Endoscopic resection cap with built-in swing stripper
By designing a medical device including a housing and a movable arm, the predetermined movement of the arm is achieved using a swing system, the problems of limited visual field and difficult to reach the peeling plane in ESD are solved, and the safety and efficiency of the surgery are improved.
Patent Information
- Application Number
- CN202080049470.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-07-08
- Filing Date
- 2020-07-07
- Publication Date
- 2025-05-27
- Estimated Expiration
- 2040-07-07
AI Technical Summary
In endoscopic submucosal dissection (ESD), the doctor performs surgery with a high incidence of complications such as bleeding and perforation due to limited visual field, small stripping plane and difficult to reach.
A medical device is designed including a housing and a movable arm that engages around the endoscope peripheral, the arm including at least one tissue peeling surface and rotatably received within the cavity of the housing, and the arm performs movement along a predetermined frequency and arc length by a swing system.
This improves physician visibility into target tissue, improves control of tissue dissection, reduces undesired cutting risks, reduces ESD surgery time, and reduces the incidence of complications.
Smart Images

Figure CN114126469B_ABST
Abstract
Description
[0001] Cross - Reference to Related Applications
[0002] This application is a non - provisional application claiming priority to U.S. Provisional Application Serial No. 62 / 871,450, filed on Jul. 8, 2019, which is incorporated herein by reference in its entirety. Technical Field
[0003] Endoscopic submucosal dissection (ESD) is a minimally invasive method for removing cancerous or other lesions along the gastrointestinal (GI) tract. ESD can be used when cancerous or other target tissues are within the first two inner - facing layers of the GI wall (the mucosal layer and the submucosal layer). The GI tract contains four layers: the innermost layer is the mucosa (which can include epithelium, lamina propria, and muscularis mucosa), beneath which is the submucosa, then the muscularis propria, and the outermost layer called the adventitia. The structure of these layers varies in different regions of the digestive system. If the target tissue extends into any deeper layer of the GI wall, a surgical resection or endoscopic full - thickness resection may be required. In Western countries, the average operating time for doctors is about 1 to 2 hours because doctors must carefully make many small incisions to completely dissect the entire area. Two major complications associated with this technique are bleeding and perforation through the muscularis propria and / or adventitia, and due to the technical difficulty of the procedure, the incidence of complications is quite high.
[0004] These iatrogenic complications occur for several reasons. First, during the resection, the mucosal flap may not be elevated high enough, which obstructs the doctor's view so that the doctor is restricted from seeing the dissection plane. In this scenario, the doctor may make a mistake and inadvertently cut a blood vessel or pierce the muscle. Second, the dissection plane is visible but small, and the doctor must make cuts through a small window because the submucosal fibers are close to the muscle and / or blood vessels. In this scenario, the doctor may make a mistake and inadvertently cut a blood vessel or pierce the muscle. Third, due to the limitations of the endoscope and dissection positioning, the doctor does not have a good position for making cuts, making it difficult to reach the dissection plane. In this scenario, the doctor may make a mistake and inadvertently cut a blood vessel or pierce the muscle. Fourth, existing available cutting knives are operated by electrocautery by delivering radio - frequency energy from an electrosurgical generator. An inherent problem with using electrocautery is the iatrogenic risk that the doctor may accidentally cut tissue, such as blood vessels or muscle tissue.
[0005] Accordingly, there is a desire to provide devices and methods that will improve a doctor's ability to perform ESD safely. In particular, there is a desire to provide devices and methods that will improve a doctor's visibility of target tissues during ESD, will improve control of tissue dissection to reduce the risk of unwanted cutting, and / or will reduce the static ESD operative time. Summary of the Invention
[0006] One general aspect of the present disclosure includes a medical device for facilitating minimally invasive surgery. The medical device includes: a housing configured to engage around an outer circumferential surface of an endoscope and including a first cavity; and an arm including at least one tissue dissection surface, the arm being movably received within the first cavity, wherein the arm is configured to perform a first predetermined motion at a predetermined frequency at least along a first plane, the first predetermined motion corresponding to a reciprocating motion of a proximal portion of the arm.
[0007] Another general aspect of the present disclosure includes a medical device for facilitating minimally invasive surgery. The medical device includes: a housing having a first cavity; an arm including at least one tissue dissection surface and rotatably received within the first cavity, the arm including a first receiving slot and a second receiving slot; a first connecting member extending between a first distal end and a first proximal end of the first connecting member; and a second connecting member extending between a second distal end and a second proximal end of the second connecting member, wherein the first distal end of the first connecting member is slidably received within the first receiving slot, and the second distal end of the second connecting member is slidably received within the second receiving slot and is configured such that manipulation of the first proximal end and the second proximal end causes the arm to rotate relative to the housing through at least an arc.
[0008] Another general aspect of the present disclosure includes a medical device for facilitating minimally invasive surgery. The medical device includes: a housing having a first cavity and a third cavity; an arm rotatably received within the first cavity, the arm including a guiding portion and a connecting portion; and a cam assembly rotatably received within the third cavity, the cam assembly including a cam track groove configured to slidably receive at least a portion of the guiding portion therein, the arm being rotatably connected to a third portion of the housing through the connecting portion, and rotation of the cam assembly causing the guiding portion to slide along a predetermined track within the cam track groove such that the arm is urged to rotate in a first plane.
[0009] Other systems, methods, features, and advantages of the presently disclosed embodiments will be or become apparent to one of ordinary skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The present disclosure can be better understood with reference to the following drawings and description. The components in the drawings are not necessarily to scale, but rather emphasize the principles of the present disclosure, although some of the drawings may be to scale and rely thereon. Additionally, in the drawings, the same reference numerals represent corresponding parts in all different views.
[0011] Figure 1 is an illustration of a perspective view of a first embodiment of an endoscopic resection cap with a built-in swing stripper, showing certain aspects in accordance with the present disclosure.
[0012] Figure 2 is an illustration showing certain aspects in accordance with the present disclosure Figure 1 of a portion of the housing of an endoscopic resection cap.
[0013] Figure 3 is an illustration showing certain aspects in accordance with the present disclosure Figure 2 of another perspective view of a portion of the housing.
[0014] Figure 4 is an illustration showing certain aspects in accordance with the present disclosure Figure 2 of another perspective view of a portion of the housing.
[0015] Figure 5 is an illustration showing certain aspects in accordance with the present disclosure Figure 1 of a perspective view of a third portion of the housing of an endoscopic resection cap.
[0016] Figure 6 is an illustration showing certain aspects in accordance with the present disclosure Figure 1 of a perspective view of a second portion of the housing of an endoscopic resection cap.
[0017] Figure 7 is an illustration showing certain aspects in accordance with the present disclosure Figure 1 of a perspective view of an arm of an endoscopic resection cap.
[0018] Figure 8 is an illustration showing certain aspects in accordance with the present disclosure Figure 1 of a perspective view of a cam assembly of an endoscopic resection cap.
[0019] Figure 9 is an illustration showing certain aspects in accordance with the present disclosure Figure 8 of another perspective view of the cam assembly.
[0020] Figure 10A is an illustration showing certain aspects in accordance with the present disclosure Figure 1 of a cross-sectional view of an endoscopic resection cap, where the built-in swing stripper moves in a first direction.
[0021] Figure 10B is a diagram showing some aspects of the present disclosure Figure 1 Illustration of a cross-sectional view of an endoscopic resection cap with a built-in swinging stripper moving along a second direction.
[0022] Figure 11 is an illustration showing a perspective view of a second embodiment of an endoscopic resection cap with a built-in swinging dissector according to certain aspects of the present disclosure.
[0023] Figure 11A is an illustration showing a perspective view of a swing system according to certain aspects of the present disclosure, the swing system being configured to cause Figure 11 The built-in swing stripper swings out.
[0024] Figure 11B is a diagram showing some aspects of the present disclosure Figure 11 Illustration of a cross-sectional view of an endoscopic resection cap with a built-in swinging dissector moved out of a first plane.
[0025] Figure 12 is an illustration showing a simplified view of an endoscope including a third embodiment of an endoscopic resection element (in accordance with any of the embodiments disclosed herein), which endoscopic resection element can be a cap removably disposed on and surrounding the distal end of a stand-alone endoscope, or the endoscopic resection element can be a component of an endoscope that is specially configured to perform endoscopic resection and other endoscopic tasks.
[0026] Figure 12A is an illustration showing a side view of an endoscopic resection element including a reciprocating dissector and an exhaust port.
[0027] Figure 12B It shows Figure 12A Illustration of a bottom view of an endoscopic resection element.
[0028] Figure 12C It shows Figures 12A to 12B Illustration of a side view of a stripper of an embodiment.
[0029] Figure 12D It shows Figures 12A to 12C Illustration of a rotational perspective view of a stripper of an embodiment.
[0030] Figure 13A , Figure 13B and Figure 13C are schematic diagrams respectively showing a center position, a leftmost position, and a rightmost position of a stripper that reciprocates relative to a holding pin.
[0031] Figure 13D shows Figures 13A to 13C a comprehensive illustration of, in which the peeling path achieved thereby is schematically depicted.
[0032] Figure 14 is an illustration showing a schematic cross-sectional view of a fourth embodiment of an endoscopic resection cap with a built-in oscillating peeler according to certain aspects of the present disclosure.
[0033] Figure 15 is an illustration showing a schematic cross-sectional view of a fifth embodiment of an endoscopic resection cap with a built-in oscillating peeler according to certain aspects of the present disclosure.
[0034] Figure 16 is an illustration showing a perspective view of a sixth embodiment of an endoscopic resection cap with a built-in oscillating peeler and a longitudinal lumen according to certain aspects of the present disclosure.
[0035] Figure 16A is an illustration showing a front view of an accessory tool configured to be incorporated into Figure 16 the endoscopic resection cap of.
[0036] Figure 17 is an illustration showing a front view of a first embodiment of an oscillating peeler configured to be incorporated into an endoscopic resection cap according to certain aspects of the present disclosure.
[0037] Figure 18 is an illustration showing a front view of a second embodiment of an oscillating peeler configured to be incorporated into an endoscopic resection cap according to certain aspects of the present disclosure.
[0038] Figure 19 is an illustration showing a front view of a third embodiment of an oscillating peeler configured to be incorporated into an endoscopic resection cap according to certain aspects of the present disclosure.
[0039] Figure 20 is an illustration showing a schematic view of a fourth embodiment of an oscillating peeler configured to be incorporated into an endoscopic resection cap according to certain aspects of the present disclosure.
[0040] Figure 21 is an illustration showing a perspective view and a cross-sectional side view of a fifth embodiment of an oscillating (and / or rotating) peeler configured to be incorporated into an endoscopic resection cap according to certain aspects of the present disclosure.
[0041] Figure 22FIG. is a schematic illustration showing a sixth embodiment of a rotational (and / or oscillatory) stripper in accordance with certain aspects of the present disclosure, the stripper being configured to be incorporated into an endoscopic resection cap.
[0042] Figure 23 FIG. is a schematic illustration showing a first embodiment of teeth of an arm in accordance with certain aspects of the present disclosure, the arm being configured to be incorporated into an endoscopic resection cap.
[0043] Figure 24 FIG. is a schematic illustration showing a second embodiment of teeth of an arm in accordance with certain aspects of the present disclosure, the arm being configured to be incorporated into an endoscopic resection cap.
[0044] Figure 25 FIG. is a schematic side view illustration of an arm in accordance with certain aspects of the present disclosure, the arm being configured to be incorporated into an endoscopic resection cap. DETAILED DESCRIPTION
[0045] Aspects are described below with reference to the drawings, where like elements are generally denoted by like reference numerals. The relationships and functions of the various elements of these aspects can be better understood by reference to the following detailed description. However, the aspects are not limited to those shown in the drawings or explicitly described below. It should also be understood that the drawings need not be to scale (although some drawings may be to scale and equally rely thereon), and in some instances, details that are not necessary for an understanding of the aspects disclosed herein, such as conventional materials, construction, and assembly, may have been omitted.
[0046] To facilitate an understanding of the presently disclosed embodiments, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe these embodiments. However, it is understood that this is not a limitation on the scope of the invention, and such changes and further modifications to the devices shown, as well as such further applications of the principles of the invention shown therein, are generally expected by those skilled in the art related to the present invention. In the present application, the term "proximal" refers generally to the direction toward the physician during a medical procedure, while the term "distal" refers generally to the direction toward the target site within the patient during a medical procedure. The term "configured to" is used to describe a structural limitation in a specific manner that requires a specific construction to achieve the stated function and / or interface or interact with another component(s), rather than for describing merely an intended or theoretical use. Related terms and broader terms, such as "substantially", "about", "essentially", etc., will be understood by those skilled in the art to provide a clear and definite scope of the disclosure and / or claims. For example, the term "substantially perpendicular" will be understood to not require exactly 90.00 degrees relative to a reference point, but to include that angle and functional equivalents.
[0047] Certain aspects of the presently disclosed embodiments of the medical device are configured for use in minimally invasive surgery, providing an endoscopic resection cap with a built-in oscillating dissector that can be driven by a corresponding oscillating system to perform a predetermined motion. The oscillating motion of the dissector can perform blunt dissection of tissue, as an alternative to electrocautery or in combination with electrocautery. Various embodiments of the oscillating dissector can be driven by various corresponding embodiments of the oscillating system to perform a predetermined motion, as described and depicted herein. Although different embodiments of the oscillating dissector may be described herein as working with one or more corresponding embodiments of the oscillating system, those of ordinary skill in the art will readily understand, after a complete reading of this specification and the drawings, how different embodiments of the oscillating dissector and / or any combination thereof can be driven by other embodiments of the oscillating system and / or any combination thereof without undue experimentation.
[0048] The endoscopic resection cap with a built-in oscillating dissector can be mounted on an existing endoscope to facilitate difficult and time-consuming procedures such as endoscopic submucosal dissection (ESD). For the sake of brevity, the various embodiments of the built-in oscillating dissector disclosed herein are described and depicted as an oscillating dissector that is incorporated into an endoscopic resection cap for use in ESD in the field of GI tissue resection. Those of ordinary skill in the art will readily understand, after a complete reading of this specification and the drawings, how the oscillating dissector can be incorporated into the same or other devices for the same or other medical and / or experimental uses, and will understand which other devices and uses may be suitable without undue experimentation. For example, the oscillating dissector can be successfully implemented for use in peroral endoscopic myotomy (POEM), gastric peroral endoscopic myotomy (G-POEM), endoscopic mucosal resection (EMR), and other procedures that require manual dissection of gastrointestinal tissue.
[0049] Reference Figures 1 to 10B, showing an embodiment of an endoscopic resection cap having a built-in swing stripper. The endoscopic resection cap 100 may include a housing 102 having a first cavity 108, a second cavity 106, and a third cavity 110. The arm 104 may be movably received within the first cavity 108, the arm including a body 142 having at least one cutting surface 125. Unless otherwise expressly stated, for the purposes of this application, it should be understood that the term "cutting" as used herein refers to blunt tissue disruption for tissue stripping and not the type of sharp cutting incision associated with a blade (such as a surgical blade). In other words, the difference is that the tissue stripping here will remove the relatively loose tissue, such as the diseased tissue in the submucosa of the gastrointestinal tract, but will not invade or damage the underlying muscularis propria. The second cavity 106 may be configured to engage around the circumferential surface of the endoscope, where it may be fixed (removably or non-removably), for example, using a friction fit, an attachment structure (such as an adhesive, a threaded connector, a band, etc.), and / or any other attachment means. The cam assembly 126 of the swing system 124 may be rotatably received within the third cavity 110 such that a second predetermined movement (e.g., rotation) of the cam assembly 126 may cause the arm 104 to perform a first predetermined movement 128 along at least a first plane 130 at a predetermined frequency.
[0050] In some embodiments, the housing 102 may include an upper portion 132 and a lower portion 114 (the upper portion 132 and the lower portion 114 may be integrally formed) connected to each other at a connection surface 120. The upper portion 132 may include a first portion 112, a second portion 116, and a third portion 118. The third portion 118 may be movably connected to the connection surface 120 of the lower portion 114 (e.g., by a threaded mechanism or any suitable mechanism) such that the third portion 118 may move substantially vertically upward (e.g., up to 5 mm) relative to the connection surface 120. The first cavity 108 and the third cavity may be established by different portions of the housing 102. The second cavity 106 may extend through at least a portion of both the upper portion 132 and the lower portion 114 of the housing 102 (e.g., as Figure 4 shown), and may be configured to receive the endoscope therein by a friction fit. The housing 102 may have a generally cylindrical upper portion 132 that extends toward a pointed end portion 188 in the lower portion 114, and the second cavity 106 extends through it along one side of the housing 102 (e.g., as Figures 1 to 4 shown). It should be understood that without departing from the scope of the present invention, the overall configuration of the housing may vary according to expectations and / or needs to accommodate the various configurations of the device (e.g., endoscope) to be coupled thereto.
[0051] In some embodiments, the endoscopic resection cap 100 may further include one or more longitudinal lumens (e.g., longitudinal lumen 16240, as Figure 16 shown), the one or more longitudinal lumens being configured to receive and guide an accessory tool (e.g., an endoscopic grasping tool and / or a dissection tool) therein. Examples of endoscopic resection caps having one or more longitudinal lumens are described in U.S. Patent Application Publication No. 2017 / 0112361, published Apr. 27, 2017 (Cook Medical Technologies LLC, of Bloomington, Ind., USA), which is incorporated herein by reference in its entirety. In some embodiments, the accessory tool may include a suction rotary accessory tool 16300, as Figure 16A shown. The suction rotary accessory tool 16300 may include a catheter 16308 having holes 16302 at its distal end, the holes being fitted into the longitudinal lumen 16240. The catheter 16308 may have a vacuum 16306 applied at the user end and may be rotated by a drive system at the user end. In use, submucosal fibers may enter the holes 16302 via suction and may be stretched and broken by rotation of the catheter 16308. The configuration of the suction rotary accessory tool 16300 may vary according to desire and / or need to accommodate the configuration of the longitudinal lumen 16240 of the endoscopic resection cap.
[0052] In some embodiments, the arm 104 may include a body 142 that extends between a proximal portion 144 and a distal portion 146 and has a first surface 138 and an opposing surface 140. One or more surfaces of at least one cutting surface 125 may be in a toothed configuration. For example, the cutting surface 125 may have a plurality of incisions 208 (e.g., three incisions as Figure 1 shown) spaced apart from each other, such that a plurality of discrete dissection surfaces 210 (e.g., four dissection surfaces as Figure 1 shown) may be formed. The number, configuration (e.g., shape, size), and position of the plurality of incisions 208 and dissection surfaces 210 may vary according to desire and / or need to obtain a desired blunt cutting surface 125 for blunt dissection of tissue when the arm performs a first predetermined motion 128 (e.g., a swinging motion), as described in more detail below. For example, as Figure 10AAs shown, the peeling surface 210a has a relatively flat surface with a larger size, and thus can be used to peel tissue when the peeling plane is relatively large. The peeling surface 210b has a relatively sharp surface with a smaller size, and thus can be used to peel tissue when the peeling plane is relatively small. In use, the endoscopic resection cap 100 can be oriented according to expectations and / or needs such that the desired peeling surface 210 can be oriented towards the tissue to be peeled to accommodate the corresponding peeling plane. The blunt cutting surface 125 can provide the ability to safely cut tissue without having to be as precise and careful to avoid inadvertently cutting important structures, thereby reducing the incidence of complications and the surgical time. In some embodiments (not shown), the incision 208 can include one or more recessed sharp cutting surfaces.
[0053] The arm 104 can further include: a connecting portion 134 that is disposed adjacent to the proximal portion 144 of the body 142 and extends outward from the first surface 138; and a guiding portion 136 that is disposed adjacent to the proximal portion 144 of the body 142 and extends outward from the opposite surface 140. Optionally, the arm 104 can further include a first extension 190 that is disposed adjacent to the proximal portion 144 of the body 142, extends outward from the opposite surface 140, and is separated from the guiding portion 136.
[0054] The connecting portion 134 can be configured and positioned to be rotatably received within the third portion 118 of the upper portion 132 (e.g., within the first groove 166 as Figure 5 shown), such that the arm 104 can rotate within the first plane 130 (e.g., as Figure 10A and Figure 10B shown). When the third portion 118 can move vertically upward relative to the connecting surface 120 of the lower portion 114, the arm 104 can correspondingly extend (e.g., move away from the connecting surface 120) and retract (e.g., move towards the connecting surface 120) relative to the lower portion 114. Advantageously, this configuration provides the ability to further peel within the tissue according to expectations and / or needs. Thus, the arm 104 can move between two fixed positions (an extended position and a retracted position), with a positive stop and a retracted positive stop at these two positions, the positive stop being used to prevent the over-advancement of the housing 102, and the retracted positive stop being used to prevent trauma when the endoscopic resection cap 100 is inserted into the patient's body.
[0055] Optionally, when the connecting portion 134 is rotatably received within the third portion 118, the first extension 190 can be configured and positioned to be rotatably received within the first portion 112 of the upper portion 132 (e.g., as Figure 2 and Figure 3within the second groove 192 shown). Even though the first extension 190 is optional, the connection between the first extension 190 and the first portion 112 can provide additional support and stability to the arm 104 during arm movement. In some embodiments, the connection portion 134 and the first extension 190 can each have a generally cylindrical configuration that extends substantially perpendicular to the first plane 130 (e.g., as shown in Figure 7 , Figure 10A and Figure 10B shown). It should be understood that, without departing from the scope of the present invention, the configuration (e.g., shape, size) and position of the connection portion 134 and the first extension 190 can vary according to expectations and / or needs (e.g., to accommodate the configuration and position of the body 142, the first groove 166, and the second groove 192 (as shown in Figure 5 and Figure 3 shown), to provide the desired support, and / or to reduce friction between the contact surfaces), as long as the arm 104 can be rotatably connected to the third portion 118 and the first portion 112 of the housing 102.
[0056] The guiding portion 136 of the arm 104 can be configured (e.g., with the cylindrical configuration shown in Figure 7 , Figure 10A and Figure 10B shown or any other suitable configuration) and positioned such that when the connection portion 134 and the first extension 190 are received in the first groove 166 and the second groove 192, respectively, the guiding portion 136 can be slidably received in the cam track groove 194 of the cam assembly 126, as described in more detail below.
[0057] In some embodiments, the cam assembly 126 can be a cylindrical cam, as illustrated in the present figures, but those skilled in the art will be able to use other cam mechanisms within the scope of the present disclosure, including its claims, through this disclosure, such as, by way of non-limiting example, (multiple) plate cams, (multiple) face cams, and / or other cams or gears configured to convert the movement of a proximal control element into the oscillating movement of an arm (any sharp and / or non-sharp peeling surface). For the currently illustrated example, Figure 8 and Figure 9 show a cylindrical cam, where the cam assembly 126 can include an upper portion 148, a lower portion 150, and an intermediate portion 152 disposed between the upper portion 148 and the lower portion 150. The upper portion 148 can have a first top surface 154 and a first bottom surface 156, and the first bottom surface 156 can be inclined toward the first top surface 154. The lower portion 150 can have a second top surface 158 and a second bottom surface 160, and the second top surface 158 can be inclined away from the second bottom surface 160.
[0058] The cam assembly 126 may further include an upper connection portion 162 extending outwardly from a first top surface 154 of the upper portion 148. The upper connection portion 162 may be configured to be rotatably connected to (e.g., received within a first inner cavity 170 as shown in Figure 1 and Figure 6 ) a second portion 116 of an upper portion 132 of the housing 102. The cam assembly 126 may further include a lower connection portion 164 extending outwardly from a second bottom surface 160 of the lower portion 150. The lower connection portion 164 may be configured to rotatably engage (e.g., received within a first notch 168, as shown in Figure 1 and Figure 5 ) a third portion 118 of an upper portion 132 of the housing 102.
[0059] In some embodiments, the upper portion 148, lower portion 150, intermediate portion 152, upper connection portion 162, and lower connection portion 164 of the cam assembly 126 may be generally cylindrical in configuration, and a second inner cavity 178 extends through the cam assembly 126. The second inner cavity 178 may be configured such that when the upper connection portion 162 is received within the first inner cavity 170 of the second portion 116, a second extension 182 of the second portion 116 (e.g., as shown in Figure 6 ) may be rotatably received within the second inner cavity 178. When the cam assembly 126 is positioned within the third cavity 110, a drive system 184 may be connected to the cam assembly 126 via a line 101 that extends through a first passage 122 of a lower portion 114 of the housing 102 and through at least a portion of the second inner cavity 178 (e.g., as shown in Figure 2 , Figure 3 , Figure 10A and Figure 10B ). The drive system 184 may include any suitable type of motor(s) positioned at a user end external to the endoscopic resection cap 100 or built into the shaft of the endoscope, the motor(s) being configured to generate mechanical motion and / or control a swing system. For example, a proximal motion (e.g., rotational motion) at the user end of the drive system 184 may be transmitted across the length of the line 101 to the cam assembly 126 such that the cam assembly 126 may rotate about a first axis 186 at a predetermined frequency (e.g., as shown in Figures 9 to 10B ), and the predetermined frequency is converted via a guide member 136 and an arm into a swinging motion of the distal end 146 at a desired frequency (such as a frequency between about 25 Hz and about 200 Hz). The term “about” is specifically defined herein to include the recited exact value and any value within 5% of that exact value.
[0060] In some embodiments, as shown in Figure 8 and Figure 9As shown, the upper portion 148 and the lower portion 150 of the cam assembly 126 may have a first outer diameter 172, which ranges from about 1.5 mm to about 6 mm. The upper connecting portion 162 and the lower connecting portion 164 may have a second outer diameter 174 that is smaller than the first outer diameter 172, and the second outer diameter ranges from about 1 mm to about 4 mm. The intermediate portion 152 may have a third outer diameter 176 that is smaller than the second outer diameter 174, and the third outer diameter ranges from about 0.5 mm to about 4 mm.
[0061] The receiving / engaging portions of the first cavity 108 and the third cavity 110 (such as Figure 5 the first cutout 168 of the third portion 118 as shown, Figure 3 the second cutout 180 of the first portion 112 as shown, and Figure 6 the second extension 182 and the first inner cavity 170 of the second portion 116 as shown) may be configured such that the corresponding portions of the cam assembly 126 can be rotatably received therein with a suitable clearance to provide the necessary support and stability during the rotation of the cam assembly 126 while minimizing the friction between the corresponding surfaces. It should be understood that without departing from the scope of the present invention, the configurations (e.g., shapes, sizes, arrangements) of the first portion 112, the second portion 116, and the third portion 118 of the upper portion 132 of the housing 102 and the different portions of the cam assembly 126 may vary to achieve the functions described herein, thereby adapting to various design requirements, including but not limited to the configurations (e.g., shapes, sizes) and positions of the connecting surface 120, the arm 104, the second cavity 106, the first passage 122, and whether the housing 102 includes additional (multiple) longitudinal inner cavities to receive and guide the attachment tool therein.
[0062] In some embodiments, the cam track groove 194 may be established by the first bottom surface 156, the second top surface 158, and the outer surface 196 of the intermediate portion 152. As Figures 9 to 10B shown, the cam track groove 194 may be configured to slidably receive at least a portion of the guiding portion 136 therein such that the rotation of the cam assembly 126 about the first axis 186 may cause the guiding portion 136 of the arm 104 to slide along a predetermined track 198 within the cam track groove 194, so that the arm 104 can be pushed to perform a predetermined swinging motion 128 about a second axis 200 that is substantially perpendicular to the first plane 130 and the first axis 186 within the first plane 130. It should be understood that without departing from the scope of the present invention, the configuration of the guiding portion 136 may vary according to the expectations and / or needs as long as the outer surface of the guiding portion 136 can engage with the first bottom surface 156 and the second top surface 158 such that the movement of the guiding portion 136 can be controlled by the rotation of the cam assembly 126.
[0063] As Figure 9 shown, for example, the first bottom surface 156 of the upper portion 148 may be inclined toward the first top surface 154 at an angle β with respect to an upper plane 202 parallel to the first top surface 154. The second top surface 158 of the lower portion 150 may be inclined away from the second bottom surface 160 at an angle α with respect to a lower plane 200 parallel to the second bottom surface 160. The angles β and α may be the same or different and may vary according to desire and / or need to achieve different predetermined tracks 198 along which the guiding portion 136 of the arm 104 may slide within the cam track groove 194. In some embodiments, the angle β may be between about 5 degrees and 45 degrees, and the angle α may be between about 5 degrees and 45 degrees. It should be understood that due to the inclined surface of the cam track groove 194, rotation of the cam assembly 126 may cause the guiding portion 136 to move up or down along the axis 186 relative to the lower portion 114 of the housing 102 (i.e., move along the predetermined track 198 relative to the cam assembly 126).
[0064] It should be understood that when the cam assembly 126 completes one rotation circle, by extending the predetermined track 198 relative to the cam assembly 126 into a curve to show a first amplitude 204 of the upward movement of the guiding portion 136 and a second amplitude 206 of the downward movement of the guiding portion 136 within the cam track groove 194, as Figure 9 shown, the curve 199 presents the actual track of the up and down movement of the guiding portion 136. It should be understood that the predetermined track 198 (e.g., the first amplitude 204, the second amplitude 206, and the shape of the curve) may be changed by changing the angles β and α, the shape of the first bottom surface 156 of the upper portion 148, and / or the shape of the second top surface 158 of the lower portion 150. For example, the larger the angles β and α, the larger the first amplitude 204 and the second amplitude 206 that can be achieved. The predetermined track 198 may be constituted by various shapes, including (but not limited to) a curved waveform, a sine waveform, and a continuous waveform. The size and configuration of the surfaces 156, 158 will directly affect both the arc length and the swing frequency of the swing movement of the arm relative to the rotation of the cam assembly 126, including the ability to provide multiple swings per rotation of the cam.
[0065] As Figure 10A and Figure 10B shown, when the cam assembly 126 rotates about the first axis 186 and causes the guiding portion 136 to move upward relative to the lower portion 114 of the housing 102, the arm 104 may be pushed to rotate counterclockwise in the first plane 130 ( Figure 10A)。That is, when the cam assembly 126 rotates, the guiding portion 136 of the arm 104 can act as a cam follower by engaging the cam track groove 194 to convert the rotational movement of the cam assembly 126 into a swinging movement of the arm 104. There is a greater mechanical advantage in the following operations: positioning the cam assembly 126 at the distal end within the endoscopic resection cap 100 rather than at the proximal user end, transmitting the force downward along the long catheter, and losing the force transmission from the rotational movement at the user end.
[0066] When the cam assembly 126 rotates about the first axis 186 and causes the guiding portion 136 to move downward relative to the lower portion 114 of the housing 102, the arm 104 can be pushed to rotate clockwise in the first plane 130 ( Figure 10B ). Continuous rotation of the cam assembly 126 about the first axis 186 can cause the arm 104 to swing along a predetermined arc length in the first plane 130. By changing the configuration of the cam track groove 194 (e.g., by changing the angles β and α to change the first amplitude 204 and the second amplitude 206), the predetermined arc length can be changed according to the expectation and / or requirement. For example, the larger the first amplitude 204 and the second amplitude 206, the larger the arc length that can be achieved. In some embodiments, the cam track groove 194 can be configured such that rotation of the cam assembly 126 can cause the arm 104 to swing along an arc length between about 0.5 mm and about 7.0 mm in the first plane 130 in response to the interaction with the rotation of the cam assembly, but the arc length can be up to about 30 mm. The swinging frequency of the arm 104 can also be predetermined by the drive system 184, such as swinging at a predetermined frequency between about 25 Hz and about 200 Hz.
[0067] Advantageously, this swinging movement of the blunt cutting surface 125 of the arm 104 (e.g., along a relatively small arc length at a relatively high frequency) provides the ability to bluntly dissect cancerous tissue in the submucosa in various visible but small dissection planes, without the need for the doctor to carefully make many small cuts to completely dissect the entire area, thereby reducing the possibility of mistakes and inadvertently cutting blood vessels or piercing muscles. The blunt dissection provided by the swinging movement of the arm 104 also provides the ability to avoid the inherent complications associated with electrocautery, such as bleeding and perforation.
[0068] Reference Figures 11 to 11A, showing another embodiment of an endoscopic resection cap having a built-in swing stripper. The endoscopic resection cap 11100 may include a housing 11102 having an upper portion 11132 and a lower portion 11114. The housing 11102 may include a first cavity 11108 and a second cavity 11106. The first cavity 11108 may be configured and positioned such that the arm 11104 may be rotatably received therein and connected to a third portion 11118 of the upper portion 11132 by a connecting portion 11134. The second cavity 11106 may be configured to engage around the outer circumferential surface of the endoscope. In some embodiments, the second cavity 11106 may extend through at least a portion of both the upper portion 11132 and the lower portion 11114 of the housing 11102 (e.g., similar to the configuration shown in Figure 4 ), and may be configured to receive the endoscope therein by a friction fit.
[0069] The arm 11104 may include at least one cutting surface 11125 having a plurality of incisions 11208 and a plurality of stripping surfaces 11210, as described in more detail above. In some embodiments, as shown in Figure 11 , the arm 11104 may include a first receiving slot 11220 and a second receiving slot 11222 on a first surface 11138. The first receiving slot 11220 and the second receiving slot 11222 may be movably connected to a first connecting member 11224 and a second connecting member 11226, respectively.
[0070] The first connecting member 11224 may extend between a first distal end 11224a and a first proximal end 11224b of the first connecting member 11224. The second connecting member 11226 may extend between a second distal end 11226a and a second proximal end 11226b of the second connecting member 11226. The first distal end 11224a of the first connecting member 11224 may be slidably received in a first receiving slot 11220, and the second distal end 11226a of the second connecting member 11226 may be slidably received in a second receiving slot 11222 such that manipulation of the first proximal end 11224b and the second proximal end 11226b may cause the arm 11104 to rotate through at least an arc in a first plane 11130 relative to the housing 11102. In some embodiments, the first connecting member 11224 and the second connecting member 11226 may be axially rigid cables, which may be composed of flexible stainless steel wire ropes, polymer compositions (including, for example, UHMWPE fibers), other stainless steel or metal structures, or other polymer structures, which applies to all embodiments. At least a portion of the first connecting member 11224 and the second connecting member 11226 may extend through respective first sheaths 11228 and second sheaths 11230. The first sheath 11228 and the second sheath 11230 may be axially compressible rigid sheaths and may be composed of a closed helical stainless steel spring with a polymer outer jacket. Each of the first distal end 11224a and the second distal end 11226a may have a cap configuration (which may be composed of a polymer material), the shape and / or size of which is determined such that the first distal end 11224a and the second distal end 11226a may be slidably received in the respective first receiving slot 11220 and second receiving slot 11222 without disengaging therefrom (e.g., falling out) during rotation of the arm 11104.
[0071] The first connecting member 11224 and the second connecting member 11226 may extend through the housing 11102 such that their respective first proximal ends 11224b and second proximal ends 11226b extend outside a lower portion 11114 of the housing 11102 and are coupled to a swing system 11124 for guiding the rotation of the arm 11104. In some embodiments, as Figure 11A shown, the swing system 11124 may include a guiding member 11232 extending between a first end portion 11232a and a second end portion 11232b. The guiding member 11232 may include a polymer or metal component. The first proximal end 11224b of the first connecting member 11224 may be connected to the first end portion 11232a of the guiding member 11232, and the second proximal end 11226b of the second connecting member 11226 may be connected to the second end portion 11232b of the guiding member 11232.
[0072] In some embodiments, the swing system 11124 may include a first strut 11234 and a second strut 11236 that are respectively coupled to the proximal ends of a first sheath 11228 and a second sheath 11230. Each of the first strut 11234 and the second strut 11236 may include an opening configured to allow the first proximal ends 11224b and 11226b of the respective first connecting member 11224 and second connecting member 1126 to pass through the opening before being respectively connected to the first end portion 11232a and the second end portion 11232b of the guide member 11232. Advantageously, the first sheath 11228 and the second sheath 11230, as well as the first strut 11234 and the second strut 11236, may provide support for the first connecting member and the second connecting member along at least a portion of the lengths of the first connecting member 11224 and the second connecting member 11226 during movement. The first strut 11234 and the second strut 11236, as well as the first sheath 11228 and the second sheath 11230, may also provide the ability to define the plane of rotation of the arm 11104 such that when the guide member 11232 rotates in the first plane 11130, the arm 11104 will also rotate in the first plane 11130.
[0073] The guide member 11232 may be connected to a drive system (e.g., the drive system discussed above) such that the guide member 11232 can rotate in the first plane 11130. When the guide member 11232 rotates in the clockwise direction in the first plane 11130, the guide member may cause one of the first connecting member 11224 and the second connecting member 11226 (e.g., the second connecting member 11226, as Figure 11 and Figure 11A shown) to be pulled such that the arm 11104 can rotate in the clockwise direction in the first plane 11130. When the guide member 11232 rotates in the counterclockwise direction in the first plane 11130, the guide member may cause the other of the first connecting member 11224 and the second connecting member 11226 (e.g., the first connecting member 11224, as Figure 11 and Figure 11A shown) to be pulled such that the arm 11104 can rotate in the counterclockwise direction in the first plane 11130. As discussed above, the swing system 11124 and the drive system may be configured such that the arm 11104 can be pushed to rotate relative to the housing 11102 along a predetermined arc length (e.g., between about 0.5 mm and about 7.0 mm, up to about 30 mm) at a predetermined frequency (e.g., between about 25 Hz and about 200 Hz). Without departing from the scope of the present invention, by changing the configuration (e.g., geometry) of the arm 11104 and the first receiving slot 11220 and the second receiving slot 11222, the predetermined arc length can be changed according to the desired and / or required.
[0074] In some embodiments, the arm 11104 may be rotatably and pivotally connected to the third portion 11118 of the upper portion 11132 by a connecting portion 11134 such that manipulation of the guide member 11132 may cause one or both of the first connecting member 11224 and the second connecting member 11226 to move such that the arm 11104 may pivot out of the first plane 11130 in the first cavity 11108. For example, as Figure 11B shown, the arm 11104 may pivot to the second plane 11133 at an angle with respect to the first plane 11130. The angle may be between about 0 degrees and about 45 degrees. In this configuration, the guide member 11132 may rotate within the second plane 11133 such that rotation of the guide member 11132 may cause the arm 11104 to rotate within the second plane 11133.
[0075] Advantageously, this configuration allows the user to set the height of the built-in oscillating dissector to facilitate cutting closer to the tissue and provides greater visibility of the edge of the cutting surface 11125. In other words, the dissector may rotate into (tilted and pointing outside the original dissection plane) the doctor's field of view (visible field of view) such that the dissection plane is well visible (e.g., adjacent to the center of the field of view), thereby facilitating accurate cutting. Otherwise, the cutting surface of the dissector may be positioned adjacent to the boundary of the field of view where the dissection plane is not well visible and the oscillating motion of the dissector may obstruct the doctor's view of the dissection plane, which will result in inaccurate cutting. For example, as Figure 11B shown, when the arm 11104 pivots to the second plane 11133, the edge of the cutting surface 11125 is adjacent to the center of the field of view 11135 of the endoscope 11139 rather than at the boundary 11137 of the field of view 11135 such that the dissection plane and the blood vessel will always be visible. Additionally, the ability of the arm 11104 to pivot into various planes and oscillate in various planes allows the arm 11104 to interact with tissue in various dissection planes, including those in difficult dissection positions. Advantageously, it provides some flexibility to accommodate different positioning of the built-in oscillating dissector due to the limitations of the endoscope, the different positions of the endoscope, and the dissection positions of the patient.
[0076] Figures 12 to 13D Another embodiment of the endoscopic resection device 12100 is shown. Figure 12Shows a general and non - restrictive endoscope 12311. This endoscope or any endoscope can be equipped with a removably mounted endoscope resection cap (e.g., cap 12311), or can be constructed with a built - in endoscope resection element using the same type of oscillating or reciprocating dissector element as shown in any of the embodiments herein, specifically including Figures 1 to 11B , Figures 14 to 20 and Figures 23 to 25 any one of. Those skilled in the art will recognize that the endoscope 12311 can include manipulation controls 12313, at least one access port 12315, at least one visualization element (not shown, but readily understood by those familiar with the endoscope field to be present), and a manipulable endoscope shaft 12317 that includes one or more end - viewing and / or side - viewing elements (not shown) near the distal end of the shaft, and other structures such as channels for illumination, irrigation, tools, and / or medications and other features known in the endoscope field. It should be noted that the term "reciprocating" is used herein to denote a motion that is not just rotation about a fixed axis, but also includes a motion that sweeps across the axis with or without any rotation relative to the fixed axis. The structure and function of this reciprocating motion, as well as the longitudinal curve of the arm described below, distinguish this embodiment from Figure 11 the embodiments of, but the remaining features are similar or otherwise interchangeable, and Figure 11A the motion mechanism of can also be used with this embodiment.
[0077] As Figure 12A and Figure 12B shown, the endoscope resection cap 12100 includes a housing 12102 that has an upper portion 12132 and a lower portion 12114. It can also include a discharge orifice 12117 that is configured to assist in clearing material from the field of view of the endoscope. The housing 12102 can include an external first cavity 12108 and an internal second cavity 12106. The first cavity 12108 can be configured and positioned such that the arm 12104 can be received therein and is laterally reciprocally connected to a third portion 12118 of the upper portion 12132 by a connecting pin 12134. The second cavity 12106 can be configured for removably engaging around the outer circumferential surface of the endoscope (or can be substantially absent in embodiments where the resection portion is integrally constructed with the endoscope). In some embodiments, the second cavity 12106 can extend through at least a portion of both the upper portion 12132 and the lower portion 12114 of the housing 12102 (e.g., similar to the configuration shown in Figure 4 ), and can be configured to releasably fix the cap to the endoscope by a friction fit or other releasable / removable attachment means for use as an endoscope accessory tool, thereby receiving the endoscope therein.
[0078] The arm 12104 may include at least one cutting surface 12125 having a plurality of incisions 12208 and a plurality of peeling surfaces 12210, as described in more detail above. In this embodiment, the arm 12104 includes a first receiving channel 12220 and a second receiving channel 12222. The first receiving channel 12220 and the second receiving channel 11222 provide slidable channels for a first connecting member implemented as a first pull wire 12224 and a second connecting member implemented as a second pull wire 12226, respectively. Figures 12C to 12D A side view and a rotated perspective view of the arm 12104 are shown, respectively. The arm is bent along its proximal-distal longitudinal axis and includes a bent end opposite the peeling end. The curvature of the longitudinal dimension (shown along the broken longitudinal axis 12104b, contrasted with the curvature imaginary line 12104a) is configured to provide an effective peeling operation during actuation of the arm 12104 by orienting its distal peeling surface 12210 towards the target tissue, without the need for a significant change in the orientation of the endoscope according to the normal alignment within the body passage being entered. Figure 12C The difference between the straight axis 12104b and the curvature 12104a in this embodiment (exemplary arm length is 0.48 inches and width is 0.28 inches) is represented by the gap C. Wherein, the shown radius of curvature is 2 inches and the gap C is 0.03 inches. The radius of curvature of other embodiments can be from 0.5 inches to 5 inches, and the corresponding gaps are from 0.005 inches to 2 inches, which can vary according to the size of different arms. In particular, this angle provides an angle relative to the target tissue such that when the doctor manipulates the endoscope (with a cap or an integrated peeling tool tip), the curve of the arm is oriented towards the muscularis propria. This curvature provides an advantage over a straight dissector because it allows the doctor to move the endoscope forward along the main axis of the endoscope in the effective area while still targeting the correct peeling plane. In an embodiment with a straight (and non-adjustable as taught elsewhere herein) dissector, the doctor would need to actively tilt the endoscope with a cap (or an integrated tool tip) towards the muscularis propria to disrupt the upper target tissue. This typically requires multiple fine directional adjustments of the endoscope. In addition, with a straight / non-adjustable dissector longitudinally aligned with a forward-facing endoscope, the endoscope camera trajectory would be forced to point towards the muscularis propria to bring the arm into contact with the target tissue, which may limit the observation of the submucosal space. Accordingly, the curved arm 12104 provides an advantage over existing systems and devices.
[0079] The first wire 12224 extends and is connected to one side of the arm 12104, and the second wire 12226 extends and is connected to the opposite side of the arm 12104, wherein when the arm is in as Figure 12B and Figure 13AWhen in the neutral centered position shown, most of the lengths of the first and second lines (not shown, between the resection portion and the proximal line ends) can be parallel or substantially parallel. The elongated stadium-shaped orifice 12133 through the arm 12104 and between these lines provides for lateral reciprocating movement of the arm relative to the pin 12134 (the oval orifice shown is formed by a rectangular body having parallel linear sides and semi-circular or oval ends, but the shape of the orifice can vary within the scope of the present application to vary the desired movement of the arm relative to the housing, e.g., using an oval, arcuate or other shaped orifice that provides reciprocating movement across the pin rather than simple pivotal rotation about the pin). This placement and attachment of the first and second lines and the pin are configured such that manipulation of the first proximal line and the second proximal line causes the arm 12104 to reciprocate in the first plane 12130 such that the dissection surface 12210 depicts at least an arc 12211 relative to the housing 12102, as Figure 13A (centered), Figure 13B (pull the left line to move the arm 12104 such that its distal end is at the far left and its proximal end is at the far right), Figure 13C (pull the right line to move the arm 12104 such that its distal end is at the far right and its proximal end is at the far left) and Figure 13D shown. The arm reciprocates back and forth across the pin while rocking back and forth in response to pulls on the corresponding lines, the range of motion being limited by the housing 12102 and the relationship between the pin and the orifice. As Figure 13D shown, which is Figure 13A 、 Figure 13B and Figure 13C a combination of, when the proximal arm end reciprocates back and forth relative to the pin (with some pivotal movement) and the distal arm end swings correspondingly, the distal surface of the arm depicts a flat arc for contacting the target tissue.
[0080] Figure 14 FIG. shows another embodiment of an endoscopic resection cap 14100 with a built-in swinging dissector, which endoscopic resection cap can include an arm 14104, a connecting guide 14136, and a swinging system 14124. The connecting guide 14136 can extend between a distal end 14136a and a proximal end 14136b connected to the arm 14104. The swinging system 14124 can include a cam assembly 14126 having a cam surface 14194 configured to engage the proximal end 14136b of the connecting guide 14136. The cam assembly 14126 can be coupled to a drive system (e.g., a pulley system) such that the cam assembly 14126 can rotate in the first plane 14130. In some embodiments, as Figure 14As shown, rotation of the cam assembly 14126 in the first plane 14130 can cause the proximal end 14136b of the connection guide 14136 to move along at least a portion of the cam surface 14194 such that, in response, the arm 14104 can perform a first predetermined motion (e.g., a swinging motion along a predetermined arc length) at a predetermined frequency, as discussed in more detail above.
[0081] Figure 15 Another embodiment of an endoscopic resection cap 15100 with a built-in swinging stripper is shown, where the swinging system 15124 can include a gear assembly 15126 rotatably connected to the arm 15104 such that rotation of the gear assembly 15126 in the first plane 15130 can cause the arm 15104 to perform a first predetermined motion (e.g., a swinging motion along a predetermined arc length) in the first plane 15130 at a predetermined frequency, as discussed in more detail above. The gear assembly 15126 can be positioned within the housing 15102 of the endoscopic resection cap 15100 and powered by a drive system (e.g., any suitable type of motor) at the user end. In this embodiment, the arm 15104 can have a gear configuration, and the gear teeth of the arm 15104 can serve as the stripping surface 15210.
[0082] Figures 17 to 19 Three embodiments of an arm are shown that can be incorporated into an endoscopic resection cap for the same or different cutting purposes. As Figure 17 shown, the arm 17104 can have a sharp cutting surface 17125. The cutting surface 17125 can have reverse incisions / barbs to facilitate grasping of tissue such that the arm 17104 can more effectively break fibers and shorten the surgical time. As Figure 18 shown, the arm 18104 can have a T-shaped configuration having a relatively flat cutting surface 18125 and two relatively flat edges 18129. The T-shaped configuration can provide the ability to hook tissue. The two relatively flat edges 18129 can include cauterizing surfaces (e.g., electrodes) configured to cauterize blood vessels or fibrotic tissue that cannot be stripped by the relatively flat cutting surface 18125. As Figure 19 shown, the arm 19104 can include a curved cutting surface 19125 having one or more teeth 19210 disposed between a plurality of U-shaped incisions. Due to the position of the incisions, Figure 17 and Figure 19 the embodiments shown can strip tissue moving forward (distally) and laterally (laterally relative to the distal-proximal axis of those embodiments), while Figure 18The illustrated embodiments can dissect tissue that moves forward (distally). Additionally or alternatively, in some embodiments, the cutting surface 19125 can be a rough surface with uneven features that can perform blunt dissection of tissue during oscillation. It should be understood that any embodiment of the arm and any variation or combination of the above-described embodiments of the arm, along with the corresponding oscillation system, can be incorporated into an endoscopic resection cap for performing a predetermined oscillatory motion at a predetermined frequency.
[0083] It should be understood that without departing from the scope of the present invention, the radius of rotation of the arm and the tooth height of the arm can vary according to the desire and / or need to achieve a desired arc length of rotation. For example, as Figures 17 to 19 shown, the arms (17104, 18104, 19104) can rotate about axes (17141, 18141, 19141) with a radius (17131, 18131, 19131) in the range of from about 2.5 mm to about 10 mm. In Figure 19 the illustrated embodiment, one or more teeth 19210 can have a tooth height 19143 in the range of from about 0.1 mm to about 2 mm, and the arc length of rotation of the arm 19104 per oscillation can be in the range of from about 0.5 mm to about 7.0 mm and can be up to 30 mm.
[0084] It should be understood that without departing from the scope of the present invention, the teeth of the arm can have various configurations. As Figure 23 shown, for example, the teeth 23210 can have a geometry in which the (multiple) inlet openings 23211 into the teeth can have a smaller diameter than the (multiple) bottom regions 23213 between the bases 23214 of the teeth, such that each tooth helps to capture and tear the target tissue. As another example, as Figure 24 shown, the teeth 24210 can have protrusions of different heights to capture multiple tissue densities, where the larger teeth (e.g., 24210a and 24210b) can capture the looser tissue, and the smaller teeth (e.g., 24210c - 24210e) can capture the slightly denser tissue but not the denser, healthy underlying tissue of the muscularis propria. In some embodiments, as Figure 25 shown, the edges of the teeth 25210 can be chamfered, asymmetrically rounded, triangular, asymmetrically trapezoidal, or any suitable configuration according to the desire and / or need. In each of these tooth / tooth configurations, preferably, each will only cut and / or tear soft target tissue (e.g., intestinal mucosa and submucosal tissue, especially if diseased) without cutting or tearing the underlying or adjacent healthy tissue (e.g., healthy blood vessels, muscle tissue).
[0085] Other embodiments of the arm and corresponding oscillating systems can be considered to perform blunt dissection of tissue. In some embodiments, such as Figure 20 shown, the arm 20104 can be a permanent magnet or directly attached to a permanent magnet. Adjacent inductors 20124 with alternating current (e.g., coils wound around ferromagnetic material) can cause the arm 20104 to oscillate between a first state 20111 and a second state 20113. The power supply and circuitry for the inductor 20124 can be located at the user end. This embodiment provides the ability to incorporate the arm as part of an oscillating system, eliminating coupling mechanical components (e.g., gears, levers) that would be necessary if a separate, different oscillating system were used.
[0086] In some embodiments, such as Figure 21 shown, the endoscopic resection cap 21100 can include an arm 21104 (e.g., having a rotary blade configuration) behind the distal end 21117 of the cap. The distal end 21117 of the cap can include a plurality of holes 21115 such that connective tissue can be aspirated through the holes 21115, and the arm 21104 can rotate faster than the naked eye, thus not compromising visibility. This embodiment can provide the ability to perform blunt dissection by safely and rapidly stripping the submucosal fibers while preventing blood vessels from entering through the holes 21115 without damaging the blood vessels.
[0087] In some embodiments, the arm can include two parallel arm members, where one arm member is fixed and the other oscillates relative to the fixed arm member such that a shearing action can occur when the dynamic arm member is enabled, which will be readily understood with reference to this drawing and embodiment (e.g., those skilled in the art will readily envision and understand the placement of single-tooth or multi-tooth arms for such embodiments, which operate similar to power hair clippers). In some embodiments, the arm can include polymers or wires, strings, monofilaments, braided constructs, etc., which can be attached to a rotating mechanism such that the modulus is adjusted to overcome the viscoelasticity of the connective tissue without damaging the tissue found in muscle and arteries, operating similar to a polymer string trimmer. This embodiment will allow the arm to perform blunt dissection without the need for a mechanism for oscillatory motion. As Figure 22 shown, for example, the dissector can be an arrangement of a cap design, where the arm 22104 rotates and / or oscillates perpendicular (right side of Figure 22 ) or parallel (left side of Figure 22 ) to the axis of rotation via a cam assembly 22126. In some embodiments, the dissector can include or even consist of a torque cable / tube passing through a catheter, with the arm attached to the distal end of the torque cable / tube.
[0088] One general aspect includes a medical device, wherein the housing further includes a longitudinal lumen configured to receive and guide an endoscopic grasping tool, and wherein engagement around the outer circumferential surface of the endoscope is provided by a second cavity configured to receive the endoscope therein by friction fit.
[0089] Embodiments may include one or more of the following features. A medical device in which a first predetermined motion includes a swinging motion of a distal portion of an arm, wherein the arc length of the swinging motion is between about 0.5 mm and about 7.0 mm (and can be up to 30 mm), and the predetermined frequency is between about 25 Hz and about 200 Hz. A medical device in which the arm bends along a longitudinal axis of the arm. A medical device in which the arm includes an elongated aperture that is reciprocally movable relative to a pin attached to the housing. A medical device in which the swinging system includes a cable, each cable extending between a respective proximal end and a distal end of each cable, and the distal end of the cable is attached to the arm such that manipulation of the proximal end of the cable causes the arm to perform the first predetermined motion. A medical device in which the swinging system includes a cam assembly having a cam track groove configured to receive at least a portion of a guiding portion of the arm therein, and the guiding portion of the arm moves along at least a portion of the cam track groove in response to rotation of the cam assembly such that the arm performs the first predetermined motion. A medical device further including a connecting guide extending between a distal end and a proximal end, wherein the distal end of the connecting guide is connected to the arm, wherein the swinging system includes a cam assembly having a cam surface configured to engage the proximal end of the connecting guide, and wherein the proximal end of the connecting guide moves along at least a portion of the cam surface in response to rotation of the cam assembly such that the arm performs the first predetermined motion. A medical device in which the swinging system includes a gear assembly rotatably connected to the arm such that rotation of the gear assembly causes the arm to perform the first predetermined motion. A medical device in which the swinging system includes an inductor having alternating current configured to cause the arm to perform the first predetermined motion.
[0090] One general aspect includes a medical device for facilitating minimally invasive surgery, the medical device including: a housing including a first cavity; an arm including at least one tissue dissection surface and rotatably received within the first cavity, the arm including a first receiving slot and a second receiving slot; a first connecting member extending between a first distal end and a first proximal end of the first connecting member; and a second connecting member extending between a second distal end and a second proximal end of the second connecting member, wherein the first distal end of the first connecting member is slidably received within the first receiving slot, and the second distal end of the second connecting member is slidably received within the second receiving slot and is configured such that manipulation of the first proximal end and the second proximal end causes the arm to rotate relative to the housing through at least an arc. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.
[0091] Embodiments may include one or more of the following features. A medical device further includes a swing system, wherein the swing system includes a guiding member extending between a first end portion and a second end portion, wherein a first proximal end of a first connecting member is connected to the first end portion, and a second proximal end of a second connecting member is connected to the second end portion, and is configured such that movement of the guiding member causes the first connecting member and the second connecting member to move, such that the arm rotates relative to the housing. A medical device, in which the guiding member is rotatable in a first plane in a clockwise direction and a counterclockwise direction, when the guiding member rotates in the first plane in the clockwise direction, the guiding member causes one of the first connecting member and the second connecting member to be pulled, such that the arm rotates in the clockwise direction, and when the guiding member rotates in the first plane in the counterclockwise direction, the guiding member causes the other of the first connecting member and the second connecting member to be pulled, such that the arm rotates in the counterclockwise direction in the first plane. A medical device, in which the guiding member is connected to a drive system such that the guiding member is rotatable out of the first plane. A medical device, in which the arm is rotatably and pivotally connected to a third portion of the housing, the guiding member is configured such that manipulation of the guiding member causes one or both of the first connecting member and the second connecting member to move, such that the arm pivots at an angle relative to the first plane into a second plane, and rotation of the guiding member causes the arm to rotate in the second plane. A medical device, in which the first connecting member and the second connecting member are wire ropes. A medical device, in which manipulation of the first proximal end and the second proximal end causes the arm to rotate relative to the housing along an arc length between about 0.5 mm and about 30 mm and at a frequency between about 25 Hz and about 200 Hz. A medical device, in which the arm has one or more surfaces in a tooth configuration. A medical device, in which the housing further includes a second cavity, and the second cavity is configured to receive an endoscope therein by friction fit.
[0092] One general aspect includes a medical device for facilitating minimally invasive surgery, the medical device including: a housing including a first cavity and a second cavity; an arm rotatably received within the first cavity, the arm including a guiding portion and a connecting portion; and a cam assembly rotatably received within the second cavity, the cam assembly including a cam track groove configured to slidably receive at least a portion of the guiding portion therein, the arm being rotatably connected to a third portion of the housing through the connecting portion, and rotation of the cam assembly causing the guiding portion to slide along a predetermined track within the cam track groove such that the arm is urged to rotate in a first plane.
[0093] Embodiments may include one or more of the following features. A medical device in which a cam track groove is configured such that rotation of a cam assembly causes a guide portion to move up and down, which pushes an arm to rotate in a first plane. A medical device in which when the cam assembly rotates and causes the guide portion to move upward, the arm is pushed to rotate counterclockwise in the first plane, and when the cam assembly rotates and causes the guide portion to move downward, the arm is pushed to rotate clockwise in the first plane. A medical device in which rotation of the cam assembly about a first axis causes the arm to rotate about a second axis, and the first axis is generally perpendicular to the second axis. A medical device in which the cam assembly includes an upper portion, a lower portion, and an intermediate portion disposed between the upper portion and the lower portion, the upper portion having a first top surface and a first bottom surface, and the first bottom surface being inclined toward the first top surface, the lower portion having a second top surface and a second bottom surface, and the second top surface being inclined away from the second bottom surface, and the first bottom surface, the second top surface, and the outer surface of the intermediate portion are configured such that rotation of the cam assembly causes the arm to perform a predetermined swinging motion in the first plane. A medical device in which the upper portion, the lower portion, and the intermediate portion are substantially cylindrical in configuration. A medical device in which the arm has one or more surfaces in a tooth configuration. A medical device in which the cam assembly is a barrel cam. A medical device in which the cam assembly is connected to a drive system such that the cam assembly is rotatable about the first axis. A medical device in which a third portion of the housing is configured to move upward relative to a lower portion of the housing. A medical device in which rotation of the cam assembly causes the arm to rotate in the first plane along an arc length between about 0.5 mm and about 30 mm and at a frequency between about 25 Hz and about 200 Hz.
[0094] Although various embodiments of the present disclosure have been described, the present disclosure is not otherwise limited except as to the appended claims and their equivalents. Those skilled in the relevant art will recognize that various changes and modifications can be made to the above embodiments without departing from the scope of the invention as defined by the appended claims, explicitly including that different shown arm and tooth configurations can be interchanged between embodiments, and each embodiment of the excision cap can be configured as an attachment for removably attaching to an endoscope or can be included as a component of the endoscope. Additionally, the advantages described herein are not necessarily the only advantages of the present disclosure, and it is not necessarily expected that every embodiment of the present disclosure will achieve all of the advantages described.
Claims
1. A medical device for facilitating minimally invasive surgery, the medical device comprising: a housing, the housing being configured to engage around the outer circumferential surface of an endoscope and including a first cavity; and an arm, the arm including at least one tissue dissection surface, the arm being movably received within the first cavity, wherein a distal portion of the arm is configured to perform a first predetermined motion at a predetermined frequency at least along a first plane, the first predetermined motion corresponding to a reciprocating motion of a proximal portion of the arm; wherein the arm includes an elongated aperture that is capable of reciprocally moving past a pin attached to the housing.
2. The medical device according to claim 1, wherein, the housing further includes a longitudinal lumen that is configured to receive and guide an endoscope grasping tool, and wherein the engagement around the outer circumferential surface of the endoscope is provided by a second cavity that is configured to receive the endoscope therein by a friction fit.
3. The medical device according to claim 1 or 2, wherein, the first predetermined motion includes a swinging motion of a distal portion of the arm, wherein an arc length of the swinging motion is between 0.5 mm and 30 mm, and wherein the predetermined frequency is between 25 Hz and 200 Hz.
4. The medical device according to claim 1 or 2, wherein, the arm bends along a longitudinal axis of the arm.
5. The medical device according to claim 1, including wherein the swinging system includes wire ropes, each wire rope extending between a respective proximal end and a distal end of each wire rope, and wherein, the distal ends of the wire ropes are attached to the arm such that manipulation of the proximal ends of the wire ropes causes the arm to perform the first predetermined motion.
6. The medical device according to claim 1, including a gear assembly that is rotatably connected to the arm such that rotation of the gear assembly causes the arm to perform the first predetermined motion.
7. The medical device according to claim 1 or 2, further including at least one visualization element and a manipulable endoscope shaft with controls, wherein, the medical device is configured to be integrated with the manipulable endoscope shaft or is configured to be removably attached to the endoscope shaft for use as an endoscope accessory tool.
8. A medical device for facilitating minimally invasive surgery, the medical device comprising: a housing, the housing including a first cavity; an arm, the arm including at least one tissue dissection surface and being rotatably received within the first cavity, the arm including a first receiving slot and a second receiving slot; a first connecting member, the first connecting member extending between a first distal end and a first proximal end of the first connecting member; and a second connecting member, the second connecting member extending between a second distal end and a second proximal end of the second connecting member, wherein the first distal end of the first connecting member is slidably received within the first receiving slot, and the second distal end of the second connecting member is slidably received within the second receiving slot, and is configured such that manipulation of the first proximal end and the second proximal end causes the arm to rotate relative to the housing through at least an arc; wherein the arm includes an elongated aperture that is capable of reciprocally moving past a pin attached to the housing.
9. The medical device according to claim 8, further comprising a swing system, wherein, the swing system includes a guiding member extending between a first end portion and a second end portion, wherein, a first proximal end of the first connecting member is connected to the first end portion, and a second proximal end of the second connecting member is connected to the second end portion, and is configured such that movement of the guiding member causes the first connecting member and the second connecting member to move, so that the arm rotates relative to the housing.
10. The medical device according to claim 9, wherein, the guiding member is capable of rotating in a first plane in a clockwise direction and a counterclockwise direction, wherein, when the guiding member rotates in the clockwise direction in the first plane, the guiding member causes one of the first connecting member and the second connecting member to be pulled, so that the arm rotates in the clockwise direction, and wherein, when the guiding member rotates in the counterclockwise direction in the first plane, the guiding member causes the other of the first connecting member and the second connecting member to be pulled, so that the arm rotates in the counterclockwise direction in the first plane.
11. The medical device according to claim 10, wherein, the guiding member is connected to a drive system such that the guiding member can rotate out of the first plane.
12. The medical device according to claim 10, wherein, the arm is rotatably and pivotably connected to a third portion of the housing, wherein, the guiding member is configured such that manipulation of the guiding member causes one or both of the first connecting member and the second connecting member to move, so that the arm pivots at an angle relative to the first plane into a second plane, and wherein, rotation of the guiding member causes the arm to rotate in the second plane.
13. The medical device according to any one of claims 8 to 12, wherein, the first connecting member and the second connecting member are wire ropes.
14. The medical device according to any one of claims 8 to 12, wherein, manipulation of the first proximal end and the second proximal end causes the arm to rotate relative to the housing along an arc length between 0.5 mm and 30 mm and at a frequency between 25 Hz and 200 Hz.
15. The medical device according to any one of claims 8 to 12, wherein, the arm has one or more surfaces in a tooth configuration.
16. The medical device according to any one of claims 8 to 12, wherein, the housing further includes a second cavity, and wherein, the second cavity is configured to receive an endoscope therein by a friction fit.
17. An endoscope, the endoscope comprising: an integrated distal tool end or a removable tool end, the tool end being configured to facilitate minimally invasive surgery, the tool end including: a housing, the housing including a first cavity; and An arm comprising at least one tissue stripping surface, the arm being movably received within the first cavity, wherein a distal portion of the arm is configured to perform a first predetermined motion at a predetermined frequency along at least a first plane, the first predetermined motion corresponding to a reciprocating motion of a proximal portion of the arm, wherein the arm is bent along a longitudinal axis of the arm, and the arm comprises an oblong aperture configured to reciprocate back and forth across a pin securing the arm to the first cavity, wherein the reciprocating motion comprises a pivoting motion consistent with at least one tissue stripping surface describing an arc as the arm reciprocates relative to the pin.
Citation Information
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