WO2007053813A2

WO2007053813A2 - Method of reducing nasal fluid resistance

Info

Publication number: WO2007053813A2
Application number: PCT/US2006/060311
Authority: WO
Inventors: John Collier; M.D. Martin Weisberg
Original assignee: Ethicon, Inc.
Priority date: 2005-10-31
Filing date: 2006-10-27
Publication date: 2007-05-10

Description

ETH5245

METHOD OF REDUCING NASAL FLUID FLOW RESISTANCE

Field of the Invention

The invention relates generally to the field of devices for the remodeling of fluid flow through the nasal passageway. Background

People suffering from nasal airway restriction, such as from a deviated septum, have difficulty drawing enough air through their nose, resulting in the need to breath orally. This condition can lead to snoring, dry mouth, and may impact the body's ability to fight off disease. In addition, it may affect physical performance by limiting the rate of airflow. By reorienting or remodeling the nasal passage geometry, the flow of air through the nose can be improved.

There are a number of approaches used to improve nasal airflow that range from surgical operations to removable devices to sprays. A deviated septum is typically surgically treated by breaking and repositioning the septum, and then maintaining the septum in a fixed position while it heals. This surgery requires a long recovery time and is not always effective. Devices are used temporarily, usually during sleep or exercise, and include nasal adhesive strips, such as Breathe Right® external nasal dilator, that temporarily hold open the nasal airway by externally stiffening the nasal wall, and plastic inserts that are inserted directly into the nasal passage to mechanically expand the nasal opening. Finally, nasal sprays are used to temporarily reduce congestion or the swelling of nasal tissue. ¹

These approaches do not include minimally invasive surgical procedures, like those used to treat facial ptosis, methods of treatment which include the use of barbed fasteners. In such methods, surgeons generally use two methods. In the first, a surgeon uses a hollow needle to create a first, entrance puncture in the skin and, after advancing the needle through tissue, creates a second, exit puncture in the skin distance from the first puncture along a predetermined pulling vector. The barbed fastener is then advanced through the hollow needle and grasped at the exit puncture, and the needle is withdrawn. The surgeon then manipulates the tissue and exposed barbed suture to create the desired effect; i.e., lift the sagging skin. Finally, the exposed ends of the suture are cut below the surface of the skin. In some cases, a dimple can form at one or both of the exit points, and the surgeon releases some of the barbs near the surface to eliminate any dimple. ETH5245

The second method involves the use of straight needles that are attached to opposite ends of the barbed fastener, and creates three punctures. First, the surgeon creates an entrance puncture at the approximate midpoint of the area to be treated, and advances the needle along with one end of the barbed fastener until the needle exits the skin some distance away at a location along a predetermined pulling vector. Next, the surgeon inserts a second needle, attached to the opposite end of the barbed fastener, through the initial midpoint puncture, and advances it in the direction opposite to that of the first needle through the tissue. The second needle is pushed through the tissue until it exits, creating a third puncture in the skin. The surgeon then manipulates the tissue and the exposed barbs on either end of the fastener to create the desired effect. Finally, the exposed ends of the suture are cut below the surface of the skin.

These types of methods are performed using different types of prior art devices for delivering barbed fasteners, which include, for example, those described in U.S. Patent Nos. 3,716,058 (Tanner) and 5,342,376 (Ruff). The Tanner device teaches that the barbed fastener needs to be inserted in two steps. First, one barbed end of the fastener is carried by the needle and when located at the desired location, the other barbed end of the fastener is loaded into the needle and placed at a second desired location. Ruff describes a barbed fastener insertion device that houses the barbs except for perhaps one barb that may extend from the distal end to prevent the fastener from being pulled through the body of the insertion device. The fastener of Ruff includes a pointed end that facilitates entry of the device into tissue. Ruff discloses passing the pointed end of the fastener and the insertion device into and out of the tissue, thereby creating two punctures. Among the disadvantages of the Tanner and Ruff devices, they do not allow for intimate contact during insertion between a plurality of barbs and the tissue within which the barbs will be anchored. Further Tanner and Ruff do not describe a method in which a barbed fastener can be applied within tissue in a single pass while creating only one puncture.

It would be desirable to provide a minimally invasive surgical procedure to reduce treat nasal fluid flow resistance.

Summary of the Invention The invention consists of a surgical implantation procedure to reduce nasal fluid flow restriction and treat nasal airway restriction. In one method, barbed sutures can be implanted alongside the nose, preferably the upper region, just under the eye to reposition or pull tissue ETH5245

away from the nose. This repositioning increases the cross sectional area of the upper nasal cavity, thereby permitting increased airflow though the nasal passageway. In such a method, a barbed fastener delivery device can be configured to dissect tissue and permit a plurality of barbs to contact the tissue through which it is passed during insertion. The present invention provides a method of reducing nasal fluid flow resistance that includes the steps of providing a fastener having a body and at least two barbs extending from the body, creating a passageway through a first layer of tissue, inserting at least a distal end of the fastener to a first location below the first layer of tissue, anchoring a distal end of the fastener at the first location, and displacing tissue near the nostril by engaging the at least two barbs with tissue at a second location to reduce resistance to the flow of fluid through the nose.

The advantage of the inventive method is that it is a less-invasive method of inserting a barbed fastener that can permanently improve nasal airflow, which can improve snoring, dry mouth (during sleeping), sleep apnea, and breathing during strenuous activity. These and other objects, features and advantages of the present invention will be apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.

Brief Description of the Drawings

Figs. Ia, Ib and Ic are perspective views of different embodiments of barbed fasteners that may be used with the present disclosure;

Fig. 2 is a perspective view illustrating one embodiment of a delivery system having a sharpened distal end and a distal opening;

Fig. 3 is a side cross-sectional view of Fig. 2; Fig. 4 is an end view of Fig. 2; and Figs. 5a-5c illustrate steps of one method of using the fastener delivery device of the present disclosure to reduce nasal fluid flow resistance.

Detailed Description

Referring now to Figs. Ia through Ic, different types of barbed fasteners are depicted as examples of those types of fasteners that may be deployed in the method of the invention. One example, depicted in Fig. Ia, is a barbed fastener 10 having a body 11, a distal portion 12 and a proximal portion 13. Fastener 10 may have barbs 14a, 15a that extend along its ETH5245

entire length or along only a portion or portions of its length. In a preferred embodiment, a first set or plurality of barbs 14 and a second set or plurality of barbs 15 each may include a plurality of barbs 14a, 15a, that preferably number at least three, and more preferably at least five. First set of barbs 14 extend from distal portion 12 of body 11 substantially along a first predetermined length L in a first direction at an angle α that is less than 90 degrees relative to the longitudinal axis. Second set of barbs 15 extend from proximal portion 13 of body 11 substantially along a second predetermined length M in a second direction at an angle β that is greater than 90 degrees but less than 180 degrees relative to the longitudinal axis.

As shown in Fig. Ib, each barb 14a, 15a extends from body 11 at a base 14b, 15b to a free end 14c, 15c. Fastener 10 may include a predetermined unbarbed length between first set of barbs 14 and second set of barbs 15. First set of barbs 14 may be offset radially from the second set of barbs 15, as is shown in Fig. Ia, preferably by approximately 180 degrees. Alternatively, fastener 10 may include barbs 14a that extend radially from different points along the circumference of body 11 in a staggered manner, as shown in Fig. Ib, or in an aligned manner, i.e., extending from approximately the same position along the length of body 11, but offset radially by some angle, as shown in Fig. Ic. Fastener 10 may include a body that has a circular, ovate, elliptical or triangular cross section, for example. In one embodiment, fastener 10 does not have any barbs along a length of proximal end 11.

Fastener 10 may be manufactured according to the method described in U.S. Application Serial No. 11/169,869, filed on , 2005 (Docket No. ETH5215), the disclosure of which is hereby incorporated by reference, and may be made of any suitable nonabsorbable material such as polypropylene, or any suitable absorbable material such as poly(glycolide-lactide) or poly(glycolide-ε-caprolactone). Alternatively, fastener 10 could be formed from a shape memory polymer, such as a polyurethane-based polymer, so as to facilitate deployment of the barbs after exposure to the transition temperature of the shaped memory polymer. The suture size may vary but preferably ranges from size 3-0 to size 1, most preferably size 2-0 to size 0.

Referring to Fig. 2, a first embodiment of a fastener delivery device 30 is depicted that includes a cannula 20 and a barbed fastener 10 at least partially disposed within a lumen 25 of cannula 20. Lumen 25 of cannula 20 is preferably coaxial with the longitudinal axis that intersects the center of the cannula cross section, but may be offset from such longitudinal axis. In this case, fastener 10 has a first plurality of barbs 14 extending from distal end 12 of body 11 and a second plurality of barbs 15 extending from proximal end 13 of body 11 that ETH5245

are offset radially approximately 180 degrees from the first plurality of barbs. Cannula 20 has a distal end 21 and a proximal end 22, a distal tip 23 and an opening 24 that extends from the distal tip in a proximal direction for a predetermined length. Distal tip 23 is preferably sharp, but must at least be configured so as to dissect tissue and thereby create a pathway through which cannula 20 may pass. In one embodiment, distal tip 23 is ground at a 45 degree angle to a sharpened point.

Opening 24 may be formed by removing a portion of cannula 20 to form a slot. Opening 24 is configured to be of a length that permits at least two barbs 14a to be exposed to tissue through which cannula 20 is passed. That is, as is best seen in Fig. 3, the free ends of at least two barbs 14a extend beyond the cannula wall such that the free ends 14c are exposed to tissue when fastener delivery device 30 is in use. Opening 24 is configured to have a width that is less than the diameter of body 11 of fastener 10 so as to prevent fastener 10 from being inadvertently released from cannula 40.

The cross section of cannula 20 may be of any shape, such as circular, ovate or triangular, for example, but preferably is configured to have a portion that provides space to hold barbs in a deflected position; i.e., a position in which the barb extends from the body at an angle relative to the longitudinal axis. One example is shown in Fig. 4, where the cross section of cannula 20 is ovate to better conform to a fastener having a second set of barbs 15 that are 180 degrees radially offset from the first set of barbs 14. In that case, the second set of barbs 15 can be disposed within cannula 20 without being constrained in a flattened position. If barbs 15 are constrained for a period of time, they may retain a memory of that position and may not extend to a configuration that is better able to bite and hold tissue.

Methods of Improving Nasal Fluid Flow Resistance One method that fastener delivery device 30 can be used to advantage is to reduce nasal fluid flow resistance as depicted in Figs. 5a-5c. In such a method, a fastener delivery device 30 having a fastener 10 and a cannula 20 is provided, as shown in Fig. 5a. The user pierces tissue T to create puncture S with distal end 23 into the soft tissue at a position near the izygomatic bone below the eye and in a medial direction toward the nose, preferably the transverse part of the nasalis muscle. Distal end 23 dissects tissue to provide a pathway for cannula 20. The distal end of the device is passed through the soft tissue layer, to a tissue plane superior to the superficial musculoaponeurotic system (SMAS) in the subcutaneous ETH5245

tissue to a position near the upper region of the nostril. This position is shown in Fig. 5a. While cannula 20 is passed through tissue, the plurality of distal barbs are exposed to tissue T and are deflected back toward body 11 of fastener 10 by tissue T to permit fastener 10 and cannula 20 to pass through tissue T without undue resistance. Upon reaching the position depicted in Fig. 5a, cannula 20 is withdrawn, as depicted in Fig. 5b, and the distal barbs engage tissue to prevent fastener 10 from being pulled out with cannula 20. The surgeon may then grasp the proximal, exposed end of the fastener 13, and massage the tissue (skin) located superior of that portion of fastener 10 that is disposed within the tissue, in a lateral direction, so as to move the tissue laterally away from the nostril. Alternatively, proximal end 13 of fastener 10 is pulled proximally to a position within the tissue so as to engage the tissue with the proximal set of barbs 15 to displace tissue near the nostril. Either of these actions will cause tissue near the nostril to be displaced and change the geometry of the nasal passage in such a way as to create a larger effective opening (dilate the nasal passage) for improved fluid flow. Upon achieving the desired effect, the suture is cut just below the skin to remove the excess material as shown in Fig. 5c. Multiple sutures or fasteners may be placed in a region to displace tissue on either side of the nostrils and assist in the remodeling of the nasal passageway.

Optionally, prior to the method, the patient's nasal passage fluid flow may be measured and compared to the fluid flow just prior to the step of cutting the proximal end of the fastener. In this way, the surgeon may determine whether the geometry of the nasal passage has been effectively altered to improve fluid flow. If it has not, the surgeon may reorient the fastener to displace additional tissue.

It should be understood that the surgical approach of using fastener delivery device 30 may differ from that described above and achieve similar results. For example, a surgeon can approach tissue superior to the SAMS with cannula 20 through the nostril or nasal cavity or transbuccally; i.e., through the mouth.

An alternative method of using fastener delivery device 30 differs from the above methods as follows. Rather than preloading the barbed fastener, fastener 10 can be loaded into cannula 20 once cannula 20 is positioned within the tissue proximate the nostril region. Another method for surgically reducing nasal fluid flow resistance utilizes a transbuccal approach using a fastener having a single-direction set of barbs on one end and an anchor formed at the other end for attachment to the zygomatic bone. This method includes ETH5245

the steps of making an incision through the buccal mucosa and dissecting tissue to the zygomatic arch or bone. Next, an anchor can be secured to bone by way of any know affixation method, including glue or a mechanical anchor. The fastener is then loaded into a cannula 20 and positioned toward the lateral portion of the nostril. Finally, cannula 20 is passed into the nostril. The cannula 20 is removed, leaving a fastener in place. Tissue is positioned above fastener 10 to obtain the desired effect prior to trimming proximal end 13 of fastener in the nostril.

Yet another alternative method of deploying a barbed fastener may use surgical needles attached at each end of the barbed fastener to access the appropriate tissue layer. In this embodiment, a cannula with a sharpened distal end is not necessary as the needles perform the function of tissue penetration and dissection. In this method, a needle on one end of the barbed fastener accesses the tissue plane and is passed out through the epidermis, where the needle is detached from the fastener. The barbed fastener is applied to the tissue in a manner similar to that method described above. The barbed fastener may be sheathed to prevent the barbs from hanging up on the tissue prior to time the surgeon intends to dispose the barbs in the tissue.

Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments and that various other changes and modifications may be effected herein by one skilled in the art without departing from the scope or spirit of the invention.

Claims

ETH5245What Is Claimed Is:

1. A method of reducing nasal fluid flow resistance, comprising the steps of: providing a fastener having a body and at least two barbs extending from the body; creating a passageway through a first layer of tissue; inserting at least a distal end of the fastener to a first location below the first layer of tissue; anchoring a distal end of the fastener at the first location; and displacing tissue near the nostril by engaging the at least two barbs with tissue at a second location to reduce resistance to the flow of fluid through the nose.

2. The method of claim 1, further comprising the step of providing a cannula, having a slot on a distal end, and wherein the fastener is at least partially disposed within the cannula such that the at least two barbs are exposed to the first layer of tissue when the suture is inserted through the first layer of tissue.

3. The method of claim 1, wherein the second location is in tissue located superior to the superficial musculoaponeurotic system.

4. The method of claim 1, wherein the inserting step comprises inserting the distal end to a position proximal to epidermis without creating an exit puncture in the epidermis.