Patent Application
20120253123
This application is based upon and claims the benefit of priority from the prior Japanese Patent Application No. 2011-072998 filed on Mar. 29, 2011 and International Application No. PCT/JP2011/77583 filed on Nov. 29, 2011, the entire contents of which are incorporated herein by reference.
1. Technical Field
The present invention relates to an otorhinolaryngological treatment device to be used for treatment of sinusitis or the like and an otorhinolaryngological treatment method thereof.
2. Description of Related Art
An accessory nasal cavity is an intraosseous cavity adjacent to a nasal cavity, and communicates with the nasal cavity through a small hole called natural ostium. Secretions, bacteria and the like in the accessory nasal cavity are excreted through the natural ostium. When the mucous membrane in the nasal cavity is swollen due to common cold-induced rhinitis or allergic rhinitis or the like or the inside of the nasal cavity is narrowed due to deflected nasal septum or hypertrophic rhinitis or the like, however, the natural ostium is stenosed and chronic inflammation is generated in the accessory nasal cavity. Such a disease is called sinusitis. Conventionally, the method for treatment of sinusitis has generally been a surgical operation in which the lesion causing stenosis of the natural ostium is removed by use of forceps, a drill or the like while confirming the video image of the inside of the nasal cavity through an endoscope. In recent years, however, a sinusitis treatment method based on the use of a balloon catheter and not including a surgical operation has been developed, and has been drawing attention from the viewpoint of minimal invasiveness to the patient.
In the treatment method developed recently, a guide wire and a balloon catheter are sequentially inserted into the nasal cavity, and, after it is radioscopically confirmed that the balloon catheter has been disposed in the natural ostium, the balloon catheter is expanded to force open the stenosed part of the natural ostium. According to this treatment method, the communicating passage between the nasal cavity and the accessory nasal cavity can be recovered while greatly alleviating the bleeding in the nasal cavity, damage to the mucous membrane, etc. In connection with this technique, Japanese Patent Application Publication No. 2008-513125 proposes a balloon catheter in which a plurality of radiopaque markers for marking the balloon proximal end, distal end and the like are disposed on the inner surface of the balloon. On the other hand, from the viewpoint of prevention of exposure of the patient to X-rays, there is an increasing demand for a balloon catheter which enables easy positioning (alignment) of the balloon inside the nasal cavity without relying on radioscopy.
The present invention has been made aiming at solving the above-mentioned problems involved in the related art. Accordingly, it is an object of the present invention to provide an otorhinolaryngological treatment method in which positioning (alignment) of an expansion body inside a nasal cavity can be easily carried out without need for radioscopy.
A first mode of the present invention provides an otorhinolaryngological treatment device including: a flexible elongated body to be inserted into a living body; an expansion body which is provided on the elongated body and has an effective expansive section capable of radial expansive deformation within a natural ostium located between a nasal cavity and an accessory nasal cavity in the living body to force open a stenosed part of the natural ostium; and imaging unit for obtaining an image on the front side of a distal end of the elongated body, which is provided integrally with the elongated body on the distal side of the elongated body relative to the expansion body.
The treatment device, preferably, includes a long-shaped holding member contained in the elongated body and having a rigidity by which the external shape of the elongated body in the living body is held such that at least a part of the elongated body is bent into a direction crossing an axial direction of the elongated body.
In the treatment device, preferably, the imaging unit includes an image sensor part disposed inside the elongated body, and a protective member which has an opening part for leading out a connection cable electrically connected to the image sensor part and which covers the image sensor part; and a distal end of the protective member is disposed on the distal side of the elongated body relative to a part of the connection cable which is led out through the opening part.
In the treatment device, preferably, the holding member is disposed at least at a position in the extending direction of the elongated body where the effective expansive section of the expansion body is located.
In the treatment device, preferably, the elongated body is provided with a marker for confirming that the elongated body is moved along the extending direction of the natural ostium by the distance between an image obtaining plane of the imaging unit and the effective expansive section.
In the treatment device, the marker may be configured to be movable along the extending direction of the elongated body and to be fixable to the elongated body.
In the treatment device, preferably, the marker is configured to be detachable from the elongated body.
In the treatment device, the marker may have graduations for indicating the distance.
In the treatment device, the elongated body may be provided with a first lighting unit for illuminating the front side of the distal end of the elongated body.
In the treatment device, preferably, the expansion body has a light-permeability; and a second light for illuminating the outer periphery of the expansion body through the expansion body is disposed inside the expansion body.
In the treatment device, preferably, a center position in the radial direction of the expansion body and a center position of an image obtaining plane of the imaging unit are coaxially-arranged with each other.
In the treatment device, the imaging unit may be located at the distal end of the elongated body.
A second mode of the present invention provides a method of dilating a stenosed part of a natural ostium located between a nasal cavity and an accessory nasal cavity in a living body, including: a step of introducing into the living body a elongated body provided with an expansion body capable of expansive deformation and contractive deformation and imaging unit for obtaining an image of the inside of the living body, disposed on the distal side of the elongated body relative to the expansion body, each of which is integrated with the elongated body; a guiding step of obtaining an image on the front side of a distal end of the elongated body by the imaging unit, and guiding an effective expansive section of the expansion body for applying a pressure to the stenosed part of the natural ostium, into the stenosed part of the natural ostium on the basis of the obtained image; and a dilating step of expanding the expansion body to thereby dilate the stenosed part of the natural ostium.
In the method of dilating a stenosed part, preferably, the guiding step includes a step of positioning an image obtaining plane of the imaging unit on the proximal side of an entrance to the accessory nasal cavity, and thereafter advancing the elongated body distally by the distance between the image obtaining plane and the effective expansive section of the expansion body thereby to position the effective expansive section with respect to the stenosed part of the natural ostium.
In the method of dilating a stenosed part, preferably, the dilating step includes at least a step of causing expansive deformation and contractive deformation in the expansion body while advancing the elongated body distally or retreating the elongated body proximally.
The method of dilating a stenosed part may further include a suctioning step for suctioning a fluid in the living body through a lumen disposed in the elongated body in a state where the elongated body has been introduced into the living body.
In the treatment device according to the first mode of the present invention, by advancing the elongated body within the nasal cavity while observing the image obtained by the imaging unit, it is possible to easily confirm the arrival of the elongated body at the accessory nasal cavity, so that the expansion body provided on the elongated body can be positioned accurately in the stenosed part of the natural ostium. According to the treatment device, therefore, the stenosed part of the natural ostium can be forced open by the expansion body more assuredly, and a therapeutic effect on sinusitis can be enhanced. Further, by the treatment device, the elongated body can be prevented from being excessively advanced into the accessory nasal cavity, so that safety in treating sinusitis can be enhanced. In addition, the treatment device does not need any radioscopic device, and therefore enables treatment of sinusitis even in a small hospital or the like where such a special device is not installed.
Where the treatment device includes the long-shaped holding member as above-mentioned, the elongated body can be reshaped at the time of introduction into a living body. Further, the external shape (reshaped shape) of the elongated body can be maintained in the living body. Accordingly, the elongated body and the expansion body can be easily and assuredly guided into the vicinity of a stenosed part of the natural ostium, irrespectively of differences in introduction path to each accessory nasal cavity to be treated and individual differences in anatomical structure from patient to patient.
Where the distal end of the holding member is disposed on the distal side of the elongated body relative to a part of the connection cable which is led out through the opening part in the protective member, a starting point of reshaping into a curved shape or the like by means of the holding member can be prevented from being formed in the led-out part of the connection cable from the opening part. This ensures that the connection cable can be prevented from suffering a damage such as breaking of wire. In addition, since reshaping into a curved shape or the like does not occur at the elongated body portion where the protective member is disposed, the image sensor part contained in the protective member can be prevented from suffering a breakage or a deterioration in function.
Where the holding member is disposed at least at a position in the extending direction of the elongated body where the effective expansive section of the expansion body is located, the outer peripheral surface of the expansion body can be reshaped in conjunction with the elongated body. Therefore, the treatment device becomes applicable not only to a natural ostium having a rectilinear inner cavity shape but also to a natural ostium having a curved inner cavity shape. Accordingly, while using a single treatment device, it is possible to widely cope with natural ostia which are located at different parts of a living body.
Where the elongated body is provided with the marker as above-mentioned, after the arrival of the image obtaining plane of the imaging unit at the accessory nasal cavity is confirmed through the image obtained by the imaging unit, the operator can further advance the elongated body by the distance between the image obtaining plane and the effective expansive section of the expansion body while observing the marker provided on the proximal operating section, whereby the effective expansive section can be disposed over the whole range of the stenosed part. Therefore, the stenosed part of the natural ostium can be forced open more assuredly, and the therapeutic effect on sinusitis can be more enhanced.
Where the marker is movable as above-mentioned, the position of the marker can be varied according to the naris (opening of nasal cavity), so that positioning of the expansion body can be carried out more accurately. Therefore, the stenosed part of the natural ostium can be forced open more reliably, so that the therapeutic effect on sinusitis can be enhanced further.
Where the marker is detachable from the elongated body, it is possible to remove the marker before or after the positioning of the expansion body. This promises better usability of the treatment device.
Where the marker has graduations for indicating the distance, the elongated body can be more accurately advanced by the distance. Therefore, the stenosed part of the natural ostium can be forced open more assuredly, so that the therapeutic effect on sinusitis can be enhanced further.
Where the elongated body is provided with the first lighting unit as above-mentioned, a favorable visual field for the imaging unit can be secured by the light emitted from the first lighting unit, so that the expansion body provided on the elongated body can be more accurately disposed in the stenosed part of the natural ostium. Therefore, the therapeutic effect on sinusitis and safety in treatment can be further enhanced.
Where the expansion body is light-transmitting and the second light as above-mentioned is provided inside the expansion body, the light emitted from the second lighting unit enters the accessory nasal cavity at the time when the expansion body arrives at the accessory nasal cavity through the stenosed part of the natural ostium. Therefore, the elongated body can be advanced while checking whether or not the light from the second lighting unit has entered the accessory nasal cavity, whereby the expansion body can be disposed over the whole range of the stenosed part. Accordingly, the stenosed part can be forced open more assuredly, so that the therapeutic effect on sinusitis can be more enhanced.
Where the expansion body and the image obtaining plane of the imaging unit are coaxially-arranged, the image obtaining plane is always located at the center of the path of the elongated body, so that penetrability of the elongated body into the nasal cavity can be enhanced. Besides, since a favorable visual field can be secured, the arrival of the elongated body at the accessory nasal cavity can be confirmed more accurately. Therefore, the therapeutic effect on sinusitis and safety in treatment can be enhanced further.
Where the imaging unit is provided at the distal end of the elongated body, the image obtaining plane is always located in the forefront of the path of the elongated body, the arrival of the elongated body at the accessory nasal cavity can be confirmed more accurately. Therefore, the therapeutic effect on sinusitis and safety in treatment can be enhanced further.
The method of dilating a stenosed part of the natural ostium according to the present invention ensures that the elongated body can be prevented from being excessively advanced into the accessory nasal cavity, so that safety in treatment of accessory nasal cavity can be enhanced. In addition, the method does not need any radioscopic device, and therefore enables treatment of sinusitis even in a small hospital or the like where such special device is not installed.
Where the elongated body is advanced further by the distance between the image obtaining plane of the imaging unit and the effective expansive section of the expansion body after confirmation of the arrival of the image obtaining plane at the accessory nasal cavity through the image obtained by the imaging unit, as above-mentioned, the effective expansive section can be disposed over the whole range of the stenosed part. This ensures that the stenosed part of the natural ostium can be forced open more assuredly, so that the therapeutic effect on sinusitis can be more enhanced.
Where expansive deformation and contractive deformation are caused in the expansion body while the elongated body being advanced or retreated, the stenosed part of the natural ostium can be forced open more securely.
Where the fluid in the living body is suctioned through the lumen disposed in the elongated body in the condition where the elongated body has been introduced into the living body, as above-mentioned, adhesion of body fluid or secretions onto the image obtaining plane of the imaging unit can be prevented, so that a clearer image can be obtained.
Now, embodiments of the present invention will be described below referring to the drawings. For convenience of description, ratios of the dimensions of components in individual drawings and ratios of the dimensions of the same component in the plurality of drawings are varied, as required, and are therefore not necessarily conforming to the actual ratios.
Here, the term “CCD camera” means a digital video camera using a CCD image sensor as an imaging element. The hub 15 includes an image port 15a as the connection port for connection to the external apparatus, a pressure supply port 15b, and a light supply port 15c. These ports will be described later. Incidentally, the catheter 1 is inserted into the patient's nasal cavity from its end portion where the CCD camera 13 is disposed, to be used for treatment of sinusitis. In the following description, the end portion of the catheter 1 for insertion into the nasal cavity will be referred to as distal end, and the end portion on the opposite side will be referred to as proximal end.
As shown in
Incidentally, the imaging unit in the present embodiment is not restricted to the CCD camera, but may be any of a digital video camera using other imaging element such as a CMOS image sensor, an image fiber for obtaining and transmitting images by means of optical fibers, and an imaging system for transmitting images by means of an objective lens and an optical system including a plurality of relay lenses. The “image obtaining plane” in the cases of using various cameras or optical imaging systems means a predetermined part of the imaging unit disposed so as confront an organ in a living body at the time of introduction into the inside of the living body, and the image obtaining plane may be a distal-end surface of a protective member of the image sensing element or a lens, for example.
The lighting unit in the present embodiment is not limited to the LED light, but may be other lighting units such as a halogen lamp and a high-intensity discharge lamp (HID lamp). Apart from the example shown in
As shown in
As shown in
Incidentally, the indication section 152 may be provided with any of various fixing devices for fixing the position thereof relative to the first elongated body 11 more assuredly. Further, the indication section 152 may be in the shape of a clip for gripping of the outer peripheral surface of the first elongated body 11, and may be detachably mounted on the first elongated body 11. This ensures that the indication section 152 can be detached from the first elongated body 11 before or after the positioning (alignment) of the balloon 12, so that usability of the catheter 1 can be enhanced.
The marker M may be formed by direct printing of a scale on the outer peripheral surface of the indication section 152. Or, alternatively, the marker M may be formed by a method in which a transparent film or the like with scales preliminarily printed thereon is adhered to the outer peripheral surface of the indication section 152 by an adhesive or the like. The scale preferably has graduations for indicating the distance (“X” in
Incidentally, the expansion body is not restricted to the balloon, but may be stent-type expansion bodies formed from a metal with shape-memory characteristics to exert a predetermined pressing force (expansive pressure), for example.
As shown in
As shown in
As shown in
Similarly, the vicinity of the distal end of the third elongated body 17 is fitted airtight to the end wall lib of the first elongated body 11. In addition, the vicinity of the proximal end of the third elongated body 17 is fitted airtight to the base end portion 151 of the hub 15, and the proximal end of the third lumen 17a communicates with the light supply port 15c. Besides, a cable for connection between the LED light 14 and the light source device L is contained in the third lumen 17a. This cable is led out to the exterior of the catheter 1 through the light supply port 15c.
Now, materials for forming parts of the catheter 1 will be described below. First, the material for the first elongated body 11 will be described. The first elongated body 11 is formed from one of those various resin materials which are generally used in the field of medical catheters. The material should have such a degree of flexibility as to be freely bendable according to a pressure exerted from the inner wall of the nasal cavity without damaging the surrounding mucous membranes when inserted in the nasal cavity. Specific examples of the material which can be used to form the first elongated body 11 include resins such as polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and their cross-linked products and partially cross-linked products (e.g., crosslinked ethylene-vinyl acetate copolymer), polyvinyl chloride, nylon elastomer, fluorine resins, polyurethane, etc., and rubbers such as silicone rubbers, latex rubbers, etc.
Incidentally, the second elongated body 16 and the third elongated body 17 should also have such degree of flexibility as to be freely bendable according to a pressure exerted from the inner wall of the nasal cavity without damaging the surrounding mucous membranes when inserted in the nasal cavity, and they are formed from a material similar to the materials for the first elongated body 11. The first to third long bodies may be formed from the same material or from different materials.
Now, the material for the balloon 12 will be described below. The balloon 12 is formed from one of those various resin materials which are generally used in the field of stent delivery systems. Specific examples of the material for the balloon 12 include: polyamides such as homopolymers such as polytetramethyleneadipamide (nylon 46), polycaprolactam (nylon 6), polyhexamethyleneadipamide (nylon 66), polyhexamethylenesebacamide (nylon 610), polyhexamethylenedodecamide (nylon 612), polyundecanolactam (nylon 11), polydodecanolactam (nylon 12), etc. and copolymers such as caprolactam/lauryllactam copolymer (nylon 6/12), caprolactam/aminoundecanoic acid copolymer (nylon 6/11), caprolactam/w-aminononanoic acid copolymer (nylon 6/9), caprolactam/hexamethylenediammonium adipate copolymer (nylon 6/66), a copolymer of adipic acid with methaxylenediamine, a copolymer of hexamethylenediamine with m,p-phthalic acid, etc.; polyolefins such as polyalkylene resins such as polyethylene resins such as linear low-density polyethylene (LLDPE), low-density polyethylene (LDPE), and high-density polyethylene (HDPE), and polypropylene resins, etc., ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and their crosslinked products and partially crosslinked products (e.g., crosslinked ethylene-vinyl acetate copolymer), etc.; epoxy resins, urethane resins, diallyl phthalate resins (allyl resins), polycarbonate resins, fluorine resins, amino resins (urea resin, melamine resin, benzoquanamine resin), polyester resins (e.g., polyethylene terephthalate), styrol resins, acrylic resins, polyacetal resins, vinyl acetate resin, phenolic resins, vinyl chloride resin, silicone resins (silicon resins), polyarylene sulfides (e.g., polyphyenylene sulfide); silicone rubbers, latex rubbers; and nylon elastomers as block copolymers of nylon 6, nylon 66, nylon 11, nylon 12, or the like as a hard segment with polyalkylene glycol, polyether, an aliphatic polyester or the like as a soft segment.
These materials may be used either singly or in combination of two or more of them. In addition, the material is used in the form of a monolayer film or a multilayer film. Besides, a synthesized product of the above-mentioned polymeric material may be used, or a commercial product of the polymeric material may also be used.
Now, dimensions of various parts of the catheter 1 will be described below. Since the catheter 1 is used in a method of treating sinusitis as described later, the dimensions of various parts of the catheter 1 are preferably in ranges suitable for insertion of the catheter 1 into a nasal cavity. Specifically, the whole length (“L1” in
Now, the dimensions of the balloon 12 will be described below. The whole length (“L3” in
In addition, the outside diameter (“D2” in
Now, a catheter 1′ as a modification of the catheter 1 according to the present embodiment will be described below.
As shown in
Now, a method of positioning (aligning) the balloon 12 using the marker M provided on the hub 15 (indication section 152) serving as the proximal operating section will be described below referring to
Next, in Step (1-2), the operator reads the graduation on the marker M that indicates the position of the nasal cavity opening O upon completion of Step (1-1). In this case, it is preferable to move the indication section 152 along the first elongated body 11, as required, so that the graduation on the marker M agrees perfectly with the nasal cavity opening O. Then, in Step (1-3), the operator advances the catheter 1 further by a length equal to the distance (see “X” in
Since the effective expansive section 12a of the balloon 12 can be disposed over the whole length of the stenosed part S by the above-described method as shown in
Now, a catheter 2 as a treatment device according to a second embodiment of the present invention will be described below.
As shown in
As shown in
Now, a method of positioning (aligning) the balloon 22 using the above-mentioned second LED light(s) 28 will be described referring to
Subsequently, in Step (2-2), the operator turns off the first LED light 24, and turns on the second LED light 28 instead. Then, in Step (2-3), the operator advances the catheter 2 further inside the nasal cavity N while checking the image obtained by the CCD camera 23 and displayed on the display device D, and stops the catheter 2 upon confirmation of the light from the second LED light 28 on the display device D. By this Step, not only the CCD camera 23 but also the vicinity of the distal end of the balloon 22 can be advanced into the accessory nasal cavity A.
As shown in
As has been described above, the treatment device according to the present invention is suitably applicable to treatment of sinusitis. Here, the form in which the treatment device of the present invention is used for treatment of sinusitis is not specifically restricted. For instance, the treatment device according to the present invention is introduced into a nasal cavity, and, when the entrance of the accessory nasal cavity (paranasal sinus) is confirmed by the imaging unit provided at the distal side on the treatment device, the expansion body is expanded to dilate a stenosed part of the accessory nasal cavity. Thus, the present invention provides a method of treating sinusitis, including: (i) introducing into a nasal cavity a flexible elongated body which integrally has an expansion body provided on the elongated body and imaging unit provided on the distal side relative to the expansion body; (ii) confirming the entrance of an accessory nasal cavity based on an image obtained by the imaging unit; (iii) expanding the expansion body so as to dilate a stenosed part of a natural ostium between the nasal cavity and the accessory nasal cavity. Incidentally, the term “accessory nasal cavity (paranasal sinus)” herein may be any of frontal sinus, ethmoidal sinus, sphenoidal sinus, and maxillary sinus.
According to the just-mentioned method, it is possible to easily and accurately position (align) the expansion body inside the nasal cavity and to dilate a stenosed part of the accessory nasal cavity assuredly and easily, by use of a simple device such as an endoscope, without using a special device such as a radioscopic device. In addition, the method according to the present invention is a minimally invasive method by means of a catheter, and, therefore, it exerts little burden on the patient.
Now, preferred embodiments of the method of treating sinusitis by use of the treatment device according to the present invention will be described referring to the drawings. Incidentally, the present invention is not to be restricted to the following embodiments.
Referring to
Referring to
In this instance, the position of the catheter 1 in the living body can be confirmed through the function of the CCD camera 13. In addition, the position of the entrance E of the accessory nasal cavity A is confirmed by confirming the advance of the CCD camera 13 into the accessory nasal cavity A on the basis of the image obtained by the CCD camera 13.
After the image of the inside of the accessory nasal cavity A is confirmed on the display device D, the catheter 1 is stopped. With the image of the inside of the accessory nasal cavity A obtained, it can be confirmed that the image obtaining plane 13a of the CCD camera 13 is passed through the stenosed part S of the natural ostium to arrive at the entrance of the accessory nasal cavity A.
Referring to
Thus, in the method according to the present invention, it is preferable that after Step (ii) (confirmation of the position of the catheter 1), the elongated body 11 is advanced further from the position confirmed in Step (ii), by a length equal to the distance between the effective expansive section 12a (of the expansion body 12) for pressing the stenosed part S and the image obtaining plane 13a of the imaging unit 13, before the step of expanding the expansion body 12 is performed.
In the case of using a catheter 2 shown in
Referring to
Referring to
Next, while observing the image obtained by the CCD camera 23 and displayed on the display device D, the catheter 2 is advanced further within the nasal cavity N. Upon confirmation of the light emitted from the second LED light 28 on the display device D, the catheter 2 is stopped. By this step, not only the CCD camera 23 but also a portion near the distal end of the balloon 22 can be advanced into the accessory nasal cavity A.
Incidentally, in the present invention, the treatment device (catheter 1, 2) according to the present invention may be advanced directly through the naris and the nasal cavity N into the vicinity of the entrance E of the accessory nasal cavity A, but this is not restrictive. Alternatively, the treatment device 1, 2 may be disposed into the vicinity of the entrance E of the accessory nasal cavity A by use of an assisting device such as a guide catheter or a guide wire.
An example of the method of introducing the treatment device (catheter 1, 2) by use of a guide catheter or a guide wire will be described in brief.
Referring to
Referring to
The guide catheter 34 to be used in introducing the catheter 1 is not specifically restricted, and the same or equivalent guide catheters to those commonly used in the medical field can be similarly used. Taking operability and less-invasiveness to nasal cavity into consideration, however, a flexible guide catheter is preferred. Specific examples of the material which can be used to form the guide catheter, therefore, include: such polymers as polyimides, polyurethane, nylon, polyvinyl chloride (PVC), high-density polyethylene (HDPE), polyether ether ketone (PEEK), etc.; fluorinated polymers such as polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), etc.; and metals such as stainless steel. In addition, the diametral size (thickness) and length of the guide catheter 34 are not particularly limited but may be appropriately selected according to the weight and body type of the patient. The guide catheter 34 may have its surface coated with an appropriate coating such as a surface lubricating coating, for favorable sliding thereof.
Referring to
The guide wire 33 to be used for the introduction is not specifically restricted, and the same or equivalent guide catheters to those commonly used in the medical field can be used similarly.
Referring to
Incidentally, only the guide wire 33 is advanced into the vicinity of the entrance E of the accessory nasal cavity A without using the guide wire 34, and then the catheter 1′ is advanced along the guide wire 33 into the vicinity of the entrance E of the accessory nasal cavity A.
Now, an operation of dilating a stenosed part S of the natural ostium will be described below.
Referring to
The expansion of the balloon 12 may be carried out by use of a medium, which may be the same or equivalent to those commonly used in the medical field. Specific examples of the medium which can be used here include gases such as air, nitrogen, carbon dioxide, etc.; and liquids such as physiological saline, a radiopaque material. Besides, the amount of the medium injected into the expansion body is not particularly limited but may be appropriately selected according to the inside diameter of the stenosed part S (the inside diameter of the natural ostium), the inside diameter of the natural ostium after dilation, or the like.
The expansion of the balloon 12 can be performed with the catheter 1 being positionally-fixed, or while the elongated body 12 is advanced forward or retreated backward.
According to the method in which the expansion is conducted with the catheter 1 being positionally-fixed, a pressure can be exerted on the stenosed part S more assuredly, so that a smooth and speedy technique can be achieved. On the other hand, the method in which the expansion is conducted while the elongated body 12 is advanced forward or retracted backward can be suitably applied to the case where the stenosed part S has a comparatively long extension along the natural ostium.
After the balloon 12 is thus expanded, the catheter 1 is evulsed. In this instance, the evulsion of the catheter 1 is preferably carried out while confirming that the stenosed part S has been dilated, based on the image obtained by the imaging unit 13. By this step, it can be visually confirmed that the stenosed part S has been dilated securely. In addition, the evulsion of the catheter 1 is preferably performed, for example, with the expansion body 12 contracted, or while expansive deformation and contractive deformation of the expansion body 12 are carried out in an appropriate manner. By such an operation, more assured dilation can be achieved.
Besides, the operation of advancing the catheter 1 beyond the stenosed part S into the vicinity of the entrance of the accessory nasal cavity A can be conducted concurrently with the operation of expanding the balloon 12. This ensures that the catheter 1 can be advanced while forcing open the stenosed part S, so that the stenosed part S can be dilated more assuredly.
Referring to
According to the method of the present invention as above-described, the expansion body (balloon) can be disposed over substantially the whole length of the stenosed part, so that the stenosed part can entirely be forced open when the expansion body (balloon) is expanded. This makes it possible to force open the stenosed part of the natural ostium more assuredly, so that the therapeutic effect on sinusitis can be enhanced. In addition, according to the above-described method, the catheter can be effectively prevented from being excessively advanced into the accessory nasal cavity, so that safety in treating sinusitis can be enhanced.
Furthermore, according to the method of the present invention, it is possible to easily and accurately position (align) the expansion body inside the nasal cavity and to reliably and easily dilate the stenosed part of the accessory nasal cavity, by use of an existing CCD camera or the like, without using a special device such as a radioscopic device. Besides, the method according to the present invention is a minimally invasive method based on the use of a catheter, so that it exerts little burden on the patient.
Now, a catheter 3 as a treatment device according to a third embodiment of the present invention will be described below.
Accessory nasal cavities (paranasal sinuses) include frontal sinus, ethmoidal sinuses, sphenoidal sinus and maxillary sinus, and paths of introduction of the treatment device from the nasal cavity into the individual accessory nasal cavities are different from each other. In treating sinusitis, therefore, for guiding the treatment device into the vicinity of the desired one of the accessory nasal cavities, it may be necessary to prepare a plurality of kinds of treatment devices respectively having product specifications (external shapes) according to the introduction paths and introduction angles for the treatment devices, which needs much labor and cost. In addition, even where the plurality of treatment devices differing in product specifications are prepared, it is difficult to cope also with individual differences in anatomical structure from patient to patient. The catheter 3 according to the present embodiment is so configured that a first elongated body 31 constituting a main body portion of the catheter 3 can be reshaped at the time of introduction into a living body. With the first elongated body 31 thus made to be reshapable, the catheter 3 having the first elongated body 31 as a main body portion thereof can be reshaped. Furthermore, the external shape of the catheter 3 can be maintained in the living body. As a result, the catheter 3 and a balloon 32 can be easily and assuredly guided into the vicinity of a stenosed part of the natural ostium, irrespectively of differences in introduction path to each accessory nasal cavity to be treated and individual differences in anatomical structure from patient to patient.
The catheter 3 according to the present embodiment will be described referring to
The catheter 3 includes the first elongated body 31 provided with the balloon 32 as an expansion body, a holding member 40 enclosed in the first elongated body 31, an outer tube member 37 so disposed as to cover predetermined portions of the first elongated body 31 and the holding member 40, a hub 35 used as a proximal operating section, and a main port 35a and a pressure supply port 35b which are provided on the hub 35.
Expansion of the balloon 32 is conducted by a method in which a pressurizing medium such as a liquid is fed into a pressurizing medium holding space defined between the balloon 32 and the first elongated body 31, through a pressuring medium lumen 51 disposed in the catheter 3.
A CCD camera 33 includes an image sensor part 61 disposed inside the first elongated body 31, a connection cable 63 for signal transmission/reception which is electrically connected to the image sensor part 61, and a protective member 65 covering the image sensor part 61. The image sensor part 61 covered with the protective member 65 and the connection cable 63 are disposed in a CCD camera lumen 53.
The image sensor part 61 contains precision apparatuses such as optical elements (e.g., camera lens), light receiving elements, and circuit elements for generation and transmission/reception of various signals at the time of obtaining an image. The transmission/reception of signals between the image sensor part 61 and a display device is conducted through the connection cable 63.
The protective member 65 is provided for preventing the image sensor part 61 from being broken. The protective member 65 is formed in a tubular shape, and the image sensor part 61 is housed in the protective member 65. The protective member 65 can protect the image sensor part 61 from external shocks. Besides, the protective member 65 can also prevent the image sensor part 61 from being excessively curved or bent.
The protective member 65 can be formed, for example, from a metallic material such as iron or aluminum. However, the material of the protective member 65 is not restricted to metallic materials, and the material can be changed appropriately insofar as it can protect the image sensor part 61. In addition, the protective member 65 is provided with an opening 67 through which to lead out the connection cable 63 connected to the image sensor part 61.
The lumen 51 for balloon expansion is connected to a pressure supply device P, such as an indeflator, through a predetermined tube 55 and the pressure supply port 35b provided on the hub 35. The CCD camera 33 is electrically connected to a display device D, such as an LCD, through the connection cable 63 and the main port 35a provided on the hub 35. An optical fiber 34 is connected to a light source device L via the main port 35a provided on the hub 35. Incidentally, other lighting units such as an LED lamp, a halogen lamp and a high-intensity discharge lamp (HID lamp) can also be used, in place of the optical fiber.
The first elongated body 31 has a suction lumen 71 for suctioning fluids present in a living body, such as body fluid and various secretions (refer to
The holding member 40 has a metallic bar member of a long shape extending in the extending direction of the first elongated body 31. The holding member 40 is composed of a bar member of a metallic material which is comparatively flexible or soft.
The “long shape” possessed by the holding member 40 is a shape extending in the extending direction of the first elongated body 31. With the holding member 40 having such a shape, the catheter 3 as a whole can be deformed so that it is curved into an arbitrary direction crossing the axial direction thereof. In addition, when the first elongated body 31 is curved, the first holding member 40 can prevents the first elongated body 31 from being excessively bent. As a result, the first elongated body 31 can be prevented from being broken, and each of the lumens provided in the first elongated body 31 can be prevented from being greatly changed in inner cavity shape.
Besides, the expression “the holding member is enclosed in the first elongated body” includes a form of the holding member 40 being disposed in a lumen formed inside the first elongated body 31, and a form of the holding member 40 being embedded in the inner wall of the first elongated body 31. Thus, the expression widely means disposition of the holding member 40 in the state of being covered with the first elongated body 31.
On the proximal side of the holding member 40, there is provided a proximal section 43 having a metallic bar member of a material more rigid than the holding member 40.
The holding member 40 can be composed of a bar member formed, for example, from copper, brass or other soft metal. The rigidity of the holding member 40 is set at such a magnitude that the first elongated body 31 introduced into a living body can be thereby held in a predetermined curved shape (an external shape with which at least a part of the first elongated body 31 being curved into a direction crossing the axial direction). Therefore, the rigidity of the holding member 40 is designed to be at least higher than the rigidity of the first elongated body 31. In addition, the rigidity is preferably at such a level that reshaping of the first elongated body 31 can be achieved by a simple manual operation. Accordingly, for example, the rigidity of the holding member 40 is designed to be about 50 to 150 Hv. On the other hand, the rigidity of the first elongated body 31 can be designed appropriately within the range below the rigidity of the holding member 40.
The outer tube member 37 and the proximal section 43 for the holding member 40 can be formed, for example, of a material which is higher than the holding member 40 in rigidity, such as iron, stainless steel, and rigid resin materials. In the example shown in the drawings, the holding member 40 and the proximal section 43 are integrally configured by jointing two metallic bars which are different in rigidity.
The proximal section 43 and the outer tube member 37 are intended to enhance pushability of the catheter 3, and to prevent the holding member 40 from kinking on the proximal operating section side. For instance, both of the proximal section 43 and the outer tube member 37 can be provided for the catheter 3. Alternatively, only either one of the proximal section 43 and the outer tube member 37 can be provided for the catheter 3. Besides, the arrangement of the proximal section 43 and the outer tube member 37 can be omitted in the case where the first elongated body 31 is sufficiently provided with pushability and kink resistance.
Incidentally, while a form in which a solid bar member is utilized as the holding member is shown in the drawings, a hollow tubular member can also be utilized as the holding member, as will be described later. Besides, the proximal section 43 can similarly be composed of a hollow tubular member.
The distal end 41 of the holding member 40 is located on the distal side (the left side in
The holding member 40 is preferably disposed at least at the position in the extending direction of the first elongated body 31 (the left-right direction in
Now, a method of using the catheter 3 according to the present embodiment will be described below, referring to
Prior to introduction of the catheter 3 into a living body, reshaping of the catheter 3 is conducted. The reshaping can be easily conducted, for example, by the operator's manual operation. Specifically, a distal portion of the catheter 3 is reshaped into a desired shape according to the anatomical shape of the path to the sinusitis to be treated.
Referring to
Referring to
Referring to
It is also possible to clean the image obtaining plane and the inside of the accessory nasal cavity by supplying a liquid such as water through the suction lumen 71 before or after the inflation of the balloon 32. This ensures removal of body fluid or secretions adhered onto the image obtaining surface of the CCD camera 33, thereby allowing the CCD camera 33 to obtain a clearer image.
After the treatment, the catheter 3 is removed from the living body. After the catheter 3 is taken out of the living body, the external shape of the catheter 3 can be returned into the original shape before reshaping or can be deformed into a different external shape. In the cases of using the catheter 3 to other natural ostia to be treated of the same patient or in the cases of using the catheter 3 for other patients, the catheter 3 can be reshaped into an external shape according to the inner cavity shape of the natural ostium to be treated, each time of such treatment.
Now, the catheter according to Modification (1) of the catheter 3 in the present embodiment will be described below.
As shown in
Now, a catheter 3′ according to Modification (2) of the catheter 3 in the present embodiment will be described below.
In the catheter 3′, a pressurizing medium lumen 51 is not formed inside a first elongated body 31 but is formed between the first elongated body 31 and a elongated body 80 which is disposed to cover the first elongated body 31 for the purpose of defining the pressurizing medium lumen 51. With the pressurizing medium lumen 51 not formed inside the first elongated body 31, it is possible for the first elongated body 31 to be made smaller in diametral size.
The elongated body 80 for defining the pressurizing medium lumen 51 is formed from the same or similar material to that of the first elongated body 31. In addition, a predetermined part of a balloon 32 is attached to the elongated body 80, with the inside of the balloon 32 kept in a liquid-tight and air-tight condition.
The distal end 41 of a holding member 40 is tapered distally. Where a protective member 65 is formed of a metal or the like, the sum of the rigidity possessed by the protective member 65 and the rigidity possessed by the holding member 40 is added to the distal end of the first elongated body 31. In such a case, the rigidity at the distal end of the first elongated body 31 may become excessively high, making it difficult to deform that portion into an arbitrary shape by manual operation. In view of this, by lowering the rigidity at the distal end of the holding member 40, the rigidity of the first elongated body 31 is made to be uniform along the longitudinal direction so that the first elongated body 31 can be deformed into an arbitrary shape on the distal end side. Incidentally, where the holding member 40 of the same material is utilized, the rigidity of the holding member 40 can be controlled by evenly decreasing or increasing the diameter of the holding member 40 along the longitudinal direction.
In addition, as shown in the figure, the first elongated body 31 may be tapered near the distal end in conformity with the tapered shape of the holding member 40. Such a configuration enables the catheter 3′ to be smoothly introduced, advanced and retracted in a living body.
As shown in Modification (1) and Modification (2) above, the catheter according to the present embodiment can be appropriately modified, insofar as a long-shaped member having such a rigidity as to enable reshaping of the first elongated body 31 by manual operation or the like and to hold the first elongated body 31 in the reshaped state is used as the holding member. Other modifications which can be adopted to include a form wherein a plurality of comparatively short holding members are jointed in the longitudinal direction to be used as a single elongated body, and a form wherein the axis of the first elongated body 31 and the axis of the holding member 40 are not set in parallel and wherein the holding member 40 is embedded in the first elongated body 31 in the state of being curved in the circumferential direction of the first elongated body 31.
Besides, in each of the catheters in the third embodiment, also, the catheter may be provided with a marker, in the same manner as in the first embodiment and the second embodiment. An operation of positioning (aligning) the balloon by use of the marker can be incorporated into the treatment procedure by use of each of the catheters according to the third embodiment.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2011-072998 | Mar 2011 | JP | national |
| PCT/JP2011/077583 | Nov 2011 | JP | national |
