BIOPSY DEVICE CANNULA SEALS
20230011601 · 2023-01-12
Inventors
- John GIRGENTI (Marlborough, MA, US)
- Kenneth F. DEFREITAS (Marlborough, MA, US)
- Brent BURCHFIELD (Marlborough, MA, US)
- Justin GILLUM (Marlborough, MA, US)
Cpc classification
F16J15/322
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F16J15/3236
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
International classification
Abstract
A biopsy device includes an elongated housing having a manifold, an outer cannula partially and slidably disposed in the manifold, and an inner cannula partially and slidably disposed in a lumen of the outer cannula. The biopsy device further includes an outer cannula seal disposed between the manifold and the outer cannula, the outer cannula seal including an interference ring portion disposed adjacent an inner surface of the manifold, a beaded ring portion that contacts an outer surface of the outer cannula, and a flexible portion extending between the interference ring portion and the beaded ring portion.
Claims
1. A biopsy device, comprising: an elongated housing having a manifold; an outer cannula partially and slidably disposed in the manifold; an inner cannula partially and slidably disposed in a lumen of the outer cannula; and an outer cannula seal disposed between the manifold and the outer cannula, the outer cannula seal comprising an interference ring portion disposed adjacent an inner surface of the manifold, a beaded ring portion that contacts an outer surface of the outer cannula, and a flexible portion extending between the interference ring portion and the beaded ring portion.
2. The biopsy device of claim 1, wherein the outer cannula seal is configured to allow longitudinal movement of the outer cannula relative to the manifold while maintaining a fluid-tight seal therebetween.
3.-4. (canceled)
5. The biopsy device of claim 1, further comprising a manifold cap coupled to a distal end of the manifold, wherein the manifold cap and the manifold together define an annular space adjacent to the distal end of the manifold, and wherein the interference ring portion of the outer cannula seal is at least partially disposed in the annular space.
6. The biopsy device of claim 5, wherein the interference ring portion of the outer cannula seal forms an interference fit between the inner surface of the manifold and an inner surface of the manifold cap.
7. The biopsy device of claim 5, wherein the interference ring portion of the outer cannula seal defines a distally facing annular detent configured to engage a proximally facing annular lip of the manifold cap.
8. The biopsy device of claim 1, wherein the flexible portion of the outer cannula seal is biased to cause the beaded ring portion to apply a force against the outer surface of the outer cannula to create a fluid-tight seal between the beaded ring portion and the outer surface of the outer cannula.
9. The biopsy device of claim 1, wherein the flexible portion of the outer cannula seal is configured to allow the interference ring portion and beaded ring portion to move longitudinally relative to each other while maintaining a fluid-tight seal between the outer cannula and the manifold.
10.-11. (canceled)
12. A biopsy device, comprising: an elongated housing having a seal sleeve; an outer cannula; an outer cannula hub coupled to a proximal end of an outer cannula, the outer cannula hub being partially and slidably disposed in the seal sleeve; an inner cannula partially and slidably disposed in a lumen of the outer cannula; and an inner cannula seal disposed between the seal sleeve and the inner cannula, the inner cannula seal comprising an interference ring portion disposed adjacent an inner surface of the seal sleeve, a beaded ring portion that contacts an outer surface of the inner cannula, and a flexible portion extending between the interference ring portion and the beaded ring portion.
13. The biopsy device of claim 12, wherein the inner cannula seal is configured to allow longitudinal movement of the inner cannula relative to the seal sleeve while maintaining a fluid-tight seal therebetween.
14.-15. (canceled)
16. The biopsy device of claim 12, wherein a proximal end of the outer cannula hub defines an annular groove adjacent a distal end of the seal sleeve, and wherein the interference ring portion of the inner cannula seal is at least partially disposed in the annular groove.
17. The biopsy device of claim 16, wherein the interference ring portion of the inner cannula seal forms an interfere fit within the annular groove.
18. The biopsy device of claim 12, wherein the inner cannula seal further comprises a middle beaded ring portion extending from on an outer surface of the flexible portion.
19. The biopsy device of claim 12, wherein the flexible portion of the inner cannula seal is biased to cause the beaded ring portion to apply a force against the outer surface of the inner cannula to create a fluid-tight seal between the beaded ring portion and the outer surface of the inner cannula.
20. The biopsy device of claim 12, wherein the flexible portion of the inner cannula seal is configured to allow the interference ring portion and the beaded ring portion to move longitudinally relative to each other while maintaining a fluid-tight seal between the inner cannula and the seal sleeve.
21.-22. (canceled)
23. A biopsy device, comprising: an elongated housing comprising a saline return fitting; an outer cannula partially and slidably disposed in the elongated housing; an inner cannula, wherein the inner cannula is partially and slidably disposed in each of a lumen of the outer cannula and a lumen of the saline return fitting; and an inner cannula seal disposed between an inner wall of the saline return fitting and the inner cannula, the inner cannula seal comprising an interference ring portion disposed adjacent an inner surface of the saline return fitting, a beaded ring portion that contacts an outer surface of the inner cannula, and a flexible portion that extends between the interference ring portion and the beaded ring portion.
24. The biopsy device of claim 23, wherein the inner cannula seal is configured to allow longitudinal movement of the inner cannula relative to the saline return fitting while maintaining a fluid-tight seal therebetween.
25.-26. (canceled)
27. The biopsy device of claim 23, further comprising a saline return fitting cap coupled to a distal end of the saline return fitting, wherein a proximal end of the saline return fitting cap defines an annular groove adjacent the distal end of the saline return fitting, and wherein the interference ring portion of the inner cannula seal is at least partially disposed in the annular groove.
28. The biopsy device of claim 27, wherein the interference ring portion of the inner cannula seal is at least partially disposed in the annular groove.
29. The biopsy device of claim 23, wherein the inner cannula seal further comprises a middle beaded ring portion extending from an outer surface of the flexible portion.
30. The biopsy device of claim 23, wherein the flexible portion of the inner cannula seal is biased to cause the beaded ring portion to apply a force against the outer surface of the inner cannula to create a fluid-tight seal between the beaded ring portion and the outer surface of the inner cannula.
31. The biopsy device of claim 23, wherein the flexible portion of the inner cannula seal is configured to allow the interference ring portion and the beaded ring portion to move longitudinally relative to each other while maintaining a fluid-tight seal between the inner cannula and the saline return fitting.
32.-33. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The drawings illustrate the design and utility of embodiments of the disclosed inventions, in which similar elements are referred to by common reference numerals. These drawings are not necessarily drawn to scale. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the disclosed inventions and are not therefore to be considered limiting of its scope.
[0017]
[0018]
[0019]
[0020]
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0021] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
[0022] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
[0023] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
[0024] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
[0025] Various embodiments of the disclosed inventions are described hereinafter with reference to the figures. It should be noted that the figures are not drawn to scale. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. In addition, an illustrated embodiment of the disclosed inventions needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment of the disclosed inventions is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the disclosed inventions and are not therefore to be considered limiting of its scope.
[0026]
[0027] The needle set 10 includes a housing 12, an outer cannula 14, an inner cannula 16, a manifold 18, an outer cannula hub 20, an inner cannula hub 22, a seal sleeve 24, and a saline return fitting 26. The outer cannula 14 has a distal tissue piercing tip 28 and a tissue receiving opening (or “aperture”) 30 defined near its distal end adjacent the distal tissue piercing tip 28. The inner cannula 16 has an open distal end 32 surrounded by an annular cutting blade. The inner cannula 16 is partially and slidably disposed within the outer cannula 14 so that it can close the tissue receiving opening 30, as shown in
[0028] The outer cannula hub 20 is coupled to a proximal end of the outer cannula 14. The inner cannula hub 22 is coupled to the inner cannula 16 between a midpoint and a proximal end thereof. The outer and inner cannula hubs 20, 22 are configured to be operatively coupled to corresponding components of a reusable portion (not shown), to thereby facilitate movement of the outer and inner cannulas 14, 16. The seal sleeve 24 disposed in the needle set 10 between the outer and inner cannula hubs 20, 22 to fix the minimum distance therebetween. The seal sleeve 24 is coupled to the outer cannula hub 20 and interferes with the inner cannula hub 22 (by way of a component on the reusable portion of the biopsy device to which the disposable needle set 10 is attached) to establish a lower limit on the distance between the outer and inner cannula hubs 20, 22. As such, the seal sleeve 24 also fixes the minimum distance between the respective distal ends of the outer and inner cannulas 14, 16. The saline return fitting 26 is configured to house a proximal end of the inner cannula 16 and to couple to and external vacuum source (not shown) for aspiration of severed tissue from the lumen of the inner cannula 16.
[0029] As described above, the inner cannula 16 is partially, slidably and coaxially disposed in the lumen of the outer cannula 14. The outer cannula 14 (and the inner cannula 16 disposed therein) are also partially and slidably disposed in the manifold 18 in the housing 12. When the outer cannula 14 slides longitudinally relative to the housing 12, it also slides longitudinally relative to the manifold 18, which is coupled to the housing 12. Because fluid passes through the manifold 18 to the respective lumens of the outer and inner cannulas 14, 16, the junction between the outer cannula 14 and the manifold 18 must be sealed/fluid-tight to prevent fluid leakage during operation of the needle set 10, which includes the outer cannula 14 sliding longitudinally relative to the manifold 18. One such fluidically active joint between the outer cannula 14 and the manifold 18 is labeled “D” in
[0030] As shown in
[0031] As shown in
[0032] The distal end of the manifold 18 includes a manifold cap 34 at a distal end thereof. During assembly, the distal end of the manifold 18 and the manifold cap 34 may be permanently coupled by laser and/or ultrasonic welding of the manifold cap 34 onto the distal end of the manifold 18 to permanently couple the outer cannula seal 100 to the distal end of the manifold 18. The distal end of the manifold 18 and the manifold cap 34 together define an annular space 36 adjacent the distal end of the manifold 18. As shown in
[0033] As shown in
[0034] The flexible portion/bellows feature 116 is configured to deform (e.g., bend, straighten and/or stretch) to thereby allow longitudinal movement of the outer cannula 14 relative to the manifold 18 while maintaining a fluid-tight seal between those two components. The material from which the outer cannula seal 100 is formed (e.g. EPDM) facilitates the deformation of the flexible portion/bellows feature 116 with relative movement of the outer cannula 14 and the manifold 18. Accordingly, the outer cannula 14 can move longitudinally relative to the manifold 18 a predetermined distance without requiring movement between the beaded ring portion 112 and the outer cannula 14.
[0035] The interference fit between the interference ring portion 110 and the distal end of the manifold 18, the frictional fit between the beaded ring portion 112 and the outer cannula 14, and the deformation of the flexible portion/bellows feature 116 combined to form a fluid-tight seal between the outer cannula 14 and the distal end of the manifold 18. Accordingly, the outer cannula seal 100 allows longitudinal movement of the outer cannula relative to the manifold while maintaining a fluid-tight seal between the outer cannula and the distal end of the manifold.
[0036] A fluidically active joint between the inner cannula 16 and the seal sleeve 24 is labeled “E” in
[0037] As shown in
[0038] The proximal end of the outer cannula hub 20 is disposed in the open distal end of the seal sleeve 24. The proximal end of the outer cannula hub 20 defines an annular groove 40 adjacent the distal end of the seal sleeve 24. As shown in
[0039] As shown in
[0040] The flexible portion/bellows feature 214 is configured to deform (e.g., bend, straighten and/or stretch) to thereby allow longitudinal movement of the inner cannula 16 relative to the seal sleeve 24 while maintaining a fluid-tight seal between those two components. The material from which the inner cannula seal 200 is formed (e.g. EPDM) facilitates the deformation of the flexible portion/bellows feature 214 with relative movement of the inner cannula 16 and the seal sleeve 24. Accordingly, the inner cannula 16 can move longitudinally relative to the seal sleeve 24 a predetermined distance without requiring movement between the beaded ring portion 212 and the inner cannula 16.
[0041] The interference fit between the interference ring portion 210 and the seal sleeve 24, the frictional fit between the beaded ring portion 212 and the inner cannula 16, and the deformation of the flexible portion/bellows feature 214 combined to form a fluid-tight seal between the inner cannula 16 and the seal sleeve 24. Accordingly, the inner cannula seal 200 allows longitudinal movement of the inner cannula 16 relative to the seal sleeve 24 while maintaining a fluid-tight seal between the inner cannula 16 and the seal sleeve 24.
[0042] A fluidically active joint between the inner cannula 16 and the saline return fitting 26 is labeled “F” in
[0043] The interference ring portion 210 on the inner cannula seal 200′ is configured to be captured by the saline return fitting 26 (as described below) to form an interference fit/seal therewith. The saline return fitting 26 includes a saline return fitting cap 42 at a distal end thereof. The proximal end of the saline return fitting cap 42 defines an annular groove 40′ adjacent the distal end of the saline return fitting 26. As shown in
[0044] Similar to the inner cannula seal 200 depicted in
[0045] The fluidically active joints described above are configured to eliminate leakage by using high compliance seals and increased interference with the cannulas. Further, these seals reduce the frictional drag on the outer and/or inner cannulas which can improve firing speed and reduce cannula reciprocation forces. While fluidically active joints have been described between various components of the needle set 10, the needle set includes other fluidically active joints (e.g., between the outer cannula 14 and a proximal end of the manifold 18, as shown at “G” in
[0046] Although particular embodiments of the disclosed inventions have been shown and described, it is to be understood that the above description is provided for purposes of explanation and illustration only. Thus, various changes and modifications may be made without departing from the scope of the disclosed inventions. For example, not all of the components depicted and described in the disclosed embodiments are necessary, and various additional embodiments of the disclosed inventions may include any suitable combinations of the described components, and the general shapes and relative sizes of the components may be modified. While the systems and methods have been described with reference to needle sets for biopsy devices, embodiments can also be configured and utilized with any types of devices with fluidically active joints between components. Further, as will be appreciated by those with skill in the art that each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present inventions. Accordingly, embodiments are intended to exemplify alternatives, modifications, and equivalents that may fall within the scope of the claims.