Cutting system, device, and method for cutting

Abstract

A dissecting device for use in a medical procedure includes a shaft having opposing proximal and distal portions. A clamp extends from the distal portion. The clamp has a first clamp arm and a second clamp arm. The clamp is movable between an open position and a closed position. In the open position, the first clamp arm is spaced apart from the second clamp arm. In the closed position, the first clamp arm is moved toward the second clamp arm. A clamp actuator is connected to the clamp via the shaft and operable to move the clamp between the open and closed positions. A radio frequency (RF) electrode is associated with the first clamp arm. The RF electrode has a first perforated surface positioned to face the second clamp arm when the clamp is in the closed position. An electrical connector extends proximally from the RF electrode for connection to a power source.

Description

Technical Field

[0001] This specification relates to medical procedures involving the dissection of anatomical structures. More specifically, this specification relates to devices for dissection, as well as related systems and methods.

Summary of the Invention

[0002] The following summary is intended to introduce various aspects of the form for implementing the invention to the reader, but does not define or delimit the scope of any invention.

[0003] A dissection device for use in a medical procedure is disclosed. According to some aspects, the dissection device includes a shaft having a proximal portion and an opposite distal portion. A clamp extends from the distal portion of the shaft. The clamp has at least a first clamp arm and a second clamp arm. The clamp is movable between an open position and a closed position. In the open position, the first clamp arm is spaced apart from the second clamp arm. In the closed position, the first clamp arm is moved toward the second clamp arm relative to the open position. A clamp actuator is connected to the clamp via the shaft and is operable to move the clamp between the open position and the closed position. At least a first high-frequency electrode is associated with the first clamp arm. The first high-frequency electrode has a first perforated surface positioned to face the second clamp arm when the clamp is in the closed position. An electrical connector extends proximally from the first high-frequency electrode for connection to a power source.

[0004] In some examples, the first perforated surface is spaced apart from the clamp arm, the first high-frequency electrode is proximal to and laterally offset from the first perforated surface, and further includes a first dissection surface extending from the first perforated surface toward the first clamp arm.

[0005] In some examples, the cutting device further includes a second high-frequency electrode associated with the second clamping arm. The second high-frequency electrode can have a second perforated surface positioned to face the first perforated surface when the clamp is in the closed position.

[0006] In some examples, when the clamp is in the closed position, the first perforated surface and the second perforated surface are in contact.

[0007] In some examples, each of the first clamping arm and the second clamping arm has an inner end portion fixed to the shaft and an outer end portion opposite the inner end portion. The first cutting electrode can be associated with the outer end portion of the first clamping arm. Alternatively, the first cutting electrode can extend along the inner end portion and the outer end portion of the first clamping arm.

[0008] In some examples, at least a portion of the clamp is radiation-opaque.

[0009] A method for creating a cut is also disclosed. According to some aspects, the method for creating a cut includes: a) advancing a clamp of a cutting device toward a target anatomical structure; and b) after step a), clamping the clamp to the target anatomical structure to fix the clamp to the target anatomical structure and positioning a first high-frequency electrode of the clamp in contact with a first surface of the target anatomical structure; and c) activating the first high-frequency electrode to cut the target anatomical structure.

[0010] In some examples, clamping the clamp to the target anatomical structure further includes positioning a second cutting electrode of the clamp in contact with a second surface of the target anatomical structure. The second surface can be on the opposite side of the first surface.

[0011] In some examples, step c) further includes activating the second cutting electrode.

[0012] In some examples, step c) further includes applying a force to move the first high-frequency electrode along the target anatomical structure with the first high-frequency electrode activated.

[0013] In some examples, step b) includes operating a clamp actuator to clamp the clamp onto the target anatomical structure.

[0014] A cutting system for use in a medical procedure is also disclosed. According to some aspects, a cutting system for use in a medical procedure includes a high-frequency generator and a cutting device. The cutting device includes a shaft having a proximal portion and an opposite distal portion. A clamp extends from the distal portion of the shaft. The clamp has at least a first clamp arm and a second clamp arm. The clamp is movable between an open position and a closed position. In the open position, the first clamp arm is spaced apart from the second clamp arm. In the closed position, the first clamp arm is moved towards the second clamp arm relative to the open position. A clamp actuator is connected to the clamp via the shaft and is operable to move the clamp between the open position and the closed position. At least a first high-frequency electrode is associated with the first clamp arm. The first high-frequency electrode has a first perforated surface positioned to face the second clamp arm when the clamp is in the closed position. An electrical connector connects the first high-frequency electrode to the high-frequency generator.

[0015] In some examples, the first perforated surface is spaced apart from the first clamp arm, the first high-frequency electrode is proximal to the first perforated surface and lateral to the first perforated surface, and further includes a first cutting surface extending from the first perforated surface towards the first clamp arm.

[0016] In some examples, the splitting system further includes a second high-frequency electrode associated with the second clamping arm and electrically connected to a high-frequency generator. The second high-frequency electrode can have a second perforated surface positioned to face the first perforated surface when the clamp is in the closed position.

[0017] In some examples, when the clamp is in the closed position, the first perforated surface and the second perforated surface are in contact.

[0018] In some examples, the first clamping arm and the second clamping arm each have an inner end portion fixed to a shaft and an outer end portion opposite the inner end portion. The first splitting electrode can be associated with the outer end portion of the first clamping arm. Alternatively, the first splitting electrode can extend along the inner end portion and the outer end portion of the first clamping arm.

[0019] In some examples, at least a portion of the clamp is radiation-impermeable.

Brief Description of the Drawings

[0020] The accompanying drawings illustrate examples of the articles, methods, and devices of the present disclosure and are not intended to be limiting.

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Figure 9

[0021] To provide examples of embodiments of the claimed subject matter, various devices or processes or configurations are described below. The examples described below do not limit any of the claims, and any of the claims may cover processes or devices or configurations different from those described below. The claims are not limited to all of the features of any one device or process or configuration described below, or to devices or processes or configurations having some or all of the features common to the devices or processes or configurations described below. The devices or processes or configurations described below may not be embodiments of any exclusive rights granted by the issuance of this patent application. Any subject matter described below for which exclusive rights are not granted by the issuance of this patent application may be the subject of another protective document, such as a continuation patent application, and the applicant, inventor, or owner does not intend to abandon, disclaim, or dedicate such subject matter to the public by its disclosure in this document.

[0022] Generally, devices, as well as related systems and methods, that can be used in medical procedures in which a target anatomical structure is torn are disclosed herein. Such medical procedures can include transvenous structural heart procedures that can involve tearing of soft tissue. Such soft tissue can include, for example, a valve or an atrial septum. The devices disclosed herein can clamp onto a target anatomical structure, pierce the target anatomical structure, and tear the target anatomical structure.

[0023] Referring now to FIG. 1, an exemplary cleavage system 100 is shown. System 100 includes a power source in the form of a radiofrequency (RF) generator 102 and a cleavage device 104. The cleavage device 104 is electrically connectable to the RF generator 102 to supply RF energy to the electrodes of the cleavage device 104 (described below). The system 100 shown in FIG. 1 is designed to operate in monopolar mode. However, in an alternative, the system can operate in bipolar mode. In embodiments where the system operates in monopolar mode, the system can also include one or more ground pads (not shown) connected to the RF generator.

[0024] Still referring to FIG. 1, in the illustrated embodiment, the cleavage device 104 includes an elongated shaft 106 having a proximal portion 108 that defines a proximal end 110 and a distal portion 112 that defines a distal end 114. The shaft can be optionally fixed or manipulable. A handle 116 is connected to the proximal end 110 of the shaft 106. The handle 116 can optionally include various controls for, for example, controlling the delivery of RF energy from the generator or operating a clamp of the device (described below). The shaft 106 can be of various structures. For example, the shaft 106 can be in the form of a plastic tube that houses various other components (e.g., wires and mechanical components of the device).

[0025] Referring now to FIGS. 2A, 2B, and 3, clamp 118 extends from the distal portion 112 of shaft 106. Clamp 118 has a first clamp arm 120 and a second clamp arm 122. The first clamp arm 120 has an inner end portion 124 fixed to the shaft 106 and an outer end portion 126 opposite the inner end portion 124. Similarly, the second clamp arm 122 has an inner end portion 128 fixed to the shaft 106 and an outer end portion 130 opposite the inner end portion 128. Clamp 118 is movable between an open position shown in FIGS. 2A and 2B and a closed position shown in FIG. 3. In the open position, the first clamp arm 120 is spaced from the second clamp arm 122. In the closed position, the first clamp arm 120 is moved toward the second clamp arm 122 relative to the open position. More specifically, in the open position, the outer end portions 126, 130 of the clamp arms 120, 122 are spaced apart, and in the closed position, the outer end portions 126, 130 of the clamp arms 120, 122 are moved toward each other.

[0026] The open position may include angles other than those shown in FIGS. 2A and 2B. For example, when the clamp is in the open position, the clamp arms may be 180 degrees apart.

[0027] Still referring to FIGS. 2A, 2B, and 3, in the illustrated embodiment, the cutting device 104 includes a clamp actuator that is on the handle 116 and is connected to the clamp 118 via the shaft 106. The clamp actuator can be operated to move the clamp 118 between an open position and a closed position. More specifically, referring to FIGS. 2A and 2B, in the illustrated embodiment, the clamp actuator is in the form of a slide 132, and the slide 132 is connected to the inner end portion 124 of the first clamp arm 120 via a pull wire 134 that extends through the shaft 106 between the first clamp arm 120 and the slide 132. The first clamp arm is pivotable about a pivot pin 136, and the second clamp arm 122 does not move. By sliding the slide 132 proximally, the inner end portion 124 of the first clamp arm 120 is pulled proximally, pivoting the first clamp arm 120 to the closed position about the pivot pin 136. By sliding the slide 132 distally, the inner end portion 124 of the first clamp arm 120 is pushed distally, pivoting the first clamp arm 120 to return to the open position about the pivot pin 136. Optionally, a spring or other biasing member (not shown) can be provided to bias the clamp 118 to the closed position or the open position.

[0028] In an alternative, both the first clamp arm and the second clamp arm can be movable, or the second clamp arm can be movable while the first clamp arm may not move.

[0029] Referring now to FIGS. 4 and 5, in the illustrated embodiment, each of the clamp arms 120, 122 includes a high-frequency electrode. That is, a first high-frequency electrode 138 is associated with an outer end portion 126 of the first clamp arm 120, and a second high-frequency electrode 140 is associated with an outer end portion 130 of the second clamp arm 122. As used herein, the term "associated with" means that a first reference portion (i.e., in this case, the high-frequency electrodes 138, 140, respectively) and a second reference portion (i.e., in this case, the clamp arms 120, 122, respectively) are configured such that the first reference portion moves with the second reference portion. For example, the first reference portion can be attached to, extend from, be adhered to, be embedded in, be a part of, be formed by, and / or be integrated with the second reference portion. A first electrical connector 142 (e.g., a first insulated wire) extends proximally from the first high-frequency electrode 138 through the first clamp arm 120 and the shaft 106 (not shown in FIGS. 4 and 5) for connection to an RF generator 120 (not shown in FIGS. 4 and 5) via a handle 116 (not shown in FIGS. 4 and 5), and a second electrical connector 144 (e.g., a second insulated wire) extends proximally from the second high-frequency electrode 140 through the second clamp arm 122 and the shaft 106 for connection to an RF generator 102 via the handle 116. Supply of RF energy from the RF generator 102 to the RF electrodes 138, 140 causes the RF electrodes 138, 140 to cut (i.e., pierce or tear, as described below) tissue.

[0030] In an alternative, the first and second high-frequency electrodes can share wiring and be actuated simultaneously.

[0031] Still referring to FIGS. 4 and 5, in the illustrated embodiment, each of the high-frequency electrodes 138, 140 has a pair of cut surfaces. That is, the first high-frequency electrode 138 has a perforated surface 146 (also referred to herein as the "first perforated surface") and a split surface 148 (also referred to herein as the "first split surface"). The first perforated surface 146 is positioned to face the second clamp arm 122 when the clamp 118 is in the closed position and is spaced from the first clamp arm 120. The first split surface 148 is proximal to and transverse to the first perforated surface 146 and extends rearwardly from the first perforated surface 146 toward the first clamp arm 120. The second high-frequency electrode 140 also has a perforated surface 150 (also referred to herein as the "second perforated surface") and a split surface 152 (also referred to herein as the "second split surface"), which are configured similarly to the first perforated surface 146 and the first split surface 148. In the illustrated embodiment, when the clamp 118 is in the closed position, the first perforated surface 146 and the second perforated surface 150 face each other and are in contact.

[0032] In the illustrated embodiment, the high-frequency electrodes 138, 140 are relatively short in length compared to the clamp arms 120, 122 and are associated with the outer end portions 126, 130 of the clamp arms 120, 122. In an alternative (not shown), the high-frequency electrodes may be relatively long so as to extend along both the inner and outer end portions of the first and second clamp arms, respectively.

[0033] Optionally, at least a portion of the clamp may be radiation-opaque. For example, the clamp arms may include a radiation-opaque marker (not shown) proximate to the high-frequency electrodes, or the clamp arms may be constructed of a radiation-opaque material for viewing the clamp arms under fluoroscopy.

[0034] In the illustrated embodiment, the clamp arms are substantially straight. In an alternative (not shown), the clamp arms may be curved or bent.

[0035] In an alternative to the cutting device (not shown), the clamp can include only a single high-frequency electrode. That is, the first clamp arm can include the high-frequency electrode, and the second clamp arm can be electrically neutral.

[0036] Optionally, the clamp and / or catheter can be configured to inject a fluid (e.g., dextrose or another non-ionic fluid for electrically insulating the electrode from its surroundings). For example, the clamp and / or catheter can include a lumen that extends to the handle to enable fluid injection.

[0037] Referring now to FIGS. 6-9, during use, the cutting device 104 can be used to cut a target anatomical structure 600. For simplicity, the piercing surfaces 146, 148 and the cutting surfaces 150, 152 are labeled only in FIG. 6 and not in FIGS. 7-9. Referring first to FIG. 6, the cutting device 104 can be advanced toward the target anatomical structure 600 (e.g., advanced intravenously via a sheath), and with the clamp 118 in the open position, the clamp 118 can be positioned such that the target anatomical structure 600 is between the clamp arms 120, 122. Referring to FIG. 7, the clamp 118 can then be moved toward the closed position by operating a slide 132 (not shown in FIGS. 6-9), whereby the clamp 118 is clamped to the target anatomical structure 600. When clamping the target anatomical structure, the high-frequency electrodes 138, 140, and more specifically the respective piercing surfaces 146, 150, are positioned in contact with the opposing first surface 602 and second surface 604 of the target anatomical structure 600. Referring to FIG. 8, the high-frequency electrodes 138, 140 can then be actuated (i.e., by supplying RF energy from an RF generator 102 not shown in FIGS. 6-9), whereby cutting of the respective piercing surfaces 146, 150 of the high-frequency electrodes 138, 140 is caused and the target anatomical structure 600 is pierced. When the high-frequency electrodes 138, 140 pierce the target anatomical structure 600, i.e., when the piercing surfaces 146, 150 are in contact with each other, with the high-frequency electrodes 138, 140 still actuated, a force can be applied to move the cutting device 104 along the target anatomical structure 600. For example, the cutting device 104 can be pulled using a handle 116 (not shown in FIGS. 6-9). Referring to FIG. 9, by applying a force, cutting of the cutting surfaces 148, 152 is caused and the target anatomical structure 600 is cut.

[0038] After the cleavage is complete, the high-frequency electrodes 138, 140 can be stopped (e.g., by turning off the RF generator 102). If the target anatomical structure 600 is cleaved and the target anatomical structure 600 is divided into two sections (not shown), the clamp 118 remains in the closed position and the cleavage device 104 can be withdrawn from the patient's body. Alternatively, if the target anatomical structure 600 cannot be divided into two sections, the clamp 118 can be moved to the open position to release it from the target anatomical structure 600, then moved away from the target anatomical structure 600, then returned to the closed position, and then the cleavage device 104 can be withdrawn from the patient's body. Alternatively, if the clamp can be moved to the open position and the clamp arms are separated by 180 degrees or nearly 180 degrees, the cleavage device can be withdrawn while the clamp is in the open position.

[0039] The above description provides examples of one or more processes or apparatuses or configurations, but it will be understood that other processes or apparatuses or configurations may be within the scope of the appended claims.

[0040] To the extent that any correction, characterization, or other statement made previously with respect to any art, prior art, or otherwise (including in this patent or any related patent application or patent, including parent, sibling, or child patents) can be construed as a waiver of any subject matter supported by the present disclosure of this application, the applicant hereby cancels and withdraws such waiver in this specification. The applicant also respectfully submits that any prior art previously considered in any related patent application or patent, including any parent, sibling, or child patent, may need to be reexamined.

Claims

1. A cutting device for use in a medical procedure, comprising: a shaft having a proximal portion and an opposite distal portion; a clamp extending from the distal portion of the shaft, the clamp having at least a first clamp arm and a second clamp arm, the clamp being movable between an open position and a closed position, wherein in the open position, the first clamp arm is spaced from the second clamp arm, and in the closed position, the first clamp arm is moved toward the second clamp arm relative to the open position; a clamp actuator connected to the clamp via the shaft and operable to move the clamp between the open position and the closed position; at least a first high-frequency electrode associated with the first clamp arm, the first high-frequency electrode having a first perforated surface positioned to face the second clamp arm when the clamp is in the closed position, the first high-frequency electrode having a first cutting surface proximal to and transverse to the first perforated surface; an electrical connector extending proximally from the first high-frequency electrode for connection to a power source.

2. The cutting device according to claim 1, wherein the first perforated surface is spaced from the clamp arm, and the first cutting surface extends from the first perforated surface toward the first clamp arm.

3. The cutting device according to claim 1, further comprising a second high-frequency electrode associated with the second clamp arm, the second high-frequency electrode having a second perforated surface positioned to face the first perforated surface when the clamp is in the closed position.

4. The cutting device according to claim 3, wherein the first perforated surface and the second perforated surface are in contact when the clamp is in the closed position.

5. Each of the first clamp arm and the second clamp arm has an inner end portion fixed to the shaft and an outer end portion opposite the inner end portion; The cutting device according to claim 2, wherein the first high-frequency electrode is associated with the outer end portion of the first clamp arm.

6. The first clamping arm and the second clamping arm each have an inner end portion fixed to the shaft and an outer end portion on the opposite side of the inner end portion. The splitting device according to claim 2, wherein the first high-frequency electrode extends along the inner end portion and the outer end portion of the first clamping arm.

7. The splitting device according to claim 1, wherein at least a part of the clamp is radiation-impermeable.

8. A splitting system for use in a medical treatment, comprising: A high-frequency generator; A splitting device, wherein the splitting device comprises: (i) A shaft having a proximal portion and an opposite distal portion; (ii) A clamp extending from the distal portion of the shaft, the clamp having at least a first clamping arm and a second clamping arm, the clamp being movable between an open position and a closed position, in the open position, the first clamping arm is spaced apart from the second clamping arm, and in the closed position, the first clamping arm is moved towards the second clamping arm with respect to the open position; (iii) A clamp actuator connected to the clamp via the shaft and operable to move the clamp between the open position and the closed position; (iv) At least a first high-frequency electrode associated with the first clamping arm, the first high-frequency electrode having a first perforated surface positioned to face the second clamping arm when the clamp is in the closed position, the first high-frequency electrode having a first splitting surface proximal to the first perforated surface and transverse to the first perforated surface; (v) An electrical connector connecting the first high-frequency electrode to the high-frequency generator.

9. The splitting system according to claim 8, wherein the first perforated surface is spaced apart from the first clamping arm, and the first splitting surface extends from the first perforated surface towards the first clamping arm.

10. The slitting system according to claim 8, further comprising a second high-frequency electrode associated with the second clamp arm and electrically connected to the high-frequency generator, the second high-frequency electrode having a second perforated surface positioned to face the first perforated surface when the clamp is in the closed position.

11. The slitting system according to claim 8, wherein the first perforated surface and the second perforated surface are in contact when the clamp is in the closed position.

12. Each of the first clamp arm and the second clamp arm has an inner end portion fixed to the shaft and an outer end portion opposite to the inner end portion. The slitting system according to claim 9, wherein the first high-frequency electrode is associated with the outer end portion of the first clamp arm.

13. Each of the first clamp arm and the second clamp arm has an inner end portion fixed to the shaft and an outer end portion opposite to the inner end portion. The slitting system according to claim 9, wherein the first high-frequency electrode extends along the inner end portion and the outer end portion of the first clamp arm.

14. The slitting system according to claim 8, wherein at least a portion of the clamp is radiation-impermeable.

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