Hysteroscopic system.

(54) Title: HYSTEROSCOPIC SYSTEM.

(54) Title: HYSTEROSCOPIC SYSTEM.

(57) Summary

A hysteroscopy system is described that includes an extension having an internal channel, a sheath removably attached to the extension, and an effusion channel; the sheath has a distal flange that extends internally to an outer surface of the extension; the effusion channel is formed between an inner surface of the sheath and an outer surface of the extension; The distal flange forms a distal end of the effusion channel, and is generally located between the extension and the sheath.

(57) Abstract

A hysteroscopy system includes a scope having an internal channel, a sheath removably coupled to the scope, and an outflow channel. The sheath has a distal flange extending internally towards an outer surface of the scope. The outflow channel is formed between an inner surface of the sheath and an outer surface of the scope. The distal flange forms a distal end of the outflow channel and is generally located between the scope and the sheath.

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Institute

Mexican Property

Industrial

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PATENT TITLE NO. 344597

Headlines):

SMITH &amp; NEPHEW INC.

Home:

150 Minuteman Road, Andover, Massachusetts, 01810, USA

Denomination:

HYSTEROSCOPIC SYSTEM.

Classification:

lnt.CI.8: A61B1 / 00; A61B1 / 015; A61B1 / 018; A61B1 / 307; A61B17 / 32

Inventors):

MIRA SAHNEY; CEMAL SHENER-IRMAKOGLU

REQUEST

Number:

International filing date:

MX / a / 2013/003535 September 2011

PRIORITY

Country:

Date:

Number:

US September 2010

12/892,355

Validity: Twenty years

Expiration Date: September 28, 2031

The reference patent is granted based on articles 1^or, 2nd section V, 6th section III, and 69 of the Law (Industrial Property web.

In accordance with article 23 of the Industrial Property Law, this patent has a non-extendable term of twenty years, cut from the filing date of the international application and will be subject to the payment of the tafite for mantaher in force.

'Who subscribes the present title does so with force in the provisions of articles 6' sections III and 7^or bis 2 of the Industrial Property Law (Official deferment of the Federation tEWhF-) 06/27/1991, amended on 08/02/1994, 10/25/1996, 12/26/1997, 05/17/1999, 01/26/2004, 06/16/2005 ^ 01/25/2006, 06/05/2009 / 06/01/201 «, 1ΜβΟ01Ο, 06/28/2010, 01/27/2012 and 04/09/2012 ); items 1^or, 3 'fraction V ancisto a), 4 ° and 12 ° fractions I III of the Regulations of the InsWMdJMteMM Industrial (DOF 12/14/1999, amended on 07/01/2002, 07/15/2004, 07/28/2 ^) 4 and 7/09/2007); Articles 1, 3, 4 », í» tetaBíSnVtaeso a), 16 sections I and III and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007), 1st, 3rd and 5th paragraph a) of the Agreement that delegates powers to The Deputy General Directors, Coordinator, Divisional Directors, Regional Office Holders, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

Issue Date: December 20, 2016

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HYSTEROSCOPIC SYSTEM

IMPI

Mexican Institute of Industrial Property

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RECIPROCAL REFERENCE TO THE RELATED REQUEST

This application is a PCT international patent application claiming priority to US patent application Serial No. 12/892355, the disclosure of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to hysteroscopy systems and, more particularly, to a hysteroscopy system that is small in size for use in an office setting.

BACKGROUND OF THE INVENTION

Hysteroscopy generally refers to the inspection of a uterine cavity using a hysteroscope with access through the cervix. As such, hysteroscopy allows the diagnosis of intrauterine pathology and, in addition, can be used for surgical intervention. The hysteroscope typically includes an extension and a sheath.

A problem associated with some hysteroscopy systems

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INDUSTRIAL current, is that they must be used in the operating room environment while the patient is under some type of anesthesia. Particular anesthesia is required, because the size of current hysteroscopes is large and as such can cause discomfort and pain to the patient. For example, a typical hysteroscope may have an outer diameter of about 9 millimeters. Such hysteroscopes include an extension having a diameter of approximately 8 millimeters and a sheath having a diameter of approximately 9 millimeters. In comparison, the scientific literature on the subject agrees that hysteroscopy can be carried out using a vaginoscopic procedure, which can be carried out in an office setting, only when the outermost diameter of the hysteroscope is approximately 6 millimeters or less. .

Another problem associated with current extensions is that they typically include a blunt flange at the distal end of the extension. The flange extends outward from the extension and makes it difficult, if not impossible, to use the extension without the sheath and / or without a plug. Accordingly, the size of some current hysteroscopes is limited by the size of the extension and sheath, for example, a diameter of 9 millimeters.

What is needed, therefore, is a hysteroscopy system for an office setting that lists the problems noted above and other problems.

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BRIEF DESCRIPTION OF THE INVENTION

In accordance with one aspect of the present invention, a hysteroscopy system is intended for performing a chemical procedure in a practice setting. The hysteroscopy system includes an extension that has an outer surface, an inner canal defined by an inner surface, and a distal end. A sheath is removably coupled to the extension, and has a tip at which a distal flange extends internally to the outer surface of the extension. The sheath also has an inner surface and a plurality of effusion holes near the distal flange. An effusion channel forms between the inner surface of the sheath and the outer surface of the extension, the distal flange forming a distal end of the effusion channel. An operating channel is formed within the internal channel of the extension to receive at least one of a surgical tool and an influx fluid, and a viewing channel is formed adjacent to the operating channel to receive a viewing device.

In accordance with another aspect of the invention, a hysteroscopy system for a medical procedure includes an extension in the form of an elongated tubular member having an outer surface and an inner surface. The internal surface of the extension defines an internal channel of the extension. A sheath is in the form of an elongated tubular member removably coupled to the extension, the sheath having an outer surface and an inner surface. The sheath has a flange that extends

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the pod. An operative member is located within the internal channel of the extension, and is in the form of an elongated D-shaped tubular member. The operating member has an outer surface and an inner surface, the outer surface being spaced from the inner surface of the extension to form a viewing channel.

In accordance with another aspect of the invention, a hysteroscopy system includes an extension having an outer surface and an internal channel, and a sheath removably coupled to the extension. The sheath has an inner surface and a distal flange, the distal flange extending internally towards the outer surface of the extension. An effusion channel is formed between the inner surface of the sheath and the outer surface of the extension, the distal flange forming a distal end of the effusion channel between the extension and the sheath.

Additional aspects of the invention will be apparent to those skilled in the art in view of the detailed description of various embodiments, which is made in relation to the drawings, the brief description of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a hysteroscopy system.

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Figure 2A is an enlarged perspective view of the distal end of the hysteroscopy system.

Figure 2B is an enlarged side view of the distal end of the hysteroscopy system.

Figure 2C is an enlarged cross-sectional end view of the distal end of the hysteroscopy system.

Figure 2D is an enlarged cross-sectional top view of the distal end of the hysteroscopy system.

Figure 3 shows the dimensions associated with the distal end of Figure 2A.

Figure 4 is a perspective view of the hysteroscopy system having a sheath removed from an extension.

Figure 5 is an enlarged perspective view of the distal end of the hysteroscopy system of Figure 4.

Figure 6 is a perspective view of an alternative embodiment of the hysteroscopy system.

While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings, and will be described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms described. Rather, the invention is to encompass all modifications, equivalents, and alternatives that are within the spirit and scope of the invention as defined by the appended claims.

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Referring to Figure 1, a hysteroscopy system 100 includes a hysteroscope 102 having, among other things, a sheath 104, an inflow valve 106, an effusion valve 108, a light pole 110 and a morcellator 112. The sheath 104 is a generally elongated tubular member having a distal end 114 and a proximal end 116. Hysteroscopy system 100 also includes an arm 117 that is connected to an imaging device (eg, a camera) that captures images received by means of a display device (eg, display device 124).

In accordance with some examples of modalities, the hysteroscopy system 100 is intended for morcellation of uterine pathology with an extension and accessories having a sufficiently small diameter that it can be inserted into the uterus of a patient using the vaginoscopic procedure. In particular, hysteroscopy system 100 provides a way to minimize patient pain because a tenaculum and speculum are not typically used.

Also, anesthesia is not required, and medical procedures can be performed in an office setting. This can result, for example, in faster surgery with less pain and faster recovery, and can potentially lower the cost of the surgery. However, another advantage of the hysteroscopy system 100 is that a surgeon has the

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with an attached pod 104) or smaller diameter instruments (eg, with a removed pod 104), depending on the patient's case.

Referring to Figure 2A, sheath 104 is removably coupled to an extension 118, which is generally an elongated tubular member having (similar to sheath 104) a distal end 114 and a proximal end 116. More specifically, sheath 104 is desirably fitted in an overlapping manner over extension 118.

Extension 118 includes an operating member 120, which is in the form of an elongated D-shaped tubular member.

Operating member 120 internally receives a surgical tool 122, which can be selected from a variety of different tools. For example, surgical tool 122 may be a rotary morcellator, an alternate morcellator, or a morcellator having reciprocal and rotary capabilities. Extension 118 further includes a display device 124. Display device 124 is adjacent to operating member 120, and may include various imaging devices. For example, display device 124 may include fiber optic technology for lighting and image transmission.

To maintain continuous effusion, a plurality of effusion holes 126 are formed near distal end 114 of sheath 104. Flow valve 106 (shown in Figure 1) regulates the flow of a liquid through operating member 120, as represented by

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MEXK ^ iNC INSTITUTE OF INDUSTRIAL PROPERTY

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arrows 107 extending from operating member 120. Liquid is used, for example, to distend and irrigate a patient's uterus. Furthermore, the liquid is generally received from an access pump, which supplies the fluid to produce a substantially constant predetermined pressure level within a union cavity, eg, a uterus. The effusion valve 108 (shown in Figure 1) regulates the effusion of the liquid through the effusion holes 126 by means of an effusion channel 128 (shown in Figure 2C) formed between the sheath 104 and the extension 118. The effusion of the liquid is represented by the arrows 109 extending into the effusion holes 126. The effusion liquid is generally sent to a waste container.

Referring to FIG. 2B, sheath 104 has at its distal end 114 a flange 130 that extends inwardly toward extension 118 to form a closed end of effusion channel 128 (shown in FIG. 2C). Flange 130 has a generally oval shape, and includes two pairs of opposite sides 130a-130d.

In accordance with the illustrated mode, the shape of the flange

130 it is non-uniform. For example, a second side 130b extends a greater distance internally toward the center of extension 118 than a first side 130a. Similarly, based on the symmetrical characteristics of this embodiment, a fourth side 130d extends a greater distance internally toward the center of extension 118 than a third side 130c. In alternative embodiments, flange 130 can have different shapes and sizes.

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Referring to Figures 2C-2D, sheath 104 has an outer surface 104a and an inner surface 104b, and extension 118 has an outer surface 118a and an inner surface 118b. Inner surface 104b of sheath 104 defines an internal channel in which extension 118 and display device 124 are located. The inner surface 118b of extension 118 defines an inner channel in which the outer member and thus surgical tool 122 is located.

Operating member 120 has an outer surface 120a, an inner surface 120b, and a flat outer surface 120c (clearly shown in Figure 2C). The flat outer surface 120c is spaced from the inner surface 118b of extension 118 to form a viewing channel 132 (clearly shown in Figure 2C), in which the viewing device 124 is located. Viewing channel 132 is only a small part of the larger internal channel of extension 118.

Effusion channel 128 is formed between the inner surface 104b of sheath 104 and the outer surface 118a of extension 118. An inflow channel 134 is formed in the internal channel of extension 118. If surgical tool 122 is removed, flow channel 134 is simply the entire internal channel of extension 118. If the surgical tool 122 is in place, the flow channel 134 is limited to the area between the surgical tool 122 and the inner surface 120b of the operating member 120.

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Relative to FIG. 3, the hysteroscopy system 100 is designed to be of a size that can be used in an office setting. Specifically, the outermost diameter is designed to be approximately 6 millimeters or less. In accordance with the illustrated embodiment, the outer diameter D1 of sheath 104 (which is the same diameter as the diameter of outer surface 104b) is approximately 5.6 millimeters. For example, in an alternative embodiment, the diameter of the sheath

104 is 5.5 millimeters. The outer diameter D2 of the surgical tool

122 (eg morcellator) is approximately 2.9 millimeters.

Extension 118 has an oval shape with a long diameter D3 of approximately 5.15 millimeters, and a short diameter D4 of approximately 4.6 millimeters. Operating member 120 has a curvature dimension L1 of approximately 3.1 millimeters, and a flat dimension L2 of approximately 3.95 millimeters.

The relatively small dimensions of the hysteroscopy system 100 allow a patient to be treated in an office setting. In general, medical procedures can be provided to a patient with the use of the current hysteroscopy system 100, so that little to no anesthesia may be necessary. Clearly, an advantage of the hysteroscopy system 100 is that it is small enough in diameter to be suitable for the vaginoscopic procedure.

Referring to Figure 4, the hysteroscopy system 100 is also usable without the sheath 104, while still providing a continuous flow through

IMPI institute mlxkmnc · gave the INDUSTRIAL nonuMO a diagnostic cannula 135 (for example, a cannula with a diameter of approximately 2.9 millimeters). Specifically, sheath 104 is removed to allow insertion of extension 118 only in a patient, eg, in a uterus. Removal of sheath 104 decreases the outermost diameter of hysteroscopy system 100. For example, in accordance with the dimensions described above in relation to Figure 3, the outermost diameter decreases to about 5.15 millimeters (the long diameter D3) from about 5.6 millimeters (the outer diameter D1). When the sheath 104 is removed, the effusion can be provided by an operating tool, such as the morcellator 112 described above (shown in Figures 1 to 3), or by the diagnostic cannula 135.

In contrast to previous extensions, extension 118 does not have a flange that extends outwardly from its distal end. The flange extending outward from the previous extensions unnecessarily increased the outermost diameter of the respective extensions, and created an aggressive distal end that made it difficult, if not impossible, to insert it into a patient without a sheath and obturator.

Referring to Figure 5, the hysteroscopy system can be used for diagnostic purposes when sheath 104 is removed. Sheath 104 is likely to be used in operational cases primarily to clear the field of view prior to the introduction of a morcellator blade. Diagnostic cannula 135, which has a distal end 136, is used to

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create a smaller overall diameter of the system for diagnostic purposes. In accordance with the dimensions described above, a reduction of approximately 0.5 millimeters can be achieved by removing the sheath 104. Another advantage of the cannula 135, is that it can be made reusable. Another advantage of cannula 135 is that it can be used to distend and irrigate the patient's uterus during the diagnostic procedure.

Cannula 135 allows continuous effusion, but does not extend beyond the distal end of extension 118. For example, cannula 135 provides a replacement for effusion channel 128, which is removed with removal of sheath 104. Specifically, cannula 135 provides an alternative effusion channel 138 to replace the effusion channel 128 formed by sheath 104. As such, continuous flow can be maintained even if sheath 104 is removed.

Referring to Figure 6, the hysteroscopy system 100 alternatively includes a flow device 140 inserted into the operating member 120. The flow device 140 has a tubular inflow element 142 and a tubular effusion element 144, both of which they can be joined elements or separate elements.

The distal ends of the tubular elements 142, 144 terminate at different points within the operating member 120. Preferably, the distal end of the tubular inflow element 142 terminates at the distal end 114 of extension 118, and the distal end of the element

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Tubular effusion tubing 144 terminates at a distance from distal end 114 within operating member 120. Termination of tubular members 142, 144 at different points along operating member 120, eliminates the possibility of fluid short circuit, and provides better circulation and, therefore, irrigation within the uterus.

In accordance with an example, flow device 140 is made of stainless steel and as such can be a reusable device. In accordance with another example, flow device 140 is made of a much more cost-effective material, such as a polymer. If a polymer is used, flow device 140 will typically be considered as a single-use device.

In practice, for example, a surgeon will insert flow device 140 into operating member 120 of hysteroscope 102 prior to insertion into a patient's uterus. After introduction of the hysteroscope into the uterus, an inflow valve 146 of the flow device 140 will be opened, and the uterus will be distended. Then, by opening an effusion valve 148 of flow device 140, irrigation is accomplished. In the case of a diagnostic procedure, flow device 140 could remain in place for the time that surgery takes. In the case of an operating procedure, flow device 140 is removed and an operating tool (eg morcellator 112) is inserted into extension 118.

While the best ways to carry out the present invention have been described in detail, those skilled in the art to which this

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The IPPI invention relates to several alternative designs and embodiments for practicing the invention within the scope of the appended claims. For example, sheath 104, extension 118, and surgical tool 122 may be circular or oval in shape or any other uniform shape (i.e., a discrete shape such as a shape that does not have an outwardly extending flange) . In another example, the operating member 120 may have a circular shape or any other shape similar to the illustrated D shape.