阅读说明：本技术 流量控制阀 (Flow control valve ) 是由 迈克尔·沃尔什 达伦·柯伦 奥托·范·德·库伊 丹尼尔·塔克 哈维尔·帕洛马-莫雷诺 杰夫 于 2019-03-22 设计创作，主要内容包括：本发明总体上涉及医疗装置以及在体腔之间建立流体连通的领域。特别地,本发明涉及用于在体腔之间建立受控的流动或进入通路的装置和方法。(The present invention relates generally to the field of medical devices and establishing fluid communication between body lumens. In particular, the present invention relates to devices and methods for establishing a controlled flow or access path between body lumens.)

1. A medical device, comprising:

an elongate tubular body comprising a proximal portion, a distal portion, and a length therebetween, the elongate tubular body defining a lumen along the length;

the elongated tubular body having an unexpanded configuration and an expanded configuration wherein the proximal portion expands into the proximal retaining member and the distal portion expands into the distal retaining member leaving a length of the saddle region extending therebetween; and

a flexible member disposed around the saddle region and along at least a portion of the length of the saddle region;

wherein the flexible member is configured to contract at least a portion of the length of the saddle region.

2. The medical device of claim 1, wherein the flexible member is removably disposed about the saddle region.

3. The medical device of any one of claims 1-2, wherein the flexible member is permanently disposed about the saddle region.

4. The medical device of any one of claims 1-3, wherein the flexible member is a sheath disposed about the saddle region and along a portion of all or a majority of the length of the saddle region.

5. The medical device of any one of claims 1-3, wherein the flexible member is disposed about the saddle region and along a portion of the length of the saddle region.

6. The medical device of claim 5, further comprising two collars spaced apart from each other and disposed about the saddle region, wherein a portion of the length of the saddle region between the collars defines a reservoir.

7. The medical device of any one of claims 1-6, wherein the flexible member defines a lumen, and wherein the flexible member is configured to move from a first, non-expanded configuration to a second, expanded configuration.

8. The medical device of claim 7, wherein an inner dimension of the lumen of the flexible member in the first non-expanded configuration is smaller than an inner dimension of the lumen of the flexible member in the second expanded configuration.

9. The medical device of claim 8, wherein the lumen of the constricted portion of the length of the saddle region is fully closed when the flexible member is in the first non-expanded configuration.

10. The medical device of claim 9, wherein the lumen portion of the constricted portion of the length of the saddle region is closed when the flexible member is in the first non-expanded configuration.

11. The medical device of claim 6, further comprising a therapeutic agent disposed within the reservoir.

12. The medical device of claim 11, wherein the therapeutic agent flows from the reservoir through the proximal retention member.

13. The medical device of claim 11, wherein the therapeutic agent flows from the reservoir through the distal retention member.

14. The medical device of any one of claims 1-13, wherein a surface of the proximal retention member is configured to contact an inner surface of a tissue wall of a first body lumen, and a surface of the distal retention member is configured to contact an inner surface of a tissue wall of a second body lumen.

15. The medical device of any one of claims 1-14, wherein the contracted portion of the length of the flexible member and the saddle region are configured to move from a first diameter configuration to an expanded second diameter configuration in response to a threshold level of force.

Technical Field

The present invention relates generally to the field of medical devices and establishing fluid communication between body lumens. In particular, the present invention relates to devices and methods for establishing a controlled flow or access path between body lumens.

Background

Under various circumstances and conditions, there is a need to establish a channel between two body lumens to create fluid communication from one to the other. Various medical devices (e.g., anastomosis devices, drainage stents, etc.) are capable of establishing an open flow or access pathway between body lumens. For example, a transgastric or transduodenal drainage device that facilitates transgastric or transduodenal drainage of symptomatic pancreatic pseudocysts adhering to the stomach or intestinal wall may remain implanted for up to 60 days. The open access path provided by the device may allow fluid and/or debris to continue to flow from the pancreatic pseudocyst into the stomach or duodenum. The flow of acidic gastric fluid into the pseudocyst may also enhance resolution of the pancreatic pseudocyst, which neutralizes alkalinity and increases the viscosity of fluids and/or debris. While continuous unidirectional flow or bidirectional flow through a medical device may be advantageous in certain circumstances, a variety of medical conditions require controlled periodic or intermittent drainage and/or access to a body cavity or organ.

A variety of advantageous medical results may be achieved by the devices and/or methods of the present invention, which allow, for example, infusion and/or drainage of a body cavity or organ in a controlled manner over a period of time.

Disclosure of Invention

In one aspect, the present disclosure is directed to a medical device comprising an elongate tubular body that may include a proximal portion, a distal portion, and a length therebetween. The elongate tubular body can define a lumen along a length. The elongate tubular body can have an unexpanded configuration and an expanded configuration, wherein the proximal portion can be expanded into the proximal retaining member and the distal portion can be expanded into the distal retaining member, leaving a length of a saddle region (e.g., a cylindrical saddle region) extending therebetween. The flexible member may be disposed around the saddle region and along at least a portion of a length of the saddle region. The flexible member may be configured to contract at least a portion of the length of the saddle region. The flexible member may be removably disposed about the saddle region. The flexible member may be permanently disposed about the saddle region. The flexible member may include a sheath disposed around the saddle region and along a portion of all or a majority of the length of the saddle region. The flexible member may include a loop disposed around the saddle and along a portion of the length of the saddle region. The medical device may include two (or more) flexible loops spaced apart from each other and disposed around the saddle region. A portion of the length of the saddle region between the two flexible collars may define the reservoir. The flexible member may define a cavity. The flexible member may be configured to move from a first, non-expanded configuration to a second, expanded configuration. The inner dimension of the lumen of the flexible member in the first, non-expanded configuration may be less than the inner dimension of the lumen of the flexible member in the second, expanded configuration. The lumen of the constricted portion of the length of the saddle region may be fully closed when the flexible member is in the first non-expanded configuration. The lumen of the constricted portion of the length of the saddle region may be partially closed when the flexible member is in the first non-expanded configuration. The therapeutic agent may be disposed within the reservoir. The therapeutic agent may flow from the reservoir through the proximal retention member. The therapeutic agent may flow from the reservoir through the distal retaining member. A surface of the proximal retention member may be configured to contact an inner surface of a tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an inner surface of a tissue wall of the second body lumen. Additionally or alternatively, a surface of the proximal retention member may be configured to contact an inner surface of the tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an outer surface of the tissue wall of the first body lumen. The distal retaining member, the proximal retaining member, and/or the saddle region may be covered. The flexible member and the contracted portion of the length of the saddle region may be configured to move from a first diameter configuration to an expanded second diameter configuration in response to a threshold level of force, including, for example, a force exerted by a second medical device inserted into a lumen of the medical device. The second medical device may extend through a lumen of the saddle region. The second medical device may deliver a therapeutic agent into the second body cavity. The second medical device may be configured to aspirate fluid or debris from within the second body lumen. The second medical device may be a drainage device.

In another aspect, the present invention is directed to a medical device comprising an elongate tubular body that may include a proximal portion, a distal portion, and a length therebetween. The elongate tubular body can define a lumen along a length. The elongate tubular body can have an unexpanded configuration and an expanded configuration, wherein the proximal portion can be expanded into the proximal retaining member and the distal portion can be expanded into the distal retaining member, leaving a length of a saddle region (e.g., a cylindrical saddle region) extending therebetween. A flexible collar may be disposed around the saddle region and along a length of a portion of the saddle region. The flexible collar may be configured to contract at least a portion of the length of the saddle region. A flexible collar may be removably disposed about the saddle region. The flexible collar may be permanently disposed around the saddle region. The flexible collar may define a cavity. The flexible collar may be configured to move from a first, non-expanded configuration to a second, expanded configuration. The inner dimension of the lumen of the flexible collar in the first, non-expanded configuration may be less than the inner dimension of the lumen of the flexible collar in the second, expanded configuration. The lumen of the constricted portion of the length of the saddle region may be fully closed when the flexible loop is in the first non-expanded configuration. The lumen of the constricted portion of the length of the saddle region may be partially closed when the flexible loop is in the first non-expanded configuration. A surface of the proximal retention member may be configured to contact an inner surface of a tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an inner surface of a tissue wall of the second body lumen. Additionally or alternatively, a surface of the proximal retention member may be configured to contact an inner surface of the tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an outer surface of the tissue wall of the first body lumen. The distal retaining member, the proximal retaining member, and/or the saddle region may be covered. The constricted portions of the flexible collar and saddle region may be configured to move from a first diameter configuration to an expanded second diameter configuration in response to a threshold level of force, including, for example, a force applied by a second medical device inserted into a lumen of the medical device. The second medical device may extend through a lumen of the saddle region. The second medical device may deliver a therapeutic agent into the second body cavity. The second medical device may be configured to aspirate fluid or debris from within the second body lumen. The second medical device may be a drainage device. The second medical device may be a valve.

In yet another aspect, the present invention relates to a medical device comprising an elongate tubular body that may include a proximal portion, a distal portion, and a length therebetween. The elongate tubular body can define a lumen along a length. The elongate tubular body can have an unexpanded configuration and an expanded configuration, wherein the proximal portion can be expanded into the proximal retaining member and the distal portion can be expanded into the distal retaining member, leaving a length of a saddle region (e.g., a cylindrical saddle region) extending therebetween. Two (or more) flexible loops may be provided around the saddle region along separate portions of its length. Each of the flexible loops may be configured to constrict at least a portion of the saddle region. A portion of the saddle region between the flexible collars may define a reservoir. A flexible collar may be removably disposed about the saddle region. The flexible collar may be permanently disposed around the saddle region. Each flexible collar may define a cavity. Each flexible collar may be configured to move from a first, non-expanded configuration to a second, expanded configuration. The inner dimension of the lumen of each flexible collar in the first non-expanded configuration may be less than the inner dimension of the lumen of each flexible collar in the second expanded configuration. The lumen of the constricted portion of the length of the saddle region may be fully closed when the flexible loop is in the first non-expanded configuration. The lumen of the constricted portion of the length of the saddle region may be partially closed when the flexible loop is in the first non-expanded configuration. The therapeutic agent may be disposed within the reservoir. The therapeutic agent may flow from the reservoir through the proximal retention member. The therapeutic agent may flow from the reservoir through the distal retaining member. A surface of the proximal retention member may be configured to contact an inner surface of a tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an inner surface of a tissue wall of the second body lumen. Additionally or alternatively, a surface of the proximal retention member may be configured to contact an inner surface of the tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an outer surface of the tissue wall of the first body lumen. The distal retaining member, the proximal retaining member, and/or the saddle region may be covered. The contracted portion of the length of the flexible collar and saddle region may be configured to move from the first diameter configuration to the second expanded diameter configuration in response to a threshold level of force, including, for example, a force exerted by a second medical device inserted into a lumen of the medical device. The second medical device may extend through a lumen of the saddle region. The second medical device may deliver a therapeutic agent into the second body cavity. The second medical device may be configured to aspirate fluid or debris from within the second body lumen. The second medical device may be a drainage device. The second medical device may be a valve.

In yet another aspect, the present invention relates to a medical device comprising an elongate tubular body that may include a proximal portion, a distal portion, and a length therebetween. The elongate tubular body can define a lumen along a length. The elongate tubular body can have an unexpanded configuration and an expanded configuration, wherein the proximal portion can be expanded into the proximal retaining member and the distal portion can be expanded into the distal retaining member, leaving a saddle region (e.g., a cylindrical saddle region) extending therebetween. The flexible sheath may be disposed around the saddle region and along all or a majority of the length of the saddle region. The flexible sheath may be configured to constrict at least a portion of the saddle region. A flexible sheath may be removably disposed about the saddle region. The flexible sheath may be permanently disposed around the saddle region. The flexible sheath may define a lumen. The flexible sheath may be configured to move from a first, non-expanded configuration to a second, expanded configuration. The lumen of the flexible sheath may have an inner dimension in the first, non-expanded configuration that is less than an inner dimension of the lumen of the flexible sheath in the second, expanded configuration. The lumen of the constricted portion of the length of the saddle region may be fully closed when the flexible sheath is in the first non-expanded configuration. The lumen of the constricted portion of the length of the saddle region may be partially closed when the flexible sheath is in the first non-expanded configuration. A surface of the proximal retention member may be configured to contact an inner surface of a tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an inner surface of a tissue wall of the second body lumen. Additionally or alternatively, a surface of the proximal retention member may be configured to contact an inner surface of the tissue wall of the first body lumen, and a surface of the distal retention member may be configured to contact an outer surface of the tissue wall of the first body lumen. The distal retaining member, the proximal retaining member, and/or the saddle region may be covered. The flexible sheath and the constricted portion of the saddle region may be configured to move from a first diameter configuration to an expanded second diameter configuration in response to a threshold level of force, including, for example, a force applied by a second medical device inserted into a lumen of the medical device. The second medical device may extend through a lumen of the saddle region. The second medical device may deliver a therapeutic agent into the second body cavity. The second medical device may be configured to aspirate fluid or debris from within the second body lumen. The second medical device may be a drainage device. The second medical device may be a valve.

Drawings

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

fig. 1A to 1D provide side (fig. 1A to 1B) and front (fig. 1C to 1D) perspective views of a medical device according to an embodiment of the invention;

FIGS. 2A-2B provide front perspective views of a medical device according to one embodiment of the present invention;

FIGS. 3A through 3C provide side perspective views of a medical device according to one embodiment of the present invention;

FIGS. 4A through 4F illustrate steps involved in deploying a medical device between first and second body lumens, according to one embodiment of the present invention;

FIGS. 5A-5B provide side perspective views of a medical device extending through the medical device according to one embodiment of the present invention;

fig. 6A-6C provide side perspective views of a medical device according to one embodiment of the present invention.

Detailed Description

The invention is not limited to the specific embodiments described. 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 this invention belongs.

Although embodiments of the present invention are described with particular reference to medical devices (e.g., anastomosis devices, drainage stents, etc.) and systems for establishing and/or maintaining controlled periodic or intermittent flow or access from the stomach or duodenal wall into or between the peritoneal cavity, it should be understood that such medical devices may also be used in a variety of medical procedures, including natural orifice endoscopic surgery (NOTES) (e.g., external biliary drainage diversion, enteroenterostomy, gastrojejunostomy, gastroduodenal anastomosis, and ileocecal anastomosis, transcolonic surgery, transgastric surgery, transtracheal surgery, transvaginal surgery, cholelithiasis surgery, choledocholithiasis surgery, etc.) to establish and/or maintain a flow or access from a variety of bodily organs, cavities, conduits, vessels, fistulas, cysts, and/or spaces (e.g., skin, catheters, vessels, fistulas, cysts, and/or spaces, Stomach, duodenum, jejunum, small intestine, gallbladder, kidney, pancreas, biliary/pancreatic tree, bladder, ureter, abscess, encapsulated pancreatic necrosis (WOPN), bile duct, etc.) or a controlled periodic or intermittent flow or access pathway therebetween. The device may be inserted via different access points and means, e.g., percutaneous, endoscopic, laparoscopic, or some combination thereof. The medical devices disclosed herein are self-expanding, but in other embodiments, the medical devices may be expanded by other means, including, for example, balloon catheters. Moreover, such medical devices are not limited to drainage, but may facilitate controlled access to an organ, vessel, or body cavity for other purposes (such as delivering therapeutic agents and/or creating pathways to divert or bypass fluids or solids from one location to another, removing obstructions, and/or performing non-invasive or minimally-invasive manipulations of tissue).

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.

As used herein, the term "distal" refers to the end that is furthest from the medical professional when the device is introduced into a patient, while the term "proximal" refers to the end that is closest to the medical professional when the device is introduced into a patient.

In one embodiment, the present invention relates to a medical device (e.g., an anastomosis device, a drainage stent, etc.) that may allow an efficient mechanism for controlled periodic access to a body lumen or organ to facilitate direct endoscopic delivery of advanced therapeutic pharmaceutical products (ATMPs) (e.g., immune checkpoint inhibitors, therapeutics, drugs, cell therapy solutions, etc.) to achieve maximum therapeutic effect and minimal patient discomfort. For example, the medical devices of the present invention may support controlled repeated/intermittent endoscopic delivery of an immunopotentiating therapeutic solution through the stomach or duodenal wall to a body cavity containing or adjacent to a diseased organ or tissue.

Referring to fig. 1A, in one embodiment, a medical device 100 of the present invention may include an elongate tubular body 110 forming a lumen and including a proximal portion 112, a distal portion 122, a length, and a diameter. The elongate tubular body 110 can include an unexpanded configuration (e.g., constrained, undeployed, or delivery configuration; not shown) and an expanded configuration (e.g., unconstrained, delivered, or deployed configuration) in which the proximal portion 112 radially expands into the proximal retaining member 114 and the distal portion 122 radially expands into the distal retaining member 124, leaving a length of saddle region 130 (e.g., a cylindrical saddle region) extending therebetween. The proximal and distal retaining members 114, 124 can extend radially from the elongate tubular body 110 (e.g., perpendicular to its circumference) to define respective surfaces 116, 126. In various embodiments, flexible member 140a may be disposed around the saddle region (e.g., around its entire circumference) and along at least a portion of the length of saddle region 130. The flexible member 140a may be formed from various compliant or semi-compliant materials (e.g., rubber, silicone, elastomeric materials, polymeric materials, etc.) configured to reduce the diameter (e.g., shrink, collapse, narrow, etc.) of the cavity of the saddle region 130. Still referring to fig. 1A, in one embodiment, flexible member 140a may comprise a ring or loop, e.g., having a length L less than saddle region 130₂Length L of₁Such that only a portion of the lumen along the length of the saddle region 130 is constricted. Although the flexible member 140a (e.g., a ring/collar) is positioned at approximately the midpoint of the saddle region 130, in various embodimentsFlexible member 140a may also be positioned along any portion of the length of saddle region 130 between proximal and distal retaining members 114, 124. Additionally or alternatively, as discussed in more detail below (e.g., fig. 3A-3C), more than one flexible member 140a (e.g., two or more rings/collars) may be disposed around the saddle region 130 and spaced apart from one another. Referring to FIG. 1B, in one embodiment, flexible member 140B may comprise a sheath or tube, e.g., having a length L equal to or slightly less than saddle region 130₂Length L of₃Such that all or a majority of the length of the lumen of saddle region 130 is contracted.

Referring to the cross-sectional view of fig. 1C, in various embodiments, the flexible members 140a, 140b may include a relaxed configuration defining a cavity 141 with a first inner dimension d1 configured to fully close the cavity along at least a portion of the length of the saddle region 130, thereby eliminating/preventing the flow of fluids and/or materials therethrough. For example, fig. 1D provides an anterior perspective view of the medical device 100, 200 of fig. 1A or 1B with the flexible member (not shown) in a relaxed configuration such that substantially no openings or access passages extend through the lumen of the saddle region 130.

Referring to the cross-sectional view of fig. 2A, in various other embodiments, the flexible members 140a, 140b may include a relaxed configuration defining a cavity 141 with a first inner dimension d configured to close the cavity along at least a portion of the length of the saddle region 130₂Thereby restricting or slowing (rather than preventing) the flow of fluids and/or materials therethrough. For example, fig. 2B provides an anterior perspective view of the medical device 100, 200 of fig. 1A or 1B with the flexible member (not shown) in a relaxed configuration such that a narrowed or constricted opening or access passage extends through the lumen of the saddle region 130.

By way of non-limiting example, the first inner dimension d of the lumen 141 of the flexible member 140a, 140b depends on the flow and/or access requirements of a particular medical procedure₂The lumen may be constricted or narrowed along at least a portion of the length of saddle region 130, for example, by at least 90%, at least 80%, at least 70%, at least 60%, at least 50%, at least40%, at least 30%, at least 20% or at least 10%.

In various embodiments, the flexible members 140a, 140b may be permanently attached to or integrally formed with the woven or braided filaments of the elongate tube body 110, e.g., disposed around the saddle region and along at least a portion of the elongate tubular body forming the saddle region 130, using suitable glue, adhesive, resin, solder, or other bonding techniques (as is generally known in the art). In various other embodiments, the flexible member may be removably attached to the elongate tubular body (e.g., fig. 6A-6C), for example, via a friction fit or an interference fit.

Referring to fig. 3A, in one embodiment, a medical device 300 of the present invention may include the same features of medical device 100 with two flexible members 140a, e.g., spaced apart from each other and disposed about saddle region 130 by a length L₄A separate ring/collar. In various embodiments, the ring/collar 140a may include an inner dimension d₁Which fully or partially constricts/closes the lumen of saddle region 130, thereby defining a reservoir 146 between the rings/collars. Referring to fig. 3B, in one embodiment, the non-constricting portion of the saddle region 130 defining the reservoir 146 may be filled, loaded, or pre-loaded with a therapeutic agent (e.g., using a syringe, etc.) such that the therapeutic agent is maintained at a predetermined pressure level within the reservoir 146. In various embodiments, the pressure exerted by the therapeutic agent loaded within reservoir 146 may provide for controlled delivery of the therapeutic agent through one (or both) of the rings/collars into the respective body lumen. By way of non-limiting example, the therapeutic agent may be delivered in the form of a controlled drip or flow over the course of minutes, hours, days, and/or months.

In one embodiment, the contractive force applied by each of the rings/loops 140a disposed around and along a portion of the saddle region 130 may be substantially the same (fig. 3A-3B). Alternatively, in one embodiment, the contraction force of the ring/collar 140a may be different, for example, by changing the shape, composition, thickness, and/or durometer value of the flexible member such that the flow of therapeutic agent from the reservoir 146 occurs in one direction.

For example, referring to fig. 3C, the contractive force of the ring/collar 140a positioned adjacent to the proximal retention member 114 may be greater than the contractive force of the ring/collar 140a positioned adjacent to the distal retention member 124 such that the therapeutic agent flows from the reservoir 146, through the distal retention member 124, and, for example, into the second body lumen. Additionally or alternatively, the ring/collar 140a positioned adjacent the proximal retention member 114 may include an inner dimension d that fully constricts/closes the lumen of the saddle region 130₁And ring/collar 140a positioned adjacent distal retaining member 124 may include lumen 141 with an inner dimension d of the lumen not completely closing the saddle region₂Thereby providing controlled release of the therapeutic agent from reservoir 146 through distal retaining member 124. As discussed above, the inner dimension d of the distal-most ring/collar lumen 141₂May be varied as desired depending on the desired release profile of the therapeutic agent from reservoir 146.

In various other embodiments, the contraction force of the ring/collar 140a may be reversed, for example, such that the contraction force of the ring/collar adjacent the distal retaining member 124 is greater than the contraction force of the ring/collar adjacent the proximal retaining member 114, thereby supporting the flow of therapeutic agent from reservoir 146 through the proximal retaining member 114 and, for example, into the first body lumen. Alternatively, in one embodiment, the direction of flow from reservoir 146 may be determined by switching the relative positions of proximal and distal flanges 114, 124 within the patient. For example, the medical device 300 may be positioned within a patient such that the proximal retention member 114 is placed in contact with a tissue wall of a second body cavity and the distal retention member 124 is placed in contact with a tissue wall of a first body cavity to accomplish the same purpose.

In various embodiments, the surface 116 of the proximal retention member 114 may non-invasively engage a (e.g., inner) tissue wall of a first body lumen, and the surface 126 of the distal retention member 124 may non-invasively engage a (e.g., inner) tissue wall of a second body lumen (e.g., adjacent or juxtaposed) to prevent or limit movement/migration of the deployed medical device 100, 200, 300 within or between the first and second body lumens. Alternatively, in one embodiment, the respective surfaces 116, 126 of the proximal and distal retaining members 114, 124 may non-invasively engage opposite sides of a single tissue wall to prevent or limit migration of the deployed medical device. For example, the medical devices 100, 200, 300 of the present invention may be configured to extend through a wall of a body cavity or organ (e.g., a stomach), such that a pleural cavity outside the stomach may be accessed by a medical device extending from inside the body cavity through a lumen of the medical device.

Referring to fig. 4A-4F, in use and by way of example, a delivery device 154 (e.g., an endoscope, an ultrasonic endoscope, a duodenoscope, etc.) may be advanced into the first body lumen 158 such that a distal end of a delivery catheter 160 extending through the lumen of the delivery device 154 is positioned at a tissue wall adjacent the first body lumen 158. A medical device (not shown) of the present invention may be disposed within a lumen of a delivery catheter 160 in an unexpanded configuration, and the delivery catheter 160 may include a tissue-piercing element 152 (fig. 4A). The sharpened distal end of the tissue-penetrating element 152 may be advanced through a tissue wall of a first body lumen 158 (e.g., stomach or duodenum) and through a tissue wall of a second body lumen 159 (e.g., peritoneal cavity) (fig. 4B). Additionally or alternatively, the tissue-penetrating element may include an electrically conductive element (e.g., a halo wire cone with proximally extending arms) configured to receive heat or energy (e.g., RF energy) for creating the opening.

In various embodiments, the tissue-penetrating element 152 may be advanced over a guidewire (not shown) previously advanced through the first and second body lumens 158, 159 such that a distal end of the guidewire is disposed within the second body lumen 159. Alternatively, in the above-described method, a separate instrument with a sharp distal tip may be advanced along a path over and into the second body cavity 159 to create the path. A guide wire (not shown) may be placed in place or, if used to guide a separate instrument, left in place and the separate instrument withdrawn over the guide wire.

The medical device 100, 200, 300 according to the various embodiments described above loaded on the delivery catheter 150 may be inserted over a guidewire and subsequently deployed according to the steps outlined below.

Subsequently, the distal portion 122 of the medical device 100, 200 can be advanced distally beyond the lumen of the delivery catheter 150 (which may or may not include the tissue penetrating element 152), and/or the outer sheath of the delivery catheter 150 can be retracted proximally from an end of the medical device such that the distal retaining member 124 is fully deployed within the second body lumen 159 (fig. 4C).

Subsequently, the delivery catheter 150 can be retracted to place the surface 126 of the distal retaining member 124 in contact with the inner surface of the tissue wall of the second body lumen 159 (fig. 4D). In one embodiment, the flexible member 140b (e.g., of the medical device 200) may be disposed about an outer surface of the distal portion of the delivery catheter 150. With the distal portion of the delivery catheter 150 disposed within the gap 157 between the first and second body lumens 158, 159, the medical professional can lift the elevator 155 on the delivery device 154 such that the leading edge of the elevator engages the proximal end of the flexible member 140 (fig. 4D). The medical professional may then further proximally retract the delivery catheter 150 to peel or roll the flexible member 140 out of the delivery catheter 150 and over/around the saddle region 130 and along all or a substantial portion of the length of the saddle region 130, e.g., extending in the gap 157 between the first and second body lumens 158, 159 (fig. 4E). Although not shown, in various embodiments, the flexible member 140a of the medical device 100 or 300 may be disposed around the outer surface of the distal portion of the delivery catheter and peeled/rolled out as described above.

In other embodiments, for example, where the flexible members 140a, 140b are permanently attached to or integrally formed with the elongate tubular body 110, the flexible members may be disposed around the elongate tubular body 110 within the lumen of the delivery catheter 150 such that upon retraction of the delivery catheter 150, the flexible members 140a, 140b and the saddle region 130 deploy simultaneously within the gap 157 between the first and second body lumens 158, 159.

The delivery catheter 150 can then be further proximally retracted into the first body lumen 158 and the proximal portion of the medical device 100, 200, 300 advanced distally beyond the lumen of the delivery catheter 150 and/or the outer sheath of the delivery catheter 150 can be further proximally retracted from around the medical device such that the proximal retention member 114 is fully deployed within the first body lumen 158 and the surface 116 of the proximal retention member 114 is placed in contact with the inner surface of the tissue wall of the first body lumen 158 (fig. 4F).

In various embodiments, the compliant or semi-compliant material comprising the flexible members 140a, 140b can be configured such that the lumen 141 can be sized from the first or second inner dimension d₁、d₂Moved (e.g. stretched) to be greater than the respective first or second inner dimension d₁、d₂Third inner dimension d₃(not shown). For example, a separate medical device may be advanced into the saddle region 130 and through the saddle region 130 with a threshold level of force sufficient to extend through the constricted portion of the saddle region 130. In various embodiments, the flexible members 140a, 140b may be collapsed around and in sealing engagement with the outer surface of the individual medical device extending through the saddle region 130.

Referring to fig. 5A, in one embodiment, a user may advance a medical tool 153a (e.g., a drainage catheter, an infusion catheter, a micro-infusion catheter, etc.) through a previously implanted medical device 200, e.g., under endoscopic guidance, with or without a previously placed guidewire for the medical tool. In response to a threshold level of force applied by medical tool 153a to the constricted portion of saddle region 130, lumen 141 of flexible member may be from first or second inner dimension d₁Or d₂To a third, larger inner dimension d₃Allowing medical tool 153a to extend into second body cavity 159. In various embodiments, the medical tool 153a can deliver a therapeutic agent into a cavity or space surrounding or adjacent to a diseased tissue or organ. In addition to delivering an effective dose of the therapeutic agent directly within the target body cavity to achieve the maximum beneficial effect, the ability of the flexible member 140b and saddle region 130 of the medical device 200 to move between the closed and open configurations may allow for a long-term dosing regimen (e.g., weeks, months, or years) of administering one or more therapeutic agents without causing undue discomfort to the patient. Additionally or alternatively, the medical tool 153a may be configured to treat abscesses or pseudolitesIrrigation and/or aspiration of fluid and/or debris within the cyst.

Referring to fig. 5B, in another embodiment, a drainage device 153B (e.g., a plastic biliary stent, etc.) can be positioned within the previously implanted medical device 200, e.g., under endoscopic guidance to provide an open flow path therethrough. Upon proximal withdrawal of the medical tool (fig. 5A) or drainage device (fig. 5B) from within the medical device 200, the lumen 141 of the flexible member 140B may return to the first or second inner dimension d₁、d₂And the saddle region 130 may return to a fully or partially closed position to restrict and/or prevent flow therethrough.

Referring to fig. 6A-6C, in embodiments of the invention in which the flexible members 140b are not permanently attached to or integrally formed with the elongate tubular body 110, the medical professional may remove or retrieve the flexible members 140b from their position around the saddle region 130 and along at least a portion of the length of the saddle region 130 such that the saddle region 130 moves to a completely unconstrained position. For example, using forceps or another suitable grasping tool, a medical professional can grasp an edge of the proximal retention member and pull the proximal retention member into a lumen of a delivery catheter (not shown), thereby returning (e.g., collapsing) the proximal retention member to a constrained position. A second medical tool 153, such as forceps or the like, may then be advanced through the lumen of the delivery catheter, or along the outer surface of the delivery catheter, to grasp the proximal end of the flexible member 140 b. While maintaining the position of the medical device 200, the medical professional can proximally retract and remove the flexible member 140b from the elongate tubular body 110 of the medical device 200 within the respective first and second body lumens 158, 159. The unconstrained medical device may then allow unrestricted flow and/or access through the saddle region.

It should be understood that fig. 5A-5B and 6A-6B are provided for illustrative purposes only and are in no way limited to medical device 200, but may include either of medical devices 100, 300. The elongate tubular body 110 of any of the medical devices 100, 200, 300 depicted in fig. 1A-3C can be formed from more than one braided filament (e.g., nitinol)Nordic, etc.). Proximal retaining member 114, distal retaining member 124, and/or saddle region 130 may further include a film, covering, or coating on its inner and/or outer surfaces to define a continuous open internal pathway configured for controlled flow (e.g., bodily fluids, materials, etc.) therethrough and/or access. The coating may comprise a variety of non-degradable and biocompatible polymeric materials (e.g., upon exposure to bodily fluids such as bile), including, for example, silicone, rubber, polyethylene, PVDF, and the like,And a thermoplastic elastomer such that the coating conforms to the medical device in the unexpanded and expanded configurations.

Although the flexible members 140a, 140b of the present invention are depicted as being substantially circular, in various embodiments, the flexible members, such as the ring/collar 140a or the sheath/tube 140b, may comprise various sizes, shapes, configurations, and/or thicknesses. As will be understood by those skilled in the art, the contraction force exerted by the flexible member may be determined based on the size, shape, thickness, durometer value, and/or composition of the material comprising the flexible member. Additionally or alternatively, in various embodiments, the flexible sheath 140b of the present disclosure may include an inner/inner portion that is thinner, weaker, and/or more flexible than the surrounding outer/end portion, thereby providing a reservoir, e.g., for a therapeutic agent (as discussed above).

The proximal and distal retaining members 114, 124 of any of the medical devices 100, 200, 300 depicted in fig. 1A-3C may include various configurations such that one or more retaining members extend radially from a longitudinal axis of the elongate tubular body at an angle that is not necessarily perpendicular to the elongate tubular body, and/or the surface is not necessarily planar. In various embodiments, the angle of the retaining member relative to the circumference and longitudinal axis of the elongate tubular body can assume other degrees (e.g., 30 degrees, 45 degrees, 60 degrees, 75 degrees, etc.), or can vary in degrees along the length of the retaining member, thereby creating an inflection point in the retaining member. For example, one or both of the proximal and distal retaining members may extend outward toward one end of the elongate tubular body, extend rearward toward a central portion of the elongate tubular body, or change direction in some combination of the two.

For example, one or both of the proximal and distal retaining members may flare away from the longitudinal axis of the saddle region into a flanged configuration on the opposite end of the saddle region when in the expanded configuration. Each flange configuration may include at least first and second inflection points that may define first and second sections of the flange. The first segment may extend from a first inflection point toward a central plane perpendicular to the longitudinal axis of the tubular body, and the second segment may extend from the first inflection point away from the central plane. An angle of a first inflection point defined by the first segment and the saddle region may be at least as large as a relative angle of a second inflection point defined by the first segment and the second segment.

As another example, each flange may include at least first and second inflection points defining first and second segments of the flange, wherein the second inflection point may also be radially spaced further from the longitudinal axis than the first inflection point, and the second inflection point may be closer to the central plane along the longitudinal axis than the first inflection point. The flanges on opposite ends of the saddle region may touch a plane parallel to the longitudinal axis, at least one plane above and below the longitudinal axis each at least two separate points along the parallel planes.

As another example, each flange configuration may include at least first and second inflection points that define first and second segments of the flange. The first segment may extend from a first inflection point toward a central plane perpendicular to the longitudinal axis of the tubular body, and the second segment may extend from a second inflection point away from the central plane. An intersection of the saddle region and the first segment may define a first inflection point, and an intersection of the first segment and the second segment may define a second inflection point. An angle of the first inflection point may be 90 degrees or less, and an opposite angle of the second inflection point may be 90 degrees or less.

In various embodiments, one or both of the proximal and distal retaining members may comprise an outer diameter d that is greater than the saddle region₂Outer diameter d of₁. For example, externallyDiameter d₁May be larger than the outer diameter d of the saddle region₂75% to 100% larger. By way of non-limiting example, the outer diameter d₁Can be about 7.0mm to about 30mm, and an outer diameter d₂And may be about 3.0mm to about 15.0 mm. In various embodiments, the size (e.g., diameter) of the opening formed between the first and second body lumens may be increased or decreased by increasing or decreasing the size (e.g., width) of the proximal and distal retaining members (e.g., increasing or decreasing the surface area of the layers of tissue compressed between the proximal and distal retaining members). Additionally or alternatively, the length of the elongate tubular body in the expanded configuration may be shortened, e.g., at least 40% shorter than the length of the elongate tubular body, when in the unexpanded configuration.

Various embodiments, for example, in the expanded configuration, the medical devices 100, 200, 300 of the present invention may include double-walled flanges as proximal and distal retaining members at either end of the elongate tubular body. In various other embodiments, the proximal and/or distal retaining members may comprise a variety of other configurations, including but not limited to a single-walled flange structure at either end and/or more than one single-walled or double-walled flange structure at either end. The walls of the flange above and/or below the longitudinal axis may be symmetrical or may be asymmetrical. As mentioned above, the wall of the flange above and/or below the longitudinal axis may have a plurality of inflection points that define segments of the wall of the flange that change direction as the wall extends radially away from the longitudinal axis (e.g., the segments may extend radially parallel to, away from, and/or toward a radial centerline of the body). The segments may extend along straight lines or may be curved, or may comprise a combination of straight and curved lines.

In various embodiments, any of the woven, braided, and/or knitted filaments comprising the elongate tubular body can comprise a variety of different cross-sectional shapes (e.g., oval, circular, flat, square, etc.) and can be formed from metals and/or polymers, including shape memory metals and polymers. The woven, braided and/or knitted filament may also comprise a single filament woven on itself or a plurality of filaments woven together.

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 apparatus and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the apparatus 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 invention. 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 invention as defined by the appended claims.