Conventional microwave ablation systems are used during laparoscopic surgical procedures to treat target tissue, such as a tumor located within the abdomen or pelvis, by delivering microwave energy to the target tissue by way of a percutaneous microwave ablation instrument. The instrument typically includes an elongated tubular member, which has a needle at a distal tip, and which serves as a conduit within which the microwave energy from an energy source, such as a generator, is guided through an incision in the patient and toward the target tissue. The length of the tubular member varies based on application. In some cases, microwave instruments with relatively long tubular members are employed to reach target tissue that is located deep within the body of the patient. Unfortunately, as the length of the tubular member increases, the flexure of the tubular member during operation also increases, thereby reducing or distorting the tactile feedback from a distal tip of the instrument to a handle located at a proximal portion of the instrument. Although stiffness of the tubular member may be increased by increasing a diameter of the tubular member along its entire longitudinal axis, doing so would also result in larger needle track sizes, an increased risk of bleeding and damage to the target tissue, and an increased post-surgery healing time.
In one aspect of this disclosure, a tubular member for a laparoscopic microwave ablation instrument is described. The tubular member includes a proximal portion, a distal portion, and an intermediate portion, which is interposed between the proximal portion and the distal portion. A maximum outer diameter of the proximal portion is greater than or equal to a maximum outer diameter of the intermediate portion. The maximum outer diameter of the intermediate portion is greater than or equal to a maximum outer diameter of the distal portion. And the maximum outer diameter of the proximal portion is greater than the maximum outer diameter of the distal portion
In embodiments, the intermediate portion has an outer diameter at least a portion of which increases in a direction from the distal portion to the proximal portion.
In embodiments, the proximal portion, the distal portion, and the intermediate portion are each tubular, and the proximal portion, the distal portion, and the intermediate portion each have an equivalent inner diameter that remains uniform along a longitudinal axis of the tubular member.
In embodiments, the outer diameter of the distal portion remains uniform along a longitudinal axis of the distal portion.
In embodiments, the outer diameter of the proximal portion remains uniform along a longitudinal axis of the proximal portion.
In embodiments, a length of the distal portion is predetermined based on an expected insertion depth of the distal portion into a target tissue.
In embodiments, a length of the intermediate portion is predetermined based on an expected insertion depth of the intermediate portion into an abdominal cavity of a patient.
In embodiments, the intermediate portion has an outer diameter that increases linearly in a direction from the distal portion toward the proximal portion.
In embodiments, the intermediate portion includes a plurality of subportions, and wherein each of the plurality of subportions has an outer diameter that increases linearly, at a respective angle, in a direction from the distal portion toward the proximal portion.
In embodiments, the intermediate portion has an outer diameter that increases exponentially in a direction from the distal portion toward the proximal portion.
In embodiments, the intermediate portion includes a plurality of subportions, and each of the plurality of subportions has an outer diameter that increases exponentially, at a respective growth rate, in a direction from the distal portion toward the proximal portion.
In embodiments, the intermediate portion includes a first subportion and a second subportion, the first subportion having an outer diameter that increases linearly in a direction from the distal portion toward the proximal portion, and the second subportion having an outer diameter that increases exponentially in the direction from the distal portion toward the proximal portion.
In embodiments, the first subportion and the second subportion are arranged in a direction from the distal portion to the proximal portion.
In embodiments, near a junction between the first subportion and the second subportion, the outer diameter of the second subportion is greater than the outer diameter of the first subportion, thus forming a step at the junction between the first subportion and the second subportion.
In embodiments, the first subportion and the second subportion are arranged in a direction from the proximal portion to the distal portion.
In embodiments, near a junction between the first subportion and the second subportion, the outer diameter of the first subportion is greater than the outer diameter of the second subportion, thus forming a step at the junction between the first subportion and the second subportion.
In embodiments, the intermediate portion has an outer diameter that increases linearly in a direction from the distal portion toward the proximal portion, and, near a junction between the distal portion and the intermediate portion, the outer diameter of the intermediate portion is greater than an outer diameter of the distal portion, thus forming a step at the junction between the distal portion and the intermediate portion.
In embodiments, near a junction between the intermediate portion and the proximal portion, an outer diameter of the proximal portion is greater than the outer diameter of the intermediate portion, thus forming a step at the junction between the intermediate portion and the proximal portion.
In embodiments, the intermediate portion has an outer diameter that increases exponentially in a direction from the distal portion toward the proximal portion, and, near a junction between the distal portion and the intermediate portion, the outer diameter of the intermediate portion is greater than an outer diameter of the distal portion, thus forming a step at the junction between the distal portion and the intermediate portion.
In embodiments, near a junction between the intermediate portion and the proximal portion, an outer diameter of the proximal portion is greater than the outer diameter of the intermediate portion, thus forming a step at the junction between the intermediate portion and the proximal portion.
Various aspects and features of the present laparoscopic microwave instrument tubular members are described herein below with references to the drawings, wherein:
The present disclosure is directed to tubular members for laparoscopic microwave ablation instruments. In general, as described in further detail below, the various tubular members of the present disclosure have geometries, such as geometries with outer diameters that vary along the longitudinal axes of the tubular members, that exhibit increased stiffness, even for relatively large tubular member lengths, thereby minimizing the flexure of the tubular member during operation and improving the tactile feedback from a distal tip of the instrument to a handle located at a proximal portion of the instrument. At the same time, the tubular members of the present disclosure also minimize needle track size and invasiveness, particularly at the distal portion where the tubular member enters target tissue, thereby minimizing the risk of bleeding and damage to the target tissue and minimizing post-surgery healing time.
Throughout this description, the term “proximal” refers to the portion of the device or component thereof that is closer to the clinician and the term “distal” refers to the portion of the device or component thereof that is farther from the clinician. The phrases “in an embodiment,” “in embodiments,” “in some embodiments,” or “in other embodiments” may each refer to one or more of the same or different embodiments in accordance with the present disclosure. A phrase in the form “A or B” means “(A), (B), or (A and B).” A phrase in the form “at least one of A, B, or C” means “(A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C).”
Further, as shown in
The second tubular member 20 has a geometry with an outer diameter 50 that remains substantially constant along a longitudinal axis A of the second tubular member 20. Owing in part to its geometry, the second tubular member 20 may exhibit flexure during operation, for instance, in embodiments where the second tubular member 20 is relatively long (for example, 30 cm). Such flexure reduces and distorts the tactile feedback from the distal tip of the microwave ablation instrument 10 to the handle assembly 46. Although stiffness of the second tubular member 20 may be increased by uniformly increasing the diameter 50 of the second tubular member 20 along an entire length of the second tubular member 20 along the longitudinal axis A, doing so would also result in larger needle track sizes in the target tissue, an increased risk of bleeding and damage to the target tissue, and an increased post-surgery healing time. In embodiments, the various tubular members of the present disclosure have geometries with outer diameters that vary along the longitudinal axes of the tubular members. More particularly, the outer diameters of the tubular members of the present disclosure increase at various rates and at various points along the longitudinal axes thereof in a direction from the distal portion toward the proximal portion. By virtue of their geometries, the various tubular members of the present disclosure exhibit increased stiffness, even for relatively large tubular member lengths, thereby minimizing the flexure of the tubular member during operation and improving the tactile feedback from a distal tip of the instrument to a handle located at a proximal portion of the instrument. At the same time, with relatively small outer diameters at a distal portion, the tubular members of the present disclosure also minimize needle track size, thereby minimizing the risk of bleeding and damage to the target tissue and minimizing post-surgery healing time.
In contrast to the second tubular member 20 of the instrument 10 (
Because the patient skin (for instance, the abdominal or thoracic wall) exhibits a lower risk of complication from larger punctures than internal organs, such as the liver, exhibit, invasiveness in the patient skin 302 region may be increased relative to the invasiveness in the insufflated cavity 304 and target organ 306 regions. Thus, in embodiments, the outer diameter of the proximal portion 202 is larger than the outer diameter of the intermediate portion 204, which itself is larger than the outer diameter of the distal portion 206. In some examples, the outer diameter of the proximal portion 202 ranges from 3 to 5 mm. By enlarging the outer diameter of the tubular member 201 within the proximal portion 202, where the patient skin 302 can bear larger punctures, while minimizing the outer diameter of the tubular member 201 within the distal portion 206, where the target organ 306 fares better with a smaller puncture, the overall stiffness of the tubular member 201 is increased while minimizing the invasiveness at the target organ 306.
In embodiments, a length of the distal portion 206 is predetermined based on an expected insertion depth of the distal portion 206 into the target organ 306, such as a portion of a particular internal organ, or target lesion 308. For example, for a laparotomy or a liver ablation procedure, between approximately 10 cm and 20 cm of the tubular member 201 is expected to be inserted into the liver to reach target tissue. Therefore, in some embodiments, the length of the distal portion 206 may range from 10 cm to 20 cm. A length of the intermediate portion 204 is predetermined based on an expected insertion depth of the intermediate portion 204 into the abdominal cavity 304 of the patient. The length of the proximal portion 202, which is the portion of the tubular member 201 having the largest diameter, is predetermined to provide sufficient stiffness of the tubular member 201 and maneuverability of the instrument 200. In some examples, the length of the proximal portion 202 is approximately 10 cm.
For a tubular member, such as the second tubular member 20 (
Having described certain aspects of the laparoscopic microwave ablation instrument 200 and how the instrument 200 may be used to treat the target lesion 308 in connection with
In designing the geometries of the outer and inner diameters of the tubular member 201 along its longitudinal axis B, various factors may be considered. In particular, the area moment of inertia of a cross-section of a beam is a property used to calculate a beam's deflection and resulting stresses caused by bending that beam. The area moment of inertia of a cylindrical tube (Itube) is defined by Equation 1 below, where OD represents the outer diameter of the tube and ID represents the inner diameter of the tube.
The bending stiffness (K) is the resistance of the tube to bending defined by Equation 2 below, where P represents the applied force and W represents an amount of deflection.
The bending stiffness (K) is a function of the elastic modulus (Etube) of the tube, the area moment of inertia of the tube (Itube), the length of the tube (L) and the boundary/loading condition of the tube. The relationship between the applied moment M (force over a length) and the change in deflection of the tube is given by Equation 3 below.
Substituting for Itube in Equation 3 yields Equation 4 below.
Although increasing the inner diameter may not be as effective, a small increase in the outer diameter (OD) of the majority of the tube leads to a large increase in overall bending moment, in other words, a stiffer tube. This increase in stiffness enables the movement imparted by the user at the handle to be more efficiently translated to the movement of the distal tip, which, as noted above, is particularly useful in laparoscopic surgical procedures.
Accordingly, with continued reference to
In some embodiments, after the tubular member 201 has been formed by pultrusion and grinding, depth indicators 702 are pad printed on an outer surface of the tubular member 201 to indicate to the user, during a surgical procedure, a depth to which the tubular member 201 is inserted into the patient.
After the depth indicators 702 have been printed on the outer surface of the tubular member 201, multiple sizes of heatshrink material 806, 808, 810, 812, 814 are adhered to the outer surface of the tubular member 201. In order to match the geometry of the tubular member 201, each of the heatshrink materials 806, 808, 810, 812, 814 has a particular pre-shrunken diameter and shrunken diameter, and is affixed to a corresponding portion of the tubular member 201 as depicted in view 800. As shown in view 804, heatshrink material is omitted from the angled surface 816. As shown in view 802, hub divider 40 is bonded to portion 402 of the tubular member 201 at locations 818 using epoxy or any suitable adhesive, and area 820 and trocar surface 822 remain unblocked by any epoxy or adhesive.
The outer diameter of the tubular member 201 described and shown in connection with
The intermediate portion 904 of the tubular member 908 has an outer diameter 932 that increases linearly, at a uniform angle 934 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902.
The intermediate portion 904 of the tubular member 910 includes multiple subportions 904a and 904b. The subportions 904a and 904b of the tubular member 910 have outer diameters 936 and 938, respectively, that increase at angles 940 and 942, respectively, with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902.
The intermediate portion 904 of the tubular member 912 has an outer diameter 944 that increases exponentially in a direction from the distal portion 906 toward the proximal portion 902.
The intermediate portion 904 of the tubular member 914 includes multiple subportions 904a and 904b. The subportion 904a of the tubular member 914 has an outer diameter 946 that increases linearly, at an angle 950 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902. The subportion 904b of the tubular member 914 has an outer diameter 948 that increases exponentially in the direction from the distal portion 906 toward the proximal portion 902. Although not shown in
The intermediate portion 904 of the tubular member 916 includes multiple subportions 904a and 904b. The subportion 904a of the tubular member 916 has an outer diameter 952 that increases exponentially in the direction from the distal portion 906 toward the proximal portion 902. The subportion 904b of the tubular member 916 has an outer diameter 954 that increases linearly, at an angle 956 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902. Although not shown in
The intermediate portion 904 of the tubular member 918 has an outer diameter 958 that increases linearly, at an angle 960 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902. Additionally, near a junction between the distal portion 906 and the intermediate portion 904, the outer diameter 958 of the intermediate portion 904 is greater than an outer diameter 964 of the distal portion 906, thus forming a step 962 at the junction between the distal portion 906 and the intermediate portion 904.
The intermediate portion 904 of the tubular member 920 has an outer diameter 966 that increases linearly, at an angle 968 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902. Additionally, near a junction between the intermediate portion 904 and the proximal portion 902, an outer diameter 970 of the proximal portion 902 is greater than the outer diameter 966 of the intermediate portion 904, thus forming a step 972 at the junction between the intermediate portion 904 and the proximal portion 902.
The intermediate portion 904 of the tubular member 922 has an outer diameter 974 that increases linearly, at an angle 976 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902. Additionally, near a junction between the intermediate portion 904 and the proximal portion 902, the outer diameter 970 of the proximal portion 902 is greater than the outer diameter 974 of the intermediate portion 904, thus forming a step 978 at the junction between the intermediate portion 904 and the proximal portion 902. Additionally, near a junction between the distal portion 906 and the intermediate portion 904, the outer diameter 974 of the intermediate portion 904 is greater than the outer diameter 964 of the distal portion 906, thus forming a step 980 at the junction between the distal portion 906 and the intermediate portion 904.
The intermediate portion 904 of the tubular member 924 has an outer diameter 982 that increases exponentially in a direction from the distal portion 906 toward the proximal portion 902. Additionally, near a junction between the proximal portion 902 and the intermediate portion 904 of the tubular member 924, the outer diameter 970 of the proximal portion 902 is greater than the outer diameter 982 of the intermediate portion 904, thus forming a step 984 at the junction between the proximal portion 902 and the intermediate portion 904.
The intermediate portion 904 of the tubular member 926 has an outer diameter 986 that increases exponentially in a direction from the distal portion 906 toward the proximal portion 902. Near a junction between the distal portion 906 and the intermediate portion 904, the outer diameter 986 of the intermediate portion 904 is greater than the outer diameter 964 of the distal portion 906, thus forming a step 988 at the junction between the distal portion 906 and the intermediate portion 904. Additionally, near a junction between the proximal portion 902 and the intermediate portion 904, the outer diameter 970 of the proximal portion 902 is greater than the outer diameter 986 of the intermediate portion 904, thus forming a step 990 at the junction between the proximal portion 902 and the intermediate portion 904.
The intermediate portion 904 of the tubular member 928 includes multiple subportions 904a and 904b. The subportion 904a of the tubular member 928 has an outer diameter 992 that increases linearly, at an angle 994 with respect to the longitudinal axis B, in the direction from the distal portion 906 toward the proximal portion 902. The subportion 904b of the tubular member 928 has an outer diameter 996 that increases linearly, at an angle 998 with respect to the longitudinal axis B, in a direction from the distal portion 906 toward the proximal portion 902. Additionally, near a junction between the subportion 904a and the subportion 904b of the tubular member 916, the outer diameter 992 of the subportion 904a is greater than the outer diameter 996 of the subportion 904b, thus forming a step 1000 at the junction between the subportion 904a and the subportion 904b.
The intermediate portion 904 of the tubular member 930 includes multiple subportions 904a and 904b. The subportion 904a of the tubular member 928 has an outer diameter 1002 that increases exponentially, at a corresponding growth rate, with respect to the longitudinal axis B, in the direction from the distal portion 906 toward the proximal portion 902. The subportion 904a of the tubular member 930 has an outer diameter 1004 that increases exponentially, at a corresponding growth rate (which may be equivalent to, or unequal to, the growth rate at which the outer diameter 1002 of the subportion 904a grows), with respect to the longitudinal axis B, in the direction from the distal portion 906 toward the proximal portion 902.
In addition to the embodiments shown in
The embodiments disclosed herein are examples of the disclosure and may be embodied in various forms. For instance, although certain embodiments herein are described as separate embodiments, each of the embodiments herein may be combined with one or more of the other embodiments herein. Specific structural and functional details disclosed herein are not to be interpreted as limiting, but as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Like reference numerals may refer to similar or identical elements throughout the description of the figures.
The foregoing description is only illustrative of the present laparoscopic microwave ablation instrument tubular members. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figures are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods, and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.