Methods and Systems for Submucosal Implantation of a Device for Diagnosis and Treatment with a Therapeutic Agent

• US 20120071812A1
• Filed: 11/23/2011
• Published: 03/22/2012
• Est. Priority Date: 07/11/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation), Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Mitelberg, Vladimir, Jones, Donald K., Yuan, David Y., Naglreiter, Brett E., McWilliams, Dennis L., Pasricha, Pankaj J.
• Granted Patent: US 8,491,472 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/2933 camming or guiding means
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00

Abstract

Instruments, systems, implants, and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. A submucosal implant device for diagnosing and treating disorders of the body may be implanted. A passive submucosal implant device may take the form of a drug delivery depot in which a therapeutic agent within the depot elutes from the depot according to a predetermined elution profile. An active submucosal implant device may take the form of a drug delivery device that incorporates a self-contained diagnostic system to determine the appropriate delivery time and dosage of a therapeutic agent to be administered.

Claims

1. A submucosal implant system comprising:

a safe access needle injection means having a needle member adapted to pierce a mucosal tissue and deliver fluid to a submucosal layer;

a submucosal tunneling means;

a submucosal dissection means; and

, an implantable therapeutic agent delivery device.

2. A submucosal implant system according to claim 1 wherein said safe access needle injection means comprises:

an elongate tubular member having proximal and distal ends and a lumen extending therethrough;

a tissue holding member positioned adjacent the distal end of said elongate tubular member and is adapted to engage a desired region of a mucosal layer; and

,

said needle member having a lumen wherein said needle member is slidably disposed within the lumen of said elongate tubular member and adapted to pierce a desired region of the mucosal layer engaged by said tissue holding member and enter the submucosal layer such that delivery of a fluid through the lumen of said needle member enters said submucosal layer to thereby elevate said desired region of the mucosal layer.

3. A submucosal implant system according to claim 1 wherein said submucosal tunneling means comprises:

an elongate tubular member having proximal and distal ends and a lumen extending therethrough; and

,

an expandable member having proximal and distal ends wherein the proximal end of said expandable member is attached to the distal end of said tubular member and the distal end of said expandable member is everted and positioned within the lumen of said tubular member,

wherein the distal end of said elongate tubular member is adapted to enter an opening through the mucosal layer and into the submucosal layer of a mammal.

4. A submucosal implant system according to claim 1 wherein said submucosal dissecting means comprises an elongate tubular member having proximal and distal sections and an expandable member disposed at the distal section of said tubular member.

5. A submucosal implant system according to claim 3 wherein said submucosal dissecting means comprises an elongate tubular member having proximal and distal sections and an expandable member disposed at the distal section of said tubular member.

6. A submucosal implant system according to claim 5 wherein said submucosal tunneling means and said submucosal dissecting means are integrally formed.

7. A submucosal implant system, comprising:

a safe access needle injection means having a needle member adapted to pierce mucosal tissue and deliver fluid to the submucosal layer;

a submucosal tunneling means;

a submucosal dissection means; and

,

an implantable drug delivery device.

8. A submucosal implant system according to claim 7 wherein said safe access needle injection means comprises:

an elongate tubular member having proximal and distal ends and a lumen extending therethrough;

a tissue holding member positioned adjacent the distal end of said elongate tubular member and is adapted to engage a desired region of a mucosal layer; and

,

said needle member having a lumen wherein said needle member is slidably disposed within the lumen of said elongate tubular member and adapted to pierce a desired region of the mucosal layer engaged by said tissue holding member and enter the submucosal layer such that delivery of a fluid through the lumen of said needle member enters said submucosal layer to thereby elevate said desired region of the mucosal layer.

9. A submucosal implant system according to claim 7 wherein said submucosal tunneling means comprises:

an elongate tubular member having proximal and distal ends and a lumen extending therethrough; and

,

an expandable member having proximal and distal ends wherein the proximal end of said expandable member is attached to the distal end of said tubular member and the distal end of said expandable member is everted and positioned within the lumen of said tubular member,

wherein the distal end of said elongate tubular member is adapted to enter an opening through the mucosal layer and into the submucosal layer of a mammal.

10. A submucosal implant system according to claim 7 wherein said submucosal dissecting means comprises an elongate tubular member having proximal and distal sections and an expandable member disposed at the distal section of said tubular member.

11. A submucosal implant system, comprising:

a safe access needle injection means having a needle member adapted to pierce mucosal tissue and deliver fluid to the submucosal layer;

a submucosal tunneling means; and

,

an implantable drug delivery device.

12. A submucosal implant system according to claim 11 wherein said safe access needle injection means comprises:

an elongate tubular member having proximal and distal ends and a lumen extending therethrough;

a tissue holding member positioned adjacent the distal end of said elongate tubular member and is adapted to engage a desired region of a mucosal layer; and

,

said needle member having a lumen wherein said needle member is slidably disposed within the lumen of said elongate tubular member and adapted to pierce a desired region of the mucosal layer engaged by said tissue holding member and enter the submucosal layer such that delivery of a fluid through the lumen of said needle member enters said submucosal layer to thereby elevate said desired region of the mucosal layer.

13. A submucosal implant system according to claim 11 wherein said submucosal tunneling means comprises:

an elongate tubular member having proximal and distal ends and a lumen extending therethrough; and

,

an expandable member having proximal and distal ends wherein the proximal end of said expandable member is attached to the distal end of said tubular member and the distal end of said expandable member is everted and positioned within the lumen of said tubular member,

wherein the distal end of said elongate tubular member is adapted to enter an opening through the mucosal layer and into the submucosal layer of a mammal.

14. A submucosal implant system according to claim 11 wherein said implantable drug delivery device includes an anchor.

15. A submucosal implant system according to claim 12 wherein said implantable drug delivery device includes an anchor.

16. A submucosal implant system according to claim 13 wherein said implantable drug delivery device includes an anchor.

17-42. -42. (canceled)

43-52. -52. (canceled)