Tissue-layer dissection cannula and system

Abstract

A tissue dissection system for directing a cannula between natural tissue layers includes a tube defining a lumen therethrough; an attachment and stabilization device configured to receive and guide the tube at an operation angle with respect to the natural tissue layers; and an actively steerable cannula (ASC) configured to pass through the lumen of the tube between the natural tissue planes. The ASC defines first and second substantially parallel lumens therethrough configured to receive corresponding first and second steering wires. An attachment and stabilization device for a tissue dissection system is configured to receive and guide a tube at an operation angle with respect to natural tissue layers. The device includes a base having a size and shape so as to securely attach to a body part of interest for tissue dissection.

Description

TISSUE-LAYER DISSECTIONCANNULA AND SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present patent application claims priority benefit to U.S. Provisional Patent Application No. 63 / 653,419, filed on May 30, 2024. the entire content of which is incorporated herein by reference. All references cited anywhere in this specification, including the Background and Detailed Description sections, are incorporated by reference as if each had been individually incorporated.BACKGROUND1. Technical Field

[0002] The currently claimed embodiments of the present invention relate to tissue-layer dissection systems and components, and more particularly to dissection systems and components for directing a cannula between natural tissue layers.2. Discussion of Related Art

[0003] Hydro-dissection can be useful for directing a tool between layers of material that meet at a boundary. However, there are currently no such systems and corresponding components for directing a cannula between natural tissue layers. Thus, there remains a need for hydro-dissection systems and components for directing a cannula between natural tissue layers.SUMMARY

[0004] A tissue dissection system for directing a cannula between natural tissue layers according to an embodiment of the current invention includes a tube defining a lumen therethrough; an attachment and stabilization device configured to receive and guide the tube at an operation angle with respect to the natural tissue layers; and an actively steerable cannula (ASC) configured to pass through the lumen of the tube between the natural tissue planes. The ASC defines first and second substantially parallel lumens therethrough configured to receive corresponding first and second steering wires.

[0005] An attachment and stabilization device for a tissue dissection system according to an embodiment of the current invention is configured to receive and guide a tube at an operation angle with respect to natural tissue layers. The device includes a base having a size and shape so as to securely attach to a body part of interest for tissue dissection.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Embodiments of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

[0007] FIG. 1 is a schematic illustration of a tissue dissection system according to an embodiment of the current invention.

[0008] FIG. 2 illustrates a body attachment and stabilization device according to an embodiment of the current invention.

[0009] FIG. 3 illustrates the embodiment of FIG. 2 in a changed configuration.

[0010] FIG. 4 illustrates a section of an actively steerable cannula according to an embodiment of the current invention.

[0011] FIG. 5 is a cross-sectional view of a body attachment and stabilization device according to an embodiment of the current invention.

[0012] FIG. 6 illustrates a body attachment and stabilization device according to another embodiment of the current invention.

[0013] FIG. 7 is a cross-sectional view of a body attachment and stabilization device according to another embodiment of the current invention.

[0014] FIGS. 8-13 illustrate an example of a procedure for an embodiment of the tissue dissection.DETAILED DESCRIPTION

[0015] Some embodiments of the current invention are discussed in detail below. In describing embodiments, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected. A person skilled in the relevant art will recognize that other equivalent components can be employed, and other methods developed, without departing from the broad concepts of the present invention. All references cited anywhere in this specification are incorporated by reference as if each had been individually incorporated.

[0016] Some aspects of the current invention are directed to a device that is or includes a flexible cannula primarily used to separate tissues to allow the cannula to progress within natural tissue planes with minimal damage to the tissue layers. In particular, an embodiment of the current invention can be used to progress between the choroid and retina within the eye and allow for treatments to be placed in the central subretinal space. Hydro-dissection uses liquid to gently separate tissues. An embodiment of the current invention provides a device that measures the axial motion of the cannula and simultaneously injects fluid at a rate proportional to the forward axial speed. The ratio of flow rate to forward speed is adjustable by the user and may var7with speed to compensate with to the rate of fluid dispersion within the space. For example, at loweradvance speeds the fluid may dissipate and close the space created faster than at higher advance speeds.

[0017] An embodiment of the device uses a geared set of rollers to advance the cannula and measure its axial speed. However, general concepts of the current invention are not limited to only this embodiment. In this case, it measures the forward speed using a quadrature encoder on the input gear. As the input gear is turned (either manually or via motor), a microcontroller measures the time between encoder counts to determine the speed of axial advancement. The proximal end of the cannula is connected to a syringe pump that is controlled by a computer / microcontroller. An interface is used to adjust the ratio of flow rate to forward speed and / or select from various profiles.

[0018] FIG. 1 provides a schematic illustration of a tissue dissection system 100 for directing a cannula between natural tissue layers according to an embodiment of the current invention. The tissue dissection system 100 includes a tube 102 defining a lumen therethrough, an attachment and stabilization device 104 configured to receive and guide the tube 102 at an operation angle 106 (e.g., FIGS. 2, 3) with respect to the natural tissue layers, and an actively steerable cannula (ASC) 108 (e.g., FIG. 4) configured to pass through the lumen of the tube 102 between the natural tissue planes. The ASC 108 defines first and second substantially parallel lumens (1 10, 112) therethrough configured to receive corresponding first and second steering wires (114, 116).

[0019] The tissue dissection system 100 further includes a steering system 1 18 that includes first pre-curved wire 114 extending through the first lumen 110 of the ASC 108, a second precurved wire 116 extending through the second lumen 112 of the ASC 108, and a steering actuation device 120 in operative connection with the first and second pre-curved wires (114, 116).

[0020] The tissue dissection system 100 further includes an insertion actuation and measurement system 122 in mechanical contact with the ASC 108 and configured to advance and retract the cannula 102.

[0021] In some embodiments, the ASC 108 further defines a third lumen 124 configured to pass a fluid therethrough to cause the natural tissue layers to separate sufficiently to allow the ASC 108 to advance between the natural tissue planes. In an embodiment, the tissue dissection system 100 also has a fluid delivery system 126 in fluid connection with the third lumen 124defined by the ASC 108. The fluid can be a gas, a liquid or a suspension, for example. However, the general concepts of the current invention are not limited to including a fluid delivery' system 126 for hydro-dissection and / or pneumatic dissection for example. Other embodiments can provide mechanical dissection between layers of tissue, for example. In some embodiments, the ASC 108 can have an end that is tapered or rounded to facilitate smooth travel between layers of tissue.

[0022] The hydro-dissection system 100 also has a computer 128 configured to communicate with the insertion actuation and measurement system 122 and the fluid delivery' device 126. The insertion actuation and measurement system 122 includes a mechanical assembly configured to advance the ASC 108 and to measure a rate of advancement of the ASC 108 and provide the measured rate to the computer 128. The computer 128 is configured to provide instructions to the fluid delivery' system 126 to provide a flow rate based on the measured rate of advancement of the ASC 108.

[0023] In some embodiments the ASC 108 further defines a fourth lumen 130 configured to allow an optical fiber 132 of an optical coherence tomography (OCT) probe to pass therethrough. In some embodiments, the hydro-dissection system 100 also includes an optical coherence tomography (OCT) system 134 that includes the OCT probe and is configured to communicate with the computer 128.

[0024] In some embodiments, the tube 102 has a curved end 136 (FIG. 11) suitable to at least partially align with a surface 138 of said natural tissue layers.

[0025] In some embodiments, the hydro-dissection system 100 includes a needle 140 configured to be insertable through the tube 102 prior to inserting the ASC 108 through the tube 102. (See, FIGS. 7-10.) The needle 140 has a bevel 142. In some embodiments, the needle 140 can have an OCT probe attached thereto. In some embodiments, the attachment and stabilization device 104 is adjustable to allow adjustment of the operation angle 106 of the tube 102. In some embodiments, the attachment and stabilization device 104 has a base 144 with a shape that conforms to an eye 145 for ocular surgery. (See, e.g., FIG. 6.)

[0026] While various embodiments of the present invention have been described above, they have been presented by way of example only, and not limitation. Thus, the breadth and scope ofthe present invention should not be limited by any of the above-described illustrative embodiments but should instead be defined only in accordance with the following claims and their equivalents.

[0027] The embodiments illustrated and discussed in this specification are intended only to teach those skilled in the art how to make and use the invention. In describing embodiments of the disclosure, specific terminology is employed for the sake of clarity. However, the disclosure is not intended to be limited to the specific terminology so selected. The above-described embodiments of the disclosure may be modified or varied, without departing from the invention, as appreciated by those skilled in the art considering the above insights. It is therefore to be understood that, within the scope of the claims and their equivalents, the invention may be practiced otherwise than as specifically described. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

WE CLAIM:

1. A tissue dissection system for directing a cannula between natural tissue layers, comprising: a tube defining a lumen therethrough; an attachment and stabilization device configured to receive and guide said tube at an operation angle with respect to said natural tissue layers; and an actively steerable cannula (ASC) configured to pass through said lumen of said tube between said natural tissue planes, wherein said ASC defines first and second substantially parallel lumens therethrough configured to receive corresponding first and second steering wires.

2. The tissue dissection system according to claim 1, further comprising a steering system, comprising: a first pre-curved wire extending through said first lumen of said ASC, a second pre-curved wire extending through said second lumen of said ASC, and a steering actuation device in operative connection with said first and second pre-curved wires.

3. The tissue dissection system according to claim 1 or 2, further comprising an insertion actuation and measurement system in mechanical contact with said ASC and configured to advance and retract said ASC.

4. The tissue dissection system according to any one of claims 1-3, wherein said ASC further defines a third lumen configured to pass a fluid therethrough to cause said natural tissue layers to separate sufficiently to allow said ASC to advance between said natural tissue planes.

5. The tissue dissection system according to claim 4. further comprising a fluid deliverysystem in fluid connection with said third lumen defined by said ASC.

6. The tissue dissection system according to claim 5, further comprising a computer configured to communicate with said insertion actuation and measurement system and said fluid delivery- device, wherein said insertion actuation and measurement device comprises a mechanical assembly configured to advance said cannula and to measure a rate of advancement of said ASC and provide said measured rate to said computer, and wherein said computer is configured to provide instructions to said fluid delivery system to provide a flow rate based on said measured rate of advancement of said ASC.

7. The tissue dissection system according to any one of claims 1-6, wherein said ASC further defines a fourth lumen configured to allow an optical fiber of an optical coherence tomography (OCT) probe to pass therethrough.

8. The tissue dissection system according to claim 7. further comprising an optical coherence tomography (OCT) system comprising said OCT probe and configured to communicate with said computer.

9. The tissue dissection system according to any one of claims 1-8, wherein said tube has a curved end suitable to at least partially align with a surface of said natural tissue layers.

10. The tissue dissection system according to any one of claims 1-9, further comprising a needle configured to be insertable through said tube prior to inserting said ASC through said tube.

11. The tissue dissection system according to claim 10, further comprising an OCT probe attached to said needle.

12. The tissue dissection system according to any one of claims 1-11, wherein said attachment and stabilization device is adjustable to allow adjustment of said operation angle of said tube.

13. The tissue dissection system according to any one of claims 1-12. wherein said attachment and stabilization device has a base with a shape that conforms to an eye for ocular surgery'.

14. An attachment and stabilization device for a tissue dissection system configured to receive and guide a tube at an operation angle with respect to natural tissue layers comprising a base having a size and shape so as to securely attach to a body part of interest for tissue dissection.

15. The attachment and stabilization device according to claim 14, wherein said body part of interest is an eye.

16. The attachment and stabilization device according to claim 14 or 15, comprising a base that is pivotable with respect to a body of said attachment and stabilization device.

17. The attachment and stabilization device according to claim 16, further comprising a suction cup attached to said base.

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