Delivery tools for sleep disorders treatment implant and methods of implantation

• US 7,980,248 B2
• Filed: 07/07/2008
• Issued: 07/19/2011
• Est. Priority Date: 09/21/2004
• Status: Expired due to Fees

• Current Assignee: Pavad Medical, Inc.
• Original Assignee: Pavad Medical, Inc.
• Inventors: Houle, Phil, Owen, Chris D., Li, Kasey Kai-Chi, Hegde, Anant V., Hallsten, Casidy
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US12/168,820
• Publication Number:
  US 20100049227A1
• Time in Patent Office: 1,107 Days
• Field of Search: 128/848, 606/167, 606/170, 606/174
• US Class Current: 128/848
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61F 2/00 Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00

Abstract

Methods and tools are disclosed for inserting an implant device that treats snoring and apnea of a patient by altering the position of a soft palate. Methods and tools can make an incision in patient'"'"'s soft and hard palate to create a cavity that can house the implant. The tools can have visually observable markings that can be aligned with the incision, thus controlling the depth of the cavity. A needle having an incision edge can be used to make an incision in patient'"'"'s soft palate. The needle can be bent into a suitable longitudinal shape to allow easier access and visualization of the process. A blade that makes the cavity in the tissue can be housed inside a channel in the needle. The tools may have stoppers to prevent excessive extension and retraction of the blade thus preventing an excessive cavity depth. Some tools may also house the implant device, which may be implanted after the cavity is formed.

Claims

1. A method for treating snoring and/or apnea of a patient comprising the steps of:

incising a periosteum inferior to the hard palate with a cavitation tool, wherein the incising creates an incision, and wherein the cavitation tool comprises a needle comprising a posterior end, an anterior end, a channel extending the length of the needle from the posterior end of the needle to the anterior end of the needle, a blade wherein the blade is adapted and configured to slide through the channel and out the posterior end of the needle, and an incising edge at the posterior end of the needle for incising the periosteum inferior to the hard palate and/or for incising the soft palate;

creating a cavity within the periosteum inferior to the hard palate and within a soft palate using the cavitation tool, the creating of the cavity comprising

entering with the needle the periosteum inferior to the hard palate through the incision created by the cavitation tool,

extending the blade through the channel of the needle wherein the blade extends posterior to the posterior end of the needle, and

cutting a cavity in the hard and soft palate wherein the cutting comprises separating the periosteum from the hard palate and advancing the blade into the soft palate tissue;

entering the cavity created within the periosteum inferior to the hard palate and the soft palate with an implant device loaded on an implant delivery tool, the implant delivery tool comprising an implant support upon which the device rests and a retractable sheath extending over at least a portion of the device and at least a portion of the implant support; and

deploying the implant device into the cavity created within the periosteum inferior to the hard palate and within the soft palate, whereby the deploying comprises

positioning the implant device within the cavity, wherein the implant device is loaded on the implant delivery tool,

retracting the delivery tool sheath while keeping the implant device and the implant support fixed relative to each other and in a substantially fixed position within the cavity,

removing the delivery tool from the cavity, and

leaving the implant device within the cavity.

2. The method of claim 1 further comprising a step chosen from a group consisting of closing the incision, securing the implant device within the cavity, or a combination thereof.

3. The method of claim 2 wherein the step of securing is chosen from a group consisting of suturing the device to a tissue, adhering the device to a tissue using a tissue adhesive, or a combination thereof.

4. The method of claim 1 wherein the cavitation tool and the delivery tool are part of a single unit.

5. The method of claim 1 wherein the step of entering the periosteum includes approximately aligning a marking on the needle with the incision created by the cavitation tool.

6. The method of claim 5 wherein the step of extending the blade includes limiting the blade from extending more than a distance from the marking of the needle.

7. The method of claim 6 wherein the step of limiting the blade posterior motion includes using a relative configuration of the blade and needle to create an cavity appropriately sized for the implant device, wherein the relative configuration of the blade and needle results from the blade comprising a stopper at an anterior end of the blade wherein the stopper prevents the blade from extending out the posterior end of the needle more than a distance from a marking on the needle.

8. The method of claim 7 wherein the distance is approximately 2.5 centimeters.