Non-traumatic tip for use with surgical instruments

Abstract

A distal tip for an endoscope inserted into a lumen of a human or animal body, comprising: a proximal attachment portion for connecting the distal tip to the distal end portion of the endoscope; a distal end of the distal tip for engaging with the distal soft tissue of the endoscope during the advancement of the endoscope; and a flexible bending portion positioned between the distal end and the proximal attachment portion, configured to allow lateral bending of the distal end relative to the proximal attachment portion.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology. In particular, the present invention relates to a distal tip for use in surgical devices such as endoscopes that are at least partially inserted into the human or animal body.

Background Art

[0002] An endoscope is a surgical device that can be used to access (e.g., observe or remove) or treat tissues within a patient's body by inserting one or more medical tools into the body through an incision or an opening in the body. An endoscope can include an interface / control unit and an insertion tube coupled to the interface / control unit. The insertion tube is configured to be inserted into the patient's body and can include one or more conduits for providing access to tissues within the body. The one or more conduits can be configured to receive, for example, medical tools and / or fluids and guide the medical tools and fluids to the target tissues, respectively.

[0003] An endoscope can be characterized by a camera for guiding the advancement of the endoscope through the body's surgical or biological anatomical structures in order to observe and / or treat soft tissues within the patient's body, particularly as part of the performance or monitoring of the patient's treatment, for example as part of minimally invasive surgery.

[0004] The insertion tube can be bendable to facilitate insertion into the patient's body. To this end, the insertion tube can include one or more passive and / or actively bendable sections for navigating a substantially tubular biological lumen, such as the esophagus, duodenum, jejunum, and / or ileum, or a lumen that deviates from a strictly tubular shape, such as an organ, such as the stomach.

[0005] Flexible endoscopes are, in most cases, inserted into the body through a natural opening. While the endoscope is being inserted into the body, it can be guided along the biological lumen to the site of observation or treatment, while the user can navigate the biological lumen with visual feedback from the camera or tactile feedback from collisions with soft tissue.

[0006] Endoscopes generally have rounded edges and are developed to be as non-traumatic and flexible as possible to minimize the possibility of causing soft tissue damage or perforation; however, the necessary flexibility is often partially counterproductive to therapeutic interventions where the stability and rigidity of the endoscope may be useful. Similarly, the smaller the endoscope, the greater the risk of tissue perforation. Duodenal endoscopes, in particular, have a lateral camera into which the endoscope is inserted semi-blindly, and the camera has no or limited field of view of the distal tip, further increasing the possibility of accidental perforation. U.S. Patent Application Publication No. 2015 0297 391 discloses a medical catheter, more specifically, a delivery catheter for delivering an occlusion device into a body lumen. The delivery device can be delivered into a lumen or anatomical passage, for example, via the use of an endoscope, and its tip includes an inclined facial opening for deploying the occlusion device. The inclined facial opening takes a substantially oval shape to improve the flexibility of the tip. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent Application Publication No. 2015 0297 391 [Overview of the project] [Problems that the invention aims to solve]

[0008] To avoid accidental tissue damage, polymer caps can cover the endoscope head, for example, to smooth the features of the endoscope head. However, known surgical instruments, especially when using an endoscope to treat or observe lateral tissue sections relative to the direction of endoscope extension, or when using instruments with small diameters, may still suffer accidental tissue damage during insertion of the surgical instrument through the lumen, or may require highly skilled personnel. With such instruments, visual monitoring and control of the advancement of the endoscope head are limited or prone to error. However, such features, such as a lateral camera, may be advantageous in endoscopic retrograde cholangiopancreatography (ERCP) applications, for example, in situations of bile duct and pancreatic duct access for observation or surgery.

[0009] Therefore, the aim is to facilitate user control of surgical instruments and minimize accidental tissue damage or perforation during endoscope use, for example, when advancing surgical instruments through a biological lumen, during surgical procedures, or when removing material from the intervention site. [Means for solving the problem]

[0010] According to a first embodiment, a distal tip for a surgical instrument, particularly an endoscope, is provided, which is inserted into a lumen of the human or animal body. The distal tip comprises a proximal attachment portion for connecting the distal tip to the distal end portion of the surgical instrument, a distal end of the distal tip for engaging with the distal soft tissue of the endoscope as the surgical instrument advances, and a flexible bending portion positioned between the distal end and the proximal attachment portion. The flexible bending portion is configured to allow lateral bending of the distal end relative to the proximal attachment portion.

[0011] The distal tip may be the distal end of the insertion tube of the endoscope. The endoscope may be part of an endoscopic system, such as a robotic or manual endoscopic system. The distal tip may be configured to guide the advancement of the surgical instrument through lumens such as the patient's esophagus and stomach, and may be located distal to the endoscope head assembly. The distal tip may engage with biological tissue to guide the distal head assembly along the natural geometric shape of the lumen as it advances through the lumen. The distal end may be located on the distal end face of the distal tip, and a distal contact point may be defined for contacting various geometric shapes of the biological lumen. The distal end may be configured to initially engage with soft tissue, for example, to engage with the stomach wall while advancing the endoscope along the digestive tract, for example, while advancing through the biological lumen and / or while navigating the expanded space of the biological lumen. If contact of the distal tip with the soft tissue portion hinders the advancement of the distal tip, the distal end may bend laterally around a flexible bending portion to prevent accidental tissue damage and / or to provide feedback to the user. The lateral bending may be lateral to the direction of advancement of the distal tip and / or lateral to the direction of extension of the distal tip along the extension from the proximal attachment portion to the distal end.

[0012] The direction of advancement can be defined by the surgical device, which can advance through the lumen as a tubular device, and the direction of advancement can follow the main extension direction of the surgical device. At the distal tip, the direction of advancement may be defined by the proximal attachment portion, for example, perpendicular to the attachment surface of the proximal attachment portion. The attachment portion can define the orientation of the distal tip relative to the distal end portion of the surgical device, and therefore the direction of advancement of the distal tip can be defined based on the attachment configuration on the distal end portion of the surgical device.

[0013] The flexure of the distal end across the direction of advancement can increase the effective surface area of ​​the distal tip in contact with the surrounding soft tissue, deflect the forward force applied along the direction of advancement of the distal head assembly, and provide the user with visual and / or tactile feedback. For example, if the surgical device features a camera with a field of view oblique to the direction of advancement, the lateral flexure of the distal end can induce a lateral shift of the camera's field of view relative to the surrounding tissue, for example, to provide the user with visual feedback of contact.

[0014] The length of the distal tip extending from the distal end face of the surgical instrument may be greater than 50% of the maximum lateral extension (e.g., diameter) of the surgical instrument, greater than the maximum lateral extension of the surgical instrument, or greater than 1.5 or 2 times the maximum lateral extension of the surgical instrument, for example, to promote lateral flexure of the distal end.

[0015] In some cases, the flexible bending portion is formed integrally with the distal end and / or proximal attachment portion.

[0016] For example, the flexible tip portion may be an integrally formed polymer portion having different parts that define the distal end, the flexible bending portion, and the proximal attachment portion.

[0017] In some examples, the flexible bending portion has a hardness of 20 to 90, particularly 20 to 80, preferably 30 to 80, on the Shore hardness scale A.

[0018] The flexible bending portion of the distal tip can effectively define the force-to-bend ratio and can be configured to prevent accidental tissue damage when advancing the surgical instrument along the lumen based on the shape of the distal end portion. The stiffness can be selected to define the flexible component. The flexible bending portion of the distal tip may be formed integrally with the distal end and / or proximal bending portion, which may feature similar stiffness. Preferably, the stiffness is selected in combination with the shape of the distal tip so that when the distal end portion flexes in response to a force insufficient to cause accidental tissue damage during normal use of the endoscope, the resulting surface area of ​​the distal tip, when viewed from the advancing direction of the distal head assembly, is greater than the maximum cross-sectional area of ​​the proximal distal head assembly at the proximal attachment portion.

[0019] Based on the geometric shape of the distal tip, the effective stiffness of the proximal attachment portion may be greater than that of the flexible bending portion to allow for lateral deflection of the distal end relative to the proximal attachment portion. The flexible bending portion may be configured to allow deflection of the distal end in response to contact of the distal end with the soft tissue wall, by more than 10% of the (maximum) lateral extension of the proximal attachment portion and / or distal tip, for example, more than 20% of the lateral extension of the proximal attachment portion and / or distal tip, for example, 25% or 50% of the lateral extension of the proximal attachment portion and / or distal tip. For example, in the case of an elliptical (e.g., circular, elliptical, or hyperelliptical) cross-section of the proximal attachment portion, the distal end may bend laterally by an amount equal to half or the radius of the elliptical cross-section.

[0020] The flexible tip portion may include a flexible polymer body to allow lateral deflection of the distal end and / or to provide a soft contact surface. The polymer material may be selected based on surgical considerations, for example, based on the desired flexibility and / or rigidity of the flexible tip portion based on the dimensions and application of the surgical device.

[0021] In some examples, the flexible bending portion includes one or more of silicone, thermoplastic urethane, rubber, isoprene-based polymers, and / or additively manufactured materials.

[0022] The distal end may be the distal end portion of the distal tip integrally formed with the flexible bending portion, may similarly be formed from a flexible polymer, or may include a flexible polymer. As another example, the distal tip may be additively manufactured from a photocurable resin or a laser sintered polymer. Additive manufacturing can, for example, enable the formation of an integral part with varying effective stiffness along the forward direction of the endoscope head, and the material, material density, and / or substructure of the distal tip can be varied as part of the additive manufacturing process.

[0023] In some examples, the distal tip is additively manufactured as a single part with the distal end portion of the endoscope from a configurable multi-rigidity material or a plurality of materials.

[0024] The distal tip can form a cap having a distal end portion onto which a sleeve is attached on the endoscope head. In some examples, the distal tip is integrally formed with the casing of the endoscope head.

[0025] In some examples, the flexible bending portion defines a bending mode of the distal tip in which the distal tip is deflected laterally with respect to the forward direction.

[0026] The flexible bending portion can be shaped to promote lateral deflection of the distal tip in contrast to longitudinal compression, such as to facilitate a direction-changing force applied along the forward direction to prevent inadvertent tissue damage.

[0027] In some examples, the cross-section of the flexible bending portion along the extension of the distal tip tapers towards a tissue engagement segment of the distal end disposed distally with respect to the flexible bending portion.

[0028] For example, the distal tip may have a tongue-like shape that is curled in the forward direction, such that it provides a distal portion that extends laterally to provide a flat engagement surface with soft tissue in the forward direction, and connects the laterally extending distal portion to the proximal attachment portion to define a longitudinally extending portion that defines a flexible bending portion.

[0029] As another example, the distal tip may be characterized by a tapered shape, and a tapered segment with a reduced cross-section can define a flexible bending portion that allows for lateral deflection of the distal end.

[0030] The reduced cross-section within the distal tip segment may be positioned proximal to the bulging tissue engagement segment, which can provide additional tactile feedback, for example, when passing through a narrowed portion of the lumen, and can facilitate user control of the surgical instrument.

[0031] In some cases, the (maximum) cross-section of the tissue engagement segment is greater than or equal to the (maximum) cross-section of the proximal attachment portion of the distal tip when viewed along the forward direction.

[0032] In some examples, the flexible bending portion has a reduced diameter with respect to the bulging segment located between the distal end and the flexible bending portion, and optionally, with respect to the segment of the proximal attachment portion located proximal to the flexible bending portion.

[0033] The bulging segment may feature lateral dimensions that are larger than the corresponding lateral dimensions of the flexible bending portion. For example, all lateral dimensions of the bulging segment in the forward direction may be larger than the corresponding dimensions of the flexible bending portion.

[0034] In some examples, the distal tip may feature a shape symmetrical with respect to the forward direction (e.g., axial symmetry), and the diameter of the distal tip may vary along the forward direction, with, for example, a first diameter related to the proximal attachment portion, a second diameter related to the flexible bending portion, and a third diameter related to the tissue engagement segment, where the second diameter is smaller than the third and first diameters.

[0035] In some cases, the cross-section of the flexible bending portion is asymmetrical with respect to the instrument axis at the distal tip.

[0036] The instrument axis of the distal tip may be the central axis of the distal tip, aligned in the normal direction and centered relative to the proximal attachment portion. The proximal attachment portion may be connected to the distal end portion of the surgical device so as to cover the distal end face of the surgical device, and the instrument axis may be aligned along the forward projection of the distal end portion of the surgical device and centered relative to the periphery of the surgical device. In some examples, the instrument axis of the distal end is the longitudinal axis of the surgical device and is aligned with the center of the distal end face of the surgical device.

[0037] The asymmetrical cross-section of the distal tip with respect to the instrument axis can facilitate lateral bending of the distal tip in response to longitudinal contact forces on the distal end. For example, the flexible bending portion may be shifted in the first lateral direction from the instrument axis to facilitate bending of the distal portion of the distal tip in the opposite direction to the first lateral direction in response to longitudinal contact forces, for example, when the distal tip encounters an obstruction or stenosis along the lumen.

[0038] The asymmetrical arrangement of the flexible bending portion relative to the instrument axis can facilitate a predetermined lateral bending direction at the distal end.

[0039] In some cases, the center of mass of the distal tip shifts relative to the instrument axis between the distal tip and the flexible bending portion.

[0040] For example, the center of mass of the cross-section of the distal tip may be shifted from a position shifted laterally toward the instrument axis between the flexible bending portion and the distal tip.

[0041] A shifted and / or asymmetrical cross-section of the distal tip relative to the instrument axis near the flexible bending portion can facilitate the curling motion of the distal tip in response to contact with a constriction, for example, by increasing the surface area that engages with the surrounding soft tissue and / or by defining a slope for flexing the distal tip when encountering an occlusion. The curling motion can further provide tactile features as the distal end passes through a constriction along the lumen, for example, when the distal tip unfolds from a curled configuration.

[0042] In some examples, the distal tip includes a curled tongue-like section, which in turn includes a distal end portion and a flexible, bendable portion.

[0043] The curled tongue shape may extend from an off-axis position relative to the instrument axis toward the distal end, and the distal end may be positioned close to or opposite the instrument axis. The curled tongue shape may be configured to define a flexural inclination for the surgical device, and the distal tip may bend in a predetermined direction according to the curvature of the curled tongue shape of the distal tip when the distal tip encounters occlusion.

[0044] In some examples, the curled tongue-shaped section is configured to compress and / or curl up in response to distal contact at the distal end.

[0045] The curled, tongue-like shape allows for a dynamic increase in surface area when compressed / rolled up, reducing the possibility of accidental tissue damage. The restoring force of the flexible flex portion can facilitate flexion of the distal tip in the opposite direction to the rolling motion, which can induce visible tissue flexion to assist the user.

[0046] In some examples, the curled, tongue-shaped section is configured to facilitate a predetermined preferred bending direction at the distal end.

[0047] A predetermined preferred deflection direction may be aligned with the oblique camera field of view axis of the surgical instrument, for example, to improve visual feedback to the user advancing the surgical instrument along the lumen. A predetermined preferred deflection direction may also be aligned with the curvature of the curled tongue-shaped section.

[0048] In some cases, when the distal end flexes, the resulting end face area of ​​the distal tip, viewed along the forward direction of the distal tip, is larger than the maximum cross-sectional area of ​​the proximal attachment portion.

[0049] For example, the distal tip may be configured to flex by an amount that increases the effective surface area in contact with soft tissue beyond the cross-sectional area of ​​the proximal attachment portion and / or distal head assembly before reaching a force threshold associated with inadvertent tissue damage. For example, the area of ​​the end face resulting from the distal tip may increase by at least 10% or 20% when viewed along the forward direction, and in particular, it may increase by more than 110% of 120% of the maximum cross-sectional area of ​​the proximal attachment portion and / or distal head assembly.

[0050] The distal tip may be connected to a surgical device by one or more of the following: shape-fitting engagement, press-fitting engagement, or permanent fitting, for example, by bonding the distal end to the distal end face of the surgical device.

[0051] In some examples, the proximal attachment portion includes an attachment mechanism configured to connect with a corresponding attachment mechanism on the distal end portion of the surgical device.

[0052] The distal tip may be characterized by lateral extension of the surgical device, such as a (maximum) lateral extension that matches the diameter, such as less than 25 mm or 5 mm to 20 mm, for example, 10 mm to 15 mm.

[0053] According to a second embodiment, a distal head assembly is provided for a surgical device to be inserted into a lumen of a human or animal body, comprising a distal tip according to the first embodiment and a viewport for acquiring an image at the position of the distal head assembly.

[0054] The distal head assembly may feature duct connections for guiding surgical instruments to the position of the distal head assembly and / or tools for accessing the intervention site along the lumen, for example. The distal head assembly may be configured as an endoscope head, such as a duodenal endoscope head. The camera may be positioned proximal to the viewport of the distal head assembly, for example, to a mounting mechanism for attaching the distal tip.

[0055] In some cases, the distal tip is firmly bonded to the distal end of the surgical device. For example, the distal tip may be overmolded or bonded onto the distal head assembly.

[0056] In some cases, the field axis of the viewport is oblique to the forward direction of the distal head assembly on the surgical instrument.

[0057] In duodenal endoscopy, the camera field of view may be oblique to the direction of extension of the duodenal endoscope tube, for example in a lateral viewing configuration, in order to monitor the accessories that are passed through the intervention site by the elevator of the duodenal endoscope head.

[0058] An oblique camera field axis can prevent monitoring of the distal end of the surgical instrument. However, using the distal tip of the first embodiment can facilitate navigation of the lumen by providing the user with tactile feedback, for example, by providing visual feedback through the relative lateral flexure of the camera and surrounding tissue when the distal end flexes laterally while in contact with soft tissue, or by reducing the possibility of inadvertent tissue damage when the surgical instrument encounters an obstruction or stenosis along the lumen.

[0059] In some examples, the flexible bending portion is configured to allow bending toward the visual field axis at the distal end.

[0060] For example, the flexible bending portion may be configured to define a preferred bending direction at its distal end based on, for example, an off-axis shift of the flexible bending portion with respect to the instrument axis, and the preferred bending direction may be aligned with the camera field axis.

[0061] In some cases, the maximum cross-section of the tissue engagement segment located between the distal end and the flexible bending portion, along the forward direction of the distal head assembly, is greater than or equal to the maximum cross-section of the distal head assembly.

[0062] In some cases, when the distal end flexes, the resulting end face area of ​​the distal tip is larger than the maximum cross-sectional area of ​​the proximal distal head assembly when viewed from the forward direction of the distal head assembly.

[0063] The distal tip and distal head assembly may be supplied as a kit, and the distal tip may be replaceable. In some cases, the distal tip and distal head assembly may be supplied as part of an endoscopy kit, such as a duodenal endoscopy kit.

[0064] According to a third embodiment, an endoscope is provided that comprises the distal head assembly of the second embodiment. The endoscope may be a duodenoscope equipped with a lateral-viewing camera. [Brief explanation of the drawing]

[0065] The features and numerous advantages of the apparatus and system according to the present invention will be best understood from the detailed description of preferred embodiments with reference to the accompanying drawings. [Figure 1] This diagram schematically shows an example of a distal head assembly for a surgical device that will be inserted into a biological lumen in the human or animal body. [Figure 2A]This is a side view of an example of the distal tip, similar to the example in Figure 1. [Figure 2B] This is a cross-sectional view of a distal tip example similar to the example in Figure 1. [Figure 2C] This is a cross-sectional view of a different location of the distal tip, similar to the example in Figure 1. [Figure 2D] This is a cross-sectional view of a similar distal tip example as in Figure 1, but at yet another location. [Figure 3] This is a schematic enlarged view of an example of a distal tip on a distal head assembly, where the distal tip is shown as a transparent element. [Figure 4] This diagram schematically shows another example of a distal head assembly. [Figure 5A] This is a side view of an example of the distal tip, similar to the example in Figure 4. [Figure 5B] This is a cross-sectional view of a distal tip similar to the example in Figure 4. [Figure 5C] This is a cross-sectional view of a different location of the distal tip, similar to the example in Figure 4. [Figure 5D] This is a cross-sectional view of a similar distal tip example as in Figure 4, but at yet another location. [Modes for carrying out the invention]

[0066] Figure 1 schematically shows an example of a distal head assembly 10 of a surgical device, specifically an endoscope, that is inserted into a biological lumen of a human or animal body (not shown). The distal head assembly 10 comprises a side-view camera located in a camera viewport 12 and an optical output port 13 for monitoring the access site along the biological lumen, and an elevator 14 for moving accessories into the camera field of view of the camera viewport 12. Accessories can be supplied and / or controlled via conduits connected to the distal head assembly 10 via an endoscope connection 16. The conduits may include conduits for applying suction force or for an air / water supply system, for example, lens cleaning and air insufflation. The optical output port 13 can provide light supplied from the proximal portion of the endoscope and / or can be coupled to an illumination device located in the distal head assembly 10.

[0067] The distal head assembly 10 can be positioned at the distal end of an endoscope, such as a duodenal endoscope, and can be introduced into the biological lumen through the biological lumen along the forward direction 18 of the endoscope. The forward direction 18 may be the projection of the longitudinal axis of the cylindrical tube of the endoscope at the distal end of the tube, and may follow the natural shape of the biological lumen as the surgical instrument advances toward the access site to observe and / or treat soft tissue.

[0068] The distal head assembly 10 is connected to a distal tip portion 20 located on the distal end portion 22 of the distal head assembly 10, and the distal tip portion 20 can be attached to the distal end portion 22 of the distal head assembly 10 by a proximal attachment portion 24. The distal tip portion 20 extends along the forward direction 18 from the proximal attachment portion 24 to the distal end 26 and has a flexible bending portion 28 located between the distal end 26 and the proximal attachment portion 24.

[0069] The distal tip 26 is configured to engage with the distal soft tissue of the endoscope as the distal head assembly 10 advances through the biological lumen along the forward direction 18. In the illustrated example, the distal tip 20 features a J-shape or curled tongue shape extending from the proximal attachment portion 24 to the distal end 26. The tissue-engaging portion of the distal tip near the distal end 26 extends obliquely with respect to the forward direction 18, and the flexible bending portion 28 extends substantially along the forward direction 18, thereby causing the distal tip 20 to extend at an angle with respect to the forward direction 18 near the distal end 26.

[0070] When the distal tip 20 encounters an obstruction of a biological lumen such as the stomach wall, the distal end 26 can bend laterally around the flexible bending portion 28, and the distal end 26 can bend laterally with respect to the forward direction 18 and in the opposite direction to the forward direction 18.

[0071] The curled, tongue-like shape of the distal tip 20 allows for a curling motion of the distal tip 20 when the distal end 26 engages with the occlusion as the distal head assembly 10 advances through the biological lumen. As part of the curling motion of the distal tip 20, the distal end can bend laterally with respect to the extension of the distal tip 20 as the flexible bending portion 28 deforms in response to the contact force.

[0072] The flexure of the distal end 26 can increase the effective surface area that engages with the surrounding soft tissue at the occlusion. In some examples, the distal end 26 is characterized by a tapered shape, and the cross-section of the distal tip 20 along its extension may gradually increase from the distal end 26 to the flexible bending portion 28.

[0073] Furthermore, the curled tongue shape of the distal tip 20 can further define a flexural inclination that causes the distal head assembly 10 and surrounding tissues to bend laterally relative to each other according to the curvature of the curled tongue shape. The curvature of the distal tip may be aligned with the field of view direction 32 of the side-view camera viewport 12, for example, to provide the user with visual feedback when engaging with obstacles.

[0074] In some cases, the curvature of the tongue can act like a slope to facilitate bending in a particular direction of the distal end 26 when anatomical limits are reached. For example, in the example shown in Figure 1, contact between the tissue and the distal tip 20 tends to bend the distal head assembly 10 forward in the field of view 32 of the lateral view camera viewport 12.

[0075] In the illustrated example, the flexible bending portion 28 is shifted laterally with respect to the instrument axis 30 of the distal head assembly 10. The instrument axis 30 extends along the forward direction 18 and is located at the center of the distal head assembly 10. The instrument axis 30 may be aligned with the momentum vector of the distal head assembly 10 as the distal head assembly 10 advances through the biological lumen on the endoscope tube.

[0076] Figures 2A to 2D show examples of distal tip portions 20 similar to the example in Figure 1. Figure 2A shows a side view of the distal tip portion 20, and Figures 2B to 2D, indicated by the letters B to D respectively, show cross-sectional views of the distal tip portion 20 of Figure 2A passing through a plane extending perpendicularly to the instrument axis 30. In the cross-sectional views of Figures 2B to 2D, the instrument axis 30 is the center, the x-axis extends within the projection plane of Figure 2A, and the y-axis extends perpendicularly to the x-axis and the instrument axis 30.

[0077] As shown in Figure 2B, the distal tip portion 20 may feature an elliptical cross-section similar to that of the proximal attachment portion, which may be similar to the cross-section of the distal head assembly 10 shown in Figure 1.

[0078] As schematically shown in Figure 2C, in the flexible bending portion 28, the distal tip portion 20 may extend substantially parallel to the instrument axis 30 and may feature a cross-section having a smaller area than the proximal attachment portion, and the center of mass of the cross-section can be shifted relative to the instrument axis 30 (center of the coordinate system in Figure 2C).

[0079] The thickness of the flexible bending portion 28 may be less than 50% of the maximum lateral extension of the distal tip portion 20 at the proximal attachment portion 24, for example, less than 40% or less than 30% of the maximum lateral extension of the distal tip portion 20 at the proximal attachment portion 24. For example, in the case of an endoscope with a maximum lateral extension of about 13 mm, the thickness of the flexible bending portion 28 may be less than 4 mm or 3 mm, for example, less than 1 mm or 2 mm, or less than 5 mm. The thickness of the flexible bending portion 28 may also be the lateral extension of the cross-section of the flexible bending portion 28 when viewed along the instrument axis 30.

[0080] From the cross-section of the flexible bending portion 28 shown in Figure 2C, the distal tip portion 20 can be curved toward the instrument axis 30 so that the distal tip portion 20 can extend obliquely toward the instrument axis 30, close to the distal end 26 of the distal tip portion 20.

[0081] The cross-section perpendicular to the instrument axis 30 shown in Figure 2D may feature a larger area at the flexible bending portion 28 of the distal tip 20 than the cross-section of the distal tip 20 shown in Figure 2C. The increased cross-section near the distal end 26 can correspond to an increased contact area for engaging with the soft tissue of the surrounding lumen, for example, and can provide tactile feedback when passing through a narrowed portion of a biological lumen.

[0082] As shown in Figures 1 and 2A to 2D, a preferred bending direction can be defined that can be aligned with the curvature of the distal tip 20 having a curled tongue shape, based on the arrangement of the laterally shifted flexible bending portion 28. As a result, the distal end 26 can preferentially bend in a preferred bending direction, which may be the opposite direction to the laterally shifted direction of the flexible bending portion 28.

[0083] The preferred deflection direction may be aligned with the field of view direction 32 of the camera viewport 12, for example, parallel or perpendicular, in order to improve visual feedback when the distal tip 20 encounters an obstruction while the distal head assembly 10 is advancing through the biological lumen.

[0084] Those skilled in the art will understand that, based on the shape of the distal tip 20, the distal tip 20 may be a tip that is compressible in the axial direction, and as a result, it may be larger / flatter than is possible with a rigid, rounded tip, and the surface area may be increased.

[0085] Those skilled in the art will further understand that when the distal tip 20 engages with the geometric shape of a specific obstacle, such as an obstacle that abuts longitudinally against the distal tip 20, the distal tip 20 may, in principle, be flexible in all lateral directions, and the preferred deflection direction may be defined only by different effective stiffness coefficients for different deflection directions.

[0086] The distal tip portion 20 can be integrated with other components of the distal head assembly 10, for example, as an overmolded feature or as a multi-durometer 3D printed part. In some examples, the distal tip portion 20 is a separate part that is fixedly connected to the distal end portion 22 of the distal head assembly 10, for example, by bonding. In some examples, the distal tip portion 20 fits into the rigid mounting geometry of the distal head assembly 10, in addition to or instead of an integrated / bonded connection.

[0087] Figure 3 shows a schematic enlarged view of an example of a distal tip 20 on a distal head assembly 10, where the distal tip 20 is shown as a transparent element. The distal tip 20 is attached to the distal end portion 22 of the distal head assembly 10 at the proximal attachment portion 24, and the distal end portion 22 of the distal head assembly 10 is characterized by an interlock attachment shape 34 that connects to a corresponding recess of the distal tip 20 to hold the distal tip 20 in a predetermined position on the distal end portion 22 of the distal head assembly 10.

[0088] The interlock mounting shape 34 may feature lateral projections, such as the barbed feature shown in Figure 3, which can interlock with the corresponding cavity of the distal tip 20 to prevent relative rotation between the distal tip 20 and the distal head assembly 10. The interlock mounting shape 34 can maintain a predetermined orientation of the distal tip 20 relative to the camera viewport 12, for example, to provide the user of the surgical instrument with consistent visual and / or tactile feedback.

[0089] Those skilled in the art will understand that although the distal tip portion 20 is shown having a recess for connecting with a protruding mounting shape 34 located on the distal end portion 22 of the distal head assembly 10, the distal tip portion 20 may also include a protruding connecting shape for engaging with and connecting with the corresponding recessed shape of the distal end portion 22.

[0090] Furthermore, although the distal tip portion 20 is shown as a component attached to the distal end face of the distal head assembly 10 in the examples of Figures 1 to 3, the distal tip portion 20 may also be implemented as an extension of a fixed or removable cap that covers several features of the distal head assembly 10.

[0091] In some examples, the distal tip 20 is part of the lateral shroud portion of the shroud tip of the distal head assembly 10 that houses the camera viewport 12 and / or elevator 14. In some examples, the shroud tip includes a mounting mechanism that engages laterally with the distal head assembly 10 to hold the shroud tip in place on the distal head assembly 10. For example, the shroud tip can be snapped onto the distal head assembly 10 to laterally shroud a portion of the distal head assembly 10.

[0092] Figure 4 schematically shows another example of a distal head assembly 10 of a surgical device to be inserted into a biological lumen of a human or animal body (not shown). The distal head assembly 10 is similar to the example shown in Figure 1, but the shape of the distal tip 20 is different.

[0093] In the example shown in Figure 4, the distal tip portion 20 also features a proximal attachment portion 24 for attaching the distal tip portion 20 to the distal end portion 22 of the distal head assembly 10, and the distal tip portion 20 extends along the forward direction 18 from the proximal attachment portion 24 to the distal end 26. Between the distal end 26 and the proximal attachment portion 24, the distal tip portion 20 features a tapered segment that implements a flexible bending portion 28 that allows for lateral deflection of the distal end 26 with respect to the forward direction 18.

[0094] Distal to the tapered segment, the distal tip 20 is characterized by a bulging tissue engagement segment 36 located proximal to the distal end 26. The bulging tissue engagement segment 36 may be ball-shaped and is characterized by a greater maximum lateral extension, such as diameter, than the tapered segment associated with the flexible bending portion 28.

[0095] A ball-shaped (or similar) form located at the distal tip 20, positioned after the tapered transition, can function as an initial landmark providing tactile feedback to the user. When the user can feel the advancement of the bulging tissue engagement segment 36 through a specific anatomical structure, the tapered shank behind it can give the user the perception of passing an initial landmark, as the next feature must advance through a narrow path.

[0096] Furthermore, the lateral and longitudinal extensions of the tapered segment implementing the flexible bending portion 28 may be configured to allow lateral flexure of the distal tip portion 20. Lateral flexure of the bulging tissue engagement segment 36 can dynamically increase the effective surface area that contacts obstacles as the surgical instrument advances within the lumen, thereby reducing the possibility of accidental tissue damage. In addition, lateral flexure of the distal end can deflect forces from the soft tissue wall, thereby further reducing the possibility of accidental tissue damage or facilitating the passive adaptation of the distal tip shape to the shape of the surrounding lumen.

[0097] Figures 5A to 5D show examples of distal tip portions 20 similar to the example in Figure 4. Figure 5A shows a side view of the distal tip portion 20, and Figures 5B to 5D, indicated by the letters B to D respectively, show cross-sectional views of the distal tip portion 20 of Figure 5A passing through a plane extending perpendicularly to the instrument axis 30. In the cross-sectional views of Figures 5B to 5D, the instrument axis 30 is the center, the x-axis extends within the projection plane of Figure 5A, and the y-axis extends perpendicularly to the x-axis and the instrument axis 30.

[0098] As shown in Figure 5B, the distal tip portion 20 may feature an elliptical cross-section similar to that of the proximal attachment portion 24, which may be similar to the cross-section of the distal head assembly 10. In the example in Figure 5B, the cross-section of the distal tip portion 20 is substantially circular in diameter, which may be similar to the lateral extension of the distal head assembly 10 to which the distal tip portion 20 is attached.

[0099] As shown in Figure 5C, in the flexible bending portion 28, the distal tip portion 20 may be tapered, characterized by a smaller diameter than the proximal attachment portion 24, while maintaining a substantially circular shape.

[0100] As shown in Figure 5C, the bulging tissue engagement segment 36 may be characterized by a circular cross-section having a diameter larger than the diameter of the distal tip 20 of the flexible bending portion 28, such that the rigidity of the flexible bending portion 28 may be less than the rigidity of the bulging tissue engagement segment 36.

[0101] Apart from allowing lateral bending of the bulging tissue engagement segment 36 around the flexible bending portion 28, changes in the lateral extension of the distal tip portion 20 along the forward direction 18 can improve tactile feedback to the user when passing through the restriction along the lumen.

[0102] The ball shape of the bulging tissue engagement segment 36 shown in the examples in Figures 4 and 5A to 5D can provide a smooth tissue engagement segment for various diameters of the surrounding lumen, but other shapes may be used in embodiments. For example, the bulging tissue engagement segment 36 may be provided with a pointed tip at the distal end 26 to facilitate entry into and expansion into small spaces, for example, when the hardness of the material is low enough to prevent accidental perforation of soft tissue.

[0103] In some examples, the curvature of the distal end is greater than the radius of the proximal attachment portion 24 in order to facilitate the advancement of the distal tip portion 20 into an orifice having a smaller lateral dimension.

[0104] The bulging tissue engagement segment 36 can be sized in relation to the most prominent feature of the surgical instrument so that tactile feedback to the user can indicate the size of the surgical instrument relative to the narrowest entrance orifice.

[0105] Due to the lateral extension of the bulge tissue engagement segment 36, which is larger than that of the surgical device, tactile feedback to the user can indicate that if the bulge tissue engagement segment 36 is insertable, the other parts of the surgical device can advance through the lumen without anticipated complications.

[0106] In the case of lateral extension of a bulging tissue engagement segment 36 of nominal size, for example, a similar diameter, relative to the maximum lateral extension of the surgical instrument, characteristic tactile feedback to the user can indicate that similar difficulties are expected when advancing the surgical instrument.

[0107] In the case of lateral extension of the bulging tissue engagement segment 36 that is smaller than the maximum lateral extension of the surgical device, characteristic tactile feedback to the user may indicate that if the distal tip 20 is having difficulty advancing, the rest of the endoscope will encounter even more resistance, and the distal tip 20 can function as an advancing probe.

[0108] As those skilled in the art will understand, while the examples in Figures 4, 5A to 5D show examples with a circular cross-section, other examples may feature a non-circular cross-section, such as an elliptical cross-section, to provide a smooth periphery that conforms to the shape of the duodenal endoscope head. In some examples, the distal tip 20 features a hyperelliptical cross-section, for example, at the proximal attachment portion 24, which may approximate a rectangle with rounded edges. Furthermore, the shape of the cross-section may vary along the forward direction, for example, to facilitate a predetermined preferred bending direction of the bulging tissue engagement segment 36 around the flexible bending portion 28.

[0109] In the example shown in the figure, as shown in Figures 4, 5A to 5D, the proximal attachment portion 24, the flexible bending portion 28, and the distal end 26 are substantially axially symmetric with respect to the device axis 30. However, in some examples, the distal end 26 and / or the flexible bending portion 28 may also be positioned off-axis to facilitate a preferred bending direction of the distal end 26 toward, for example, the camera viewport 12.

[0110] In some examples, the embodiments of the examples in Figures 1-3 and Figures 4, 5A-5D can be combined to include a bulging tissue engagement segment 36 located distal to the potentially tongue-shaped extraaxial flexible bending portion 28, for example, to combine the advantageous effects of different examples.

[0111] According to a third aspect, an endoscope is provided comprising the distal head assembly of the second aspect, as described above. The endoscope may be equipped with a camera, which may be positioned within the endoscope as a lateral-viewing camera or a lateral camera. In particular, the endoscope may be a duodenoscope equipped with a lateral-viewing camera.

[0112] In the case of a lateral camera, the endoscope may be particularly well suited for performing endoscopic retrograde cholangiopancreatography (ERCP) applications, for example, in situations requiring access to the bile ducts and pancreatic ducts for observation or surgery. When using a lateral camera, the direction of advancement of the endoscope within the lumen of the human or animal body does not preferably coincide with the field of view of the endoscope. For example, the direction of advancement and the field of view of the lateral camera can encompass an angle in the range of 60 to 120 degrees, preferably between 70 and 110 degrees, more preferably between 80 and 100 degrees, and most preferably around 90 degrees. In the latter case, the lateral camera may be positioned within the endoscope such that the camera's field of view is essentially perpendicular to the direction of advancement of the endoscope.

[0113] It should be noted that, in at least some examples, the distal tip of the present invention does not include an opening for delivering surgical instruments or occlusion devices. The distal tip according to the present invention may be designed to be blunt in shape. This can be achieved, for example, by the rigid portion of the distal tip and / or by the camera of the endoscope being a side camera. In the latter case, the endoscope may not have a front-facing exit port that could cause damage to the tissue or other parts of the human or animal body.

[0114] One of the advantageous effects that can be achieved with the distal tip according to the present invention is that the distal tip can form a wider surface area at the distal tip compared to the already blunt anterior surface of the distal end, due to its construction and its ability to flex laterally. By being able to flex laterally, the cross-section of the distal tip can be enlarged, and as a result the distal tip becomes blunter when in contact with tissue or mucosa. This technique differs from conventional devices such as catheters or delivery devices described in the prior art, whose oblique cutting openings can easily penetrate mucosa or other tissues, thus skimming the wall at a shallow angle of attack. According to the present invention, an already blunt distal tip is modified to create a geometric shape that can expand the distal tip and / or the cross-section of the distal tip to be even larger than the original size of the endoscope, especially when pushing against tissue at a more vertical angle of attack. Thus the distal tip becomes even blunter or softer. As described in the prior art, catheters or delivery devices can be delivered through an endoscope or the working conduit of an endoscope. Therefore, they represent accessories that can be deployed through an endoscope, particularly an endoscope having a front camera. Such accessories often have tips that require protection, but endoscopes do not have sharp tips that require protection from the lumen of human or animal body tissue.

[0115] The description of preferred embodiments and drawings is merely for illustrative purposes to illustrate the invention and its associated beneficial effects, and should not be understood as implying limitations. The scope of the invention should be determined solely by the appended claims. [Explanation of Symbols]

[0116] 10. Distal head assembly 12 Camera Viewport 14 Elevator 16 Endoscope connection section 18 Forward direction 20 Distal tip 22 Distal attachment portion of distal head assembly 24 Proximal attachment portion of the distal tip 26 Distal end 28 Flexible bending part 30 Instrument axis 32 Camera field of view direction 34 Interlock mounting shape 36. Bulging tissue engagement segment

Claims

1. A distal tip (20) for an endoscope that is inserted into a lumen of the human or animal body, A proximal attachment portion (24) for connecting the distal tip portion (20) to the distal end portion (22) of the endoscope, The distal end (26) of the distal tip (20) for engaging with the distal soft tissue of the endoscope during its advance, The distal tip portion (20) comprises a flexible bending portion (28) positioned between the distal end (26) and the proximal attachment portion (24), and configured to allow lateral bending of the distal end (26) relative to the proximal attachment portion (24).

2. The distal tip portion (20) according to claim 1, wherein the flexible bending portion (28) is integrally formed with the distal end (26) and / or the proximal attachment portion (24).

3. The flexible bending portion (28) includes one or more of silicone, thermoplastic urethane, rubber, isoprene-based polymer, or additive manufacturing material, and / or The distal tip portion (20) according to claim 1 or 2, wherein the distal tip portion (20) is added together with the distal end portion (22) of the endoscope as a single component from a configurable multi-rigidity material or a plurality of materials.

4. The distal tip portion (20) according to any one of claims 1 to 3, wherein the flexible bending portion (28) defines a bending mode of the distal tip portion (20) in which the distal tip portion (20) bends laterally with respect to the forward direction (18) of the distal tip portion (20).

5. The distal tip portion (20) according to any one of claims 1 to 4, wherein the cross-section of the flexible bending portion (28) along the extension of the distal tip portion (20) is reduced relative to the tissue engagement segment (36) of the distal end (26) which is located distal to the flexible bending portion (28).

6. The distal tip portion (20) according to any one of claims 1 to 5, wherein the flexible bending portion (28) has a reduced diameter with respect to a bulging segment positioned between the distal end (26) and the flexible bending portion (28), and optionally with respect to a segment of the proximal attachment portion (24) positioned proximal to the flexible bending portion (28).

7. The cross-section of the flexible bending portion (28) is asymmetrical with respect to the instrument axis (30) of the distal tip portion (20), and / or The distal tip portion (20) according to any one of claims 1 to 6, wherein the center of mass of the distal tip portion is shifted with respect to the instrument axis (30) between the distal tip portion (20) and the flexible bending portion (28).

8. The distal tip portion (20) according to any one of claims 1 to 7, wherein the proximal attachment portion (24) is configured to connect with a corresponding attachment mechanism on the distal end portion (22) of the endoscope.

9. The distal tip (20) according to any one of claims 1 to 8, wherein the distal tip (20) includes a curled tongue-shaped section, the curled tongue-shaped section includes the distal end (26) and the flexible bending portion (28), and the curled tongue-shaped section is optionally configured to compress and / or curl up in response to distal contact of the distal end (26).

10. A distal head assembly (10) for an endoscope to be inserted into a lumen of a human or animal body, comprising a distal tip (20) according to any one of claims 1 to 9, and a viewport (12) for acquiring an image at the position of the distal head assembly (10).

11. The maximum cross-section of the distal tip portion (20) of the distal head assembly (10) along the forward direction (18), particularly the tissue engagement segment (36) positioned between the distal end (26) and the flexible bending portion (28), is greater than or equal to the maximum cross-section of the distal head assembly (10), and / or The head assembly (10) according to claim 10, wherein when the distal end (26) bends, the area of ​​the resulting end face of the distal tip portion (20) is larger than the maximum cross-sectional area of ​​the distal head assembly (10) proximal to the proximal mounting portion (24) when viewed along the forward direction (18) of the distal head assembly (10).

12. The distal head assembly (10) according to claim 10 or 11, wherein the distal head assembly (10) comprises a camera positioned in the viewport (12).

13. The distal head assembly (10) according to any one of claims 10 to 12, wherein the field axis of the viewport (12) is oblique to the forward direction (18) of the distal head assembly (10) on the endoscope, and the flexible bending portion (28) is optionally configured to allow the distal end (26) to bend toward the field axis.

14. The distal head assembly (10) according to any one of claims 10 to 13, wherein the distal tip portion (20) is firmly joined to the distal end portion (22) of the endoscope.

15. An endoscope comprising a distal tip (20) according to any one of claims 1 to 9 or a distal head assembly (10) according to any one of claims 10 to 14.

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