Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-12-14
2003-06-24
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S910000
Reexamination Certificate
active
06582395
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a device and method for placing a tube for tube feeding a patient. Specifically, the invention relates to a novel tube feeding device that separates and thus allows insertion and removal by an advantageous combination of techniques.
2. Discussion of Related Art
Tube feeding is necessary when a patient requires long-term feeding assistance. In tube feeding placements, an incision is made through a patient's abdominal wall and stomach and a catheter is inserted therein. The patient is then fed a nutrient solution directly through the catheter into the stomach. However, methods for placing the catheter vary, as do the catheter specifications and techniques for removing the catheters.
Current methods for insertion of a percutaneously placed catheter include a pull-through technique, a push technique, and an introducer technique. Both the pull-through and the push technique require a catheter to be passed through the mouth, down the esophagus, through the stomach, and out the incision. The passage of the catheter in this manner can cause damage to the back of the throat and esophagus, especially when the catheter includes an apparatus at its leading and trailing ends for use in feeding and in holding the catheter in place. In addition, when a retention apparatus is included, removal of the device must usually be accomplished with a second endoscopy. Both of these disadvantages are particularly problematic in neonates, who have smaller less well-developed passageways and are thus more prone to injury from tube placement. Moreover, neonates often require potentially risky general anesthetic for each endoscopy. Another method of inserting a catheter, the introducer technique, avoids these problems by pushing the catheter directly into the patient's incision. A dilating sheath must first be inserted though the incision, then the catheter is inserted by pushing it through the sheath. The sheath is then removed and the catheter is fixed in place. In this technique, endoscopy is not required for removal since an inflatable (Foley) bolster is used. It can be deflated and the entire catheter removed with a gentle pull. However, the incision made in an introduction insertion must be larger than in the other techniques, and the larger incision in the abdominal wall and stomach creates a higher likelihood of leaking around the area of the catheter.
It would therefore be desirable to have a device which would enable the passage of a catheter without damaging the back of the patient's mouth and esophagus, would not require an unacceptably large incision in the patient's abdominal wall, and would not require repeat endoscopy for removal.
SUMMARY OF THE INVENTION
The present invention provides a device and a method which may be used for tube feeding procedures such as percutaneous endoscopic gastrostomy (PEG). The device allows easy passage of a catheter through a patient, does not require an excessively large incision, and does not require repeat endoscopy for removal.
The device of the present invention allows easy passage by providing a catheter with a tapered insertion portion and an inflatable internal bolster, and also providing a separate catheter head. The slim profile of the device allows easier insertion into a patient, even a neonatal patient whose esophagus is small, than any existing device, while still providing the required internal bolster and feeding port.
The device of the present invention thus enables a physician to use the push technique to insert a catheter without fear of damaging the patient. After placing the catheter, the physician can inflate the bolster and remove the tapered insertion portion, then attach the catheter head to the catheter for feeding.
Because the push technique of insertion is enabled without the risks of damage previously encountered, the incision need not be any larger than necessary to allow the passage of the catheter. Moreover, because the slim profile that eases passage of the catheter includes an inflatable internal bolster, removal of the device does not require repeat endoscopy.
These, and other, aspects and objects of the present invention will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments of the present invention, is given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications.
REFERENCES:
patent: 3633586 (1972-01-01), Sheridan
patent: 3805794 (1974-04-01), Schlesinger
patent: 4367740 (1983-01-01), Evanoski, III
patent: 4551130 (1985-11-01), Herbert et al.
patent: 4601701 (1986-07-01), Mueller et al.
patent: 4701159 (1987-10-01), Brown et al.
patent: 4796615 (1989-01-01), Bullock et al.
patent: 5391159 (1995-02-01), Hirsch et al.
patent: 5458583 (1995-10-01), McNeely et al.
patent: 6010479 (2000-01-01), Dimitri
Caulfield,Percutaneous Endoscopic Gastrostomy Placement in Children, Pediatric Endoscopy, vol. 4, No. 1, Jan. 1994, pp. 179-193.
Davidson, et al.,Technique and Complications of Percutaneous Endoscopic Gastrostomy in Children, Aust. N.Z. J. Surg, 65, pp. 194-196 (1995).
Kimber, et al.,Limitations of percutaneous endoscopic gastrostomy in facilitating enteral nutrition in children: Review of the shortcomings of a new technique, J. Paediatr. Child Heath, 35, pp. 427-431 (1999).
Jarnagin et al.,The Efficacy and Limitations of Percutaneous Endoscopic Gastrostomy, Arch Surg., vol. 127, Mar. 1992.
Deitel, et al.,Percutaneous Endoscopic Gastrostomy by the “Pull” and “Introducer” Methods, The Canadian Journal of Surgery, vol. 31, No. 2, Mar. 1988.
Crombleholme et al.,Simplified “Push” Technique for Percutaneous Endoscopic Gastrostomy in Children, Journal of Pediatric Surgery, vol. 28, No. 10, Oct. 1993, pp. 1393-1395.
Gauderer, et al.,Gastrostomy Without Laparotomy: A Percutaneous Endoscopic Technique, Journal of Pediatric Surgery, vol. 15, No. 6, Dec. 1980, pp. 872 and 874.
Werline, et al.,Early feeding after percutaneous endoscopic gastrostomy is safe in children, Gastrointestinal Endoscopy, vol. 40, No. 6, 1994, pp. 692-693.
Mollitt, et al.,Complications of Retained Internal Bolster After Pediatric Percutaneous Endoscopic Gastrstomy, Journal of Pediatric Surgery, vol. 33, No. 2, Feb. 1998, pp. 271-273.
Khattak, et al.,Percutaneous Endoscopic Gastrostomy in Pediatric Practice: Complications and Outcome, Journal of Pediatric Surgery, vol. 33, No. 1, Jan. 1998, pp. 67-72.
Quintão, et al.,Improvement of children's nutritional status after enteral feeding by PEG: an interim report, Gastrointesinal Endoscopy, vol. 50, No. 2, 1999, pp. 183-188.
Grief, et al.,Fatal necrotizing fascitis complicating percutaneous endoscopic gastrostomy, Gastrointestinal Endoscopy, vol. 32, No. 4, 1986, pp. 292-294.
American Gastroenterological Association,American Gastroenterological Association Medical Position Statement: Guidelines for the Use of Enternal Nutrition, http://www.wbsaunders.com/gastro/policy.
ASGE: Procedure Manual, http://www.asge.org/resources/maual.
Role of Percutaneous Endoscopc Gastrostomy, A SAGES Co-Endorsed ASGE Guideline for Clinical Application, http://www.sages.org.
Cook Diagnostic & Interventional Products,Gastroenterology, http://www.cookincorporated.com.
Mill-Rose Labroatories, Inc., Instruments for Endoscopy, http://www.mrlabsinc.com.
Bard Interventional Products Division,Gastrostomy Feeding Devices, http://www.bardinterventional.com.
Applied Medical Technology—Product Info—G-Tube, http://www.appliedmedical.net.
Abbott Laboratories, Ross Product Division,Enteral Feeding Devices, Tubes, http://www.ross.com.
Burkett Jeffrey S.
Georgen Raymond F.
Boyle Fredrickson Newholm Stein & Gratz S.C.
J & R Medical Devices, Inc.
Kennedy Sharon
LandOfFree
Feeding tube device and method does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Feeding tube device and method, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Feeding tube device and method will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3108526