Patent Application
20240285278
The present invention relates to the fields of (i) anastomosis creation using minimally invasive techniques, and (ii) endoluminal navigation. Some embodiments relate to endoluminal apparatus for use in anastomosis creation.
An anastomosis is a surgical cross-connection or bridge between two different sections of body duct lumen. The gastro-intestinal tract is the luminal route in the body from the esophagus to the anus. Anastomoses formed somewhere along or in the gastrointestinal tract are one form of therapy used to treat digestion-related problems, such as diabetes, obesity, bowel diseases and obstructions. An anastomosis can be used to bypass a portion of the gastro-intestinal tract, such as a portion of the small intestine, to avoid sensitive areas or to influence or reduce absorption of nutrients.
Currently, open-surgery provides most comprehensive access to the internal anatomy for forming an anastomosis. However, open-surgery is highly invasive, and unsuitable for many patients and conditions to be treated. Minimally invasive procedures have been proposed, but significant challenges remain in forming anastomoses equally effectively by a minimally invasively procedure, especially endoluminally. In an endoluminal procedure, one or more tools are introduced into the body principally through the body duct in which the anastomosis is to be made.
Current endoluminal techniques are best suited to anastomosis procedures that are relatively shallow in the body duct and formed between wall sections that are already situated naturally in proximity to each other. This limits, for example, the versatility of the procedure for the small intestine which, in most adults, can have a length of up to 6 or 7 meters and is folded on itself many times in the abdomen.
Current techniques for endoluminal navigation within the gastrointestinal tract also rely on the ease of following the tract within the anatomy, and ease of passage from one section of the tract to another. However, unless complex and expensive steering is implemented, there are regions of the anatomy, where the tendency of an apparatus to naturally follow a minimum curvature path, may impede ease of navigation.
It would be desirable to address and/or mitigate one or more of the above issues.
Aspects of the invention are defined in the claims.
Broadly speaking, one aspect of the present invention provides apparatus insertable into a body duct (for example, the gastrointestinal tract) and operable to manipulate body duct tissue to create a target site for an anastomosis by bringing sections of the body duct tissue into close relation with each other.
The apparatus can comprise an anchor assembly and at least a first pulling assembly.
The anchor assembly includes an anchor for anchoring at a selected position within the body duct.
The first pulling assembly is configured for contracting a portion of the body duct in a lengthwise direction from within the body duct, by pulling distant tissue towards the anchor assembly. Contraction of the tissue in a lengthwise direction may also be referred to herein as foreshortening.
In some embodiments, the first pulling assembly comprises at least one elongate member that is extendable and retractable for movement within the body duct, and at least one distal balloon inflatable for frictionally engaging an interior surface of the body duct to enable the frictionally engaged tissue to be pulled towards the anchor assembly.
Such an arrangement can greatly facilitate manipulation of body duct tissue, enabling a tissue wall section that is naturally distant from the anchor to be brought much closer to the anchor assembly by pulling the tissue atraumatically from within the body duct itself. The body duct is contracted in the lengthwise direction, effectively concertinaing, or gathering up, the body wall tissue to pull the distant tissue closer. Optionally, the apparatus is configured for endoluminal introduction into the body duct.
In some embodiments, the elongate member may be extendable from the anchor assembly within the body duct for accessing the distant tissue. The balloon may be expanded for frictionally engaging tissue at the distant position. The elongate member may be retracted back towards the anchor assembly to pull the frictionally engaged tissue towards the anchor assembly, and thereby contract the body duct lengthwise to bring distant tissue closer to the anchor assembly.
In some embodiments, the first pulling assembly optionally comprises first and second elongate members, each carrying a respective (first and second, respectively) inflatable balloon.
This can permit stepwise contraction of the body duct tissue and/or is especially suitable for tortuous body ducts, such as the small intestine. For example, in use, the first elongate member may be extended with its balloon deflated, while the second elongate member remains retracted, optionally with its balloon inflated to hold back any pre-contracted tissue. Once the first elongate member has been extended to access distant tissue, the first balloon may be inflated to engage against and anchor the distant tissue. The second balloon may be deflated, and the second elongate member extended adjacent to the first elongate member and balloon, and the second balloon inflated to engage against tissue adjacent to the first balloon. The first and second members may be retracted in unison, with at least one balloon, optionally both balloons, frictionally engaging body duct tissue to enable the tissue to be pulled towards the anchor assembly during the retraction. Thereafter, the first balloon may be deflated, and the first member again extended to access a next region of distant tissue, while the second balloon keeps the contracted body duct tissue in its contracted state. The process can be repeated multiple times in order to contract the body duct tissue in lengthwise steps, and hence facilitate access to distant and folded tissue even deep within, for example, the small intestine.
In some embodiments, the first and second elongate members of the first pulling assembly may be nested one within another. At least one, optionally both, of the elongate members may be tubular. For example, the first elongate member may be nested within, and slidable lengthwise with respect to, the second elongate member.
At least one elongate member of the first pulling assembly may be at least partly deflectable and/or steerable, for example at its tip, to facilitate navigation when extending within the body duct.
The term “balloon” is used herein to refer to any inflatable body or inflatable cuff, that may be distended by an inflation fluid. The inflation fluid may be liquid (e.g. saline) or it may be gas (e.g. air). At least one, optionally each, balloon may be generally spherical in shape (e.g. generally frusto-spherical), or generally egg-shaped, or generally cylindrical in shape. Any other shape of balloon may be used as desired to suit the body duct.
The anchor of the anchor assembly may be deployable from a collapsed condition to a deployed condition. The deployable anchor may, for example, comprise an inflatable anchoring balloon.
One or more assemblies of the apparatus can comprise or consist of polyether ether ketone, polyethylene terephthalate, polyimide and/or polyamide.
Howsoever the first puling assembly and/or the anchor assembly is implemented, the apparatus may optionally further comprise a lateral movement device and/or a deployment device for deploying one or more tools and/or devices for creating an anastomosis.
The lateral movement device, if provided, may be configured for moving first and second sections of the body duct tissue that are spaced lengthwise along the body duct, laterally towards and/or into wall-to-wall engagement with each other.
The lateral movement device can enable two sections of body duct tissue, for example, previously distant sections brought closer together by the first pulling assembly, to be (e.g. further) pulled towards and/or into wall-to-wall engagement with each other to become suitable as a target site for an anastomosis. For example, if the two wall sections are close but offset from one another, the second pulling assembly can pull the two sections into wall-to-wall engagement, such that exterior surfaces of the wall sections are in engagement. The lateral movement device may, for example, cause the body duct to bend such that the wall sections approach each other.
By using the first pulling assembly first to contract the body duct lengthwise, and hence draw distant tissues closer together, the lateral movement device need move tissue only a relatively short distance in order to bring tissues towards or into wall-to-wall engagement.
The combination of the first pulling assembly and the lateral movement device can enable access to and manipulation of tissues even deep within the anatomy, increasing the versatility and efficacy of minimally invasive procedures for anastomosis creation, especially endoluminally.
Various types of lateral movement device are possible. For example, the lateral movement device could be implemented as part of the elongate member of the first pulling assembly, configured to allow lateral forces to be applied to move or bend the duct laterally. In some embodiments, the lateral movement device comprises a second pulling assembly configured for spanning positions along the body duct by passing outside the body duct, and for pulling the spanned positions towards wall-to-wall engagement with each other, e.g. exterior wall-to-wall engagement.
Similarly to that which is already described above, by using the first pulling assembly first to contract the body duct lengthwise, and hence draw distant tissues closer together, the second pulling assembly need span only a relatively short distance in order to connect and pull tissues into wall-to-wall engagement. Operation of the second spanning assembly to span across the tissue positions outside the duct needs only local guidance, for example, fluoroscopy or ultrasound imaging, because the distance is relatively short.
In some embodiments, the second pulling assembly comprises an extendable and retractable spanning element for passing through tissue walls at two different sections and spanning the distance between them. The second pulling assembly further comprises a connecting device in the form of a deployable distal shoulder for engaging behind one of the tissue wall sections to enable the tissue wall sections to be pulled towards wall-to-wall engagement with each other. Additionally or alternatively, a connecting device in the form of a suction port may be used to allow the spanning element to connect externally to a tissue wall using negative pressure to maintain the connection.
In some embodiments, the spanning element is configured for penetrating through the tissue wall(s) when extended. Optionally, the spanning element is at least partly deflectable and/or steerable, for example, at its tip, for navigating when extending to span the distance between the first and second sections.
In some embodiments, the spanning element may be extendable from the anchor assembly and be advanceable to pass through the adjacent tissue wall and outside the body duct. The spanning element may be advanceable towards a distal end of the first pulling assembly, to penetrate back through the tissue wall near or at the first pulling assembly.
Alternatively, the spanning element may be extendable from the first pulling assembly and be advanceable to pass through the adjacent tissue wall and outside the body duct. The spanning element may be advanceable towards the anchor assembly, to penetrate back through the tissue wall near or at the anchor assembly.
In either case, the distal shoulder may be deployed to anchor behind the penetrated tissue wall, thereby permitting the tissue wall to be pulled when the spanning element is retracted.
The deployable shoulder may, for example, comprise an inflatable balloon or a deployable mechanical structure, such as a self-expanding frame or stent.
A partially deployed stent could comprise a deployable shoulder which in an at least partially deployed state can be used for retracting a body duct section and in the fully deployed state serves as an implanted stent for creating an anastomosis. The stent optionally creates a temporary through-channel anastomosis.
A temporary through-channel can allow digestive products to pass through the gastro-intestinal tract until a permanent anastomosis is created, thereby making a second operational procedure obsolete.
Additionally or alternatively to the second pulling assembly, the deployment device may be configured for deploying one or more tools and/or devices for creating an anastomosis. For example, the deployment device may be configured for deploying the one or more tools and/or devices at a position established by the second pulling assembly where the sections of duct wall are pulled towards wall-to-wall engagement.
Devices for creating an anastomosis may optionally include a stent for creating a stented-anastomosis, and/or a magnetic device for creating a magnetic compression anastomosis.
A stent for creating an anastomosis can be configured to be monolithic (a single fully connected piece) so that the stent is deployed on either sides inside the body duct being pierced through the body duct walls. The magnetic device may be configured to apply forces from both sides of adjacent tissue walls, or the device may be one component of a pair of separate devices deployable at different positions in the duct in register with one another, and attracted to each other by magnetic attraction. The other component may also be deliverable and deployable by the same apparatus (e.g. by a second deployment device of the apparatus).
Tools for creating an anastomosis may optionally include a tissue cutter and/or a tissue fixation device for inserting sutures and/or staples or other tissue fixings for joining the tissues of opposed duct walls sections together around mutual openings defining an anastomosis channel.
The device and/or tool for creating an anastomosis may be introducible through a working channel of the apparatus, and/or may be loadable or loaded into an accommodation region of the deployment device, the device and/or tool being deployable from the accommodation region upon operation of the deployment device.
In some embodiments the deployment device is positioned in proximal direction from the anchoring assembly. In an alternative embodiment the deployment device is positioned in distal direction from either the first advanceable balloon and/or second advanceable balloon. This arrangement allows deploying a tool for creating an anastomosis outside of the region of contracted body duct between the anchoring assembly and an advanceable balloon.
In some embodiments the apparatus comprises a connecting device, which can comprise a second pulling device.
The connecting device can be configured to bring the outer surfaces of the two sections of a body duct in close contact with each other at the target site for creating an anastomosis by bending the body duct and fixing the target site of the outer surface sections relative to each other.
The connecting device can comprise a suction device for aligning and/or positioning the body duct walls relative to each other and/or deploying a tissue cutter by applying a negative pressure.
In one embodiment at least a section of the apparatus, preferably the inner assembly can assume a bent configuration without piercing the body duct, thereby bringing the target site for the anastomosis of the two sections of the body duct into closer contact.
The anchoring assembly and/or the balloons can be conceived to assume a predetermined shape designed at an angle such that the contracted portion of the body duct assumes an arc which brings the sections of the body duct into closer contact. In one embodiment the anchoring assembly and/or balloons are configured to be non-symmetric around the inner assembly or outer assembly. The anchoring assembly and/or balloons can be configured to have a longer extension in the longitudinal direction on one side of the inner assembly, pulling assembly and/or outer assembly than on the other side in a deployed and/or inflated state such that the apparatus can assume a bent shape.
The tissue cutter can comprise a cutting element, a puncturing element, an electrical or optical ablation element. The tissue cutter can further comprise a cutting element which comprises a laterally expandable and/or collapsible profile and/or periphery. In one embodiment the cutting element comprises a counter surface which can be deployed on the opposing side of the body duct to be cut. The counter surface covers the target area of the body duct wall and thereby prevents leakage. In one embodiment of the apparatus, the counter surface also comprises a laterally expandable and/or collapsible profile and/or periphery.
The laterally expanded profile and/or periphery of the cutting element and/or the counter surface can preferably assume a predetermined dimension.
The cutting element further can be configured to be rotatable along its circumferential direction, optionally in a helical movement along the longitudinal direction.
The apparatus can comprise temporary compression elements for creating a compression anastomosis. In one embodiment the temporary compression elements comprise magnetic elements. The temporary compression elements are preferably positionable on either side of the body duct tissue at the target site to create a compression anastomosis.
The connecting device can comprise a spanning element.
The deployable shoulder can reversibly be converted to a stowed configuration and an expanded configuration. The deployable shoulder can comprise a balloon element, a shape-memory alloy, a wire mesh, a monolithic structure, a frame structure and/or a polygon structure such that the spanning element can increase its lateral dimension in the expanded configuration to a greater lateral dimension than the stowed configuration.
The increased lateral dimension by the deployable shoulder in the expanded configuration is preferably greater than an incision, puncture and/or cut by the tissue cutter.
The increase in lateral dimension is greater than 200 percent, optionally greater than 300 percent, in particular optionally greater than 400 percent.
A reversibly convertible balloon and/or assembly and/or element by unfolding to a predetermined lateral dimension allows for use of inelastic materials which are more resilient in view of wear and tear and thus increase safety of a patient.
The unfoldable balloon and/or assembly and/or element can ensure a fixed predetermined maximum and minimum lateral dimension when applying proper pressure and can frictionally engage the tissue to be pulled with maximised tightness.
In such an embodiment, different geometric shapes such as a folded zigzag structure and/or concertina structure could be conceived.
Such an unfoldable balloon and/or assembly and/or element does not rely on elastic deformation, so the material used can be radially stiff.
An unfoldable balloon and/or assembly and/or element may comprise or consist of polyamide, polyethylene terephthalate and/or polyether block amide.
In one embodiment the apparatus can comprise a pressuring device, optionally located in a region at a proximal end of the apparatus that can be brought into fluid communication with at least one balloon such that fluid is transferable from the pressuring device into the balloon, preferably into at least two balloons independently of each other. The pressuring device can reversibly convert the at least one balloon from the collapsed condition to an expanded condition.
The pressuring device can comprise a simple system of multiple syringes or a more sophisticated system of automated pumps.
It would also be conceivable that the pressuring device comprises a communication interface which automatically moves the apparatus without a user manually controlling the fluid supply. The user could enter an input into the communication interface, such as a length to be contracted of portion of the body duct.
It would also be conceivable that the pressuring device is located within the apparatus with a predetermined supply of compressed fluid.
The balloons are arranged in fluid communication with the pressuring device via at least one flow channel. In a preferred embodiment the balloons are in fluid communication with the pressuring device via individual flow channels. However, it is conceivable that fluid can be transferred from one balloon directly to another balloon with the pressuring device.
The apparatus can comprise at least one visualization element, preferably comprising at least one: (i) a camera, (ii) a radiopaque material, (iii) ultrasound impermeable material.
An optional visualization element may allow for locating the position of the delivery device.
The visualization element can preferably allow for locating the relative position of at least one balloon, preferably multiple balloons, relative to the anchoring assembly.
A further aspect of the invention, usable optionally independently of the preceding aspects or in combination with any of the preceding aspects, relates to endoluminal navigation within the gastro-intestinal tract.
This aspect provides apparatus for insertion into the gastrointestinal tract through a patient's mouth, and for navigating at the pylorus, the apparatus optionally according to any preceding aspect, the apparatus comprising:
The shape of the anatomy in the region of the stomach antrum and the pylorus can cause problems for endoluminal navigation of devices, introduced via the patient's mouth, passing through the stomach towards the small intestine. By displacing the tip away from the stomach wall, for example, the stomach floor in the antrum, the tip can be better aligned with the pylorus in order to enable more straightforward and atraumatic navigation through the pylorus, for example, avoiding the tip lodging in the pyloric antrum.
The first portion may be near or at the tip of the first elongate tubular member.
In some embodiments, the apparatus is configured for delivering a device through the pylorus for placement at least partly within the duodenum and/or at least partly traversing the pylorus. Optionally, the device may comprise a duodenal liner sheath and/or an anchor for anchoring near or at the pylorus. The device may optionally be part of the apparatus.
A further aspect of the invention provides a method of endoscopically manipulating body duct tissue to create a target site for an anastomosis by bringing sections of body duct tissue into close relation with each other, using an apparatus insertable endoluminally into the body duct, the apparatus optionally as defined in any preceding aspect, the method comprising:
The step of operating the first pulling assembly may comprise contracting a portion of the body duct in a lengthwise direction such that the first and second sections of body duct tissue move from a distant relation to a closer relation in the lengthwise direction.
The optional step of operating the lateral movement device may further bring the first and second sections of body duct tissue from the closer relation into wall-to-wall engagement by relatively moving one or both of the first and second sections laterally with respect to the other.
A further aspect of the invention provides a method of endoscopically navigating within the gastro-intestinal tract of a patient, the method optionally including any of the method steps and/or apparatus of the any of the preceding aspects, the method comprising:
The first portion of the first elongate member may be at or near a tip of the first elongate member.
In some embodiments, the restriction of the gastro-intestinal tract is a pylorus.
The method may optionally further comprise a step of deploying an implant into the gastro-intestinal tract. Optionally, the implant comprises at least one selected from: a duodenal sleeve; a duodenal anchor for a duodenal sleeve; a trans-pyloric anchor for a duodenal sleeve; a gastric anchor for a duodenal sleeve.
In any of the aspects disclosed herein, the apparatus or any component may optionally be formed by three-dimensional printing.
Although certain ideas, features and advantage have been highlighted above, protection is claimed for any novel feature disclosed herein and/or in the drawings, whether or not emphasis has been placed thereon.
Non-limiting embodiments of the invention are now described by way of example only, with reference to the accompanying drawings. In the drawings, the same reference numerals are used to denote the same or equivalent features, whether or not described explicitly.
Referring to
Each inner assembly 14a, 14b generally comprises a respective elongate member 16a, 16b carrying a respective distal balloon 18a, 18b (shown schematically in its deflated or collapsed state by a solid line, and in its inflated state by a broken line). The inner assemblies 14a, 14b are nested slidably one within another, the elongate members 16a, 16b being tubular. The innermost assembly 14a extends distally of its surrounding assembly 14b. Each assembly 14a, 14b is slidable at least partly independently of the other, and independently of the surrounding anchor assembly 12.
At least one of the inner assemblies (for example, at least the inner-most assembly 14a), and optionally both inner assemblies 14a and 14b is/are at least partly deflectable and/or steerable, for example, at their tips.
The anchor assembly 12 further comprises a deployable anchor 20, optionally an inflatable anchor balloon 20 shown schematically in its deflated or collapsed state by a solid line, and in its inflated state by a broken line.
The apparatus 10 further comprises a lateral movement device (illustrated later below), one part of which is a second pulling assembly formed collectively by a spanning element 22 with a deployable distal shoulder 24. The spanning element 22 is extendable and retractable with respect to the anchor assembly 12 via an aperture 26. The aperture 26 may optionally communicate with a working channel or accommodation region of the apparatus, described later. The spanning element 22 may be at least partly deflectable and/or steerable, for example, at its tip.
The deployable distal shoulder 24 may, for example, comprise an inflatable balloon, or it may comprise a deployable structure such as a self-expanding structure, e.g. a stent, carried by the spanning element 22.
The apparatus 10 optionally further comprises, at its proximal, end a handle and/or operator unit 28 by which the different elements described above may be manually or remotely controlled. For example, the unit 28 may comprise manual controls and/or ports for: manipulating the elongate members 16a and 16b; for controlling inflation of the balloons 18a and 18b collectively or independently; for controlling steering of steerable elements; for manipulating the spanning element 22; for controlling inflation of the balloons 20 and 24.
The balloons 20, 18a, 18b and 24 may have any suitable shape or shapes, for example selected from: spherical (or part spherical), doughnut-shaped, cuff-shaped, etc.
The same reference numerals are used in both groups of figures, and the same description applies universally.
Referring to
By way of example, the body duct may be the gastro-intestinal tract 40 of a patient. The apparatus 10 may be introducible through the mouth and esophagus, and advanced through the stomach 42 towards the pylorus and small intestine 44, until the distal end region of the apparatus reaches a selected position in the body duct (
b to 16d illustrate operation of the first pulling assembly for contracting a portion of the body duct in a lengthwise direction from within the body duct, by pulling distant tissue towards the anchor assembly 12. Referring to
Initially, prior to any contraction of the body duct, the other inner assembly 14 by may optionally be advanced in unison with the inner-most assembly 14a, as depicted in
Referring to
Referring to
Once the distant tissue has been reached, the distal balloon 18a of the inner assembly 14a can again be inflated to frictionally engage the tissue (
Referring to
The above steps may be repeated as many times as appropriate to move distant tissue progressively towards the anchor assembly 12, for example, until a desired position along the duct has been reached, and/or a sufficient bypass length of body duct has been accumulated in the concertinaed tissue.
Provision of both balloons 18a and 18b assists in frictional engagement that is sufficiently firm to be able to pull tissue walls, yet with forces that are distributed and atraumatic for the tissue walls. Provision of both balloons 18a and 18b (and assemblies 14a and 14b generally) also enables a stepped approach to be used to pull distant tissue, with one balloon used to hold back pre-contracted tissue while the other balloon can be advanced (in its deflated state) to access other distant tissue. Provision of both balloons 18a and 18b (and assemblies 14a and 14b generally) also facilitates contraction of tissue that is not straight, by using a stepped approach. However, in other embodiments, a single inner assembly 14 and single balloon 18 could also be used instead.
e-g illustrate operation of one or more lateral movement devices to bring first and second sections of body duct tissue that are spaced apart from each other in the lengthwise direction of the duct, laterally towards and/or into wall-to-wall engagement with each other. Two different types of lateral movement device are described, which may each be used independently of the other, or both together in the same apparatus (as in the example of
Referring to
Referring to
In the illustrated examples, the spanning element 22 penetrates the opposed tissue wall section, after which the distal shoulder 24 may be deployed (
Referring to
Referring to
Referring to
It will be appreciated that the above technique can facilitate a substantially endoluminal technique for anastomosis creation.
Body duct tissues deep within the anatomy, for example, deep in the small intestine, can be accessed and manipulated to create a target site for the anastomosis even if the tissues are not already in close proximity with each other. The technique of contracting body duct tissues lengthwise from within the body duct by pulling distant tissue towards the anchor assembly 12, followed by laterally moving spaced apart tissues towards and/or into wall-to-wall engagement, greatly expands the possibilities for minimally invasive anastomosis creation by practitioners.
Referring to
Referring to
Referring to
The balloon 102 may optionally be one of the inflatable balloons described in the preceding example, used here to facilitate navigation of the apparatus towards a target site beyond the pylorus.
It will be appreciated that use of the balloon 102 can facilitate navigation through a duct restriction, for example, the pylorus, even in the case of an unguided catheter 100.
It is emphasized that the above description merely refers to a non-limiting example of the invention, and that many modifications and equivalents may be used within the scope and/or principles of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21315100.4 | Jun 2021 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/066977 | 6/22/2022 | WO |
