Necrotic tissue debridement device

Abstract

The present disclosure provides a tissue debridement device and describes an exemplary treatment for ANP using the tissue debridement device. The tissue debridement device has a sheath, a distal tip, and a plurality of rotating teeth coupled to the distal tip and the sheath. The distal tip can be adjusted closer to or farther from the sheath to change the diameter of the rotating teeth, thereby changing the cutting diameter of the tissue debridement device.

Description

[Technical Field]

[0001] The present disclosure relates generally to necrotic tissue debridement. In particular, although not exclusively, the present disclosure relates to debridement of necrotic tissue from pancreatic pseudocysts. [Background technology]

[0002] In the United States, the incidence of pancreatitis is approximately 185,000 cases per year. At least 80% of cases are attributable to alcohol and cholelithiasis. Acute necrotizing pancreatitis (ANP) has been reported by some to occur in approximately 20% of all pancreatitis episodes. ANP is often treated with endoscopic necrosectomy, which involves passing a flexible endoscope transorally and then transmurally into the necrotic cavity. After puncturing the gastric or duodenal wall into the cystic cavity, the duct is dilated with a balloon, and multiple large-diameter double-pigtail stents or removable self-expanding stents are placed. Debridement and irrigation are performed with various devices (snares, baskets, balloons, forceps, nets, and irrigation). Achieving adequate or complete debridement of necrotic tissue often requires three to six sessions.

[0003] The results of endoscopic necrosectomy are promising. However, endoscopic necrosectomy suffers from several limitations or disadvantages, such as the need for multiple repeat procedures, requiring multiple sessions of sedation or anesthesia. Additionally, the debridement of necrotic tissue can be difficult to grasp and remove from the cavity, which can result in multiple, lengthy, and frustrating sessions before healthy granulation tissue is visible. Other drawbacks include the difficulty or inability to quantify the necrotic burden, manage large necrotic tissue burdens, manage deep retroperitoneal extensions, and treat distal left-sided collections. Furthermore, endoscopic necrosectomy has technical limitations, such as the lack of dedicated instruments, the difficulty of securing the intestinal lumen to the cavity wall using staples or sutures, and the difficulty of avoiding critical structures (e.g., blood vessels) within the necrotic cavity. Summary of the Invention

[0004] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0005] In some embodiments, the present disclosure may be implemented as a tissue debridement device. The tissue debridement device may include a sheath, a distal tip, and a plurality of rotating teeth coupled to the distal tip and the sheath.

[0006] In a further embodiment, the tissue debridement device may include a suction port disposed at the distal end of the sheath. In a further embodiment of the tissue debridement device, the rotating teeth are configured to morsel the tissue.

[0007] In a further embodiment of the tissue debridement device, the rotating teeth are configured to generate, via rotation, a flow of morsel tissue toward the suction port. In a further embodiment, the tissue debridement device may include an injection port.

[0008] In a further embodiment of the tissue debridement device, the distal tip is atraumatic. In a further embodiment of the tissue debridement device, the distal tip comprises a probe configured to present healthy tissue.

[0009] In a further embodiment of the tissue debridement device, each of the rotating teeth comprises a sharp portion disposed between a plurality of blunt portions. In a further embodiment of the tissue debridement device, the rotating teeth comprise wires, with the sharp portion comprising a smaller diameter than the blunt portion.

[0010] In a further embodiment of the tissue debridement device, the rotating teeth comprise a wire and the blunt portion comprises a coating. In a further embodiment of the tissue debridement device, the rotating teeth comprise wires and the sharp portion has a flattened or teardrop-shaped profile.

[0011] In a further embodiment of the tissue debridement device, the distance between the distal tip and the sheath can be adjusted to adjust the diameter of the rotating teeth. In a further embodiment, the tissue debridement device may include a central guide connecting the distal tip to the sheath, the central guide being connected to a handle at the proximal end of the sheath, and the distance between the distal tip and the sheath being adjustable by the handle.

[0012] In a further embodiment of the tissue debridement device, the sheath is configured to be inserted into a working channel of an endoscope. In a further embodiment of the tissue debridement device, the distal tip comprises a camera.

[0013] In some embodiments, the present disclosure may be implemented as a method for debridement of tissue. The method may include introducing a tissue debridement device into a cyst cavity, the tissue debridement device including a sheath, a distal tip, and a plurality of rotating teeth coupled to the distal tip and the sheath, adjusting a cutting diameter of the rotating teeth of the tissue debridement device, and actuating a motor drive unit coupled to the tissue debridement device to morsel necrotic tissue within the cyst cavity.

[0014] In a further embodiment of the method, the rotating teeth comprise wire, the sharp portion comprising a smaller diameter than the blunt portion. In a further embodiment of the method, the rotating tooth comprises a wire and the blunt portion comprises a coating.

[0015] In a further embodiment of the method, the rotating teeth comprise wires and the sharp portion has a flattened or teardrop-shaped profile. In some embodiments, the present disclosure may be implemented as a system. The system may include a tissue debridement device including a sheath, a distal tip, and a plurality of rotating teeth coupled to the distal tip and the sheath, and an endoscope configured to receive the tissue debridement device.

[0016] To easily identify the discussion of any element or act, the most significant digit(s) of a reference number refers to the number of the figure in which that element is first introduced. [Brief explanation of the drawings]

[0017] [Figure 1] 1 shows a tissue debridement device. [Figure 2A] 1 shows the tissue debridement device of claim 1 in further detail. [Figure 2B] 1 shows the tissue debridement device of claim 1 in further detail. [Figure 3] 1 shows a tissue debridement device. [Figure 4] 1 shows a tissue debridement device. [Figure 5] 1 shows a tissue debridement device. [Figure 6] 1 shows a tissue debridement device. [Figure 7] 1 shows a tissue debridement device. [Figure 8] Here's how. [Figure 9] Indicates the environment of the procedure. DETAILED DESCRIPTION OF THE INVENTION

[0018] As introduced above, the present disclosure provides a tissue debridement device and describes an exemplary treatment for ANP using the tissue debridement device. The tissue debridement device has a sheath, a distal tip, and a plurality of rotating teeth coupled to the distal tip and the sheath. The distal tip can be adjusted closer to or farther from the sheath to change the diameter of the rotating teeth, thereby changing the cutting diameter of the tissue debridement device.

[0019] The foregoing has outlined broadly the features and technical advantages of the present disclosure in order that the following detailed description of the disclosure may be better understood. It will be appreciated by those skilled in the art that the disclosed embodiments may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present disclosure. The novel features of the present disclosure, both as to its organization and method of operation, together with further objects and advantages, will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present disclosure.

[0020] 1 illustrates a tissue debridement device 100 according to some embodiments of the present disclosure. The tissue debridement device 100 includes a sheath 102 and a distal tip 104 coupled to the sheath 102 via rotating teeth 106 and a central guide 108. The sheath 102 can be any of a variety of materials, such as, for example, an elastomeric material such as a polyurethane elastomer, a polyester elastomer, or the like.

[0021] The rotating teeth 106 may be arranged to rotate axially to debride necrotic tissue, as outlined herein. Stated another way, the rotating teeth 106 may be arranged to rotate about the longitudinal axis of the tissue debridement device 100 such that the rotating teeth 106 cut, morsel, and / or otherwise debride necrotic tissue. The central guide 108 may be used to change the cutting diameter 114 of the rotating teeth 106. For example, the central guide may be coupled to a handle disposed at the proximal end of the sheath 102. The handle may be configured to move the distal tip 104 closer or farther relative to the sheath 102 to change the cutting diameter 114. Additionally, the central guide 108 may be configured to stabilize the distal tip 104 and the rotating teeth 106 during use. For example, the rotating teeth 106 may be formed from a thinner material than the central guide 108 so that the teeth are sharper or can cut through tissue. In some examples, the rotating teeth 106 may be formed from a single wire, braided wire, or flattened wire. In some embodiments, the rotating teeth 106 may be a polymer or plastic material and may be oval, teardrop-shaped, or flattened. If the rotating teeth 106 are teardrop-shaped, the narrow pointed portion of the teardrop may be rotationally disposed, as described in more detail below.

[0022] Although not shown here, the rotating teeth 106 may be coupled to a motor drive unit (e.g., via a drive shaft, etc.) at the proximal end of the sheath 102. The motor drive unit may drive axial rotation of the rotating teeth 106 during use. In this manner, rotation of the blades or teeth is configured to feed morselized necrotic tissue toward the suction port. For example, the tissue debridement device 100 may include a suction port 110 through which the morselized tissue is removed by suction. In some examples, the suction port 110 may be coupled to a vacuum pump disposed at the proximal end of the sheath 102. The vacuum pump may generate suction to assist in drawing the morselized tissue from the area of ​​debridement into the stomach, into a medical waste trap, etc.

[0023] Tissue debridement device 100 may further include an injection port 112. Injection port 112 may be coupled to a fluid reservoir and pump system and configured to inject or irrigate a fluid, such as water, saline, hydrogen peroxide, or the like, into the area of ​​debridement. In some examples, the fluid may be heated, cooled, or remain at room temperature. In some examples, injection port 112 may be located at the distal tip 104 of the tissue debridement device such that a pressure gradient can be created from the distal tip 104 to the suction port 110, thereby creating a flow of morselized necrotic tissue that is suctioned toward the port 110.

[0024] In some examples, the distal tip 104 can be configured to be atraumatic (e.g., blunt, rounded, smooth, etc.). In some embodiments, the distal tip 104 can include a sensor or probe configured to indicate healthy tissue. For example, the distal tip 104 can be configured with a depth guide positioned to provide feedback (e.g., to a physician, etc.) when the distal tip 104 encounters a boundary between healthy tissue and necrotic tissue.

[0025] 2A and 2B show tissue debridement device 100 with cutting diameter 114 adjusted to different diameters. Figure 2A shows tissue debridement device 100 in a collapsed or stretched state, with central guide 108 moved further from the proximal end of sheath 102, such that distal tip 104 is moved distally along the longitudinal axis of sheath 102 and away from the distal end of sheath 102 to stretch rotating teeth 106 and reduce cutting diameter 114.

[0026] Conversely, FIG. 2B shows the tissue debridement device 100 in an expanded or shortened state in which the central guide 108 is moved closer to the proximal end of the sheath 102 such that the distal tip 104 is moved proximally along the longitudinal axis of the sheath 102 and closer to the distal end of the sheath 102 to expand the rotating teeth 106 and increase the cutting diameter 114.

[0027] In some implementations, the sheath 102 may be configured (e.g., sized and / or shaped) for insertion into a working channel of an endoscope. For example, the tissue debridement device 100 shown in FIG. 1 may be configured for insertion into an endoscope that provides navigation and vision. In other examples, the device may be independently steerable and / or include a camera, light source, or other visualization capabilities. FIG. 3 illustrates a tissue debridement device 300 according to some embodiments of the present disclosure. The tissue debridement device 300 includes a sheath 302 and a distal tip 304 coupled to the sheath 302 via rotating tines 306 and a central guide 308. The tissue debridement device 300 further includes a suction port 310 and an injection port 312. The tissue debridement device 300 may be arranged for independent navigation; more specifically, the rotating tines 306 may move in a direction relative to the longitudinal axis of the sheath 302. For example, the central guide 308 may include navigation mechanisms and structures similar to those of a conventional endoscope. Additionally, in some examples, the distal tip 304 may include a camera and / or a light source to provide vision. In some examples, the camera can provide a view distal to the distal tip 304. In some examples, the camera can provide a view proximal to the distal tip 304, or more specifically, back toward the sheath 302. In further embodiments, the camera can provide a view angled away from the longitudinal axis of the sheath 302 to provide a view of the area where the rotating teeth 306 contact tissue. In some examples, the camera can provide both a distal view and a proximal view from the distal tip 304.

[0028] In some embodiments, the retractable sheath 314 can be retracted within the sheath 302 to expose the rotating teeth 306. For example, the retractable sheath 314 can extend from the sheath 302 toward the distal tip 304 to cover the rotating teeth 306, and the tissue debridement device 300 can be inserted orally into a patient's stomach and then transmurally into a necrotic cavity (e.g., a portion of the biliary system, etc.). Thus, the retractable sheath 314 can prevent accidental cutting or injury to the patient during insertion. Once the distal end of the tissue debridement device 300 is inserted into the necrotic cavity, the retractable sheath 314 can be retracted to expose the rotating teeth 306, which can be adjusted to achieve a desired cutting diameter.

[0029] In some implementations, the entire rotating tooth is a "sharp" cutting portion. In other examples, only a portion of the rotating tooth may be configured to debride tissue. For example, FIG. 4 illustrates a tissue debridement device 400 according to some embodiments of the present disclosure. The tissue debridement device 400 includes the rotating tooth 106, like the tissue debridement device 100 of FIG. 1. However, the rotating tooth 106 includes a blunt portion 402 and a sharp portion 404 that exhibits a cutting region 406 when rotated. As described above, the rotating tooth 106 may be formed from wire, braided wire, flattened wire, plastic components, etc. In some examples, the rotating tooth 106 may be a partially coated wire. Specifically, the blunt portion 402 may be coated (e.g., with a plastic, polymer, etc.), while the sharp portion 404 may be exposed or uncoated. In other implementations, the blunt portion 402 may be of a larger diameter than the sharp portion 404. In yet other implementations, blunt portion 402 may not be flat, while sharp portion 404 may be flat. In yet another example, blunt portion 402 may be circular or oval shaped, while sharp portion 404 may be teardrop shaped. For example, if sharp portion 404 is teardrop shaped, the tooth cross section may be teardrop shaped (or airfoil shaped) with the narrow portion of the teardrop cross section facing the direction of rotation.

[0030] In some implementations, the rotating teeth may be arranged to "tear" or pull tissue rather than "cut" it. For example, FIG. 5 shows a tissue debridement device 500 according to some embodiments of the present disclosure. The tissue debridement device 500 includes rotating teeth 106 like the tissue debridement device 100 of FIG. 1. However, the rotating teeth 106 include a tearing region 502 in which the rotating teeth 106 are configured with a V-shape 504. In some embodiments, the rotating teeth 106 include a V-shape 504 (or other concave shape) that is positioned to pinch, pull, tear, or separate necrotic tissue from healthy tissue rather than resect the necrotic tissue.

[0031] In some embodiments, the rotating teeth 106 include a plurality of concave or V-shaped grooves. For example, Figure 6 shows a tissue debridement device 600 according to some embodiments of the present disclosure. The tissue debridement device 600 includes the rotating teeth 106 like the tissue debridement device 500 of Figure 5. However, the rotating teeth 106 include a plurality of V-shaped grooves 504 within the tearing region 502.

[0032] In some embodiments, the tissue debridement devices described herein may be configured without a suction port. For example, FIG. 7 shows a tissue debridement device 700 according to some embodiments of the present disclosure. The tissue debridement device 700 includes a sheath 702 without a suction port. In such embodiments, an umbrella 704 can be used to collect and pull necrotic tissue from the necrotic cavity into the stomach. The umbrella 704 may be formed from a mesh, net, or membrane and configured to collect necrotic tissue that has been cut or removed from the cavity.

[0033] FIG. 8 illustrates a method 800 for removing necrotic tissue from ducts within a patient's biliary tree. For example, method 800 can be performed to treat acute necrotizing pancreatitis. Accordingly, method 800 will be described with reference to a patient's biliary system 900 in FIG. 9 , which illustrates a stomach 902 and a pancreas 904. The patient's biliary system 900 further illustrates a pancreatic pseudocyst 906 and necrotic tissue 908. It should be understood that pancreatic pseudocysts 906, also known as necrotic spaces, can develop adjacent to the pancreas 904 due to alcohol or cholelithiasis, as outlined above. As a result of the pancreatic pseudocyst 906, necrotic tissue 908 can develop.

[0034] The method 800 may begin at block 802. In block 802, a tissue debridement device is introduced into the cystic cavity. For example, the tissue debridement device 100 may be introduced into the pancreatic pseudocyst 906 in block 802. Often, the pancreatic pseudocyst 906 has necrotic tissue 908. Furthermore, the tissue debridement device (such as, for example, the tissue debridement device 100) has a sheath, a distal tip, and a plurality of rotating teeth coupled to the distal tip and the sheath. Furthermore, the tissue debridement device may have a suction port and / or an injection port. In some examples, the tissue debridement device may be introduced into the necrotic cavity via an endoscope. In certain examples, the tissue wall between the stomach 902 and the pancreatic pseudocyst 906 may be secured using a lumen-facing metal stent, such as an Axios™ stent.

[0035] Proceeding to block 804, the cutting diameter of the tissue debridement device may be adjusted. For example, the cutting diameter 114 of the tissue debridement device may be adjusted (e.g., via the handle and central guide 108, etc.). Proceeding to block 806, the motor drive unit may be activated to morsel the necrotic tissue within the cyst cavity. For example, the motor drive unit coupled to the rotating teeth 106 may be activated to rotate the rotating teeth 106 to morsel the necrotic tissue 908. The rotation speed may be adjusted (e.g., in block 806) such that care is taken to avoid trauma to healthy tissue. In some embodiments, the rotation speed may be less than or equal to 2 revolutions per minute (rpm), for example, when delicate tissue structures (e.g., blood vessels, etc.) are in close proximity to the rotating teeth 106.

[0036] In some examples, the tissue debridement device may include suction and / or injection ports, so that during the procedure, the pancreatic pseudocyst 906 can be irrigated and aspirated to remove or assist in the removal of morselized necrotic tissue 908.

[0037] Terms used in this specification should be given their ordinary meaning in the relevant art or as indicated by their use in context, except that if a clear definition is provided, that meaning will control.

[0038] References herein to "one embodiment" or "an embodiment" do not necessarily refer to the same embodiment, but may. Throughout this specification and claims, words such as "comprise," "comprising," and the like, should be construed in an inclusive sense, i.e., "including, but not limited to," as opposed to an exclusive or exhaustive sense, unless the context clearly dictates otherwise. Words using the singular or plural also include the plural or singular, respectively, unless expressly limited to one or more. Furthermore, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole and not to any portion of this application. When a claim uses the word "or" in connection with a list of two or more items, the word encompasses all of the following interpretations of that word, i.e., any of the items in the list, all of the items in the list, and any combination of the items in the list, unless expressly limited to one or the other. Any terms not expressly defined herein have their conventional meanings as commonly understood by those of ordinary skill in the art.

Claims

1. Sheath and a distal tip; a plurality of rotating teeth coupled to the distal tip and the sheath.

2. The tissue debridement device of claim 1 , comprising a suction port disposed at a distal end of the sheath.

3. The tissue debridement device of claim 1 or 2, wherein the rotating teeth are configured to morsel tissue.

4. The tissue debridement device of claim 3 , wherein the rotating teeth are configured to generate a flow of the morsel tissue toward the suction port via rotation.

5. The tissue debridement device of any one of claims 1 to 4, comprising an injection port.

6. The tissue debridement device of any one of claims 1 to 5, wherein the distal tip is atraumatic.

7. The tissue debridement device of any one of claims 1 to 6, wherein the distal tip comprises a probe configured to indicate healthy tissue.

8. The tissue debridement device of any one of claims 1 to 7, wherein each of the rotating teeth comprises a sharp portion disposed between a plurality of blunt portions.

9. The tissue debridement device of claim 8 , wherein the rotating teeth comprise wires, and the sharp portion comprises a smaller diameter than the blunt portion.

10. The tissue debridement device of claim 8 , wherein the rotating teeth comprise a wire and the blunt portion comprises a coating.

11. The tissue debridement device of claim 8 , wherein the rotating teeth comprise wires and the sharp portion has a flattened or teardrop-shaped profile.

12. The tissue debridement device of any one of claims 1 to 11, wherein the distance between the distal tip and the sheath can be adjusted to adjust the diameter of the rotating teeth.

13. 13. The tissue debridement device of claim 12, comprising a central guide connecting the distal tip to the sheath, the central guide being connected to a handle at a proximal end of the sheath, the distance between the distal tip and the sheath being adjustable by the handle.

14. The tissue debridement device of claim 12 , wherein the sheath is configured to be inserted into a working channel of an endoscope.

15. The tissue debridement device of claim 12 , wherein the distal tip comprises a camera.

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