Cutting assembly of a surgical instrument having a clogging-reducing tip
By setting protrusions at the proximal boundary of the cutting window, the cross-sectional area of the lumen is reduced, and the blockage problem of ENT resection device during endoscopic sinus surgery is solved, and the efficiency and effect of the surgery are improved.
Patent Information
- Application Number
- CN202111633402.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2016-07-14
- Filing Date
- 2017-07-14
- Publication Date
- 2025-07-01
- Estimated Expiration
- 2037-07-14
AI Technical Summary
Obstruction of the ENT resection device is a common problem during endoscopic sinus surgery, mainly due to the limitation of the sinus bone and tissue at the proximal tip of the cutting window.
A cutting assembly with a blocking reduction tip is designed. By providing a protrusion at the proximal boundary of the cutting window, the protrusion extends from the distal end of the proximal boundary to the proximal end in the lumen, reducing the cross-sectional area of the lumen, thereby reducing the size of the material and reducing the possibility of blockage.
It effectively reduces the risk of blockage of cutting components, ensures that the material can pass through the cutting window smoothly, and improves the efficiency and effectiveness of the surgery.
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Figure CN114271899B_ABST
Abstract
Description
[0001] This application is a divisional application of a Chinese patent application with application number 201780043525.5, filing date July 14, 2017, and invention title "Cutting Assembly for a Surgical Instrument with an Occlusion-Reducing Tip".
[0002] Cross - Reference to Related Applications
[0003] This subject patent application claims the benefit of priority and all rights of U.S. Provisional Patent Application No. 62 / 362,117, filed July 14, 2016, the entire content of which is incorporated herein by reference. Technical Field
[0004] The present disclosure generally relates to surgical instruments, and more particularly to surgical instruments for a patient having an occlusion - reducing tip. Background Art
[0005] It is well known that medical practitioners have found it useful to use surgical instruments to assist in the performance of surgical procedures. Surgical instruments are designed to be applied to a surgical site of a patient. A practitioner can position a surgical instrument at a site of the patient where the instrument will perform a medical or surgical procedure. Endoscopic surgical procedures are routinely performed to accomplish various surgical tasks. In an endoscopic surgical procedure, small incisions called ports are made in the patient's body. An endoscope, which is a device that allows medical personnel to view the surgical site, is inserted into one of the ports. Surgical instruments for performing specific surgical tasks are inserted into other ports. The surgeon views the surgical site through the endoscope to determine how to manipulate the surgical instrument to complete the surgical procedure. The advantages of performing endoscopic surgery are that since the body part being incised is minimized, the body part that needs to heal after surgery is also reduced. Additionally, in an endoscopic surgical procedure, only a relatively small portion of the patient's internal organs and tissues are exposed to the open environment. This minimal opening of the patient's body reduces the degree to which the patient's organs and tissues are open to infection.
[0006] Many tube devices for surgical procedures have been developed. They are valuable because they help reduce the incision size, improve access and visibility, while enhancing surgical results and increasing the speed of recovery. Some are cutting devices having two tubes (one inside the other) or a single tube with a cutting window. Such cutting devices can be ear, nose, and throat (ENT) dissector devices.
[0007] During endoscopic sinus surgery, blockage of an ENT dissector device is a common annoyance. Common causes of blockage are restriction of sinus bone and tissue at the distal tip of the ENT dissector device just proximal to the cutting window. Another common cause of blockage is restriction of sinus bone and tissue just proximal to the tube of the cutting device.
[0008] A surgical instrument is desired that overcomes these challenges. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The advantages of the present disclosure will be readily understood as it is better appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings.
[0010] Figure 1 is a perspective view of a surgical instrument according to an exemplary embodiment of the present disclosure.
[0011] Figure 2 is an exploded perspective view of the Figure 1 surgical instrument with the drive assembly removed.
[0012] Figure 3 is of the Figure 1 and Figure 2 surgical instrument according to an exemplary embodiment of the present disclosure
[0013] Figure 4 is a partial front view schematically showing the removed material Figure 3 of the blockage reducing tip of the cutting assembly.
[0014] Figure 5 is Figure 3 another partial front view of the blockage reducing tip of the cutting assembly.
[0015] Figure 6 is Figure 3 yet another partial front view of the blockage reducing tip of the cutting assembly.
[0016] Figure 7 is Figure 3 a cross-sectional view of the cutting assembly taken along line 7-7.
[0017] Figure 8 is a perspective view of a blockage reducing tip according to another exemplary embodiment of the present disclosure.
[0018] Figure 9 is Figure 8 a partial perspective view of the blockage reducing tip.
[0019] Figure 10 is a perspective view of a blockage reducing tip according to yet another exemplary embodiment of the present disclosure.
[0020] Figure 11 is Figure 10 A partial perspective view of the blockage reducing tip.
[0021] Figure 12 is a perspective view of a blockage reducing tip according to another exemplary embodiment of the present disclosure.
[0022] Figure 13 is Figure 12 A front view of the blockage reducing tip.
[0023] Figure 14 is Figure 12 An angled view of the blockage reducing tip.
[0024] Figure 15 is Figure 12 A plan view of the blockage reducing tip.
[0025] Figures 16 - 19 is a schematic view showing a machining process for forming the Figures 12 - 15 blockage reducing tip.
[0026] Figure 20 is Figure 1 A cross-sectional view taken along line 20 - 20 of the surgical instrument. DETAILED DESCRIPTION
[0027] Referring to Figure 1 , an embodiment of a surgical instrument 10 according to the present disclosure is shown for a medical procedure on a patient (not shown). In one embodiment, the surgical instrument 10 is disposable and is an ENT dissector for removing sinus bone and tissue during endoscopic sinus surgery. As shown, the surgical instrument 10 includes a drive assembly generally designated 12 and shown in phantom, and a cutting assembly generally designated 14 that is removably coupled (attached) to the drive assembly 12. The drive assembly 12 is operative to rotate a portion of the cutting assembly 14 to remove tissue, bone, etc. from the surgical site of the patient. It should be understood that the surgical instrument 10 may be operated by a user such as a surgeon (not shown).
[0028] As Figure 1 shown, the drive assembly 12 includes an axially extending housing 15. The housing 15 is generally cylindrical. The drive assembly 12 also includes a motor 16 disposed within the housing 15 and having a rotatable drive element 18 that is coupled to the cutting assembly 14. The motor 16 may be an electric or pneumatic type motor. In one embodiment, the drive element 18 is removably coupled to the cutting assembly 14.
[0029] It should be understood that in one embodiment, the cutting assembly 14 may not have any motors. Thus, the cutting assembly 14 can be configured to be disposable after a single use or a series of uses. Since the cutting assembly 14 may not include any motors, the cost of the cutting assembly 14 can be reduced.
[0030] Referring Figures 1 - 7 , the cutting assembly 14 includes a plurality of tubes or tube assemblies generally designated 20 that axially extend between a distal end 23 and a proximal end 21 ([ Figure 20 ) opposite the distal end 23. The tube assembly 20 has a longitudinal axis 24 defined between the proximal end 21 and the distal end 23. The tube assembly 20 includes a window 22, such as a cutting window, near or at the distal end 23, where the window 22 is adapted to be applied to a surgical site of a patient. In certain embodiments, the tube assembly 20 includes an outer tube (or first tube) 26 and an inner tube (or second tube) 28. The inner tube 28 is coupled to the drive assembly 12 and is rotatable relative to the outer tube 26 by a drive element 18. The inner tube 28 may be detachably coupled to the drive element 18 (e.g., in embodiments where the cutting assembly 14 is disposable after a single use or a series of uses).
[0031] In one embodiment, the outer tube 26 is non-rotatable and the inner tube 28 is rotatable relative to the outer tube 26. The inner tube 28 has a lumen 30 that extends between the proximal end 21 and the distal end 23 of the tube assembly 20. The inner tube 28 may include a proximal region 32 and a distal region 34 to be described. The inner tube 28 includes, forms, or defines an inner cutting window (or first cutting window) 36 at or near the distal end 23 of the tube assembly 20, such as within the distal region 34 of the inner tube 28.
[0032] Each of the inner tube 28 and the outer tube 26 may be a generally hollow axially extending cylinder and have a generally circular cross-sectional shape. The diameter of the outer tube 26 is greater than the diameter of the inner tube 28 such that the inner tube 28 is disposed within the outer tube 26. In other words, the outer tube 26 has a lumen that extends between the proximal end 21 and the distal end 23 of the tube assembly 20, where the inner tube 28 is at least partially disposed within the lumen of the outer tube 26. In one embodiment to be described (see Figure 20 ), the axial length of the inner tube 28 is greater than the axial length of the outer tube 26 such that when the inner tube 28 is disposed within the outer tube 26, the inner tube 28 extends beyond the proximal region 38 of the outer tube 26.
[0033] As Figure 2As shown, the outer tube 26 may include a proximal region 38 and a distal region 40. The outer tube 26 forms an outer cutting window (or second cutting window) 42 at or near the distal end 23 of the tube assembly, such as within the distal region 40 of the outer tube 26. The inner cutting window 36 and the outer cutting window 42 define the cutting window 22 of the tube assembly 20. In one exemplary embodiment, the outer tube 26 may include a radially reduced step 44 within the distal region 34 to allow the outer surface of the inner tube 28 and the inner surface of the outer tube 26 to be in close contact with each other.
[0034] In one embodiment, the tube assembly 20 may further include a non-rotatable sheath or third or overtube 46 disposed on a portion of the outer tube 26. The overtube 46 has an axial length that is less than the axial length of the outer tube 26. The overtube 46 may be angled, straight, or extensible. It should be understood that the overtube 46 is optional. Additionally, it should be understood that the overtube 46 is coupled to a connection hub 68 that will be described. Further, it should be understood that any suitable tube construction may be used as long as the cutting assembly 14 defines the cutting window 22 and can be driven by the drive assembly 12.
[0035] Depending on the application, the inner tube 28 and the outer tube 26 are made of a metallic material such as stainless steel or a non-metallic material such as a composite material. Depending on the application, the overtube 46 may be made of a metallic material or a non-metallic material such as a composite material. It should be understood that the wall thicknesses of the inner tube 28 and the outer tube 26 are relatively thin, such as approximately 0.1 to approximately 0.5 millimeters (mm), to allow the tube assembly 20 to have a relatively small diameter and also be lightweight. It should also be understood that the inner tube 28 and the outer tube 26 have relatively small diameters, such as approximately 2.0 mm to approximately 5.0 mm, in order to work within a small opening in a patient's nasal cavity or oral cavity and to prevent obstruction of the user's line of sight. In one embodiment, the tube assembly 20 may have a bend (not shown) near the distal end 23. It should also be understood that, depending on the application, the inner tube 28 and the outer tube 26 may be scaled larger or smaller.
[0036] The cutting assembly 14 further includes a drive hub generally designated 48 and disposed about the proximal end of the inner tube 28 to allow the inner tube 28 to be connected to the drive element 18 to facilitate rotation of the inner tube 28 about the longitudinal axis 24. The drive hub 48 includes a hub member 50 disposed about the inner tube 28. The hub member 50 extends axially and is generally cylindrical. As Figure 2As shown, the hub member 50 has an axially extending hole 52 that at least partially passes therethrough to receive the inner tube 28. The hub member 50 may also include a plurality of ridges 54 that extend radially and axially and are circumferentially spaced therearound. The hub member 50 may also include a reduced diameter portion 56 adjacent to the ridges 54. The reduced diameter portion 56 of the hub member 50 defines a reduced hole 53 that communicates with the hole 52, wherein the diameter of the reduced hole 53 is smaller than the diameter of the hole 52 (see Figure 20 ). The reduction in diameter from the hole 52 to the reduced hole 53 forms a lip 55 that is adapted to be positioned adjacent to or in abutting relationship with the proximal end 21 of the tube assembly 20 in a manner to be described. The hub member 50 also includes a flange 58 that extends radially at its distal end. The hub member 50 may be made of a non-metallic material. The hub member 50 may be complete, integral, and integrally formed.
[0037] The drive hub 48 may also include a spring 60 disposed in the reduced diameter portion 56 around the hub member 50 at its proximal end and a seal 62 such as an O-ring. The drive hub 48 may include a washer 64 disposed around the distal end of the inner tube 28 at its distal end and a seal 66 such as an O-ring. It should be understood that the drive hub 48 allows rotation of the inner tube 28 and may allow fluid transfer through the inner tube 28. It should also be understood that the cutting assembly 14 may be used with various drive coupling configurations.
[0038] The cutting assembly 14 further includes a connection hub generally designated 68 and disposed about a portion of the inner tube 28 and the drive hub 48 to permit the drive assembly 12 to be removably coupled to the cutting assembly 14. The connection hub 68 includes a housing hub 70 adapted to be engaged and supported by at least a portion of the user's hand and to cover the outer tube 26 or the cover tube 46. The housing hub 70 includes a bore 72 extending axially therethrough to receive the outer tube 26 or the cover tube 46. The housing hub 70 may include a plurality of gripping members 74 extending radially and axially and a flange 76 extending radially outwardly at one end to support one or more fingers of the hand. The connection hub 68 further includes a coupling member 78 disposed about the inner tube 28. The coupling member 78 extends axially and is generally cylindrical. The coupling member 78 has a bore 72 extending axially therethrough to receive the inner tube 28. The coupling member 78 includes a cavity 80 extending axially into its proximal end to receive the distal end of a fluid coupling. The coupling member 78 may include one or more ridges 82 extending radially and circumferentially at the proximal end and circumferentially spaced apart from each other to couple to the housing 15 of the drive assembly 12. The coupling member 78 may include one or more grooves 84 extending radially inwardly and circumferentially and axially spaced apart from each other, and one or more seals 86 such as O-rings disposed in the grooves 84. The connection hub 68 is made of a non-metallic material. The connection hub 68 may be integral, unitary and formed in one piece. It should be understood that the connection hub 68 permits the drive assembly 12 to be coupled to the cutting assembly 14.
[0039] Reference Figure 3 , the cutting window 22 includes an inner cutting window 36 formed in the inner tube 28 as an opening extending axially and diametrically through the wall on one side near the distal end 23 of the tube assembly 20. The cutting window 22 further includes an outer cutting window 42 formed in the outer tube 26 as an opening extending axially and diametrically through the wall on one side near the distal end 23 of the tube assembly 20. The inner and outer cutting windows 36 and 42 are generally elongated oval in shape, but may be of any suitable shape. The inner cutting window 36 may include at least one or more cutting edges 90. The cutting edges 90 may include a plurality of teeth 92 forming a serrated edge. The outer cutting window 42 may include at least one or more cutting edges 94. The cutting edges 94 may include a plurality of teeth 92 forming a serrated edge. The inner cutting window 36 is adapted to be temporarily (transiently) radially aligned with the outer cutting window 42 to receive material within the cutting window 22 as the inner tube 28 rotates within the outer tube 26. As the inner tube 28 rotates within the outer tube 26, the inner and outer cutting windows 36 and 42 are disengaged from the radially aligned state such that the cutting edges 90 and 94 cut or reduce the material positioned within the cutting window 22 of the tube assembly 20.
[0040] In Figure 1In one illustrated embodiment, the surgical instrument 10 includes an irrigation connector 95 on the housing 15 for connection to a fluid source, and an irrigation path or passage 96 that extends through the housing 15 between the irrigation connector 95 and the cutting assembly 14 and between the inner tube 28 and the outer tube 26 to a window 22 to provide lubrication. The surgical instrument 10 also includes a suction or aspiration connector 97 on the housing 15 for connection to a suction source, and a suction or aspiration path or passage 98 that extends through the housing 15 between the suction connector 97 and the inner cutting window 36 of the inner tube 28.
[0041] Figures 4 - 6 A partial front view of a blockage-reducing tip, generally designated 104, in accordance with an exemplary embodiment of the present disclosure is shown. Referring initially to Figure 4 , the cutting window 22 of the tube assembly 20 includes a distal boundary 103 and a proximal boundary 101 that is opposite the distal boundary 103. In one embodiment, the boundaries 101 and 103 may be defined as imaginary planes that extend perpendicular to the longitudinal axis 24 of the tube assembly 20 at the nearest and farthest points, respectively, of the cutting window 22. Thus, in the Figure 4 illustrated exemplary embodiment, the outer tube 26 extends beyond the distal end of the inner tube 28 to define the proximal boundary 101 of the cutting window 22, and at the distal end 23, the inner tube 28 is positioned proximal (i.e., within) the outer tube 26 to define the distal boundary 103 of the cutting window 22. Stated another way, when the cutting window 22 is viewed in a plan view, the proximal and distal boundaries 101 and 103 may be seen as the nearest and farthest points, respectively, of the cutting window 22. In certain embodiments, the portion of the inner tube 28 distal to the proximal boundary 101 of the cutting window 22 defines a distal region 34 of the inner tube 28.
[0042] As Figure 4 shown, the blockage-reducing tip 104 of the tube assembly 20 includes a protrusion 112 within the lumen 30 of the inner tube 28. The protrusion 112 is adapted to reduce the size of the material that can be removed through the cutting window 22, thereby reducing blockage of the tube assembly 20. In certain embodiments, at least a portion of the protrusion 112 is positioned distal to the proximal boundary 101 (in the direction of arrow 102 in Figure 4 ) to provide a cross-sectional area of the lumen 30 that is reduced relative to the cross-sectional area of the lumen 30 proximal to the protrusion 112. In another example, the protrusion 112 occupies a volume V within the distal region 34 of the inner tube 28 112 ( Figure 5)。The protrusion 112 reduces the amount of material 106 that can penetrate the cutting window 22. Thus, the cutting action (by cutting edges 90 and 94) generated by rotating the inner tube 28 within the outer tube 26 reduces the material 106 into small enough pieces before the material 106 can pass through the lumen 30 at the proximal end of the cutting window 22, thereby reducing the likelihood of blockage of the tube assembly 20.
[0043] In some embodiments, the reduced cross-sectional area of the lumen 30 can be defined as the difference between the cross-sectional area of the lumen 30 (e.g., π*d, where d is the diameter of the lumen 30) and the cross-sectional area of the protrusion 112. In one example, the ratio of the reduced cross-sectional area of the lumen 30 to the cross-sectional area of the lumen 30 is in the range of 1:1.1 to 1:2.0, and more specifically in the range of 1:1.3 to 1:1.8, and even more specifically in the range of 1:1.5 to 1:1.6. The reduced cross-section is adapted to ensure that the size of the material 106 (e.g., bone and / or tissue fragments) is not greater than the cross-sectional area of the lumen 30, and more specifically is less than the cross-sectional area of the lumen 30 by a coefficient predetermined based on the above ratio. In other exemplary embodiments, the volume V (occupied) of the protrusion 112 provided within the distal region 34 112 in the volume V of the distal region 34 of the tube assembly 20 20 is in the range of 10%-70% of, and more specifically in the range of 20%-60% of the volume V (occupied) of the distal region 34 (see 20 ). Figure 5 )。
[0044] In an exemplary operation of a conventional ENT resectoscope, material can pass through the cutting window to contact the inner tube opposite the cutting window, such that the size of the reduced material is approximately equal to the diameter of the lumen. Reduced material having a size approximately equal to the diameter of the lumen increases the likelihood of the reduced material becoming blocked within the lumen, particularly near the cutting window. Additionally, in cases where the axial length of the cutting window is greater than the diameter of the lumen, the likelihood of blockage of the reduced material in a conventional ENT resectoscope is further increased.
[0045] The blockage-reducing tip 104 of the present disclosure significantly reduces the likelihood of blockage by, for example, setting the distance from the proximal boundary 101 of the cutting window 22 at the outer tube 26 to the nearest point on the protrusion 112 (approximately the Figure 4 point 105 shown) to be less than the diameter of the lumen 30. Thus, the size of any reduced material 106 that can pass through the "throat" (i.e., the distance from the cutting window 22 to the nearest point 105) is less than the diameter of the lumen 30 itself. Thus, once the reduced material reaches the lumen 30 at the proximal end of the protrusion 112, it is increasingly unlikely for the reduced material to block the tube assembly 20.
[0046] Before the material is sufficiently reduced to pass through the "throat" of the inner tube 28, the protrusion 112 (and the proximal boundary 101 of the cutting window 22) holds the material 106 in place such that the cutting action continuously reduces the material 106 with each rotation of the inner tube 28. Although the material 106 may remain positioned near the cutting window 22 for a longer time, empirical studies have shown minimal impact on the material removal ability of the tube assembly 20 including the obstruction reducing tip 104, almost or completely eliminating the obstructions typically associated with conventional ENT resecters.
[0047] Continuing to refer Figure 4 and simultaneously referring Figure 6 , the protrusion 112 can extend within the lumen 30 from near the distal end 23 of the tube assembly 20 to a position proximal to the proximal boundary 101 (i.e., in the direction of arrow 100). In other words, another portion 113 of the protrusion 112 can be positioned proximal to the proximal boundary 101. In other words, the axial length L of the protrusion 112 112 can be greater than the axial length L of the cutting window 22 22 . Positioning the portion 113 of the protrusion 112 proximal to the proximal boundary 101 ensures that the material 106 passing through the proximal boundary 101 is reduced to a size smaller than the cross-sectional area of the lumen 30 of the tube assembly 20. It should be understood that the axial length L of the protrusion 112 112 can be greater than the axial length L of the outer cutting window 42 42 and / or less than the axial length L of the inner cutting window 36 36 . In certain embodiments, the protrusion 112 of the obstruction reducing tip 104 can extend even more proximal to the proximal boundary 101 with a shallower tapered proximal second portion 110b than shown in Figure 4 and Figure 6 .
[0048] The protrusion 112 of the obstruction reducing tip 104 has a shelf or inner surface 110. The inner surface 110 is radially inwardly displaced relative to the inner surface 108 of the lumen 30 (i.e., the proximal end of the protrusion 112) toward the longitudinal axis 24 of the tube assembly 20. Referring Figure 5 , the protrusion 112 can be angled relative to the inner surface 108 of the lumen 30. For example, a line extending between the distal end and the proximal end of the protrusion 112 can be oriented at an angle α in the range of about 5 degrees to about 40 degrees relative to the inner surface 108 of the lumen 30. In other embodiments, the angle α is between about 10 degrees and about 30 degrees, and more specifically between about 15 degrees and about 25 degrees. The angle α generally provides the protrusion 112 with a tapered profile narrowing in the direction of arrow 100 (when viewed as in Figures 4 - 6when viewed in the front view shown). In other words, the distance from the longitudinal axis 24 to the protrusion 112 at the distal boundary 103 of the cutting window 22 is less than the distance from the longitudinal axis 24 to the protrusion 112 at the proximal boundary 101 of the cutting window 22, such that the protrusion 112 tapers in a direction toward the proximal boundary 101. The tapering of the protrusion 112 advantageously keeps the material 106 near the distal boundary 103 closer to the cutting edges 90 and 94 to reduce the material 106 into smaller pieces as the reduced material 106 moves along the inner surface 110 of the protrusion 112 toward the lumen 30 at the proximal end of the cutting window 22. The tapering of the protrusion 112 also ensures a gradual transition through the "throat" as described above, such that the reduced material 106 passing through the "throat" immediately encounters a larger cross-sectional area of the lumen 30 and is rapidly pushed proximally within the lumen 30 under the action of the force from the suction source.
[0049] In some embodiments, the inner surface 110 of the protrusion 112 further includes a distal first portion 110a and a proximal second portion 110b proximal to the distal first portion 110a, or is defined by the distal first portion 110a and the proximal second portion 110b proximal to the distal first portion 110a. Refer Figure 5 and Figure 6 . The distal first portion 110a may be oriented substantially parallel to the longitudinal axis 24 of the tube assembly 20. When viewed in the front view, the distal first portion 110a may be substantially planar. The proximal second portion 110b may be inclined or angled relative to the distal first portion 110a and the inner surface 108 of the lumen 30. When viewed in the front view, the proximal second portion 110b may be arcuate (curved) to provide a smooth transition to the distal first portion 110a. The proximal second portion 110b may be oriented at an angle β in the range of about 20 degrees to about 60 degrees relative to the inner surface 108 of the lumen 30. In other embodiments, the angle β is between about 30 degrees and about 50 degrees.
[0050] Refer Figure 7 , the protrusion 112 may be positioned about the longitudinal axis 24 radially opposite (more specifically, radially opposite the inner cutting window 36) to the cutting window 22 of the tube assembly 20. In the case where the protrusion 112 is located within the lumen 30 of the inner tube 28, the relative positioning between the protrusion 112 and the inner cutting window 36 remains unchanged when the inner tube 28 rotates within the outer tube 26. Figure 7 The radial position of the cutting window 22 of
[0051] The protrusion 112 is positioned around the circumference of the lumen 30 in a manner sufficient to appropriately reduce the material 106 to prevent blockage of the tube assembly 20. In certain embodiments, the protrusion 112 is positioned around less than half of the circumference of the lumen 30. For example, an axial cross-sectional view Figure 7 shows that one side of the protrusion 112 is radially positioned at approximately the 4 o'clock position, and the other side of the protrusion 112 is radially positioned at approximately the 8 o'clock position. In other words, the angle γ extending around the longitudinal axis 24 and between opposite sides of the protrusion 112 is in the range of approximately 70 degrees to approximately 180 degrees, and more specifically in the range of approximately 90 degrees to approximately 160 degrees, and even more specifically in the range of approximately 110 degrees to approximately 150 degrees. Other suitable values for the angle γ are considered at least partially based on the diameter of the lumen 30, the intended application of the surgical instrument 10, etc.
[0052] In certain embodiments, the blockage reducing tip 104 includes an insert fixed within the lumen 30 of the inner tube 28. The insert defines the protrusion 112 and forms the inner surface 110. For example, the insert can be bonded (attached) to the lumen 30 of the inner tube 28. The insert can include an outer surface 111 and an inner surface 110, where the outer surface 111 is shaped to conform to a portion of the lumen 30 (see Figure 7 ). The inner surface 110 can define the protrusion 112. The insert can have a thickness defined between the inner surface 110 and the outer surface 111, where the thickness of the insert tapers in the axial direction, i.e., in the direction 100 toward the proximal boundary 101 of the cutting window 22. It should also be understood that, as Figure 7 shown, the thickness of the insert can taper radially around the longitudinal axis 24 of the tube assembly 20.
[0053] In Figure 10 and Figure 11 yet another exemplary embodiment of the blockage reducing tip 104 shown, the protrusion 112 is defined by the lumen 30 at the distal end of the proximal boundary 101 and is formed radially inwardly toward the longitudinal axis 24. In other words, Figures 4 - 6 the protrusion 112 of Figure 10 and Figure 11 is located within the lumen 30, where the inner tube 28 has a generally cylindrical outer profile to the distal end 23 of the tube assembly 20, while
[0054] reference Figures 12 - 15, shows a blockage reducing tip 104 according to yet another embodiment of the present disclosure. In this embodiment, the blockage reducing tip 104 includes an inner surface 110 formed by drilling an eccentric bore within a distal region 34 of the inner tube 28. The bore is eccentric with respect to the longitudinal axis 24 of the tube assembly 20. The eccentric bore communicates with the cutting window 22 and the lumen 30 of the inner tube 28. Tips of this type are typically machined. As shown, the inner surface 110 has a smaller cross-section at the inner cutting window 36. The process of machining the blockage reducing tip 104 is shown in Figures 16 - 19 is shown in.
[0055] The present disclosure provides a method for operating a surgical instrument 10 on a patient according to an embodiment of the present disclosure. The method includes the step of providing a cutting assembly 14 including an axially extending tube assembly 20. The tube assembly 20 includes a rotatable inner tube 28 having a lumen 30 and coaxially disposed within an outer tube 26. The inner tube 28 forms an inner cutting window 36, and the outer tube 28 forms an outer cutting window 42. The inner cutting window and the outer cutting window 36, 42 define the cutting window 22 of the tube assembly 20. The method may further include the step of providing a protrusion 112 within the lumen 30 of the inner tube 28, wherein at least a portion of the protrusion 112 is disposed within the distal region 34 of the inner tube 28 with the protrusion 112. In certain embodiments, the protrusion 112 is positioned distal to the proximal boundary 101 of the cutting window 22. The protrusion 112 provides a reduced cross-sectional area of the lumen of the inner tube 28 relative to the proximal end of the protrusion 112. In certain embodiments, the protrusion 112 is a volume V that occupies the volume V of the lumen 30 at the distal end of the proximal boundary 101 of the cutting window 22 20 of volume V 112 . The method includes the step of applying the cutting window to a surgical site of a patient and rotating the inner tube 28 relative to the outer tube 26 via a drive assembly 12 to cut material 106 through the interaction of the inner cutting window 36 and the outer cutting window 42, wherein the protrusion 112 reduces the size of the material 106 removed through the cutting window 22 to reduce blockage of the tube assembly 20.
[0056] The surgical instrument 10 of the present disclosure also advantageously reduces the likelihood of blockage at or just proximal to the tube assembly 20 of the surgical instrument 10. Figure 20 is Figure 1 a cross-sectional view of a portion of a surgical instrument, particularly showing the interface 114 between the tube assembly 20 and the drive hub 48. As previously mentioned, the hub member 50 of the drive hub 48 includes a reduced diameter portion 56 defining a reduced bore 53 that communicates with the bore 52 of the drive hub 48 (and the connecting hub 68). The lip 55 is formed by the reduction in diameter from the bore 52 to the reduced bore 53. As Figure 20As shown, the axial length of the inner tube 28 is greater than the axial length of the outer tube 26 such that the inner tube 28 extends beyond the proximal region 38 of the outer tube 26 and into the connection hub 68 and the drive hub 48.
[0057] During the assembly of the surgical instrument 10, for example when coupling the tube assembly 20 to the drive hub 48, the inner tube 28 is slidably inserted into the bore 52 of the drive hub 48 and positioned adjacent to or in abutting relation with the lip 55. The lip 55 facilitates proper axial positioning of the tube assembly 20 relative to the housing 15 and other structures of the surgical instrument 10. As Figure 20 shown, the lumen 30 of the inner tube 28 is in fluid communication with the reduced bore 53 of the drive hub 48 such that reduced material 106 can pass from the lumen 30 to the suction source.
[0058] The diameter of the lumen 30 of the inner tube 28 is less than the diameter of the reduced bore 53 at the interface 114. In other words, when the material 106 passes through the interface 114, the reduced material 106 moves from the smaller cross-sectional area of the lumen 30 to the larger cross-sectional area of the reduced bore 53. In effect, the passage through which the reduced material moves expands, thereby reducing the likelihood of blockage. As a comparative example, if the diameter of the lumen 30 of the inner tube 28 is greater than the diameter of the reduced bore 53, the reduced material 106 may become stuck on the lip 55 and increase the likelihood of blockage at the interface 114.
[0059] Accordingly, in one exemplary embodiment of the present disclosure, a cutting assembly for a surgical instrument having a drive assembly, the cutting assembly comprising: a tube assembly including a cutting window near a distal end and adapted for application to a surgical site of a patient, an outer tube, an inner tube coaxially disposed within the outer tube and rotatable relative to the outer tube by the drive assembly, wherein the inner tube includes a lumen; and a drive hub coupled to the inner tube, wherein the drive hub defines a bore adapted to slidably receive a proximal end of the inner tube and defines a reduced bore in communication with the bore, wherein the diameter of the reduced bore is less than the diameter of the bore, and wherein when the proximal end of the inner tube is slidably received within the bore, the diameter of the lumen is less than the diameter of the reduced bore to reduce blockage of the surgical instrument when removed material moves from the lumen to the reduced bore of the drive hub. A lip is formed at an interface between the bore and the reduced bore, wherein the proximal end of the inner tube is adapted to be positioned adjacent to the lip.
[0060] Accordingly, the surgical instrument 10 of the present disclosure reduces the occurrence of blockage by providing a blockage-reducing tip 104 having a protrusion 112 that is configured to reduce the cross-sectional area of the lumen 30 at the distal end of the proximal boundary 101 of the cutting window 22 and / or to provide a volume V within the volume V of the distal region 34 of the tube assembly 20 20 within the volume V that can enter the distal region 34 of the inner tube 28 112 . The size of the material 106 that can enter the distal region 34 of the inner tube 28 is restricted and held in place for further reduction by the cutting action. Additionally, only the material 106 that is reduced in size small enough can pass through the "throat" of the tube assembly 20, after which the reduced material 106 also encounters a larger cross-section of the lumen 30 under the action of suction. The protrusion 112 can be an insert fixed to the lumen 30 of the inner tube 28 or can be formed integrally with the inner tube 28, for example, by deforming the distal region 34 of the inner tube 28, providing a bore that is eccentric to the longitudinal axis 24 of the tube assembly 20, or appropriately milling within the inner tube 28 to define the protrusion 112. The surgical instrument 10 of the present disclosure cuts and aspirates tissue in accordance with a current resector system that utilizes suction. It should be understood that in another embodiment, the surgical instrument 10 can be used with a surgical tool or can be a dedicated tool or instrument.
[0061] It will be further understood that the terms include ("include", "includes", and "including") have the same meaning as the term comprise ("comprise", "comprises", and "comprising").
[0062] The invention has been described in an illustrative manner. It should be understood that the terms used are intended to describe the nature of the words rather than being restrictive. In view of the above teachings, many modifications and variations of the invention are possible. Accordingly, the invention can be practiced otherwise than as specifically described.
[0063] The embodiments of the present disclosure can be described with reference to the following exemplary clauses:
[0064] Clause 1 - A cutting assembly of a surgical instrument for cutting tissue, the cutting assembly being configured to be coupled to a drive assembly that includes a motor having a rotatable drive element encapsulated in a housing, and the cutting assembly including: a rotatable first tube having a lumen with a proximal region and a distal region, the first tube forming a first cutting window in the distal region; a second tube disposed over the first tube, the second tube having a proximal region and a distal region, the second tube forming a second cutting window in the distal region; the first tube being rotatable relative to the second tube; the cross-sectional area of the proximal region of the lumen being greater than the cross-sectional area of the distal region of the lumen such that tissue cut by the interaction of the first cutting window and the second cutting window has a suitable size to permit passage through the first cutting window and the distal region of the lumen to the proximal region of the lumen, thereby preventing blockage of the distal region of the lumen.
[0065] Clause 2 - The cutting assembly according to Clause 1, wherein the proximal region of the lumen has an inner surface and the distal region of the lumen has an inner surface opposite the first cutting window.
[0066] Clause 3 - The cutting assembly according to Clause 2, wherein the inner surface is radially inwardly displaced relative to the inner surface.
[0067] Clause 4 - The cutting assembly according to Clause 2, wherein the inner surface extends radially and axially relative to the inner surface at an angle greater than zero.
[0068] Clause 5 - The cutting assembly according to Clause 2, the cutting assembly including an insert disposed within the distal region of the lumen opposite the first cutting window and forming the inner surface.
[0069] Clause 6 - The cutting assembly according to Clause 5, wherein the insert is bonded to the first tube.
[0070] Clause 7 - The cutting assembly according to Clause 5, wherein the insert includes the inner surface that extends radially and axially relative to the inner surface at an angle greater than zero.
[0071] Clause 8 - The cutting assembly according to Clause 5, wherein the insert has a cross-sectional profile of one of a generally arcuate, semi-circular, and rectangular shape.
[0072] Clause 9 - The cutting assembly according to Clause 5, wherein the insert is made of one or more different materials.
[0073] Clause 10 - The cutting assembly as described in Clause 2, wherein the inner surface is defined by the inner tube in the distal region of the lumen opposite the first cutting window.
[0074] Clause 11 - The cutting assembly as described in Clause 2, wherein the inner surface axially extends from the distal end of the distal region of the lumen to less than the proximal end of the first cutting window and at least one of the proximal ends of the first cutting window.
[0075] Clause 12 - The cutting assembly as described in Clause 11, wherein the axial length of the first cutting window is less than the axial length of one of the inner surface and the second cutting window.
[0076] Clause 13 - The cutting assembly as described in Clause 11, wherein the angle of the inner surface relative to the wall of the distal region of the lumen is between approximately 20 degrees and approximately 90 degrees.
[0077] Clause 14 - The cutting assembly as described in Clause 11, wherein the radial height of the inner surface is greater than the radial height of the inner surface.
[0078] Clause 15 - The cutting assembly as described in Clause 1, the cutting assembly comprising a third tube disposed above the second tube.
[0079] Clause 16 - The cutting assembly as described in Clause 1, wherein the distal region of the lumen has a profile formed by one of a drawing process and a machining process.
[0080] Clause 17 - The cutting assembly as described in Clause 16, wherein the distal region of the lumen has a non-circular cross-section.
[0081] Clause 18 - The cutting assembly as described in Clause 1, wherein the first cutting window includes at least one cutting edge.
[0082] Clause 19 - The cutting assembly as described in Clause 1, the cutting assembly comprising a suction path connected to either the first tube or the second tube.
[0083] Clause 20 - The cutting assembly as described in Clause 1, wherein the cross-section of the distal region of the lumen has a ratio of 1:1.5, 1:3, or 1:6 to the cross-section of the proximal region of the lumen.
[0084] Clause 21 - The cutting assembly as described in Clause 1, wherein the axial length of the first cutting window relative to the diameter of the distal region of the lumen is such that the size of the cut bone fragments is not greater than the diameter of the lumen in the proximal region.
[0085] Clause 22 - A surgical instrument for a patient, the surgical instrument comprising: a cutting assembly including a plurality of axially extending tubes, the tubes including at least one rotatable inner tube having a lumen with a proximal region and a distal region, the inner tube forming an inner cutting window in the distal region, an outer tube disposed over the inner tube, the outer tube having a proximal region and a distal region, the outer tube forming an outer cutting window in the distal region, the inner tube being rotatable relative to the outer tube; a drive assembly including a motor having a rotatable drive element, a housing for enclosing the motor and detachably coupled to the cutting assembly, a suction connector on the housing for connection to a suction source, and a suction passage extending from the inner window through the inner tube and through the housing to the suction connector; a flush connector on the housing for connection to a fluid source; a flush passage extending through the housing between the flush connector and the cutting assembly and between the inner tube and the outer tube to the cutting window to provide lubrication and to flush blood, tissue, and bone; a suction connector on the housing for connection to a suction source; a suction passage extending through the housing between the suction connector and the cutting window of the inner tube; and the cross-sectional area of the proximal region of the lumen being greater than the cross-sectional area of the distal region of the lumen such that tissue cut by the interaction of the inner cutting window and the outer cutting window has a suitable size to permit passage through the inner cutting window and the distal region of the lumen to the proximal region of the lumen, thereby preventing blockage of the distal region of the lumen.
[0086] Clause 23 - A method of operating a surgical instrument on a patient, the method comprising the steps of: providing a cutting assembly including a plurality of axially extending tubes, the tubes including an inner tube having at least one rotatable lumen with a lumen, the lumen having a proximal region and a distal region, the inner tube forming an inner cutting window in the distal region; an outer tube disposed on the inner tube, the outer tube having a proximal region and a distal region, the outer tube forming an outer cutting window in the distal region, the inner tube being rotatable relative to the outer tube; providing a drive assembly including a motor having a rotatable drive element, a housing for encapsulating the motor and detachably coupled to the cutting assembly, a suction connector on the housing for connection to a suction source, and a suction passage extending from the inner window through the inner tube and through the housing to the suction connector; providing a proximal region of the lumen having a cross-sectional area greater than a cross-sectional area of the distal region of the lumen; rotating the inner tube relative to the outer tube by the drive assembly; cutting bone and / or tissue on the patient by an interaction of the inner cutting window and the outer cutting window; and allowing cut bone and / or tissue of a suitable size to pass through the inner cutting window and the distal region of the lumen to the proximal region of the lumen to prevent blockage of the distal region of the lumen.
[0087] Clause 24 - A surgical instrument, cutting assembly, and method as disclosed and described herein, including equivalents not specifically recited herein.
Claims
1. A cutting assembly configured to be removably coupled to a drive assembly of a surgical instrument, the cutting assembly comprising: A tube assembly defining a cutting window and including an outer tube and an inner tube coaxially disposed within the outer tube and defining a lumen in communication with the cutting window, wherein the inner tube is configured to be rotatable relative to the outer tube by the drive assembly; A drive hub including a hub member coupled to a proximal end of the inner tube to define a suction path through the hub member and the inner tube, wherein the hub member defines a first bore and a reduced bore, the inner tube being received within the first bore, the reduced bore being adjacent to the first bore and having an inner diameter smaller than the inner diameter of the first bore to form a lip therebetween, wherein the proximal end of the inner tube abuts the lip, and wherein the diameter of the lumen of the inner tube is smaller than the inner diameter of the reduced bore of the drive hub to prevent reduced material from jamming on the lip at the interface between the inner tube and the drive hub; A connection hub disposed around the inner tube and a portion of the drive hub to allow the drive assembly to be removably coupled to the cutting assembly, wherein the connection hub defines a cavity; And A seal disposed within the cavity.
2. The cutting assembly according to claim 1, wherein, The lip is positioned at the proximal end of the cavity.
3. The cutting assembly according to claim 1, wherein, The smaller cross-sectional portion of the suction path is disposed within the cavity of the connection hub.
4. The cutting assembly according to any one of claims 1 to 3, wherein, The axial length of the inner tube is longer than the axial length of the outer tube such that the inner tube extends beyond the proximal region of the outer tube and into the drive hub.
5. The cutting assembly according to any one of claims 1 to 3, wherein The drive hub includes a hub member disposed around the inner tube, the hub member including a reduced diameter portion and a plurality of ridges radially and axially extending adjacent to the reduced diameter portion and circumferentially spaced apart.
6. The cutting assembly of claim 5, further comprising a spring disposed around the reduced diameter portion of the hub member of the drive hub.
7. The cutting assembly of claim 5, further comprising a seal disposed around the proximal end of the reduced diameter portion of the hub member of the drive hub.
8. The cutting assembly of any one of claims 1 to 3, further comprising a seal disposed at the distal end of the drive hub and around the inner tube.
9. The cutting assembly according to any one of claims 1 to 3, wherein, The connection hub includes a housing hub adapted to be engaged and supported by at least a portion of a user's hand for the outer tube and a coupling member disposed around the inner tube, the coupling member extending axially and being generally cylindrical, wherein the coupling member includes a bore axially extending therethrough to receive the inner tube and a cavity axially extending into the proximal end to receive a fluid coupling.
10. The cutting assembly according to claim 9, wherein, The coupling member includes one or more ridges radially extending at the proximal end and circumferentially spaced apart from each other to couple to a housing of the drive assembly.
11. The cutting assembly according to claim 10, wherein, The coupling member includes one or more grooves radially and circumferentially extending and axially spaced apart from each other and one or more seals disposed within the one or more grooves.
12. The cutting assembly according to any one of claims 1 to 3, wherein, The connection hub is made of a non-metallic material.
13. The cutting assembly according to any one of claims 1 to 3, wherein, The hub member is integral, monolithic, and integrally formed.
Citation Information
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