Methods and systems for submucosal implantation of a device for diagnosis and treatment with a therapeutic agent

• US 8,066,689 B2
• Filed: 07/11/2007
• Issued: 11/29/2011
• Est. Priority Date: 07/11/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation), Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Yuan, David Y., McWilliams, Dennis L., Mitelberg, Vladimir, Pasricha, Pankaj J., Jones, Donald K., Naglreiter, Brett E.
• Primary Examiner(s): Bouchelle; Laura
• Application Number:
  US11/776,097
• Publication Number:
  US 20090018604A1
• Time in Patent Office: 1,602 Days
• Field of Search: 604/19, 604/890.1, 604/891.1, 604/502, 604/57, 604/59, 604/60, 604/93.01, 604/96.01, 604/104, 604/509, 604/506, 606190-192, 606/198, 623/23.65, 623/23.64, 623/23.67
• US Class Current: 604/509
• 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 blunt suture needles A61B2017/06085
• 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 method of placing an implantable device within a submucosal layer, comprising:

elevating a mucosal layer by injecting a fluid into the submucosal layer using a needle assembly;

inserting a submucosal tunneling instrument into the elevated mucosal layer said submucosal tunneling instrument comprising 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;

operating said submucosal tunneling instrument to expand distally to create an elongate tunnel in the submucosal layer;

removing the submucosal tunneling instrument from said elongate tunnel;

positioning a submucosal dissecting instrument within the elongate tunnel formed by said tunneling instrument, said submucosal dissecting instrument discrete from said tunneling instrument such that said submucosal dissecting instrument is separately insertable from said submucosal tunneling instrument into said elongate tunnel;

operating said submucosal dissecting instrument to expand radially, within the elongate tunnel to thereby dissect a large area having a diameter larger than the diameter of said elongate tunnel; and

depositing a drug delivery device within the large area created by the submucosal dissecting instrument.

2. A method according to claim 1 wherein said implant device is an active drug delivery device.

3. A method according to claim 2, wherein said expandable member of said submucosal tunneling instrument comprises a balloon.

4. A method according to claim 3, further comprising delivering therapeutic agents from said drug delivery device to the submucosal layer.

5. A method according to claim 3, further comprising controlling said drug delivery device externally by telemetry to deliver therapeutic agents.

6. A method of placing an implantable device within a submucosal layer, comprising:

providing a least one submucosal instrument;

elevating a mucosal layer by delivering a fluid into the submucosal layer;

inserting one of said submucosal instruments into the elevated mucosal layer;

operating one of said submucosal instruments to first expand distally to form an elongate tunnel in the submucosal layer;

then operating another one of said submucosal instruments in said formed elongate tunnel to second expand substantially radially and not substantially distally and dissect the mucosal layer from the submucosal layer to define a dissected space; and

depositing a drug delivery device within said dissected space.

7. A method according to claim 6, wherein said at least one submucosal instrument comprises a needle knife.

8. A method according to claim 6 wherein said at least one submucosal instrument includes a submucosal tunneling instrument adapted to distally expand through tissue and a distinct submucosal dissection instrument adapted to radially expand within tissue.

9. A method according to claim 8 wherein said submucosal tunneling instrument 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.

10. A method according to claim 9 wherein said implant device is an active drug delivery device.

11. A method according to claim 10, wherein said expandable member of said submucosal tunneling instrument comprises a balloon.

12. A method according to claim 11 wherein said step of depositing said drug delivery device further includes depositing a plurality of drug delivery devices.

13. A method of placing an implantable device within a submucosal layer, comprising:

elevating a mucosal layer by delivering a fluid into the submucosal layer;

inserting a submucosal tunneling instrument into the elevated mucosal layer, said tunneling instrument including a distal end having an everted member that is axially and radially expandable;

operating said submucosal tunneling instrument to create an elongate tunnel in the submucosal layer by axially and radially expanding said distal end of said tunneling instrument;

then removing said submucosal tunneling instrument from said elongate tunnel;

then inserting a submucosal dissecting instrument distinct from said submucosal tunneling instrument into said elongate tunnel;

then dissecting an area under the mucosal layer with the submucosal dissecting instrument, the area having a diameter larger than a diameter of said elongate tunnel; and

depositing a drug delivery device within the dissected area.

14. A method according to claim 13, further comprising delivering therapeutic agents from said drug delivery device to the submucosal layer.

15. A method according to claim 13, further comprising controlling said drug delivery device externally by telemetry to deliver therapeutic agents.

16. A method according to claim 13, wherein the everted member is a balloon.

17. A method of placing an implantable device within a submucosal layer, comprising:

elevating a mucosal layer by delivering a fluid into the submucosal layer;

inserting a submucosal tunneling instrument into the elevated mucosal layer, said tunneling instrument adapted to distally expand through tissue, said tunneling instrument comprising 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;

operating said tunneling instrument to first expand distally to form an elongate tunnel in the submucosal layer;

then inserting a submucosal dissecting into said elongate tunnel, said dissecting instrument adapted to radially expand within tissue;

then operating said dissecting instrument in said formed elongate tunnel to second expand radially and dissect the mucosal layer from the submucosal layer to define a dissected space; and

depositing a drug delivery device within said dissected space.

18. A method of placing an implantable device within a submucosal layer, comprising:

elevating a mucosal layer by injecting a fluid into the submucosal layer using a needle assembly;

inserting a submucosal tunneling instrument into the elevated mucosal layer;

operating said submucosal tunneling instrument to expand distally to create an elongate tunnel in the submucosal layer;

removing the submucosal tunneling instrument from said elongate tunnel;

positioning a submucosal dissecting instrument within the elongate tunnel formed by said tunneling instrument, said submucosal dissecting instrument discrete from said tunneling instrument such that said submucosal dissecting instrument is separately insertable from said submucosal tunneling instrument into said elongate tunnel;

operating said submucosal dissecting instrument to expand substantially radially but not substantially distally within the elongate tunnel to thereby dissect a large area having a diameter larger than the diameter of said elongate tunnel; and

depositing a drug delivery device within the large area created by the submucosal dissecting instrument.

19. A method according to claim 18, wherein said tunneling instrument includes an elongate tubular member having proximal and distal ends and a lumen extending therethrough and an axially and radially expandable member, and wherein the distal end of said elongate tubular member is adapted to enter an opening through the mucosal layer and into the submucosal layer.

20. A method according to claim 19, wherein said expandable member has proximal and distal ends and said 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 said distal end of said elongate tubular member is adapted to enter an opening through the mucosal layer and into the submucosal layer.