# US 9,872,952 B2 · Soft dual-layer rectal speculum

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- Number: US 9,872,952 B2
- Document ID: US9872952B2
- Status: Granted
- Kind: B2
- Application number: 13/176,260
- Filed: 2011-07-05
- Published: 2012-01-05
- Granted: 2018-01-23
- Earliest claimed: 2010-07-03
- Applicants: Deborah Solomon
- Inventors: Deborah Solomon
- Web page: https://patentgrep.com/patent/US9872952B2

## CPC

- A61M 3/0279: {Cannula; Nozzles; Tips; their connection means}
- A61B 1/015: Control of fluid supply or evacuation
- A61B 1/31: for the rectum, e.g. proctoscopes or sigmoidoscopes
- A61B 1/32: Devices for opening or enlarging the visual field, e.g. of a tube of the body
- A61M 2210/1064: Large intestine
- 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)

## Abstract

A soft dual-layer rectal speculum includes a main tube member having a distal end for insertion into a patient's rectum and a proximal end for connection to a waste removal hose where at least a portion of the main tube member includes an inner hard layer and an outer soft layer, and an inlet tube member for directing fluids into the main tube member. The inlet tube member may include a swivel mechanism and the portion of the main tube member having an inner hard layer and an outer soft layer may include a measurement gauge that is visible through the outer soft layer but can't be felt through the outer soft layer. A rectal speculum assembly includes the soft dual-layer rectal speculum described above and an obturator which includes an elongated member having a tapered distal end capable of extending through the distal end of the main tube member. The tapered distal end of the obturator may be made of a soft, pliable material or an inner hard layer (or member) and an outer soft layer.

## Claims

### Claim 1

A dual-layer rectal speculum for use with colon hydrotherapy comprising:
a main tube member having a distal end for insertion into a patient's rectum and a proximal end tor connection to a waste removal hose wherein at least a portion of the main tube member comprises an inner hard layer and an outer soft layer that is transparent; and
an inlet tube member for directing fluids into the main tube member wherein the inlet tube member has a diameter less than a diameter of the main tube member and further includes a swivel mechanism capable of enabling a fluid line connected to the inlet tube member to rotate in relation to the main tube member.

### Claim 2 (depends on 1)

The dual-layer rectal speculum of claim 1 wherein the main tube member further comprises a distal portion located near the distal end of the main tube member and a proximal portion located near the proximal end of the main tube member.

### Claim 3 (depends on 2)

The dual-layer rectal speculum of claim 2 wherein the distal portion of the main tube member comprises an inner hard layer and an outer soft layer.

### Claim 4 (depends on 3)

The dual-layer rectal speculum of claim 3 wherein the outer soft layer adheres to the inner hard layer.

### Claim 5 (depends on 4)

The dual-layer rectal speculum of claim 4 wherein adhesion of the outer soft layer to the inner hard layer is performed by at least one of thermal bonding, chemical bonding, and mechanical bonding.

### Claim 6 (depends on 3)

The dual-layer rectal speculum of claim 3 wherein the distal portion of the main tube member further comprises an annular depression.

### Claim 7 (depends on 6)

The dual-layer rectal speculum of claim 6 wherein the distal portion further comprises annular expansions on opposite sides of the annular depression.

### Claim 8 (depends on 3)

The dual-layer rectal speculum of claim 3 wherein the main tube member further comprises a measurement gauge visible through the outer soft layer.

### Claim 9 (depends on 8)

The dual-layer rectal speculum of claim 8 wherein the measurement gauge is imprinted within, or tooled into, the inner hard layer of the main tube member.

### Claim 10 (depends on 3)

The dual-layer rectal speculum of claim 3 wherein the inner hard layer comprises at least one of a polypropylene and a synthetic resin and the outer soft layer comprises at least one of a polyethylene, a silicone, a soft urethane, a thermoplastic elastomer, and a thermoplastic polyurethane.

### Claim 11 (depends on 2)

The dual-layer rectal speculum of claim 2 wherein the inlet tube member is located on the proximal portion of the main tube member near the proximal end of the main tube member.

### Claim 12 (depends on 1)

The dual-layer rectal speculum of claim 1 wherein the portion of the main tube member comprising the inner hard layer and the outer soft layer is created by a two step molding process where the inner hard layer is molded first and the outer soft layer is molded second such that the outer soft layer adheres to the inner hard layer.

### Claim 13 (depends on 1)

The dual-layer rectal speculum of claim 1 wherein the inner hard layer comprises at least one of a polypropylene and a synthetic resin and the outer soft layer comprises at least one of a polyethylene, a silicone, a soft urethane, a thermoplastic elastomer, and a thermoplastic polyurethane.

### Claim 14 (depends on 1)

The dual-layer rectal speculum of claim 1 wherein the main tube member further comprises a measurement gauge visible through the outer soft layer.

### Claim 15 (depends on 1)

The dual-layer rectal speculum of claim 1 further comprising a thumb rest extending outward from an outer surface of the main tube member opposite the inlet tube member.

### Claim 16 (depends on 1)

The dual-layer rectal speculum of claim 1 wherein the proximal end of the main tube member includes one or more ribs for securing the proximal end of the main tube member to a waste removal hose.

### Claim 17 (depends on 1)

The dual-layer rectal speculum of claim 1 wherein the inlet tube member intersects the main tube member near the proximal end of the main tube member.

### Claim 18 (depends on 11)

The dual-layer rectal speculum of claim 11 wherein the distance between an end of the distal portion of the main tube member opposite the distal end and the inlet tube member is at least greater than one half of the length of the distal portion of the main tube member to enable waste and fluid lines connected to the dual-layer rectal speculum to be further away from a patient during use.

### Claim 19

A rectal speculum assembly for use with colon hydrotherapy comprising:
a main tube member having a distal end for insertion into a patient's rectum and a proximal end for connection to a waste removal hose wherein at least a portion of the main tube member comprises an inner hard layer and an outer soft layer that is transparent;
an inlet tube member for directing fluids into the main tube member wherein the inlet tube member has a diameter less than a diameter of the main tube member and further includes a swivel mechanism capable of enabling a fluid line connected to the inlet tube member to rotate in relation to the main tube member, and
an obturator removably positioned within the main tube member of the rectal speculum for facilitating insertion of the rectal speculum in a patient's rectum wherein the obturator comprises an elongated member having a tapered distal end capable of extending through the distal end of the main tube member and a proximal end having a handle portion for assistance in inserting the obturator into the main tube member and removing the obturator from the main tube member.

### Claim 20 (depends on 19)

The rectal speculum assembly of claim 19 wherein the tapered distal of the obturator comprises a soft pliable material.

### Claim 21 (depends on 20)

The rectal speculum assembly of claim 20 wherein the tapered distal end comprises at least one of a polyethylene, a silicone, a soft urethane, a thermoplastic elastomer, and a thermoplastic polyurethane.

### Claim 22 (depends on 20)

The rectal speculum of claim 20 wherein the elongated member comprises one or more stabilizing flanges.

### Claim 23 (depends on 19)

The rectal speculum assembly of claim 19 wherein the tapered distal end of the obturator comprises an inner hard layer and an outer soft layer.

### Claim 24 (depends on 23)

The rectal speculum assembly of claim 23 wherein the inner hard layer comprises at least one of a polypropylene and a synthetic resin and the outer soft layer comprises at least one of a polyethylene, a silicone, a soft urethane, a thermoplastic elastomer, and a thermoplastic polyurethane.

### Claim 25 (depends on 23)

The rectal speculum of claim 23 wherein the elongated member comprises one or more stabilizing flanges.

### Claim 26

A dual-layer rectal speculum for use with colon hydrotherapy comprising:
a main tube member comprising a distal portion having a distal end for inserting into a patient's rectum and a proximal portion having a proximal end for connection to a waste removal hose wherein the distal portion comprises and inner hard layer and an outer soft layer; and
an inlet tube member for directing fluids into the proximal portion of the main tube member wherein the distance between an end of the distal portion opposite the distal end and the inlet tube member is greater than one half of the length of the distal portion of the main tube member and further includes a swivel mechanism capable of enabling a fluid line connected to the inlet tube member to rotate in relation to the main tube member.
