Method for installing the cuff

Abstract

The present disclosure relates to a method for installing a cuff around a target biological structure. The method may include: inserting a guide wire through an incision in a patient and below an outer surface of the target biological structure; guiding a ramp device through the guide wire to a position below the target biological structure so that the target biological structure is partially supported by the ramp device; guiding a cuff deployment tool through the guide wire to the ramp device, the cuff deployment tool including an internal space and a cuff located in the internal space; and deploying the cuff from the cuff deployment tool so that the cuff moves from the internal space to an extended position. In the extended position, at least a portion of the cuff is positioned between the ramp device and the target biological structure.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Application No. 62 / 611,244, filed on December 28, 2017, and U.S. Provisional Application No. 62 / 615,711, filed on January 10, 2018, both of which are incorporated herein by reference in their entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to devices for partially isolating a target biological structure, and more particularly to non-invasive devices and methods for partially isolating and supporting a target biological structure that provide multi-directional access to the target biological structure. Background Art

[0004] Traditionally, laparoscopic surgery is performed through a series of small incisions on a patient (e.g., on the patient's abdomen). During laparoscopic surgical procedures, biological structures such as the splenic artery are often found to be in close proximity to other vascular systems, neural tissue, or organs. In many cases, the surgical procedure requires modifying, ligating, cutting, or attaching a tool to one of these biological structures. Currently, these surgical procedures can be performed with balloon dissection tools to separate tissue at natural tissue plane boundaries. The tissue can be retracted by a gross retractor tool or by a silicone vascular retractor, which may cause trauma to surrounding structures. Therefore, these laparoscopic surgical procedures require devices and techniques that cause less trauma. Summary of the invention

[0005] In some embodiments, the present disclosure relates to a device for partially isolating a target biological structure on a patient. The device may include a body including a front and a back, the body having a proximal end and a distal end. The distal end may be arcuate in a first state and may be substantially flat in a second state. The device may also include one or more balloons disposed on the distal end of the body. Each of the one or more balloons is deflated in the first state, and each of the one or more balloons is inflated in the second state. When each of the one or more balloons is inflated in the second state, the distal end of the body is configured to be deformed into a substantially flat shape. In one aspect, the device may also include an additional balloon on the back of the body, and the additional balloon may be a hemostatic balloon. In another aspect, the one or more balloons include a first balloon on a first side of the body and a second balloon on a second side of the body. In the second state, there is a channel between the first balloon and the second balloon. In the second state, the first balloon and the second balloon support the target biological structure above the front of the body, and the channel is located below the target biological structure.

[0006] In another embodiment, the present disclosure relates to a method. The method may include forming an incision in a patient, inserting a device in a first state through the incision to access a target biological structure on the patient, positioning the device at least partially below the target biological structure on the patient, and transforming the device from the first state to a second state. The device may include a body including a front and a back surface, the body having a proximal end and a distal end. The distal end may be arched in the first state and may be substantially flat in the second state. The device may also include one or more balloons disposed on the distal end of the body. Each of the one or more balloons is deflated in the first state, and each of the one or more balloons is inflated in the second state. When each of the one or more balloons is inflated in the second state, the distal end of the body is configured to be deformed to be substantially flat. In the transformation step, each of the one or more balloons is at least partially inflated, and the target biological structure is at least partially supported by each of the one or more balloons.

[0007] In another embodiment, the present disclosure relates to a device for locating a target biological structure on a patient. The device may include a base plate including a front and a back side, the base plate having a proximal end and a distal end. The base plate includes a first side wall disposed on a first end of the front side and a second side wall disposed on a second end opposite to the front side. There is a channel between the first side wall and the second side wall. The base plate may include an end wall positioned between the first side wall and the second side wall at the distal end of the base plate. The end wall is inclined relative to the proximal end of the base plate. In one aspect, the first side wall, the second side wall, and the end wall each have a constant height defining a channel area, wherein the target biological structure is supported on the first side wall and the second side wall. On the other hand, each of the first side wall and the second side wall includes a recess on a portion of the surface of each of the first side wall and the second side wall opposite to the front side of the base plate.

[0008] In another embodiment, the present disclosure relates to a method. The method may include forming an incision in a patient, inserting a device through the incision to access a target biological structure on the patient, and positioning the device at least partially below the target biological structure on the patient. The device may include a substrate plate including a front and a back side, the substrate plate having a proximal end and a distal end. The substrate plate includes a first side wall disposed on a first end of the front side and a second side wall disposed on an opposite second end of the front side. There is a channel between the first side wall and the second side wall. The substrate plate includes an end wall, which is positioned between the first side wall and the second side wall on the distal end of the substrate plate. The end wall is inclined relative to the proximal end of the substrate plate. The target biological structure is at least partially supported on the first side wall and the second side wall above the substrate plate. In one aspect, the back side of the substrate plate may include a pipeline configured to receive a guide wire. The step of positioning the device includes passing the device through the guide wire to the target biological structure.

[0009] In another embodiment, the present invention relates to a method. The method includes inserting a guide wire through an incision on a patient toward the outer surface of a target biological structure. After inserting the guide wire, a ramp device can be guided to a position below the target biological structure via the guide wire so that the target biological structure is partially supported by the ramp device. The ramp device can have a bend relative to the long axis of the guide wire. After guiding the ramp device, a cuff deployment tool is guided to the ramp device via the guide wire. The cuff deployment tool may include an internal space and a cuff located in the internal space. After the cuff deployment tool is guided to the ramp device via the guide wire, the cuff is deployed from the cuff deployment tool so that the cuff moves from the internal space to an extended position. In the extended position, at least a portion of the cuff is positioned between the ramp device and the target biological structure.

[0010] In another embodiment, a method is provided. The method includes forming a first incision and a second incision on the skin of a patient, and placing a first trocar in the first incision and placing a second trocar in the second incision. Then, the area below the patient's skin can be inflated to access the target biological structure. After inflating, a guide wire can be guided through the first trocar to a position below the target biological structure to the second trocar. The guide wire can have a proximal end and a distal end, wherein the distal end of the guide wire can be fixed at the second trocar. After fixing the distal end of the guide wire, a balloon tool is guided to a position below the target biological structure through the guide wire. The balloon tool can include a balloon, and when the balloon tool is in a position below the target biological structure, the balloon can be inflated to provide pressure to the target biological structure. After removing the balloon, a ramp device can be guided to a position below the target biological structure through the guide wire so that the target biological structure is partially supported by the ramp device. The ramp device can include an end wall having a bend relative to the long axis of the guide wire. After the ramp device is guided to the target biological structure, a cuff deployment tool is guided to the ramp device via a guide wire. The cuff deployment tool may include an interior space and a cuff located in the interior space. After the cuff deployment tool is guided to the ramp device via a guide wire, the cuff is deployed from the cuff deployment tool so that the cuff moves from the interior space to an extended position. In the extended position, at least a portion of the cuff is positioned between the ramp device and the target biological structure.

[0011] These illustrative embodiments are not mentioned to limit or define the scope of the present disclosure, but to provide examples to aid understanding thereof. Illustrative embodiments are discussed in the detailed description that provides further description. By reviewing this specification, the advantages provided by various embodiments can be further understood. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more specific embodiments and, together with the description of the embodiments, serve to explain principles and examples of certain embodiments.

[0013] Figure 1 A front perspective view of a device according to one embodiment of the present invention is shown.

[0014] Figure 2 A rear perspective view of a device according to one embodiment of the present invention is shown.

[0015] Figure 3 A perspective view of a device according to another embodiment of the invention is shown in a first state.

[0016] Figure 4 A perspective view of a device in a second state is shown according to an embodiment of the present invention.

[0017] Figure 5 A rear perspective view of a device in a second state is shown according to another embodiment of the invention.

[0018] Figure 6 A device for supporting a target biological structure according to one embodiment of the present invention is shown.

[0019] Figure 7 A front perspective view of a device according to another embodiment of the present invention is shown.

[0020] Figure 8 A top view of a device according to one embodiment of the present invention is shown.

[0021] Fig. 9 A rear perspective view of a device according to one embodiment of the present invention is shown.

[0022] Fig.10 Shown is the skin of a patient and a target biological structure beneath the skin in accordance with one embodiment of the present invention.

[0023] Fig.11 A trocar is shown inserted into an incision in the skin according to one embodiment of the present invention.

[0024] Fig.12 An insufflation area beneath the skin is shown according to one embodiment of the present invention.

[0025] Fig.13 A laparoscopic tool is shown inserted through a trocar to create a path to a target biological structure according to one embodiment of the present invention.

[0026] Fig.14 A guidewire is shown inserted through a first trocar into a target biological structure according to one embodiment of the present invention.

[0027] Fig.15 A guidewire is shown inserted from a first trocar into a position beneath a target biological structure in accordance with one embodiment of the present invention.

[0028] Fig.16 A guidewire secured at a second trocar is shown according to one embodiment of the present invention.

[0029] Fig.17 A balloon tool is shown inserted over a guidewire through a first trocar, according to one embodiment of the present invention.

[0030] Fig.18 A balloon tool is shown at a location along a guidewire in accordance with one embodiment of the present invention.

[0031] Fig.19A balloon tool is shown being guided to a position beneath a target biological structure in accordance with one embodiment of the present invention.

[0032] Fig. 20 A balloon tool is shown being introduced to a second trocar, in accordance with one embodiment of the present invention.

[0033] Fig.21 A balloon tool according to one embodiment of the present invention is shown.

[0034] Fig. 22 A ramp device is shown introduced over a guidewire through a first trocar, according to one embodiment of the present invention.

[0035] Fig.23 A ramp arrangement is shown at a location along a guidewire according to one embodiment of the present invention.

[0036] Fig.24 A ramp device is shown being directed to a position beneath a target biological structure according to one embodiment of the present invention.

[0037] Fig.25 A cuff deployment tool is shown introduced over a guidewire through a first trocar, according to one embodiment of the present invention.

[0038] Fig.26 A cuff deployment tool is shown at a location along a guidewire in accordance with one embodiment of the present invention.

[0039] Fig. 27 A cuff deployment tool is shown engaged with a ramp device at a location partially underlying a target biological structure in accordance with one embodiment of the present invention.

[0040] Fig.28 A retainer wire is shown being removed from a cuff deployment tool to deploy a cuff in accordance with one embodiment of the present invention.

[0041] Fig.29 A cuff wrapped around a target biological structure is shown according to one embodiment of the present invention.

[0042] Fig.30 A cuff deployment tool according to one embodiment of the present invention is shown.

[0043] Fig.31 Removal of the cuff deployment tool via a first trocar is shown in accordance with one embodiment of the present invention.

[0044] Fig.32 Removal of a balloon tool using a medical tool is shown according to one embodiment of the present invention.

[0045] Fig.33 Removal of a ramp device using a medical tool is shown according to one embodiment of the present invention.

[0046] Fig.34 Removal of the guidewire via a first trocar is shown according to one embodiment of the present invention.

[0047] Fig.35 A target biological structure with a cuff is shown according to one embodiment of the present invention. DETAILED DESCRIPTION

[0048] Those skilled in the art will recognize that the following description is illustrative only and is not intended to be limiting in any way. Reference will now be made in detail to embodiments of the present invention as shown in the accompanying drawings. The same reference numerals will be used throughout the accompanying drawings and the following description to refer to the same or similar items.

[0049] The present disclosure relates to devices that allow a user to partially isolate and access a target biological structure on a patient. As used herein, the phrase "target biological structure" refers to any type of vasculature, artery, tissue, or organ. As used herein, the term "patient" refers to any multicellular organism, such as an animal (e.g., a human).

[0050] In the illustrative embodiments discussed below, the device may be discussed in the context of locating an artery in a neurovascular bundle near the pancreas. However, the devices and methods disclosed herein may be used in any laparoscopic surgical procedure. The device enables a user to partially isolate a target biological structure from surrounding structures, i.e., partially pull or separate the target biological structure from the surrounding structures, without causing trauma to the surrounding structures or the target biological structure. The device also supports the target biological structure in a manner that provides multi-directional access to an area of ​​the target biological structure.

[0051] In some embodiments, the device can be used during laparoscopic surgery. Laparoscopic surgery can be performed through a very small incision in the patient's abdomen, which is usually used to provide an entrance for a trocar or cannula device. After the incision, in order to expand the abdominal cavity to provide space for performing laparoscopy, gas can be insufflated into the patient's abdomen. In this example, the device can be inserted through a small incision so that a user (e.g., a surgeon) can position and support the target biological structure thereon. While the target biological structure is supported on the device, the user can manipulate (e.g., modify, ligate, cut) the target biological structure or attach a tool to the target biological structure.

[0052] Device

[0053] Figure 1 and Figure 21 and 10. The front perspective view and rear perspective view of a device according to an embodiment of the present invention are shown respectively. The device 100 may include a body 102, and the body 102 includes a front side 104 and a back side 106. The body 102 has a proximal end 108 and a distal end 110. The distal end 110 of the body 102 is substantially arcuate. As used herein, the term "proximal end" refers to a first end of the body, and the term "distal end" refers to a second end opposite to the first end. For example, the proximal end may be the end of the body closest to the user, and the distal end may be the end of the body farthest from the user.

[0054] The proximal end 108 of the body 102 is substantially flat and planar relative to the distal end 110. In some embodiments, the proximal end 108 may include a handle 112. The handle 112 may be removably attached to the proximal end 108. In some embodiments, the handle 112 may be an articulated handle. In use, a user may use a hemostat to grasp the handle 112 of the device 100. In other embodiments, the handle 112 may include a through hole to allow a suture used as a holding line to pass through. In other embodiments, the handle 112 may be provided on the distal end 110 of the body 102.

[0055] The distal end 110 of the body 102 is substantially arcuate, that is, the distal end 110 has a curvature that is transverse to the longitudinal axis of the proximal end 108. For example, arcuate can refer to that the distal end 110 is formed or bent in an arc or bow relative to the proximal end 108 of the body 102. In some embodiments, the distal end 110 can have a constant curvature. In other embodiments, the distal end 110 can have a varying degree of curvature. The distal end 110 enables the device 100 to pull away and isolate the target biological structure from the surrounding structures. For example, the distal end 110 can be positioned in a manner to lift and separate the target biological structure from the surrounding tissue. In some embodiments, the distal end 110 of the device 100 can be used to separate the splenic artery from the neurovascular bundle adjacent to the pancreas.

[0056] In some embodiments, the distal end 110 is deformable so that the distal end 110 deforms in response to a sufficient force applied to the distal end 110. In particular, the distal end 110 can be deformed by the applied force to adjust the curvature of the distal end 110. In this way, the curvature of the distal end 110 can be adjusted for different surgical operations. Initially, the distal end 110 is arcuate. The distal end 110 of the body 102 with a chamfered edge can be sufficiently curved so that it does not cause trauma to surrounding structures. For example, the corners of the distal end are rounded.

[0057] The device 100 can be formed of a flexible polymer material such as a thermoplastic polymer. For example, the device 100 can be formed of a strong, lightweight plastic material such as polyetheretherketone (PEEK) or polyurethane. The device 100 can also be formed of other flexible medical grade plastic materials. In some embodiments, the device can be formed of a forgeable metal such as stainless steel or aluminum. In other embodiments, the device 100 is formed of a rigid material so that it is substantially not deformed by an applied force.

[0058] In one embodiment, the device 100 can be used to isolate the splenic artery from the pancreas. In a laparoscopic surgical procedure, after a target biological structure, such as the splenic artery, is separated from the pancreas, there is a space, such as about 3 mm to 12 mm, between the target biological structure and the pancreas. When a medical tool is inserted into the space between the target biological structure and the pancreas, the medical tool may contact the surrounding biological structures and cause damage. In this regard, the device 100 can be used as a pad under the target biological structure. This allows the user to apply force to the device 100 and deviate the force from the target biological structure or surrounding structures. The device 100 distributes a portion of the force to the structure below the target biological structure, such as the pancreas. After the surgical procedure is completed, the device 100 can be removed from the area so that it no longer supports the splenic artery. The device 100 can then be removed from the patient via an incision.

[0059] Inflatable device

[0060] In another embodiment, the device may include one or more balloons disposed on the body, the one or more balloons being configured to transition the device between a first state and a second state. Figure 3 The device is shown in a first state according to one embodiment. In this embodiment, the device 100 isolates the target biological structure from the surrounding structure and supports the target biological structure. As described above, the device 100 can include a body 102, which includes a front side 104, a back side 106, a proximal end 108, and a distal end 110.

[0061] In this embodiment, the device 100 includes one or more balloons 114, 115 disposed on the distal end 110 of the body 102. In some embodiments, the one or more balloons 114, 115 are disposed in a lateral position of the body 102. In a first state, the one or more balloons 114, 115 are deflated. In this configuration, the distal end 110 is substantially arcuate. In some embodiments, each of the one or more balloons 114, 115 includes a recess 118 on a portion of the surface of the balloon opposite to the front face 104 of the body 102. The recess 118 provides a space for holding a target biological structure on the device 100 above the front face 104 of the body 102.

[0062] Figure 4 The device is shown in a second state according to one embodiment. In the second state, the one or more balloons 114, 115 are inflated (as described below). The distal end 110 of the body 102 is configured to deform to be substantially flat when each of the one or more balloons 114, 115 is inflated. As the one or more balloons 114, 115 are inflated, the increased pressure from the one or more balloons 114, 115 applies a force sufficient to flatten the distal end 110 of the body 102. For example, the one or more balloons are inflated to a pressure that flattens the distal end 110 to a substantially flat, flat position flush with the proximal end 108. In another embodiment, the distal end 110 of the body 102 is deformed, but may still have some curvature.

[0063] In some embodiments, the device 100 includes one or more channels that attach each of the one or more balloons 114, 115 to an inflation controller configured to inflate the one or more balloons. For example, the channel can be a thin catheter that can supply fluid to the one or more balloons 114, 115 via a pump or syringe. In some embodiments, a bifurcated catheter ("Y-tube") can be attached to each of the one or more balloons through a lower fitting. The distal end of the catheter can be attached to the one or more balloons 114, 115, and the proximal end of the catheter can be attached to a pump or a fluid-filled syringe. The pump or syringe can inflate the one or more balloons 114, 115 by filling the one or more balloons 114, 115 with fluid to a desired degree of expansion or pressure, and then deflate the balloon by withdrawing the fluid.

[0064] In some embodiments, the one or more balloons 114, 115 are angioplasty balloons made of relatively strong but generally elastic materials that can be folded into a compact small diameter cross-section. Due to the need for strength and rigidity, the one or more balloons 114, 115 can be rated as high pressure depending on the diameter. In other embodiments, the one or more balloons 114, 115 include a soft, very elastic material (e.g., natural rubber latex) as a balloon. Latex and other highly elastic materials will usually continue to expand when the internal pressure increases until the material ruptures. As a result, these balloons are usually rated by volume so that they can be appropriately expanded to the desired size. Although these balloons are relatively fragile, they do have the following advantages: after inflation and subsequent deflation, they tend to easily return to their initial size and scale. It can also be considered that the balloon can also be made of any medical grade balloon material (e.g., polyurethane or polyethylene terephthalate). In some embodiments, the one or more balloons 114, 115 are relatively small, such as having a diameter in the range of 1 mm to 5 mm and a length in the range of 5 mm to 30 mm.

[0065] In some embodiments, each of the one or more balloons 114, 115 is provided in an elastic cover. When each of the one or more balloons 114, 115 is inflated in the second state, the elastic cover expands to the size of the balloon. During inflation, the one or more balloons 114, 115 apply a force to deform the distal end of the body 102. In some embodiments, the inflation of the one or more balloons 114, 115 deforms the distal end 110 of the body 102 from an arched configuration to a substantially flat flat configuration.

[0066] Figure 5 A rear perspective view of the device in a second state according to one embodiment is shown. In some embodiments, the back side 106 of the body 102 includes an additional balloon 116. The additional balloon 116 can be a hemostatic balloon. In some embodiments, the additional balloon 116 is inflated in the first state and deflated in the second state. During the surgical procedure, if any bleeding occurs, the additional balloon 116 can apply pressure to stop any bleeding. In this regard, the additional balloon 116 can be selectively inflated and deflated during the laparoscopic surgical operation. After the bleeding has stopped, the additional balloon 116 can be deflated. The additional balloon 116 can also include a channel attached to the inflation controller as described above. In some embodiments, the channel for the additional balloon 116 is separated from the channel of the one or more balloons 114, 115. The additional balloon 116 can be inflated independently via the inflation controller.

[0067] Figure 6A target biological structure supported on a device according to one embodiment is shown. In one embodiment, the one or more balloons 114, 115 include a first balloon 114 on a first side of the body 102 and a second balloon 115 on a second side of the body 102. The first side and the second side are edges between the proximal end 108 and the distal end 110 of the body 102. In a second state, there is a channel 120 between the first balloon 114 and the second balloon 115. In the second state, the first balloon 114 and the second balloon 115 support the target biological structure 122 above the front face 104 of the body 102. The channel 120 is located below the target biological structure 122 to allow the tool to reach the target biological structure from multiple directions.

[0068] In use

[0069] In one embodiment, a method for partially isolating a target biological structure is provided. The method may include forming an incision in a patient. In some embodiments, the incision is a laparoscopic incision in the abdominal region of the patient. In use, the device can be introduced into the abdominal cavity of the patient through the incision or alternatively through a trocar or cannula device inserted into the incision to hold the incision open.

[0070] After forming the incision, the device in the first state is inserted through the incision to reach the target biological structure. For example, the device can be inserted into the target biological structure through the incision by threading the device on the guide wire. In some embodiments, the device can be a device having one or more of the above-mentioned features. For example, the device may include a main body and one or more balloons arranged on the distal end of the main body. The main body may include a front and a back side with a proximal end and a distal end. The distal end of the device may have a first state and a second state, wherein the distal end is arched in the first state and is substantially flat in the second state. In the first state, each of the one or more balloons can be deflated. In the second state, each of the one or more balloons can be inflated. The distal end of the main body is configured to deform to be substantially flat when each of the one or more balloons on the front side is inflated in the second state.

[0071] After the device is inserted through the incision, the device is at least partially positioned below the target biological structure on the patient. For example, the distal end is positioned below the target biological structure. Then, the device is transformed from the first state to the second state by at least partially inflating each of the one or more balloons. The inflation of the one or more balloons applies pressure to the distal end, which flattens the distal end into a substantially flat structure that is flush with the flat proximal end. After inflation, the target biological structure is at least partially supported by each of the one or more balloons. In some embodiments, the transition from the first state to the second state is also caused by inflating an additional balloon disposed on the back of the body, wherein the additional balloon is a hemostatic balloon. In some embodiments, the hemostatic balloon is inflated prior to each of the one or more balloons.

[0072] In some embodiments, the one or more balloons include a first balloon on a first side of the body and a second balloon on a second side of the body. The first side and the second side are between the proximal end and the distal end of the body. In the second state, there is a channel between the first balloon and the second balloon. The target biological structure can be supported on the first balloon and the second balloon above the channel. In some embodiments, the method can also include inserting a tool into the channel to access the target biological structure.

[0073] In some embodiments, the device can remain substantially rigid at room temperature, and its insertion through an incision or trocar is smooth and unimpeded. However, once the device is inserted into the abdomen, the flexible thermoplastic material of the device may become more susceptible to deformation. The change in the stiffness of the device may be attributed to the relationship between the properties of the material constituting the device (e.g., glass transition temperature) and the patient's body temperature. In this regard, this situation can be avoided if the device is made of PEEK plastic, which has a relatively high glass transition temperature.

[0074] According to this embodiment, the device can be inserted into the patient's abdomen through a small incision in a first state. Then, when the device is positioned near the target biological structure, the balloon of the device can be inflated in a second state. In the second state, the balloon on the body is inflated and serves both to isolate and support the target biological structure thereon. Finally, the balloon can be deflated back to the first state and removed through the incision.

[0075] In use, the device isolates and locates the target biological structure. In the second state, the one or more balloons act to flatten the distal end of the device. The one or more balloons elevate the target biological structure above the front face of the body and provide a channel under the target biological structure. The back face includes a hemostatic balloon to provide pressure around the retractor body to stop bleeding from surrounding structures.

[0076] It is recognized that the device can be constructed in a variety of configurations that meet the primary purpose of providing an inflatable non-traumatic laparoscopic device. The above-described device can be used in a variety of applications using conventional trocar and cannula designs in the range of about 5-12 mm. Of course, the size of the device and the specific shape of the device (including the balloon) can be specifically adapted to address a particular situation.

[0077] Rigid device

[0078] Figure 7 and Figure 8 2 and 3 show a front view and a top view of a device according to another embodiment, respectively. The device 200 includes a base plate 202, which includes a front side 204, a back side 206, a proximal end 208, and a distal end 210. On the front side 204 of the base plate 202, a first side wall 212 is disposed on a first end, and a second side wall 214 is disposed on an opposite second end. In some embodiments, the device 200 includes a single unitary structure formed of a thermoplastic material (as described above). In other embodiments, the device 200 is formed of a non-deformable rigid material.

[0079] The device 200 also includes an end wall 216 on the distal end 210 of the base plate 202. In some embodiments, the end wall 216 is between the first side wall 212 and the second side wall 214 on the distal end 210 of the base plate 202. The end wall 216 is inclined relative to the proximal end 208 of the base plate 202. The proximal end 208 of the base plate 202 is substantially flat. In some embodiments, the end wall 216 has an inclination of at least 30 degrees or more relative to the proximal end 208, such as 40 degrees or more, 50 degrees or more, 60 degrees or more, 70 degrees or more, 80 degrees or more, or 90 degrees or more. In some embodiments, the end wall 216 can have an arcuate curvature. The end wall 216 spans the width of the base plate 202 and bridges the first side wall 212 and the second side wall 214 at the distal end 210 of the base plate 202.

[0080] The first sidewall 212 and the second sidewall 214 form a channel 218 therebetween. The channel 218 is an area between the sidewalls that provides a path to a target biological structure. In some embodiments, the first sidewall 212 and the second sidewall 214 each include a recess 220 on a portion of a surface of each of the first sidewall 212 and the second sidewall 214 opposite the front face 204 of the base plate 202. The recess 220 is configured to isolate and support the target biological structure above the channel 218. The target biological structure can be a vessel, artery, nerve, tissue, or organ of a patient.

[0081] In some embodiments, the proximal ends of the first side wall 212 and the second side wall 214 are substantially perpendicular to the proximal end 208 of the base plate 202. The proximal ends of the first side wall 212 and the second side wall 214 can each include a nose-like structure (e.g., a rounded protrusion) to separate tissue and other vasculature from the target biological structure. The proximal end 208 of the base plate 202 is substantially flat. In some embodiments, the device 200 can include a handle on the proximal end 208 of the base plate 202. For example, the handle can be a grasping forceps configured to be grasped by a Maryland forceps.

[0082] Fig. 9 A rear perspective view of a device according to another embodiment is shown. Fig. 9 As shown, the device 200 may also include a conduit 222 on the back side 206 of the base plate 202. The conduit 222 may extend the entire length of the base plate 202. The conduit 222 is configured to receive a guide wire passing therethrough. In this way, the device 200 may be passed through the guide wire to the target biological structure.

[0083] In one embodiment, a method for partially isolating a target biological structure is provided. The method may include forming an incision in a patient. In use, the device may be introduced into the patient's abdominal cavity through a laparoscopic incision or alternatively through a trocar or cannula device inserted into the incision in the patient.

[0084] After the incision is formed, the device is inserted through the incision to access the target biological structure. In some embodiments, the back side of the base plate includes a conduit configured to receive a guide wire. In this way, the device can be inserted into the target biological structure through the incision by threading the device over the guide wire. In some embodiments, the device includes: a base plate, including a front side and a back side, the base plate having a proximal end and a distal end; a first side wall positioned on a first end of the front side and a second side wall disposed on an opposite second end of the front side, wherein a channel exists between the first side wall and the second side wall; and an end wall positioned on the distal end of the body between the first side wall and the second side wall. The end wall is inclined relative to the proximal end of the base plate.

[0085] After the device is inserted through the incision, the device is positioned at least partially below the target biological structure on the patient. The target biological structure is supported on the first side wall and the second side wall above the base plate. In some embodiments, the first side wall and the second side wall include a recess that is used to isolate the target biological structure above the channel formed between the side walls. The user can insert a tool into the channel to access the target biological structure. In some embodiments, the angle of the tool can be adjusted by contacting the tool with the end wall.

[0086] The design of each device advantageously allows a user to partially isolate a target biological structure and more easily reach all areas of the target biological structure from multiple directions. In this way, during a laparoscopic surgical procedure, the user can modify the target biological structure, such as ligating, cutting the target biological structure, or attaching tools to the target biological structure. The device advantageously allows a user to separate tissue and surrounding structures from the target biological structure, position and hold the target biological structure, create a working space under and around the target biological structure and end walls for steering surgical tools.

[0087] Method for placing a cuff on a target biological structure

[0088] The present disclosure also relates to a method for placing a cuff on a target biological structure on a patient. In some embodiments, the method provides access to a target biological structure (e.g., a splenic artery) using a laparoscopic device guided by a guidewire. The method provides a non-invasive technique for supporting a target biological structure and partially isolating it from surrounding biological structures (e.g., a pancreas) to place a cuff around the target biological structure. For example, the method can temporarily lift a target biological structure away from surrounding biological structures to place one or more cuffs on the target biological structure with minimal damage to the surrounding biological structures.

[0089] In the illustrative embodiments discussed below, the method may be discussed in the context of locating an artery (e.g., the splenic artery) in a neurovascular bundle near the pancreas. However, the method disclosed herein may be used in any laparoscopic surgical procedure. The method enables a user to partially isolate a target biological structure from surrounding structures, i.e., partially pull or separate the target biological structure from the surrounding structures, to place a cuff thereon without causing trauma to the surrounding structures or the target biological structure.

[0090] Figure 10-13 An exemplary embodiment of preparing a surgical site (eg, splenic artery) for surgery is shown. More specifically, a ramp device and a cuff device are used to isolate a target biological structure to enable surgical access to at least a portion of the target biological structure from its surrounding biological environment. Figure 10-29 and Figure 31-35 The steps to perform this isolation are shown.

[0091] Fig.10The patient's skin 300 and a target biological structure 310 beneath the skin are shown. The method can begin by making one or more incisions on the patient's skin 300 to access the target biological structure 310 beneath the skin 300. In one example, the one or more incisions can be near the patient's abdominal area. In some embodiments, the one or more incisions can have a diameter in the range of 1 mm to 10 mm (e.g., 2 mm to 8 mm or 4 mm to 6 mm).

[0092] Fig.11 Trocars are shown inserted into two incisions on the patient's skin 300. After the incisions through the skin 300 are formed, the incisions can be enlarged with a medical tool such as a scalpel to accommodate a trocar 320, 325 in each incision. Trocars used in this method, such as a first trocar 320 and a second trocar 325, typically include a hollow hole cannula. The ends of the trocars 320, 325 can be multi-faceted beveled or conical. The ends of the trocars 320, 325 are inserted into the incisions and can be forced through the underlying fascial layer, such as in the abdomen, using downward pressure and drilling motions. For example, the abdominal wall can be pierced to form an incision, and then the tubular trocar can be inserted into the abdominal cavity.

[0093] Fig.12 An insufflation area under the skin 300 is shown according to one embodiment of the present invention. After the cannula needles 320, 325 are inserted into the incision, the space under the skin 300 is insufflated. The insufflation may include the introduction of a gas (e.g., CO2 gas). In some embodiments, an insufflation device for delivering gas is inserted into the cannula needles 320, 325 to expand the surgical area that touches the target biological structure 310. In some embodiments, when an incision is made in the patient's abdominal cavity, a needle is inserted through one or more cannula needles. The needle may include a sharp needle with a lumen. By insufflating the area under the skin, it can retract the anterior abdominal wall, exposing the surgical area for the target biological structure.

[0094] Fig.13A laparoscopic tool 326 is shown placed through the trocars 320, 325 to create a path to the target biologic structure 310, according to one embodiment of the present invention. In some embodiments, after insufflation, the method can include manually dissecting a biologic structure using one or more laparoscopic tools 326 to create a path to the target biologic structure 310. The laparoscopic tools 326 can dissect an area beneath the skin 300 to provide a path to the target biologic structure 310. For example, a laparoscopic tool 326, such as a grasper, can be inserted through each of the trocars 320, 325 to move or dissect a biologic structure along a natural tissue plane, thereby providing access to the target biologic structure 310. In other embodiments, laparoscopic tools, such as graspers, dissectors, scissors, retractors, etc., are placed through the trocars for a user, such as a surgeon, to manipulate the surgical field or target biologic structure.

[0095] Figure 14-16 The path of the guide wire 330 is shown as it is inserted through the first trocar 320 to a position below the target biological structure 310 and then reaches the second trocar 325. The guide wire 330 can be inserted through the one or more trocars 320, 325 to provide a route for a medical tool to reach the target biological structure 310. For example, Fig.14 A guidewire 330 is shown inserted through the first trocar 320 toward the outer surface of the target biological structure 310. In some embodiments, the guidewire 330 is threaded through the path after manual dissection with laparoscopic tools.

[0096] Fig.15 A guidewire 330 is shown passing under and around a target biological structure 310. The guidewire 330 includes a proximal end and a distal end. The proximal end can be the end of the guidewire 330 closest to the user, and the distal end can be the end of the guidewire 330 farthest from the user. The distal end of the guidewire 330 can be inserted into the target biological structure 310 through the first trocar 320. In some embodiments, the distal end of the guidewire 330 includes a non-traumatic tip 332. The non-traumatic tip 332 at the distal end can have a bend relative to the long axis of the guidewire 330. For example, the tip of the distal end can be a soft J-shaped tip. In some embodiments, the distal end of the guidewire 330 is configured to pass under and around the target biological structure 310.

[0097] Then, from a location beneath the target biological structure 310 , the guidewire 330 is threaded to a second trocar 325 . Fig.16 A guide wire 330 is shown passing from the first trocar 320 to a position below the target biological structure 310 to the second trocar 325. The guide wire 330 can be passed around the target biological structure 310 to the second trocar 325. Fig.16As shown, a laparoscopic tool such as a grasping forceps can be inserted through the second trocar 325 to secure the distal end of the guidewire 330. The grasping tool can guide the distal end of the guidewire 330 toward the second trocar 325. In some embodiments, tension can be applied to the guidewire 330 to move or position the target biological structure 310 away from surrounding biological structures.

[0098] Figure 17-20 330 from the first trocar 320 to a position below the target biological structure 310 to reach the second trocar 325. Specifically, the balloon tool 340 can be inserted through the first trocar 320 through the guide wire 330 ( Fig.17 The balloon tool 340 is guided through the guide wire 330 ( Fig.18 ) to a position below the target biological structure 310 ( Fig.19 ). The balloon tool 340 includes a balloon that can be inflated to provide pressure to the target biological structure 310 when the balloon tool 340 is in position below the target biological structure 310. In this way, the balloon tool 340 can be used to separate the target biological structure 310 from surrounding biological structures (e.g., tissues, organs, or other vasculature). In particular, the balloon tool is capable of dissecting a blind area behind the target biological structure 310 without using conventional blunt dissection equipment.

[0099] In some embodiments, the balloon of the balloon tool 340 can be selectively inflated and deflated at multiple locations along the guidewire 330. For example, the balloon can be a hemostatic balloon that is inflated at multiple locations along the guidewire 330. The balloon is guided along the guidewire path along the natural tissue plane to the target biological structure 310 and beneath the target biological structure 310 to separate the biological structure. Finally, the balloon can be deflated and removed from the patient through the second trocar 325 ( Fig. 20 ).

[0100] Fig.21 One embodiment of a balloon tool is shown. In some embodiments, the balloon tool can be integrated with an over-the-wire dilatation catheter. The over-the-wire dilatation catheter tool can follow the guidewire down to the target biological structure, and the balloon tool can be inflated and deflated at different locations along the guidewire. The dilatation catheter can include a tapered end to easily move along the guidewire without damaging the surrounding biological structure. When the dissection is completed, the deflated balloon can be removed with the dilatation catheter.

[0101] Figure 22-24 A ramp device 350 is shown being guided over a guidewire 330 from a first trocar 320 to a position beneath a target biological structure 310 in accordance with an embodiment of the present invention. Fig. 22 and Fig.23 The ramp device 350 is shown inserted through the first trocar 320 to a position along the guide wire over the guide wire 330. The ramp device 350 may include a back side with a conduit for receiving the guide wire. Ultimately, the ramp device 350 passes from the first trocar 320 over the guide wire 330 to a position below the target biological structure 310, so that the target biological structure 310 is partially supported by the ramp device 350.

[0102] like Fig.23 As shown, the ramp device 350 is at a position along the guide wire 330. In this position, an external device, such as a push tool 355, can be inserted through the first trocar 320 to push the ramp device 350 along the guide wire 330. In some embodiments, the ramp device 350 can include an elastomeric material. The elastomeric material can be a flexible material that enables the ramp device 350 to deform to pass through the first trocar 320, but once it passes through the first trocar 320, it rebounds back to its original form. The ramp device 350 can have a bend relative to the long axis of the guide wire 330. In some embodiments, the ramp device 350 can be any of the above-mentioned devices.

[0103] Fig.24 A ramp device 350 is shown partially below the target biological structure 310. In some embodiments, the ramp device 350 includes a first sidewall and a second sidewall positioned opposite the first sidewall. The first sidewall and the second sidewall form a cavity or channel between them. When the ramp device 350 is positioned below the target biological structure 310, a portion of the target biological structure 310 extends from being positioned on the first sidewall to extending across the cavity to being positioned on the second sidewall. In this way, a portion of the target biological structure 310 is supported on the ramp device 350.

[0104] Figure 25-27 A cuff deployment tool 360 is shown being guided over a guidewire 330 to a target biological structure 310 in accordance with an embodiment of the present invention. Fig.25 The cuff deployment tool 360 is shown introduced through the first trocar 320 over a guidewire. The cuff deployment tool 360 may include an interior space and a cuff 370 located within the interior space. The cuff 370 in the cuff deployment tool 360 may be deployed such that the cuff 370 moves from within the interior space to an extended position. In the extended position, at least a portion of the cuff 370 is positioned between the ramp device 350 and the target biological structure 310.

[0105] The cuff deployment tool 360 is guided along the guide wire 330 to a position beneath the target biological structure 310. For example, Fig.26The cuff deployment tool 360 is shown at a position along the guidewire 330. In this position, an external device such as a push tool 355 can be inserted through the first trocar 320 to push the cuff deployment tool 360 along the guidewire 330. The cuff deployment tool 360 is pushed along the guidewire 330 until it is partially underneath the target biological structure 310.

[0106] Fig. 27 The cuff deployment tool 360 is shown engaged with the ramp device 350 at a position partially below the target biological structure 310. In this position, a portion of the cuff deployment tool 360 can extend into the channel between the side walls of the ramp device 350. For example, the cuff 370 within the interior space of the cuff deployment tool 360 can extend into the channel of the ramp device 350. With this configuration, when the cuff 370 is deployed, it can move along the bend of the ramp device 350 onto the target biological structure 310. In some embodiments, the cuff deployment tool 360 includes a retaining wire 365. When the cuff deployment tool 360 is worn on the guide wire, the retaining wire 365 can be positioned in a first position. In the first position, the cuff 370 is retained in the interior space.

[0107] Fig.28 The retaining wire 365 is shown being removed from the cuff deployment tool 360 to deploy the cuff 370. In the second position, the cuff 370 is deployed onto the target biological structure 310. When the cuff 370 is deployed, it transitions to the deployed state. The cuff 370 can be in a helical configuration in the deployed state. Fig.29 As shown, cuff 370 is wrapped around a portion of target biological structure 310. In some embodiments, when cuff deployment tool 360 is guided over the guidewire to ramp device 350, cuff deployment tool 360 contacts the end wall of ramp device 350 to tilt cuff 370 around target biological structure 310.

[0108] Fig.30 A cuff deployment tool 360 is shown according to one embodiment of the present invention. The cuff deployment tool 360 is configured to deliver a cuff 370 to a target biological structure 310. The cuff deployment tool 360 may include a body 362 including an interior space for receiving the cuff 370. The body 362 may include one or more recessed portions 364 adjacent to the interior space. The cuff 370 may include one or more protrusions 372 nested within the one or more recessed portions 364 of the body 362. Each protrusion 372 on the cuff 370 includes a hole. In some embodiments, the cuff 370 is a flat spiral cuff.

[0109] The cuff deployment tool 360 may also include a retaining wire 365. The retaining wire 365 may pass through a recessed portion 364 in the body 362 and a corresponding protrusion 372 of the cuff 370 to retain the cuff 370 within the interior space. In a first position, the cuff 370 is retained within the interior space in a flat configuration via the retaining wire 365. In a second position, the retaining wire is removed to deploy the cuff 370. In the deployed state, the cuff 370 is in a spiral configuration.

[0110] After the cuff is deployed, each tool used in the method is removed from the surgical site. Figure 31-34 As shown, the cuff deployment tool 360, ramp device 350, balloon tool 340 and guidewire are all removed via one of the trocars 320, 325. For example, Fig.31 Removal of the cuff deployment tool 360 from the surgical site through the first trocar 320 is shown. Fig.32 Removal of balloon tool 340 via second trocar 325 using a medical tool is shown. Fig.33 Removal of the ramp device 350 using a medical tool through the second trocar 325 is shown. Fig.34 Removal of guidewire 330 via first trocar 320 is shown. Fig.35 A cuff surrounding a target biological structure is shown according to one embodiment of the present invention.

[0111] Although the present invention has been described in detail, modifications within the spirit and scope of the present invention will be apparent to those skilled in the art. In view of the foregoing discussion, the relevant knowledge in the art and the disclosures of the references discussed above in conjunction with the background technology and detailed description are all incorporated herein by reference. In addition, it should be understood that the embodiments of the present invention and parts of various embodiments and the various features described above and / or in the appended claims may be combined or interchanged in whole or in part. In the above description of various embodiments, those skilled in the art will understand that those embodiments that reference another embodiment may be appropriately combined with other embodiments.

Claims

1. A system for installing a cuff around a target biological structure, the system comprising: a guidewire configured to be insertable through an incision in a patient and beneath an outer surface of the target biological structure; a ramp device configured to be coupled to the guidewire and move along the guidewire, the ramp device having a curvature relative to a long axis of the guidewire; as well as a cuff deployment tool configured to be coupled to the guidewire and move along the guidewire to engage the ramp device, the cuff deployment tool comprising an interior space and a cuff located within the interior space, Wherein the cuff deployment tool is operable to move the cuff from within the interior space to an extended position wherein at least a portion of the cuff extends along the curvature of the ramp means.

2. The system according to claim 1, further comprising: a balloon tool configured to be coupled to the guidewire and move along the guidewire, the balloon tool comprising a balloon, The balloon is inflatable to provide pressure to the target biological structure.

3. The system of claim 2, wherein the balloon is a hemostatic balloon configured to selectively inflate and deflate at multiple locations along the guidewire.

4. The system according to claim 1, further comprising: One or more trocars, each configured to be positioned in a corresponding incision in the patient's skin.

5. The system according to claim 4, further comprising: a grasping tool configured to grasp one end of the guide wire, The grasping tool is operable to position the one end of the guide wire to be secured at the trocar.

6. The system of claim 1, wherein the distal end of the guidewire comprises a tip having a curve relative to the long axis of the guidewire.

7. The system of claim 6, wherein the tip comprises an atraumatic J-shaped tip.

8. The system of claim 1, wherein the ramp device comprises a front side and a back side having a conduit for receiving the guide wire, the front side comprising: a first side wall; a second side wall opposite to the first side wall; as well as A cavity is formed between the first sidewall and the second sidewall.

9. The system of claim 1 wherein the cuff deployment tool further comprises a retention wire, the cuff deployment tool being movable between a first position for retaining the cuff within the interior space and a second position wherein the cuff is deployed in a helical configuration.

10. The system according to claim 1, wherein: The cuff deployment tool is configured to contact an end wall of the ramp device to ramp the cuff deployment tool around the target biological structure.

11. The system of claim 1 , wherein the ramp comprises an elastomeric material.

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