Article, system, and method for securing medical device to tissue or organ

• US 20060235446A1
• Filed: 08/31/2005
• Published: 10/19/2006
• Est. Priority Date: 04/14/2005
• Status: Abandoned Application

• Current Assignee: Norman Godin
• Original Assignee: Norman Godin
• Inventors: Godin, Norman
• Application Number:
  US11/215,904
• Publication Number:
  US 20060235446A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence

Abstract

An surgical tilt-tag staple comprising an elongated joining member having a first end and a second end, a first tilt-tag joined to the first end of the joining member and a second tilt-tag joined to the second end of the joining member, each of the first and second tilt-tags normally aligned perpendicularly to the joining member, the tilt-tags bendable under resistance into a position substantially parallel to the joining member and returning to the normal position when resistance is removed, is used to attach a medical device to the inner mucosa of a gastro-intestinal tract of a patient using ultrasound real time visualization and a flexible endoscope. Tilt-tag staples constructed of nickel-titanium alloy are preferred. Removal of such tilt-tag staples can be facilitated by cooling a tilt-tag. Medical devices with an electrical lead can be implanted without conventional suturing by using one terminal tilt tag on the lead to implant it.

Claims

1. An article comprising an elongated joining member having a first end and a second end, a first tilt-tag joined to the first end of the joining member and a second tilt-tag joined to the second end of the joining member, each of the first and second tilt-tags normally aligned perpendicularly to the joining member, the tilt-tags bendable under resistance into a position substantially parallel to the joining member and returning to the normal position when resistance is removed, the article constructed of nickel-titanium alloy.

2. A surgical method comprising attaching medical device to the inner mucosa of a gastro-intestinal tract of a patient with a double tilt-tag staple using ultrasound real time visualization and a flexible endoscope.

3. The method of claim 2 wherein the endoscope has a working channel and a pusher in the working channel, the double tilt-tag staple comprising an elongated joining member having a first end and a second end, a first tilt-tag joined to the first end of the joining member and a second tilt-tag joined to the second end of the joining member, each of the first and second tilt-tags normally aligned perpendicularly to the joining member, the tilt-tags bendable under resistance into a position parallel to the joining member and returning to the normal position when resistance is removed, the method comprising placing the joining member and the first tilt-tag of a first tilt-tag staple in the channel of a slit needle, placing the slit needle in a flexible tube so that the second tilt-tag is outside the slit needle and within the flexible tube, the tilt-tags maintained in a stressed position substantially parallel to the joining member, placing the flexible tube containing the tilt-tag staple in the working channel of the flexible endoscope, placing the flexible endoscope in the patient'"'"'s gastro-intestinal tract and through the medical device, directing the needle into and through the inner mucosa portion of the tract, using the pusher to release the first tilt-tag outside of the tract, and pulling the needle back so that the second tilt-tag is released within the tract, thereby stapling the device to the tract.

4. The method of claim 3 wherein comprising placing a plurality of double tilt-tag staples within the needle and stapling the device to the tract at a plurality of locations.

5. The method of claim 2 wherein the device is a gastrointestinal anti-reflux device (GARD) having a collapsible ring, the method comprising stapling the ring in a hiatus hernia at the juncture of the patient'"'"'s esophagus and stomach at a plurality of locations.

6. The method of claim 2 wherein the tilt-tag staple is constructed of a nickel-titanium alloy, steel, and/or nylon.

7. The method of claim 2 wherein the tilt-tags are constructed of absorbable material and the device is a sensor designed for temporary implantation in the patient.

8. The method of claim 2 wherein the needle comprises a first lumen and a second lumen, using the first lumen for injection of saline and using the second lumen for holding and releasing the tilt-tag.

9. The method of claim 2 wherein the device is a pacemaker and the tilt-tag staples are used for placement of pace-maker leads and electrodes with a rigid trocar through the abdominal wall into the stomach or from outside the stomach inward.

10. A method of removing a tilt-tag staple having a nitinol tilt-tag, the staple previously implanted in a patient'"'"'s esophagus, stomach, or bowel, comprising a step of cooling the nitinol tilt-tag to soften the tilt-tag.