Methods and systems for performing submucosal medical procedures

• US 8,317,771 B2
• Filed: 01/15/2010
• Issued: 11/27/2012
• Est. Priority Date: 07/11/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Mitelberg, Vladimir, Jones, Donald K.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US12/688,249
• Publication Number:
  US 20100174306A1
• Time in Patent Office: 1,047 Days
• Field of Search: 606/185, 606/142, 604/93.01
• US Class Current: 604/506
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• 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 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include safe access needle injection instruments incorporating electrosurgical capability, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

Claims

1. A method of forming a submucosal bleb comprising the steps of:

inserting a safe access needle injection instrument through a natural orifice in a patient, the safe access needle injection instrument including,

i) an elongate tubular member having proximal and distal ends and a lumen extending therethrough,

ii) a tissue holding member having a coil configuration positioned adjacent the distal end of said elongate tubular member and adapted to engage a desired region of a mucosal layer, the coiled configuration defining a diameter,

iii) a needle member having a lumen wherein said needle member is longitudinally movably 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, and

iv) an electrosurgical connection electrically coupled to the tissue holding member for receiving a cautery current from a cautery current supply;

positioning said safe access needle injection instrument adjacent a target site in the digestive tract;

operating said safe access needle injection instrument to engage tissue at said target site, said operating including rotating the coiled configuration of the tissue holding member into the tissue such that coils of the coiled configuration extend within the tissue;

elevating a mucosal layer by injecting a fluid into a submucosal layer at said target site to form a bleb using said safe access needle injection instrument;

applying a cautery energy to the tissue holding member in the coiled configuration to cauterize a hole of the diameter of the coiled configuration in the tissue at said target site, wherein the cauterization of the hole releases engagement of the tissue holding member from the tissue; and

removing said safe access needle injection instrument from said patient.

2. A method of forming a submucosal bleb according to claim 1, wherein said method step of operating said safe access needle injection system to engage tissue additionally includes piercing tissue with a needle member of said safe access needle injection instrument.

3. A submucosal layer dissection method comprising the steps of:

elevating a mucosal layer by injecting a fluid into a submucosal layer using a needle injection instrument having a coil tissue holding member to form a bleb;

applying a current to said coil to cauterize a hole in the mucosal layer down to the submucosal layer, the hole having a diameter approximating a diameter of the coil, wherein the cauterization of the hole releases engagement of the tissue holding member from the mucosal and submucosal layers;

inserting a submucosal tunneling instrument into the bleb through the hole;

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

positioning a submucosal dissecting instrument within the elongate tunnel formed by said tunneling instrument; and

operating said submucosal dissecting instrument within the elongate tunnel to thereby dissect an area having a diameter larger than the diameter of said elongate tunnel.

4. A submucosal layer dissection method according to claim 3 further including the step of operating said needle injection instrument to thereby create an opening through the mucosal layer adapted to receive additional instruments.

5. A submucosal layer dissection method comprising the steps of:

engaging a mucosal layer of tissue with a helical coil;

then injecting a fluid into a submucosal layer beneath the mucosal layer to form a bleb; and

then applying a current to said helical coil to cauterize a hole in the mucosal layer down to the submucosal layer, the hole having a diameter approximating a diameter of the helical coil.

6. A submucosal dissection method according to claim 5, further comprising:

inserting a submucosal tunneling instrument into the bleb through the hole;

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

positioning a submucosal dissecting instrument within the elongate tunnel formed by said tunneling instrument; and

operating said submucosal dissecting instrument within the elongate tunnel to thereby dissect an area having a diameter larger than the diameter of said elongate tunnel.

7. A submucosal dissection method according to claim 6, wherein:

said injecting occurs in a pathway within a space defined by the helical coil.