Retractor members and related systems and methods
By designing a retractor component for an attachment device, the problem of soft tissue obstruction at the distal opening of the access tube was solved, achieving stable visualization and access to the treatment site, especially clear visualization of nerves, adapting to changes in the patient's anatomical structure, and improving the safety and efficiency of the surgery.
Patent Information
- Application Number
- CN202080088825.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-12-20
- Filing Date
- 2020-12-17
- Publication Date
- 2026-01-09
- Estimated Expiration
- 2040-12-17
AI Technical Summary
In minimally invasive surgery, the distal opening of the inlet tube is easily blocked by soft tissue, which limits the visualization and access to the treatment site, especially the visualization of nerves.
A retractor component with an attachment device is designed, which can be selectively attached to the inner surface of the entry component and its position can be adjusted by longitudinal translation and rotation to maintain the stability and flexibility of the retractor in the working channel, including attachment methods such as magnetic materials, vacuum pressure and flexible wire.
It effectively prevents soft tissue from entering the distal opening of the access tube, ensuring visualization and accessibility of the treatment site, especially the visualization of nerves, adapting to changes in the patient's anatomical structure, and improving the safety and efficiency of the surgery.
Smart Images

Figure CN114828757B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present invention relates to retractor members for retracting soft tissue at a surgical treatment site within a patient's anatomy, and systems and methods related to positioning retractor members relative to an access tube. BACKGROUND
[0002] Access tubes and / or retractors can be used to provide a physician with an access port or "working channel" to a surgical treatment site within a patient's anatomy. Various minimally invasive procedures can be performed through such access ports, including spinal procedures such as decompression, fusion, external fixation, etc. Access tubes used in these procedures must often be secured in place relative to the treatment site via external devices such as, by way of non-limiting example, table top mounted devices and / or anatomical mounted devices such as bone anchors, including pedicle anchors, etc. Once an access tube is positioned relative to a patient's anatomy so as to provide a working channel open to a target treatment site, a retractor member (also referred to as a "retractor blade" or simply a "blade") can be inserted through the working channel and manipulated to engage soft tissue at the treatment site and pull the soft tissue toward the wall of the access tube. Additional retractor members can be inserted through the working channel as needed to pull additional soft tissue toward the wall of the access tube. In this manner, soft tissue can be retracted from the treatment site, providing the physician with increased access and visualization of the treatment site, including visualization of exiting nerves. However, during a surgical procedure, some soft tissue can tend to move or "creep" into the distal opening of the access tube, which can hinder visualization of the treatment site, including visualization of exiting nerves. SUMMARY
[0003] According to embodiments of the present disclosure, a retractor member includes a body having a proximal end and a distal end and spaced apart from one another along a longitudinal direction, the retractor member configured for insertion through a channel of an access member and to move soft tissue at a treatment site accessible through the channel. The distal end defines a retractor blade and the body defines first and second surfaces opposite one another along a transverse direction substantially perpendicular to the longitudinal direction. The retractor includes an attachment device configured to selectively attach the body to a portion of the access member such that, when the body is attached to the portion of the access member, the body is extendable through the working channel and is translatable relative to the access member along the longitudinal direction.
[0004] The body can have a first side and a second side spaced apart from one another along a lateral direction substantially perpendicular to the longitudinal direction and the lateral direction, and the attachment device can extend from at least one of the first side and the second side at a longitudinal portion of the body intermediate the proximal end and the distal end, such that the attachment device is configured to reside within the working channel for securing the retractor member to an inner surface of the access member.
[0005] The attachment device can include a pair of wings each extending circumferentially from the first side and the second side, respectively, at the longitudinal position, wherein the pair of wings are compliant and configured to flex inwardly toward one another from an intermediate configuration toward a flexed configuration by the inner surface of the access member when the pair of wings are disposed in the channel, such that a return force of the pair of wings urges the pair of wings to engage the inner surface of the access member so as to attach the body to the portion of the access member.
[0006] At the longitudinal portion and in a plane orthogonal to the longitudinal direction, the second surface of the body can define a first radius, and an outer surface of the wing can define another radius that is greater than the first radius when the pair of wings are in the intermediate configuration.
[0007] The body can define a proximal body portion extending from the pair of wings to the proximal end, and a distal body portion extending from the pair of wings to the distal end along the longitudinal direction, and the distal body portion and the proximal body portion can be at least partially circumferentially offset from one another.
[0008] The distal body portion and the proximal body portion can be completely circumferentially offset from one another.
[0009] The attachment device can include an attachment member separate from the body, wherein the attachment member includes:
[0010] a sliding formation configured to slidably engage a complementary sliding formation of the body so as to allow the attachment member to translate along the body and within the channel; and
[0011] a locking member extending circumferentially away from the sliding formation, wherein the locking member can be compliant and configured to flex inwardly toward a central axis of the access member when the locking member is disposed in the channel, such that a return force of the locking member urges the locking member to engage the inner surface of the access member so as to attach the body to the portion of the access member.
[0012] The complementary slide-forming feature of the body can include a guide slot, the locking member can include a circumferential wall configured to annularly slide between the outer surface of the body and an inner surface of the access member, wherein the slide-forming feature of the attachment member can include a slider configured to reside within the guide slot, wherein the slider can extend inwardly from the circumferential wall along the transverse direction.
[0013] The attachment device can include an attachment member separate from the body, at least a portion of the attachment member can include a magnetic material, and the body can include one or more magnets each configured for selective attachment to the magnetic material of the at least a portion of the attachment member.
[0014] The body can define an interior chamber, and can further define a proximal port and a plurality of vacuum ports each in fluid communication with the interior chamber, wherein the plurality of vacuum ports can be defined in the second surface, and the proximal port is connectable to a vacuum source; and
[0015] The attachment device can include a plurality of ring seals each seated in one of the plurality of vacuum ports, wherein the plurality of ring seals can be configured to sealingly engage an inner wall surface of the access member when vacuum pressure is supplied within the interior chamber.
[0016] The attachment device can include a wire configured to transition from an inserted configuration to a deployed configuration, wherein the wire is configured to be contained within an elongate insertion device when in the inserted configuration, and the wire is further configured to be ejected outwardly so as to at least partially extend circumferentially about an inner wall surface of the access member so as to force the body toward the inner wall surface when in the deployed configuration.
[0017] The body can have a first side and a second side spaced apart from one another along a lateral direction substantially perpendicular to the longitudinal direction and the transverse direction, the first surface can be arcuate and concave between the first side and the second side in a plane orthogonal to the longitudinal direction, and the second surface can be arcuate and convex between the first side and the second side in the plane.
[0018] At least at one of the proximal end and the distal end, the body can define a flared end portion such that the end portion defines a maximum lateral dimension that is greater than a maximum lateral dimension of an adjacent portion of the body extending from the end portion toward an opposite one of the proximal end and the distal end.
[0019] At least at one of the proximal end and the distal end, the body can define an end portion that is angularly offset from an adjacent portion of the body that extends from the end portion toward an opposite one of the proximal end and the distal end.
[0020] The end portion can be angularly offset from the adjacent portion of the body.
[0021] At least a proximal portion of the body can be plastically deformable so as to bend away from a central axis of the access member after the body is attached to the portion of the access member.
[0022] The body can include at least one electrically conductive sensor at the distal end, and the at least one electrically conductive sensor can be in electrical communication with an electrical lead that is spaced apart from the at least one electrically conductive sensor, and can be configured to transmit sensor information obtained by the at least one sensor to a control unit.
[0023] The body can be formed of an electrically conductive material, and the retractor member can further include an electrical insulator that covers a majority of the body, wherein the body can include a distal exposed portion at the distal end that can define the at least one electrically conductive sensor, the body can further include a proximal exposed portion at the proximal end, and the proximal exposed portion can define the electrical lead.
[0024] The body can be formed of an electrically insulating material, and the at least one electrically conductive sensor can be embedded in the body at the distal end.
[0025] According to another embodiment of the present disclosure, a system for retracting soft tissue includes an access member having a proximal end and a wall extending from the proximal end to a distal end of the access member. The wall extends about a central axis in a plane orthogonal to the central axis such that an inner surface of the wall defines a channel extending in an axial direction oriented along the central axis. The system includes a retractor body having a proximal end and a distal end configured to engage soft tissue and spaced apart from the proximal end of the retractor body in a longitudinal direction. The retractor body defines first and second surfaces opposite one another in a transverse direction substantially perpendicular to the longitudinal direction. The system includes an attachment device coupled to the retractor body and including proximal and distal mounts configured to mount to the proximal and distal ends of the access member, respectively. At least one of the proximal and distal mounts is configured to move between: an unlocked configuration in which the proximal mount is longitudinally spaced apart from the distal mount by a first distance; and a locked configuration in which the proximal mount is longitudinally spaced apart from the distal mount by a second distance less than the first distance. The second distance corresponds to a distance between the proximal and distal ends of the access member in the axial direction.
[0026] The proximal and distal mounts can each include a hook configured to hook the respective proximal and distal ends of the access member.
[0027] At least when the attachment device is in the locked configuration, the retractor body can be longitudinally translatable relative to the proximal and distal mounts.
[0028] The system can further include an actuator configured to actuate the at least one of the proximal and distal mounts from the unlocked configuration to the locked configuration.
[0029] The actuator can include at least one elongate member extending from the distal mount through a receptacle of the proximal mount and to a control member spaced apart from the proximal mount in a proximal direction oriented along the longitudinal direction, wherein the control member can be configured to be manipulated to actuate the at least one of the proximal and distal mounts from the unlocked configuration to the locked configuration.
[0030] The retractor body can define a slot extending along the longitudinal direction, and each of the proximal mount and the distal mount can include a sliding member extending within the slot and configured to longitudinally slide along the slot so as to guide longitudinal movement of the respective mount relative to the retractor body.
[0031] The retractor body can further define a series of ratchet grooves arranged longitudinally along the slot, and the proximal mount can include a flexible member having a tooth configured to engage the series of ratchet grooves, wherein the flexible member can be configured to alternate between: 1) an intermediate configuration in which the tooth resides within one of the ratchet grooves so as to maintain a relative longitudinal position between the proximal mount and the retractor member; and 2) a disengaged configuration in which the tooth is distanced from each of the series of ratchet grooves.
[0032] The proximal mount can include a handle portion.
[0033] The system can further include an instrument releasably coupled to the attachment device, the instrument can include:
[0034] a handle extending from a rear end of the instrument to a front end of the instrument; and
[0035] a coupling mechanism at least partially located at the front end of the instrument, the coupling mechanism configured to alternate between: 1) a coupled configuration in which
[0036] the instrument is rigidly coupled to the retractor body; and 2) an uncoupled configuration in which the instrument is uncoupled from the retractor body and is removable from the retractor body.
[0037] The coupling mechanism can be further configured to move the actuator so as to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
[0038] The proximal mount can include a mounting base and an engagement member, wherein the actuator can extend between the mounting base and the engagement member and can be configured to actuate longitudinal movement of the engagement member relative to the mounting base between the unlocked configuration and the locked configuration.
[0039] The actuator can include a biasing mechanism having at least one spring biasing the engagement member in a biasing direction away from the mounting base along the longitudinal direction so as to actuate the engagement member to the locked configuration;
[0040] The biasing mechanism can further include a return member configured to move the engagement member toward the mounting base and into the unlocked configuration in a direction opposite the biasing direction; and
[0041] The coupling mechanism can include a movement member configured to move the return member in a direction opposite the biasing direction.
[0042] The retractor body can include an aperture, and the coupling mechanism can include a pin configured to 1) reside within the aperture to couple with the retractor member when the coupling mechanism is in the coupled configuration; and 2) move away from the aperture to uncouple with the retractor member when the coupling mechanism is in the uncoupled configuration.
[0043] The coupling mechanism can include a button connected to the pin and can be configured to alternate between a first position in which the pin resides within the aperture and a second position in which the pin is away from the aperture.
[0044] The actuator can be a tension member configured to selectively apply tension between the proximal mount and the distal mount to actuate the at least one of the proximal mount and the distal mount.
[0045] According to additional embodiments of the present disclosure, a system for retracting soft tissue includes an access member having a proximal end and a wall extending from the proximal end to a distal end. The wall extends about a central axis in a plane orthogonal to the central axis such that an inner surface of the wall defines a channel extending in an axial direction oriented along the central axis. The system includes a retractor body having a proximal end and a distal end configured to engage soft tissue and spaced apart from the proximal end of the retractor body in a longitudinal direction. The retractor body defines first and second surfaces opposite one another in a transverse direction substantially perpendicular to the longitudinal direction. At least one of the access member and the retractor body defines one or more openings, and the other of the access member and the retractor body includes one or more protrusions complementary to the one or more openings and configured for insertion within the one or more openings to couple the retractor body to the access member.
[0046] Each of the one or more protrusions can define a stem and a head extending outwardly from the stem, the head being wider than the stem.
[0047] The one or more openings can include an array of openings extending outward from an inner surface of the wall into the wall, the array can define a plurality of columns, each of the columns including a longitudinally aligned subset of the plurality of openings, wherein the columns can be circumferentially spaced apart from one another along the wall,
[0048] The one or more protrusions can include a plurality of protrusions each extending from the second surface of the retractor member along the transverse direction and aligned with one another along the longitudinal direction, wherein the plurality of protrusions can be configured to selectively reside within at least one of the columns such that the head overlaps at least a portion of the wall along the axial direction.
[0049] The retractor body can have a proximal portion and a distal portion configured to be angularly offset from one another in a plane extending along the longitudinal direction and the transverse direction, and at least one of the one or more openings can extend from the first surface through the proximal portion to the second surface, and
[0050] The one or more protrusions can include a plurality of protrusions extending from a proximal surface of the access member along the longitudinal direction, wherein the proximal surface can be located at a proximal end of the access member, and the plurality of protrusions can be circumferentially spaced apart from one another along the proximal surface. BRIEF DESCRIPTION OF DRAWINGS
[0051] The foregoing summary, as well as the following detailed description of exemplary implementations of the present application, will be better understood when read in conjunction with the accompanying drawings, in which: For the purpose of illustrating the application, there is shown in the drawings exemplary implementations. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:
[0052] Figure 1A is a perspective view of a spinal surgical system including a surgical access system in accordance with embodiments of the present disclosure;
[0053] Figure 1B is Figure 1A is another perspective view of the spinal surgical system shown in
[0054] Figure 1C is a perspective view of a surgical access system in accordance with embodiments of the present disclosure; Figure 1B is a perspective view of the surgical access system shown in
[0055] Figure 1D is Figure 1Cpartial top view of an entry member having a retractor attached to an inner wall surface of the entry member;
[0056] Figure 2A is a perspective view of a retractor including a straight end portion and including a flexible attachment spring for securing the retractor to Figures 1A to 1C an inner wall surface of an entry member as shown in
[0057] Figure 2B is a perspective view of a retractor having an angularly offset end portion and further similar to the retractor as shown in Figure 2A
[0058] Figure 2C is a perspective view of a retractor as Figure 2B a partial side view of a retractor as shown in
[0059] Figure 2D is a perspective view of a retractor having a flared end portion and further similar to the retractor as shown in Figure 2A
[0060] Figure 2E is a perspective view of a retractor having a flared and angularly offset end portion and further similar to the retractor as shown in Figure 2A
[0061] Figure 2F is a perspective view of a retractor having a flexible attachment spring and proximal and distal portions circumferentially offset from one another along the attachment spring;
[0062] Figure 2G is a perspective view of a retractor defining a plurality of apertures;
[0063] Figure 3A is a perspective view of a surgical entry system having an entry member and a retractor having a guide feature for guiding movement of a separate attachment spring;
[0064] Figure 3B is a perspective view of a surgical entry system as Figure 3A
[0065] Figure 3C Figure 3B is a perspective view of a surgical entry system as shown in, showing the attachment spring connected to the guide feature in a position distal from the entry member; is a perspective view of a surgical entry system as shown in, showing the attachment spring advanced distally along the guide feature to a position within a working channel of the entry member, wherein the attachment spring firmly pushes the retractor against an inner wall surface of the entry member.
[0066] Figure 3D This is a partial cross-sectional perspective view of a surgical access system having an access member, a retractor, and an independently attached spring according to an embodiment of the present disclosure, wherein the independently attached spring carries one or more magnets for magnetic attachment to the retractor.
[0067] Figure 4A This is a perspective view of a surgical access system according to an embodiment of the present disclosure, the surgical access system including an instrument in a coupled configuration with an attachment device for a retractor, in which the instrument is maneuverable to engage and retract soft tissue through a working channel. An attachment device in a locked configuration with an access member is also shown, the attachment device being operable by the instrument to attach the retractor to a selected circumferential position on the access member, the attachment device also being configured to allow longitudinal translation of the retractor relative to the access member when the attachment device is in the locked configuration.
[0068] Figure 4B It is in a connection and locking configuration. Figure 4A Another perspective view of the surgical entry system shown;
[0069] Figure 4C yes Figure 4A The side view of a portion of the device shown shows a part of the coupling mechanism of the device in a coupling configuration with the attachment device, and also shows a proximal mount of the attachment device in a locking configuration with the entry member;
[0070] Figure 4D yes Figure 4C The diagram shows a side view of a portion of the device, which illustrates a portion of the coupling mechanism in a disengaged configuration, wherein the device is disengaged from the attachment device; it also shows a proximal mounting member that retains the entry member in a locked configuration;
[0071] Figure 4E yes Figure 4A The surgical access system shown is a cross-sectional side view, which illustrates the alternation of the proximal mount relative to the access member between locked and unlocked configurations;
[0072] Figure 4F yes Figure 4A A cross-sectional perspective view of the biasing mechanism of the attachment device shown;
[0073] Figure 4G yes Figure 4A A cross-sectional perspective view of the connecting mechanism of the device shown;
[0074] Figure 4H yes Figure 4A A cross-sectional perspective view of the connecting mechanism shown;
[0075] Figure 4I is decoupled from the instrument shown in Figure 4A is a cross-sectional perspective view of the attachment device shown in
[0076] Figure 4J is Figure 4I is a perspective view of the attachment device shown in
[0077] Figure 4K is Figure 4J is another perspective view of the guide feature shown in
[0078] Figure 5A is a perspective view of another embodiment of an instrument releasably coupled to a retractor, wherein the instrument is directly coupled to the retractor, the retractor carries an attachment device for attaching the retractor to a selected circumferential location of an access member, and the attachment device is operable independent of the instrument;
[0079] Figure 5B is a cross-sectional perspective view of the coupling mechanism of the instrument taken along Figure 5A the section line 5B-5B shown in
[0080] Figure 6A is a side plan view of another embodiment of an instrument releasably coupled to a retractor, wherein the retractor includes an attachment device that employs a tensile actuator for attaching the retractor to a selected circumferential location of an access member;
[0081] Figure 6B is Figure 6A is a rear plan view of a distal mount of the attachment device shown in
[0082] Figure 6C is Figure 6A is a perspective view of the attachment device shown in
[0083] Figure 6D is a side plan view of a surgical access system showing an instrument, a retractor, and an attachment device attached to an access member Figure 6A shown in
[0084] Figure 6E is Figure 6A is a perspective view of a proximal mount of the attachment device shown in
[0085] Figure 6F is Figure 6BBottom plan view of the distal mount and retractor blade shown in FIG. 1 1 1 ;
[0086] Figure 7A Perspective view of a retractor according to an embodiment of the present disclosure, having an attachment device with a handle member, and employing a ratchet mechanism;
[0087] Figure 7B is Figure 7A Perspective view of another embodiment of the handle member shown in FIG. 1 1 1 ;
[0088] Figure 7C is along Figure 7A Cross-sectional perspective view of the attachment device taken along section line 7C-7C shown in FIG. 1 1 1 ;
[0089] Figure 7D is Figure 7A Perspective view of the retractor and attachment device shown in FIG. 1 1 1 ;
[0090] Figure 7E is along Figure 7D Cross-sectional perspective view of the retractor and attachment device taken along section line 7E-7E shown in FIG. 1 1 1 ;
[0091] Figure 7F is Figure 7A Perspective view of the ratchet mechanism shown in FIG. 1 1 1 ;
[0092] Figure 7G is Figure 7A Rear plan view of the pawl of the ratchet mechanism shown in FIG. 1 1 1, with the handle member truncated for visibility purposes;
[0093] Figure 7H is along Figure 7G Cross-sectional perspective view of the pawl taken along section line 7H-7H shown in FIG. 1 1 1 ;
[0094] Figure 8A Cross-sectional view of a retractor according to an embodiment of the present disclosure, having a suction attachment device for attaching the retractor to a selected circumferential location of an access member;
[0095] Figure 8B is Figure 8A Rear plan view of the retractor shown in FIG. 1 1 1 ;
[0096] Figure 8C is along Figure 8B Cross-sectional end view of the retractor taken along section line 8C-8C shown in FIG. 1 1 1 ;
[0097] Figure 9Ais an exploded partial cross-sectional view of a surgical access system having an attachment device in accordance with embodiments of the present disclosure, the attachment device including protrusions and complementary openings configured for selective mating engagement to attach a retractor to selected circumferential locations of an access member;
[0098] Figure 9B is a cross-sectional side view showing mating engagement between the protrusions and openings shown in Figure 9A
[0099] Figure 9C is a cross-sectional side view showing alternative mating engagement between the protrusions and openings shown in Figure 9A
[0100] Figure 9D is a perspective view of an access member having a proximal surface and a series of protrusions arranged circumferentially along the proximal surface for selective mating engagement with complementary openings in a retractor;
[0101] Figure 9E is a cross-sectional side view of a retractor in near mating engagement with the access member shown in Figure 9D
[0102] Figure 10A is a partial cross-sectional view of a surgical access system in accordance with embodiments of the present disclosure, the surgical access system including an introducer for inserting a flexible string attachment device shown in an inserted configuration into a working channel of an access member;
[0103] Figure 10B is a cross-sectional view of the surgical access system shown in Figure 10A
[0104] Figure 10C is a front view of another embodiment of a flexible string attachment device loaded in an introducer in an inserted configuration;
[0105] Figure 10D is a front plan view of the flexible string attachment device shown in Figure 10C
[0106] Figure 11A is a front plan view of a retractor having an electrically insulating sheath and further having a sensor for obtaining electrical information at a surgical treatment site;
[0107] Figure 11B is a front plan view of a retractor composed of an electrically insulating material and having a sensor for obtaining electrical information at a surgical treatment site;
[0108] Figure 12A This is a perspective view of an apparatus carrying a retractor including a chain, according to another embodiment of this disclosure;
[0109] Figure 12B yes Figure 12A A perspective view of the retractor shown;
[0110] Figure 12C This is a perspective view of a puller with an alternative tether according to another embodiment of this disclosure;
[0111] Figure 12D The adoption of the implementation scheme of this disclosure Figure 12A The image shows a perspective view of a surgical entry system for a retractor, the surgical entry system having a receiving formation for connection to a tether; and
[0112] Figure 12E It is based on another embodiment of this disclosure. Figure 12D The image shows a perspective view of a surgical access system with retaining clips for connection to a tether. Detailed Implementation
[0113] This disclosure will be more readily understood with reference to the following detailed description, taken in conjunction with the accompanying drawings and examples that form a part of this disclosure. It should be understood that this disclosure is not limited to the specific apparatus, method, application, condition, or parameters described and / or shown herein, and the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to limit the scope of this disclosure. Furthermore, unless the context clearly indicates otherwise, as used in this specification (including the appended claims), the singular forms “a” and “the” include the plural, and references to a particular numerical value include at least that particular value.
[0114] As used herein, the term "multiple" means more than one. When referring to a range of values, another embodiment includes from one specific value and / or to other specific values. Similarly, when a value is expressed as an approximation using "about," it should be understood that the specific value of that value constitutes another embodiment. All ranges include end values and are composable.
[0115] As used herein, the terms “about” and “substantially” with respect to dimensions, angles, and other geometries take into account manufacturing tolerances. Furthermore, the terms “about” and “substantially” can include being greater than or less than 10% of the stated dimension or angle. Additionally, the terms “about” and “substantially” can be applied equivalently to the specific values stated.
[0116] The embodiments described below relate to retractor members (also referred to herein as "tractors") for use in surgical access systems that include an access member, such as an access tube. In particular, the embodiments described below relate to retractors configured for insertion through a working channel of an access member to engage and retract soft tissue at a surgical treatment site located distal of the working channel. More particularly, the embodiments described below include various attachment devices that allow the tractors to be selectively attached to circumferential locations of the access tube, thereby securing the soft tissue in a retracted position. As used herein with reference to an access member, the term "circumferential" generally refers to a direction that is rotational about a central axis of the access member, and in particular refers to any direction that has a directional component that is offset from both (1) a radial direction that is perpendicular to the central axis and (2) an axial direction that extends along the central axis. Thus, as used herein with reference to an access member, the term "circumferential" refers to a direction that is along any of a straight line, an arc, a circle, an ellipse, a polygon, or an irregular shape that is at least partially rotational about the central axis of the access member.
[0117] Some of the attachment devices described below are located entirely on the tractor, while others are used in complementary components or features of the tractor and the access member, and still others are used in separate components of the surgical access system. In addition, most of the attachment devices described below allow the tractor to be moved relative to the access member in the following ways while remaining secured to an inner wall surface thereof: in an axial direction that is oriented along the central axis of the member; and in a circumferential rotation (i.e., revolution) about the central axis along the inner wall surface. These movements allow the physician to adjust the tractor position within the working channel as needed to account for variations in patient anatomy, such as between different patients. Such tractors and complementary attachment devices that can be moved in any of the foregoing ways can also be repositioned during a surgical procedure to adjust the retraction of soft tissue as needed while still remaining attached to the inner wall, such that the attachment devices will maintain the position of the tractor relative to the access member after the physician releases the tractor when the physician has repositioned the tractor to a satisfactory position.
[0118] In additional embodiments described below, the tractor is used as part of a surgical access system that includes an instrument coupled to a proximal end of the tractor and configured for manipulating the tractor to engage soft tissue. The instruments described below are configured to be selectively coupled and decoupled from the tractor as needed. In other embodiments, the insertion instrument is also configured to actuate the attachment device from an unattached configuration in which the attachment device is not attached to the access member to an attached configuration in which the attachment device attaches the tractor to the access member, as described above.
[0119] Reference is now made to Figure 1A An exemplary embodiment of a surgical access system 100 for spinal surgery includes an access member 102 for providing access to a surgical treatment site within a patient, and a retractor member 2 configured to extend through the access member 102 and engage soft tissue at the treatment site. The access member 102 has a body 103, which can be tubular, and is configured to extend distally from an extracorporeal location to an intracorporeal target location within a patient anatomy relative to the patient anatomy. By way of non-limiting example, the access member 102 can be configured to extend through a skin line 90 and to a target location at or adjacent to an intended surgical treatment site. The access member 102 includes a hood or wall 104 defining an internal port or passageway 106 (also referred to herein as a “working channel” 106) that is elongated along a central axis 108 of the access member 102 and is open in an axial direction X (i.e., a direction oriented along the central axis 108) from the extracorporeal location to the target location. The access member 102 extends in the axial direction X from a proximal end 110 to a distal end 112. In the illustrated example, the central axis 108 defines a spinal access axis that is oriented along an intertransforaminal approach, such as through Kambin’s triangle. In this example, the target location of the access member 102 is at a facet line 92 of adjacent vertebral bodies 94, and the treatment site includes an intervertebral disc space 96. However, it will be appreciated that other approaches are within the scope of the present disclosure, including but not limited to interlaminar, lateral, and anterior approaches. With the access member 102 positioned at an appropriate depth and orientation so as to extend to the treatment site, the central axis 108 intersects the treatment site. In this manner, instruments can be advanced distally through the access member 102 toward the treatment site as needed. To prepare the treatment site for certain instruments, one or more retractor members 2 can be inserted through the working channel 106, such as along the central axis 108, and can be manipulated to engage and retract soft tissue, including soft tissue near an exiting nerve, such as by pulling or otherwise moving the soft tissue in a radial direction R away from and substantially perpendicular to the central axis 108 (and thus also substantially perpendicular to the axial direction X). If a portion of the engaged soft tissue extends within the working channel, the retraction moves this soft tissue toward the wall 104 of the access member 102. Among other things, the retraction of the soft tissue can serve to expose and provide visualization of the exiting nerve so that a practitioner can avoid injuring or contacting the exiting nerve during spinal surgery.
[0120] The surgical access system 100 can be used as a subsystem of a primary surgical system 200, such as a spinal surgical system. For the depicted spinal surgical procedure, the spinal surgical system 200 can include, among other things, a connector 202 having one or more arms 204 for connecting the access member 102 to an anchor, such as a pedicle anchor, such as a contralateral pedicle anchor 206, as illustrated. In this manner, the position of the access member 102 and its working channel 106 can be fixed relative to the patient anatomy, such as through the anchor 206 and the connector 202. The spinal surgical system 200 can be configured as more fully described in U.S. Patent Publication No. 2018 / 0008253 Al, entitled “Multi-Shield Spinal Access System compress,” published January 11, 2018 (“‘253 Reference”); and U.S. Patent Application No. 16 / 692,342, entitled “CONTROL MEMBER FOR ADJUSTING ACCESS TUBE POSITION, AND RELATED SYSTEMS AND METHODS,” filed November 22, 2019 (“‘342 Reference”), the entire disclosures of each of which are incorporated herein by reference.
[0121] Referring now to Figures 1B to 1D As shown, the wall 104 of the access member 102 defines an outer wall surface 114 and an inner wall surface 116 that are spaced apart from one another along the radial direction R. As illustrated, the outer wall surface 114 can have an elliptical profile in a plane that is orthogonal to the central axis 108. Additionally, the wall 104 can also define a secondary channel 107 along the axial direction X. For example, the inner wall surface 116 can define one or more protrusions 117 that extend generally inwardly radially toward the central axis 108 in order to define a partition between the working channel 106 and the secondary channel 107. In the illustrated embodiment, by way of non-limiting example, the secondary channel 107 can house one or more optical instruments, such as a camera or other type of image sensor. In such embodiments, the partition between the working channel 107 and the secondary channel 107 helps to prevent mechanical interference between the optical instrument and any instruments extending through the working channel 106. The secondary channel 107 is preferably open to the working channel 106 at least along a direction having a directional component along the radial direction R. As illustrated, the wall 104 can extend a full turn about the central axis 108, thereby providing the access member 102 with its tubular configuration. However, it should be appreciated that the wall 104 can extend less than a full turn about the central axis 108 while continuing to provide the working channel 106, and optionally also the secondary channel 107.
[0122] As Figure 1CAs shown in the middle, the retractor member 2 (also referred to herein as "retractor" 2) has a retractor body 3 extending from a proximal end 4 spaced apart from a distal end 6 along a longitudinal direction L. It will be appreciated that by way of non-limiting example, the retractor body 3 can define the entire retractor 2 in an integral manner, or can combine with one or more separate but connected (or connectable) portions of the retractor 2 to define a portion, such as a main portion, of the retractor 2. The distal end 6 can have a blade-like geometry, and can thus be referred to as a "retractor blade", or simply "blade". The retractor 2 has a length along the longitudinal direction L that is greater than a length of the access member 102 along the axial direction X. In this way, the retractor 2 can be inserted through the working channel 106 to the treatment site, and can be manipulated by its proximal end 4 in order to control placement of the distal end 6 to engage soft tissue as desired at or near the treatment site. It will be appreciated that the proximal end 4 can also have a blade-like geometry, and can thus also be referred to as a "retractor blade" or "blade". Such a relative blade configuration can be advantageous in that it does not necessarily require a particular end to be inserted through the access member 102.
[0123] In the case of soft tissue engagement, the retractor 2 can be moved to the inner wall surface 116 described in more detail below, and attached to said inner wall surface by an attachment means. As Figure 1D As shown in the middle, the retractor body 3 has a first or "inner" surface 10 and a second or "outer" surface 12 spaced apart from each other along a transverse direction T that is substantially perpendicular to the longitudinal direction L. The outer surface 12 of the retractor body 3 is preferably arcuate and convex in a plane orthogonal to the longitudinal direction L. In addition, the outer surface 12 preferably defines a radius Rl that is substantially equal to the radius R2 of the inner wall surface 116. In this way, the retractor body 3 can be moved flush with the inner wall surface 116 for attachment thereto in order to avoid obstructing the working channel 106. It will be appreciated that when the retractor body 3 is flush with the inner wall surface 116, the transverse direction T is oriented substantially along the radial direction R of the access member 102. The inner surface 10 of the retractor body 3 is preferably arcuate and concave in the orthogonal plane, and preferably extends in the orthogonal plane in parallel with, or in a concentric manner with, the convex outer surface 12.
[0124] The retractor 2 is formed of a biocompatible material, i.e. a "biomaterial", and has sufficient rigidity such that manipulation at the proximal end 4 causes retraction of soft tissue at the distal end 6 (or vice versa in the case of insertion through the working channel 106 at the opposite end). The material also preferably provides deformability to the retractor body 3, such as via plastic deformation, thereby allowing a first portion 3a of the retractor body 3 to bend relative to a second portion 3b of the retractor body, as Figure 1CIn this way, when the retractor body 3 has achieved satisfactory retraction of the soft tissue (and the retractor body 3 has been secured to the access member 102 by the attachment device, as described in more detail below), the physician can bend the first portion 3a away from the central axis 108 and off the path, thereby reducing the profile of the retractor body 3 in the proximal direction P. By way of non-limiting example, such retractor body materials can be metals (e.g., stainless steels such as 300 series and / or 400 series stainless steels), polymers (e.g., polyphenylsulfone (PPSU)), and / or composite materials (e.g., carbon fiber).
[0125] Reference is now made to Figures 2A to 2F different variants of the retractor body 3 are shown, each of which includes an integrated attachment device 14 for coupling the retractor body 3 to the wall 104 of the access member 102. For example, the attachment device 14 is configured to attach the retractor body 3 to a circumferential portion of the inner wall surface 116 as selected by the physician. In particular, the attachment device 14 shown in each of these variants includes at least one compliant member 16 that is configured to flex from an intermediate configuration when disposed outside the working channel 106 to a flexed configuration when inserted within the working channel 106. The compliant member 16 can also be referred to as a “locking spring” or a “locking ring.” When in the flexed configuration, the compliant member 16 exerts a return force (which can also be referred to as a “locking force”) against the inner wall surface 116 that is sufficient to urge the retractor body 3 toward the inner wall surface 116, effectively securing the retractor body 3 in place relative to the wall 104. It will be appreciated that the compliant member 16 is configured such that the locking force is sufficient to maintain retraction of the soft tissue engaged by the distal end 6 of the retractor body 3, but not so great as to prevent the physician from subsequently further manipulating the retractor body 3 to adjust the engagement with the soft tissue, such as translating the retractor body 3 in the axial direction X, rotating the retractor body 3 about the central axis 108, or any combination of the foregoing. Moreover, the compliant member 16 of the present embodiments is configured to effectively automatically secure the retractor body 3 in place within the working channel 106 when the physician has completed manipulating the proximal end 4 of the retractor body (as long as the compliant member 16 resides within the working channel 106).
[0126] Each of the retractor bodies 3 defines a first side 20 and a second side 22 that are spaced apart from one another along a lateral direction A that is substantially perpendicular to the longitudinal direction L and the transverse direction T. The compliant members 16 of the attachment device 14 can include a pair of compliant members 16, or "wings," that extend outwardly circumferentially from the first and second sides 20, 22 at a longitudinal portion 3c of the retractor body 3 intermediate the proximal end 4 and the distal end 6 thereof. Thus, the longitudinal portion 3c can also be referred to as the "middle" portion 3c of the retractor body 3. The retractor body 3 also defines a proximal body portion 3d that extends from the middle portion 3c in a proximal direction P to the proximal end 4, and a distal body portion 3e that extends from the middle body portion 3c in a distal direction D to the distal end 6. It will be appreciated that the proximal direction P and the distal direction D are each a unidirectional component of the longitudinal direction L, which is bidirectional. The radially outer surface of the wings 16 defines a radius R3 that is slightly greater than the radius R2 of the inner wall surface 116 when in the intermediate configuration. In this manner, insertion of the wings 16 into the working channel 106 causes the wings 16 to flex inwardly toward the central axis 108 (and also toward one another), thereby providing a locking force. One or both of the wings 16 can define a helical end surface 18 that is continuous with the respective first or second side 20, 22 of the retractor body 3. In the illustrated embodiment, the helical end surface 18 defines a proximal surface of each wing 16, but the distal surface of one or both of the wings 16 can also extend helically to the respective first or second side 20, 22 in a similar manner.
[0127] As shown in Figure 2B and Figure 2C The retractor body 3 can define a proximal end portion 3f that is angularly offset from the adjacent portion 3h at an acute angle a1, as measured in a plane that extends along the longitudinal direction L and the transverse direction T, which can be referred to as an "L-T plane." The adjacent portion 3h can be characterized as a portion of the body 3 that extends from the end portion 3f of the retractor body 3 toward the opposite end 6. The retractor body 3 can alternatively or additionally define a distal end portion 3g that is angularly offset from the adjacent portion 3h at an acute angle a2 in the L-T plane. In embodiments in which the retractor body 3 has proximal and distal end portions 3f, 3g that are angularly offset from the adjacent portion 3h, the acute angular offset angles a1, a2 can be substantially equal, as shown, or can differ from one another.
[0128] As shown in Figure 2DAs shown in
[0129] As Figure 2E As shown in
[0130] Referring now to Figure 2F , the proximal body portion 3d and the distal body portion 3e can be at least partially, and optionally entirely, circumferentially offset from one another. In such embodiments, the proximal body portion 3d can extend in the distal direction D from the proximal end 4 to the locking spring 16, and the distal body portion 3e can extend in the distal direction D from the locking spring 16 to the distal end 6. Further, in such embodiments, the locking spring 16 can include an interconnecting portion 16a that connects the proximal body portion 3d and the distal body portion 3e together.
[0131] As Figure 2G As shown in Figure 1CThe orifices 24 can effectively define a bend-enhanced region of the retractor body 3. Additionally or alternatively, one or both of the wings 16 can define orifices 26 for increasing the flexibility of the wings 16, such as for elastically deforming between the intermediate and flexed configurations described above. One advantage of employing orifices 24, 26 to increase flexibility is that stronger materials can be used to form the retractor body 3. Moreover, the shape of the orifices 26 can be elliptical, which can mitigate material fatigue from multiple bends being applied at or near the same location of the retractor body 3. Additionally, at one or both of the proximal end 4 and the distal end 6, the retractor body 3 can define an end formation 27 for connecting to a wire, flexible tube, or other component or instrument of the surgical access system 100. Non-limiting examples of such end formations 27 can include an orifice 28 and a prong 29 extending over the orifice 27, such as in the longitudinal direction X.
[0132] It should be appreciated that the locking spring 16 of any of the foregoing embodiments can be disposed at different longitudinal locations along the retractor body 3 to compensate for deflection in response to soft tissue engaged by the distal end 6 and / or other surrounding tissue in contact with the retractor 2. For example, the foregoing embodiments can be combined with the embodiments described above with reference to Figures 2A to 2G Any combination of the retractors 2 described above can be provided in a kit comprising multiple versions of each retractor 2, with the respective locking springs 16 located at different longitudinal locations along the retractor body 3.
[0133] It should also be appreciated that the foregoing embodiments can be combined with the embodiments described above with reference to Figures 2A to 2G The design of the retractors 2 described above allows for more than one retractor 2, such as two (2) or more retractors 2, to be inserted within the working channel 106 and secured to the inner wall surface 116 for retracting soft tissue. In inserting a second retractor 2 into the working channel 106 that has already been attached with a first retractor 2, the physician can select the second retractor 2 to be one in which its locking spring 16 will be longitudinally offset from the locking spring of the first retractor 2 when both are secured within the working channel 106, thereby avoiding interference between the locking springs 16. Additionally or alternatively, the physician can select the second retractor 2 to have the same design as the first retractor and can select to insert the opposite end of the second retractor 2 into the channel 106 (i.e., can flip the second retractor 2 relative to the first retractor 2) so that the locking springs 16 do not interfere with each other.
[0134] Reference is now made to Figures 3A to 3CIn other embodiments, the attachment device 14 can include an attachment member 17 that is separate from the retractor 2 and that is connectable to the retractor, such as before, during, or after the retractor 2 is inserted through the working channel 106. In such embodiments, the retractor 2 and the attachment member 17 can have complementary mounting formations. For example, the attachment member 17 can include a sliding formation, such as a slider 30, that is configured to slidably engage a complementary sliding formation of the retractor body 3, such as a guide slot 32. The guide slot 32 of the present embodiment guides the translation, longitudinal movement of the slider 30 (and thus also the attachment member 17) along the retractor body 3 into and out of the working channel 106 as desired. The slider 30 and the guide slot 32 preferably have complementary geometries that allow the slider 30 to enter into and exit from the guide slot 32 at least at one location of the guide slot 32, such as at a proximal end thereof. For example, the proximal end of the guide slot 32 can have a widened portion or opening that allows the slider 30 to enter therein, while a retainer of the guide slot 32 is configured to retain the slider 30 therein. The distal end of the guide slot 32 can effectively provide a physical termination that prevents the slider 30 (and thus also the attachment member 17) from over- translating in the distal direction D.
[0135] Similar to the embodiments described above, the attachment member 17 includes a locking member, such as a locking spring 16, that can be configured similarly as described above. The locking spring 16 can define one or more compliant wings, each of which can be referred to as a circumferential wall that extends circumferentially away from the sliding formation 30 and that is configured to flex inwardly toward the central axis 108 of the access member 102 to provide a locking force when the locking member 16 is seated in the working channel 106. The locking spring 16 can be positioned to annularly slide between the outer surface 12 of the retractor body 3 and the inner surface 116 of the access member 102 when inside the working channel 106. The slider 30 can extend inwardly from the locking spring 16 in the transverse direction T (i.e., toward the central axis 108 of the access member 102) and into the guide slot 32. In other embodiments, the slider 30 can extend outwardly transversely from the locking spring 16, in which case the retractor body 3 can be annularly positioned between the locking spring 16 and the inner wall surface 116. The attachment member 17 includes a gripping member, such as a proximal extension 34, that allows a physician to manipulate the attachment member 17 relative to the retractor body 3 in the longitudinal direction L. It will be appreciated that the proximal extension 34 can be configured to curve away from the central axis 108 and off the path so as to reduce its profile in the proximal direction P, similar to the manner described above with reference to the embodiments of Figs. 1-3. Figure 1C
[0136] The retractor body 3 of this embodiment can be freely inserted through the working channel 106 to engage soft tissue, and once engaged, an attachment member 17 can be accommodated. This attachment member can be advanced distally D along the guide slot 32 until a locking spring 16 resides in the desired longitudinal position within the working channel 106, providing a locking force at this position. The longitudinal position of the attachment member 17 can then be adjusted as needed to reduce retractor deflection in response to surrounding tissue. Furthermore, if further adjustments to the engagement between the distal end 6 of the retractor body 3 and the soft tissue are required, the attachment member 17 can be withdrawn proximally from the working channel 106, optionally while remaining engaged with the guide slot 32, and can be repositioned within the working channel 106 as needed, such as after adjustments to the soft tissue have been completed. In this way, the attachment member 17 can be withdrawn from the working channel 106 during readjustments to the soft tissue retraction, allowing the physician more freedom to manipulate the retractor body 3 as needed.
[0137] Now for reference Figure 3D In other embodiments, the separate attachment member 17 and the retractor 2 may be configured to be magnetically attached to each other within the working channel 106. For example, at least a portion of the locking spring 16 of the attachment member 17 may be made of an ferrous (e.g., magnetic) material, and the retractor 2 may include a series of magnets 35 for selectively attaching to the attachment member 17 (or at least to its ferrous portion). The attachment member 17, including the locking spring 16 and its proximal extension 34, may also be configured similarly as referenced above. Figures 3A to 3C As described. In this embodiment, the attachment member 17 can be inserted into the working channel 106, and the retractor 2 can then be inserted through the working channel 106 to engage and retract soft tissue. In the case of soft tissue engagement, the physician can move the retractor 2 toward the inner wall surface 116 (and therefore also toward the locking spring 16), and a selected magnet in the magnets 35 can be magnetically engaged with the locking spring 16 (or at least its ferrous portion), thereby attaching the retractor to the inner wall surface 116. In an additional embodiment, the retractor 2 may be made of ferrous material, and the locking spring 16 may carry one or more magnets. In other embodiments, the retractor 2 and the locking spring 16 may carry magnets of opposite polarities for attachment therebetween.
[0138] Now for reference Figures 4A to 4D, the surgical access system 100 can include an instrument 300 that is releasably coupled to the retractor body 3 for manipulating the retractor body 3 so as to engage and retract soft tissue using the distal end 6 thereof. The instrument 300 includes a handle 302 that extends from a rear end 304 of the instrument 300 in a forward direction FD to a coupling mechanism 308 at a front end 306 of the instrument 300. The coupling mechanism 300 releasably couples the instrument 300 to the retractor body 3. For example, the coupling mechanism 308 can be configured to alternate between a coupled configuration (shown in Figures 4A to 4C ) in which the instrument 300 is rigidly coupled to the retractor body 3; and an uncoupled configuration (shown in Figure 4D ) in which the instrument 300 is uncoupled from the retractor body 3 and can be removed therefrom, as described in greater detail below.
[0139] The instrument 300 can also be configured to operate an attachment device 314 that is coupled to the retractor body 3. As described above, the attachment device 314 is configured to attach the retractor body 3 to the access member 102, particularly the inner wall surface 116, after the distal end 6 of the retractor body 3 has thereby engaged soft tissue to be retracted. In the present embodiment, the attachment device 314 can have a proximal mount 316 and a distal mount 318 that are configured to mount to the proximal end 110 and the distal end 112, respectively, of the access member wall 104. The proximal mount 316 defines one or more mating surfaces 317 that are configured to engage one or more complementary mating surfaces 307 defined at the front end 306 of the instrument 300. The mating surfaces 307, 317 can be aligned with the axial and longitudinal directions, respectively, thereby allowing the instrument 300 to be lifted away from the proximal mount 316 in the longitudinal direction L when in the uncoupled configuration, as shown in Figure 4D .
[0140] Reference is now made to Figure 4E, the proximal mount 316 and the distal mount 318 can each include an engagement member 320a, 320b configured to engage the access member 102, such as at its proximal end 110 and distal end 112, in a manner that secures the attachment device 314 (and thus also the retractor body 3) to the wall 104. As illustrated, each of the engagement members 320a, 320b can be a hook configured to hook or otherwise latch onto the respective proximal end 110 and distal end 112 of the access member 102. In addition, at least one of the proximal mount 316 and the distal mount 318, such as their engagement members 320a, 320b, can be configured to move between a non-locked configuration, in which the proximal mount 316 is longitudinally spaced apart from the distal mount 318 by a first distance LI, and a locked configuration, in which the proximal mount is longitudinally spaced apart from the distal mount by a second distance L2 that is less than the first distance LI. In particular, the second distance L2 corresponds to the distance between the proximal end 110 and the distal end 112 of the wall 104 along the axial direction X. In this way, the proximal mount 116 and the distal mount 118 can be configured to achieve a secure grip on the access member 102 for attaching the retractor body 3 thereto.
[0141] The surgical access system 100 includes an actuator 330 configured to actuate at least one of the proximal mount 316 and the distal mount 318 from the non-locked configuration to the locked configuration. For example, the proximal mount 316 can include a mount base 322 coupled to the engagement member 320a. In the illustrated embodiment, the actuator 330 extends between and connects the mount base 322 and the engagement member 320a. In addition, the actuator 330 is configured to actuate the longitudinal movement of the engagement member 320a relative to the mount base 322 between the non-locked configuration and the locked configuration.
[0142] Reference is now made to Figure 4F The actuator 330 can include a biasing mechanism 331 for biasing one or both of the proximal mount 316 and the distal mount 318 into the locked or non-locked configuration. In the illustrated embodiment, the biasing mechanism 331 includes a spring assembly 332 including at least one spring 334, such as a pair of springs 334, that exerts a biasing force on the engagement member 320a in a biasing direction, such as the distal direction D, away from the mount base 322, thereby actuating the engagement member 320a to the locked configuration. The spring assembly 332 can also include one or more spring guide members 336, such as a pair of guide rods 336 or dowels, that extend centrally through the springs 334 as illustrated and are configured to guide the movement of the engagement member 320a along the longitudinal direction L toward and away from the mount base 322.
[0143] The coupling mechanism 308 of the instrument 300 can be configured to move the actuator 330 in a manner that urges or at least facilitates movement of one or both of the proximal mount 316 and the distal mount 318 between a locked configuration and an unlocked configuration. For example, in the illustrated embodiment, the coupling mechanism 308 can include one or more moving members, such as a pair of arms 340, that are configured to operably connect to the engagement members 320a of the proximal mount 316 in a manner that urges movement of the engagement members 320a relative to the mounting base 322, as described in greater detail below. As shown, the arms 340 can be spaced apart from one another along a transverse direction A, and can be translatable relative to the handle 302, such as along an arm translation direction that has at least a directional component along the forward direction FD and / or the reverse direction RD opposite the forward direction FD. The arms 340 can travel along complementary guide formations, such as guide slots 342 defined in the body 305 of the handle 302. As shown, the guide slots 342 and the arms 340 can have complementary dovetail geometries.
[0144] Reference is now made to Figure 4G , the arms 340 can be coupled together by a yoke member 344, which can also couple the arms 340 to a central arm 346 that is biased along the forward direction FD or the reverse direction RD. In the illustrated embodiment, the coupling mechanism 308 includes an arm biasing member 348, such as a spring, that can reside in a slot 350 defined centrally within the handle body 305. The depicted biasing member 348 is a compression spring that engages the central arm 346 so as to bias the central arm, and the arms 340, in the forward direction FD into a coupled configuration with the retractor body 3. In this embodiment, when in the coupled configuration, the distal ends 341 of the arms 340 are engaged with and coupled to the mounting base 322, which rigidly couples the instrument 300 to the retractor body 3. As shown, when in the coupled configuration, the distal ends 341 of the arms 340 can extend within complementary shaped receptacles 326 in the mounting base 322 (see also Figure 4C ). The arms 340 are also configured to translate in the reverse direction RD to withdraw the distal ends 341 of the arms 340 from the receptacles 326 of the mounting base 322, moving the instrument 300 into an uncoupled configuration. In this manner, the arms 340 can be translated in the forward direction FD and the reverse direction RD to alternate the coupling mechanism 308 between the coupled configuration and the uncoupled configuration. The outer surfaces of the arms can include grip-enhancing features 352, such as serrations, to facilitate manual distraction of the arms 340. As Figure 4DAs shown in the middle, as the distal end 341 of the arm 340 is distanced from the receptacle 326 of the mounting base 322, the instrument 300 can be moved away from the attachment device 314, which remains attached to the access member 102.
[0145] Referring now to Figure 4H While the coupling mechanism 308 is in the coupled configuration with the mounting base 322, the instrument 300 can also be configured to engage the actuator 330 for moving the engagement member 320a relative to the mounting base 322, such as to the unlocked configuration. As shown, the central arm 346 is operably connected to a return member 335 of the biasing mechanism 331. The return member 335 is configured to move the engagement member 320a in a direction opposite the biasing direction, such as a proximal direction P opposite the distal direction D, toward the mounting base 322 so as to move the engagement member 320a to the unlocked configuration. The return member 335 can be an elongate member that extends proximally from the engagement member 320a of the proximal mount 316 and through an opening 309 at the front end 306 of the instrument 300 and into a cavity 311 defined within the handle body 305. The opening 309 can be defined between the handle body 305 and the base member 322 of the proximal mount 316. As shown, the return member 335 can be integral with the engagement member 320a or, alternatively, can be a separate member connected to the engagement member 320a.
[0146] The instrument 300 can include a connector 337 that connects the central arm 346 to the return member 335. A front end 337a of the connector 337 can be configured to reside within a recess 339 defined by the return member 335 when the coupling mechanism 308 is in the coupled configuration, as shown. The front end 337a of the connector 337 and the recess 339 can have complementary geometries such that, when the front end 337a resides in the recess 339, the connector 337 holds the return member 335 in the unlocked configuration (against the biasing force). The instrument 300 can include a second actuator, such as a button 360, that is configured to alternate the engagement member 320a of the proximal mount 316 between the locked and unlocked configurations. The button 360 can be configured to alternate between a first or intermediate button position, in which the proximal mount 316 is in the locked configuration, and a second or depressed button position, in which the proximal mount 316 is in the unlocked configuration. In particular, the button 360 can be biased into one of the intermediate and depressed button positions by a button biasing member, such as a spring 362, which can reside within a button spring receptacle 364 defined within the handle body 305.
[0147] The button 360 can include one or more extensions or legs 366, such as a pair of legs 366 that span the center arm 346. At least one of the button legs 366 can include a camming protrusion 367 that is configured to travel along a complementary groove 369 defined in the connector 337. The connector 337 can be pivotably coupled to the center arm 346 via a pin joint 347 such that when the button 360 is depressed, the camming 367 and groove 369 engagement causes the connector 337 to pivot about the pin joint 347 such that the forward end 337a of the connector 337 pulls the return member 335 in the proximal direction P against the biasing force, thereby moving the engagement member 320a of the proximal mount 316 to the unlocked configuration. Additionally, when the button 360 is alternated to its intermediate position, the camming 367 and groove 369 engagement causes the connector 337 to pivot in the opposite direction about the pin joint 347, thereby allowing the biasing mechanism 331 to return the engagement member 320a to the locked configuration. Thus, a physician can operate the button 360 to move the proximal mount 316 between the locked and unlocked configurations as desired. It will be appreciated that the forward end 337a of the connector 337 is configured to move away from the receptacle 339 in the rearward direction RD when the instrument 300 is in the decoupled configuration. Thus, moving the arm 340 in the forward direction FD and the rearward direction RD to alternate the coupling mechanism 308 between the coupled and decoupled configurations engages and disengages the connector 337 with the return member 335.
[0148] The operation of the instrument 300 in retracting soft tissue at the treatment site will now be described. The instrument 300 can be inserted through the working channel 106 into the retractor body 3 to engage and retract soft tissue. Specifically, the physician can manipulate the retractor body 3 to engage and retract soft tissue via the handle 302. Once the soft tissue is engaged, the physician can use the instrument 300 to pull the soft tissue toward the wall 104. The attachment device 314 is designed to allow the physician to choose whether to first attach the proximal mount 316 or the distal mount 318 to the corresponding proximal end 110 or distal end 112 of the entry member 102. The selected mount 316, 318 is secured to the corresponding end 110, 112 of the entry member 102 by engaging the hooks 320a, 320b of the ends 110, 112 with the mounts 316, 318. To secure the selected mounts 316, 318 to the respective ends 110, 112 of the entry member 102, the physician may press button 360 to move the engagement member 320 of the proximal mount 316 to an unlocked configuration. It should be understood that with one of the mounts 316, 318 secured, the physician may optionally use the secured mount 316, 318 as a pivot or fulcrum to align the other of the proximal mount 316 and distal mount 318 with the respective ends 110, 112 of the entry member 102. With the two mounting pieces 316, 318 aligned with the ends 110, 112 of the entry member 102, the physician can then release button 360, thereby allowing the biasing mechanism 331 to bias the proximal engagement member 320a away from the mounting base 322 in a manner that reduces the longitudinal distance between the mounting pieces 316, 318, until both mounting pieces 316, 318 are locked to the ends 110, 112 of the entry member 102 in a locking configuration.
[0149] Now for reference Figures 4I to 4K The attachment device 314 may be configured to allow the retractor body 3 to translate relative to the entry member 102 in the longitudinal direction L while attaching to the wall 104. For example, the attachment device 314 may include one or more elongated members 370, such as a pair of rods, extending from the proximal mount 316 to the distal mount 318 within the working channel 106. The rods 370 are spaced apart from each other in the lateral direction A, such that the retractor body 3 can extend between the rods 370. One or both of the proximal mount 316 and the distal mount 318 may include guiding features, such as guide shoes 372 that engage the sides 20, 22 of the retractor body 3. For example, the guide shoes 372 and the sides 20, 22 of the retractor body 3 may have complementary shapes to guide the retractor body 3 to translate in the longitudinal direction L. One or both of the proximal mount 316 and the distal mount 318 may further define a guide channel 374 having a complementary geometry to the retractor body 3 for further guiding its translational movement 3 in the longitudinal direction L.
[0150] The attachment device 314 can include a retention mechanism for retaining the relative longitudinal position between the retractor body 3 and the attachment device 314. For example, as shown in Figure 4H The base member 322 can include a flexible tab or pawl 380 having a tooth 382 at the distal free end of the pawl 380. As the retractor body 3 is translated relative to the mounting base 322, the tooth 382 is configured to continuously engage a longitudinal series of complementary ratchet grooves 384 defined in the outer surface 12 of the retractor body 3. The tooth 382 and the ratchet grooves 384 can have complementary geometries that allow the physician to manually longitudinally translate the retractor body 3 relative to the attachment device 314 as desired, but provide sufficient resistance to retain the relative longitudinal position between the retractor body 3 and the attachment device 314 after the physician stops manipulating the retractor body 3. It will be appreciated that the complementary geometries of the tooth 382 and the ratchet grooves 384 can be tailored as desired to provide the desired amount of resistance to relative longitudinal movement between the attachment device 314 and the retractor body 3.
[0151] Reference is now made to Figure 5A , which shows another embodiment of a surgical access system 100 that includes an instrument 400 that is releasably coupled to the retractor body 3. As with the embodiments described above, the instrument 400 is configured to alternate between a coupled configuration, in which the instrument is coupled to the retractor body 3, and an uncoupled configuration, in which the instrument 400 is uncoupled from the retractor body 3 and can be removed from the retractor body. For the sake of brevity, the following disclosure will focus on the differences between this embodiment and the embodiments described above with reference to Figures 4A to 4K .
[0152] In the present embodiment, the retractor body 3 carries an attachment device 414 that is operable between a locked configuration and an unlocked configuration independently of the operation of the instrument 400. As shown, the attachment device 414 includes a proximal mount 416 and a distal mount 418 that can each have a hook-like geometry for engaging the proximal end 110, the distal end 112 of the access member 102. An elongated actuator 430 extends proximally from the distal mount 418 through a receptacle defined by the proximal mount 416 and to a control member 435 spaced apart from the proximal mount 416 in the proximal direction P. The elongated actuator 430 can be a rod that can be rigidly coupled to the distal mount 418 and configured to slide the distal mount 418 along the retractor body 3 and relative to the proximal mount 416 so as to adjust the longitudinal distance between the proximal mount 416 and the distal mount 418 as needed to attach to the access member 102. The control member 435 can be a finger tab that allows a push-push operation of the elongated actuator 430 in the longitudinal direction L.
[0153] The instrument 400 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. As above, once the soft tissue is engaged, the physician can use the instrument 400 to pull the soft tissue toward the wall 104, selecting to first secure either the proximal mount 416 or the distal mount 418 to the respective proximal end 110 or distal end 112 of the access member 102 by hooking the ends 110, 112 with the hooks of the mounts 416, 418. From this position, the physician can align the other of the proximal mount 416 and the distal mount 418 with the respective end 110, 112 of the access member 102 and subsequently operate the control member 435 to reduce the longitudinal distance between the mounts 416, 418 until both mounts 416, 418 are secured to the ends 110, 112 of the access member 102 in the locked configuration. The proximal mount 316 and the distal mount 318 preferably each define a guide channel 474 (shown in Figure 5B the retractor body 3 for further guiding the translational movement of the retractor body 3 in the longitudinal direction L at least after the instrument 400 is decoupled from the attachment device 414.
[0154] Reference is now made to Figure 5BThe instrument 400 includes a coupling mechanism 408 that is directly coupled to the retractor body 3. In particular, the instrument 400 has an instrument body 405 that has a mounting sleeve 410 at its forward end 406. The mounting sleeve 410 defines a receptacle 411 that is configured to receive a proximal portion of the retractor body 3 in the proximal direction P. In addition, the coupling mechanism 408 includes a locking pin 422 that resides within a pin receptacle 424 defined within the instrument body 405 along a pin axis 425. The pin axis 425 is orientable in the transverse direction T. The pin receptacle 424 is aligned with a locking aperture 426 defined within a forward portion of the mounting sleeve 410. In the present embodiment, the retractor body 3 defines a locking aperture 7 that extends from the inner surface 10 to the outer surface 12 in the transverse direction T. The proximal end 4 of the retractor body 3 is insertable in the proximal direction P within the mounting sleeve 410 until the locking aperture 7 is aligned with the locking pin 422. Once aligned, the locking pin 422 is advanceable from a decoupled configuration in which the pin 422 is distal from the locking aperture 7 to a coupled configuration in which the locking pin 422 extends through the locking aperture 7 of the retractor body 3 and into the locking aperture 426.
[0155] The locking pin 422 is alternatable between the coupled and decoupled configurations by the button 460 moving along a button axis 465 between a first button position and a second button position. The button axis 465 is angularly orientable relative to the pin axis 425. As shown, the button 460 and the pin 422 can define a complementary cam mechanism that can include a side pin or protrusion that extends laterally from the pin 422 and into a cam groove 467 defined in a body 469 of the button 460. In this way, the alternating motion of the button 460 along its axis 465 can drive the alternating motion of the locking pin 422 along its axis 425 between the coupled and decoupled configurations. It will be appreciated that a biasing member, such as a spring, can extend between the button 460 and the instrument body 305 that can operate in a complementary manner with the cam mechanism to effectively toggle the locking pin 422 between the coupled and decoupled configurations.
[0156] Reference is now made to Figures 6A to 6FThe instrument 400 described above can be configured to employ a tensile actuator, such as the suture member 431, for pulling the distal mount 418 toward the proximal mount 416 and moving the attachment device 414 into the locked configuration. In such embodiments, the distal mount 418 can include one or more receiving formations for housing at least a portion of the suture member 431. Such receiving formations can include one or more apertures 470 defined by the distal mount 418, such as a pair of apertures 470 spaced apart from one another along the lateral direction A. The pair of apertures 470 can extend through a rear portion of the distal mount 418 along a direction having a directional component along the transverse direction T. The suture member 431 can be threaded through the apertures 470 so as to define one or more suture leads 434, such as a pair of suture leads 434, that can be operably coupled to the proximal mount 416. The proximal mount 416 can include one or more additional receiving formations 437, such as suture channels, cleats, or the like, for receiving and securing the one or more suture leads 434 thereto. The instrument 400 can also include additional receiving formations, such as channels, cleats, or the like, for receiving and / or securing free ends of the one or more suture leads 434 extending from the proximal mount 416, thereby allowing the physician to secure the one or more suture leads 434 in a fixed but non-locked configuration relative to the instrument 400.
[0157] As Figure 6E The one or more receiving formations 437 of the proximal mount 416 can be configured such that the respective suture leads 434 can be locked thereto via friction, as illustrated in FIG. 48. The suture member 431 can extend from its first end 439a through a first receiving formation 437 at the proximal mount 416, along the retractor body 3 along the longitudinal direction L, through the apertures 470 in the distal mount 418, back along the retractor body 3 and toward the proximal mount 416, through a second receiving formation 437 at the proximal mount 416, and to a second end 439b of the suture member 431 opposite the first end 439a. In this manner, the suture lead 434 adjacent the second end 439b can be manipulated by the physician to tension the suture member 431 to pull the distal mount 418 toward the proximal mount 416, thereby moving the attachment device 414 into the locked configuration. Once in the locked configuration, the suture lead 434 adjacent the second end 439b can be secured to the second receiving formation 437, thereby locking the attachment device 414 in the locked configuration. It will be appreciated that the first end 439a of the suture member 431 can be tied off, or otherwise configured for retaining a knot at the first receiving formation 437. Further, the second end 439b of the suture member 431 can be optionally coupled to a pulling member, such as a rigid ring or collar, for assisting the physician in tensioning the suture member 431.
[0158] In the unlocked configuration, the instrument 400 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. Once the soft tissue is engaged, the physician can use the instrument 400 to pull the soft tissue toward the wall 104. During this procedure, the physician can choose to secure at least one of the proximal mount 416 and the distal mount 418 to the respective proximal end 110 and / or distal end 112 of the access member 102, such as by hooking the hooks of the mounts 416, 418 onto the ends. As above, the design of the attachment device 414 allows the physician to first hook either the proximal mount 416 or the distal mount 418 to the respective end 110, 112. From this position, the physician can align the other of the proximal mount 416 and the distal mount 418 with the respective end of its access member 102 and subsequently apply a tensioning force to the suture member 431, such as by pulling the free suture lead 434 adjacent the second end 439b, until the proximal mount 416 and the distal mount 418 are secured to the ends 110, 112 of the access member 102 in the locked configuration, as shown in Figure 6D From this position, the physician can attach the free suture lead 434 to the second receiving formation 437 of the proximal mount 416 (so that both suture leads 434 are secured to the proximal mount 416), thereby maintaining the mounts 416, 418 in the locked configuration. The physician can also detach one or both of the ends 439a, 439b of the suture lead 434 from the receiving formation of the instrument 400, thereby allowing the instrument 400 to decouple from the proximal mount 416, with the proximal mount 416 and the distal mount 418 secured in the locked configuration.
[0159] Similarly, as described above, the proximal mount 416 and the distal mount 418 preferably each define a guide channel having a complementary geometry to the retractor body 3 for guiding the translational movement of the retractor body 3 relative to the mounts 416, 418 in the longitudinal direction L after the instrument 400 is decoupled from the proximal mount 416. For example, as shown in Figure 6F the one or both of the proximal mount 416 and the distal mount 418 can define a channel 474 having trapezoidal channel sidewalls 475 that hold the retractor body 3 within the channel 474 while allowing the retractor body 3 to longitudinally translate relative to the mount. Additionally, the outer surface 12 of the retractor body 3 can optionally define a longitudinal channel or groove 492 configured to receive the suture member 431. It should also be appreciated that the instrument 400 of the present embodiment can employ a design similar to that described above with reference to Figure 5BThe coupling mechanism 408 described is the same or similar coupling mechanism for selective direct coupling to and decoupling from the retractor body 3. In such embodiments, the proximal mount 416 can be rigidly attached to the mounting sleeve 410 of the coupling mechanism. It will also be appreciated that in additional embodiments, the above references to the coupling mechanism 408 described above with reference to Figures 6A to 6F The instrument 400 described can be configured to employ a tensile actuator, which by way of non-limiting example, can alternatively be an elastic member, such as an elastic band.
[0160] Reference is now made to Figures 7A to 7C The surgical access system 100 can include an attachment device 714 having a proximal mount 716 and a distal mount 718 and employing a retention mechanism, such as a ratchet or ratchet-like mechanism, for securing the mounts 716, 718 in a locked configuration to the access member 102. Similar to the above references to the coupling mechanism 408 described above with reference to Figures 4A to 6D The proximal mount 716 and the distal mount 718 of the present embodiments are each configured to alternate between a non-locked configuration and a locked configuration. Additionally, as above, the mounts 716, 718 include an engagement member 720a, 720b, such as a hook, configured to hook, latch or otherwise secure to the respective proximal end 110 and distal end 112 of the access member 102 when in the locked configuration. For the sake of brevity, the following disclosure will focus on the differences between the present embodiments and the above-described embodiments with reference to Figures 4A to 6D
[0161] As shown in Figure 7A Each of the proximal mount 716 and the distal mount 718 can include an elongate body portion 719 elongated along the longitudinal direction L and conforming to the outer surface 12 of the retractor body 3 for guiding translational movement of the retractor body 3 relative to the mounts 716, 718. The elongate body portions 719a, 719b are configured to extend within the working channel 106 and reside between the retractor body 3 and the inner wall surface 116 of the access member 102. The proximal mount 716 can also include an elongate handle portion 702 extending from the elongate body portion 719a and configured to allow a physician to manipulate the retractor body 3 for engaging soft tissue at a treatment site. For example, the elongate handle portion 702 can be configured for manipulation by the physician's index finger. As shown in Figure 7B In other embodiments, the handle portion 702 can have a circular shape. In yet other embodiments, the handle portion 702 can be configured to deflect between at least one of an elongate configuration Figure 7A ) and a circular configuration Figure 7B ).
[0162] The attachment arrangement 714 includes an elongate actuator 730 that extends proximally from the distal mount 718, through and / or along the proximal mount 716, and to a control member 735 spaced apart from the proximal mount 716 in the proximal direction P. As illustrated, the elongate actuator 430 can be a pair of rods 731 that can be rigidly coupled to the distal mount 718 and configured to move the distal mount 718 along the retractor body 3 and relative to the proximal mount 716 to alternate the mounts 716, 718 between the locked and unlocked configurations, as described above with reference to Figure 5A The control member 735 can be a finger tab that allows push-push operation of the actuator rods 731 in the longitudinal direction L, as above. For example, the control member 735 can be configured for manipulation by the physician’s thumb, while the handle portion 702 is configured for manipulation by the physician’s index finger. As Figure 7C As illustrated in
[0163] Referring now to Figure 7D and Figure 7E , the retractor body 3, as well as the proximal and distal mounts 716, 718, can include guide features for guiding translational movement of the retractor body 3 relative to the mounts 716, 718, and vice versa, such as for translating the retractor body 3 relative to the entry member 102. For example, the retractor body 3 can define a slot 740 elongated along the longitudinal direction L. The mounts 716, 718 can each include a slide member 742 that extends from the respective elongate body portion 719a, 719b and within the slot 740 and is configured to travel longitudinally along the slot. Within the slot 740, the retractor body 3 can define side walls 744 that slope inwardly toward one another, and the slide members 742 can have a flared geometry that dovetails with the sloped geometry of the side walls 744. In this way, the side walls 744 can retain the slide members 742 within the slot 740, and thus the proximal and distal mounts 716, 718, in engagement with the outer surface 12 of the retractor body 3.
[0164] Referring now to Figures 7F to 7HA holding mechanism for selectively maintaining the relative longitudinal position between the proximal mount 716 and the distal mount 718 will now be described. The retractor body 3 may define, for example, a series of ratchet recesses 750 arranged longitudinally along a slot 740 and configured to engage at least one complementary ratchet tooth 752 of at least one of the proximal mount 716 and the distal mount 718. The ratchet recesses 750 may be defined in the outer surface 12 of the retractor body 3 and may also be defined at least partially by sidewalls 744 within the slot 740.
[0165] like Figure 7G and Figure 7H As shown, ratchet teeth 752 may extend from a flexible tab 754, also referred to as a "pawl," and may be defined by an elongated body portion 719a of a proximal mount 716. The ratchet teeth 752 are configured to sequentially and selectively engage at least one and at most each of the ratchet recesses 750 as the proximal mount 716 translates longitudinally relative to the retractor body 3. The ratchet teeth 752 may be located at a first end 756 of the pawl 754, opposite a second end 758 of the pawl 754. The second end 758 may include a hook 320a of the proximal mount 716. The pawl 754 may reside within a recess in a cutout 760 defined by the elongated body portion 719a. The pawl 754 may be connected to the remainder of the elongated body portion 719a by a pair of arms 762 opposing each other in the lateral direction A. The pair of arms 762 provide the pawl 752 with rotational flexibility along a plane defined by the longitudinal and lateral directions T. In this way, the pawl 754 can be configured to alternate between intermediate or engaged configurations (such as...). Figure 7G (as shown in the diagram), wherein the tooth 752 resides in one of the ratchet recesses of the ratchet recess 750 to maintain the relative longitudinal position between the proximal mount 716 and the retractor body 3; and a flexure or disengagement configuration wherein the tooth 752 is disengaged from each of the ratchet recesses of the ratchet recess 750.
[0166] The teeth 752 and ratchet grooves 750 can have complementary geometries that provide substantially equal resistance to proximal or distal movement of the proximal mount 716 relative to the retractor body 3. It will be appreciated that the complementary geometries of the teeth 752 and ratchet grooves 750 can be customized as desired to provide a desired amount of resistance to relative longitudinal movement between the proximal mount 716 and the retractor body 3. In other embodiments, the teeth 752 and ratchet grooves 750 can have complementary geometries that prevent proximal movement of the proximal mount 716 relative to the retractor body 3 in the engaged configuration. In such embodiments, the pawl 754 can optionally include a disengagement feature for manually rotating the pawl 754 to a disengaged configuration. It will be appreciated that the retention mechanism of the foregoing embodiments can provide audible and / or tactile feedback regarding relative longitudinal movement between the proximal mount 716 and the retractor body 3 as the teeth 752 click in and out of the ratchet grooves 750. It will be appreciated that in other embodiments, controlled movement of the proximal mount 716 and the distal mount 718 relative to one another can be used in a friction-based retention mechanism.
[0167] Operation of the retractor 2 of the present embodiments will now be described. The handle portion 702 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. Once the soft tissue is engaged, the physician can use the handle portion 702 to pull the soft tissue toward the wall 104, thereby selecting to first secure either the proximal mount 716 or the distal mount 718 to the respective proximal end 110 or distal end 112 of the access member 102 by hooking the hooks of the mounts 716, 718 around the ends 110, 112. From this position, the physician can align the other of the proximal mount 716 and the distal mount 718 with the respective end 110, 112 of the access member 102, and subsequently operate the control member 735 to reduce the longitudinal distance between the mounts 716, 718, thereby causing the ratchet teeth 752 to sequentially engage the ratchet grooves 750 until both mounts 716, 718 are secured to the ends 110, 112 of the access member 102 in a locked configuration.
[0168] It will be appreciated that each of the embodiments described above with reference to Figures 4A to 7H Each of the embodiments described above allows multiple retractors 2 to be simultaneously attached to various selected circumferential locations of the access member 102 with the respective attachment devices 314, 414, 714 attached to the ends 110, 112 of the access member 102.
[0169] Reference is now made to Figures 8A to 8CThe surgical access system 100 can include a suction attachment device 814 configured to selectively attach the retractor body 3 to a circumferential portion of the inner wall 116 of the access member 102. For example, the retractor body 3 can define an internal chamber 816 in fluid communication with a plurality of vacuum ports 818 defined in the outer surface 12 of the retractor body 3. The internal chamber 816 is also in fluid communication with a proximal port 820 that can be connected to a tube 822 that, in turn, can be connected to a vacuum source 824, such as a vacuum pump. A plurality of ring seals 826 are located in the vacuum ports 818 and are configured to provide a sealing engagement with the inner wall surface 116 when the ring seals 826 are in contact with the inner wall surface 116, and the vacuum source 824 supplies a vacuum pressure to the internal chamber 816, and thus also to the vacuum ports 818. The suction attachment device 814 can be configured to provide a customized, adequate suction force that allows the retractor body 3 to at least longitudinally translate relative to the access member 102 while the retractor body 3 remains attached to the access member 102 via the suction attachment device 814. It will be appreciated that the present embodiment allows a plurality of retractors 2 to be simultaneously attached to various selected circumferential locations of the inner wall surface 116 via suction.
[0170] Referring now to Figures 9A to 9C The surgical access system 100 can include an attachment device 914 that employs a mating engagement between a protrusion 920 and an opening 922 for selectively attaching the retractor body 3 to a circumferential portion of the access member 102. For example, at least one of the inner wall surface 116 and the retractor body 3 can define one or more openings 922, and the other of the inner wall surface 116 and the retractor body 3 can include one or more protrusions 920 that are complementary to the one or more openings 922. In other words, the one or more protrusions 920 are configured for insertion within the one or more openings 922 in order to couple the retractor body 3 to the access member 102.
[0171] As Figure 9AAs shown, the wall 104 of the access member 102 may define an array 924 of openings 922, and the retractor 2 may include a series of protrusions 920 for engagement within selected openings in the openings 922. The protrusions 920 may be defined by and integral with the retractor body 3, or may be carried by an insert connectable to the retractor body 3. The protrusions 920 extend outward from the outer surface 12 of the retractor body 3 and are aligned with each other in the longitudinal direction L. The openings 922 may each extend outward from their inner surfaces 116 into the wall. The array 924 may include one or more columns 926 and one or more rows 928 of openings 922. In each column 926, the openings may be aligned with each other in the longitudinal direction L. Thus, each column 926 may be characterized as defining a longitudinally aligned subset of openings 922 in the array 924. The columns 926 are circumferentially spaced from each other along the wall 104. In each row 928, the opening 922 can be aligned along the lateral direction A. Therefore, each row 928 can be characterized as a laterally aligned subset of the openings 922 in the defined array 924. The rows 928 are spaced apart from each other along the axial direction X of the entry member 2 (and also along the longitudinal direction L of the retractor 2 when the retractor 2 is attached to the entry member 102). Figure 9A In the illustrated embodiment, the protrusion 920 is configured for insertion into any of the columns 926 to selectively attach the retractor body 3 to the circumferential portion of the entry member 102. It should be understood that the retractor 2 may have fewer protrusions 920 than the number of openings 922 in the columns 926. In such embodiments, the retractor 2 may also be selectively attached to the entry member 102 at a selected depth (i.e., a selected longitudinal position).
[0172] The protrusion 920 optionally defines a handle 930 extending from the retractor 2, and a head 932 located at the outer end of the handle 930 and wider than the handle 930. For example... Figure 9B As shown, opening 922 extends radially from inner wall surface 116 through wall 104 to outer wall surface 114. In this type of embodiment, protrusion 920 may be configured such that handle 930 extends through opening 922, and when retractor body 3 is attached to entry member 102, at least a portion of head 932 is located radially outside of outer wall surface 114. As shown, handle 930 may be long enough such that the entire head 932 is located radially outside of wall 102. In this type of embodiment, when retractor 2 is attached to entry member wall 104, at least a portion of head 932 may overlap at least a portion of wall 104 in the axial direction X of entry member 102 (and therefore also in the longitudinal direction L of retractor 2). Thus, protrusion 920 and opening 922 may be cooperatively configured to resist unintentional disengagement of retractor 2 from entry member wall 104 in the lateral direction T.
[0173] In other implementations, such as Figure 9CAs shown in the middle, the openings 922 can extend from the inner wall surface 116 and terminate at a radially inward location of the outer wall surface 114. In such embodiments, the openings 922 can include an axial receptacle 934 configured to receive a portion of the mating head 932 such that at least a portion of the head 932 overlaps at least a portion of the wall 104 in the axial direction X and the longitudinal direction L, respectively, as above. It will be appreciated that other complementary protrusion 920 and opening 922 geometries for providing secure, selective attachment of the retractor 2 to the access member wall 104 are within the scope of the present disclosure. It will also be appreciated that in other embodiments, the protrusions 920 can extend inwardly from the inner wall surface 116 of the access member 102 and the openings 922 can be defined in the retractor body 3.
[0174] In a surgical procedure using the surgical access system 100 of the present embodiments, a physician can insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. Once the soft tissue is engaged, the physician can manipulate the proximal end 4 of the retractor 2 to pull the soft tissue toward the wall 104. In particular, the physician can identify a row 926 of the openings 922 in the inner wall surface 116 that is substantially radially aligned with a desired retraction direction for coupling with the protrusions 920 of the retractor 2. Subsequently, the physician can insert the protrusions 920 of the retractor 2 into selected openings 922 of the row 926 at a desired longitudinal position of the retractor 2 relative to the access member 102, thereby attaching the retractor 2 to the inner wall surface 116 at the selected circumferential and longitudinal position of the inner wall surface 116. It will be appreciated that multiple retractors 2 can be attached to the inner wall surface 116 in a similar manner to retract soft tissue as desired.
[0175] Reference is now made to Figure 9D and Figure 9E show additional embodiments in which one or more protrusions 920 extend proximally from the proximal surface 111 of the access member 102. The proximal surface 111 can define the proximal end 110 of the access member 102. In such embodiments, the one or more protrusions 920 can include a plurality of protrusions 920 circumferentially spaced apart from one another along the proximal surface 111. The proximal surface 111 can be defined by a flange 113 at the proximal end 110 of the access member 102. In the present embodiments, the retractor body 3 defines one or more openings 922 extending therefrom from the inner surface 10 to the outer surface 12. In particular, the retractor body 3 of the present embodiments can be pre-curved or bendable such that a first or proximal portion 3a of the retractor body 3 is angularly offset relative to a second or distal portion 3b of the retractor body 3, as above with reference to Figure 1CThe proximal portion 3a defines at least one opening 922 extending along the axial direction X and thus can mate with a selected one of the protrusions 920 associated with a selected circumferential portion of the entry member 102 for attaching the retractor body 3 thereto. As shown, the proximal portion 3a, the distal portion 3b of the retractor body 3 can be angularly offset from one another in the L-T plane such that the distal portion 3b extends substantially along the axial direction X through the working channel 106 while the proximal portion 3a is elongated along the radial direction R (or at least along a direction having a directional component along the radial direction R).
[0176] In embodiments in which the retractor body 3 is pre-curved, the proximal portion 3a defines a single opening 922. In embodiments in which the retractor body 3 is bendable, the retractor body 3 can define a plurality of openings 922 spaced serially along the longitudinal direction L, thereby allowing the physician to bend the retractor body 3 at a selected longitudinal location to define respective lengths of the proximal portion 3a and the distal portion 3b, thereby defining an insertion depth of the distal portion 3b when attached to the retractor body 3. It will be appreciated that, as above, the protrusions 920 can have a stem 930 and a head 932 and can be cooperatively configured with the openings 922 such that, when the retractor body 3 is attached to the entry member 102, the heads 932 can overlap at least a portion of the retractor body 3 along the radial direction R. Such overlap can increase the stability of the attachment between the retractor body 3 and the entry member 102.
[0177] During use of the embodiments shown in Figure 9D and Figure 9E , the physician can identify a protrusion 920 on the proximal surface 111 that is substantially radially aligned with a desired direction of retraction for coupling with an opening 922 of the retractor 2. The physician can insert the retractor body 3 through the working channel 106 and engage and retract soft tissue in the radial direction R, thereby causing the distal portion 3b of the retractor body 3 to be directed toward the inner wall surface. In embodiments in which the retractor body 3 is pre-curved, the foregoing steps also align the opening 922 in the curved proximal portion 3a with the selected protrusion 920. In embodiments in which the retractor body 3 is bendable, the physician can bend the retractor body 3 at a selected longitudinal location to provide the distal portion 3b with a desired axial depth relative to the entry member 102. In either embodiment, as the distal portion 3b engages the soft tissue and is moved toward the selected circumferential portion of the inner wall surface 116, the physician can move the proximal portion 3a such that the opening 922 receives the selected protrusion 920, thereby attaching the retractor body 3 to the entry member 102 as desired. It will be appreciated that multiple retractors 2 can be attached to the entry member 102 in a similar manner to retract soft tissue as desired.
[0178] Reference is now made to Figure 10A and Figure 10BThe attachment device 1014 for the surgical access system 100 can include a flexible wire 1050 that is configured to be inserted into the working channel 106 of the access member 102 in a first or insertion configuration, and subsequently transformed into a second or deployed configuration for pushing the retractor body 3 against the inner wall surface 116 and securing the retractor body onto the inner wall surface. For example, the wire 1050 can be pre-shaped, for example, into an intermediate shape such as one or more coils, and subsequently can be loaded into a guide instrument 1070 (also referred to herein as a guide 1070) that maintains the wire 1050 in the insertion configuration. The guide 1070, or at least an end portion thereof, can be inserted within the working channel 106, and the wire 1050 can be deployed (i.e., driven out) from the guide 1070 and into the working channel 106, where the wire 1050 elastically deforms from its insertion configuration to a deployed configuration. This deformation can cause the wire 1050 to form one or more coils that extend circumferentially around the inner wall surface 116 and exert a radially outward spring force F that firmly pushes the retractor body 3 against the inner wall surface 116 when the wire 1050 attempts to return to its intermediate configuration. In other embodiments, the wire 1050, when in the intermediate configuration, can be configured as a helical spring and can also be helically twisted so as to reduce its spring diameter when in the insertion configuration. Once inserted to a desired position within the working channel 106, the wire 1050 can be released so as to expand to the deployed configuration within the working channel 106. It will be appreciated that the wire 1050 can be composed of a shape memory material, such as Nitinol, that is also biocompatible, by way of non-limiting example.
[0179] The wire 1050 can have a substantially pure coiled shape in the deployed configuration. In other embodiments, as illustrated in FIGS. 13A and 13B, the wire 1050 can have an alternative shape in the deployed configuration. For example, the wire 1050 can be configured such that when it is in the deployed configuration, the wire 1050 can define a longitudinal portion 1052 that is configured to engage along the length of the retractor body 3, and one or more arm portions 1054 that are configured to engage the inner wall surface 116 of the access member 102. It will be appreciated that other deployed configurations are within the scope of the present disclosure. Figure 10C and Figure 10D The wire 1050 can have a substantially pure coiled shape in the deployed configuration. In other embodiments, as illustrated in FIGS. 13A and 13B, the wire 1050 can have an alternative shape in the deployed configuration. For example, the wire 1050 can be configured such that when it is in the deployed configuration, the wire 1050 can define a longitudinal portion 1052 that is configured to engage along the length of the retractor body 3, and one or more arm portions 1054 that are configured to engage the inner wall surface 116 of the access member 102. It will be appreciated that other deployed configurations are within the scope of the present disclosure.
[0180] The retractor body 3 of any of the preceding embodiments can be composed of a biocompatible material including, by way of non-limiting example, a metal, a polymer, a composite material, or any combination of the foregoing.
[0181] It will be appreciated that the retractor 2 and attachment devices 14, 314, 414, 714, 814, 914 described above allow for selective placement of the retractor 2 relative to the access member 102 (including in both circumferential and longitudinal manners), and thus also relative to the patient anatomy for fine control of the patient anatomy. Such fine control of soft tissue retraction is particularly beneficial as it, among other things, reduces the need for excision (removal) of soft tissue at the treatment site.
[0182] Referring now to Figure 11A and Figure 11B The retractor member 2 of any of the embodiments described above can include at least one sensor 1102 that is electrically conductive and is located at or near the distal end 12 of the retractor 2. The sensor 1102 can be used for nerve monitoring at the treatment site (e.g., for detecting the presence, proximity, health, and / or other attributes of neural tissue), such as to navigate the retractor 2 around (e.g., away from) neural tissue, to safely retract neural tissue using the retractor 2, and / or to assess the health of neural tissue at the treatment site, as more fully described in the '253 reference. It will be appreciated that the sensor 1102 can include a single sensor or multiple sensors. The sensor 1102 can be in electrical communication with an electrical lead 1104 located at or near the proximal end 10 of the retractor 2 and configured to transmit electrical information obtained by the sensor to a control unit 1106, which can employ a processor 1108 to interpret the electrical information.
[0183] As shown in Figure 11A In one such embodiment employing the sensor 1102, the retractor 2 can include a retractor body 3 composed of an electrically conductive material. The retractor 2 can also include an electrically insulating sheath 1110 disposed over a main portion 3i of the retractor body 3. The sheath 1110 can be configured to provide an exposed portion 3j of the retractor body 3 that defines the sensor 1102. The exposed portion 3j can extend from the sheath 1110 to the distal end 12. The sheath 1110 can also be configured to provide another exposed portion 3k of the retractor body 3 that defines the electrical lead 1104, which can extend from the sheath 1110 to the proximal end 10. It will be appreciated that, as an alternative to the sheath 1110, the retractor body 3 can be coated with a layer of insulating material that can be formed or finished so as to provide an exposed portion of the retractor body 3 at or near the distal end 12 that can define or carry the sensor 1102. The coating can also be configured to provide additional exposed portions of the retractor body 3, such as at or near the proximal end 12 to provide the electrical lead 1104.
[0184] As shown in Figure 11BAs shown in FIG. 11, in another embodiment employing sensor 1102, retractor 2 can include a retractor body 3 composed of an electrically insulating material, and sensor 1102 can be disposed above or embedded within retractor body 3, at or near distal end 12 thereof. Electrical lead 1104 can also be disposed above or embedded within retractor body 3, such as at proximal end 10 thereof. Retractor 2 can include an electrical transmission element, such as a wire or trace extending along or through retractor body 3 from sensor 1102 to electrical lead 1104.
[0185] By way of non-limiting example, the insulating material described above can include parylene, silicone rubber, fluoropolymers, and elastomers. It will be appreciated that in other embodiments employing sensor 1102, sensor 1102 can be in wireless communication with control unit 1106 and / or processor 1108.
[0186] Reference is now made to Figures 12A to 12E In yet other embodiments, attachment device 1214 for surgical access system 100 can include a tether 1211 extending from proximal end 4 of retractor body 3. As shown in FIG. 12, tether 1211 can be a wire, suture member, string, or cord. Alternatively, as shown in FIG. 13, tether 1211 can be a band, such as an elastic band. Tether 1211 can be configured to secure to one or more receiving formations 1215 defined by or carried by access member 102. Figure 12A As shown in FIG. 14, retractor body 3 can be carried by instrument 1200, which can include a distal elongate portion 1205 extending in longitudinal direction L and carrying retractor body 3, such as by bracing sides of retractor body 3. Distal elongate portion 1205 is configured for insertion into access member 102 for use of retractor body 3 to engage soft tissue. Retractor body 3 can define a distal mount 1218, such as a hook, which can extend from outer surface 12 of retractor body 3. In addition, distal mount 1218 can be configured to engage distal end 112 of access member 102. Additionally or alternatively, distal mount 1218 can be configured to selectively engage any of a plurality of slots 1220 defined in wall 104 of access member 102, as shown in FIG. 15. Figure 12D and Figure 12E as shown in FIG. 14.
[0187] By way of non-limiting example, tether 1211 can be a wire, suture member, string, or cord. Alternatively, as shown in FIG. 13, tether 1211 can be a band, such as an elastic band. Tether 1211 can be configured to secure to one or more receiving formations 1215 defined by or carried by access member 102. Figure 12C By way of non-limiting example, tether 1211 can be a wire, suture member, string, or cord. Alternatively, as shown in FIG. 13, tether 1211 can be a band, such as an elastic band. Tether 1211 can be configured to secure to one or more receiving formations 1215 defined by or carried by access member 102. Figure 12D By way of non-limiting example, tether 1211 can be a wire, suture member, string, or cord. Alternatively, as shown in FIG. 13, tether 1211 can be a band, such as an elastic band. Tether 1211 can be configured to secure to one or more receiving formations 1215 defined by or carried by access member 102. Figure 12EAs shown, alternatively or in addition to the receiving member 1215, the tether 1211 may also be attached to the proximal end 110 of the entry member 102, for example, using a spring clip 1270.
[0188] Although this disclosure has been described in detail, it should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention as defined by the appended claims. For example, features of the various embodiments described herein may be incorporated into one or more, and at most all, of the other embodiments described herein. Furthermore, the scope of this disclosure is not intended to be limited to the specific embodiments described herein. Those skilled in the art will readily appreciate that existing or future processes, machines, manufactures, material compositions, apparatuses, methods, or steps may be utilized according to this disclosure to perform substantially the same functions or achieve substantially the same results as the corresponding embodiments described herein.
Claims
1. A retractor member configured for insertion through a passageway of an access member and for moving soft tissue at a treatment site accessible through the passageway, the retractor member comprising: a body having a proximal end and a distal end and spaced apart from one another along a longitudinal direction, the distal end defining a retractor blade, the body defining first and second surfaces opposite one another along a transverse direction substantially perpendicular to the longitudinal direction; and an attachment device configured to selectively attach the body to a portion of the access member such that the body is extendable through a working passageway and is translatable relative to the access member along the longitudinal direction when the body is attached to the portion of the access member; wherein the attachment device comprises an attachment member separate from the body, wherein the attachment member comprises: a slide formation configured to slidably engage a complementary slide formation of the body so as to allow the attachment member to translate along the body and within the passageway; and a locking member extending circumferentially away from the slide formation, wherein the locking member is compliant and configured to flex inwardly toward a central axis of the access member when the locking member is disposed in the passageway such that a return force of the locking member urges the locking member to engage an inner surface of the access member so as to attach the body to the portion of the access member.
2. The retractor member of claim 1, wherein the body has first and second sides spaced apart from one another along a lateral direction substantially perpendicular to the longitudinal direction and the transverse direction, and the attachment device extends from at least one of the first and second sides at a longitudinal portion of the body intermediate the proximal end and the distal end such that the attachment device is configured to reside within the working passageway for securing the retractor member to an inner surface of the access member.
3. The retractor member of claim 2, wherein the attachment device comprises a pair of wings each circumferentially extending from the first and second sides, respectively, at the longitudinal portion, wherein the pair of wings are compliant and configured to flex inwardly toward one another from an intermediate configuration to a flexed configuration by the inner surface of the access member when the pair of wings are disposed in the passageway such that a return force of the pair of wings urges the pair of wings to engage the inner surface of the access member so as to attach the body to the portion of the access member.
4. The retractor member of claim 3, wherein the second surface of the body defines a first radius and an outer surface of the wing defines another radius, which is greater than the first radius when the pair of wings are in the intermediate configuration, at the longitudinal portion and in a plane orthogonal to the longitudinal direction.
5. The retractor member of claim 3 or 4, wherein the body defines a proximal body portion extending from the pair of wing portions to the proximal end portion, and a distal body portion extending from the pair of wing portions to the distal end portion along the longitudinal direction, and the distal body portion and the proximal body portion are at least partially circumferentially offset from one another.
6. The retractor member of claim 5, wherein the distal body portion and the proximal body portion are completely circumferentially offset from one another.
7. The retractor member of claim 1, wherein the complementary slide formation of the body comprises a guide slot, the locking member comprises a circumferential wall configured to annularly slide between the second surface of the body and an inner surface of the access member, wherein the slide formation of the attachment member comprises a slider configured to reside within the guide slot, wherein the slider extends inwardly from the circumferential wall along the transverse direction.
8. The retractor member of claim 1, wherein the attachment device comprises an attachment member separate from the body, at least a portion of the attachment member comprises a magnetic material, and the body comprises one or more magnets each configured for selective attachment to the magnetic material of the at least a portion of the attachment member.
9. The retractor member of claim 1, wherein: the body defines an interior chamber, and further defines a proximal port and a plurality of vacuum ports each in fluid communication with the interior chamber, wherein the plurality of vacuum ports are defined in the second surface, and the proximal port is connectable to a vacuum source; and the attachment device comprises a plurality of ring seals each disposed in one of the plurality of vacuum ports, wherein the plurality of ring seals are configured to sealingly engage an inner wall surface of the access member when vacuum pressure is supplied within the interior chamber.
10. The retractor member of claim 1, wherein the attachment device comprises a wire configured to transition from an inserted configuration to a deployed configuration, wherein the wire is configured to be contained within an elongate insertion device when in the inserted configuration, and the wire is further configured to jump outwardly so as to at least partially circumferentially extend about an inner wall surface of the access member so as to force the body toward the inner wall surface when in the deployed configuration.
11. The retractor member of claim 1, wherein the body has a first side and a second side spaced apart from one another along a lateral direction substantially perpendicular to the longitudinal direction and the transverse direction, the first surface is arcuate and concave between the first side and the second side in a plane orthogonal to the longitudinal direction, and the second surface is arcuate and convex between the first side and the second side in the plane.
12. The retractor member of claim 11, wherein at least at one of the proximal end and the distal end, the body defines a flared end portion such that the end portion defines a maximum lateral dimension that is greater than a maximum lateral dimension of an adjacent portion of the body that extends from the end portion toward an opposite one of the proximal end and the distal end.
13. The retractor member of claim 11 or 12, wherein at least at one of the proximal end and the distal end, the body defines an end portion that is angularly offset from an adjacent portion of the body that extends from the end portion toward an opposite one of the proximal end and the distal end.
14. The retractor member of claim 1, wherein at least a proximal portion of the body is plastically deformable so as to bend away from a central axis of the access member after the body is attached to the portion of the access member.
15. The retractor member of claim 1, wherein the body includes at least one electrically conductive sensor at the distal end, and the at least one electrically conductive sensor is in electrical communication with an electrical lead that is spaced apart from the at least one electrically conductive sensor and is configured for transmitting sensor information obtained by the at least one sensor to a control unit.
16. The retractor member of claim 15, wherein the body is formed of an electrically conductive material, and the retractor member further includes an electrical insulator that covers a majority of the body, wherein the body includes a distal exposed portion at the distal end that defines the at least one electrically conductive sensor, the body further includes a proximal exposed portion at the proximal end, and the proximal exposed portion defines the electrical lead.
17. The retractor member of claim 15, wherein the body is formed of an electrically insulating material, and the at least one electrically conductive sensor is embedded in the body at the distal end.
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