Delivery systems for devices with unsupported structure

Abstract

The present disclosure relates generally to the field of medical devices and medical device delivery. In particular, the present disclosure relates to medical devices and delivery systems for positioning and delivering medical devices with an unsupported structure, for example, within a distant and/or tortuous portion of body lumen. For example, a delivery system may position a supported structure of a medical device within a proximal portion of a body lumen and an unsupported structure of the medical device within a distal portion of the body lumen. Examples include delivery systems within an unsupported structure of a medical device to be delivered, wherein a number of balloons are arranged un-inflated within an unsupported structure, with a distal balloon removably attached to a distal portion of the unsupported structure, and the balloons are inflatable in series to deploy the unsupported structure linearly from a distal end of the delivery system.

Claims

1. A medical device delivery system extending along a longitudinal axis between a proximal end and a distal end, the system comprising: an elongate member having a proximal portion and a distal portion; a medical device disposed within the elongate member, the medical device comprising a proximal structure, and a distal structure extending distally from a distal end of the proximal structure and having a wall with a proximal terminal end and a distal terminal end, the medical device configured to move from a first position, in which the proximal structure is disposed within the distal portion of the elongate member in a first configuration proximal to the distal structure, to a second position in which the proximal structure extends beyond a distal end of the elongate member and is expanded into a second configuration proximal to the distal structure; a plurality of balloons disposed within the distal structure, and between the proximal terminal end of the wall of the distal structure and the distal terminal end of the wall of the distal structure when the medical device is in the first position; and a fluid delivery lumen having a proximal end configured to fluidly connect to a fluid source and a distal end in fluid communication with the plurality of balloons; wherein: balloons of the plurality of balloons are in collapsed configurations when the medical device is in the first position; and the wall of the distal structure is expandable, when the medical device is in the second position, from a first collapsed configuration over the plurality of balloons, into a second, longitudinally expanded configuration by expansion of at least one of the balloons of the plurality of balloons within the distal structure.

2. The medical device delivery system of claim 1, wherein: the balloons of the plurality of balloons include a proximal balloon, a distal balloon, and one or more intermediate balloons extending between the proximal balloon and the distal balloon; and at least one of the balloons of the plurality of balloons is configured to expand distally outside and away from the proximal structure when the proximal structure is in the second configuration.

3. The medical device delivery system of claim 1, wherein: the balloons of the plurality of balloons include a proximal balloon, a distal balloon, and one or more intermediate balloons extending between the proximal balloon and the distal balloon; and a proximal end of the proximal balloon includes an opening configured to fluidly receive the distal end of the fluid delivery lumen.

4. The medical device delivery system of claim 1, wherein: adjacent balloons of the balloons of the plurality of balloons are attached by a flexible connector; and the flexible connector between the adjacent balloons includes a lumen extending through the flexible connector such that the adjacent balloons are in fluid communication with each other along a length of the plurality of balloons.

5. The medical device delivery system of claim 4, further comprising a plug removably disposed within the lumen of the flexible connector, wherein the plug is configured to prevent or limit a flow of an inflation fluid into one or more of the balloons of the plurality of balloons until a proximally adjacent balloon of the balloons of the plurality of balloons is in a longitudinally expanded configuration.

6. The medical device delivery system of claim 1, wherein: the balloons of the plurality of balloons are collapsed in a concertinaed configuration and are configured to longitudinally expand from the concertinaed configuration sequentially from a proximal direction to a distal direction into a longitudinally expanded configuration; and the wall of the distal structure is configured to move from the first collapsed configuration distally into the second, longitudinally expanded configuration as the balloons of the plurality of balloons move from the concertinaed configuration to the longitudinally expanded configuration of the balloons of the plurality of balloons.

7. The medical device delivery system of claim 1, wherein the distal structure is formed of a layer of material including an impermeable membrane lacking rigidity and coupled to the proximal structure.

8. The medical device delivery system of claim 1, wherein the proximal structure includes one or more radially self-expanding portions and is configured to anchor the medical device across a pylorus of a patient within a body lumen when the medical device is in the second position, and the distal structure is coupled to the proximal structure to extend distally from the distal structure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:

(2) FIGS. 1A-1B provide perspective views of a medical device delivery system, according to one embodiment of the present disclosure.

(3) FIGS. 2A-2I illustrate representative steps of a medical device deployed within a body lumen using the medical device delivery system of FIGS. 1A-1B, according to one embodiment of the present disclosure.

(4) FIGS. 3A-3F provide perspective views of a medical device delivery system, according to one embodiment of the present disclosure.

DETAILED DESCRIPTION

(5) The present disclosure is not limited to the particular embodiments described herein. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

(6) Although embodiments of the present disclosure are described with specific reference to a medical device delivery system for delivering a medical device (e.g., an anti-obesity device) with a supported portion and an unsupported portion across the pylorus and the duodenum and into a portion of the jejunum of a patient, it should be appreciated that such medical device delivery systems may be used to deliver a variety of medical devices (e.g., guidewires, access sheaths, cannulas, stents, catheters, etc.) into a variety of different body lumens and or passageways, including, for example, anal access to the transverse colon, ascending colon or ileum, Roux-en Y procedures, jejuncolic bypass procedures, jejunoileal bypass procedures, gastrectomy procedures, biliopancreatic diversion with duodenal switch (BPD-DS) procedures, gastrojejunostomy procedures, segmental colonic resection procedures, and the like.

(7) As used herein, the singular forms a, an, and the are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms comprises and/or comprising, or includes and/or including when used herein, specify the presence of stated features, regions, steps elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.

(8) As used herein, the term distal refers to the end farthest away from the medical professional when introducing a device into a patient, while the term proximal refers to the end closest to the medical professional when introducing a device into a patient.

(9) Referring to FIGS. 1A-1B, in one embodiment, a medical device delivery system 100 of the present disclosure may include an elongate member 110 (e.g., delivery catheter, endoscope, etc.) and a medical device 120 disposed (e.g., loaded) within a distal portion 112 of the elongate member 110. In various embodiments, the medical device 120 may include a first (e.g., proximal) supported structure 122 and a second (e.g., distal) unsupported structure 124. The elongate member 110 may be configured to move (e.g., slide, etc.) from a first position (e.g., distally extended) in which the supported structure 122 is disposed within the distal portion 112 of the elongate member 110 in a first configuration (e.g., constrained, non-expanded, non-deployed or delivery configuration, etc.) to a second position (e.g., proximally retracted) in which the supported structure 122 extends beyond a distal end 114 of the elongate member 110 in a second configuration (e.g., unconstrained, expanded, deployed, etc.).

(10) A plurality of balloons 130 (e.g., non-compliant dilation balloons) may be disposed (e.g., loaded) in a tandem or linear configuration within (e.g., inside) the unsupported structure 124 of the medical device 120 and the distal portion 112 of the elongate member 110. In various embodiments, the plurality of balloons 130 may include a proximal balloon, a distal balloon and one or more intermediate balloons. For example, an embodiment of the present disclosure which includes six balloons in a tandem or linear configuration may include a proximal balloon 130a (e.g., first balloon progressing distally), a distal balloon 130f (e.g., sixth balloon progressing distally) and second 130b, third 130c, fourth 130d and fifth 130e intermediate balloons therebetween. Similarly, and by way of non-limiting example, an embodiment of the present disclosure which includes ten balloons may include a proximal balloon (e.g., first balloon) a distal balloon (e.g., tenth balloon) and second, third, fourth, fifth, sixth, seventh, eighth and ninth balloons therebetween. Each balloon 130a-130f of the plurality of balloons 130 may be disposed within the unsupported structure 124 and within the distal portion 112 of the elongate member 110 in a concertinaed configuration (e.g., collapsed in an accordion-like configuration). In addition, the unsupported structure 124 may be disposed in a concertinaed configuration over the respective outer surfaces of each of the plurality of concertinaed balloons 130a-130f. A distal end of the unsupported structure 124 may be attached to a distal end of the distal balloon 130f (e.g., the distal-most balloon of the plurality of balloons) by a release mechanism 126 (e.g., clip, hook, adhesive, perforated or frangible portion, etc.) as are commonly known in the art. In various additional embodiments, an inner surface of the unsupported structure 124 may be intermittently attached or glued to an outer surface of one or more of the balloons 130a-130f, e.g., using a silicone-based adhesive. Glue may be able to dissolve in the body to break the attachment. Other structure and/or function for detaching the unsupported structure from the balloons are contemplated as desired for a particular application. For example, different possibilities for detachment, include mechanical, chemical and/or electric based attachments, wherein the attachment between the unsupported structure and balloons may be broken by applying force to overcome a mechanical attachment, or an electrical current or chemical substance may act to sever the attachment.

(11) A fluid delivery lumen 140 (e.g., inflation lumen) may extend through a full length of the elongate member 110, with a proximal end of the fluid delivery lumen configured to fluidly connect to a fluid source 142 (e.g., syringe, pump, etc.) and a distal end of the fluid delivery lumen in fluid communication with an opening in the proximal end of the proximal balloon 130a (e.g., the proximal-most balloon of the plurality of balloons) to deliver an inflation fluid (e.g. air, water, saline, etc.) from the fluid source 142 sequentially (e.g., from the proximal to distal direction) into each of the plurality of balloons 130a-130f.

(12) In one embodiment, the proximal end of the proximal balloon 130a may include an opening in fluid communication with the distal end of a fluid delivery lumen 140 (as discussed above) and the distal balloon 130f may include a closed/sealed distal end. In various embodiments, adjacent balloons 130a-130f of the plurality of balloons 130 may be attached to each other by a flexible connector 136a, 136b, 136c, 136d, 136e (e.g., section of flexible tubing). Each of the flexible connectors 136a-136e may include an open lumen extending therethrough such that the adjacent balloons, and therefore each of the plurality of balloons including the proximal and distal balloons, are in fluid communication with each other. In addition to providing fluid communication between each of the plurality of balloons, the flexible connectors 136a-136e may also provide a flexible junction or pivot point between adjacent balloons to carry the unsupported structure 124 through challenging navigation paths, such as a tortuous anatomy, as the balloons 130a-130f sequentially move (e.g., in a proximal to distal direction) from a concertinaed configuration to a linearly expanded (e.g., elongated) configuration. For example, as each balloon 130a-130f sequentially moves from the concertinaed configuration to the linearly expanded configuration, the corresponding portion of the unsupported structure 124 may also move from the concertinaed configuration to a linearly extended configuration to track (e.g., pulled or carried distally) through the body lumen along with the sequentially linearly expanded configuration of the balloons. In embodiments of the present disclosure in which the concertinaed unsupported structure 124 and respective underlying concertinaed balloon(s) 130a-130f are attached (e.g., glued using a silicone-based adhesive), the linearly and/or outward expansion of the balloons may provide sufficient force (e.g., radial and/or longitudinal force) to break or otherwise disrupt the attachment point(s) to release the unsupported structure from the balloon(s).

(13) Referring to FIGS. 2A-2I, in use and by way of example, the elongate member 110 of a medical device delivery system 100 of the present disclosure may be advanced through the esophagus and into a the stomach 10 of a patient, and the distal portion 112 of the elongate member 110 positioned across the pylorus 12 with the distal end 114 of the elongate member 110 extending into the duodenum 14 (FIG. 2A).

(14) Referring to FIG. 2B, the distal portion 112 of the elongate member 110 may then be proximally retracted to advance (e.g., extend) the medical device 120 beyond the distal end 114 of the elongate member 110 (e.g., medical device 120 is deployed within the patient) with the supported structure positioned/anchored across the pylorus 12 in the second configuration and the unsupported structure 124 and balloons 130a-130f disposed within the duodenum 14 in the concertinaed configurations. In one embodiment, in the second configuration the supported structure 122 may include a self-expanding flared flange 122a (e.g., disposed within the stomach 10), a self-expanding cylindrical portion 122b distal to the flared flange 122a (e.g., disposed within the duodenum 14) and an elastomeric membrane 122c extending between, and connecting, the flared flange 122a and the cylindrical portion 122b (e.g., disposed across the pylorus 12). In various embodiments, the elastomeric membrane 122c may extend around an entire inner and/or outer surface of the flared flange 122a and/or cylindrical portion 122b. The unsupported structure 124 may include a sleeve or liner formed from or otherwise including an impermeable membrane (e.g., elastomeric membrane, etc.) attached to or integrally formed with an inner and/or outer surface of the cylindrical portion 122b. In various embodiments, the elastomeric membrane 122c and the unsupported structure 124 may include the same or different materials. In various additional embodiments, the elastomeric membrane 122c and the unsupported structure 124 may be formed from or otherwise include a single continuous (e.g., unitary) sheet of the elastomeric membrane.

(15) Referring to FIG. 2C, with the supported structure 122 of the medical device anchored across the pylorus 12, inflation fluid may be introduced from the fluid source 142 (FIG. 1A) through the fluid delivery lumen 140 (FIG. 1A) and into the proximal balloon 130a to move the proximal balloon 130a from the concertinaed configuration to a linearly expanded configuration. The concertinaed portion of the unsupported structure 124 disposed over and/or in contact with the proximal balloon 130a may also move from the concertinaed configuration to a linearly extended configuration as the linearly expanded proximal balloon 130a pulls the unsupported structure 124 distally through the duodenum 14 and towards the jejunum 16.

(16) Referring to FIGS. 2D-2H, inflation fluid may continue to be introduced through the fluid delivery lumen 140 to sequentially inflate balloons 130b (FIG. 2D), 130c (FIG. 2E), 130d (FIG. 2F) and 130e (FIG. 2H) and 130f (FIG. 2H), and sequentially/incrementally move the corresponding concertinaed portions of the unsupported structure 124 disposed over and/or in contact each of the respective balloons 130b-130f 124 to a linearly extended configuration to track (e.g., pull, carry, etc.) the unsupported structure 124 further into the duodenum 14 towards the jejunum 16. Referring to FIGS. 2G-2H as exemplary embodiments, the flexible connector 136d connecting balloons 130d and 130e and the flexible connector 136e connecting balloons 130e and 130f may allow those balloons and the respective portion of the unsupported structure 124 to atraumatically bend or curve through a curved or tortuous portion of the duodenum 14.

(17) Referring to FIG. 2H, with the distal balloon 130f in the linearly expanded configuration, an attachment point between the distal end of the distal balloon 130f and the distal end of the unsupported structure 124 may be separated by activating a release mechanism 126, such as described above. Referring to FIG. 2I, the balloons 130a-130f may then be removed from within the patient, either in the linearly expanded configuration or in a deflated configuration, and the balloons 130a-130f and elongate member 110 removed from the patient. Alternatively, the balloons 130a-130f may remain in place within the unsupported structure, either in linearly expanded configuration or in a deflated configuration.

(18) Referring to FIGS. 3A-3F, in one embodiment, a plug 138a, 138b, 138c, 138d, 138e (e.g., stoppers, corks, stopping balls, etc.) may be disposed within the lumens of the respective flexible connectors 136a, 136b, 136c, 136d, 136e. The plugs 138a-138e may be configured to prevent or limit the flow of inflation fluid into respective balloons 130b-130f until the immediately adjacent proximal balloon is fully inflated (e.g., linearly expanded), thereby further ensuring that the balloons sequentially expand in a proximal to distal direction to carry/pull the unsupported structure distally within the duodenum 14 towards the jejunum 16. For example, with the proximal balloons 130a in the linearly expanded (e.g., fully inflated) configuration (FIG. 3A) the internal pressure within the proximal balloon 130a may reach a threshold level to eject the plug 138a from within the lumen of the flexible connector 136a to allow inflation fluid to flow into and linearly expand the immediately adjacent balloon 130b (FIG. 3B). Inflation fluid may continue to be introduced to through the linearly expanded balloons to sequentially linearly expand the immediately adjacent balloons 130c (FIG. 3C), 130d (FIG. 3D), 130e (FIG. 3E) and 130f (FIG. 3F). In various additional embodiments, the flexible connectors 136a-136e may be twisted to close their respective internal lumens to prevent or limit the flow of inflation fluid into respective balloons 130b-130f until the immediately adjacent balloon is fully inflated.

(19) In various embodiments, each of the balloons 130a-130f may include a length of approximately 40.0 mm and a width of approximately 6.0 mm in the linearly expanded configuration. In addition, the flexible connectors may include a length of approximately 5.0 mm and a lumen with an inner diameter of approximately 2.0 mm. Although the medical device delivery system 100 of the present disclosure includes six balloons with substantially identical sizes/shapes, in various embodiments the number of balloons and/or their respective lengths and diameters when linearly expanded may vary, including repeating or non-repeating patterns of long and short balloons, e.g., depending on the specific medical device and body lumen. For example, the unsupported structure 124 of the medical device 120 of the present disclosure may include an impermeable membrane extending approximately 600 mm past the pylorus and into a distal portion of the jejunum to prevent or limit absorption of nutrients across the wall of the duodenum and jejunum.

(20) Although the medical device delivery system 100 of the present disclosure includes an inflation lumen configured to deliver inflation fluid (e.g., gas, liquid, gel, etc.) into the proximal-most balloon for sequential inflation of the balloons in a proximal to distal direction, in various embodiments the inflation lumen may extend over/along an outer surface of the plurality of balloons to deliver inflation fluid into the distal-most balloon for sequential inflation of the balloons in a distal to proximal direction.

(21) In various additional embodiments, a medical device delivery system of the present disclosure may be configured to deliver a guidewire (rather than an unsupported structure of a medical device) within a body lumen. For example, the medical device delivery system may further include a contiguous lumen extending through the full length of the elongate member and through each of the plurality of balloons. The balloons may then be sequentially linearly expanded as discussed above to provide a contiguous guidewire lumen through which a guidewire may then be introduced. The balloons may then be retracted over the guidewire and removed from the patient, and a subsequent medical device tracked along/over the guidewire. Alternatively, the guidewire may be disposed within the contiguous lumen as the balloons are linearly expanded.

(22) In various additional embodiments, the balloons 130a-130f of the present disclosure may be formed from or otherwise include a variety of flexible and non-compliant materials (e.g., silicone, polyethylene terapthelate (PET), nylon, hard rubbers, etc.) such that the balloons do not over-expand within the body lumen. In addition, or alternatively, rather than including a plurality of balloons, a medical device delivery system of the present disclosure may include a single elongate balloon disposed in a concertinaed configuration within the unsupported structure. The single elongate balloon may incrementally move from the concertinaed configuration to a plurality of incrementally increasing partially expanded configurations to track the unsupported structure through a body lumen.

(23) In various additional embodiments, the balloons and/or unsupported structure may be collapsed, compacted and/or folded in a non-concertinaed configuration when in an undeployed (e.g., non-expanded or non-extended) state. In various embodiments, one or more of the balloons may be formed from a variety of non-compliant materials such that each balloon may move to a single pre-determined expanded configuration. Alternatively, one or more of the balloons may be formed from a variety of compliant materials such that each balloon may move to a variety of different expanded configurations. Although the balloons of the present disclosure are depicted including an expanded configuration with a cross-sectional dimension less than a corresponding inner dimension of the unsupported structure, in various embodiments one or more of the balloons may include an expanded configuration substantially equal to an inner dimension of the unsupported structure. In various embodiments, the balloons and/or the unsupported structure may be formed from a sufficiently pliable or flexible material(s) to allow the balloons and unsupported structure to bend or flex when advanced through tortuous body passages.

(24) In various additional embodiments, fewer than all of the plurality of balloons may be linearly expanded when delivering the unsupported structure into a body lumen. For example, one or more of the balloons may remain in the concertinaed configuration once the unsupported structure is determined to have reached a desired portion of the body lumen. In various embodiments, one or more of non-expanded balloons may be moved to the expanded configuration during a subsequent medical procedure.

(25) In various additional embodiments, the present disclosure is not limited to anchoring a medical device across the pylorus and delivering the unsupported structure into the duodenum. By way of non-limiting example, a medical device of the present disclosure may be anchored across an esophagus and the unsupported structure delivered through the stomach and across the pylorus into the duodenum.

(26) All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this disclosure have been described in terms of preferred embodiments, it may be apparent to those of skill in the art that variations can be applied to the devices and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.