system

Abstract

The method may include inserting a first device into a body lumen having a curve, sliding a first sheath having a first sheath diameter over the first device, sliding a second sheath having a second sheath diameter larger than the first sheath diameter over the first device, and moving the first device through and past the curve. The method may also include at least partially straightening the first device to at least partially straighten the curve, removing the first device and the first sheath from the body lumen leaving the second sheath in place within the at least partially straightened curve, and introducing a second device into the second sheath and moving the second device through the at least partially straightened curve to an opening in the second sheath.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 305,454, filed February 1, 2022, the entire contents of which are incorporated herein by reference in their entirety.

[0002] The present disclosure relates to surgical apparatus, systems, and procedures for minimally invasive surgery. More specifically, the present disclosure relates to surgical apparatus, systems, and procedures for controlling, navigating, and deploying medical devices to targeted sites. [Background technology]

[0003] Certain transluminal procedures may utilize certain devices that are at least partially flexible and / or steerable. Traditionally, the larger the device, the less flexible the device. Certain body lumens (e.g., the colon) define tortuous paths with sharp turns and / or multiple bends that are difficult to navigate with less compliant devices. Thus, such lumens may limit the size and type of devices that can be used for transluminal procedures at or beyond the location of the tortuous path.

[0004] Such conventional methods and systems have generally been considered satisfactory for their intended purposes. However, there remains a need in the art for improved systems and methods. The present disclosure provides a solution to this need. Summary of the Invention

[0005] According to at least one aspect of the present disclosure, a method for deploying a medical device may include inserting a first device into a body lumen having a curve, sliding a first sheath having a first sheath diameter over the first device, sliding a second sheath having a second sheath diameter larger than the first sheath diameter over the first device, and moving the first device through and over the curve. The method may also include at least partially straightening the first device to at least partially straighten the curve, removing the first device and the first sheath from the body lumen leaving the second sheath in place within the at least partially straightened curve, and introducing a second device into the second sheath and moving the second device through the at least partially straightened curve to an opening in the second sheath.

[0006] In certain embodiments, sliding the first sheath over the first device may occur after at least partially straightening the first device and before removing the first device from the body lumen. In certain embodiments, sliding the second sheath over the first sheath may occur after sliding the first sheath over the at least partially straightened first device and before removing the first device from the body lumen.

[0007] In certain embodiments, the first sheath and the second sheath may slide together over the first device. In certain embodiments, removing the first device may include removing the first device and the first sheath together or sequentially. In certain embodiments, inserting the first device may include inserting the first device with the first sheath over the first device and the second sheath over the first sheath.

[0008] In certain embodiments, the second device may be less compliant and / or less steerable than the first device. For example, the diameter of the second device may be greater than the diameter of the first device. In certain embodiments, the diameter of the first device may be about 13 mm or less and the diameter of the second device may be about 18 mm or more. Any suitable relative sizes are contemplated herein.

[0009] In certain embodiments, the first device may be an endoscope configured to fit within the first sheath, hi certain embodiments, the second device may be or include an overtube configured to fit within the second sheath.

[0010] In certain embodiments, moving the curved portion may include positioning an opening of the second sheath at or near the target site. In certain embodiments, the method may include extending the second device from the second sheath to the target site. In certain embodiments, the method may include inserting one or more robotic surgical tools through the second device and extending from the second device for access to the target site. Any other suitable procedure is contemplated herein.

[0011] In certain embodiments, the body lumen is the colon. For example, the curvature may be the sigmoid colon. Any other suitable body lumen or curvature thereof is contemplated herein.

[0012] According to at least one aspect of the present disclosure, a method for moving a medical device may include moving an overtube through a pre-positioned outer sheath and extending from the outer sheath toward a target site at an intestinal location beyond the sigmoid colon. In certain embodiments, the method may also include pre-positioning the outer sheath across the sigmoid colon with a colonoscope and a colonoscope sheath, at least partially straightening the sigmoid colon and the outer sheath with the colonoscope, and removing the colonoscope and colonoscope sheath to leave the pre-positioned outer sheath for insertion of the overtube. In certain embodiments, the method may include inserting one or more robotic surgical tools through the overtube and extending from the overtube to access the target site. In certain embodiments, the method may include performing a robotic surgical procedure at the target site with the one or more robotic tools.

[0013] According to at least one aspect of the present disclosure, a system for deploying a medical device may include an endoscope having an endoscope diameter, where the endoscope is configured to move through and over curves in a body lumen, and an overtube having an overtube outer diameter greater than the endoscope diameter. The overtube may not be configured to move through and over curves in a body lumen until the curve is at least partially straightened. The system may also include a first sheath having a first sheath inner diameter and a first sheath outer diameter that are complementary in size to the endoscope outer diameter. The system may also include a second sheath having a second sheath inner diameter that is complementary in size to both the first sheath outer diameter and the overtube outer diameter. In certain embodiments, the endoscope diameter may be about 13 mm or less and the overtube diameter is about 18 mm or more.

[0014] These and other features of the subject disclosed embodiments will become readily apparent to those skilled in the art from the following detailed description taken in conjunction with the drawings. [Brief description of the drawings]

[0015] Embodiments thereof are described in detail herein with reference to certain figures so that those skilled in the art to which the subject disclosure pertains will readily understand, without undue experimentation, how to make and use the devices and methods of the subject disclosure.

[0016] [Figure 1A] 1 illustrates one embodiment of a method according to the present disclosure. [Figure 2A] 1 illustrates a portion of one embodiment of a method according to the present disclosure, the method including navigating the sigmoid colon with a colonoscope. [Figure 2B] 1 illustrates a portion of a method according to the present disclosure, the method including at least partially straightening the sigmoid colon with a colonoscope, eg, straightening the sigmoid colon such that it is shortened on the colonoscope. [Figure 2C] 1 illustrates a portion of a method according to the present disclosure, the method including inserting a first sheath and a second sheath over a colonoscope. [Figure 2D] 2D shows a cross-sectional view of the structure of FIG. 2C within a body lumen with a first sheath and a second sheath over a colonoscope. [Figure 2E] 1 illustrates a portion of a method according to the present disclosure, the method including removing a first sheath and a colonoscope (eg, simultaneously, or, eg, the colonoscope first), leaving a second sheath in place. [Figure 2F] 2F shows a cross-sectional view of the remaining structure of FIG. 2E within a body lumen, with only the second sheath. [Figure 2G] FIG. 13 illustrates a portion of a method according to the present disclosure, the method including inserting an overtube having multiple lumens into a second sheath (e.g., the overtube having a videoscope disposed therein during insertion). [Figure 2H] 2E shows a cross-sectional view of the structure of FIG. 2E within a body lumen, with a second sheath surrounding the overtube. [Figure 3A] 1 illustrates a portion of one embodiment of a method according to the present disclosure, in which an endoscope (eg, a colonoscope) having a first sheath and a second sheath thereon is inserted into a body lumen (eg, the sigmoid colon). [Figure 3B] 1 illustrates a portion of an embodiment of a method according to the present disclosure, in which an endoscope is moved toward a target site. [Figure 3C] 1 illustrates a portion of one embodiment of a method according to the present disclosure, where an endoscope is positioned at or near a target site. [Figure 3D] 1 illustrates a portion of one embodiment of a method according to the present disclosure, in which a first sheath and a second sheath are advanced over an endoscope toward a target site while the endoscope is positioned at or near the target site such that a distal end of the second sheath is at or near the target site. [Figure 3E] 1 illustrates a portion of one embodiment of a method according to the present disclosure in which the first sheath and endoscope are removed, leaving behind a second sheath having a distal end positioned at or near the target site. [Figure 3F] 1 illustrates a portion of one embodiment of a method according to the present disclosure, in which an overtube is inserted and advanced through a second sheath to be positioned at or near a target site. [Figure 3G] 1 illustrates a portion of one embodiment of a method according to the present disclosure, in which multiple instruments (e.g., configured to be robotically controlled) are advanced through the overtube, extend from the overtube, and positioned at or near a target site so as to affect the target site. [Figure 3H] FIG. 3F is a perspective view of the distal end of the assembly of FIG. 3G shown positioned at a target site, showing the assembly having an overtube, a videoscope extending through the overtube, and two instruments extending through the overtube. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Reference is now made to the drawings, in which like reference numerals identify similar structural features or aspects of the subject disclosure. For purposes of explanation and illustration, and not limitation, an exemplary diagram of one embodiment of a method according to the present disclosure is shown in Figure 1 and generally designated by reference character 100. Other embodiments and / or aspects of the present disclosure are shown in Figures 2A-3H.

[0018] 1 and 2A-2H, in accordance with at least one aspect of the present disclosure, a method 100 may include, for example, at block 101, inserting a first device 201 (e.g., an endoscope such as a colonoscope) into a body lumen 203 (e.g., a colon or any other suitable body lumen) having a curve 204 (e.g., a sigmoid colon, a splenic flexure, and / or any other suitable curve). The method 100 may include, for example, at block 103, sliding a first sheath 205 having a first sheath diameter over the first device 201, and, for example, at block 105, sliding a second sheath 207 having a second sheath diameter larger than the first sheath diameter over the first device 201. The method 100 may include, for example, at block 107, moving the first device 201 through and over the curve.

[0019] Method 100 may also include at least partially straightening the first device 201 to at least partially straighten the curve, e.g., in block 109. In certain embodiments, straightening certain body lumens 203 (e.g., such as the sigmoid colon) may cause shortening of tissue (e.g., folding of tissue onto itself, such as a bellows), also referred to as intussusception.

[0020] The method 100 may include, for example, at block 111, removing the first device 201 and the first sheath 205 from the body lumen 203 leaving the second sheath 207 in place within the at least partially straightened curve. The method 100 may include, for example, at block 113, introducing the second device 209 into the second sheath 207 and moving the second device 209 through the at least partially straightened curve to an opening in the second sheath 207. The second sheath 207 may have a stiffness suitable to maintain the body lumen 203 in an at least partially straightened position such that when the first device 201 and the first sheath 205 are removed, the body lumen 203 is suitably maintained straight for insertion of the second device 209.

[0021] 2B, sliding the first sheath 205 over the first device 201 may occur after at least partially straightening the first device 201 and before removing the first device 201 from the body lumen 203. In certain embodiments, sliding the second sheath 207 over the first sheath 205 may occur after sliding the first sheath 205 over the at least partially straightened first device 201 and before removing the first device 201 from the body lumen 203.

[0022] In certain embodiments, the first sheath 205 and the second sheath 207 may slide together over the first device 201. In certain embodiments, removing the first device 201 may include removing the first device 201 and the first sheath 205 together or sequentially. In certain embodiments, inserting the first device 201 may include inserting the first device 201 with the first sheath 205 over the first device 201 and the second sheath 207 over the first sheath 205, for example, as shown in FIG. 3A.

[0023] In certain embodiments, the second device 209 may be less compliant and / or less steerable than the first device 201. For example, the diameter of the second device 209 may be greater than the diameter of the first device 201, for example. In certain embodiments, the diameter of the first device 201 may be about 13 mm or less and the diameter of the second device 209 may be about 18 mm or more. Any suitable relative sizes are contemplated herein. In certain embodiments, the second device 209 is not capable of steering or bending through one or more curves in the body lumen 203, whereas the first device 201 is.

[0024] In certain embodiments, the first device 201 may be an endoscope configured to fit within the first sheath 205. In certain embodiments, the second device 209 may be or may include an overtube (e.g., as shown in FIG. 2G and 3F-3H) configured to fit within the second sheath 207. In certain embodiments, the length of the first device 201 is greater than the length of the first sheath 205, which in turn is greater than the length of the second sheath 207. The first sheath 205 and the second sheath 207 may include, for example, tapered ends 211 (e.g., FIG. 3A) formed at the distal ends of the first sheath 205 and the second sheath 207. This can assist the second sheath 207 in sliding over the first sheath 205, which in turn slides over the at least partially straightened first device 201, to control, for example, compliance (the ability of the medical device to follow the tip around a curve), steerability, and torqueability.

[0025] 2A-2H illustrate an embodiment of a method according to the present disclosure. FIG. 2A illustrates a portion of an embodiment of a method that may include using a colonoscope to move the sigmoid colon. FIG. 2B illustrates a portion of a method that may include using a colonoscope to at least partially straighten the sigmoid colon, e.g., causing the sigmoid colon to shorten on the colonoscope. FIG. 2C illustrates a portion of a method that may include inserting a first sheath and a second sheath over the colonoscope. FIG. 2D illustrates a cross-sectional view of the structure shown in the method of FIG. 2C within a body lumen with the first sheath and the second sheath over the colonoscope. FIG. 2E illustrates a portion of a method that may include removing the first sheath and colonoscope (e.g., simultaneously, or e.g., the colonoscope first) to leave the second sheath in place. FIG. 2F illustrates a cross-sectional view of the remaining structure of FIG. 2E within a body lumen with only the second sheath. Figure 2G illustrates a portion of a method that may include inserting an overtube having multiple lumens into a second sheath (e.g., the overtube having a videoscope disposed therein during insertion), and Figure 2H illustrates a cross-sectional view taken from the method of Figure 2E within a body lumen with a second sheath around the overtube.

[0026] 3A-3H illustrate one embodiment of a method according to the present disclosure. FIG. 3A illustrates an endoscope (e.g., a colonoscope) having a first sheath and a second sheath thereon inserted into a body lumen (e.g., the sigmoid colon). FIG. 3B illustrates the endoscope moving toward a target site. FIG. 3C illustrates the endoscope being positioned at or near the target site. FIG. 3D illustrates the first sheath and the second sheath being advanced over the endoscope toward a target site while the endoscope is positioned at or near the target site such that the distal end of the second sheath is at or near the target site. FIG. 3E illustrates the first sheath and endoscope being removed leaving the second sheath with a distal end positioned at or near the target site. FIG. 3F illustrates an overtube being inserted and advanced through the second sheath to be positioned at or near the target site. Figure 3G illustrates a configuration in which multiple instruments (e.g., configured to be robotically controlled) are positioned at or near a target site such that they can extend from the overtube, advance through the overtube, and act on the target site. Figure 3H is a perspective view of the distal end of the assembly of Figure 3G shown positioned at a target site, showing the assembly having an overtube 209, a videoscope 313 extending through the overtube 209, and two instruments 315, 317 extending through the overtube 209.

[0027] As shown in FIGS. 3B-3H , in certain embodiments, moving the curved portion can include positioning an opening of the second sheath 207 at or near the target site 202 (e.g., a site for robotic surgery). In certain embodiments, the method can include extending the second device 209 from the second sheath 207 to the target site 202. In certain embodiments, the method can include inserting one or more robotic surgical tools through the second device 209 and extending from the second device 209 for access to the target site 202. Any other suitable procedures are contemplated herein.

[0028] In certain embodiments, the body lumen 203 is the colon. For example, the curvature may be the sigmoid colon. Any other suitable body lumen or curvature thereof (e.g., the splenic flexure) is contemplated herein.

[0029] According to at least one aspect of the present disclosure, the method may include moving an overtube through the pre-positioned outer sheath to extend from the outer sheath toward a target site at an intestinal location beyond the sigmoid colon. In certain embodiments, the method may also include pre-positioning the outer sheath across the sigmoid colon with a colonoscope and a colonoscope sheath, at least partially straightening the sigmoid colon and the outer sheath with the colonoscope, and removing the colonoscope and colonoscope sheath to leave the pre-positioned outer sheath for insertion of the overtube. In certain embodiments, the method may include inserting one or more robotic surgical tools through the overtube to extend from the overtube to access the target site. In certain embodiments, the method may include performing a robotic surgical procedure at the target site with the one or more robotic tools.

[0030] According to at least one aspect of the present disclosure, the system may include an endoscope (e.g., device 201) having an endoscope diameter, the endoscope configured to move through and over curves in a body lumen. The system may include an overtube (e.g., overtube 209) having an overtube outer diameter larger than the endoscope diameter. The overtube (e.g., overtube 209) may not be configured to move through and over curves in a body lumen until the curve is at least partially straightened. The system may also include a first sheath 205 having a first sheath inner diameter and a first sheath outer diameter complementary in size to the endoscope outer diameter. The system may also include a second sheath 207 having a second sheath inner diameter complementary in size to both the first sheath outer diameter and the overtube outer diameter. In certain embodiments, the endoscope diameter may be about 13 mm or less and the overtube diameter is about 18 mm or more. Overtube 209 may be any suitable overtube, such as a flexible, elongated insertion tube or steerable shaft having one or more instrument channels therein for advancement / retraction of a medical device therethrough, and may be manually and / or robotically controlled. For example, in certain embodiments, the overtube may be an overtube as disclosed in commonly owned PCT Application No. PCT / US2022 / 051259, filed November 29, 2022, which is incorporated herein by reference in its entirety.

[0031] Although the method embodiments are disclosed herein in a particular literal or depicted order, the method can be performed in any suitable order (e.g., the literal order, the depicted order, or other order) to achieve a desired result (e.g., introduction of a second device through a curved portion of a body lumen to a target site) and is not limited to the literal order described or depicted. For example, the order of operations in the embodiments disclosed herein can be as depicted, or can be in any other suitable order (e.g., an order in which the second sheath remains in an at least partially straightened body lumen before the second device is introduced). For example, the first and second sheaths can be slid before straightening the first device, as described above with respect to FIG. 1, or can be slid after straightening the first device, as shown in the embodiment of FIGS. 2A-2H. Also, as shown in FIGS. 3A-3H, the first and second sheaths can be disposed on the endoscope prior to insertion of the endoscope.

[0032] Although the embodiments are illustrated as having particular parts, the embodiments may include any other suitable methods and / or parts thereof. Any suitable additional or alternative steps are contemplated herein.

[0033] The embodiments may be used to provide robotic surgery in any lumen of the body, regardless of the complex curvature of the lumen. For example, procedures in the colon beyond the sigmoid colon may be possible. For example, the embodiments may enable robotic surgery to be inserted transluminally through the rectum to target sites in the sigmoid colon, descending colon, splenic flexure, and / or transverse colon.

[0034] Embodiments may include a dual sheath configuration: for example, a conventional colonoscope may be smaller than the overtube, and therefore both types of sheaths may be used to allow removal of the colonoscope and insertion of the overtube.

[0035] Method embodiments may include using a smaller diameter colonoscope having two sheaths to navigate the sigmoid colon, then straightening, then withdrawing the smaller diameter colonoscope and the first overtube component leaving the second, e.g., outer, sheath in the straightened position, and then inserting a larger diameter robotic surgical overtube into the straightened channel. Although embodiments are disclosed using an endoscope as the straightening device, any suitable straightening device is contemplated herein.

[0036] Those skilled in the art will understand that any numerical value disclosed herein may be an exact value or may be a value within a range. Furthermore, any term of approximation used in this disclosure (e.g., "about," "approximately," "approximately") may refer to a stated value within a range. For example, in certain embodiments, the range may be within 20% (plus or minus), or within 10%, or within 5%, or within 2%, or within any other suitable percentage or number as understood by those skilled in the art (e.g., relative to known tolerance limits or margins of error).

[0037] As used herein and in the appended claims, the articles "a," "an," and "the" are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article, unless the context clearly indicates otherwise. By way of example, "an element" means one element or more than one element.

[0038] The phrase "and / or" as used in the specification and claims should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjointly present in some cases and disjointly present in other cases. Multiple elements marked with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so conjoined. Other elements other than the elements specifically identified by the "and / or" clause may optionally be present, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B," when used with open-ended language such as "comprising," may refer in one embodiment to only A (optionally including elements other than B), in another embodiment to only B (optionally including elements other than A), in yet another embodiment to both A and B (optionally including other elements), etc.

[0039] As used in the specification and claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be understood as inclusive, i.e., including at least one, but also including more than one number or list element, and optionally including additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein should only be interpreted as an exclusive alternative (i.e., "one or the other, but not both") when preceded by an exclusive term, such as "either," "only one of," or "exactly one of."

[0040] Any suitable combination of any of the disclosed embodiments and / or any suitable portions thereof is contemplated herein as would be recognized by one of ordinary skill in the art upon reference to this disclosure.

[0041] The embodiments of the present disclosure described above and illustrated in the drawings represent improvements in the art to which they pertain. While the subject disclosure includes reference to specific embodiments, those skilled in the art will readily appreciate that changes and / or modifications thereto may be made without departing from the spirit and scope of the subject disclosure.

Claims

1. 1. A system for deploying a medical device, comprising: an endoscope having an endoscope outer diameter, the endoscope configured to move through and across curves in a body lumen; an overtube having an outer diameter greater than an outer diameter of the endoscope, the overtube not being configured to move through and over the curved portion of the body lumen until the curved portion is at least partially straightened; a first sheath having a first sheath inner diameter and a first sheath outer diameter complementary to the endoscope outer diameter; a second sheath having a second sheath inner diameter sized complementary to both the first sheath outer diameter and the overtube outer diameter.

2. The system of claim 1 , wherein the endoscope outer diameter is about 13 mm or less and the overtube outer diameter is about 18 mm or more.

3. The system described in claim 1, wherein the first sheath and the second sheath are flexible.

4. The system described in claim 1, wherein the overtube includes a steerable shaft.

5. The system described in claim 1, wherein the overtube has one or more channels into which one or more surgical tools are inserted and extended through the overtube.

6. The system described in claim 5, wherein the one or more surgical tools are robotically controlled.

7. The system described in claim 1, wherein the overtube has at least three channels into which a videoscope and two instruments are inserted and extended through the overtube.

8. The system described in claim 1, wherein the endoscope is a colonoscope.

9. The system described in claim 1, wherein the first sheath and the second sheath include tapered ends.

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