# US 10,441,746 B2 · Flexible and steerable device

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- Number: US 10,441,746 B2
- Document ID: US10441746B2
- Status: Granted
- Kind: B2
- Application number: 15/756,729
- Filed: 2016-09-02
- Published: 2019-02-28
- Granted: 2019-10-15
- Earliest claimed: 2015-09-04
- Applicants: Petrus A. Besselink
- Inventors: Petrus A. Besselink
- Web page: https://patentgrep.com/patent/US10441746B2

## CPC

- A61M 25/0054: {with regions for increasing flexibility}
- A61B 1/0056: {the insertion parts being asymmetric, e.g. for unilateral bending mechanisms}
- A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence)
- A61F 2/88: the wire-like elements formed as helical or spiral coils
- A61M 25/0013: {Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility}
- A61M 25/0051: {made from fenestrated or weakened tubing layer}
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/104: {used for angioplasty}
- A61M 27/00: Drainage appliance for wounds or the like {, i.e. wound drains, implanted drains} ({negative pressure wound therapy devices A61M1/90;} implements for holding wound open A61B17/02 {; middle ear drainage A61F11/202})
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 2017/003: {Steerable}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/00331: {with preformed bends}
- A61B 2017/00867: {shape memory effect}
- A61B 2018/00577: {Ablation}
- A61F 2002/016: {made from wire-like elements}
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 2025/0063: {having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A device, a method of making a device and a method of inserting a device into a tubular path. The device includes a tubular sheath with one or more helical slots formed therein and a control element that fits within the sheath. In one form, the device is an endoluminal device that simultaneously improves flexibility and structural rigidity though variations in one or both of slot width along the length of the slot and slot pitch along the length of the tubular sheath. When the operator pulls at the proximal end of the control element while holding the outer sheath in place, the slots will tend to close in a preferential manner such that more precise control of device length and bending is enabled, while simultaneously providing improvements in structural rigidity during device insertion and navigation through a body lumen or related tubular member where tortuous paths may be encountered along the member path.

## Claims

### Claim 1

A steerable device comprising:
a tubular sheath comprising:
a proximal end;
a distal end opposite the proximal end; and
at least one reconfigurable section disposed intermediate the proximal and distal ends and possessive of an increased flexibility, the at least one reconfigurable section comprising at least one helical slot formed through the wall thereof, the at least one helical slot defining:
a pitch along the axial dimension of the tubular sheath; and
a pattern with a periodically-varying width along a length axis of the tubular sheath; and
an elongate control element defining a proximal end and a distal end, the control element attached to at least one part of the tubular sheath in order to enable an operator to vary the length of the tubular sheath by imposing a force to the control element that also causes a relative tangential rotation between adjacent wall sections that define the slot, resulting in a known, limited, controllable torsional rotation of the distal end of the tubular sheath without torsional rotation of the proximal end of the tubular sheath.

### Claim 2 (depends on 1)

The device of claim 1, wherein the helical slot further defines a plurality of interlocking members having a nesting shape fit between adjacent wall sections defined within the tubular sheath.

### Claim 3 (depends on 1)

The device of claim 1, wherein the at least one reconfigurable section bends upon increasing force imparted by the control element to the tubular sheath.

### Claim 4 (depends on 3)

The device of claim 3, wherein applying a certain preload causes effects comprising reducing the floppiness of the reconfigurable sections, tangential rotation of at least one reconfigurable section and bending of at least one reconfigurable section.

### Claim 5 (depends on 1)

The device of claim 1, wherein locking members limit the relative tangential rotation between adjacent coils to a desirable and controllable maximum value.

### Claim 6 (depends on 5)

The device of claim 5, wherein applying a certain preload causes effects comprising reducing the floppiness of the reconfigurable sections, tangential rotation of at least one reconfigurable section and bending of at least one reconfigurable section.

### Claim 7 (depends on 1)

The device of claim 1, wherein the tangential rotation is compensated by using two reconfigurable sections, a first one with a clockwise helical cut and a second one with a counterclockwise helical cut.

### Claim 8 (depends on 1)

The device of claim 1, wherein pure torsional rotation is achieved by supporting a certain part of the helical section with an internal or external guiding member that prevents bending of the part of the helical section.

### Claim 9 (depends on 8)

The device of claim 8, wherein the guiding member has a shape comprising a curvature in one or more planes with an angle between 0 and 180 degrees.

### Claim 10 (depends on 9)

The device of claim 9, wherein the guiding member is integrated with the elongate control element.

### Claim 11 (depends on 8)

The device of claim 8, wherein the guiding member is integrated with the elongate control element.

### Claim 12 (depends on 1)

The device of claim 1, wherein the control element has a tubular shape, thus enabling an operator to reach the distal end through the lumen in the control element.

### Claim 13 (depends on 1)

The device of claim 1, further comprising an endoluminal device configured to slidably fit over the tubular sheath.

### Claim 14 (depends on 13)

The device of claim 13, wherein at least a part of the endoluminal device is selected from the group consisting of a catheter, steerable tip, endoscope, laser system, ablation system, stent, angioplasty balloon, drain, dilator, filter, basket, filterbasket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

### Claim 15 (depends on 1)

The device of claim 1, further comprising an endoluminal device configured to slidably fit through the control element.

### Claim 16 (depends on 15)

The device of claim 15, wherein at least a part of the endoluminal device is selected from the group consisting of a catheter, steerable tip, endoscope, laser system, ablation system, stent, angioplasty balloon, drain, dilator, filter, basket, filterbasket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

### Claim 17 (depends on 1)

The device of claim 1, wherein at least a part of the device is selected from the group consisting of minimal invasive devices, surgical tools, steerable drilling tools, instruments, rotating instruments, placement of pacemaker leads and implants, comprising using a catheter, steerable tip, endoscope, laser system, ablation system, stent, angioplasty balloon, drain, dilator, filter, basket, filterbasket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

### Claim 18 (depends on 17)

The device of claim 17, further comprising a tool coupled to at least one of the control element or the tubular sheath, the tool configured to regulate relative axial positions between the control element and the tubular sheath and thereby effect a transition in the shape of at least one of the reconfigurable sections, comprising one of the effects selected from bending, reducing flexibility, improving pushability, locking to prevent torsion, active torsion by tension and combinations thereof.

### Claim 19 (depends on 18)

The device of claim 18, wherein the tool comprises indicia configured to apprise a user of an amount of deformation of the reconfigurable sections.

### Claim 20 (depends on 18)

The device of claim 18, wherein the tool comprises a connector to facilitate removable attachment of the tool to the at least one of the control element or the tubular sheath.

### Claim 21 (depends on 18)

The device of claim 18, wherein the tool comprises a display configured to inform an operator about an operational status of the reconfigurable section.

### Claim 22 (depends on 1)

The device of claim 1, wherein the elongate control element is made of at least one of a composite, a polymer wire, a polymer strip, a polymer tube, a metal wire, a metal strip, a metal tube, a tube or wire of a shape memory alloy with shape memory, linear elasticity, superelasticity, and combinations thereof.

### Claim 23 (depends on 1)

The device of claim 1, wherein the proximal end of the control element is located near the proximal end of a reconfigurable section.

### Claim 24 (depends on 23)

The device of claim 23, wherein the control element is activated by a remote controlled actuator, working on a principle comprising a shape memory effect, hydraulic pressure, electric or magnetic signal, electromotor, direct or with a lever or mechanical gear box and combinations thereof.

### Claim 25 (depends on 1)

The device of claim 1, comprising steerable devices selected from the group consisting of a drilling tool, a robot arm, beam or antenna for use in outer space or under water, manipulators in aircraft, submarines, drones, robotics, vacuum environments, laboratory equipment and other fields, endoluminal use in water, oil and gas exploration and production and combinations thereof.

### Claim 26 (depends on 1)

The device of claim 1, wherein a change in shape of the reconfigurable section comprises a change into a state that is suitable for inserting, steering into and being removable from a body lumen.

### Claim 27 (depends on 1)

The device of claim 1, wherein the periodically-varying width of the pattern is configured so that a change in length of the tubular sheath causes at least one of distal end bending, improved pushability, improved torquability and reduced flexibility therein.

### Claim 28 (depends on 27)

The device of claim 27, wherein the bending of the at least reconfigurable section comprises bending in only one plane.

### Claim 29 (depends on 27)

The device of claim 27, wherein the bending of the at least reconfigurable section comprises bending in more than one plane.

### Claim 30 (depends on 27)

The device of claim 27, wherein the bending of the at least reconfigurable section comprises bending in a helical shape.

### Claim 31 (depends on 27)

The device of claim 27, wherein the bending of the at least reconfigurable section comprises bending in a pig-tail shape.

### Claim 32 (depends on 1)

The device of claim 1, wherein the pitch defined along the tubular sheath axial dimension is constant.

### Claim 33 (depends on 1)

The device of claim 1, wherein the pitch defined along the tubular sheath axial dimension is variable.

### Claim 34 (depends on 1)

The device of claim 1, wherein the helical slot has a pattern with alternating minimum and maximum slot width, the locations with minimum slot width located on a line parallel to the tubular sheath axial dimension.

### Claim 35 (depends on 34)

The device of claim 34, wherein the change in length is a shortening such that the minimum slot width becomes closed while the maximum slot width remains open through at least a portion of the change in length, the closed condition of the minimum slot width resulting in a decrease of the axial flexibility of at least the respective portion of the tubular sheath.

### Claim 36 (depends on 35)

The device of claim 35, wherein further increasing the imposed force in the control element causes closure of portions of the tubular sheath that are circumferentially opposite of the minimum slot width along with an increased bending of the reconfigurable section, while axial flexibility of the tubular sheath is further reduced until all slots are fully closed when the bending is complete.

### Claim 37 (depends on 1)

The device of claim 1, wherein the periodically-varying width pattern defines alternating minimum and maximum slot width, the locations with minimum slot width located on a line that is not parallel to the tubular sheath axial dimension.

### Claim 38 (depends on 37)

The device of claim 37, wherein the change in length is a shortening such that the minimum slot width becomes closed while the maximum slot width remains open through at least a portion of the change in length, the closed condition of the minimum slot width resulting in a decrease of the axial flexibility of at least the respective portion of the tubular sheath.

### Claim 39 (depends on 38)

The device of claim 38, wherein further increasing the imposed force in the control element causes closure of portions of the tubular sheath that are circumferentially opposite of the minimum slot width along with an increased bending of the reconfigurable section, while axial flexibility of the tubular sheath is further reduced until all slots are fully closed when the bending is complete.

### Claim 40 (depends on 1)

The device of claim 1, wherein the periodically-varying width along at least a portion of the helical slot length comprises at least one of (a) interlocking members having a nesting shape fit and (b) interruptions in the helical slot that define at least one tangential torsional rigidity-enhancing hinge.

### Claim 41 (depends on 40)

The device of claim 40, wherein a change in shape in response to an operator imposing a force to the control element to enable the operator to vary the length of the tubular sheath comprises a shortening of the portion of the tubular sheath that defines the hinges, such shortening causes a gradual closure of the opposing slots and a bending of the respective portion of the tubular sheath.

### Claim 42 (depends on 40)

The device of claim 40, wherein a shortening of the section comprising the interlocking members causes a closure of the gap around the locking members, resulting in at least one of a reduced axial flexibility and an increased tangential torsional rigidity of the respective portion of the tubular sheath.

### Claim 43 (depends on 42)

The device of claim 42, wherein a further gradual closure of the slots opposing the locks results in a bending of the respective portion of the tubular sheath.

### Claim 44 (depends on 40)

The device of claim 40, wherein a change in shape in response to an operator imposing a force to the control element to enable the operator to vary the length of the tubular sheath comprises a lengthening of the portion of the tubular sheath that defines the hinges, such lengthening causes a gradual opening of the opposing slots and a bending of the respective portion of the tubular sheath.

### Claim 45 (depends on 44)

The device of claim 44, wherein a lengthening of the section comprising the locking members causes a closure of the gap around the locking members, resulting in an at least one of a reduced axial flexibility and increased tangential torsional rigidity of the respective portion of the tubular sheath.

### Claim 46 (depends on 45)

The device of claim 45, wherein a further gradual widening of the slots opposing the locking members results in a bending of the section.

### Claim 47 (depends on 40)

The device of claim 40, wherein the slot width around the interlocking members is smaller than on the circumferential opposing side where no interlocking members are present.

### Claim 48 (depends on 1)

The device of claim 1, wherein a relative torsional displacement between adjacent loops in the helical wall of the tubular sheath is prevented by an additional rigidity element, comprising a polymer, glue or related material that fills the gaps and resists change of length and tangential shear between adjacent coils.

### Claim 49 (depends on 1)

The device of claim 1, wherein an additional polymer sheath, applied on the outer surface of the helix prevents a relative torsional displacement between adjacent loops in the helical wall of the tubular sheath.

### Claim 50 (depends on 49)

The device of claim 49, wherein the polymer sheath has a wall thickness that is larger on the convex side than on the concave side.

### Claim 51 (depends on 1)

The device of claim 1, wherein an eccentric reinforcement element is attached to the helical sheath by a technique comprising dipping, extrusion, welding, crimping, brazing, gluing and embedding in a cover material that is surrounding the sheath.

### Claim 52 (depends on 1)

The device of claim 1, further comprising at least one additional slot configured to provide additional flexibility and/or steerability by bending.

### Claim 53 (depends on 52)

The device of claim 52, wherein two or more continuous helical slots are used to reduce the risk of failure.

### Claim 54 (depends on 52)

The device of claim 52, wherein steerability by bending is achieved by additional short slots located at the concave side only, which run over an angle less than 360 degrees, between the slots of the main helix.