WO2006031934A2

WO2006031934A2 - Surgical sheath with instrument fixation structures

Info

Publication number: WO2006031934A2
Application number: PCT/US2005/032851
Authority: WO
Inventors: Myron Jay Winship; Steven Rose Daly
Original assignee: Light Sciences Corporation
Priority date: 2004-09-15
Filing date: 2005-09-15
Publication date: 2006-03-23
Also published as: TW200613022A; WO2006031934A3

Abstract

A surgical sheath having a lumen extending therethrough along a longitudinal axis is provided with an inflatable external member that is selectively inflated to secure the sheath in a desired position within a patient's body. An internal inflatable member is positioned within the lumen of the sheath, which is selectively inflatable to secure a device, such as a light source, within the sheath as a desired depth of penetration within the patient's body. To aid a user in positioning the sheath in a desired location, a reference scale may be provided on an outer surface of the sheath.

Description

SURGICAL SHEATH WITH INSTRUMENT FIXATION STRUCTURES

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to devices known as introducing sheaths through which instruments are introduced into the body, used in the fields of surgery and medicine.

Description of the Related Art

In many surgical applications, a surgeon often uses an introducing sheath having a lumen extending therethrough, to create a passage for insertion of other instruments into a patient's body through the sheath. In general, these introducing sheaths surround a penetrating device, which is introduced into the body and then removed, leaving the sheath behind as a passageway, for insertion of other instruments therethrough, to reach tissue to be treated. Once the instruments, for example, a catheter, are in place, the introducing sheath is typically removed from the body. Applicants believe that it would be desirable to provide an introducing sheath that may be secured within a patient, and more particularly, secured at a selected location. Applicants further believe that it would be desirable to be able to secure instruments at a selected location within the body. For example, a developing technology treats certain diseases by introducing a photosensitizer chemical into the body that preferentially seeks out and associates with diseased or unwanted cells. These photosensitizers are then activated or "excited" by subjecting them to light at their excitation wavelength. The photo excitation results in treatment of the diseased or otherwise undesirable cells. It is important to minimize injury to surrounding cells during the procedure, while at the same time treating all diseased cells. This represents a challenge both in terms of the photosensitizer and its selectivity for the targeted diseased cells over healthy cells, and also with respect to the accuracy and precision with which the light is applied. In general, there are a range of devices used to apply light, some transmitting light to a site in the body from an outside light source, and others bearing a micro light source that is inserted into the body to provide light at the photosensitized site. There is always a chance that the light-providing device, regardless of type, will shift during the photo treatment, and as a result, cells that should be treated fail to be treated, while others that should not be treated may suffer injury from the light energy. By way of example, therefore, applicants believe that it would be desirable to secure a light source in a patent at a selected location. The present invention provides these and other benefits.

BRIEF SUMMARY OF THE INVENTION

The invention provides a surgical sheath that can be immobilized through affixation in body tissue to provide a passage through which instruments are introduced into a patient. In one embodiment, instruments are selectively secured within the patient's body at a desired location. Such instruments include, but are not limited to, a light-providing implement, such as a light bar, that is used to provide light energy to a site within a body for photo reactive treatment of all kinds.

In one embodiment, the sheath has an elongated hollow shape for insertion into the body as an outer cover on a sharp pointed penetrating implement. The surgical sheath is held relatively immobile but releasably on the outer surface of the penetrating implement, by friction or other means. The sheath may have outer graduated markings to indicate to the clinician the depth of insertion of the implement. One or more expandable balloons are provided on an outer surface of the sheath, that are selectively inflated and deflated. Thus, when the penetrating implement is inserted to the appropriate location, it is withdrawn leaving behind the sheath. To secure the sheath in the selected location, the outer balloons attached to the sheath are inflated to frictionally or otherwise engage body tissue around the sheath and thereby hold the sheath in place. It will be understood that various arrangements of balloons may be used. For example, a single balloon surrounding a circumferential section of the sheath might be used, or, two balloons may be used, one opposite the other on the sides of the sheath. In other embodiments more than two balloons may be used. The balloons may be spaced radially and longitudinally along an outer surface of the sheath, depending upon the body part to be penetrated and which arrangement might provide better temporary affixation. In some cases the balloon(s) may be integral to the sheath and in others, they may be attached to the sheath.

Additionally and alternatively, the invention provides a surgical sheath with an internal inflatable balloon that is selectively inflated and deflated to engage a device positioned within the sheath, thereby holding the device in place by friction. Again, one or more balloons may be used. For example, two internal balloons may be paired, one opposite the other, or one may be provided along an inner circumference of the sheath's lumen to surround the device provided within the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a surgical sheath provided in accordance with one embodiment of the present invention.

Figure 2 is a cross-sectional elevational view of the sheath of Figure 1 illustrating internal and external balloons in a deflated condition, in accordance with an embodiment of the invention.

Figure 3 is a cross-sectional elevational view of the sheath of Figure 2, illustrating the balloons in an inflated condition, and illustrating an instrument secured within the sheath, in accordance with one embodiment of the present invention.

Figure 4 is a cross-sectional elevational view of an embodiment of the invention illustrating a sheath provided with two pairs of external balloons along the length of the sheath.

DETAILED DESCRIPTION OF THE INVENTION In accordance with one embodiment of the present invention, as illustrated in Figure 1 , a surgical sheath 100 is provided with a body 101 having a lumen 103 extending therethrough along a longitudinal axis 104 of the body. An external inflatable member 102, such as a balloon, is provided on an outer surface 106 of the body. As illustrated in Figure 2, the balloon 102 is coupleable to a source of fluid 107 via a passageway 104 provided in a sidewall 108 of the sheath body 101.

The sheath 100 is introduced into a patient's body 111 in any conventional manner. For example, the sheath 100 may be introduced into the patient's body 111 by releasably coupling it to a penetrating implement (not shown), which is inserted into the patient's bodily tissue as desired by the surgeon. Once the sheath 100 is in a selected position, the surgeon holds onto the sheath 100, for example by gripping handle 114, and removes the penetrating implement from within the lumen 103 of the sheath. In one embodiment, a reference scale 109 is provided on the outer surface 106 of the sheath body, to aid the surgeon in positioning the sheath 100 to a selected depth within the patient's body 111.

Once the sheath 100 is positioned at a selected location within the patient's body 111 , as illustrated in Figure 3, the balloon 102 is inflated until it frictionally engages surrounding tissue in the patient's body, thereby securing the sheath 100 in a desired position. It will be understood that the external inflatable member may take various forms. For example, the sheath may be secured within the patient's body via a single balloon 102 provided around a circumference of the outer surface of the sheath body 101 , or the sheath 100 may be provided with a plurality of balloons provided at selected locations around a circumference of the body of the sheath. For example, as illustrated in Figure 4, two pairs of balloons 115, 116 are spaced radially and longitudinally along a length of the body 101 of the sheath 100, such that both longitudinal and rotational motion of the sheath is restricted. It will be understood that while various numbers and positions of balloons have been illustrated in the figures, these are merely examples, and any number of balloons may be provided at any desired locations along an outer surface of the sheath.

Additionally or alternatively, as illustrated in Figures 2 and 3, the surgical sheath 100 is provided with an internal inflatable member 110, positioned in the lumen 103 of the sheath, in accordance with another embodiment of the present invention. The internal inflatable member 110 is coupleable to a source of fluid 107 via a passageway 112 provided in the sidewall 108 of the sheath. It will be understood that any desired number of passageways and one or more sources of fluid may be used to selectively provide fluid, for example air or liquid, to all external and internal inflatable members provided on the sheath. The arrangement of passageways illustrated in the drawings is merely for illustrative purposes.

By providing one or more internal inflatable members 110, a device, such as a light source 113, may be secured within the sheath 100, as best seen in Figure 3. More particularly, once the sheath 100 is positioned at a desired location within a patient's body 111 , and secured in place by inflating balloon 102, the device 113 is positioned within the sheath at a desired location. The internal balloon 110 is then inflated, until it frictionally engages an outer surface of the device 113, thereby securing the device 113 in the selected location. Again, while Figure 3 illustrates the use of a single balloon 110 surrounding an internal circumference of the lumen 103, a pair of opposing balloons may be used, or a plurality of balloons may be used at desired locations within the lumen 103 of the sheath 100. In one embodiment, a "Touhy-Borst" fitting as is known in the art may be coupled to the sheath to further secure the device within the sheath.

While any device may be secured within a patient's body in accordance with the present invention, in one embodiment, a light bar, for example, for use in photodynamic therapy, is secured within the position-stabilized sheath 100. By securing the device, such as the light bar, in a selected location via internal balloon 110, photoreactive treatment may commence with greater assurance that diseased cells will receive the targeted light energy, as desired. All of the above U.S. patents, U.S. patent application publications,

U.S. patent applications, foreign patents, foreign patent applications and non- patent publications referred to in this specification and/or listed in the Application Data Sheet, are incorporated herein by reference, in their entirety.

From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.

Claims

1. A surgical sheath comprising: a body having a lumen extending therethrough along a longitudinal axis of the body; and an external inflatable member provided on an outer surface of the body and being coupleable to a source of fluid, the external inflatable member being selectively inflatable and deflatable.

2. The surgical sheath according to claim 1 wherein a plurality of external inflatable members are provided at selected locations around a circumference of the body of the sheath.

3. The surgical sheath according to claim 2 wherein the plurality of external inflatable members are spaced radially and longitudinally on the outer surface of the body of the sheath.

4. The surgical sheath according to claim 1 , further comprising: an internal inflatable member provided in the lumen of the body of the sheath, the internal inflatable member being coupleable to the source of fluid and being selectively inflatable and deflatable.

5. The surgical sheath according to claim 4, further comprising: a passageway provided in the body of the sheath to provide fluid communication between the source of fluid and the external and internal inflatable members.

6. The surgical sheath according to claim 1 , further comprising: a reference scale provided on the outer surface of the body of the sheath.

7. The surgical sheath according to claim 1 , further comprising: a handle coupled to the body of the sheath.

8. A surgical sheath comprising: a body having a lumen extending therethrough along a longitudinal axis of the body; and an internal inflatable member provided in the lumen and being coupleable to a source of fluid, the internal inflatable member being selectively inflatable and deflatable.

9. The surgical sheath according to claim 8 wherein a plurality of internal inflatable members are provided at selected locations within the lumen.

10. The surgical sheath according to claim 9 wherein the plurality of internal inflatable members are spaced radially and longitudinally along the lumen.

11. The surgical sheath according to claim 8, further comprising: a passageway provided in the body of the sheath to provide fluid communication between the source of fluid and the internal inflatable member.

12. A method for securing a sheath in a patient's body comprising: inserting a sheath into the body of a patient; and inflating a balloon provided on an outer surface of the sheath until the balloon frictionally engages surrounding tissue.

13. The method according to claim 12, further comprising: reading a reference scale provided on the outer surface of the sheath to insert the sheath to a desired depth.

14. A method for securing a device in a patient's body comprising: inserting a sheath into the body of the patient; inserting a device into the sheath; and inflating a balloon provided on an inner surface of the sheath until the balloon frictionally engages the device.

15. The method according to claim 14, further comprising: inflating an external balloon provided on an outer surface of the sheath until the external balloon frictionally engages surrounding tissue.

16. The method according to claim 14 wherein the device is a light source.