Patent Application
20090064999
All patents, patent applications, documents and/or references referred to herein are incorporated by reference, and may be employed in the practice of the invention.
This invention relates to a tracheostomy device comprising an outer cannula, an inner cannula, and an obturator for insertion into the trachea of patients with normal-sized and extra-long stomas. Specifically, this invention is directed to an inner cannula and obturator having a means for easing handling during insertion and removal from the outer cannula, and an improved means of interlocking the inner and outer cannula and interlocking the obturator and outer cannula together.
Tracheostomy is a common procedure used to open a direct airway through an incision in the trachea. The procedure is often performed when the need arises for prolonged airway support in patients with respiratory failure, as it allows for a more secure and manageable airway, safer enteral feeding, and better overall management of the patient. A tracheostomy is also performed in other situations such as for sleep apnea related to obstruction from obesity, congenital abnormality of the larynx or trachea, severe neck or mouth injuries or cancer, inhalation injuries, presence of a large foreign obstruction in the airway, vocal cord paralysis that affects swallowing and increases risk of aspiration, inability to clear secretions, and tracheal stenosis or malacia.
Tracheostomy involves the placement of a tube into the trachea, which is a cartilaginous tubular structure in the throat comprised of 18 to 22 C-shaped rings of rigid cartilage oriented anteriorly and laterally, and a membranous posterior portion. There are two types of tracheostomy techniques: surgical tracheostomy and percutaneous tracheostomy. Surgical tracheostomy typically involves the placement of the tube in the region of the second to fourth tracheal rings. During this procedure, an anterior part of one of the tracheal rings is removed to either produce a stoma, or create a flap with the severed part of the rings. In contrast, percutaneous tracheostomy involves the placement of a tracheostomy tube between the first and second, or between the second and third tracheal rings. This technique involves placing a guide wire between the tracheal rings, and sequentially forcing a series of stiff plastic dilators into the tracheal wall over the guide wire until a stoma is created that can sufficiently accommodate the tracheostomy tube.
Tracheostomy tubes are used to administer positive-pressure ventilation, to protect against aspiration, to provide an airway in patients prone to upper airway obstruction, and to provide access to the lower respiratory tract for airway clearance. Tubes can vary in rigidity, internal and external diameter, and cuff design. Rigidity is dependent on the material of the tube, although more rigid tubes may have a greater tendency to cause mucosal trauma and an increased risk of perforating the tracheal wall. The cuff is a balloon-like device around the distal end of the tracheostomy tube, which can be inflated to protect the airway; this is useful, for example, in patients who are at risk of aspirating.
Dual-cannula tracheostomy devices are designed to be used with an inner cannula. The inner cannula is inserted into the tube or outer cannula, and is used to maintain the airway provided by the outer cannula as clean. The inner cannula may be disposable or may be reusable such that it is cleaned or replace periodically with a new inner cannula. It is believed that cleaning or replacement may reduce biofilm formation and the incidence of ventilator-associated pneumonia. The inner cannula can be a low-profile inner cannula which is used for spontaneous breathing, or an inner cannula with a connector to attach a ventilator.
For insertion of the dual-cannula tracheostomy device into the airway, an obturator is first placed inside the outer cannula to provide rigid support. The outer cannula is then inserted through the stoma and into the airway. Once the outer cannula is in place, the obturator is removed. An inner cannula is then inserted into the outer cannula, and once the lumen becomes compromised by a build-up of mucus and other deposits, the inner cannula can be replaced with a new inner cannula.
Importantly, there are problems associated with tracheostomy devices due to their design. For instance, the obturator or inner cannula may move or change position while inserted into the outer cannula. In addition, there is often no convenient means of handling the obturator or inner cannula during insertion and removal from the outer cannula.
There are few patented devices associated with tracheostomy tubes that are directed to improving the positioning of inner cannula/obturator or providing easier insertion or removal of the cannula/obturator. U.S. Pat. No. 3,659,612 relates to a tracheostomy tube comprising an outer and inner cannula, wherein the outer cannula and inner cannula are sealed together by attachment of a removal fitting which partially fits over the outer and inner cannula. Unfortunately, the attachment and detachment procedure of the inner cannula to the outer cannula are not simple to perform and the inner cannula is not easy to handle. Other patents such as U.S. Pat. Nos. 3,639,624, 4,009,720, 4,135,505, 5,067,515, and 5,067,496 provide a means of clamping the inner cannula to the outer cannula, although this type of engagement can be accidentally disconnected by the patient. U.S. Pat. No. 5,460,176 relates to a device comprising an outer cannula, an inner cannula, a connector head that circumscribes the end of the outer cannula, a connector body that links to the inner cannula and is locked to the connector head, and a securing component that is fitted over the interlocked connector head and body. While this secures the inner and outer cannulas, it does not provide an easy means of removing the inner cannula from the outer cannula and requires the manipulation and handling of multiple components. Furthermore, U.S. Pat. No. 6,481,436 relates to an obturator and tracheostomy tube, wherein the end of the obturator that is towards the outside of the patient's body has a cruciform section with a catch that snaps onto the lip-like edge of the flange on the tracheostomy tube. The obturator is removed by twisting the flange about 20° so that the catch comes out of engagement with the lip-like edge. This type of design, however, can lead to accidental disengagement of the obturator from the tube if the flange or obturator is incidentally twisted during the insertion of the tube into the trachea. Clearly, there is not an effective design for a tracheostomy device wherein the obturator and inner cannula can be sufficiently locked to the outer cannula and manageably inserted and removed from the outer cannula.
The problem of having an ineffectively designed tracheostomy devices is especially important for tracheostomy devices inserted into obese patients. Obese patients typically encounter difficulties when using an average shape/size tracheostomy device, as the tracheal tube/outer cannula does not match the anatomy of the stoma in an obese patient. The tracheal stoma in such patients is longer due to the increased distance between the exterior of the neck and the anterior tracheal wall. Difficulties associated with inefficiently designed tracheostomy device include tube impingement on the posterior tracheal wall, blood clots, mucous plugs, and partial displacement. Patients with a long stoma require a tracheostomy device with a shape that reflects the anatomy of the stoma and the extra distance between the proximal stoma opening and the anterior tracheal wall. The radius of the resultant outer cannula is not constant, posing a geometry that makes the introduction of a typical obturator and inner cannula difficult. Both components would need to be flexible in order to travel through the lumen of the extra-long outer cannula.
Citation or identification of any document in this application is not an admission that such document is available as prior art to the present invention.
The present invention is directed to a dual-cannula tracheostomy device that provides an improved means of stabilizing the inner cannula when it is inserted into the outer cannula tracheostomy tube, and an improved means of handling the inner cannula during its insertion and removal from the outer cannula.
Another aspect of the invention is an improved means of stabilizing the obturator when it is inserted into the outer cannula tracheostomy tube, and an improved means of handling the obturator during its insertion and removal from the outer cannula.
Yet another aspect of the invention is directed to a dual-cannula tracheostomy device for insertion into patients having extra-long tracheal stomas. This device has a means of locking the inner cannula and/or obturator when it is inserted into the outer cannula, and a means of handling the inner cannula and/or obturator during its insertion and removal from the outer cannula.
Another aspect of the invention is a method of inserting a tracheostomy device into the trachea of a patient having a normal or extra-long stoma.
The present invention may comprise an outer cannula and a removable inner cannula. The outer cannula may comprise a distal end that is inserted into the trachea, a proximal end that is outside of the trachea, and a middle lumen therebetween which may have a horizontal section adjacent proximally to a section having a general curvature. The inner cannula may comprise a distal end that is inserted into the outer cannula, a proximal end that is outside of the trachea, and a middle region therebetween which also has a horizontal section proximally adjacent to a section having a general curvature. The inner cannula features a gripping means on its proximal end, which enables ease in handling of the inner cannula during its insertion and removal from the outer cannula, and an interlocking means for holding the inner cannula within the outer cannula. The interlocking means engage with a connecting means that is attached to the outer cannula.
The present invention may also comprise an obturator which helps guide and support the outer cannula during the outer cannula's insertion into the trachea. The obturator comprises a distal end that is inserted into the outer cannula, a proximal end that is outside of the trachea, and a middle region therebetween which has a horizontal section proximally adjacent to a section having a general curvature. The obturator features wing-like structures which contribute to positioning the obturator when inserted in the outer cannula, and an interlocking means which holds the obturator within the outer cannula. The interlocking means of the obturator engage with a connecting means that is attached to the outer cannula.
Moreover, the present invention may comprise an outer cannula and a removable inner cannula that is designed for insertion into the trachea of a patient having an extra-long stoma. This outer cannula comprises a distal end that is inserted into the trachea, a proximal end that is outside of the trachea, and a lumen therebetween which may have a horizontal section adjacent proximally to a section having a general curvature. The horizontal section of the outer cannula in this embodiment is longer as compared to the horizontal section of an outer cannula designed for a normal stoma. The inner cannula comprises a distal end that is inserted into this extra-long outer cannula, a proximal end that is outside of the trachea, and a middle region therebetween which may have a horizontal section adjacent proximally to a section having a general curvature. The horizontal section of the inner cannula of this embodiment is longer as compared to the horizontal section of an inner cannula designed for a normal stoma. This extra-long inner cannula features a gripping means on its proximal end, which enables ease in handling the inner cannula during its insertion and removal from the extra-long outer cannula, and an interlocking means for holding the inner cannula within the extra-long outer cannula. The interlocking means engage with a connecting means that is attached to the outer cannula.
The present invention may further comprise an obturator which helps guide and support the outer cannula during insertion into the trachea of a patient having an extra-long stoma. The obturator comprises a distal end that is inserted into the extra-long outer cannula, a proximal end that is outside of the trachea, and a middle region therebetween which may have a horizontal section adjacent proximally to a section having a general curvature. The horizontal section of the obturator of this embodiment is longer as compared to the horizontal section of the obturator designed for a normal stoma. This extra-long obturator features wing-like structures which contribute to positioning the obturator when it is inserted in the extra-long outer cannula, and an interlocking means which holds the extra-long obturator within the extra-long outer cannula. The interlocking means of the extra-long obturator engage with a connecting means that is attached to the extra-long outer cannula.
The present invention may also comprise a tracheostomy tube kit for patients having a normal-sized stoma, or a tracheostomy tube kits for patients having an extra-long stoma. These kits comprise the outer cannula, the inner cannula, and the obturator of the invention as disclosed above.
The present invention may comprise a method of inserting a tracheostomy device into the trachea of a patient having a stoma, comprising inserting the obturator of the present invention into the outer cannula of the present invention, inserting the outer cannula/obturator assembly through the stoma and into the airway, removing the obturator, and then inserting the inner cannula of the present invention into the outer cannula.
The present invention may further comprise a method of inserting a tracheostomy tube into trachea of a patient having an extra-long stoma, comprising inserting the extra-long obturator of the present invention into the extra-long outer cannula of the present invention, inserting the extra-long outer cannula/extra-long obturator assembly through the extra-long stoma and into the airway, removing the extra-long obturator, and then inserting the extra-long inner cannula of the present invention into the extra-long outer cannula.
Accordingly, it is an object of the invention to not encompass within the invention any previously known product, process of making the product, or method of using the product such that Applicants reserve the right and hereby disclose a disclaimer of any previously known product, process, or method. It is further noted that the invention does not intend to encompass within the scope of the invention any product, process, or making of the product or method of using the product, which does not meet the written description and enablement requirements of the USPTO (35 U.S.C. 112, first paragraph) or the EPO (Article 83 of the EPC), such that Applicants reserve the right and hereby disclose a disclaimer of any previously described product, process of making the product, or method of using the product.
It is noted that in this disclosure and particularly in the claims and/or paragraphs, terms such as “comprises”, “comprised”, “comprising” and the like can have the meaning attributed to it in U.S. Patent law; e.g., they can mean “includes”, “included”, “including”, and the like; and that terms such as “consisting essentially of” and “consists essentially of” have the meaning ascribed to them in U.S. Patent law, e.g., they allow for elements not explicitly recited, but exclude elements that are found in the prior art or that affect a basic or novel characteristic of the invention.
These and other embodiments are disclosed or are obvious from and encompassed by, the following Detailed Description.
The following detailed description, given by way of example, but not intended to limit the invention solely to the specific embodiments described, may best be understood in conjunction with the accompanying drawings, in which:
In the following description, like reference characters designate like or corresponding parts throughout the figures. Additionally, in the following description, it is understood that such terms as “front,” “back,” “left,” “right,” “transverse,” “longitudinal,” “upward,” “downward,” “superior” and “inferior” and the like are words of convenience and are not to be construed as limiting terms.
The present invention is directed to a dual-cannula tracheostomy device for insertion into the trachea of a patient having a stoma. The device is comprised of an outer cannula and a removable inner cannula, wherein the inner cannula features a gripping means to provide easier handling of the inner cannula during its insertion and removal from the outer cannula, and an interlocking means for stabilizing the inner cannula within the outer cannula.
The present invention is also directed to a tracheostomy device that additionally comprises an obturator. The obturator features wing-like structures to position the obturator when it is inserted into the outer cannula, and an interlocking means which holds the obturator within the outer cannula.
Moreover, the present invention is directed to a tracheostomy device for insertion into the trachea of a patient having an extra-long stoma. The device is comprised of an outer cannula and a removable inner cannula which are both extended in length. The extra-long inner cannula features a gripping means to provide easier handling of the extra-long inner cannula during its insertion and removal, and an interlocking means for holding the extra-long inner cannula within the extra-long outer cannula.
The present invention is directed to a tracheostomy tube device that further comprises an obturator for use with a patient having an extra-long stoma. The obturator is extended in length and features wing-like structures, which position the extra-long obturator in the extra-long outer cannula, and an interlocking means, which holds the extra-long obturator within the extra-long outer cannula.
In a preferred embodiment, the outer cannula 1 also comprises a flange 7 on the proximal end, which provides a means to stabilize the outer cannula outside of the patient's body. A connecting means can be attached to the flange to eliminate separation from the ventilation circuit and prevent air leakage. The attachment of the connecting means to the flange may be via methods known in the art, e.g., snap-fit, adhesive, etc.
The connecting means is illustrated in
The connecting means can be comprised of a plastic such as silicone, polyester, polycarbonate, polysulfone, polypropylene, and the like.
In a preferred embodiment, the inner cannula contains an interlocking means 35 for holding the inner cannula within the outer cannula. The interlocking means 35 engage with the connecting means 11 attached to the flange 7 of the outer cannula I. In other words, when the inner cannula 21 is inserted into the outer cannula 1, the interlocking means 35 on the proximal end 23 of the inner cannula engages with the connecting means 11 on the proximal end of the outer cannula. Preferably, the interlocking means 35 fits securely or locks against the undercut 13 of the connecting means 11. More preferably the interlocking means fits securely within the undercut 13. Even more preferably, the interlocking means 35 extend from the surface of the inner cannula 21, and presses against the inner surface of the undercut 13. Further, the ridge 12 of the connecting means 11 provides an additional means of holding the inner cannula 21 in place when inserted in the outer cannula 1.
The interlocking means 35 may be a textured surface or ridges which can engage in a friction fit with the inner surface of the connecting means. Preferably, the interlocking means are protrusions that extend from the outer surface of the inner cannula 21. The protrusions can be of any shape or form, including cubic protrusions, cylindrical protrusions, pyramidal protrusions, and other prism-shaped protrusions, but most preferably hemispherical protrusions as illustrated in
The inner cannula 21 and outer cannula 1 may be surface treated internally and externally as described in U.S. patent application Ser. No. 11/440,905, which is herein incorporated by reference. For example, the surface may be treated with a protective polymeric coating using parylene, such as parylene N, parylene C, or parylene D in an applied thickness of 0.00003″ to 0.0001″ and preferably a thickness of 0.00005″.
In a preferred embodiment, the obturator 41 also has an interlocking means 55 which contributes to hold the obturator 41 within the outer cannula 1. The interlocking means of the obturator engage with the connecting means that is attached to the outer cannula. Preferably, the interlocking means 55 fits securely or locks against the undercut 13 of the connecting means 11. More preferably the interlocking means 55 extend radially and engage with the inner surface of the undercut 13 on the connecting means 11. Further, the ridge 12 is an additional means for holding obturator 41 in place.
The interlocking means 55 may be a textured surface or ridges which can engage in a friction fit with the inner surface of the connecting means. Preferably, the interlocking means are protrusions that extend from the outer surface of wings 51 of the obturator 41. The protrusions can be of any shape or form, including cubic protrusions, cylindrical protrusions, pyramidal protrusions, and other prism-shaped protrusions, but most preferably hemispherical protrusions as illustrated in
The obturator 41 may also comprise a ring finger 61 on its proximal end 42, which helps in handling the obturator during its insertion and removal from the outer cannula. The design of the ring finger is described in U.S. Design Pat. No. 332,140, which is herein incorporated by reference.
The flange, connecting means, and coating described above for use with the outer cannula used in patients having normal-sized stomas are also applicable to outer cannulas used in patients having extra-long stomas.
Compared to the horizontal region 25 of the inner cannula 21 designed for a patient having a normal-sized stoma as shown in
Compared to the horizontal region 45 of the obturator 41 designed for a patient having a normal-sized stoma as shown in
The present invention may also comprise a tracheostomy tube kit for patients having a normal-sized stoma, or a tracheostomy tube kits for patients having an extra-long stoma. These kits comprise the outer cannula, the inner cannula, and the obturator of the invention.
The present invention may comprise a method of inserting a tracheostomy tube into trachea of a patient having a stoma, comprising inserting the obturator of the present invention into the outer cannula of the present invention, inserting the outer cannula/obturator assembly through the stoma and into the airway, removing the obturator, and then inserting the inner cannula of the present invention into the outer cannula.
The present invention may further comprise a method of inserting a tracheostomy tube into trachea of a patient having an extra-long stoma, comprising inserting the extra-long obturator of the present invention into the extra-long outer cannula of the present invention, inserting the extra-long outer cannula /extra-long obturator assembly through the extra-long stoma and into the airway, removing the extra-long obturator, and then inserting the extra-long inner cannula of the present invention into the extra-long outer cannula.
Having thus described in detail preferred embodiments of the present invention, it is to be understood that the invention is not to be limited to particular details set forth in the above description as many apparent variations thereof are possible without departing from the spirit or scope of the present invention.
