EXPANDABLE SPACEMAKER AND RELATED METHODS

Surgical instruments and devices for creating surgical working spaces and related methods are disclosed. An example surgical spacemaking device may include surgical spacemaking device an elongated connecting portion and an expandable spacemaking portion disposed distally on the connecting portion. The spacemaking portion may include an expandable lateral base portion. an expandable first vertical lateral portion configured to extend generally orthogonally from the lateral base portion, and an expandable second vertical lateral portion configured to extend generally orthogonally from the lateral base portion.

INTRODUCTION

The present disclosure is directed to surgical instruments and devices for creating surgical working spaces and related methods, and, more specifically, to expandable spacemaking devices and related methods.

The present disclosure contemplates that some surgical operations may involve procedures performed in potential spaces. As used herein, “potential space” may refer to a space between two adjacent anatomical structures that are normally pressed together, such as in a directly apposed manner. Generally, the adjacent anatomical structures of a potential space may be readily separated to create a realized space therebetween.

The present disclosure contemplates separating anatomical structures forming a potential space may be used to facilitate surgical procedures. Surgical devices utilized to separate anatomical structures, such as those forming a potential space, may be referred to as spacemaking devices.

While known spacemaking devices have been used safely and effectively to create surgical working spaces, improvements in the construction and operation of surgical spacemaking devices may be beneficial for users (e.g., surgeons) and patients. The present disclosure includes various improvements which may enhance the construction, operation, and methods of use of surgical spacemaking devices.

It is an aspect of the present disclosure to provide a surgical spacemaking device, including an elongated connecting portion and/or an expandable spacemaking portion disposed distally on the connecting portion and configured to create a working space. The spacemaking portion may include an expandable lateral base portion, an expandable first vertical lateral portion configured to extend generally orthogonally from the lateral base portion, and/or an expandable second vertical lateral portion configured to extend generally orthogonally from the lateral base portion.

In a detailed embodiment, when expanded, the lateral base portion, the first vertical lateral portion, and the second vertical lateral portion may generally form a C-shape.

In a detailed embodiment, the device may further include one or more tension elements. The one or more tension elements may be operatively coupled between the first vertical lateral portion and the second vertical lateral portion. The one or more tension elements may include a distal lateral tension element extending generally laterally between distal aspects of the first vertical lateral portion and the second vertical lateral portion. The one or more tension elements may include a proximal lateral tension element extending generally laterally between proximal aspects of the first vertical lateral portion and the second vertical lateral portion. The one or more tension elements may be generally elastic. The one or more tension elements may be generally inelastic.

In a detailed embodiment, the lateral base portion may include at least one lateral inflatable element.

In a detailed embodiment, the first vertical lateral portion may include at least one first longitudinal inflatable element and/or the second vertical lateral portion may include at least one second longitudinal inflatable element.

In a detailed embodiment, the lateral base portion and the first vertical lateral portion may be interposed by a first fold line and/or the lateral base portion and the second vertical lateral portion may be interposed by a second fold line.

In a detailed embodiment, the connecting portion may include at least one tether operatively coupled to the spacemaking portion. The at least one tether may be configured to fluidically couple at least one of the one or more inflatable elements to an external source of inflation fluid.

In a detailed embodiment, the connecting portion may include a sheath. The at least one tether may extend through the sheath. The sheath may be configured to receive an endoscope and/or an ablation device therethrough.

It is an aspect of the present disclosure to provide a method of creating a surgical working space, including advancing a spacemaking device to a surgical site proximate a target tissue and/or expanding a spacemaking portion of the spacemaking device to create a working space. Expanding the spacemaking portion may include inflating at least one lateral inflatable element and at least two longitudinal inflatable elements. The at least two longitudinal inflatable elements may be operatively coupled by at least one generally laterally oriented tension element.

In a detailed embodiment, expanding the spacemaking portion may include expanding the spacemaking portion to generally form a C-shape with the working space at least partially therein.

In a detailed embodiment, the spacemaking device may include a sheath. The method may include, before expanding the spacemaking portion, distally unsheathing the spacemaking portion from the sheath. The method may include advancing an endoscope and/or an ablation instrument through the sheath to the working space.

In a detailed embodiment, expanding the spacemaking portion may include sequentially inflating the at least one lateral inflatable element and the at least two longitudinal inflatable elements in a desired order.

In a detailed embodiment, the method may include deflating the at least one lateral inflatable element and/or the at least two longitudinal inflatable elements. Deflating the at least one lateral inflatable element and/or the at least two longitudinal inflatable elements may include applying a vacuum to the at least one lateral inflatable element and/or the at least two longitudinal inflatable elements.

In a detailed embodiment, the method may include shielding an anatomical structure other than the target tissue from injury using the spacemaking portion while utilizing a surgical instrument on the target tissue.

In a detailed embodiment, the surgical site may include an oblique sinus and/or the target tissue may include a left atrium.

DETAILED DESCRIPTION

Example embodiments according to the present disclosure are described and illustrated below to encompass devices, methods, and techniques relating to surgical procedures. Of course, it will be apparent to those of ordinary skill in the art that the embodiments discussed below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It is also to be understood that variations of the example embodiments contemplated by one of ordinary skill in the art shall concurrently comprise part of the instant disclosure. However, for clarity and precision, the example embodiments as discussed below may include optional steps, methods, and features that one of ordinary skill should recognize as not being a requisite to fall within the scope of the present disclosure.

The present disclosure includes, among other things, surgical instruments and devices for creating surgical working spaces and related methods, and, more specifically, expandable spacemaking devices and related methods. Some example embodiments according to at least some aspects of the present disclosure may be useful in connection with ablation of cardiac tissue, such as to treat cardiac arrhythmias like atrial fibrillation. Some example embodiments according to at least some aspects of the present disclosure may at least partially shield an anatomical structure, such as to reduce the risk of thermal injury to non-targeted anatomical structures during an ablation procedure. The following description begins with an overview of an example embodiment, followed by detailed description of various specific aspects of some example embodiments, and concludes with a description of example methods of using some example embodiments.

Generally, some example spacemaking devices according to at least some aspects of the present disclosure may include one or more expandable structures that can be delivered to surgical sites in a collapsed configuration (e.g., relatively small cross-section). When expanded (e.g., by inflation), the spacemaking devices may create working spaces in which other surgical instruments (e.g., endoscopes, ablation tools, etc.) may be used on target tissues.

FIG.1is a side perspective view of an example spacemaking device100in an expanded configuration,FIG.2is an end perspective view of the example spacemaking device100in the expanded configuration,FIG.3Ais a perspective view of the example spacemaking device100in a collapsed configuration and housed within a sheath, andFIG.3Bis a perspective view of the example spacemaking device100in a collapsed configuration and extended from the sheath, all according to at least some aspects of the present disclosure. Referring toFIGS.1,2,3A, and3B, the example spacemaking device100may include an expandable spacemaking portion102and/or an elongated connecting portion104. The spacemaking portion102may be disposed distally on the connecting portion104. As used herein, “distal” may refer to a direction generally away from an operator of a system or device (e.g., a surgeon), such as toward the distant-most end of a device that is inserted into a patient's body. The connecting portion104may extend proximally from the spacemaking portion102and/or may be manipulated by a user (e.g., surgeon) to position the spacemaking portion102. As used herein, “proximal” may refer to a direction generally toward an operator of a system or device (e.g., a surgeon), such as away from the distant-most end of a device that is inserted into a patient's body. The spacemaking portion102may be expandable and/or collapsible, such as by inflation and/or deflation of one or more longitudinal inflatable elements106A,106B,106C,106D and/or one or more lateral inflatable elements108A,108B. The connecting portion104may include one or more tethers110,112, which may be operatively coupled to the spacemaking portion102. For example, the tethers110,112may fluidically couple one or more of the inflatable elements106A,106B,106C,106D,108A,108B to external components. In some example embodiments, the connecting portion104may include a sheath114. The sheath114may include one or more internal, generally longitudinal lumens, which may be used to deliver the spacemaking portion102and/or other surgical instruments to a surgical site.

FIG.4is an end perspective view of the example spacemaking device100between two structures200,202in the collapsed configuration andFIG.5is an end perspective view of the example spacemaking device100between the two structures200,202in the expanded configuration, all according to at least some aspects of the present disclosure. Referring toFIGS.4and5, the first structure200and the second structure202may form a potential space when no surgical instruments are present therebetween. Positioning of the spacemaking portion102of the spacemaking device100between the structures200,202may at least partially separate the first structure200from the second structure202. At least partially expanding the spacemaking portion102of the spacemaking device100(e.g., from the collapsed configuration to the expanded configuration), such as by at least partially inflating one or more of the inflatable elements106A,106B,106C,106D,108A,108B, may further separate the two structures200,202, creating a working space204. In some circumstances, at least partially expanding the spacemaking portion102to create the working space204may involve applying a separating force greater than the forces holding the structures200,202together. For example, at least partially expanding the spacemaking portion102may involve lifting an anatomical structure (e.g., applying a force greater than the weight of the anatomical structure200to at least partially raise the anatomical structure200).

In some example embodiments, one or more of the inflatable elements106A,106B,106C.106D,108A,108B may be at least partially inflated (e.g., expanded) using one or more inflation fluids, such as one or more liquids and/or one or more gasses. Example non-compressible liquids include saline solution, water, and/or dextrose solution. Example compressible gases include room air, nitrogen, carbon dioxide, and/or nitrous oxide. The inflation fluid may be supplied from a syringe, bulb/pump, compressed gas cylinder (e.g., single use or multi use), or other pressurized or pressurizable source of inflation fluid.

In some example embodiments, the pressure of the one or more inflation fluids supplied to the inflatable elements106A,106B,106C,106D,108A,108B (e.g., inflation pressure), may be monitored, controlled, and/or limited. For example, the inflation pressure may be regulated to a target pressure and/or pressure range, such as to obtain a desired degree of expansion of the inflatable elements106A,106B,106C,106D,108A,108B and/or to avoid overinflation of the inflatable elements106A,106B,106C,106D,108A,108B. In some example embodiments, the inflation pressure and/or a related parameter (e.g., force applied to structures200,202) may be displayed to a user (e.g., surgeon and/or assistant).

In some example embodiments, one or more of the inflatable elements106A,106B,106C,106D,108A,108B may be at least partially deflated (e.g., collapsed) by draining and/or venting the inflation fluid from the inflatable elements106A,106B,106C,106D,108A,108B, such as to ambient pressure. In some example embodiments, one or more of the inflatable elements106A,106B,106C,106D,108A,108B may be at least partially deflated (e.g., collapsed) by withdrawing the inflation fluid from the inflatable elements106A,106B,106C,106D,108A,108B, such as by applying a vacuum.

Referring toFIG.1, in some example embodiments, the spacemaking portion102of the spacemaking device100may be configured expand and/or provide rigidity in one or more directions (e.g., perpendicular axes in X, Y, and Z directions). For example, inflation of one or more inflatable elements (e.g., lateral inflatable elements108A,108B) may facilitate expansion and/or rigidity of the spacemaking portion102in a generally lateral width direction, indicated by arrow206inFIG.1. Inflation of one or more inflatable elements (e.g., longitudinal inflatable elements106A,106B,106C,106D) may facilitate expansion and/or rigidity of the spacemaking portion102in a generally longitudinal (e.g., proximal-distal) direction, indicated by arrow208inFIG.1. Inflation of one or more inflatable elements (e.g., longitudinal inflatable elements106A,106B.106C,106D) may facilitate expansion and/or rigidity of the spacemaking portion102in a generally lateral height direction, indicated by arrows210A,210B inFIG.1.

In some example embodiments, individual inflatable elements (or individual portions of inflatable elements) may be arranged to respectively facilitate expansion and/or rigidity in each desired direction. That is, an X-direction inflatable element (or portion of an inflatable element) may facilitate expansion and/or rigidity in the X direction, a Y-direction inflatable element (or portion of an inflatable element) may facilitate expansion and/or rigidity in the Y direction, and/or a Z-direction inflatable element (or portion of an inflatable element) may facilitate expansion and/or rigidity in the Z direction.

In some example embodiments, the spacemaking portion102may be configured so that one or more of the inflatable elements106A,106B,106C,106D,108A,108B may facilitate expansion and/or rigidity in two or more directions. For example, in the spacemaking portion102shown inFIGS.1-5, the longitudinal inflatable elements106A,106B may be disposed in an upstanding first lateral portion116A and/or the longitudinal inflatable elements106C,106D may be disposed in an upstanding second lateral portion116B. The lateral portions116A,116B may be configured to extend generally laterally vertically (e.g., generally orthogonally) relative to a lateral base portion118, which may include the lateral inflatable elements108A,108B. As used herein, terms such as “vertically” are to be understood as relative terms in the context of the description herein and are not to be understood as limited to a particular orientation with respect to the Earth.

In some example embodiments, one or more upstanding portions (e.g., lateral portions116A.116B) may be formed by folding a spacemaking portion body120along one or more creases (e.g., fold lines)122A,122B, which may be respectively associated with the lateral portions116A,116B. While the example embodiment shown inFIGS.1-5includes generally longitudinal (e.g., proximal-distal) creases122A,122B at least partially defining the lateral portions116A,116B, alternative example embodiments may include one or more creases oriented in any direction to at least partially define upstanding portions in other orientations.

In some example embodiments, one or more upstanding portions (e.g., lateral portions116A,116B) may be positioned in a desired orientation (e.g., a generally upstanding manner relative to the lateral base portion118) by one or more positioning elements. For example, the spacemaking portion102may include one or more tension elements124,126operatively coupled between the lateral portions116A,116B. For example, the distal lateral tension element124may extend between distal aspects of the lateral portions116A,116B and/or the proximal lateral tension element126may extend between proximal aspects of the lateral portions116A.116B. Generally, the tension elements124,126may cause the spacemaking portion body120to generally form a C-shape when the inflatable elements106A,106B,106C,106D,108A,108B are inflated, as seen inFIGS.2and5, for example. Generally, the open portion of the C-shape, which may be occupied by one or more of the tension elements124,126, may create an open space providing access to the adjacent tissue200from within the working space204. In some example embodiments, the tension elements124,126may be constructed from generally elastic and/or generally inelastic materials. As used herein, “elastic” may refer to materials that substantially elastically deform under expected loads during the intended use of the device. As used herein, “inelastic” may refer to materials that do not substantially elastically deform under expected loads during the intended use of the device. Referring toFIG.5, the spacemaking portion102may form the generally open working space204generally between the upstanding. lateral edges of the lateral portions116A,116B.

Referring toFIGS.1,2, and5, in some example embodiments, at least a portion of the spacemaking portion body120may be configured to shield nearby anatomical structures. For example, the base portion118of the spacemaking portion body120may be substantially continuous (e.g., substantially without openings extending laterally therethrough). Accordingly, the second structure202may be at least partially shielded by the base portion118from a surgical procedure performed within the working space204. That is, the base portion118may physically interpose the working space204and the second structure202. For example, if an ablation procedure is performed within the working space, the base portion118may at least partially shield the second structure202from thermal injury due to the ablation procedure.

In some example embodiments, the spacemaking portion body120may be constructed from and/or covered with one or more materials configured to provide a desired frictional engagement with the first structure200and/or the second structure202. For example, at least a portion of the spacemaking portion body120may be constructed from and/or covered by a relatively high-friction fabric having a surface roughness selected to provide a desired frictional engagement to prevent movement of the spacemaking portion body120relative to one or both of the structures200,202. In some example embodiments, at least a portion of the spacemaking portion body120may be constructed from and/or covered with a relatively low-friction material to facilitate movement of the spacemaking portion102relative to adjacent structures, such as one or both of the structures200,202and/or an interior lumen of the sheath114.

In some example embodiments, at least a portion of the spacemaking portion102may be constructed from one or more generally opaque and/or generally translucent materials of one or more desired colors. In some example embodiments at least a portion of the spacemaking portion102may be constructed from one or more generally transparent (e.g., clear) materials, which may facilitate visualization of structures and/or devices through the generally transparent portion(s).

In some example embodiments, at least a portion of the spacemaking portion102may be constructed from one or more generally compliant materials. As used herein, “compliant” may refer to a material that generally readily conforms to a surface of an abutting structure. In some example embodiments, at least a portion of the spacemaking portion102may be constructed from one or more generally non-compliant materials. As used herein, “non-compliant” may refer to a material that generally maintains its shape without readily conforming to a surface of an abutting structure. In some example embodiments, the spacemaking portion102may be constructed from both compliant and non-compliant materials, which may be arranged to achieve desired expanded/collapsed configurations, for example.

In some example embodiments, one or more portions of the spacemaking portion102may be constructed to provide more or less force or expansion in certain directions. For example, one or more portions of the spacemaking portion102may have a wall thickness that differs from a wall thickness in another portion of the spacemaking portion102. In some example embodiments, at least a portion of the spacemaking portion102may be constructed with oriented fibers arranged to provide selective expansion in one or more desired directions. For example, the expansion may be greater in one direction than another direction.

In some example embodiments, one or more portions of the spacemaking portion102may be constructed in the manner of an expandable bellows. For example, a material may include a plurality of back-and-forth folds configured generally to collapse and stack together when deflated and/or to straighten and/or unfold when inflated. Such a configuration may facilitate expansion in a desired direction, for example.

In some example embodiments, one or more of the inflatable elements106A,106B,106C,106D,108A,108B may be fluidically isolated from one or more other inflatable elements106A,106B,106C,106D,108A,108B. Such a configuration may facilitate selective inflation and/or deflation, such as inflation and/or deflation of only some, but not all, of the inflatable elements106A,106B,106C,106D,108A,108B. Such a configuration may facilitate sequential inflation and/or deflation, such as inflation and/or deflation of two or more inflatable elements106A,106B,106C.106D,108A,108B in a desired sequence. That is, one or more of the inflatable elements106A,106B,106C,106D,108A,108B may be inflated and/or deflated before or after other inflatable elements106A,106B,106C,106D,108A,108B are inflated and/or deflated. Such a configuration may prevent complete deflation of the spacemaking portion102(e.g., deflation of all of the inflatable elements106A,106B,106C.106D,108A,108B comprising the spacemaking portion102) if the integrity of one or more of the inflatable elements106A,106B,106C,106D,108A,108B is lost, such as due to failure or puncture.

In some example embodiments, the connecting portion104may be used to apply forces to the spacemaking portion102. For example, externally applied tension, compression, and/or torsion may be transmitted to the spacemaking portion102via the tethers110,112and/or the sheath114. In some example embodiments, the connecting portion104(e.g., tethers110,112and/or sheath114) may be used to prevent movement of the spacemaking portion102. For example, the connecting portion104may be externally secured to anchor the spacemaking portion102in a desired position proximate a surgical site.

In some example embodiments, the spacemaking device100may be steerable. For example, the connecting portion104may include one or more steering elements configured to steer one or more of the tethers110,112, the sheath114, and/or the spacemaking portion102. In some example embodiments, the steering elements may include steering tethers which may be tensioned proximally to direct a distal portion of the spacemaking device100. In some example embodiments, the connecting portion104may include integrated steering functionality, generally similar to a steerable sheath.

Example methods of creating a working space using example spacemaking devices according to at least some aspects of the present disclosure are described below. The following description focuses on use of the example spacemaking device100described above; however, at least some of the operations may also be applicable to other spacemaking devices according to at least some aspects of the present disclosure. Further, the example methods described below focus on the use of example spacemaking devices in the context of ablation of portions of the left atrium, such as in connection with treatment of atrial fibrillation; however, example methods according to at least some aspects of the present disclosure may be utilized in connection with surgical procedures performed at other anatomical locations and/or for other purposes.

FIGS.6-11are simplified posterior (rear) perspective views of a heart500illustrating example methods of using an example spacemaking device100, all according to at least some aspects of the present disclosure. Referring toFIG.6, the posterior left atrium502of the heart500may be an anatomic ablation target for the treatment of atrial fibrillation. The left atrium502is located generally on the posterior (rear) surface of the heart500and receives blood from the lungs through the pulmonary veins504A,504B,504C,504D. The pericardium506, the sac containing the heart500, is attached to the surface of the heart500at pericardial reflections508near the pulmonary veins504A,504B,504C,504D. These pericardial reflections508, in connection with the pulmonary veins504A,504B,504C,504D, define a potential space on the posterior side of the left atrium502referred to as the oblique sinus510. Some surgical procedures, such as ablation of portions of the left atrium502, may involve operations performed within the oblique sinus510.

Some example methods of creating a surgical working space may include directing a spacemaking device100to a surgical site (e.g., the oblique sinus510), which may be proximate a target tissue (e.g., a left atrium). For example, a surgeon may obtain access into the pericardial space512(e.g., the interior of the pericardium506). This may be accomplished using surgical and/or percutaneous methods through the skin514and intervening anatomical structures, such as via a sub-xiphoid and/or intercostal approach. As illustrated inFIG.6, in some example embodiments, the spacemaking device100(e.g., the sheath114) may be advanced into the pericardial space512, such as into the oblique sinus510. In other example embodiments, a delivery sheath separate from the spacemaking device100may be advanced into the pericardial space512(e.g., oblique sinus510), and the spacemaking device100may be delivered via the separate delivery sheath. The spacemaking device100and/or delivery sheath may be guided using endoscopy and/or fluoroscopy, for example.

Referring toFIG.7, the spacemaking portion102of the spacemaking device100may be deployed, such as into the oblique sinus510. In some example embodiments, the spacemaking portion102may be at least partially contained within the sheath114while the sheath is advanced into the pericardial space512through the pericardium506. Then, the spacemaking portion102may be unsheathed from the sheath114to deploy the spacemaking portion102into the oblique sinus510. In other example embodiments, the spacemaking device100may be inserted through a separate delivery sheath, and the spacemaking portion102may be extended distally beyond the distal end of the separate delivery sheath and into the oblique sinus510. Proximal components of the spacemaking device100, such as a proximal portion of the sheath and/or proximal portions of the tethers110,112, may remain outside of the skin514.

Referring toFIG.8, the spacemaking portion102of the spacemaking device100may be at least partially expanded. For example, one or more of the inflatable elements106A,106B,106C,106D,108A,108B (FIGS.1and2) may be inflated, such as by suppling pressurized inflation fluid via one or more of the tethers110,112. Expansion of the spacemaking portion102may separate the pericardium506(e.g., corresponding to the structure202inFIGS.4and5) from the surface of the left atrium502(e.g., corresponding to the structure200inFIGS.4and5), creating the working space204(FIGS.4,5, and8). In some example embodiments, expanding the spacemaking portion102to create the working space204in the oblique sinus510may involve at least partially lifting the heart500. In some example embodiments, the spacemaking portion102may be configured to expand in a controlled manner, such as by unfurling, unrolling, and/or unfolding.

Referring toFIG.9, after the spacemaking portion102is at least partially expanded, one or more surgical instruments516,518may be delivered into the working space204. For example, one or more visualization instruments (e.g., endoscopes) and/or one or more ablation instruments (e.g., radio-frequency ablation instruments) may be positioned and/or utilized in and/or near the working space204. Generally, the entry from the skin incision into the pericardial space512may cross multiple tissue planes and/or the path from the incision to the oblique sinus510may be three dimensional. The spacemaking device100may provide a track that other surgical instruments may follow to the oblique sinus510. In some example, embodiments, one or more surgical instruments516may be delivered to the working space204via the sheath114of the spacemaking device100. In some example embodiments, one or more surgical instruments518may be delivered to the working space204separately from the spacemaking device100, such as adjacent to the spacemaking device via the same access path and/or via another access path.

In some example embodiments, the surgical instruments516,518may be used to visualize anatomical landmarks, guide ablation tools, ablate target tissues, etc. as required to accomplish the purpose of the surgical procedure. For example, an endoscope may be utilized to visualize anatomical variations of the oblique sinus boundaries, which may vary substantially from patient to patient. Creation of the working space204and/or facilitating visualization of the anatomical landmarks may assist in standardizing some aspects of surgical procedures, such as ablation lesion placement, regardless of patient anatomical variations and user (e.g., surgeon) technique.

In some example embodiments, at least a portion of the spacemaking portion102may act as a shield to reduce the risk of injury to tissues near the surgical site. For example, the esophagus lies immediately posterior to the oblique sinus510and may be injured when ablation is performed in the oblique sinus510. In some example embodiments, the base portion118(FIGS.1and2) of the spacemaking portion102may protect the esophagus from injury when thermal ablation is performed on the left atrium502. After the operations at the surgical site within the working space204are complete, the surgical instruments516,518may be withdrawn.

Referring toFIG.10, the spacemaking portion102of the spacemaking device100may be at least partially collapsed, such as by deflating one or more of the inflatable elements106A,106B.106C,106D,108A,108B (FIGS.1and2). In some example embodiments, the spacemaking portion102may be configured to collapse in a controlled manner, such as by furling, rolling, and/or folding.

Referring toFIG.11, after the spacemaking portion102of the spacemaking device100has been at least partially collapsed, the spacemaking device100may be withdrawn from the oblique sinus510. In some example embodiments, the spacemaking portion102may be withdrawn at least partially within the sheath114, and then the sheath114may be withdrawn from the oblique sinus510. The spacemaking device100may be withdrawn from the patient's body (e.g., via the pericardium506and/or the skin514).

Example methods of manufacturing spacemaking devices and components thereof may include operations associated with acquiring, producing, and assembling various parts, elements, components, and systems described herein.

Although some example embodiments have been described above in connection with realizing a working space from a potential space, some example embodiments may be used to dilate (e.g., make wider or larger) anatomical openings and/or to develop tissue planes, such as by separating adjacent, at least partially connected tissue layers.

Unless specifically indicated, it will be understood that the description of the structure, function, and/or methodology with respect to any illustrative embodiment herein may apply to any other illustrative embodiments. More generally, it is within the scope of the present disclosure to utilize any one or more features of any one or more example embodiments described herein in connection with any other one or more features of any other one or more other example embodiments described herein. Accordingly, any combination of any of the features or embodiments described herein is within the scope of this disclosure.

Following from the above description and invention summaries, it should be apparent to those of ordinary skill in the art that, while the methods and apparatuses herein described constitute example embodiments according to the present disclosure, it is to be understood that the scope of the disclosure contained herein is not limited to the above precise embodiments and that changes may be made without departing from the scope of the disclosure. Likewise, it is to be understood that it is not necessary to meet any or all of the identified advantages or objects disclosed herein in order to fall within the scope of the disclosure, since inherent and/or unforeseen advantages may exist even though they may not have been explicitly discussed herein.