|Publication number||US7497822 B1|
|Application number||US 10/802,992|
|Publication date||Mar 3, 2009|
|Filing date||Mar 16, 2004|
|Priority date||Apr 10, 2003|
|Publication number||10802992, 802992, US 7497822 B1, US 7497822B1, US-B1-7497822, US7497822 B1, US7497822B1|
|Inventors||Chad John Kugler, Jerome Kent Grudem, JR.|
|Original Assignee||Torax Medical, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (26), Non-Patent Citations (1), Referenced by (29), Classifications (12), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. provisional patent application 60/462,578, filed Apr. 10, 2003, which is hereby incorporated by reference herein in its entirety.
This invention relates to methods and apparatus for changing the geometry of a patient's stomach, and more particularly to methods and apparatus for reducing the size or volume of a patient's stomach, e.g., as a treatment for obesity.
The prevalence of obesity in modern human populations is a major problem. Obesity is a serious health risk, affecting an estimated 50 million people in the United States alone. In addition to becoming increasingly common, the age at which people are becoming obese is getting younger. Obesity can adversely affect an individual, both physically and mentally. Physically, obesity can cause heart disease, hypertension, and diabetes. Managing health problems related to obesity is estimated to cost the health care system in the United States $40,000,000,000 per year.
Weight reduction can be achieved either by an increase in caloric expenditure (e.g., by exercising) or by reducing caloric intake. Surgical methods have been developed for reducing stomach capacity and thus reducing food intake. Although these techniques can be effective, such relatively major surgery is not without risk.
In view of the foregoing, it would be desirable to develop less invasive stomach reduction procedures.
This and other objects of the invention are accomplished in accordance with the principles of the invention by providing procedures in which at least two objects that magnetically interact with one another are implanted in the stomach, preferably trans-orally. The two magnetic objects are implanted in the stomach at respective locations that can move relative to one another in response to magnetic interaction (force) between the magnetic objects. For example, the magnetic interaction (force) between the magnetic objects may induce the associated stomach wall portions to deflect toward one another, inwardly of the stomach cavity, thereby tending to reduce the volume of the cavity. This reduces the patient's desire to eat and thereby effectively treats the patient's obesity.
Further features of the invention, its nature and various advantages, will be more apparent from the accompanying drawings and the following detailed description.
Kugler et al. U.S. Pat. No. 7,445,010 shows implanting magnetic objects in a patient to treat various conditions such as GERD (gastro-esophageal reflux disease). Many of principles discussed in that reference (which is hereby incorporated by reference herein in its entirety, and which is sometimes referred to below as “the above-mentioned reference”) are applicable to the present invention. It will not be necessary to expressly repeat herein everything from the above-mentioned reference that is applicable to the present invention. It will be sufficient to expressly provide herein a few representative examples of what can be done and what methods and apparatus can be used, and it will be understood that many other method and apparatus variations are possible, such as those that are shown and described in the above-mentioned reference. Also, some aspects and details of the construction and use of what is shown herein can be omitted from the present discussion because that information is readily found in the above-mentioned reference.
Another preliminary point is the following. For the most part this disclosure will discuss the use of magnetic objects that magnetically attract one another. This requires at least one magnetically active component (e.g., a magnetically polarized permanent magnet). The other magnetic object that magnetically cooperates with the first object can be either magnetically active and properly polarized for mutual magnetic attraction between the objects, or it can be magnetically passive (e.g., a body of ferromagnetic magnetic material that has no significant net external magnetic field in the absence of an adjacent magnetically active object). Possible variations on these arrangements include more than one magnetically passive object magnetically attracted to a magnetically active object, or two magnetically active objects that are polarized to magnetically repel (rather than attract) one another. A volume (e.g., of the stomach) can be reduced either by pulling two of its sides together using magnetic attraction, or by pushing two of its sides apart using magnetic repulsion, which causes other sides joining the first two sides to be pulled together and thereby reduces volume. Because of the ability to use either magnetically active or magnetically passive magnetic objects (as long as there is at least one magnetically active object in each group of magnetically interactive objects), the term “magnetic” will be used herein as a generic term for either magnetically active or magnetically passive components.
In the illustrative embodiment shown in
When the distal end 22 of catheter 20 is against the wall of stomach 10 at the desired location as shown in
To facilitate the above-described implanting of magnetic object 30, tension may be placed on the stomach wall at the site of the implant. This may be done prior to and during the implantation to ensure good engagement of retention fingers 36 into the stomach wall tissue. Such tension can be achieved by pulling vacuum on the tissue via catheter 20, or by mechanically expanding the stomach at the implant site.
After magnetic object 30 has been implanted in the stomach as described above, a second magnetic object (which can be generally similar to object 30) is similarly implanted in stomach 10 at a location which is different from the location of the first magnetic object but which places the second object where it can magnetically interact with the first to produce a reduction in the volume of stomach 10. For example,
Multiple pairs of magnets 30 may be implanted to achieve a desired change in the volume or geometry of the stomach cavity.
An illustrative use of the invention is to isolate the fundus area from the rest of the stomach to limit its ability to expand if the patient attempts to over-eat.
Although prongs 36 hold each magnetic object 30 securely in stomach 10 as described above, a magnetic object 30 can be removed from the stomach if desired. For example,
Although the illustrative embodiment expressly described above includes introducing magnetic objects 30 trans-orally, it will be understood that other methods (e.g., other endoscopic methods) may be used instead, if desired.
To briefly recapitulate, at least part of the scope of this disclosure is to describe methods and apparatus for modifying the geometry and/or the volume of the stomach by using one or more magnet pairs to pin the inner opposing walls of the stomach together magnetically. Because the magnets can be delivered from a catheter, trans-orally into the stomach cavity, procedural invasiveness is dramatically reduced relative to the known surgical techniques for stomach reduction. An additional benefit of the present magnetic reduction method is that the magnets can be removed by non-invasive or minimally invasive techniques similar to those by which the magnets are implanted. The procedure is therefore reversible. The number, size, and locations of the magnets within the stomach can be varied to achieve a specific result.
It is additionally mentioned here that a U.S. provisional patent application (Kugler et al. application 60/547,200, filed Feb. 23, 2004) has been filed on medicating implants of the general type shown herein. The teachings contained in that provisional patent application (which is hereby incorporated by reference herein in its entirety) can be applied in the context of this invention if desired.
It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. For example, other constructions of magnetic devices 30 are possible, and some such other constructions are shown in the above-mentioned reference (and in the provisional application on medicated implants that is also mentioned above).
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4154226||May 27, 1977||May 15, 1979||Coloplast International A/S||Magnetically operated closure for an intestinal orifice|
|US4197840||Sep 29, 1976||Apr 15, 1980||Bbc Brown Boveri & Company, Limited||Permanent magnet device for implantation|
|US4271827||Sep 13, 1979||Jun 9, 1981||Angelchik Jean P||Method for prevention of gastro esophageal reflux|
|US5176618||Aug 27, 1990||Jan 5, 1993||George Freedman||System for preventing closure of passageways|
|US5234447||Aug 28, 1990||Aug 10, 1993||Robert L. Kaster||Side-to-end vascular anastomotic staple apparatus|
|US5234448||Feb 28, 1992||Aug 10, 1993||Shadyside Hospital||Method and apparatus for connecting and closing severed blood vessels|
|US5387235||Oct 21, 1992||Feb 7, 1995||Cook Incorporated||Expandable transluminal graft prosthesis for repair of aneurysm|
|US5509888||Jul 26, 1994||Apr 23, 1996||Conceptek Corporation||Controller valve device and method|
|US5695504||Feb 24, 1995||Dec 9, 1997||Heartport, Inc.||Devices and methods for performing a vascular anastomosis|
|US5843164||Aug 19, 1996||Dec 1, 1998||Advanced Carrdiovascular Systems, Inc.||Intraluminal stent for attaching a graft|
|US5876448||Mar 13, 1996||Mar 2, 1999||Schneider (Usa) Inc.||Esophageal stent|
|US5957949||May 1, 1997||Sep 28, 1999||World Medical Manufacturing Corp.||Percutaneous placement valve stent|
|US6056744||Feb 19, 1998||May 2, 2000||Conway Stuart Medical, Inc.||Sphincter treatment apparatus|
|US6074341||Jun 9, 1998||Jun 13, 2000||Timm Medical Technologies, Inc.||Vessel occlusive apparatus and method|
|US6136006||Jul 27, 1998||Oct 24, 2000||Boston Scientific Corporation||Apparatus for deliver and deployment of a stent|
|US6146416||Sep 2, 1997||Nov 14, 2000||Boston Scientific Corporation||Medical stents for body lumens exhibiting peristaltic motion|
|US6302917||Aug 31, 1999||Oct 16, 2001||Wilson-Cook Medical Incorporated||Anti-reflux esophageal prosthesis|
|US6572629 *||Aug 15, 2001||Jun 3, 2003||Johns Hopkins University||Gastric reduction endoscopy|
|US7288101 *||Jan 14, 2003||Oct 30, 2007||Satiety, Inc.||Obesity treatment tools and methods|
|US20020091295||Jan 5, 2001||Jul 11, 2002||Wilk Peter J.||Medical treatment method and device utilizing magnetic particles|
|US20030153806||Feb 20, 2003||Aug 14, 2003||Ev&M||Active tissue augmentation materials and method|
|US20070208360 *||May 2, 2007||Sep 6, 2007||Demarais Denise M||Methods and devices for reducing hollow organ volume|
|DE3011742A1||Mar 26, 1980||Oct 1, 1981||Siemens Ag||Magnetic closure system for natural or artificial anus - has magnetic cover held in place by ring of joined individual magnets embedded in tissue of patient|
|WO2000059398A1||Apr 6, 2000||Oct 12, 2000||Endonetics Inc||Submucosal prosthesis delivery device|
|WO2001047431A2||Feb 7, 2001||Jul 5, 2001||Surgical Dev Ag||Anal incontinence treatment apparatus|
|WO2004004544A2||Jul 2, 2003||Jan 15, 2004||The Foundry Inc||Methods and devices for luminal and sphincter augmentation|
|1||Shigley et al., Mechanical Engineering Design, Fifth Edition, 1989, McGraw-Hill, Inc., New York, pp. 58-60.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7682369 *||Feb 14, 2006||Mar 23, 2010||Evalve, Inc.||Surgical device for connecting soft tissue|
|US7736388||Jan 16, 2007||Jun 15, 2010||Evalve, Inc.||Fixation devices, systems and methods for engaging tissue|
|US7753923||Aug 25, 2004||Jul 13, 2010||Evalve, Inc.||Leaflet suturing|
|US7811296||Oct 27, 2004||Oct 12, 2010||Evalve, Inc.||Fixation devices for variation in engagement of tissue|
|US7981123||Feb 3, 2010||Jul 19, 2011||Evalve, Inc.||Surgical device for connecting soft tissue|
|US7981139||Apr 11, 2006||Jul 19, 2011||Evalve, Inc||Suture anchors and methods of use|
|US7998151||Aug 25, 2004||Aug 16, 2011||Evalve, Inc.||Leaflet suturing|
|US8029518||Oct 30, 2007||Oct 4, 2011||Evalve, Inc.||Methods and devices for capturing and fixing leaflets in valve repair|
|US8052592||Oct 7, 2009||Nov 8, 2011||Evalve, Inc.||Methods and devices for tissue grasping and assessment|
|US8057493||Dec 18, 2009||Nov 15, 2011||Evalve, Inc.||Fixation devices, systems and methods for engaging tissue|
|US8123703||Feb 3, 2010||Feb 28, 2012||Evalve, Inc.||Steerable access sheath and methods of use|
|US8187299||Oct 29, 2007||May 29, 2012||Evalve, Inc.||Methods and apparatus for cardiac valve repair|
|US8216256||Feb 26, 2009||Jul 10, 2012||Evalve, Inc.||Detachment mechanism for implantable fixation devices|
|US8343174||Sep 4, 2009||Jan 1, 2013||Evalve, Inc.||Locking mechanisms for fixation devices and methods of engaging tissue|
|US8409273||Oct 30, 2007||Apr 2, 2013||Abbott Vascular Inc||Multi-catheter steerable guiding system and methods of use|
|US8481076||May 27, 2008||Jul 9, 2013||Gorham Enterprises Llc||Bariatric magnetic apparatus and method of manufacturing thereof|
|US8500761||Dec 11, 2009||Aug 6, 2013||Abbott Vascular||Fixation devices, systems and methods for engaging tissue|
|US8734505||Sep 24, 2009||May 27, 2014||Evalve, Inc.||Methods and apparatus for cardiac valve repair|
|US8740918||Jun 9, 2011||Jun 3, 2014||Evalve, Inc.||Surgical device for connecting soft tissue|
|US8740920||May 22, 2013||Jun 3, 2014||Evalve, Inc.||Fixation devices, systems and methods for engaging tissue|
|US9044246||Aug 24, 2011||Jun 2, 2015||Abbott Vascular Inc.||Methods and devices for capturing and fixing leaflets in valve repair|
|US20060135993 *||Feb 14, 2006||Jun 22, 2006||Evalve, Inc||Surgical device for connecting soft tissue|
|US20060184203 *||Apr 11, 2006||Aug 17, 2006||Evalve, Inc.||Suture anchors and methods of use|
|US20070185371 *||Aug 24, 2006||Aug 9, 2007||Mauro Bortolotti||Magnetic device and method to prevent gastroesophageal reflux, fecal incontinence and urinary incontinence|
|US20080292691 *||May 27, 2008||Nov 27, 2008||Lloyd Greg A||Bariatric magnetic apparatus and method of manufacturing thereof|
|US20090163934 *||Feb 26, 2009||Jun 25, 2009||Evalve, Inc.||Detachment mechanism for implantable fixation devices|
|US20110098731 *||Apr 28, 2011||Eric Whitbrook||Magnetically assisted clasps for prosthetic implants, and related methods|
|EP2155110A1 *||May 27, 2008||Feb 24, 2010||Gorham Enterprises Llc||Bariatric magnetic apparatus and method of manufacturing thereof|
|EP2155110A4 *||May 27, 2008||Dec 5, 2012||Gorham Entpr Llc||Bariatric magnetic apparatus and method of manufacturing thereof|
|U.S. Classification||600/37, 606/151|
|Cooperative Classification||A61F2002/044, A61B2017/00876, A61F2210/009, A61F2002/30079, A61B17/0682, A61B2017/00278, A61F5/0083, A61B17/0644|
|Mar 16, 2004||AS||Assignment|
Owner name: TORAX MEDICAL, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KUGLER, CHAD JOHN;GRUDEM, JEROME KENT, JR.;REEL/FRAME:015114/0274;SIGNING DATES FROM 20040310 TO 20040311
|Sep 4, 2012||FPAY||Fee payment|
Year of fee payment: 4