WO2020223637A1

WO2020223637A1 - Freestanding specimen retrieval bag

Info

Publication number: WO2020223637A1
Application number: PCT/US2020/031037
Authority: WO
Inventors: Leslie KAMMIRE
Original assignee: Wake Forest University Health Sciences
Priority date: 2019-05-02
Filing date: 2020-05-01
Publication date: 2020-11-05

Abstract

A device comprising a freestanding specimen retrieval bag is disclosed herein. Also disclosed is a method of using a freestanding bag during a cystectomy wherein the bag is first fastened around the mesovarium. The mouth of the bag then is positioned to encircle the ovary so that a cystectomy can be performed within the bag to catch any spills that occur. The disclosed devices, methods, and systems avoid the traditional need for additional surgical ports or an additional assistant when conducting a cystectomy within a specimen retrieval bag.

Description

FREESTANDING SPECIMEN RETRIEVAL BAG

RELATED APPLICATIONS

The present application claims priority to U.S. Provisional Patent Application No. 62/842,301, filed May 2, 2019.

BACKGROUND

Mature cystic teratomas, or dermoids, are the most common benign ovarian neoplasm. Laparoscopic cystectomy rather than oophorectomy is recommended removal of these cysts for the majority of pre-menopausal women. Rupture of the dermoid occurs approximately 80% of the time during cystectomy. Upon rupture, the dermoid spills contents such as grease, fat, and hair into the peritoneal cavity. Although most patients will have no significant consequences of rupture, there are a number of reports of chemical and granulomatous peritonitis resulting from the spill, some with very significant morbidity including bowel obstruction and need for repeated surgery and prolonged hospitalization. Currently, cystectomies are performed over a“bag on a stick” to capture any spill that occurs, but this requires an extra port site as well as an assistant to hold the bag during the surgery.

A need exists for a freestanding specimen retrieval bag that does not require an extra port site for placement or an assistant to hold the bag during surgery.

SUMMARY

Disclosed herein are embodiments of a specimen retrieval bag comprising a closed bottom end, a top end with an openable mouth, wherein the mouth is for receiving the specimen, a substantially cylindrical body flexibly connecting the bottom end to the top end, and a fastener attached to the top end, wherein the fastener is for fastening the bag to a structure within a patient.

Also disclosed is a method of using a specimen retrieval bag comprising a) inserting the bag through a surgical port, wherein the bag comprises a closed end and an open mouth end; b) fastening the bag to a stable structure and positioning the specimen to be collected within the mouth of the bag; c) surgically excising the specimen within the bag; d) unfastening the bag from the stable structure; and e) removing the bag through the port. Also disclosed is a system for retrieving a specimen comprising a) a specimen retrieval bag; b) a device for inserting the bag through a surgical port in a patient; and c) a device for assisting in fastening the bag to a stable structure within the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a perspective view of a freestanding specimen retrieval bag according to one embodiment described herein.

DETAILED DESCRIPTION OF THE INVENTION

The following description recites various aspects and embodiments of the present compositions, methods, and systems. No particular embodiment is intended to define the scope of the compositions, methods, and systems. Rather, the embodiments merely provide non-limiting examples of various compositions, methods, and systems that are at least included within the scope of the compositions, methods, and systems. The description is to be read from the perspective of one of ordinary skill in the art; therefore, information well known to the skilled artisan is not necessarily included.

Definitions

The present disclosure now will be described more fully hereinafter. The disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein; rather, these aspects are provided so that this disclosure will satisfy applicable legal requirements. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs. All patents, applications, published applications and other publications referred to herein are incorporated by reference in their entireties. If a definition set forth in this section is contrary to or otherwise inconsistent with a definition set forth in the patents, applications, published applications and other publications that are herein incorporated by reference, the definition set forth in this section prevails over the definition that is incorporated herein by reference.

When introducing elements of the present disclosure or the embodiment(s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there are one or more of the elements. The terms "comprising", "including" and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. It is understood that aspects and embodiments of the disclosure described herein include "consisting" and/or "consisting essentially of aspects and embodiments.

The term "and/or" when used in a list of two or more items, means that any one of the listed items can be employed by itself or in combination with any one or more of the listed items. For example, the expression "A and/or B" is intended to mean either or both of A and B, i.e. A alone, B alone or A and B in combination. The expression "A, B and/or C" is intended to mean A alone, B alone, C alone, A and B in combination, A and C in

combination, B and C in combination or A, B, and C in combination.

Various aspects of this disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure.

Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Device

Described herein is a specimen retrieval bag. In some embodiments, and as is shown in Fig. 1, the specimen retrieval bag (100) may have a closed bottom end (101), a top end (102) with an openable mouth (103), wherein the mouth is for receiving the specimen, a substantially cylindrical body (104) flexibly connecting the bottom end to the top end, and a fastener (105) attached to the top end (102), wherein the fastener is for fastening the bag to a structure within a patient.

In some embodiments, the body may be made of rip-stop nylon with a polyurethane coating or another appropriate material with similar physical properties.

In some embodiments, the mouth may be rigid or flexible. In some embodiments, the mouth may be capable of being closed.

In some embodiments, the mouth may be at least 5 cm or in the range of about 5 cm to about 20 cm. In some embodiments, the diameter of the mouth may be at least about 5 cm larger than the specimen being retrieved. In some embodiments, the fastener may be a clasp, a hook and eye, a snap, hook and loop fastener, other fasteners that function similarly to hook and loop fasteners, or other appropriate fasteners with similar properties.

In some embodiments, the fastener may be made of metal, plastic, fabric, or another appropriate material.

In some embodiments, the bag may be capable of being fastened to mesovarium, bowel wall, abdominal wall, appendix, uterus, or another appropriate structure.

In some embodiments, the volume of the body may be at least 100 cc’s or in the range of 100 cc’s to 2000 cc’s.

Method of Use

Also described herein are methods of using a specimen retrieval bag. In some embodiments, the method may comprise inserting the bag through a surgical port, fastening the bag to a stable structure and positioning the specimen to be collected within the mouth of the bag, surgically excising the specimen within the bag, unfastening the bag from the stable structure, and removing the bag through the port.

In some embodiments, the method may further comprise closing the bag before removing the bag through the port.

In some embodiments, the method involves inserting and removing the bag through a primary surgical port.

In some embodiments, fastening the bag to a stable structure may comprise stitching to fasten the bag around around the stable structure.

In some embodiments, the stable structure may be an anatomical structure. In some embodiments, the stable structure may be an anatomical structure related to the specimen retrieval procedure. In some embodiments, the stable structure may be the mesovarium. In some embodiments, the stable structure may be bowel wall, abdominal wall, appendix, uterus, or another appropriate structure

System

Also described herein are systems comprising a specimen retrieval bag. In some embodiments, the system may comprise the specimen retrieval bag described above as well as a device to assist the surgeon with inserting the bag through a surgical port and a device for attaching the specimen retrieval bag to a stable structure within the patient. Various embodiments of the disclosure have been described herein. It should be recognized that these embodiments are merely illustrative of the present disclosure.

Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. It is expected that skilled artisans can employ such variations as appropriate, and the disclosure is intended to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated or otherwise clearly contradicted by context.

EXAMPLES

Example 1 Examples of Certain Embodiments

Listed hereafter are non-limiting examples of certain embodiments of the technology.

A1. A specimen retrieval bag comprising

a closed bottom end;

a top end with an openable mouth, wherein the mouth is for receiving the specimen; a substantially cylindrical body flexibly connecting the bottom end to the top end; and a fastener attached to the top end, wherein the fastener is for fastening the bag to a structure within a patient.

A2. The device of embodiment Al, wherein the body is made of at least one material selected from a list comprising rip-stop nylon with a polyurethane coating or other appropriate materials with similar properties.

A3. The device of any of the preceding embodiments, wherein the mouth is rigid.

A4. The device of embodiment Al or A2, wherein the mouth is flexible. A5. The device of any of the preceding embodiments, wherein the fastener is selected from a list comprising a tie, a clasp, a hook and eye, a snap, a hook and loop closure, and other fasteners with appropriate physical properties.

A6. The device of any of the preceding embodiments, wherein the fastener is made of at least one material selected from a list comprising metal, plastic, fabric, and other materials with appropriate physical properties.

A7. The device of any of the preceding embodiments, wherein the volume of the body is at least 100 ccs or in range of 100 cc’s to 2000 cc’s.

A8. The device of any of the preceding embodiments, wherein the diameter of the mouth is at least 5 cm or in range of 5 cm to 20 cm.

A9. The device of any of the preceding embodiments, wherein the mouth can be closed prior to removal from the patient.

A10. The device of any of the preceding embodiments, wherein the structure within the patient can be chosen from a list comprising mesovarium, bowel wall, abdominal wall, appendix, uterus, and any other appropriate structure.

Bl. A method of using a specimen retrieval bag comprising

a) inserting the bag through a surgical port, wherein the bag comprises a closed end and an open mouth end;

b) fastening the bag to a stable structure and positioning the specimen to be collected within the mouth of the bag;

c) surgically excising the specimen within the bag;

d) unfastening the bag from the stable structure; and

e) removing the bag through the port.

B2. The method of embodiment Bl, further comprising closing the bag before removing the bag. B3. The method of either of embodiments B1 or B2, wherein the stable structure is an anatomical structure or a structure related to the specimen retrieval procedure.

B4. The method of any of embodiments B1 to B3, wherein the surgical port is the primary surgical port for the procedure.

Cl. A system for retrieving a specimen comprising

a) the specimen retrieval bag of any of embodiments A1 to A10; and

b) a device for inserting the bag through a surgical port in a patient; and c) a device for assisting in fastening the bag to a stable structure within the patient.

Claims

THAT WHICH IS CLAIMED IS:

1. A specimen retrieval bag comprising

a closed bottom end;

2. The device of claim 1, wherein the body is made of at least one material selected from a list comprising rip-stop nylon with a polyurethane coating or other appropriate materials with similar properties.

3. The device of any of the preceding claims, wherein the mouth is rigid.

4. The device of claims 1 or 2, wherein the mouth is flexible.

5. The device of any of the preceding claims, wherein the fastener is selected from a list comprising a tie, a clasp, a hook and eye, a snap, a hook and loop closure, and other fasteners with appropriate physical properties.

6. The device of any of the preceding claims, wherein the fastener is made of at least one material selected from a list comprising metal, plastic, fabric, and other materials with appropriate physical properties.

7. The device of any of the preceding claims, wherein the volume of the body is at least 100 cc’s or in range of 100 cc’s to 2000 cc’s.

8. The device of any of the preceding claims, wherein the diameter of the mouth is at least 5 cm or in range of 5 cm to 20 cm.

9. The device of any of the preceding claims, wherein the mouth can be closed prior to removal from the patient.

10. The device of any of the preceding claims, wherein the structure within the patient can be chosen from a list comprising mesovarium, bowel wall, abdominal wall, appendix, uterus, and any other appropriate structure.

11. A method of using a specimen retrieval bag comprising

c) surgically excising the specimen within the bag;

d) unfastening the bag from the stable structure; and

e) removing the bag through the port.

12. The method of claim 11, further comprising closing the bag before removing the bag.

13. The method of either of claims 11 or 12, wherein the stable structure is an anatomical structure or a structure related to the specimen retrieval procedure.

14. The method of any of claims 11 to 13, wherein the surgical port is the primary surgical port for the procedure.

15. A system for retrieving a specimen comprising

a) the specimen retrieval bag of any of claims 1-10; and

b) a device for inserting the bag through a surgical port in a patient; and

c) a device for assisting in fastening the bag to a stable structure within the patient.