# US 10,765,448 B2 · Medical instrument introduction device and treatment method of using the same

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- Number: US 10,765,448 B2
- Document ID: US10765448B2
- Status: Granted
- Kind: B2
- Application number: 15/844,784
- Filed: 2017-12-18
- Published: 2018-04-19
- Granted: 2020-09-08
- Earliest claimed: 2015-07-09
- Assignees: Olympus Corporation
- Applicants: Olympus Corporation
- Inventors: Kosuke Motai
- Web page: https://patentgrep.com/patent/US10765448B2

## CPC

- A61B 17/3417: {Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00)}
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 17/34: Trocars; Puncturing needles
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 18/1477: {Needle-like probes}
- A61B 1/00: Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes (examination of body cavities or body tracts using ultrasonic, sonic or infrasonic waves A61B8/12; endoscopic instruments for taking cell samples or for biopsy A61B10/04); Illuminating arrangements therefor (for the eyes A61B3/00)
- A61B 1/00064: {Constructional details of the endoscope body}
- A61B 1/00131: {Accessories for endoscopes}
- A61B 18/082: {Probes or electrodes therefor}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2017/00269: {endoscopic mucosal resection EMR}
- A61B 2017/3443: {with means for adjusting the length of a cannula}
- A61B 2017/3454: {Details of tips}
- A61B 2017/3486: {Balloon}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- A61B 2018/00285: {Balloons}
- A61B 2018/00488: {Esophagus}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00595: {Cauterization}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/1425: {Needle}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A medical instrument introduction device, includes an outer tube portion indwelled within a body wall; and an inner needle portion inserted through the outer tube portion, wherein the outer tube portion includes a base portion; a tubular conduit portion whose proximal end portion is connected to the base portion; and an anchor portion connected to a distal end portion of the conduit portion, wherein the conduit portion has a bellows folded shape in a natural state, a dimension of the conduit portion in an axial direction being capable of being increased as the folded shape is stretched by the inserted inner needle portion, and a force needed for stretching the folded shape being gradually decreased in a direction from the proximal end portion to a distal end portion of the conduit portion, and the anchor portion and the inner needle potion are couplable with each other.

## Claims

### Claim 1

A medical instrument introduction device, comprising:
an outer tube portion that is configured to be indwelled within a body wall; and
an inner needle portion that is configured to be inserted through the outer tube portion,
wherein the outer tube portion includes:
a base portion disposed at a proximal side of the outer tube portion;
a tubular conduit portion, the conduit portion being formed of a stretchable material, a proximal end portion of the conduit portion being connected to the base portion; and
an anchor portion connected to a distal end portion of the conduit portion,
wherein:
the conduit portion has a bellows folded shape in a natural state,
a dimension of the conduit portion in an axial direction is capable of being increased as the folded shape is stretched by the inserted inner needle portion, and a force needed for stretching and increasing the dimension of the folded shape in the axial direction is gradually decreased in a direction from the proximal end portion toward the distal end portion of the conduit portion, such that the distal end portion of the folded shape stretches first when the inner needle portion is inserted into the conduit portion and exerts force on the folded shape, and
the anchor portion and the inner needle portion are couplable with each other such that the anchor portion moves following an advancement or a retraction of the inner needle portion.

### Claim 2 (depends on 1)

The medical instrument introduction device according to claim 1, wherein the anchor portion is deformable such that a maximum dimension of the anchor portion in a radial direction is larger than a dimension of the conduit portion in the radial direction.

### Claim 3 (depends on 2)

The medical instrument introduction device according to claim 2, wherein the anchor portion includes a balloon which is expandable and shrinkable.

### Claim 4 (depends on 1)

The medical instrument introduction device according to claim 1, wherein the inner needle portion includes a cauterization portion arranged at a distal end of the inner needle portion, the cauterization portion being configured to cauterize tissue by conducting electric current to the cauterization portion.

### Claim 5 (depends on 1)

The medical instrument introduction device according to claim 1, wherein:
the inner needle portion includes an engaging projection projecting from an outer surface of the inner needle portion, and
the distal end portion includes a groove, and
the engaging projection is sized to fit into and slide along the groove so as to engage the outer tube portion and the inner needle portion.

### Claim 6 (depends on 1)

A treatment method on a target site in a luminal organ inside a body cavity by using the medical instrument introduction device according to claim 1 and a flexible endoscope, the treatment method comprising:
a step of determining an indwelling position at which the outer tube portion of the medical instrument introduction device is to be indwelled within a body wall of the body cavity;
a step of forming a first opening communicating with the body cavity at the indwelling position;
a step of inserting the outer tube portion into the body cavity from a side of the anchor portion through the first opening, an insertion amount of the outer tube portion being determined such that at least the base portion is positioned outside the body cavity;
a step of inserting the endoscope through a natural opening and indicating an opening formation position at which a second opening communicating with the luminal organ inside the body cavity being formed, by using the endoscope, in order to confirm the opening formation position from outside of the luminal organ;
a step of inserting the inner needle portion into the outer tube portion until a distal end portion of the inner needle portion protrudes from the anchor portion and reaches a vicinity of the opening formation position, a bellows folded shape of the conduit portion being stretched;
a step of forming the second opening at the opening formation position by using the inner needle portion; and
a step of inserting the anchor portion into the luminal organ through the second opening, and deforming the anchor portion such that a dimension of the anchor portion in a radial direction becomes larger than that of the conduit portion to engage the anchor portion with the luminal organ.

### Claim 7 (depends on 6)

The treatment method according to claim 6, further includes:
a step of removing the inner needle portion via the outer tube portion after the anchor portion is engaged with the wall of the luminal organ,
a step of inserting a medical instrument through the outer tube portion into the inside of the luminal organ,
a step of performing a treatment on the target site using the medical instrument together with another medical instrument introduced by the endoscope,
a step of removing the medical instrument through the outer tube portion after the treatment on the target site is finished, and
a step of shrinking the anchor portion and removing the outer tube portion from the luminal organ and the body cavity.