US-12616501-B2 - Surgical introducer with guidance system receptacle

US12616501B2US 12616501 B2US12616501 B2US 12616501B2US-12616501-B2

Abstract

A surgical introducer system having an outer introducer sidewall extending along a longitudinal axis from a proximal introducer end to a distal introducer end, an inner introducer sidewall extending within the outer introducer sidewall along the longitudinal axis and forming an introducer passage extending in a distal direction from a proximal passage opening at the proximal introducer end to an introducer passage end wall located proximal to the distal introducer end, and an end wall passage extending from the introducer passage end wall towards the distal introducer end. The introducer end wall passage joins the introducer end wall at one or more end wall edges defining an axial stop ring configured to contact the distal tip of a navigation probe between the probe shaft and a terminal end of the distal probe tip at a line of contact to thereby prevent movement of the navigation probe in the distal direction.

Inventors

Robert Schaefer
David Cantor

Assignees

VYCOR MEDICAL, INC.

Dates

Publication Date: 20260505
Application Date: 20241114

Claims (20)

1 . A surgical access port assembly comprising: a shaft retainer comprising: a receiver having: a receiver channel extending in a longitudinal direction and configured to receive a shaft in a proximal open end of the receiver channel, and limit movement of the shaft in a lateral direction that is perpendicular to the longitudinal direction, and a first threaded surface, and a lock having: a central passage extending in the longitudinal direction, and a second threaded surface, wherein: the lock and receiver are movable between a first configuration in which the lock and receiver allow the shaft to move relative to the lock and receiver along the longitudinal direction, and a second configuration in which the lock and receiver prevent the shaft from moving relative to the lock and receiver along the longitudinal direction, and the lock is rotatable relative to the receiver to engage the first threaded surface with the second threaded surface to thereby move the lock and receiver between the first configuration and the second configuration; an introducer extending along the longitudinal direction from a proximal introducer end to a distal introducer end, the distal introducer end defining a tapered outer surface that reduces in size in a distal direction extending away from the proximal introducer end; and a retractor removably attached to the introducer, the retractor comprising a retractor sidewall defining a hollow retractor passage extending from a proximal retractor end to a distal retractor end, wherein the retractor is configured to selectively secure to a remainder of the surgical access port assembly with the tapered outer surface of the introducer extending in the longitudinal direction distally beyond the distal retractor end, and wherein the hollow retractor passage has a retractor passage cross-sectional profile as viewed along the longitudinal direction, wherein the retractor passage cross-sectional profile comprises an elongated non-circular shape.
2 . The surgical access port assembly of claim 1 , wherein the retractor passage cross-sectional profile is oval.
3 . The surgical access port assembly of claim 2 , wherein the retractor passage cross-sectional profile is elliptical.
4 . The surgical access port assembly of claim 2 , wherein the retractor passage cross-sectional profile is oval entirely from the proximal retractor end to the distal retractor end.
5 . The surgical access port assembly of claim 1 , wherein the introducer comprises an introducer sidewall defining a hollow introducer passage extending from the proximal introducer end to the distal introducer end.
6 . The surgical access port assembly of claim 5 , wherein the hollow introducer passage has an introducer passage cross-sectional profile, as viewed along the longitudinal direction, wherein the introducer passage cross-sectional profile matches the elongated non-circular shape of the retractor passage cross-sectional profile, at least in a portion of the hollow introducer passage located within the hollow retractor passage when the introducer is attached to the retractor.
7 . The surgical access port assembly of claim 5 , wherein: the retractor sidewall has a uniform retractor sidewall thickness from a first location adjacent to the proximal retractor end to a second location adjacent to the distal retractor end; the introducer sidewall comprises a uniform introducer sidewall thickness in at least a portion of the hollow introducer passage located from the first location to the second location when the introducer is attached to the retractor.
8 . The surgical access port assembly of claim 5 , wherein the hollow introducer passage has an introducer passage cross-sectional profile as viewed along the longitudinal direction, wherein the introducer passage cross-sectional profile is oval entirely from the proximal introducer end to the distal introducer end.
9 . The surgical access port assembly of claim 8 , wherein the introducer further comprises a receptacle wall extending within the hollow introducer passage from the distal introducer end towards the proximal introducer end, the receptacle wall comprising one or more inner surfaces defining a receptacle.
10 . The surgical access port assembly of claim 9 , wherein the one or more inner surfaces define a circular cross-sectional shape as viewed along the longitudinal direction.
11 . The surgical access port assembly of claim 10 , wherein the circular cross-sectional shape tapers to reduce in size away towards the distal introducer end.
12 . The surgical access port assembly of claim 10 , wherein the circular cross-sectional shape comprises at least two stepped cylindrical wall segments.
13 . The surgical access port assembly of claim 9 , wherein the receptacle wall comprises one or more axial slots configured to permit fluid to flow radially though the receptacle wall.
14 . The surgical access port assembly of claim 9 , wherein the introducer comprises one or more openings at the distal introducer end, wherein the one or more openings are in fluid communication with the hollow introducer passage without passing through the receptacle.
15 . The surgical access port assembly of claim 9 , wherein the receiver extends into the hollow introducer passage and terminates at a distal receiver end that is spaced proximally from the receptacle wall when the shaft retainer is attached to the introducer.
16 . The surgical access port assembly of claim 5 , wherein the shaft retainer is removably connected to the introducer at the proximal introducer end by one or more releasable clamps, and wherein the one or more releasable clamps do not block an entirety of the hollow introducer passage at the proximal introducer end.
17 . The surgical access port assembly of claim 1 , wherein the retractor sidewall comprises a transparent material.
18 . The surgical access port assembly of claim 1 , wherein the distal introducer end comprises a transparent material.
19 . The surgical access port assembly of claim 1 , wherein the receiver channel comprises one or more slots extending along the longitudinal direction.
20 . The surgical access port assembly of claim 19 , wherein: at least one of the receiver and the lock comprises a tapered surface; the one or more slots extend radially thought the tapered surface; and when the lock and the receiver are in the second configuration, the tapered surface is configured to compress an inner surface of the receiver channel against the shaft.

Description

This application is a continuation of U.S. Utility application Ser. No. 17/473,282, filed Sep. 13, 2021, which is a continuation-in-part of U.S. Utility application Ser. No. 16/740,858, filed Jan. 13, 2020 (now U.S. Pat. No. 11,517,347), which is a continuation of U.S. application Ser. No. 15/805,821, filed on Nov. 7, 2017 (now U.S. Pat. No. 10,543,016), which is a continuation-in-part that claims priority to U.S. Provisional Application No. 62/418,507, entitled SURGICAL INTRODUCER WITH GUIDANCE SYSTEM RECEPTACLE, filed Nov. 7, 2016, and U.S. Utility application Ser. No. 15/372,890, filed Dec. 8, 2016 (now U.S. Pat. No. 10,376,258), the complete contents of all of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to delicate tissue surgical retractor systems for use in the brain or other tissue susceptible to retraction injury. BACKGROUND A variety of different devices have been used to retract delicate tissue during surgical procedures. One such device is illustrated in United States Patent Publication Number 2010/0010315, which is incorporated herein by reference. FIG. 1 of this publication illustrates a soft tissue retractor system having a hollow retractor 100, and an introducer 102 that is selectively inserted into the retractor 100. The retractor 100 and/or introducer 102 may include a handle 104 to facilitate manipulation and placement of the retractor system, and a lock to hold the introducer and retractor together. The handle 104 is configured to connect to a clamp 106, such as the standard surgical clamp 106 shown in FIG. 1. The device in FIG. 1 (with some modifications) is commercially sold as the “VBAS” device by Vycor Medical, Inc. of Boca Raton, Florida. A retractor system such as shown in FIG. 1 is often used by inserting the introducer 102 into the retractor 100 and locking it in place, so the two can be moved and manipulated as a unit. The combined retractor system is inserted into the patient's body and moved to the surgery site, and then the introducer 102 is unlocked and removed to permit access to the site through the retractor 100. When the unit is in place (either before or after the introducer 102 is removed), the handle 104 may be locked to a clamp 106 to hold the retractor 100 in place. Surgeons using this retractor sometimes do not use a clamp to hold the retractor at the surgery site, and often manually manipulate the retractor to access different parts of the surgery site during the surgical procedure. The retractor system and the retractor may be manipulated by holding the proximal ends of the introducer or retractor or by holding the handle. The device shown in FIG. 1 may have a transparent introducer 102 and/or retractor 100, and surgeons using such devices advantageously use the transparent introducer and retractor to observe the underlying tissue and to visually guide the unit to the surgery site. While it has been found that visual guidance by looking through the introducer 102 is very beneficial, it also has been found that some form of additional guidance or navigation may be desired in some cases. For example, in some cases, surgeons have used a probe or guide wire (a narrow elongated rod) to guide the movement of the retractor system. In such cases, the probe is advanced to the surgery site, and then the interlocked retractor system is slid over the probe until it reaches the surgery site. This is facilitated by the inclusion of a hole at the tip of the introducer that fits around the probe. If the hole through the tip of the introducer is absent, this method cannot be used. This type of system is described in United States Patent Publication Numbers 2008/0109026 and 2009/0048622, which are incorporated herein by reference. These references also show an alternative construction, in which the retractor is not locked to the introducer. It has been found that some surgeons using the above procedure may use a probe that is integrated into a computer navigation system. For example, the probe may include a so-called “starburst” or the like, on the probe's proximal end (i.e., the end opposite the distal end that is inserted to the surgical site). This and other navigation systems are known in the art. For example, frameless navigation systems and other computerized guidance systems and methods are described in U.S. Publication No. 2001/0027271 (which is incorporated herein by reference in its entirety) and others, and are commercially available from companies such as Medtronic, Inc., Stryker, BrainLab, AG, and GE Healthcare. As used herein, “computerized guidance” encompasses any method of guiding a device to or at a surgical site that relies on computer visualization and/or control. United States Patent Publication Number 2010/0010315 briefly notes the possibility of using stereotactic guidance or navigation in conjunction with a surgical retractor, but does not illustrate or describe this procedure or any apparatus for accompli