Tissue Access Guidewire System and Method

Abstract

A method and system for guiding at least a portion of a surgical device to a desired position between two tissues in a patient's body involves coupling a guidewire to the device and pulling the distal end of the guidewire to guide at least a portion of the surgical device to a desired position between the two tissues. The surgical device generally includes one or more guidewire coupling members and may comprise a tissue access device. A system may include a guidewire and a surgical device. In some embodiments, a guidewire, a tissue access device, and one or more additional devices to use with the access device may be provided. Methods, devices and systems may be used in open, less-invasive or percutaneous surgical procedures, in various embodiments.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application is related to U.S. Patent Application Serial No. ______, entitled “Tissue Access Guidewire System and Method” (Attorney Docket No. 026445-001000US), filed concurrently herewith, the disclosure of which is incorporated fully by reference.BACKGROUND OF THE INVENTION[0002]The present invention relates generally to medical / surgical devices and methods. More specifically, the present invention relates to a guidewire system and method for advancing one or more surgical devices between tissues in a patient.[0003]In recent years, less invasive (or “minimally invasive”) surgical techniques have become increasingly more popular, as physicians, patients and medical device innovators have sought to achieve similar or improved outcomes, relative to conventional surgery, while reducing the trauma, recovery time and side effects typically associated with conventional surgery. Developing less invasive surgical methods and devices,...

AI Technical Summary

Benefits of technology

[0015]In some embodiments, the distal end of the surgical device may be configured to effect blunt dissection of the natural tissue interface between the first and second tissues. Also in some embodiments, the first coupling member may comprise a shaped element at the first end for coupling with the at least one guidewire coupling member; and the second end may comprise a sharpened distal tip to facilitate passage through of the guidewire through tissue. For example, the shaped element may have a shape such as but not limited to that of a ball, a cylinder, a teardrop, a cube, a pyramid, a diamond or a hook. The sharpened distal tip, in various embodiments, may have a shape such as

Problems solved by technology

Developing less invasive surgical methods and devices, however, can pose many challenges.

For example, some challenges of less invasive techniques include working in a smaller operating field, working with smaller devices, and trying to operate with reduced or even no direct visualization of the structure (or structures) being treated.

These challenges are compounded by the fact that target tissues to be modified often reside very close to one or more vital, non-target tissues, which the surgeon hopes not to damage.

One of the initial obstacles in any given minimally invasive procedure, therefore, is positioning a minimally invasive surgical device in a desired location within the patient to perform the procedure on one or more target tissues, while avoiding damage to nearby non-target tissues.

In a patient, this may manifest as pain, impaired sensation and / or loss of strength or mobility.

Epidural steroid injections may also be utilized, but they do not provide long lasting benefits.

When these approaches are inadequate, current treatment for spinal stenosis is generally limited to invasive surgical procedures to remove ligament, cartilage, bone spurs, synovial cysts, cartilage, and bone to provide increased room for neural and neurovascular tissue.

Removal of vertebral bone, as occurs in laminectomy and facetectomy, often leaves the effected area of the spine very unstable, leading to a need for an additional highly invasive fusion procedure that puts extra demands on the patient's vertebrae and limits the patient's ability to move.

Unfortunately, a surgical spine fusion results in a loss of ability to move the fused section of the back, diminishing the patient's range of motion and causing stress on the discs and facet joints of adjacent vertebral segments.

Such stress on adjacent vertebrae often leads to further dysfunction of the spine, back pain, lower leg weakness or pain, and / or other symptoms.

Furthermore, using current surgical techniques, gaining sufficient access to the spine to perform a laminectomy, facetectomy and spinal fusion requires dissecting through a wide incision on the back and typically causes extensive muscle damage, leading to significant post-operative pain and lengthy rehabilitation.

Thus, while laminectomy, facetectomy, discectomy, and spinal fusion frequently improve symptoms of neural and neurovascular impingement in the short term, these procedures are highly invasive, diminish spinal function, drastically disrupt normal anatomy, and increase long-term morbidity above levels seen in untreated patients.

Although a number of less invasive techniques and devices for spinal stenosis surgery have been developed, these techniques still typically require removal of significant amounts of vertebral bone and, thus, typically require spinal fusion.

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