WO1999001075A1

WO1999001075A1 - Tissue grasper and method of energy delivery

Info

Publication number: WO1999001075A1
Application number: PCT/US1998/013705
Authority: WO
Inventors: Hugh R. Sharkey
Original assignee: Sharkey Hugh R
Priority date: 1997-07-02
Filing date: 1998-07-01
Publication date: 1999-01-14
Also published as: AU8474798A; WO1999001075A9

Abstract

The present invention is a non-invasive soft tissue grasper/desiccator which includes a pistol-like main body (16) with the tissue grasper (18) at the distal end. Within the tissue grasper portion is a working surface on which is disposed an energy delivery element (24). Different types of energy delivery elements may be utilized including RF energy, electrical resistance heating, microwave, or ultrasound. The energy element, and working surface are arranged such that the energy element non-invasive contacts only a surface of the tissue to treat it. The grasper may comprise two jaw-like members for grasping tissue, or alternatively other arrangements such as a vacuum device are contemplated. In use the grasper holds tissue to be treated against the energy delivery element without puncturing, or otherwise entering the tissue while energy is delivered to reduce the tissue mass. The disclosed apparatus and method are particularly useful for reducing soft tissue such as the uvula in the treatment of snoring disorders.

Description

TISSUE GRASPER AND METHOD OF ENERGY DELIVERY--

BACKGROUND OF THE INVENTION

Field Of The Invention

10 This invention relates to an apparatus and method for grasping and desiccating soft tissue, and more specifically, to an apparatus for non-invasive delivery of energy for desiccating soft palate tissue, including the uvula, to treat snoring disorders.

15

Description Of Related Art

Obstructions of the upper airway can lead to obstructive sleep apnea (also referred to as Pickwickian Syndrome) and, more commonly, snoring. Sleep apnea can be a

„_n very serious disorder and snoring ranges from an annoying social problem to, in its exaggerated form, obstructive sleep apnea. A wide variety of treatments have been proposed for these conditions, ranging from weight loss or oral prostheses to tracheostomy in severe cases of apnea. Treatment for

_.. heavy snorers ranges from relieving nasal infections or allergies to corrective surgery of obstructive conditions in the nose, pharynx or uvula.

There has been much recent work directed at devices for modifying or reducing obstructions in airway passages so

_₀ as to address severe snoring conditions. For example, U.S. Patent No. 5,624,439 discloses a device for treatment of airway obstructions which positions electrode carrying needles adjacent to the tongue and provides for insertion of the needles into the tongue to ablate and reduce tissue mass.

_-. International Publication WO97/06741 discloses variations on a similar type device. International Publication WO97/06738 discloses a device for ablating and removing tissue of the soft tissue palate, which is similar to devices disclosed in the references above, but is more specifically directed to ablation of the uvula. In this device, the uvula is captured between a cannula and retaining member, permitting insertion of a needle-like electrode into the uvula for delivery of energy. This publication also provides a more detailed discussion of the problems of snoring and summarizes state- of-the art up to that point with respect to treatment of snoring disorders.

In spite of recent advances in the art, existing techniques for removal of obstructive conditions in the airway still have a drawback in puncturing the tissue to be treated by needle- like probes. Not only is there psychological resistance on the part of patients to such procedures, the puncture wounds can create an increased risk of infection and lengthen the healing process. There therefore remains a need in the art for a simple and non- invasive means for modifying soft tissue palate structures, including the uvula.

STOflMARY OF THE INVENTION

Accordingly, it is an object of this invention to provide a non- invasive device for desiccating soft tissue in order to reduce its mass.

It is another object of the invention to provide a non- invasive desiccating device which positively locates the soft tissue to be desiccated. It is a further object of the invention to provide integral means for desensitizing the tissue to be treated and for monitoring the treatment in process .

These and other objects according to the invention are achieved in a soft tissue grasper/desiccator which includes an elongate structure having proximal and distal ends, a handle at said proximal end, a working surface at said distal end, and a non-puncturing energy delivery element disposed on the working surface. The energy delivery element is^' shaped to contact the surface of the soft tissue to be desiccated, and a lumen passing at least partly through the elongate structure and opening on the working surface adjacent the energy delivery element delivers fluids to tissue to be treated. Additionally, means for grasping soft tissue against the working surface and energy delivery element is provided at the distal end. In a preferred embodiment, the grasping means comprises first and second jaw members disposed at the distal end of the elongate structure and the working surface is the inner surface of one of the jaw members. The elongate structure may comprise a- lower member and an upper member which translate in a longitudinal direction relative to each other. The first jaw member is then disposed on the distal end of the upper member and the second jaw member is disposed on the distal end of the lower member. Alternatively, a single surface vacuum grasper may be provided.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of the soft tissue grasper/desiccator according to the present invention;

FIG. 2A is a cross-sectional view of a first embodiment of the distal end of the apparatus of FIG. 1, as viewed along line 2-2;

FIG. 2B is a cross-sectional view of an alternative embodiment of the distal end of the apparatus of FIG. 1, also as viewed along line 2-2;

FIG. 3 is a proximal end view of the apparatus of FIG. 1 as viewed along line 3-3;

FIG. 4 is a partial top view of the apparatus of FIG. 1 as viewed along line 4-4;

FIG. 5 is a further side view of the apparatus shown in FIG. 1 illustrating the motion of the apparatus to grasp tissue;

FIG. 6 is a partial perspective view of the apparatus shown in FIG. 1, illustrating the apparatus according to the invention grasping and desiccating soft tissue such as the uvula;

FIG. 7 is a side view of an alternative embodiment of the apparatus according to the present invention; FIG. 8 is a side view of a further alternative embodiment of the apparatus according to present invention; FIG. 9 is an end view of the apparatus shown in FIG. 8, as viewed along lines 9-9; and

FIG. 10 is a schematic diagram illustrating control system alternatives for use with the present invention.

DETAILED DESCRIPTION

As shown in FIG. 1, apparatus 10 according to the present invention includes a lower member 12, which is generally in a pistol shape, with an elongated upper member 14 disposed on its upper surface. Apparatus 10 has a handle 16 formed at the proximal end of lower member 12. Opposite handle 16, at the distal end of the apparatus, the distal portions of lower member 12 and upper member 14 cooperate to form grasper 18. As shown in FIG. 1, the opposed surfaces of lower member 12 and upper member 14 form a jaw-like grasper for firmly grasping soft tissue. An actuation mechanism 20, shown in the form of a lever action trigger-ring, is operatively connected to upper member 14 in order to close grasper 18 by drawing the ring portion of actuation mechanism 20 toward handle 16.

At the distal end of the apparatus, the lower member and upper member cooperate to form a guide 22 which facilitates smooth and accurate sliding between the two parts. As shown in FIG. 2A, an embodiment of guide 22 may consist of folded over edges of upper member 14 which ride on base member 12 to permit guided, relative translational movement as between the upper and lower members .

Also illustrated in FIG. 2A is the working surface of apparatus 10. This working surface is one of the opposed surfaces forming grasper 18. Disposed on the working surface is energy delivery element 24, shown in a circular form, for delivering energy to the soft tissue mass to be treated. Inside element 24 is lumen 26, which runs through upper member 14. Lumen 26 provides a passageway for a liquid anesthetic such as, for example Lidocaine™. FIG. 2B illustrates an alternative embodiment for the distal end of apparatus 10. In this embodiment, energy delivery element 24B has a particular shape designed to match the soft tissue to be treated, in this case the uvula. Shapes other than the u-shape shown may be devised by a person of ordinary skill in the art depending on a particular application. Also illustrated in FIG. 2B is a sensing device 28 for sensing the energy delivery to the site of interest. Energy delivery element 24, lumen 26 and sensing device 28 communicate with an appropriate controller (s) via connectors 32, 34 and 38, as illustrated in FIG. 10. These connectors may be conveniently collected into a single connection device or cable if desired.

As can be seen in FIG. 3, power on and off button 30 is conveniently located on the proximal side of handle 16 for easy manipulation by the user. As shown in FIG. 4 (with no tissue shown in grasper 18) , upper member 14 may be advanced up to the end portion of lower member 12. Also shown in FIG. 4 is sensing device 28. Preferably, the distal end of upper member 14 is shaped not only to hold the tissue to be treated, but also contact the tissue around the area in a seal-like manner so as to concentrate the liquid anesthetic on the area to be treated. This may be facilitated by appropriate shaping of the distal working surface, such as shown in FIG. 4 for the uvula. FIGS. 5 and 6 schematically illustrate the operation of apparatus 10 according to the present invention. By drawing actuation mechanism 20 towards handle 16, as indicated by arrow A, upper member 14 slides along lower member 12, as indicated by arrow B. FIG. 6 illustrates the grasper closed around a soft tissue structure such as the uvula U. Once the soft tissue area to be treated has been firmly grasped by grasper 22, anesthetic and energy may be applied as appropriate to reduce the tissue mass. In a preferred embodiment of the invention, the energy applied is RF energy delivered through element 24 (formed as an electrode) via connection cable 34 and a commercially available controller (see FIG. 10) . In this case, sensing device 28 may be a thermocouple, which also communicates via lead wire 32 with the controller.

Because energy delivery element 24 only contacts the surface of the tissue to be treated, a wide variety of different energy sources may be easily utilized as will be appreciated by persons of ordinary skill in the art . For example, delivery element 24 may comprise an optical fiber bundle for delivering light energy such as laser energy. Alternatively, element 24 could be an electrical resistance heating element or a microwave antenna for the delivery of microwave energy. By selection of appropriate materials, element 24 may be adapted also for the delivery of ultrasound energy. Each of these different types of energy sources are well understood in the art, with commercially available generators and controllers, such that a person of ordinary skill in the art could easily adapt a desired energy source based on the teachings of the present invention. Moreover, lumen 26 may be provided as two or more lumens for delivering different working fluids in addition to an anesthetic, such as contrast agents and chemical agents for facilitating tissue reduction.

An alternative embodiment of the present invention is schematically illustrated in FIG. 7 as apparatus 40. In this embodiment, lower member 42 translates relative to upper member 46 by squeezing together handle components 44 and 48. This results in the jaws of grasper 50 being drawn together. An energy delivery element, lumen and one or more sensing devices may be incorporated into the grasper of apparatus 40 as shown for apparatus 10. A further alternative embodiment of the present invention is illustrated in FIG. 8. In this embodiment, apparatus 52 is provided with a vacuum suction grasper 54 rather than a jaw- like grasper as previously illustrated. As illustrated in FIG. 9, grasper 54 comprises a plurality of small holes 56 or a screen- like structure surrounding lumen 26 which communicate via an internal passageway with vacuum source 58. Preferably holes 56 are sized such that tissue is. not captured in them. Trigger 60 activates an internal valve to control the vacuum pressure at openings 56.

In order to grasp tissue to be treated, the distal end of apparatus 52 is placed adjacent to tissue to be treated and trigger 60 depressed by the user to actuate the vacuum. The tissue is gently drawn against small holes 56 via the vacuum pressure. The amount of depression of trigger 60 can control the level of vacuum. While soft tissue is grasped as a result of the applied vacuum, energy is delivered via element 24 as previously described. Apparatus 52 provides certain advantages in non-invasively treating soft tissue surfaces which lack three-dimensional projections like the uvula.

FIG. 10 schematically illustrates variations of a control scheme for the present invention. The control scheme may be adapted as desired for a particular application for use with any of apparatus 10, 40 or 52 as described herein. In particular, controller module 62 communicates with sensing device 28 via leadwire 32. Energy control module 64 communicates with delivery element 24 via connection cable 34. Fluid or an anaesthetic source 66 communicates with lumen 26 via connecting tube 38. Vacuum source 58 also may be provided to supply vacuum grasper 54 in apparatus 52. Each of the control modules (and the vacuum source if desired) maybe incorporated into a centralized control unit 68. Alternatively, two or more control modules, such as sensing control module 62 and energy control module 64 may be incorporated together while fluid and vacuum sources separately provided. The description of the preferred embodiments set forth herein has been presented for the purposes of illustration only. These embodiments are not intended to be exhaustive or to otherwise limit the invention to the specific embodiments disclosed. Many modifications and variations will be apparent to persons of ordinary skill in the art based on the teachings of the instant application and the scope of the present invention is therefore defined by the following claims and their equivalents.

Claims

CLAIMSWhat is claims is :

1. An apparatus for treating soft tissue, comprising: an elongate element having a distal working end; an energy delivery element disposed on said distal working end and shaped to contact a surface of the soft tissue to be treated; and means for grasping tissue to be treated and holding the tissue surface adjacent said energy delivery element.

2. The apparatus according to claim 1 wherein: ^Γûá said grasping means comprises first and second jaw members disposed at said distal working end, said jaw members having opposed inside faces; and said energy delivery element is disposed on one of said inside faces with an exposed energy delivery surface that is substantially coplanar with said working surface so as to avoid puncturing tissue to be treated.

3. The apparatus according to claim 2 wherein said elongate element includes a lumen passing therethrough and opening on said inside surface adjacent the energy delivery element.

4. The apparatus according to claim 1, wherein: the elongate element comprises a lower member with a sliding upper member disposed thereon; said grasping means comprises a first grasping member disposed at the distal end of the lower member and a second grasping member disposed at the distal end of the upper member such that said grasping members translate relative to one another to form a jaw-like grasping means.

5. Apparatus according to claim 4 wherein the energy delivery element is disposed on a surface of one of said grasping members within said jaw-like grasping means.

6. The apparatus according to claim 4, wherein said lower member includes a handle portion at a proximal end and said apparatus further comprises a lever mechanism for advancing the upper member over the lower member to close the jaw-like grasping means.

7. The apparatus according to claim 4, wherein the lower member includes a first forward handle element and the upper member includes a second rear handle element, said handle elements being arranged such that squeezing together of the handle elements causes closing of the jaw-like grasper means .

8. The apparatus according to claim 1, wherein said grasping means comprises at least one opening in the working end adjacent the energy delivery element, said at least one opening communicating with a passageway through the elongate element and adapted to be connected to a vacuum source such that tissue may be grasped against the energy element by vacuum applied to said at least one opening.

9. The apparatus according to claim 8, wherein said grasping means comprises a plurality of small openings on the working end adjacent the energy delivery element, said openings being sized sufficiently small in order to prevent entry of tissue therein.

10. The apparatus according to claim 1, wherein the elongate element includes a fluid delivery lumen passing therethrough and opening on the working end adjacent the energy delivery element.

11. The apparatus according to claim 1, further comprising a sensing device disposed on said working end adjacent the energy delivery element for sensing energy delivery.

12. The apparatus according to claim 11, wherein said sensing device is a thermocouple.

13. The apparatus according to claim 1, wherein the energy delivery element is an RF electrode.

14. The apparatus according to claim 1, wherein the energy delivery element is an optical bundle.

15. The apparatus according to claim 1, wherein the energy delivery element is an electrical resistance heating element .

16. The apparatus according to claim 1, wherein the energy delivery element is a microwave antenna.

17. The apparatus according to claim 1, wherein the energy delivery element is an ultrasound transducer.

18. The apparatus according to claim 1, wherein the energy delivery element is shaped to match the tissue structure to be treated.

19. An apparatus for grasping and desiccating soft tissue to reduce the soft tissue mass, said apparatus comprising: an elongate structure having proximal and distal ends ; a handle at said proximal end; a working surface at said distal end; a non-puncturing energy delivery element disposed on said working surface and shaped to contact the surface of the soft tissue to be desiccated; a lumen passing at least partly through said elongate structure and opening on said working surface adjacent the energy delivery element for delivering fluids to a tissue to be treated; and means for grasping soft tissue against the working surface and energy delivery element.

20. The apparatus according to claim 19, wherein said grasping means comprises first and second jaw members disposed at the distal end of the elongate structure and wherein said working surface comprises an inner surface of at least one of said jaw members.

21. The apparatus according to claim 20, wherein: said elongate structure comprises a lower member and an upper member which translates in a longitudinal direction relative to the lower member; and said first jaw member is disposed on the distal end of the upper member and said second jaw member is disposed on the distal end of the lower member.

22. The apparatus according to claim 19, wherein said energy delivery element comprises an RF electrode.

23. The apparatus according to claim 22, wherein said electrode is shaped to match the tissue shape to be treated.

24. A method for non-invasively reducing soft tissue mass, comprising: placing an energy delivery element in contact with a surface of a soft tissue mass to be treated; grasping the soft tissue mass to force the tissue surface against the energy delivery element; holding the soft tissue surface against said element while delivering energy therewith to reduce tissue mass; and releasing the tissue.

25. The method according to claim 24, wherein said grasping and holding comprises capturing the tissue to be treated between two jaw members.

26. The method according to claim 24, wherein said, grasping and holding comprises applying a vacuum to the tissue through a working surface adjacent the energy delivery element .

27. The method according to claim 24, further comprising delivering a liquid anesthetic to the soft tissue prior to energy delivery and substantially capturing said liquid anesthetic against the tissue at least until initial energy delivery.