METHODS AND SYSTEMS FOR DISINFECTING SURGICAL SITE
20230126287 · 2023-04-27
Inventors
- Jordan N. Milford (Bethlehem, PA, US)
- Joey Magno (Dudley, MA, US)
- Kester Julian Batchelor (Mound, MN, US)
- Charles A. Baker (Rogers, MN, US)
Cpc classification
A61M31/00
HUMAN NECESSITIES
A61K33/20
HUMAN NECESSITIES
A61M2025/0019
HUMAN NECESSITIES
International classification
A61K33/20
HUMAN NECESSITIES
A61M31/00
HUMAN NECESSITIES
Abstract
A method of performing a surgical procedure comprises inserting a medical instrument into anatomy of a patient to reach target tissue within an anatomical cavity, disinfecting anatomy within the patient with the medical instrument and performing treatment of the target tissue with the medical instrument. A medical device for providing disinfecting to a surgical site, the medical device comprises an elongate shaft extending from a proximal end to a distal end, an imaging device located proximate the distal end of the elongate shaft, a lighting element located proximate the distal end of the elongate shaft, a working channel extending at least partially through the elongate shaft and a disinfecting system attached to the elongate shaft to deliver a disinfecting capability proximate the distal end of the elongate shaft.
Claims
1. A method of performing a surgical procedure comprising: inserting a medical instrument into anatomy of a patient to reach target tissue within an anatomical cavity; disinfecting anatomy within the patient with the medical instrument; and performing treatment of the target tissue with the medical instrument.
2. The method of claim 1, wherein performing treatment of the target tissue comprises removing the target tissue from a duct wall of the anatomical cavity using a tissue removal device inserted through the medical instrument.
3. The method of claim 2, wherein removing the target tissue from the duct wall of the anatomical cavity comprises leaving the duct wall intact.
4. The method of claim 2, wherein the surgical procedure comprises one of: Polypectomy, Endoscopic Mucosal Resection (EMR), or Endoscopic Submucosal Dissection (ESD).
5. The method of claim 2, wherein: the surgical procedure further comprises producing an opening in the duct wall; and disinfecting anatomy within the patient with the medical instrument comprises applying disinfectant around the opening.
6. The method of claim 2, wherein the surgical procedure comprises a full-thickness resection (FTR) or an endoscopic ultra-sound (EUS) drainage.
7. The method of claim 1, wherein disinfecting the anatomy comprises dispensing disinfectant material onto tissue surrounding the target tissue through the medical instrument.
8. The method of claim 7, wherein dispensing disinfectant material onto the anatomy through the medical instrument comprises dispensing the disinfectant material from a tubular body inserted into the medical instrument.
9. The method of claim 7, wherein dispensing the disinfectant material onto the target tissue comprises using native fluid dispensing capabilities of the medical instrument to dispense the disinfectant material.
10. The method of claim 9, further comprising adding a disinfectant packet to a fluid reservoir for the native fluid dispensing capabilities of the medical instrument.
11. The method of claim 7, wherein dispensing the disinfectant material onto the target tissue comprises: using a first fluid dispensing capability of the medical instrument to dispense irrigation fluid; and using a second fluid dispensing capability of the medical instrument do dispense the disinfectant material.
12. The method of claim 7, wherein dispensing disinfectant material onto the anatomy through the medical instrument comprises dispensing the disinfectant material from a tubular body attached to an exterior of the medical instrument.
13. The method of claim 7, wherein dispensing the disinfectant material onto the target tissue comprises dispensing Povidone-iodine (PVP-I) or Hypochlorous acid (HOCl).
14. The method of claim 7, further comprising adjusting a surface area over which the disinfectant material is distributed onto the target tissue.
15. The method of claim 7, wherein dispensing disinfectant material onto tissue surrounding the target tissue comprises applying cold plasma to the target tissue.
16. The method of claim 7, wherein dispensing disinfectant material onto tissue surrounding the target tissue comprises applying ultraviolet light to the target tissue.
17. The method of claim 1, wherein disinfecting the anatomy comprises dispensing disinfectant material onto tissue leading up to the target tissue.
18. The method of claim 17, wherein disinfecting the anatomy comprises directing ultraviolet light radially outward from the medical instrument.
19. The method of claim 17, wherein disinfecting the anatomy comprises rubbing a disinfecting coating applied to the medical instrument onto the anatomy.
20. The method of claim 1, further comprising dispensing a microbiome onto the anatomy.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0029] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
DETAILED DESCRIPTION
[0030]
[0031] Imaging and control system 12 can comprise control unit 16, output unit 18, input unit 20, light source 22, fluid source 24, suction pump 26 and disinfecting system 102.
[0032] Imaging and control system 12 can include various ports for coupling with endoscopy system 10. For example, control unit 16 can include a data input/output port for receiving data from and communicating data to endoscope 14. Light source 22 can include an output port for transmitting light to endoscope 14, such as via a fiber optic link. Fluid source 24 can include a port for transmitting fluid to endoscope 14. Fluid source 24 can comprise a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. Suction pump 26 can comprise a port used to draw a vacuum from endoscope 14 to generate suction, such as for withdrawing fluid from the anatomical region into which endoscope 14 is inserted. Output unit 18 and input unit 20 can be used by an operator of endoscopy system 10 to control functions of endoscopy system 10 and view output of endoscope 14. Control unit 16 can additionally be used to generate signals or other outputs from treating the anatomical region into which endoscope 14 is inserted. In examples, control unit 16 can generate electrical output, acoustic output, a fluid output, a gas output, and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like. Control unit 16 can be used to operate disinfecting system 102 and various instruments, components and sub-systems thereof.
[0033] Endoscope 14 can comprise insertion section 28, functional section 30 and handle section 32, which can be coupled to cable section 34 and coupler section 36. Coupler section 36 can be connected to control unit 16 to connect to endoscope 14 to multiple features of control unit 16, such as input unit 20, light source unit 22, fluid source 24 and suction pump 26.
[0034] Insertion section 28 can extend distally from handle section 32 and cable section 34 can extend proximally from handle section 32. Insertion section 28 can be elongate and include a bending section, and a distal end to which functional section 30 can be attached. The bending section can be controllable (e.g., by control knob 38 on handle section 32) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion section 28 can also include one or more working channels (e.g., an internal lumen) that can be elongate and support insertion of one or more therapeutic tools of functional section 30, such as endoscopy system 100 of
[0035] Handle section 32 can comprise knob 38 as well as port 40A. Knob 38 can be coupled to a pull wire, or other actuation mechanisms, extending through insertion section 28. Port 40A, as well as other ports, such as port 40B (
[0036] Imaging and control system 12, according to examples, can be provided on a mobile platform (e.g., cart 41) with shelves for housing light source 22, suction pump 26, image processing unit 42 (
[0037] Functional section 30 can comprise components for treating and diagnosing anatomy of a patient. Functional section 30 can comprise an imaging device, an illumination device and an elevator, such as is described further with reference to elevator 54 of
[0038]
[0039] Image processing unit 42 and light source 22 can each interface with endoscope 14 (e.g., at functional unit 30) by wired or wireless electrical connections. Imaging and control system 12 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on display unit 18. Imaging and control system 12 can include light source 22 to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). Imaging and control system 12 can connect (e.g., via an endoscope connector) to endoscope 14 for signal transmission (e.g., light output from light source, video signals from imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).
[0040] Fluid source 24 (
[0041]
[0042] In the example of
[0043] As can be seen in
[0044]
[0045] Housing 52 can comprise accommodation space 53 that houses deflector 55. Instrument 63 can comprise forceps, a catheter, or the like that extends through lumen 62. Instrument 63 can also comprise a disinfecting device described herein or another device, such as an endoscope that can receive a disinfecting device described herein. A proximal end of deflector 55 can be attached to housing 62 at pin 61 8 provided to the rigid tip 21. A distal end of deflector 55 can be located below window 65 within housing 62 when deflector 55 is in the lowered, or un-actuated, state. The distal end of deflector 55 can at least partially extend out of window 65 when deflector 55 is raised, or actuated, by wire 57. Instrument 63 can slide on angled ramp surface 51 of deflector 55 to initially deflect the distal end of instrument 63 toward window 65. Angled ramp surface 51 can facilitate extension of the distal portion of instrument 63 extending from window 65 at a first angle relative to the axis of lumen 62. Angled ramp surface 51 can include groove 69, e.g. a v-notch, to receive and guide instrument 63. Deflector 55 can be actuated to bend instrument 63 at a second angle relative to the axis of lumen 62, which is closer to perpendicular that the first angle. When wire 57 is released, deflector 55 can be rotated, e.g., counter-clockwise, back to the lowered position, either by pushing or relaxing of wire 57.
[0046]
[0047] In the example of
[0048] As can be seen in
[0049] Endoscope camera module 70 can also include a photosensitive element, such as a charge-coupled device (“CCD” sensor) or a complementary metal-oxide semiconductor (“CMOS”) sensor. In either example, imaging unit 87 can be coupled (e.g., via wired or wireless connections) to image processing unit 42 (
[0050] As discussed in greater detail below, endoscope 14 can comprise systems and devices for providing disinfectant, e.g., liquids, powders, cold plasma and ultra-violet light, to anatomy of a patient either directly or with the use of another instrument or device. For examples, FIGS. 5A and 5B show a disinfectant delivery system incorporated into a shaft of a scope and
[0051]
[0052]
[0053] Medical instrument 106 can be inserted into working tool channel 112 to obtain tissue from the patient. Disinfectant instrument 108 can be inserted into disinfectant channel 112 to deliver a disinfecting material to anatomy of a patient. Disinfectant instrument 108 and medical instrument 106 can be inserted into and withdrawn from endoscope 104 before or after insertion of endoscope 104 from duct D.
[0054] Objective lens 114 can be configured similarly as objective lens 80 of
[0055] Elongate shaft 122 of endoscope 104 can additionally be provided with steering capabilities as is described with reference to scope 14. For example, elongate shaft 122 can include pull wires that can be coupled to an actuation device to impart curvature to elongate shaft 122.
[0056] Working channel 110 and disinfectant channel 112 can be configured to receive a working tool, such as medical instrument 106, and a disinfecting system, such as disinfecting instrument 108, respectively. Working channel 110 and disinfectant channel 112 can extend from distal end face 120 to a proximal portion of elongate shaft 122. For examples, proximal ends of channel 110 and disinfectant channel 112 can be coupled to a port, such as port 40 of
[0057] Medical instrument 106 can comprise a tissue retrieval device such as a forceps or any other device suitable for separating, retrieving or collecting sample biological matter. Medical instrument 106 can comprise shaft 130 and tissue separators 132. Shaft 130 of medical instrument 106 can comprise a pliable body that can allow tissue separator 132 to be angled out of elongate shaft 122. Shaft 130 can additionally accommodate passage of control features, such as actuation wires, to tissue separator 132 to facilitate actuation of tissue separator 132 to collect tissue.
[0058] Disinfecting instrument 108 can be configured to deliver a disinfecting substance, such as a gas, liquid or powder, stored in substance reservoir 126. Disinfecting instrument 108 can comprise elongate body 140, such as a tube or hose having a lumen through which disinfecting substance can flow or be dispensed. In examples, elongate body 140 can be open at a distal end to allow disinfecting substance to flow freely therefrom. In example, disinfecting instrument 108 can comprise dispenser 142. Dispenser 142 can comprise a device for controlling or shaping flow of disinfecting substance from elongate body 140, such as a nozzle and the like. Examples of dispenser 142 are discussed in greater detail with reference to FIG. 6A. In additional examples, elongate body 140 can comprise conductor wires and gas tubes extending between disinfecting system 102 and dispenser 142, and dispenser 142 can comprise an electrode for a cold plasma applicator. A proximal end portion of disinfecting instrument 108 can be connected to one or all of disinfecting system 102, fluid source 24 and control unit 16 (
[0059] The systems and methods of the present disclosure can utilize various substances and compositions as the disinfecting substance or as an antiseptic. A variety of formulations are possible and could be in the form of a liquid, gel, or powder. Attributes of the disinfecting substance or antiseptic can comprise:
1. Destroy microbial proteins and/or DNA quickly;
2. Biocompatible with little or no side effects for the patient;
3. Antiseptic should stay in the area sprayed and provide some visual difference between treated and untreated areas;
4. Visual difference dissipates, does not affect visualization during the procedure, or enhances the visualization during the remainder of the procedure; and
5. Reasonable cost in mass production.
[0060] Suitable formulations for the disinfectant can comprise Povidone-iodine (PVP-I), which can be ingested in limited quantities, and Hypochlorous acid (HOCl), which has disinfection properties and naturally occurs within the body.
[0061] In examples, disinfecting instrument 108 can be omitted and disinfecting substance can be provided by disinfecting system 102 directly to disinfecting channel 112. In such examples, disinfecting channel 112 can comprise a leak-proof passage such as a tube or conduit that can convey liquid or powder disinfecting material from reservoir 126 to dispenser 142.
[0062] In examples, disinfecting instrument 108 can be provided on the exterior of shaft 122 and disinfecting channel 112 can be omitted, as discussed with reference to
[0063] In examples, disinfecting instrument 108 can be configured to operate with a plasma system. For example, motive device 124 and reservoir 126 can be replaced with or comprise components and devices for producing a cold plasma jet or plume at dispenser 142. In examples, motive device 124 and reservoir 126 can be replaced with or comprise one or more gas sources, one or more electrical generators, one or more gas tubes, one or more conductors and one or more electrodes. The gas sources can include supplies of gases suitable for the formation of cold plasma, such as oxygen, helium, argon, nitrogen, heliox and air. In examples, a carrier gas from a gas source, such as at reservoir 126, can be passed through a gas tube extending through shaft 140, conducting wires extending along the gas tube can be connected to electrodes on opposite sides of a discharge end of the gas tube, an electric generator can provide current through the conducting wires to produce a dielectric barrier between the electrodes, and the dielectric barrier can ignite the carrier gas into cold plasma. In examples, cold plasma can be produced by disinfecting system 102 via dielectric barrier discharge methods, floating electrode dielectric barrier discharge methods, radio frequency plasma jets, pulsed direct current-driven plasma jets and the like, as is described in Hoffmann C, Berganza C, Zhang J. Cold Atmospheric Plasma: methods of production and application in dentistry and oncology. Med Gas Res. 2013; 3(1): 21. Published 2013 Oct. 1. doi:10.1186/2045-9912-3-21, the contents of which are hereby incorporated into the present application by this reference.
[0064] In examples, versions of disinfecting instrument 108 configured for delivering disinfecting plasma are described in U.S. Pat. No. 11,197,708 to Cheng, titled “Plasma generator configured for use with an auxiliary device,” which is assigned to Gyms ACMI, Inc., the contents of which are incorporated herein by this reference.
[0065]
[0066] Disinfectant instrument 108 can be extended from disinfectant channel 112 to reach the location of target tissue 158. Endoscope 104 can be steered to guide disinfectant instrument 108 toward target tissue 158. Imaging capabilities of endoscope 104 can be used to guide disinfectant instrument 108. As mentioned, disinfectant instrument 108 can comprise a catheter or separate instrument extending from endoscope 104. However, disinfectant instrument 108 can be integrated into endoscope 104 such that disinfectant 150 can be emitted directly from endoscope 104. Additionally, disinfectant instrument 108 can be provided alongside endoscope 104. Disinfectant instrument 108 can be selectively operated by a surgeon or user to spray, dispense, emit or otherwise release disinfectant 150 in the form of gas, liquid, gel, powder, plasma, light or other forms.
[0067] Examples of procedures that can be performed using the systems, devices and methods of the present disclosure include Endoscopic Submucosal Dissection (ESD) procedures. Exemplary ESD procedures are described in U.S. Pat. No. 9,402,683 to Yamano et al., titled “Submucosal layer dissection instrument, submucosal layer dissection system, and submucosal layer dissection method,” which is assigned to Olympus Corporation, the contents of which are incorporated herein by this reference. A brief description of an ESD procedure is provided as an example procedure where the disinfectant methods and systems of the present disclosure can be used. Although, other types of procedures can be used with the methods and systems of the present disclosure.
[0068] As shown in
[0069] In a first step of the ESD procedure, the boundary of target tissue 158 can be marked using a surgical instrument. In examples, a cauterizing instrument can be used to mark indicia in mucosal layer 160C around the perimeter of target tissue 158. The boundary can be marked approximately 5 mm to 10 mm away from edges of target tissue 158. For example, a surgical instrument can comprise electrodes that can be activated by an energy source, such as at control unit 16 (
[0070] In a second step of the ESD procedure, as shown in
[0071] In a third step of the ESD procedure, mucosal layer 160C can be cut to remove target tissue 158 from duct wall 160. In examples, medical instrument 168 can be used cut through mucosal layer 160C completely around the marked perimeter. Medical instrument 168 can include electrode ring 170 that can be activated by an energy source, such as at control unit 16 (
[0072] In a fourth step of the ESD procedure, as shown in
[0073] As mentioned,
[0074]
[0075] Medical instrument 206 can comprise a tissue retrieval device such as a forceps or any other device suitable for separating, retrieving or collecting sample biological matter. Medical instrument 206 can comprise shaft 230 and tissue separators 232. Shaft 230 of medical instrument 206 can comprise a pliable body that can allow tissue separator 232 to be angled out of elongate shaft 222. Shaft 230 can additionally accommodate passage of control features, such as actuation wires, to tissue separator 232 to facilitate actuation of tissue separator 232 to collect tissue.
[0076] Disinfectant instrument 208 can comprise shaft 240, spray device 242 and orifice 244. Disinfectant instrument 208 can be connected to 102
[0077] Endoscopy system 200 of
[0078] In examples, attachment device 260 can comprise a sleeve extending along shaft 222. In examples, attachment device 260 can comprise a hoop, strap or eyelet attached to shaft 222 and a plurality of attachment devices 260 can be positioned along the length of shaft 222. In additional examples, attachment device 260 can comprise a bulge in the exterior of shaft 22 that can incorporate disinfecting channel 112 (
[0079] Positioning of disinfectant instrument 208 outside of shaft 222 can allow for the elimination of a disinfecting channel, such as disinfecting channel 112 of
[0080] Spray device 242 can comprise a nozzle or another device for controlling the pattern of spray S by adjusting the size of orifice 244. For example, spray device 242 can be adjusted by an operator, such as at disinfecting system 102 (
[0081]
[0082] Medical instrument 306 can comprise shaft 330 and tissue separators (not shown) and can be configured similarly to medical instrument 106 (
[0083] Endoscopy system 300 of
[0084] Light conductor 372 can be connected to light source 22 (
[0085] Lens 374 can be positioned at the distal end of light conductor 372 to facilitate projecting of disinfecting light distally from endoscope 304. Lens 374 can be configured to disperse light in different angles from the end face of endoscope 304. Lens 374 can be configured as a light emitter configured to emit or project light carried by conductor 372 and originated by light source 22.
[0086] Light ring 378 can be connected to light conductor 372 via linkage 376. Light ring 378 can be configured to project light radially relative to the axis of endoscope 304. Linkage 376 can be made of a light conducting material. Light ring 378 can additionally be made of a light conducting material. Thus, light from light source 22 can be transmitted through light conductor 372, through linkage 376 and into light ring 378. In examples, light conductor 372, linkage 376 and light ring 378 can be made of one or more continuous light conductors, each connecting to one of emitters 379. Emitters 379 can be configured to emit disinfecting light radially from endoscope 304 relative to the central axis of endoscope 304.
[0087] In additional examples, lens 374 can comprise a light emitter, such as one or more light emitting diodes (LEDs), and light conductor can comprise a wire or cable connecting lens 374 to a power source. Additionally, each of emitters 379 can comprise an LED or another light emitter configured to be electrically activated and linkage 376 and ring 378 can comprise wires or cables configured to conduct electrical power from light conductor 372 to emitters 379.
[0088]
[0089] Medical instrument 406 can comprise shaft 430 and tissue separators (not shown) and can be configured similarly to medical instrument 106 (
[0090] Endoscopy system 400 of
[0091] Disinfectant coating 480 can be fabricated from or include a disinfectant, such as those listed herein. The disinfectant can be embedded in or carried on the outside of disinfectant coating 480. Disinfectant coating 480 can be configured to rub off, abrade, elute, emit, molt, shed or otherwise release the disinfectant when sliding against or otherwise being in contact with another surface, such as an anatomic surface or biological tissue.
[0092] Disinfectant coating 480 can allow for passive disinfecting with endoscope 404 without direct intervention by the operator. Thus, coating 480 can provide disinfecting capabilities just by contacting tissue. In other configurations, disinfectant coating 480 can be configured to be released on demand by an operator with an activation source. In examples, shaft 422 can comprise resistance heaters that can be activated at control unit 16 (
[0093] Disinfectant coating 480 can be located on all of shaft 422 or only on parts of shaft 422. For example, disinfectant coating 480 can be located only on the distal-most portion of shaft 422, such as the distal-most 50%, 25% or 10%. In additional examples, disinfectant coating 480 can be located only along a circumferential segment of shaft 422 (e.g., only within one one-hundred-eighty or ninety-degree segment) to provide disinfecting capabilities in a partial circumferential direction.
[0094] The including of disinfectant coating 480 can reduce the space used within shaft 422 for disinfecting purposes such that the space within shaft 422 can be available for other purposes. Thu, working channel 410 can be enlarged if desired, as compared to other working channels described herein.
[0095]
[0096] At operation 502, a medical instrument can be inserted into anatomy. For example, endoscope 104 can be inserted into duct D, as shown in
[0097] At operation 504, the medical instrument can be guided to target tissue. For example, endoscope 104 can be guided to target tissue T, as shown in
[0098] At operation 506, disinfectant can be applied by the medical instrument to surfaces leading to the target tissue. For example, disinfectant can be applied while the medical instrument is being inserted through the anatomy. In examples, the disinfectant can comprise ultraviolet light, as discussed with reference to
[0099] At operation 508, disinfectant can be applied to surfaces of the target tissue. For example, disinfectant instrument 108 can be advanced through working channel 112 to reach the target tissue, as shown in
[0100] At operation 510, a tissue removal device can be advanced through the medical instrument. For example, medical device or tissue separator device 106 of
[0101] At operation 512, biological matter can be removed from the target tissue. For example, tissue separator device 106 can be used to cut, slice or otherwise remove diseased or potentially diseased tissue or other biological matter. The tissue separator device can be removed from the anatomy to retrieve the biological matter for disposal or biopsy.
[0102] At operation 514A, the duct wall of the anatomy can be left intact. In examples, the medical procedure can comprise a Polypectomy, Endoscopic Mucosal Resection (EMR), or Endoscopic Submucosal Dissection (ESD) procedure. Disinfectant applied at operations 506 and 508 can prevent the spread of bacteria and germs onto the anatomy at the target tissue, thereby improving the health and safety of the patient by reducing the risk of infection or sickness.
[0103] At operation 514B, an opening in the duct wall of the anatomy can be made. In examples the opening can be made intentionally, such as during a full-thickness resection (FTR) or an endoscopic ultra-sound (EUS) drainage procedure. In other examples, the opening can be made unintentionally, such as during a procedure of operation 514A. In either case, the application of disinfectant at operations 506 and 508 can prevent the spread of bacteria and germs through the opening.
[0104] At operation 516, microbiome can be applied to the target tissue, as discussed in greater detail below. For example, bacteria of a patient can be supplemented or replaced with donor bacteria. The donor bacteria can supplement or replace bacteria killed via disinfectant applied at operation 506 and operation 508.
[0105] At operation 518, the medical instrument can be removed from the anatomy. For example, endoscope 104 can be removed from duct D, as shown in
[0106] In another aspect of the present disclosure, the delivery devices and methods described herein can be used to perform microbiome procedures. In such procedures, the bacteria of a patient can be supplemented or replaced with donor bacteria, such as via a fecal transplant. Thus, it can be desirable to eliminate or remove the existing bacteria of the patient. The delivery devices and methods of the present disclosure can be used to deliver disinfectant to the anatomy to kill or remove the existing bacteria. The disinfectant can be delivered to a wider area than just a specific target tissue location. Thus, for example, the entire interior of the stomach can be treated with disinfectant by direct application. Thereafter, the delivery devices and methods of the present disclosure can be used to deliver donor bacteria, such as donor fecal matter, to the patient.
[0107] Any of the disinfectant systems of the present application can be used to deliver microbiomes to anatomy, particularly those configured to deliver powder or liquid disinfectant. Thus, for example, with reference to
EXAMPLES
[0108] Example 1 is a method of performing a surgical procedure comprising: inserting a medical instrument into anatomy of a patient to reach target tissue within an anatomical cavity; disinfecting anatomy within the patient with the medical instrument; and performing treatment of the target tissue with the medical instrument.
[0109] In Example 2, the subject matter of Example 1 optionally includes wherein performing treatment of the target tissue comprises removing the target tissue from a duct wall of the anatomical cavity using a tissue removal device inserted through the medical instrument.
[0110] In Example 3, the subject matter of Example 2 optionally includes wherein removing the target tissue from the duct wall of the anatomical cavity comprises leaving the duct wall intact.
[0111] In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein the surgical procedure comprises one of: Polypectomy, Endoscopic Mucosal Resection (EMR), or Endoscopic Submucosal Dissection (ESD).
[0112] In Example 5, the subject matter of any one or more of Examples 2-4 optionally include wherein: the surgical procedure further comprises producing an opening in the duct wall; and disinfecting anatomy within the patient with the medical instrument comprises applying disinfectant around the opening.
[0113] In Example 6, the subject matter of any one or more of Examples 2-5 optionally include wherein the surgical procedure comprises a full-thickness resection (FTR) or an endoscopic ultra-sound (EUS) drainage.
[0114] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include wherein disinfecting the anatomy comprises dispensing disinfectant material onto tissue surrounding the target tissue through the medical instrument.
[0115] In Example 8, the subject matter of Example 7 optionally includes wherein dispensing disinfectant material onto the anatomy through the medical instrument comprises dispensing the disinfectant material from a tubular body inserted into the medical instrument.
[0116] In Example 9, the subject matter of any one or more of Examples 7-8 optionally include wherein dispensing the disinfectant material onto the target tissue comprises using native fluid dispensing capabilities of the medical instrument to dispense the disinfectant material.
[0117] In Example 10, the subject matter of Example 9 optionally includes adding a disinfectant packet to a fluid reservoir for the native fluid dispensing capabilities of the medical instrument.
[0118] In Example 11, the subject matter of any one or more of Examples 7-10 optionally include wherein dispensing the disinfectant material onto the target tissue comprises: using a first fluid dispensing capability of the medical instrument to dispense irrigation fluid; and using a second fluid dispensing capability of the medical instrument do dispense the disinfectant material.
[0119] In Example 12, the subject matter of any one or more of Examples 7-11 optionally include wherein dispensing disinfectant material onto the anatomy through the medical instrument comprises dispensing the disinfectant material from a tubular body attached to an exterior of the medical instrument.
[0120] In Example 13, the subject matter of any one or more of Examples 7-12 optionally include wherein dispensing the disinfectant material onto the target tissue comprises dispensing Povidone-iodine (PVP-I) or Hypochlorous acid (HOCl).
[0121] In Example 14, the subject matter of any one or more of Examples 7-13 optionally include adjusting a surface area over which the disinfectant material is distributed onto the target tissue.
[0122] In Example 15, the subject matter of any one or more of Examples 7-14 optionally include wherein dispensing disinfectant material onto tissue surrounding the target tissue comprises applying cold plasma to the target tissue.
[0123] In Example 16, the subject matter of any one or more of Examples 7-15 optionally include wherein dispensing disinfectant material onto tissue surrounding the target tissue comprises applying ultraviolet light to the target tissue. In Example 17, the subject matter of any one or more of Examples 1-16 optionally include wherein disinfecting the anatomy comprises dispensing disinfectant material onto tissue leading up to the target tissue.
[0124] In Example 18, the subject matter of Example 17 optionally includes wherein disinfecting the anatomy comprises directing ultraviolet light radially outward from the medical instrument.
[0125] In Example 19, the subject matter of any one or more of Examples 17-18 optionally include wherein disinfecting the anatomy comprises rubbing a disinfecting coating applied to the medical instrument onto the anatomy.
[0126] In Example 20, the subject matter of any one or more of Examples 1-19 optionally include dispensing a microbiome onto the anatomy.
[0127] Example 21 is a medical device for providing disinfecting to a surgical site, the medical device comprising: an elongate shaft extending from a proximal end to a distal end; an imaging device located proximate the distal end of the elongate shaft; a lighting element located proximate the distal end of the elongate shaft; a working channel extending at least partially through the elongate shaft; and a disinfecting system attached to the elongate shaft to deliver a disinfecting capability proximate the distal end of the elongate shaft.
[0128] In Example 22, the subject matter of Example 21 optionally includes wherein: the disinfecting system comprises a disinfectant tube; and the disinfecting capability comprises dispensing of a disinfecting substance.
[0129] In Example 23, the subject matter of Example 22 optionally includes wherein the disinfectant tube extends within the elongate shaft.
[0130] In Example 24, the subject matter of any one or more of Examples 22-23 optionally include wherein the disinfectant tube extends alongside the elongate shaft.
[0131] In Example 25, the subject matter of Example 24 optionally includes an attachment device to hold the disinfectant tube alongside the elongate shaft.
[0132] In Example 26, the subject matter of any one or more of Examples 22-25 optionally include an adjustable nozzle connected to the disinfectant tube to change a spray diameter from the disinfectant tube.
[0133] In Example 27, the subject matter of any one or more of Examples 22-26 optionally include wherein the disinfecting substance comprises a liquid or powder comprising Povidone-iodine (PVP-I) or Hypochlorous acid (HOCl).
[0134] In Example 28, the subject matter of any one or more of Examples 22-27 optionally include wherein the disinfecting substance comprises a gas.
[0135] In Example 29, the subject matter of Example 28 optionally includes wherein the gas comprises cold plasma.
[0136] In Example 30, the subject matter of Example 29 optionally includes wherein the disinfecting capability comprises: a conductor extending along the disinfectant tube; and an electrode connected to a distal end portion of the conductor.
[0137] In Example 31, the subject matter of any one or more of Examples 21-30 optionally include wherein: the disinfecting system comprises a conductor; and the disinfecting capability comprises disinfecting light capable of being emitted from the medical device.
[0138] In Example 32, the subject matter of Example 31 optionally includes wherein the disinfecting light is emitted radially.
[0139] In Example 33, the subject matter of any one or more of Examples 31-32 optionally include wherein the disinfecting light is emitted axially.
[0140] In Example 34, the subject matter of any one or more of Examples 31-33 optionally include wherein the conductor comprises a light fiber and the disinfecting system further comprises a light-emitting diode.
[0141] In Example 35, the subject matter of any one or more of Examples 31-34 optionally include the disinfecting light comprises ultraviolet having a wavelength in a range of approximately 200 nm to approximately 280 nm.
[0142] In Example 36, the subject matter of any one or more of Examples 22-35 optionally include wherein: the disinfecting system comprises a coating positioned on at least a portion of an exterior of the elongate shaft; and the disinfecting capability comprises a disinfectant substance within the coating.
[0143] In Example 37, the subject matter of Example 36 optionally includes wherein the disinfectant substance comprises Povidone-iodine (PVP-I) or Hypochlorous acid (HOCl).
[0144] In Example 38, the subject matter of any one or more of Examples 22-37 optionally include an irrigation passage extending through the elongate shaft.
[0145] In Example 39, the subject matter of Example 38 optionally includes wherein: the disinfecting system comprises the irrigation passage; and the disinfecting capability comprises irrigation fluid having a disinfectant additive.
[0146] In Example 40, the subject matter of Example 39 optionally includes packets of disinfectant.
[0147] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
Various Notes
[0148] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
[0149] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
[0150] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
[0151] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.
[0152] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.