Intraluminal stoma interface devices and methods of manufacturing

Abstract

Stoma interface devices and methods for manufacturing the same for total laryngectomy and select partial laryngectomy patients that fit directly into the tracheostoma where the devices provide a support which can interface with standardized tracheostoma components (e.g., speaking valves) and offer hands-free alternatives for tracheoesophageal (TE) speech production. Devices hereof comprise a body having a self-expanding frame coated in multi-durometer silicone elastomers to form a distal portion with a distal flange configured to engage the tracheostoma of the patient, and a proximal portion configured to interface with the tracheostoma components.

Description

[0001] INTRALUMINAL STOMA INTERFACE DEVICES AND METHODS OF MANUFACTURING

[0002] PRIORITY

[0003] The present application is related to, and claims the priority benefit of, U.S. Provisional Patent Application Ser. No. 63 / 635,286, the contents of which is hereby incorporated by reference in its entirety into this disclosure.

[0004] TECHNICAL FIELD

[0005] The present invention relates generally to intraluminal devices which form a seal to the surrounding tissue. Specifically, the present disclosure describes intratracheal devices also known as tracheostoma buttons, for total laryngectomy and select partial laryngectomy patients. Especially pertinent are those buttons that fit directly into the tracheostoma where the framework provides a support which can interface with standardized components (e.g., speaking valves) and offer hands-free alternatives for tracheoesophageal (TE) speech production.

[0006] BACKGROUND

[0007] Worldwide nearly 200,000 laryngeal cancer cases are newly diagnosed per year. Current treatment aims for the preservation of the larynx whenever possible. However, in patients with advanced-stage disease and those who fail larynx preservation therapies, a total laryngectomy is required to save the patient’s life. Laryngectomy, the removal of the larynx, is a highly invasive procedure, resulting in gross alteration of existing anatomy. The patient’s trachea is sewn to the skin of the anterior neck, forming a tracheostoma for air exchange. This disconnects the trachea from the upper airway resulting in loss of sound production for speech and an inability to filter, regulate temperature and moisten airflow to the lungs. Various devices exist to interface the tracheostoma and heat-moisture exchangers (HME) and filters. Most of these devices are constructed of a pliable silicone material meant to lock into the patient's tracheostoma and seal the opening, allowing inflow and air passage through the HME and filter. Similar devices are used for speech restoration, which depend on the placement of a unidirectional valved prosthesis through a surgically created TE puncture. The TE puncture directs air from the lungs through the one-way valve into the esophagus, allowing sound production when the stoma is manually occluded. Simultaneously, the TE voice prosthesis prevents the aspiration of food and liquid into the lungs. Intraluminal attachments, or tracheostoma buttons, are devices that fit directly into the tracheostoma serving as attachments for HMEs, filters, speaking valves, and the like, and offer hands-free alternatives for TE speech production. Hands-free speech is thus dependent on the ability of the device to be retained in the stoma during speech production despite increased backpressure associated with spontaneous changes in loudness (yelling), throat clearing and coughing. Unfortunately, less than half of TE speakers can use hands-free devices further reducing quality of life, impeding the ability to return to normal daily routines and activities after total removal of their larynx.

[0008] Significant inter-patient variation in tracheostoma morphology often causes “poor fit” and patient discomfort and poor device performance. Current commercially available buttons are constructed in a circular geometry, while the reality of most patients is that their stomas have complex geometries resulting in regions where tissue experiences excessive contact. Current devices are rigid and unable to adapt to stomal configurations during real-time human movement and anatomical changes that alter position, and posture, such as pressure changes due to speaking, which results in device piston and excessive motion, and they are relatively heavy and thus carry excessive inertia during motion, resulting in increased friction and relative motion causing chronic injury of the stoma and chronic complications. Thus, they are frequently intolerable due to the excessive device movement that abrades dermal and tracheal tissue, creating severe discomfort and ultimate extrusion of the device with excessive force during breathing, forcible exhalation, coughing, etc. that naturally occur as people walk, run, bend, lift, etc. Furthermore, current devices are cost-ineffective and subject to the time and expense of trial and error, forcing patients to purchase new buttons to accommodate proper fitting to their anatomy. Thus, there is a need for a device with improved stability and durability, reduced pistoning and relative motion, and adaptable to various stomal geometries and configurations that can comply with patient anatomy and be sufficiently retained in the stoma during speech without needing manual occlusion or some form of secondary system to keep the device in place. The technology which provides the improved fit and seal for tracheostoma buttons, can also be incorporated into intraluminal devices that are used in other applications requiring an interface in a stoma of a patient, including but not limited to, stomas such as transperitoneal stomas including ostomy and ileostomy. SUMMARY

[0009] Accordingly, to remedy the above-identified limitations associated with current commercially available intraluminal devices, or tracheostoma buttons, the present disclosure describes one or more embodiments of a novel intraluminal device, or tracheostoma button, for use as an interface between the post laryngectomy patient’s tracheostoma and devices including, but not limited to, HME’s, filters, and manual / automatic speech valves, which is more comfortable, reduces chafing, improves retention, and increases fit range.

[0010] An embodiment of the present disclosure provides a tracheostoma button, wherein the button comprises a body having a self-expanding, low radial force frame and a flexible resilient skin covering or coating the frame (e.g., molded onto the frame). The body includes a proximal portion having a cuff configured for interfacing with a tracheostoma device (e.g., HME, filter, manual / automatic speech valve, etc.), a distal portion, which includes a distal flange, and a neck portion between the cuff and the distal flange, wherein the neck and distal flange are configured to engage with and hold the button in a patient’s tracheostoma.

[0011] In at least one embodiment of the present disclosure, the frame may be made of a biocompatible memory metal, such as Nitinol.

[0012] In at least one embodiment of the present disclosure, the skin may be made of a material such as a polymer, including silicone and / or thermoplastic polyurethane. In at least one embodiment, the skin may comprise multi-durometer silicone elastomers, including a generally stiff elastomer and at least a softer / less stiff elastomer. In at least one embodiment, the skin may comprise a <50 durometer silicone elastomer and an approximately 5 durometer silicone.

[0013] In at least one embodiment of the present disclosure, the body of the button may be formed by molding an approximately 5 durometer silicone onto the frame to form the distal portion of the body including the distal flange, and molding the proximal portion of the body, including the cuff, from a <50 durometer silicone elastomer, wherein the distal portion and the proximal portion are joined together, for example by bonding the distal portion to the proximal portion with a silicone adhesive, or similar manner, to form the body of the button, and define the neck portion therebetween.

[0014] In at least one embodiment of the present disclosure, the body of the button may be formed by molding a <50 durometer silicone elastomer onto the frame, molding an approximately 5 durometer silicone ring filled with viscoelastic silicone gel to form the distal flange of the body, and joining the distal flange at the distal end of the distal portion of the body, for example by bonding the distal flange to the body with a silicone adhesive, or similar manner.

[0015] An embodiment of the present disclosure provides a method of manufacturing a stoma interface device comprising the steps of: forming a self-expanding tubular frame having a first outer diameter and a distal flange at a distal end of the frame, the distal flange having a second outer diameter greater than the first outer diameter; molding a first material onto the frame to create a distal body portion; molding a tubular proximal body portion from a second material, the proximal body portion having a first outer diameter and a cuff at a proximal end of the proximal body portion, the cuff having a second outer diameter greater than the first outer diameter; and connecting the distal body portion to the proximal body portion.

[0016] In at least one embodiment of the present disclosure, the self-expanding tubular frame is made from a biocompatible memory metal, such as nitinol.

[0017] In at least one embodiment of the present disclosure, the first material molded onto the frame is a silicone elastomer having a durometer between 20 Shore 00 and 10 Shore A, preferably having approximately a 5 Shore A durometer.

[0018] In at least one embodiment of the present disclosure, the second material forming the proximal body portion is a silicone elastomer having a durometer between 30 Shore A and 90 Shore A, preferably having approximately a 50 Shore A durometer.

[0019] It is understood that the invention is not limited to the disclosed embodiments. They should be considered representative examples beyond limitation by dimension, material, or construction method.

[0020] BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:

[0022] FIG. 1 is a perspective view of a tracheostoma button according to an embodiment of the present invention;

[0023] FIG. 2 is a side view of a component of a tracheostoma button according to an embodiment of the present invention; FIG. 3 is a perspective view of a component of a tracheostoma button according to an embodiment of the present invention;

[0024] FIG. 4 is a perspective view of a component of a tracheostoma button according to an embodiment of the present invention;

[0025] FIG. 5 is a side view of a frame component of a tracheostoma button according to an embodiment of the present invention;

[0026] FIG. 6 is a perspective view of a frame component of a tracheostoma button according to an embodiment of the present invention;

[0027] FIG. 7 is a side view of a subassembly of components of a tracheostoma button according to an embodiment of the present invention;

[0028] FIG. 8 is a side, cross-section view of a subassembly of components of a tracheostoma button according to an embodiment of the present invention;

[0029] FIG. 9 is a perspective view of a subassembly of components of a tracheostoma button according to an embodiment of the present invention;

[0030] FIG. 10 is a perspective, cross-section view with hidden lines visible of a subassembly of components of a tracheostoma button according to an embodiment of the present invention;

[0031] FIG. 11 is an exploded cross-section view of a tracheostoma button according to an embodiment of the present invention;

[0032] FIG. 12 is a side view of a tracheostoma button according to an embodiment of the present invention;

[0033] FIG. 13 is a side, cross-section view of a tracheostoma button according to an embodiment of the present invention;

[0034] FIG. 14 is a perspective, cross-section view with hidden lines visible of a tracheostoma button according to an embodiment of the present invention;

[0035] FIG. 15 is a flow chart of steps of an exemplary method of manufacturing a tracheostoma button according to an embodiment of the present invention;

[0036] FIG. 16 is a side view of a tracheostoma button with hidden lines visible according to an embodiment of the present invention;

[0037] FIG. 17 is a side, cross-section view of a tracheostoma button according to an embodiment of the present invention; FIG. 18 is a perspective view of a frame of a tracheostoma button according to an embodiment of the present invention; and

[0038] FIG. 19 is a side view of a frame of a tracheostoma button according to an embodiment of the present invention.

[0039] As such, an overview of the features, functions and / or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described and some of these nondiscussed features (as well as discussed features) are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and / or configuration. Furthermore, wherever feasible and convenient, like reference numerals are used in the figures and the description to refer to the same or like parts or steps. The figures are in a simplified form and not to precise scale.

[0040] DETAILED DESCRIPTION

[0041] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. While the embodiments are described herein are in reference to tracheostoma buttons for use in the context of an interface between a post laryngectomy patient’s tracheostoma and devices including, but not limited to, HME’s, filters, and manual / automatic speech valves, it will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended as the technology herein can also be incorporated into intraluminal devices that are used in other applications requiring an interface in a stoma of a patient, including but not limited to, stomas such as transperitoneal stomas including ostomy and ileostomy.

[0042] FIG. 1 discloses a tracheostoma button 10 for use as an interface between a tracheostoma of a person and a tracheostoma device (e.g., an HME, filter, manual / automatic speech valve, etc.). The tracheostoma button 10 has a body 20 having a proximal portion 30 with a cuff 40 at its proximal end for engaging with a tracheostoma device (not shown), and a distal portion 50 for engaging the tracheostoma of a person. The proximal portion 30 may be made of a flexible resilient material such as a polymer, including silicone and / or thermoplastic polyurethane. In at least one embodiment the proximal portion 30 may comprise a relatively stiff silicone elastomer, i.e., based on the Shore Hardness Scales, having a Shore Hardness ranging from 30 Shore A to 90 Shore A. In at least one embodiment, the proximal portion 30 may comprise a silicone elastomer having a Shore Hardness of approximately 50 Shore A. The cuff 40 is configured for interfacing with whatever tracheostoma device (e.g., HME, filter, manual / automatic speech valve, etc.) with which the button 10 is intended to interface as is known in the art. (See FIGS. 2-4).

[0043] As illustrated in FIGS. 5-10, the distal portion 50 comprises a self-expanding frame 60 that is covered or coated with a flexible resilient skin 70, such as a polymer, including silicone and / or thermoplastic polyurethane, which is generally softer than the material of the proximal portion 30. In at least one embodiment, the frame 60 may be made of a biocompatible memory metal, such as Nitinol. Nitinol, a biocompatible memory metal, will provide a nearly constant, evenly distributed force over a relatively large range of deflection within the button 10. The skin 70 may comprise a flexible resilient material such as a polymer, including silicone and / or thermoplastic polyurethane which covers and is supported by the frame 60. In at least one embodiment, the skin 70 may comprise a relatively soft silicone elastomer, i.e., having a Shore Hardness ranging from 20 Shore 00 to 10 Shore A. In at least one embodiment, the skin 70 may comprise a silicone elastomer having a Shore Hardness of approximately 5 Shore A.

[0044] The frame 60 of the distal portion 50 is configured such that when it is coated with the skin 70, it forms a flange 80 at the distal end of the distal portion 50. The integrity of the frame 60 allows the use of the soft skin 70 to form the flange 80 with retention over a range of stoma sizes and configurations. The inclusion of the frame 60 also allows a much thinner mesh-like wall of the button 10 while maintaining the necessary radial force, thereby expanding airflow diameter, improving user breathing, comfort, and overall retention, and providing a more discreet smaller tracheostoma device interface.

[0045] As illustrated in FIGS. 11-14, the proximal portion 30 and the distal portion 50 are joined, for example by bonding the two parts together, to form the generally cylindrical body 20 of the tracheostoma button 10 having an axial lumen 90 therethrough. A neck 100 is formed between the flange 80 and the cuff 40 where the proximal portion 30 and the distal portion 50 are joined. Accordingly, in use air can flow from an opening at the proximal end of the button 10 through the lumen 90 to an opening at the distal end of the button 10 and into the trachea of a person wearing the button 10 allowing the person to breathe.

[0046] The tracheostoma button 10 may be attached to the tracheostoma of a person, such that the flange 80 of the distal portion 50 of the button 10 is inserted into the tracheostoma and a tracheostoma device is connected to the cuff 40 of the proximal portion 30 of the button 10 in a known manner.

[0047] The button 10 may be provided in various sizes. For example, the neck 100 may have a certain outer diameter (OD), which is typically determined by the size of the stoma with which the button 10 will be used, but generally the OD of the neck 100 ranges from 12-22 mm. The flange 80 is configured to have an OD greater than the OD of the neck 100, for example, having an OD 120% greater than the neck 100 OD. This example is not intended to be limiting as to the ratio between the neck 100 OD and the flange 80 OD, and a person of skill in the art will be able to determine such a ratio as necessary. The neck 100 may also have a certain length, which is typically determined by the size of the stoma with which the button 10 will be used, but generally the length of the neck 100 ranges from 4-16 mm.

[0048] An exemplary method of manufacturing the button 10 begins with selecting the appropriate button size for fabrication. The process starts by selecting a length of Nitinol braid. The braid is cut, doubled over, and heatset on a mandrel to form the desired shape with specific mechanical properties creating the frame 60. The frame 60 may be insert-molded using skin 70, which may comprise a silicone elastomer having a Shore Hardness ranging from 20 Shore 00 to 10 Shore A, preferably a silicone elastomer having a Shore Hardness of approximately 5 Shore A, forming the distal portion 50 (shown in FIGS. 7-10) that includes the distal flange 80. Concurrently, the proximal portion 30 including cuff 40 (FIGS. 2-4) is molded using a silicone elastomer having a Shore Hardness ranging from 30 Shore A to 90 Shore A, and preferably a silicone elastomer having a Shore Hardness of approximately 50 Shore A.

[0049] The distal portion 50 and the proximal portion 30 are trimmed to specific lengths, and are then bonded, for instance with a silicone adhesive, to complete the button 10. This process is illustrated in FIG. 15.

[0050] FIGS. 16-17 disclose a tracheostoma button 1010 for use as an interface between a tracheostoma of a person and a tracheostoma device (e.g., an HME, filter, manual / automatic speech valve, etc.). The tracheostoma button 1010 has a body portion 1020 having a proximal end 1030 configured for engaging with a tracheostoma device (not shown), as is known in the art, and a distal end 1050 configured for engaging the tracheostoma of a person. The tracheostoma button 1010 further includes a flange 1080 positioned around the circumference of the distal end 1050 of the body portion 1020. The body portion 1020 comprises a self-expanding frame 1060 (shown in FIGS. 18-19) that is covered or coated with a flexible resilient skin 1070. In at least one embodiment, the frame 1060 may be made of a biocompatible memory metal, such as Nitinol, and the skin 1070 may be made of a material such as a polymer, including silicone and / or thermoplastic polyurethane. In at least one embodiment, the skin 1070 of the body portion 1020 of the button 1010 may comprise a <50 durometer silicone elastomer which covers and is supported by the frame 1060.

[0051] The flange 1080 of the button 1010 is generally softer than the body portion 1020, and may comprise an approximately 5 durometer silicone configured to form a hollow ring that is filled with a viscoelastic material 1110, such as silicone gel, or the like. The addition of the material 1110, being viscoelastic, in the flange 1080 allows the flange 1080 to conform to tissues underlying the contact surface of the button 1010, further reducing contact forces and relative motion. The integrity of the frame 1060 allows the use of the soft flange 1080 with retention over a range of stoma sizes and configurations. The inclusion of the frame 1060 also allows a much thinner meshlike wall of the button 1010 while maintaining the necessary radial force, thereby expanding airflow diameter, improving user breathing, comfort, and overall retention, and providing a more discreet smaller tracheostoma device interface. The body portion 1020 and the flange 1080 may preferably be integrally formed and manufactured as one integral and monolithic body.

[0052] As illustrated in FIGS. 16-17, the tracheostoma button 1010 is configured in a generally cylindrical form providing an axial lumen 1090 therethrough. Accordingly, in use, air can flow from an opening at the proximal end 1030 of the button 1010 through the lumen 1090 to an opening at the distal end 1050 of the button and into the trachea of a person wearing the button 1010 allowing the person to breathe.

[0053] The tracheostoma button 1010 may be attached to the tracheostoma of a person, such that the distal end 1050 of the button 1010, including the flange 1080 is inserted into the tracheostoma and a tracheostoma device is connected to the proximal end 1030 of the button 1010 in a known manner.

[0054] While various embodiments of devices and systems and methods for using the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof.

[0055] Further, in describing representative embodiments, the present disclosure may have presented a method and / or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and / or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.

Claims

CLAIMS1. A stoma interface device comprising: a tubular body having a proximal portion with an open proximal end, a distal portion with an open distal end, and a lumen extending therebetween; wherein the distal portion comprises a self-expanding frame, a first material covering the self-expanding frame, and a distal flange at the distal end, the distal flange having an outer diameter that is greater than an outer diameter of the rest of the distal portion; wherein the proximal portion is formed of a second material and comprises a cuff at the proximal end, the cuff having an outer diameter that is greater than an outer diameter of the rest of the proximal portion; wherein the second material is more rigid than the first material.

2. The stoma interface device of claim 1, wherein the self-expanding frame is made from a biocompatible memory metal.

3. The stoma interface device of claim 1, wherein the self-expanding frame is made from ni tinol.

4. The stoma interface device of claim 1, wherein the first material is a silicone elastomer having a durometer between 20 Shore 00 and 10 Shore A.

5. The stoma interface device of claim 1, wherein the first material is a silicone elastomer having approximately a 5 Shore A durometer.

6. The stoma interface device of claim 1, wherein the second material is a silicone elastomer having a durometer between 30 Shore A and 90 Shore A.

7. The stoma interface device of claim 1, wherein the second material is a silicone elastomer having approximately a 50 Shore A durometer.

8. The stoma interface device of claim 1 , wherein the distal flange of the distal portion is configured to be inserted into a stoma of a patient.

9. The stoma interface device of claim 1, wherein the cuff of the proximal portion is configured to receive a tracheostoma device selected from the group consisting of a HME, a filter, and a speech valve.

10. The device of claim 1, wherein the body has a length between about 8 mm to about 25 mm.

11. A method of manufacturing a stoma interface device comprising the steps of:forming a self-expanding tubular frame having a first outer diameter and a distal flange at a distal end of the frame, the distal flange having a second outer diameter greater than the first outer diameter; molding a first material onto the frame to create a distal body portion; molding a tubular proximal body portion from a second material, the proximal body portion having a first outer diameter and a cuff at a proximal end of the proximal body portion, the cuff having a second outer diameter greater than the first outer diameter; and connecting the distal body portion to the proximal body portion.

12. The method of claim 11, wherein the self-expanding tubular frame is made from a biocompatible memory metal.

13. The method of claim 11, wherein the self-expanding tubular frame is made from ni tinol.

14. The method of claim 11, wherein the first material is a silicone elastomer having a durometer between 20 Shore 00 and 10 Shore A.

15. The method of claim 11, wherein the first material is a silicone elastomer having approximately a 5 Shore A durometer.

16. The method of claim 11, wherein the second material is a silicone elastomer having a durometer between 30 Shore A and 90 Shore A.

17. The method of claim 11, wherein the second material is a silicone elastomer having approximately a 50 Shore A durometer.

18. The method of claim 11, wherein the distal flange of the distal portion is configured to be inserted into a stoma of a patient.

19. The method of claim 11, wherein the cuff of the proximal portion is configured to receive a tracheostoma device selected from the group consisting of a HME, a filter, and a speech valve.

20. The method of claim 11, wherein the body has a length between about 8 mm to about 25 mm.

21. A stoma interface device comprising: a tubular body having a proximal portion with an open proximal end, a distal portion with an open distal end, and a lumen extending therebetween;wherein the distal portion comprises a self-expanding frame, a first material covering the self-expanding frame, and a distal flange at the distal end, the distal flange having an outer diameter that is greater than an outer diameter of the rest of the distal portion; wherein the proximal portion is formed of a second material and comprises a cuff at the proximal end, the cuff having an outer diameter that is greater than an outer diameter of the rest of the proximal portion; wherein the second material is more rigid than the first material.

22. The stoma interface device of claim 21, wherein the self-expanding frame is made from a biocompatible memory metal.

23. The stoma interface device of claim 21, wherein the self-expanding frame is made from ni tinol.

24. The stoma interface device of claim 21, wherein the first material is a silicone elastomer having a durometer between 20 Shore 00 and 10 Shore A.

25. The stoma interface device of claim 21, wherein the first material is a silicone elastomer having approximately a 5 Shore A durometer.

26. The stoma interface device of claim 21, wherein the second material is a silicone elastomer having a durometer between 30 Shore A and 90 Shore A.

27. The stoma interface device of claim 21, wherein the second material is a silicone elastomer having approximately a 50 Shore A durometer.

28. The stoma interface device of claim 21, wherein the distal flange of the distal portion is configured to be inserted into a stoma of a patient.

29. The stoma interface device of claim 21, wherein the cuff of the proximal portion is configured to receive a tracheostoma device selected from the group consisting of a HME, a filter, and a speech valve.

30. The device of claim 21 , wherein the body has a length between about 8 mm to about 25 mm.

31. The stoma interface device of claim 21, wherein the distal flange of the distal portion defines an annular cavity therein that is filled with a viscoelastic silicone gel.

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