invention. 
           [0014]      FIGS. 3A-3C  illustrate cut-away views of paddle portions of forceps of the present invention. 
           [0015]      FIGS. 4A-4F  illustrate a method of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]      FIGS. 1A and 1B  illustrate side views of one embodiment of the invention in the form of surgical forceps  100 , while  FIG. 1C  illustrates a top-down view of the same forceps. Surgical forceps  100  include distal portion  102  and proximal portion  104 . 
         [0017]    Proximal portion  104  includes two handle portions  105  and  106 , which are each configured to accommodate a finger of a user or practitioner of the invention. Forceps  100  also includes hinge member  115 , about which pivots handle portion  106 . 
         [0018]    Distal portion  102 , which includes a superior arm  116  and an inferior arm  118 , may be about 5.5 to about 6 inches in length. The distal end of the inferior arm  118  is attached to or forms inferior paddle  113  while superior arm  116  is attached to superior paddle  112  via hinge member  122 . Together, paddles  112  and  113  form a distal jaw portion  114 . 
         [0019]    One of the main differences between surgical forceps  100  of the present invention and prior art forceps commonly used to treat diseases of the nasal anatomy is that distal jaw portion  114  is configured to apply compressive pressure to a nasal turbinate without removing or significantly cutting the mucosa, bone, or other tissues making up the turbinate structure. That pressure compresses the turbinate into a smaller size to make additional room in the nasal anatomy for performing other surgical procedures, such as a sinus dilation procedures (e.g., a sinus dilation procedure using an inflatable balloon catheter). Depending upon the patient anatomy and the specifics of the surgical procedure, the compressed turbinate tissue should spring back to some extent or even to its original size over the course of minutes, hours, or days. 
         [0020]    The portions of surgical forceps  100  that are proximal to jaw portion  114  are similar to comparable proximal portions of prior art surgical forceps commonly used to treat diseases of the nasal anatomy, such as the Blakesley nasal forceps (available from a wide range of surgical instruments suppliers, including from JEDMED of St. Louis, Mo. as their catalog number 54-2992). A user may open and close jaw portion  114  by pivoting handle portion  106  about hinge member  115  and directing the proximal ends of handle portions  105  and  106  away or towards one another along direction  108 . In response, superior paddle  112  pivots about hinge member  122 , thereby opening and closing paddles  112  and  113  of jaw portion  114  along direction  110 .  FIG. 1A  illustrates forceps  100  when handle portions  105  and  106  are directed fully away from one another, thereby completely opening paddles  112  and  113 , while  FIG. 1B  illustrates forceps  100  when handle portions  105  and  106  are fully directed towards one another, thereby completely closing paddles  112  and  113 . 
         [0021]    When fully closed, the distal edge of paddle  112  contacts the distal edge of paddle  113  while a triangular space or slight gap  120  is defined between the more proximal portions of the opposing flat faces of paddles  112  and  113 , with the “base” of the triangular space (i.e., the widest portion of the gap  120 ) between the proximal edges of the opposing faces of paddle  112  and the “tip” (i.e., the narrowest portion of the gap  120 ) at the distal contacting edges of the opposing flat faces of paddles  112  and  113 . This slight gap  120  provides for more atraumatic contact between the faces of the paddles  112  and  113  when forceps  100  are compressing a nasal turbinate. As the jaw portion  114  squeezes down on a turbinate, the gap  120  between the proximal surface areas of closed paddles  112  and  113  prevents those more proximal surfaces from excessively compressing the turbinate. In some embodiments, the gap  120  between closed paddles  112  and  113  is widest at the proximal opposing edges of paddles  112  and  113  (i.e., at the proximal portion of jaw portion  114 ). The gap  120  between the proximal opposing edges of paddles  112  and  113  may be between ˜0.5 millimeters and ˜5.0 millimeters, between ˜0.5 millimeters and ˜3 millimeters, between ˜0.5 millimeters and 2.0 millimeters, between ˜1.0 millimeters and ˜2.0 millimeters. In some further embodiments, the gap  120  between the proximal opposing edges of paddles  112  and  113  is approximately 1.5 millimeters. 
         [0022]    In some embodiments, when jaw portion  114  is in a closed position, the only points of contact between the superior paddle  112  and inferior paddle  113  at any position distal to hinge member  122  is a line of contact points where the very distal edge of paddles  112  and  113  contact one another along a line. To state it another way, in these embodiments, the opposing faces of paddle  112  and  113  only contact one another along a 1-dimensional straight or curved line rather than over a broader 2-dimensional surface area. 
         [0023]      FIG. 1D  illustrates a close-up side view of jaw portion  114  when paddles  112  and  113  are in a fully opened position. When fully opened, paddles  112  and  113  may be positioned at an angle of between 35 and 55 degrees. 
         [0024]      FIGS. 2A-2D  illustrate various views of superior paddle  112 .  FIG. 2A  illustrates a close-up side view of a disassembled superior paddle  112 , while  FIG. 2B  illustrates a top view of disassembled superior paddle  112 .  FIG. 2C  illustrates a cut-away view of superior paddle  112  along lines BB in  FIG. 2B , while  FIG. 2D  illustrates a cut-away view of superior paddle  112  along lines AA in  FIG. 2B . 
         [0025]    Paddle  112  has a length  200  of between about 10 and 27 millimeters and a width  202  of between 2 and 10 millimeters. Paddle  112  also has a raised lip  204  that extends around the outer periphery of the flat inner clamping face  208  of paddle  112 . With the exception of raised lip  204 , inner clamping face  208  defines a flat continuous surface stretching from the raised lip  204  on one side of paddle  112  to the raised lip  204  on the other side of paddle  112  (best illustrated in  FIGS. 2C and 2D ). Lip  204  rises above or extends from inner clamping face  208  with a height  206  of between ˜0.005 and ˜0.025 inches. In some embodiments, height  206  is about 0.15 inches. Lip  204  has a width  210  of between about 0.01 to about 0.03 inches. In some embodiments, width  210  is about 0.02 inches. During use, lip  204  provides surgical forceps  100  with improved gripping of a turbinate while flat inner clamping face  208  provides an atraumatic surface to apply a squeezing pressure to the turbinate without excessive damage to the tissue. 
         [0026]    It will be understood that while  FIGS. 2A-2D  illustrate superior paddle  112 , inferior paddle  113  will have a similar, complementary, and symmetrical design. In some embodiments, one of the few differences between superior paddle  112  and inferior paddle  113  is that inferior paddle  113  is formed as a single unitary portion of a distal end of inferior arm  118  and therefore does not include a hinge member that allows inferior paddle  113  to pivot about a point as superior paddle  112  pivots about hinge member  122 . 
         [0027]      FIGS. 3A-3C  illustrate cut-away views of other embodiments of paddles where the raised lips are orientated at different angles relative to the respective inner clamping faces of the paddle.  FIG. 3A , for example, illustrates lip  304   a  which is at a right angle α relative to inner face  308   a  (similar to the orientation of lip  204  in the embodiments illustrated in  FIGS. 2A-2D ).  FIG. 3B  illustrates another embodiment where lip  304   b  is at an angle α that is acute relative to inner face  308   b .  FIG. 3C  illustrates yet another embodiment, where lip  304   c  is at an angle α that is obtuse relative to inner face  308   c.    
         [0028]      FIGS. 4A-4F  illustrate a method of the invention.  FIG. 4A  shows a diagram of a portion of the human nasal anatomy that includes the maxillary sinus (MS), maxillary ostium (MO), the uncinated process (UT), the inferior and middle turbinates (IT and MT, respectively), and the nasal septum (NS).  FIG. 4B  illustrates a distal portion of surgical forceps  400  of the present invention entering the nasal anatomy. 
         [0029]      FIG. 4C  illustrates a close-up view of jaw portion  414  as it approaches middle turbinate MT. Paddles  412  and  413  of jaw portion  414  are opened by moving handle portions (not illustrated) apart. The jaw portion  414  is advanced further into the anatomy until paddles  412  and  413  are on either side of middle turbinate MT. The operator squeezes middle turbinate MT with the jaw portion  414  by squeezing the handle portions together. While squeezing the middle turbinate MT, the lip and inner faces of the jaw portion  414  engage and press against the tissue of the middle turbinate MT. 
         [0030]      FIG. 4D  illustrates a close up view of middle turbinate MT just after surgical forceps  400  has been used to apply pressure to the middle turbinate MT tissue.  FIG. 4E  illustrates surgical forceps  400  being withdrawn from the nasal anatomy after the middle turbinate MT has been compressed.  FIG. 4F  illustrates the anatomy just after surgical forceps  400  has been removed, with middle turbinate MT noticeably smaller than prior to the procedure (as shown in  FIG. 4A ). With the smaller middle turbinate, a health practitioner now has more room to maneuver other instruments (e.g., a sinus dilation balloon). It is believed that the middle turbinate MT will remain in the small configuration for some relatively short period of time (e.g., minutes, hours, or days) and will eventually rebound to some larger size. 
       ENUMERATED EMBODIMENTS 
       [0031]    The following enumerated embodiments are just some examples of the present invention and are not meant to be an exclusive list of all embodiments: 
       Embodiment 1 
       [0032]    A surgical forceps for use in the nasal anatomy of a human, the surgical forceps comprising:
       a proximal portion that includes a first handle portion and a second handle portion, the first handle portion and the second handle portion configured to be grasped by a hand of a practitioner;   a distal portion configured to pass through a human nostril and into a nasal passageway, wherein the distal portion includes a jaw portion having a first paddle and a second paddle;   wherein the first paddle and the second paddle are configured to actuate between a fully closed position and an open position when the practitioner moves the first handle portion relative to the second handle portion, and wherein the first paddle defines a first flat inner clamping face and the second paddle defines a second flat inner clamping face, and wherein a proximal portion of the first flat inner clamping face does not contact the second paddle when the first paddle and the second paddle are in the fully closed position.       
 
       Embodiment 2 
       [0036]    The surgical forceps of Embodiment 1, wherein a distal portion of the first flat inner clamping face contacts the second paddle when the first paddle and the second paddle are in the fully closed position. 
       Embodiment 3 
       [0037]    The surgical forceps of either Embodiments 1 or 2, wherein the first paddle has a length of between 10 and 27 millimeters and a width of between 2 and 10 millimeters. 
       Embodiment 4 
       [0038]    The surgical forceps of any of Embodiments 1-3, wherein the first paddle includes a raised lip, wherein the raised lip extends from the first flat inner clamping face and extends about a periphery of the first flat inner clamping face. 
       Embodiment 5 
       [0039]    The surgical forceps of any of Embodiments 1-4, wherein the raised lip has a height of between 0.005 and 0.025 inches and a width of between 0.01 and 0.03 inches. 
       Embodiment 6 
       [0040]    The surgical forceps of any of Embodiments 1-5, wherein the raised lip is orientated at a right angle relative to the first flat inner clamping face. 
       Embodiment 7 
       [0041]    The surgical forceps of any of Embodiment 1-5, wherein the raised lip is orientated at an acute angle relative to the first flat inner clamping face. 
       Embodiment 8 
       [0042]    The surgical forceps of any of Embodiment 1-5, wherein the raised lip is orientated at an obtuse angle relative to the first flat inner clamping face. 
       Embodiment 9 
       [0043]    A method of compressing a nasal turbinate, the method including:
       grasping a surgical forceps (e.g., any of the forceps described in any of Embodiments 1-8), wherein the surgical forceps include a first handle portion and a second handle portion that are both grasped by a hand of a practitioner;   directing a distal portion of the surgical forceps through a human nostril and into a nasal passageway, wherein the distal portion includes a jaw portion having a first paddle and a second paddle, and wherein the first paddle and the second paddle are configured to actuate between a fully closed position and an open position when the practitioner moves the first handle portion relative to the second handle portion, and wherein the first paddle defines a first flat inner clamping face and the second paddle defines a second flat inner clamping face;   positioning the jaw portion proximate the nasal turbinate, wherein the first flat inner clamping face is positioned one a first side of the nasal turbinate and the second flat inner clamping face is positioned on a second side of the nasal turbinate opposite the first side; and   compressing the nasal turbinate with the surgical forceps by pressing the first flat inner clamping face against the first side of the nasal turbinate while simultaneously pressing the second flat inner clamping face against the second side of the nasal turbinate.       
 
       Embodiment 10 
       [0048]    The method of Embodiment 9, wherein the surgical forceps are configured so that a proximal portion of the first flat inner clamping face does not contact the second paddle when the first paddle and the second paddle are in the fully closed position 
       Embodiment 11 
       [0049]    The method of either Embodiments 9 or 10, wherein the surgical forceps are configured so that a distal portion of the first flat inner clamping face contacts the second paddle when the first paddle and the second paddle are in the fully closed position. 
       Embodiment 12 
       [0050]    The method of any of Embodiments 9-11, wherein the first paddle has a length of between 10 and 27 millimeters and a width of between 2 and 10 millimeters. 
       Embodiment 13 
       [0051]    The method of any of Embodiments 9-12, wherein the first paddle includes a raised lip, wherein the raised lip extends from the first flat inner clamping face and extends about a periphery of the first flat inner clamping face. 
       Embodiment 14 
       [0052]    The method of any of Embodiments 9-13, wherein the raised lip has a height of between 0.005 and 0.025 inches and a width of between 0.01 and 0.03 inches. 
       Embodiment 15 
       [0053]    The method of any of Embodiments 9-14, wherein the raised lip is orientated at a right angle relative to the first flat inner clamping face. 
       Embodiment 16 
       [0054]    The method of any of Embodiments 9-14, wherein the raised lip is orientated at an acute angle relative to the first flat inner clamping face. 
       Embodiment 17 
       [0055]    The method of any of Embodiments 9-14, wherein the raised lip is orientated at an obtuse angle relative to the first flat inner clamping face. 
       Embodiment 18 
       [0056]    The method of any of Embodiments 9-17, wherein compressing the nasal turbinate does not include using the surgical forceps to remove tissue from the nasal turbinate. 
       Embodiment 19 
       [0057]    The method of any of Embodiments 9-18, further including performing a surgical procedure in the nasal anatomy after compressing the nasal turbinate. 
       Embodiment 20 
       [0058]    The method of any of Embodiment 19, wherein the surgical procedure is a sinus dilation procedure. 
         [0059]    Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples. 
         [0060]    The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein. 
         [0061]    In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. 
         [0062]    In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. 
         [0063]    Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description. 
         [0064]    Any numerical ranges recited above shall be read as including support for any sub-ranges as if said sub-ranges were explicitly recited herein. For example, if a range of 1-10 is described, then it shall be understood that the range supports any subrange between 1 and 10, such as 1-3, 3-7, or 3.6 to 9.874. 
         [0065]    The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Technology Category: 1