Necrotic tissue debridement device

Abstract

The present invention provides a tissue debridement device and describes an example of treating ANP using the tissue debridement device. The tissue debridement device has a sheath, a distal tip, and a plurality of rotating tines coupled to the distal tip and the sheath. The distal tip may be adjusted closer to or farther from the sheath to vary the diameter of the rotating tines to vary the cutting diameter of the tissue debridement device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 414,731, filed on October 10, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present invention generally relates to the debridement of necrotic tissue. In particular, but not exclusively, the present invention relates to the debridement of necrotic tissue in pancreatic pseudocysts. Background Art

[0003] In the U.S., the incidence of pancreatitis is about 185,000 cases per year. At least 80% of cases are due to alcohol and cholelithiasis. According to some reports, acute necrotizing pancreatitis (ANP) accounts for about 20% of all pancreatitis attacks. ANP is usually treated with endoscopic necrotizing resection, which is performed by passing a flexible endoscope through the mouth and then entering the necrotic cavity through the wall. After puncturing the stomach or duodenal wall to the cystic cavity, the tract is enlarged by a balloon, and multiple large-caliber double pigtail stents or removable self-expanding stents are placed. Debridement and lavage are performed by various devices (snare, basket, balloon, tweezers, nets and flushing). Usually, 3 to 6 treatments are needed to achieve sufficient or complete debridement of necrotic tissue.

[0004] The results of endoscopic necrosectomy are encouraging. However, there are several limitations or disadvantages in endoscopic necrosectomy, such as the need for repeated operations, which requires multiple sedation or anesthesia. Additionally, the necrotic tissue that is debrided is difficult to grasp and remove from the cavity, which may lead to multiple, long, frustrating treatments before healthy granulation tissue can be seen. In addition, the quantification of necrotic load, how to manage a large amount of necrotic tissue load, how to manage deep retroperitoneal extension, and the difficulty or impossibility of treating distal left effusion are other disadvantages. Moreover, endoscopic necrosectomy has technical limitations, such as lack of dedicated instruments, difficulty in fixing the intestinal cavity to the cavity wall with staples or sutures, and difficulty in avoiding important structures (e.g., blood vessels, etc.) in the necrotic cavity. Summary of the invention

[0005] This Summary is provided to introduce a group of concepts in a simplified form that are further described in the Detailed Description below. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter.

[0006] In some embodiments, the present invention may be implemented as a tissue debridement device. The tissue debridement device may include a sheath, a distal tip, and a plurality of rotating tines coupled to the distal tip and the sheath.

[0007] In further embodiments, the tissue debridement device may include a suction port disposed on the distal end of the sheath.

[0008] In further embodiments of the tissue debridement device, the rotating tines are configured to pulverize tissue.

[0009] In further embodiments of the tissue debridement device, the rotating tines are configured to generate a flow of pulverized tissue toward the suction port via rotation.

[0010] In further embodiments, the tissue debridement device may include an infusion port.

[0011] In further embodiments of the tissue debridement device, the distal tip is atraumatic.

[0012] In further embodiments of the tissue debridement device, the distal tip includes a probe configured to indicate healthy tissue.

[0013] In further embodiments of the tissue debridement device, each of the rotating tines includes a sharp section disposed between blunt sections.

[0014] In further embodiments of the tissue debridement device, the rotating tines comprise wires, and wherein the sharp section comprises a smaller diameter than the blunt section.

[0015] In further embodiments of the tissue debridement device, the rotating tines comprise wires, and wherein the blunt sections comprise a coating.

[0016] In further embodiments of the tissue debridement device, the rotating tines comprise wires and wherein the sharp segments have a flat or teardrop shaped profile.

[0017] In further embodiments of the tissue debridement device, the distance between the distal tip and the sheath can be adjusted to adjust the diameter of the rotating tines.

[0018] In further embodiments, the tissue debridement device may include a central guide coupling the distal tip to the sheath, the central guide coupled to a handle at the proximal end of the sheath, the distance between the distal tip and the sheath being adjustable by the handle.

[0019] In further embodiments of the tissue debridement device, the sheath is configured to be inserted into a working channel of an endoscope.

[0020] In further embodiments of the tissue debridement device, the distal tip comprises a camera.

[0021] In some embodiments, the present invention may be implemented as a method for debridement of tissue. The method may include introducing a tissue debridement device into a cystic cavity, the tissue debridement device including a sheath, a distal tip, and a plurality of rotating tines coupled to the distal tip and the sheath; adjusting a cutting diameter of the rotating tines of the tissue debridement device; and activating a motor drive unit coupled to the tissue debridement device to pulverize necrotic tissue in the cystic cavity.

[0022] In further embodiments of the method, the rotating tine comprises a wire and the sharp section comprises a smaller diameter than the blunt section.

[0023] In further embodiments of the method, the rotating tine comprises a wire and the blunt section comprises a coating.

[0024] In further embodiments of the method, the rotating tine comprises a wire and the sharp section has a flat or teardrop shaped profile.

[0025] In some embodiments, the present invention may be implemented as a system. The system may include a tissue debridement device, the tissue debridement device including a sheath, a distal tip, a plurality of rotating tines coupled to the distal tip and the sheath, and an endoscope configured to receive the tissue debridement device. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] To easily identify the discussion of any component or activity, the highest digit or digits in a reference number refer to the figure number in which the component is first introduced.

[0027] Figure 1 A tissue debridement device is shown.

[0028] Figure 2A and Figure 2B The tissue debridement device of claim 1 is shown in alternative details.

[0029] Figure 3 A tissue debridement device is shown.

[0030] Figure 4 A tissue debridement device is shown.

[0031] Figure 5 A tissue debridement device is shown.

[0032] Figure 6 A tissue debridement device is shown.

[0033] Figure 7 A tissue debridement device is shown.

[0034] Figure 8 The method is shown.

[0035] Fig. 9 The surgical environment is shown. DETAILED DESCRIPTION

[0036] As described above, the present invention provides a tissue debridement device and describes an example of using the tissue debridement device to treat ANP. The tissue debridement device has a sheath, a distal tip, and a plurality of rotating tines connected to the distal tip and the sheath. The distal tip can be adjusted to be closer to or farther away from the sheath to change the diameter of the rotating tines, thereby changing the cutting diameter of the tissue debridement device.

[0037] The features and technical advantages of the present invention have been summarized above so that the following detailed description of the present invention can be better understood. It should be understood by those skilled in the art that the disclosed embodiments can be easily used as a basis for modifying or designing other structures to achieve the same purpose as the present invention. When considered in conjunction with the accompanying drawings, the novel features of the present invention regarding its organization and method of operation and further objects and advantages will be better understood according to the following description. However, it should be clearly understood that each of the accompanying drawings is provided for the purpose of illustration and description only and is not intended to be a definition of the limitation of the present invention.

[0038] Figure 1 A tissue debridement device 100 according to some embodiments of the present invention is shown. The tissue debridement device 100 includes a sheath 102 and a distal tip 104 coupled to the sheath 102 via rotating tines 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.

[0039] The rotating tines 106 can be arranged to rotate axially to debride necrotic tissue, as outlined herein. In other words, the rotating tines 106 can be arranged to rotate around the longitudinal axis of the tissue debridement device 100 so that the rotating tines 106 cut, crush and / or otherwise debride necrotic tissue. The central guide 108 can be used to change the cutting diameter 114 of the rotating tines 106. For example, the central guide can be coupled to a handle disposed on the proximal end of the sheath 102. The handle can be configured to move the distal tip 104 closer or farther from the sheath to change the cutting diameter 114. In addition, the central guide 108 can be configured to stabilize the distal tip 104 and the rotating tines 106 during use. For example, relative to the central guide 108, the rotating tines 106 can be formed of a thinner material so that the tines are sharper or can penetrate tissue. For some examples, the rotating tines 106 can be formed of a single wire, a braided wire, or a flat wire. In some embodiments, the rotating tines 106 may be polymer or plastic material and may be oval, teardrop shaped or flat. Where the rotating tines 106 are teardrop shaped, the narrow tip portion of the teardrop shape may be disposed in the direction of rotation. This is described in more detail below.

[0040] Although not shown herein, the rotating tines 106 can be coupled (e.g., via a drive shaft, etc.) to a motor drive unit at the proximal end of the sheath 102. The motor drive unit can drive the axial rotation of the rotating tines 106 during use. In this way, the rotation of the blades or tines is configured to deliver the pulverized necrotic tissue toward a suction port. For example, the tissue debridement device 100 may include a suction port 110, wherein the pulverized tissue is removed via suction. In some examples, the suction port 110 can be coupled to a vacuum pump disposed at the proximal end of the sheath 102. The vacuum pump can generate suction to help draw the pulverized tissue from the debridement area into the stomach, into a clinical waste trap, etc.

[0041] The tissue debridement device 100 may also include an infusion port 112. The infusion port 112 may be coupled to a fluid reservoir and pump system and configured to infuse or irrigate the debridement area with a fluid, such as, for example, water, saline, hydrogen peroxide, etc. For some examples, the fluid may be heated, cooled, or placed at room temperature. In some examples, the infusion port 112 may be located at the distal tip of the tissue debridement device 104 so that a pressure gradient may be generated from the distal tip 104 to the suction port 110, thereby generating a flow of pulverized necrotic tissue that is suctioned toward the port 110.

[0042] For some examples, the distal tip 104 can be configured to be non-invasive (e.g., can be solid, round, 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 that is arranged to provide feedback (e.g., to a physician, etc.) when the distal tip 104 encounters a boundary between healthy tissue and necrotic tissue.

[0043] Figure 2A and Figure 2B The tissue debridement device 100 is shown wherein the cutting diameter 114 is adjusted to different diameters. Figure 2A The tissue debridement device 100 is shown in a collapsed or extended state, wherein the center guide 108 moves farther from the proximal end of the sheath 102 such that the distal tip 104 moves distally along the longitudinal axis of the sheath 102 and away from the distal end of the sheath 102 to extend the rotating tines 106 and reduce the cutting diameter 114.

[0044] On the contrary, Figure 2BThe tissue debridement device 100 is shown in an expanded or shortened state, wherein the center guide 108 moves closer to the proximal end of the sheath 102 so that the distal tip 104 moves proximally along the longitudinal axis of the sheath 102 and closer to the distal end of the sheath 102 to expand the rotating tines 106 and increase the cutting diameter 114.

[0045] In some embodiments, the sheath 102 can be configured (e.g., sized and / or shaped) to be inserted into a working channel of an endoscope. Figure 1 The tissue debridement device 100 depicted in FIG. 1 can be configured to be inserted into an endoscope in which steering and visual imaging are provided. In other examples, the device can be independently steerable and / or include a camera, light, or other visualization features. Figure 3 A tissue debridement device 300 according to some embodiments of the present invention is shown. The tissue debridement device 300 includes a sheath 302 and a distal tip 304 coupled to the sheath 302 via a rotating tine 306 and a center guide 308. The tissue debridement device 300 also includes a suction port 310 and an infusion port 312. The tissue debridement device 300 can be arranged to be independently steered, or more specifically, the rotating tine 306 can be moved in a direction relative to the longitudinal axis of the sheath 302. For example, the center guide 308 can include a steering mechanism and structure like a conventional endoscope. In addition, for some examples, the distal tip 304 can include a camera and / or a light to provide a visual image. For 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, toward the back of the sheath 302. For further embodiments, the camera can provide a view angled away from the longitudinal axis of the sheath 302, so that the camera provides a view of the area where the rotating tines 306 will contact the tissue. In some examples, the camera can provide a view distally and proximally of the distal tip 304.

[0046] In some embodiments, the retractable sheath 314 can be retracted into the sheath 302 to expose the rotating tines 306. For example, the retractable sheath 314 can extend from the sheath 302 toward the distal tip 304 to cover the rotating tines 306, and the tissue debridement device 300 can be inserted into the patient's stomach through the mouth and then enter the necrotic cavity (e.g., a portion of the biliary system, etc.) through the wall. Therefore, 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 tines 306, and the rotating tines 306 can be adjusted to achieve the desired cutting diameter.

[0047] In some embodiments, the entire rotating tine is a "sharp" cutting feature. In other examples, only a portion of the rotating tine may be configured to debride tissue. For example, Figure 4 400 according to some embodiments of the present invention. The tissue debridement device 400 includes a rotating tine 106, such as Figure 1 The rotating tine 106 is similar to the tissue debridement device 100 of the present invention. However, the rotating tine 106 includes a blunt section 402 and a sharp section 404 that detects a cutting area 406 when rotating. As described above, the rotating tine 106 can be formed of a wire, a braided wire, a flat wire, a plastic component, etc. In some examples, the rotating tine 106 can be a partially coated wire. In particular, the blunt section 402 can be coated (e.g., with a plastic, a polymer, etc.), while the sharp section 404 can be exposed or uncoated. In other embodiments, the blunt section 402 can have a larger diameter relative to the sharp section 404. In other embodiments, the blunt section 402 may not be flattened, while the sharp section 404 may be flattened. In another example, the blunt section 402 can be circular or oval, while the sharp section 404 can be teardrop-shaped. For example, where the sharp section 404 is teardrop-shaped, the cross-section of the tine may be teardrop-shaped (or airfoil-shaped), with the narrow section of the teardrop-shaped cross-section facing the direction of rotation.

[0048] In some embodiments, the rotating tines may be arranged to "tear" or pull tissue rather than "cut" tissue. For example, Figure 5 1 shows a tissue debridement device 500 according to some embodiments of the present invention. The tissue debridement device 500 includes a rotating tine 106, such as Figure 1 The present invention is similar to the tissue debridement device 100 of the present invention. However, the rotating tine 106 includes a tearing region 502, wherein the rotating tine 106 is configured with a v-shape 504. In some embodiments, the rotating tine 106 includes a v-shape 504 (or other concave shape) that is arranged to pinch, pull, comb or tear necrotic tissue from healthy tissue instead of cutting the necrotic tissue.

[0049] In some embodiments, the rotating tines 106 include a plurality of concave or v-shaped grooves. For example, Figure 6 1 shows a tissue debridement device 600 according to some embodiments of the present invention. The tissue debridement device 600 includes a rotating tine 106, such as Figure 5 The tissue debridement device 500 is similar to the one of the embodiments of the present invention. However, the rotating tines 106 include a plurality of v-shaped grooves 504 in the tearing region 502.

[0050] In some embodiments, the tissue debridement devices described herein can be configured without a suction port. Figure 7A tissue debridement device 700 is shown according to some embodiments of the present invention. The tissue debridement device 700 includes a sheath 702 without a suction port. In such an embodiment, an umbrella 704 can be used to collect necrotic tissue and pull it out of the necrotic cavity into the stomach. The umbrella 704 can be formed of a mesh, a net, or a film and is configured to collect necrotic tissue cut or removed from the cavity.

[0051] Figure 8 A method 800 for removing necrotic tissue from a duct in a patient's biliary tree is shown. For example, the method 800 may be implemented to treat acute necrotizing pancreatitis. Fig. 9 Method 800 is described with reference to a patient's biliary system 900, which shows a stomach 902 and a pancreas 904. The patient's biliary system 900 further depicts a pancreatic pseudocyst 906 and necrotic tissue 908. It should be understood that the pancreatic pseudocyst 906, also referred to as a necrotic cavity, may form adjacent to the pancreas 904 due to alcohol or cholelithiasis as outlined above. As a result of the pancreatic pseudocyst 906, necrotic tissue 908 may form.

[0052] Method 800 can begin at box 802. At box 802, a tissue debridement device is introduced into a cystic cavity. For example, at box 802, a tissue debridement device 100 can be introduced into a pancreatic pseudocyst 906. Typically, the pancreatic pseudocyst 906 will have necrotic tissue 908. In addition, the tissue debridement device (e.g., tissue debridement device 100, etc.) will have a sheath, a distal tip, and a plurality of rotating tines connected to the distal tip and the sheath. In addition, the tissue debridement device can have a suction port and / or an infusion port. In some examples, the tissue debridement device can be introduced into the necrotic cavity via an endoscope. In a specific example, the tissue wall between the stomach 902 and the pancreatic pseudocyst 906 can be punctured with a metal stent that is opposed to the cavity, such as, The bracket is fixed.

[0053] Continuing with frame 804, the cutting diameter of the tissue debridement device can be adjusted. For example, the cutting diameter 114 of the tissue debridement device can be adjusted (e.g., via the handle and the center guide 108, etc.). Continuing with frame 806, the motor drive unit can be activated to crush the necrotic tissue in the cyst. For example, the motor drive unit connected to the rotating tines 106 can be activated to rotate the rotating tines 106 to crush the necrotic tissue 908. The rotation speed can be adjusted (e.g., at frame 806) so that care is taken to avoid trauma to healthy tissue. In some embodiments, the rotation speed can be less than or less than or equal to 2 revolutions per minute (rpm), such as, for example, when a fragile tissue structure (e.g., blood vessels, etc.) is adjacent to the rotating tines 106.

[0054] In some examples, the tissue debridement device may include a suction port and / or an infusion port. Thus, during surgery, the pancreatic pseudocyst 906 may be irrigated and aspirated to remove or aid in the removal of comminuted necrotic tissue 908.

[0055] Terms used herein should be given their ordinary meaning in the relevant art or the meaning indicated by their usage in context, but if an explicit definition is provided, that meaning shall prevail.

[0056] Herein, references to "an embodiment" or "an embodiment" do not necessarily refer to the same embodiment, although they may refer to the same embodiment. Unless the context clearly requires otherwise, throughout the specification and claims, the words "including", "comprising", etc. should be interpreted as inclusive, rather than exclusive or exhaustive; that is, "including but not limited to". Words using the singular or plural also include the plural or singular, respectively, unless explicitly limited to one or more. Additionally, the words "herein", "above", "below", and words of similar meaning, when used in this application, refer to the entirety of this application, rather than to any part of this application. When a claim uses the word "or" to refer to a list of two or more items, the word covers all of the following interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list, unless explicitly limited to one or another. Any term not explicitly defined herein has the conventional meaning commonly understood by those skilled in the relevant art.

Claims

1. A tissue debridement device, comprising: Sheath; distal apex; as well as A plurality of rotatable tines are coupled to the distal tip and the sheath. 2 . The tissue debridement device of claim 1 , further comprising a suction port disposed on the distal end of the sheath.

3. The tissue debridement device according to any one of claims 1 or 2, wherein the rotating tines are configured to pulverize tissue. 4 . The tissue debridement device of claim 3 , wherein the rotating tines are configured to generate a flow of the pulverized tissue toward the suction port via rotation.

5. The tissue debridement device of any one of claims 1 to 4, comprising an infusion 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 tines comprises a sharp section disposed between blunt sections.

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

10. The tissue debridement device of claim 8, wherein the rotating tines comprise wires, and wherein the blunt section comprises a coating.

11. The tissue debridement device of claim 8, wherein the rotating tines comprise wires, and wherein the sharp segments have a flat or teardrop-shaped profile.

12. The tissue debridement device according to 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 tine.

13. The tissue debridement device according to claim 12, comprising a central guide connecting the distal tip and the sheath, the central guide being connected to a handle at the 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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