METHOD AND DEVICE FOR INSERTING AT LEAST ONE MEDICAL COMPONENT WITHIN THE BODY

Abstract

The dilator catheter accepts at least one or more medical components such as electrically conductive leads, wires, or catheter for a medical device and/or procedure. The dilator catheter provides an inner sleeve and an outer sleeve. The inner sleeve inserts into an opening of the outer sleeve. The opening of the outer sleeve is sized such that the inner sleeve will contact the outer sleeve to secure the inner sleeve within the outer sleeve. The inner sleeve and the outer sleeve provide an opening that extends throughout the dilator catheter. The user places the distal end of the dilator catheter at the desired location for introducing the medical component. The user then removes the inner sleeve to enlarge the opening. The user then directs the medical component(s) through the opening to the distal end of the dilator catheter for proper placement of the medical component(s).

Claims

1. A dilator catheter device for inserting at least one or more medical components into a patient wherein the medical component passes longitudinally through the dilator catheter device, the device comprising: an outer sleeve having a proximal end and a distal end; an opening in the outer sleeve extending longitudinally from the proximal end to the distal end; an inner sleeve inserted into the opening of the outer sleeve, the inner sleeve having a proximal end and a distal end, the inner sleeve having a greater length than the outer sleeve, wherein the inner sleeve protrudes longitudinally outward from the distal end of the outer sleeve and the inner sleeve protrudes longitudinally outward from the proximal end of the outer sleeve; an opening in the inner sleeve extending longitudinally from the proximal end to the distal end.

2. The device of claim 1 wherein a cross section of the opening of the inner sleeve along the longitudinal axis is smaller than a cross section of the opening of the outer sleeve along the longitudinal axis.

3. The device of claim 1 further comprising: a flared end of the inner sleeve located at the proximal end wherein the flared end is sized not to pass through the opening of the outer sleeve.

4. The device of claim 3 further comprising: a tapered end of the inner sleeve located at the distal end.

5. The device of claim 4 wherein the inner sleeve is removable from the outer sleeve.

6. The device of claim 5 wherein the flared end of the inner sleeve is sized not to pass completely through the opening of the outer sleeve.

7. The device of claim 1 wherein the inner sleeve is flexible.

8. The device of claim 7 wherein the outer sleeve is flexible.

9. The device of claim 1 wherein the opening of the outer sleeve is sized to accept the insertion of at least two electrically conductive leads longitudinally through the opening of the outer sleeve from the proximal end to the distal end.

10. The device of claim 1 wherein the proximal end of the inner sleeve increases in size to limit passage of the inner sleeve through the outer sleeve.

11. A dilator catheter device for inserting at least one or more medical components into a patient wherein the component passes longitudinally through the dilator catheter device, the device comprising: an outer sleeve having a proximal end and a distal end; an opening in the outer sleeve extending longitudinally from the proximal end to the distal end; an inner sleeve inserted into the opening of the outer sleeve, the inner sleeve having a proximal end and a distal end, the inner sleeve having a greater length than the outer sleeve, wherein the inner sleeve protrudes longitudinally outward from the distal end of the outer sleeve and the inner sleeve protrudes longitudinally outward from the proximal end of the outer sleeve, wherein the inner sleeve is removable from the outer sleeve; an opening in the inner sleeve extending longitudinally from the proximal end to the distal end.

12. The device of claim 11 wherein the proximal end of the inner sleeve increases in size to limit passage of the inner sleeve through the outer sleeve.

13. The device of claim 11 wherein a cross section of the opening of the inner sleeve along the longitudinal axis is smaller than a cross section of the opening of the outer sleeve along the longitudinal axis.

14. The device of claim 11 further comprising: a flared end of the inner sleeve located at the proximal end wherein the flared end is sized not to pass through the opening of the outer wall.

15. The device of claim 11 wherein the outer sleeve smoothly transitions to the inner sleeve.

16. The device of claim 1 wherein the inner sleeve is flexible and the outer sleeve is flexible.

17. The device of claim 11 wherein the opening of the outer sleeve is sized to accept the insertion of at least two electrically conductive leads through the outer sleeve from the proximal end to the distal end.

18. A method of inserting a medical component into a patient, the method comprising: inserting a guide wire into the patient; placing an opening at a distal end of a dilator catheter on the guide wire, wherein the dilator catheter has an inner sleeve and an outer sleeve, wherein the opening extends through both the inner sleeve and the outer sleeve; removing the guide wire through the outer sleeve; positioning the outer sleeve along the guide wire into a desired position in the patient; removing the inner sleeve from the dilator catheter; inserting the medical component into an opening extending from a proximal end of the outer sleeve to a distal end of the outer sleeve.

19. The method of claim 18 wherein a proximal end of the inner sleeve increases in size to limit passage of the inner sleeve through the outer sleeve wherein the proximal end of the inner sleeve provides an increased surface area for removing the inner sleeve from the outer sleeve.

20. The method of claim 18 wherein the opening in the outer sleeve extending from the proximal end of the outer sleeve to the distal end of the outer sleeve is large enough to accept insertion of at least two electrically conductive leads.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In the following drawings, which form a part of the specification and which are to be construed in conjunction therewith, and in which like reference numerals have been employed throughout wherever possible to indicate like parts in the various views:

[0027] FIG. 1 is a perspective view of one embodiment of the present invention;

[0028] FIG. 2 is a sectional view of an inner sleeve of one embodiment of the present invention;

[0029] FIG. 3 is a sectional view of an outer sleeve of one embodiment of the present invention;

[0030] FIG. 4 is a sectional view of an inner sleeve of one embodiment of the present invention;

[0031] FIG. 5 is a sectional view of an outer sleeve of one embodiment of the present invention;

[0032] FIG. 6 is an environmental view of one embodiment of the present invention;

[0033] FIG. 7 is an environment view thereof; and

[0034] FIG. 8 is an environmental view thereof.

DETAILED DESCRIPTION

[0035] FIG. 1 shows the dilator catheter 100 of the present invention. The dilator catheter 100 accepts at least one or more medical components, including but not limited to electrically conductive leads, catheter(s), or at least one or more wires, medicine, or fluid(s) for a medical device and/or procedure. The dilator catheter provides an inner sleeve 102 and an outer sleeve 104. The inner sleeve 102 inserts into the interior of the outer sleeve 104. The fit of the inner sleeve 102 within the outer sleeve 104 secures the inner sleeve 102 within the outer sleeve 104. The inner sleeve 102 and the outer sleeve 104 provide an opening 106 that extends throughout the dilator catheter 100. The opening 106 extends from the proximal end 96 of the dilator catheter to the distal end 98 of the dilator catheter.

[0036] The inner sleeve 102 provides a flared end 103. The flared end 103 is located on the proximal end of the dilator catheter 100. The proximal end of the inner sleeve 102 increases in size. The increased size of the proximal end of the inner sleeve 102 prevents inner sleeve 102 from passing through the opening of the outer sleeve. The increased size of the proximal end of the inner sleeve 102 provides an increased surface area for the user to grip the inner sleeve 102 for removal of the inner sleeve 102 from the outer sleeve 104. The flared end 103 protrudes outward from the outer sleeve 104 at the proximal end.

[0037] In one embodiment, the distal end 105 of the inner sleeve 102 narrows to a tapered distal end 105. This narrowed distal end 105, such as a tapered end, of the inner sleeve 102 extends beyond the distal end of the outer sleeve 104 such that the inner sleeve 102 protrudes outward from the outer sleeve 104 at the distal end.

[0038] The user places the distal end 98 of the dilator catheter 100 at the desired location within the patient. The user then removes inner sleeve 102 from the outer sleeve 104. Removing the inner sleeve 102 increases the size of the opening 106 to opening 110 of the outer sleeve 104.

[0039] The flared end 103 increases a surface area of the proximal end. The increased surface area increases the area for the user to grip and remove the inner sleeve from the outer sleeve. The user grips flared end 103 and pulls the inner sleeve 102 from the outer sleeve 104. The outer sleeve 104 remains in place at the desired location.

[0040] Removing the inner sleeve 102 from the dilator catheter increases the size of opening 106. With the inner sleeve 102 removed from the dilator catheter 100, the size of the opening 106 increases for passage of a medical component including, but not limited to one or more leads or wires or a catheter through the outer sleeve 104 and opening 106. The user then directs the leads through opening 106, 110 to the distal end 98 of the dilator catheter 100 for proper placement of the leads.

[0041] FIG. 2 shows the inner sleeve 102, the flared end 103, and the tapered distal end 105. Opening 108 extends longitudinally through the inner sleeve 102. The opening 108 is located centrally of the inner sleeve 102 and extends from the distal end 105 at the narrow tapered end to the proximal end at which the flared end 103 is located. The opening 108 of inner sleeve 102 is smaller in size than the opening 110 of the outer sleeve 104.

[0042] The distal end of the inner sleeve provides a tapered end. The tapered distal end assists with insertion of the inner sleeve into the outer sleeve. The tapered end also reduces contact with the outer sleeve to ease the process of removing the inner sleeve from the outer sleeve.

[0043] FIG. 3 shows the outer sleeve 104. Similar to the inner sleeve 102, the opening 110 extends longitudinally through the outer sleeve 104. The opening 110 is located centrally of the outer sleeve 104 and extends from the distal end 120 to the proximal end 118.

[0044] The inner sleeve 102 is located within the outer sleeve 104. Opening 110 of the outer sleeve 104 accepts the inner sleeve 102. The opening 106 extends from the proximal end 96 of the dilator catheter 100 to the distal end 98 of the dilator catheter 100 of both the inner sleeve 102 and the outer sleeve 104.

[0045] The inner sleeve 102 fits within opening 106 of the outer sleeve 104. Removing inner sleeve 102 from the dilator catheter 100 increases the size of the opening 106 through the outer sleeve 104. The dilator catheter 100 with inner sleeve 102 removed provides sufficient space for one or more leads, or one or more wires, or a catheter to pass through the opening 110 of the outer sleeve 104. In one embodiment, the opening is sized for insertion of two or more wires or leads.

[0046] FIG. 4 shows a cross section of the inner sleeve 102. The inner sleeve 102 encompasses the opening 108. Opening 108 extends from the proximal end to the distal end of the inner sleeve 102.

[0047] FIG. 5 shows a cross section of the outer sleeve 104. The outer sleeve 104 encompasses the opening 110. Opening 110 extends from the proximal end to the distal end of the outer sleeve 104. Opening 110 is larger than opening 108. Opening 110 accepts the inner sleeve 102 within outer sleeve 104. Inner sleeve 102 inserts into opening 110 of the outer sleeve 104.

[0048] The inner sleeve 102 is sized slightly smaller than the opening 110 of the outer sleeve 104. The inner sleeve 102 contacts the inner surface of the outer sleeve 104. The inner sleeve 102 frictionally engages the outer sleeve to secure the inner sleeve 102 within the outer sleeve 104. The inner sleeve 102 is sized small enough to allow removal of the inner sleeve 102 from the outer sleeve 104.

[0049] The user removes the inner sleeve 102 from the outer sleeve 104 to enlarge opening 106 to the size of the opening 110. The enlarged opening 110 accepts the one or more components, including, but not limited to, one or more leads, including two or more leads, one or more wires, or one or more catheters. The medical component(s), such as conductors, can then pass through opening 110 to the location at which the component(s) are to be applied. The component(s) pass through opening 110 from the proximal end through the distal end.

[0050] FIGS. 6-8 show use of the dilator catheter 100. The user inserts needle 200 into the epidural space 114 between the ligamentum flavum 112 and the dura 116. A guide wire 202 is then inserted through the needle 200 and into the epidural space 114. The user guides the distal end of the wire 202 to the desired location within the patient.

[0051] FIG. 7 shows the dilator catheter 100 inserted over the wire 202. The opening 106 of the dilator catheter 100 inserts over the wire 202. The user guides the distal end of the dilator catheter 100 to the desired location.

[0052] Once the dilator catheter 100 is placed in the proper position, the user removes the wire 202 and the inner sleeve 102. The outer sleeve 104 remains in position. The distal end of the outer sleeve 104 remains in the epidural space 114. Removing the inner sleeve 102 enlarges the opening of the dilator catheter 100 to accept the medical component which includes but is not limited at least one or more leads, such as two leads 122, at least one or more wires, or one or more catheters. The user then inserts the medical component, such as the one or more leads 122, the one or more wires, or the catheter into the opening 110 of the dilator catheter.

[0053] The outer surface of the dilator catheter provides a smooth outer surface. The outer sleeve and the inner sleeve provide a smooth transition along the dilator catheter. The tapered end of the inner sleeve narrows to a point for insertion into the patient.

[0054] While the device has been discussed as being implemented within the epidural space, the device may be implemented in other areas in which a medical component, including one or more leads, wires, or catheters may be required. The leads connect to a medical device, including but not limited to a spinal cord stimulation system, pacemaker, or other medical device that requires implantation of electrically conductive leads, including neurological modulators, pacemakers, defibrillators or other medical devices providing electrical current, rhythm management, resynchronization therapy or other cardiac therapy.

[0055] Another embodiment of the present invention provides ports on the outer sleeve. Such ports allow application of fluids, dyes, medicine, or material within the body to assist with procedures.

[0056] Further areas of applicability of the present invention will become apparent from the description provided hereinafter. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present teachings.

[0057] From the foregoing, it will be seen that the present invention is one well adapted to obtain all the ends and objects herein set forth, together with other advantages which are inherent to the structure.

[0058] It will be understood that certain features and sub-combinations are of utility and may be employed without reference to other features and sub-combinations. This is contemplated by and is within the scope of the claims.

[0059] As many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.