Methods and systems for performing submucosal medical procedures

• US 8,128,592 B2
• Filed: 07/11/2007
• Issued: 03/06/2012
• Est. Priority Date: 07/11/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic), Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic), Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Mitelberg, Vladimir, Jones, Donald K., Yuan, David Y., Naglreiter, Brett E., Gilkey, J. Landon, Gostout, Christopher J., Pasricha, Pankaj J.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Danega, Renee
• Application Number:
  US11/775,996
• Publication Number:
  US 20090018602A1
• Time in Patent Office: 1,700 Days
• Field of Search: 607/40, 604/506, 604/93.01, 606/192
• US Class Current: 604/93.01
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take 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 18/1477 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 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• 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 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1425 Needle

Abstract

Instruments, systems 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, 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 submucosal dissection system for use in a patient having a mucosal layer of tissue and an underlying connected submucosal layer of tissue, said system comprising:

a safe access needle injection instrument having a needle portion having a lumen wherein said needle portion is adapted to pierce a desired region of the mucosal layer of tissue and enter the underlying connected submucosal layer such that delivery of a fluid through said lumen of said needle portion enters the submucosal layer to thereby elevate the desired region of the mucosal layer;

a submucosal tunneling instrument for tunneling between the connected mucosal and submucosal layers, said tunneling instrument being a distinct and separate instrument from said needle injection instrument such that said tunneling instrument can be inserted into the patient separately from said needle injection instrument, said submucosal tunneling instrument comprising an elongate tubular member having proximal and distal ends and a lumen extending therethrough, said distal end having a first outer diameter, and a first expandable member having proximal and distal ends wherein said proximal end of said first expandable member is attached to said distal end of said tubular member and said distal end of said first expandable member is everted and positioned within said lumen of said tubular member, said first expandable member closing said lumen to prevent fluid communication between the said lumen of said elongate tubular member of said tunneling instrument and the tissue of the patient, wherein upon expansion of said expandable member, said first expandable member expands in a longitudinal direction and a transverse diametric direction, such that said expanded outer diameter of said first expandable member is greater than said first outer diameter of said distal end, and a length of said expanded first expandable member is several times greater than said expanded outer diameter, said first expandable member adapted to be expanded with sufficient force to form an elongate tunnel between two layers of connected tissue; and

a submucosal dissection instrument comprising an elongate tubular member having proximal and distal sections and second expandable member disposed at said distal section of said tubular member, said distal section having a distal end, said second expandable member expandable greater in a diametric direction than in a longitudinal direction such that when said second expandable member is inserted into the elongate tunnel formed in the tissue by said tunneling instrument and is operated to expand said second expandable member, said second expandable member expands diametrically and not ahead of said distal end of said distal section and is adapted to dissect the layers of tissue above and below the tunnel.

2. A submucosal dissection system according to claim 1, wherein said submucosal tunneling instrument comprises an elongate tether member having proximal and distal ends and being slidably disposed within the lumen of said elongate tubular member wherein the distal end of said tether member engages the distal end of said first expandable member.

3. A submucosal dissection system according to claim 1, wherein said first expandable member is an evertable balloon, said evertable balloon enclosing the distal end of said tubular member of said tunneling instrument such that fluid communication between said tubular member of said tunneling instrument and the tissue of the patient is prevented.

4. A submucosal dissection system for use in a patient having a mucosal layer of tissue and an underlying connected submucosal layer of tissue, said system comprising:

a safe access needle injection instrument having a needle portion having a lumen wherein said needle portion is adapted to pierce a desired region of the mucosal layer of the tissue and enter the submucosal layer such that delivery of a fluid through said lumen of said needle portion enters the submucosal layer to thereby elevate the desired region of the mucosal layer;

a submucosal tunneling instrument comprising an elongate tubular member having proximal and distal ends and a lumen extending therethrough, and a first expandable member having proximal and distal ends wherein said proximal end of said first expandable member is attached to said distal end of said tubular member and said distal end of said first expandable member is everted and positioned within said lumen of said tubular member, and said first expandable member closes said lumen to prevent fluid communication between the said lumen of said elongate tubular member of said tunneling instrument and the tissue of the patient, and whereupon expansion of said tubular member, said first expandable member expands both axially in length and radially in diameter, said expanded length being multiple times greater in dimension than said expanded diameter; and

a submucosal dissection instrument comprising an elongate tubular member having proximal and distal sections and a second expandable member disposed at said distal section of said tubular member.

5. A submucosal dissection system according to claim 4, wherein said tunneling instrument and said dissection instrument are each distinct instruments.

6. A dissection method to dissection a mucosal layer of tissue from a submucosal layer of tissue, the mucosal and submucosal layers connected with connective tissue, said method comprising the steps of:

elevating a mucosal layer by injecting a fluid into a submucosal layer using a needle assembly to form a bleb;

locating a submucosal tunneling instrument into the bleb, said tunneling instrument having a first expandable member that is expandable greater in a longitudinal direction than in a diametric direction;

without first cutting the connective tissue to form a pilot hole in the bleb for receiving the first expandable member, operating said submucosal tunneling instrument to expand the first expandable member in the longitudinal direction to break apart connective tissue and create an elongate tunnel in the submucosal layer, said tunnel having a first length and a first diameter;

locating a submucosal dissecting instrument within the elongate tunnel formed by said tunneling instrument, said submucosal dissecting instrument having a second expandable member that has an outer diameter when in an non-expanded state that is smaller than said first diameter, and which is expandable to a dimension in the diametric direction that is larger than said first expandable member is capable of being expanded in the diametric direction; and

operating said submucosal dissecting instrument within the elongate tunnel to thereby expand said second expandable member in said diametric direction to dissect an area having a diameter larger than the diameter of said elongate tunnel.

7. A submucosal layer dissection method according to claim 6, wherein said submucosal tunneling instrument comprises an elongate tubular member having proximal and distal ends and a lumen extending therethrough and said first 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 first expandable member is everted and positioned within the lumen of said tubular member.

8. A submucosal layer dissection method according to claim 7, wherein said first expandable member of said submucosal tunneling instrument comprises a balloon.

9. A submucosal layer dissection method according to claim 7, wherein once operation of said tunneling instrument is initiated, said submucosal tunneling instrument creates said tunnel without moving said elongate tubular member of said tunneling instrument relative to said bleb.

10. A submucosal layer dissection method according to claim 9, wherein said bleb has a diameter, said first length of said tunnel corresponds in dimension to said diameter of said bleb, and once located within said tunnel, operation of said submucosal dissection system dissects the tissue along an entirety of said first length of said tunnel.

11. A submucosal layer dissection method according to claim 6, wherein said submucosal tunneling instrument is withdrawn from the elongate tunnel prior to positioning said submucosal dissecting instrument within the elongate tunnel.